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Are Medical Stocks Lagging Adicet Bio (ACET) This Year?
Zacks Investment Research· 2024-01-09 23:04
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Adicet Bio, Inc. (ACET) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Adicet Bio, Inc. is a member of the Medical sector. This group includes 1077 ind ...
Adicet Provides Corporate Update and Highlights Strategic Priorities for 2024
Businesswire· 2024-01-04 12:00
REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and autoimmune diseases, today provided corporate updates and highlighted upcoming priorities for its pipeline programs in 2024. “In 2024, we aim to make significant strides across our pipeline of differentiated gamma delta T cell therapies through our strategic and disciplined approach,” said Chen Schor, Pres ...
Adicet Bio to Host Conference Call to Provide Updates on its Clinical Pipeline and Corporate Outlook
Businesswire· 2024-01-03 21:01
REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced that the Company will host a conference call and webcast presentation on Thursday, January 4, 2024 at 8:00am ET to provide an update on its clinical pipeline and corporate outlook. Conference Call and Webcast Event The live webcast of the presentation can be accessed by registering under “Prese ...
Adicet Bio Reports Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
Businesswire· 2023-12-29 21:50
REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced it granted an inducement award on December 29, 2023. One individual was hired by Adicet in December 2023 and granted new hire non-qualified stock options to purchase 84,000 shares of Adicet’s common stock with an exercise price of $1.89 per share, the closing price of Adicet’s common stock as re ...
Adicet Bio(ACET) - 2023 Q3 - Quarterly Report
2023-11-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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: 001-38359 Adicet Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3305277 (State or other jurisdict ...
Adicet Bio(ACET) - 2023 Q2 - Quarterly Report
2023-08-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 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: 001-38359 Adicet Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3305277 (State or other jurisdiction o ...
Adicet Bio(ACET) - 2023 Q1 - Quarterly Report
2023-05-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 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: 001-38359 Adicet Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3305277 (State or other jurisdiction ...
Adicet Bio (ACET) Investor Presentation - Slideshow
2023-03-29 12:44
Leaders in Developing Allogeneic CAR and CAd γδ Cell Therapies to Fight Cancer Forward-Looking Statements This presentation contains "forward-looking statements" of Adicet Bio, Inc. (Adicet) within the meaning of the Private Securities Litigation Reform Act of 1995 relating to business and operations of Adicet. These forward-looking statements include, but are not limited to, express or implied statements regarding the potential safety, durability, tolerability and efficacy of ADI-001; the expected progress ...
Adicet Bio(ACET) - 2022 Q4 - Annual Report
2023-03-14 16:00
Part I [Business](index=7&type=section&id=Item%201.%20Business) Adicet Bio is a clinical-stage biotech developing allogeneic gamma delta T cell therapies for cancer, with lead candidate ADI-001 [Overview and Pipeline](index=7&type=section&id=Overview%20and%20Pipeline) Adicet Bio's pipeline includes lead candidate ADI-001 in Phase 1 for NHL, preclinical ADI-925, and licensed ADI-002 - The company is a clinical-stage biotechnology firm focused on developing "off-the-shelf" allogeneic gamma delta T cell therapies for cancer[16](index=16&type=chunk) - Lead product candidate ADI-001 is a first-in-class allogeneic gamma delta T cell therapy targeting CD20, currently in a Phase 1 study for relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL)[18](index=18&type=chunk)[19](index=19&type=chunk) - The pipeline includes ADI-925, a novel engineered CAd gamma delta T cell product candidate, with an IND application planned for the second half of **2023**[23](index=23&type=chunk) - Regeneron has exercised its option to license the exclusive worldwide rights to ADI-002, a gamma delta CAR T-cell therapy for solid tumors. Regeneron is now responsible for all development, manufacturing, and commercialization[23](index=23&type=chunk)[70](index=70&type=chunk) [Strategy and Technology](index=9&type=section&id=Strategy%20and%20Technology) Strategy focuses on advancing ADI-001 and leveraging its Vδ1 gamma delta T cell platform for 'off-the-shelf' therapies - Key strategic elements include advancing ADI-001, innovating the gamma delta T cell platform, exploring outpatient administration, and expanding intellectual property[25](index=25&type=chunk) - The company's Vδ1 gamma delta T cell platform is designed to overcome limitations of autologous alpha beta T cell therapies, such as treatment delays, manufacturing variability, and high costs[33](index=33&type=chunk)[37](index=37&type=chunk) - Key advantages of gamma delta T cells include lack of GvHD, MHC-independent tumor recognition, inherent tumor localization, and potential for re-dosing, making them suitable for an allogeneic, "off-the-shelf" approach[36](index=36&type=chunk) - The company's proprietary manufacturing process involves isolating peripheral blood cells from unrelated donors, activating Vδ1 gamma delta T cells, transducing them with CAR or CAd constructs, and expanding them over **6,000**-fold at clinical scale[49](index=49&type=chunk)[51](index=51&type=chunk) [ADI-001 Clinical Program](index=14&type=section&id=ADI-001%20Clinical%20Program) ADI-001, an allogeneic anti-CD20 CAR gamma delta T cell therapy, showed promising Phase 1 efficacy and safety in NHL ADI-001 Phase 1 Interim Efficacy Results (as of Dec 5, 2022) | Metric | Result | | :--- | :--- | | Overall Response Rate (ORR) | **75% overall response rate (ORR)** (across all dose levels) | | Complete Response (CR) Rate | **69% complete response (CR) rate** (across all dose levels) | | ORR & CR in post-CAR T LBCL patients | **100% (5/5)** | | CR Rate in LBCL patients (DL3 and above) | **86% (6/7)** | - ADI-001 has been generally well-tolerated, with no occurrences of dose-limiting toxicities, Graft versus Host Disease (GvHD), or Grade **3** or higher Cytokine Release Syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS)[64](index=64&type=chunk) - The company plans to discuss a potential pivotal study path with the FDA in Q**2** **2023** and intends to initiate a study in post-CAR T large B-cell lymphoma (LBCL) patients in the second half of **2023**[19](index=19&type=chunk) [Manufacturing, IP, and Competition](index=18&type=section&id=Manufacturing%2C%20IP%2C%20and%20Competition) The company is developing internal GMP manufacturing, holds IP, and faces intense competition in cell therapy - The company relies on third-party CDMOs for manufacturing but is also establishing internal GMP cell processing and vector manufacturing operations at its Redwood City, CA facility[88](index=88&type=chunk)[89](index=89&type=chunk) - The patent portfolio for ADI-001 includes applications which, if issued, would expire in **2039**, with additional methods of treatment applications potentially extending to **2042**[77](index=77&type=chunk) - The patent portfolio for ADI-925 includes applications which, if issued, would expire between **2042** and **2043**[77](index=77&type=chunk) - The company faces competition from numerous companies in the allogeneic T-cell therapy space (e.g., Allogene, Caribou, Fate) and autologous T-cell therapy space (e.g., Gilead, Bristol-Myers Squibb, Novartis)[94](index=94&type=chunk) [Government Regulation](index=22&type=section&id=Government%20Regulation) The company's biologics are subject to extensive FDA and international regulations, including BLA and healthcare laws - The company's cell therapy products are regulated as biologics and require submission and approval of a Biologics License Application (BLA) from the FDA before marketing[101](index=101&type=chunk) - The FDA provides expedited development programs for serious conditions, including Fast Track, Priority Review, Accelerated Approval, and Regenerative Medicine Advanced Therapy (RMAT) designation, which the company may pursue[126](index=126&type=chunk)[131](index=131&type=chunk) - The company's operations are subject to various U.S. healthcare laws, including the federal Anti-Kickback Statute, the False Claims Act, HIPAA, and the Physician Payments Sunshine Act[144](index=144&type=chunk)[145](index=145&type=chunk)[148](index=148&type=chunk)[154](index=154&type=chunk) - Recent healthcare reform, such as the Inflation Reduction Act of **2022** (IRA), may impact the business through provisions allowing government price negotiation for Medicare drugs and imposing rebates for price increases faster than inflation[165](index=165&type=chunk)[166](index=166&type=chunk) - International operations are subject to foreign regulations, including the EU's Clinical Trials Regulation and the General Data Protection Regulation (GDPR), which imposes stringent requirements for processing personal data[180](index=180&type=chunk)[186](index=186&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from limited operating history, net losses, ADI-001 dependency, and regulatory challenges - The business is highly dependent on the success of its lead product candidate, ADI-001. Any failure or delay in its development or commercialization would significantly harm the company[209](index=209&type=chunk)[211](index=211&type=chunk) - The company's gamma delta T cell candidates represent a novel approach, making it difficult to predict development time, cost, and the likelihood of regulatory approval[212](index=212&type=chunk)[215](index=215&type=chunk) - The company has a history of net losses (**$69.8 million** in **2022**) and expects to incur substantial losses in the future, which could raise doubts about its ability to continue as a going concern without additional financing[204](index=204&type=chunk)[207](index=207&type=chunk) - Reliance on third-party suppliers and manufacturers increases the risk of not having sufficient quantities of product candidates at an acceptable cost, which could impair development and commercialization[250](index=250&type=chunk) - Termination of or material breach by Regeneron of the collaboration agreement would materially harm the company's business, prospects, and financial condition[313](index=313&type=chunk) - Unstable market and economic conditions, including rising inflation and interest rates, could adversely affect the company's business, financial condition, and ability to raise capital[433](index=433&type=chunk)[437](index=437&type=chunk) [Unresolved Staff Comments](index=92&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - Not applicable[465](index=465&type=chunk) [Properties](index=92&type=section&id=Item%202.%20Properties) The company leases executive offices in Boston and significant office/lab space, including GMP facilities, in Redwood City - The company leases office and laboratory space in Boston, MA (lease expires July **2023**) and Redwood City, CA (leases expire Feb **2030** and June **2025**)[465](index=465&type=chunk) [Legal Proceedings](index=92&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[466](index=466&type=chunk) [Mine Safety Disclosures](index=92&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[466](index=466&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=93&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'ACET' and does not anticipate paying cash dividends - The company's common stock trades on The Nasdaq Global Market under the symbol "ACET"[468](index=468&type=chunk) - The company has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future[469](index=469&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=94&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's **2022** financials show increased revenue, higher expenses, a net loss, and cash for operations into H**1** **2025** [Results of Operations](index=99&type=section&id=Results%20of%20Operations) In **2022**, revenue surged from a Regeneron payment, while R&D and G&A expenses increased, leading to a wider net loss Comparison of Operations (Years Ended Dec 31) | Financial Metric | 2022 ($) | 2021 ($) | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | **$24.99M** | **$9.73M** | **157%** | | Research & Development | **$71.25M** | **$48.94M** | **46%** | | General & Administrative | **$26.30M** | **$22.22M** | **18%** | | Total Operating Expenses | **$97.54M** | **$71.16M** | **37%** | | Net Loss | **($69.79M)** | **($62.00M)** | **13%** | - The **$15.3 million** increase in revenue was primarily due to the **$20.0 million** payment received from Regeneron for the exercise of its option related to ADI-002[497](index=497&type=chunk) - R&D expenses increased by **$22.3 million**, mainly from a **$9.9 million** increase in payroll due to higher headcount, a **$4.4 million** increase in CDMO/CRO costs for ADI-001, and a **$4.2 million** increase in facility expenses[499](index=499&type=chunk) [Liquidity and Capital Resources](index=100&type=section&id=Liquidity%20and%20Capital%20Resources) As of December **31**, **2022**, the company held **$257.7 million** in cash, expected to fund operations into H**1** **2025** - As of December **31**, **2022**, the company had cash and cash equivalents of **$257.7 million**[508](index=508&type=chunk) - Management expects current cash and cash equivalents to be sufficient to fund operations into the first half of **2025**[261](index=261&type=chunk)[508](index=508&type=chunk) - In August **2022**, the company sold **2,611,723** shares of common stock through its ATM program, resulting in net proceeds of approximately **$43.4 million**[507](index=507&type=chunk) Summary Statement of Cash Flows (Years Ended Dec 31) | Cash Flow Activity | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Net cash used in Operating | **($44.77M)** | **($51.05M)** | | Net cash used in Investing | **($16.78M)** | **($2.80M)** | | Net cash provided by Financing | **$41.51M** | **$242.69M** | [Quantitative and Qualitative Disclosures About Market Risk](index=105&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on cash, but a **10%** change is not expected to be material - The company's primary market risk is interest rate risk on its **$257.7 million** of cash and cash equivalents, but an immediate **10%** change in rates is not expected to have a material impact[538](index=538&type=chunk) - Foreign currency exchange risk and inflation risk were not considered to have a material effect on the business during **2022** and **2021**[539](index=539&type=chunk)[540](index=540&type=chunk) [Financial Statements and Supplementary Data](index=105&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section incorporates by reference the company's consolidated financial statements and supplementary data from Part IV - All required financial statements and supplementary data are filed under Item **15**(a) of the Annual Report on Form **10**-K[541](index=541&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=105&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[541](index=541&type=chunk) [Controls and Procedures](index=105&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December **31**, **2022** - Management concluded that the company's disclosure controls and procedures were effective as of December **31**, **2022**[542](index=542&type=chunk) - Management assessed internal control over financial reporting and concluded it was effective as of December **31**, **2022**, based on the COSO framework[546](index=546&type=chunk) - No material changes in internal control over financial reporting occurred during the year ended December **31**, **2022**[548](index=548&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=107&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the **2023** Proxy Statement - The required information for this item is incorporated by reference from the company's **2023** Proxy Statement[551](index=551&type=chunk) [Executive Compensation](index=107&type=section&id=Item%2011.%20Executive%20Compensation) Information on executive compensation is incorporated by reference from the **2023** Proxy Statement - The required information for this item is incorporated by reference from the company's **2023** Proxy Statement[553](index=553&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=107&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership and equity compensation plans is incorporated by reference from the **2023** Proxy Statement - The required information for this item is incorporated by reference from the company's **2023** Proxy Statement[553](index=553&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=107&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on certain relationships, related transactions, and director independence is incorporated by reference from the **2023** Proxy Statement - The required information for this item is incorporated by reference from the company's **2023** Proxy Statement[554](index=554&type=chunk) [Principal Accountant Fees and Services](index=107&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information on principal accountant fees and services is incorporated by reference from the **2023** Proxy Statement - The company's independent public accounting firm is KPMG LLP. Information on fees and services is incorporated by reference from the **2023** Proxy Statement[555](index=555&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=108&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section includes consolidated financial statements, the independent auditor's report, and an index of all filed exhibits - This section includes the Report of Independent Registered Public Accounting Firm and the Consolidated Financial Statements for the years ended December **31**, **2022** and **2021**[557](index=557&type=chunk) - An index of all exhibits filed as part of the Annual Report is provided[558](index=558&type=chunk) Financial Statements [Consolidated Financial Statements](index=111&type=section&id=Consolidated%20Financial%20Statements) In **2022**, Adicet Bio reported **$330.7M** total assets, **$25.0M** revenue, **$69.8M** net loss, and **$257.7M** cash Consolidated Balance Sheet Data (as of Dec 31) | Account | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | **$257.7M** | **$277.5M** | | Total Assets | **$330.7M** | **$338.9M** | | Total Liabilities | **$38.4M** | **$35.8M** | | Total Stockholders' Equity | **$292.3M** | **$303.1M** | Consolidated Statement of Operations Data (Year Ended Dec 31) | Account | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Revenue | **$25.0M** | **$9.7M** | | Total Operating Expenses | **$97.5M** | **$71.2M** | | Loss from Operations | **($72.6M)** | **($61.4M)** | | Net Loss | **($69.8M)** | **($62.0M)** | | Net Loss Per Share | **($1.70)** | **($2.00)** | Consolidated Statement of Cash Flows Data (Year Ended Dec 31) | Activity | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | **($44.8M)** | **($51.1M)** | | Net cash used in investing activities | **($16.8M)** | **($2.8M)** | | Net cash provided by financing activities | **$41.5M** | **$242.7M** | [Notes to Consolidated Financial Statements](index=115&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, liquidity, Regeneron revenue, operating leases, stock compensation, and federal net operating loss carryforwards - The company has an accumulated deficit of **$238.1 million** as of December **31**, **2022**, but expects its cash and cash equivalents to be sufficient to fund operations for at least the next twelve months[582](index=582&type=chunk)[586](index=586&type=chunk) - All revenue for **2022** and **2021** was generated from the License and Collaboration Agreement with Regeneron. The company's performance obligations under this agreement were completed in the first quarter of **2022**[607](index=607&type=chunk)[649](index=649&type=chunk) - As of December **31**, **2022**, the company had federal net operating loss carryforwards of approximately **$271.2 million**, of which **$263.6 million** can be carried forward indefinitely[709](index=709&type=chunk) - In August **2022**, the company sold **2,611,723** shares of common stock under its ATM offering, raising net proceeds of **$43.4 million**[585](index=585&type=chunk)[715](index=715&type=chunk)
Adicet Bio(ACET) - 2022 Q3 - Quarterly Report
2022-11-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 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 No. 001-38359 Adicet Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3305277 (State or other jurisdiction ...