Adicet Bio Inc

Announcement: ACET 8-K Special Filing

Performance Analysis:

Adicet Bio, Inc. is a clinical stage biotechnology company that is focused on discovering and developing allogeneic gamma delta T cell therapies for cancer. According to the company's Management's Discussion and Analysis of Financial Condition and Results of Operations, as of December 31, 2022, the company had a net loss of $87.8 million for 2022, compared to a net loss of $55.1 million for 2021.

During the period, Adicet Bio, Inc. reported significant progress in its lead product candidate, ADI-001, a first-in-class allogeneic gamma delta T cell therapy, which is in an ongoing Phase 1 study for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. In April 2022, ADI-001 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for NHL, and in December 2022, interim results from the trial were presented at the American Society of Hematology (ASH) annual meeting.

The company also reported that it entered into a Capital On Demand™ Sales Agreement with JonesTrading Institutional Services LLC to provide for the offering, issuance, and sale of its common stock from time to time in “at-the-market” offerings (ATM Program) and sold an aggregate of 2,611,723 shares of common stock at $17.23 per share resulting in net proceeds to us of $43.4 million after deducting sales agent commissions and expenses. The New Prospectus covered the offer and sale of up to $100.0 million of shares of its common stock from time to time through Sales Agent, acting as their sales agent, under the ATM Program, which includes the $30.0 million of shares of their common stock not sold pursuant to the existing prospectus and up to an additional $70.0 million of shares of their common stock.

Forward-looking Analysis:

Adicet Bio, Inc. has a promising pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and chimeric adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. The company also has several additional internal gamma delta T cell therapy programs in discovery and preclinical development for both hematological malignancies and solid tumors.

Furthermore, the company is expected to provide an additional clinical update for the ADI-001 Phase 1 study in the second quarter of 2023. Subject to further patient follow-up, Adicet Bio, Inc. plans to discuss a path forward for a potential pivotal program for ADI-001 with the FDA during the second quarter of 2023, and later with the EMA. The company also intends to initiate a first potential pivotal study in post-CAR T large B-cell lymphoma (LBCL) patients in the fourth quarter of 2023.

It is worth noting that the biotechnology industry is extremely competitive and subject to rapid technological change. It is also subject to stringent regulatory requirements that can impact the development and commercialization of products. Any delay in the development of products or regulatory approval, or the inability to secure necessary funding could adversely affect the company's operations. Investors should also closely monitor the ongoing clinical trials and regulatory developments related to ADI-001 and other product candidates to assess the potential risks and opportunities associated with the company.

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Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Adicet Bio Reports Progress on Cancer Therapy: Performance Analysis

Adicet Bio, Inc. (NASDAQ: ACET), a clinical-stage biotech company developing allogeneic gamma delta T-cell therapies for cancer, has reported its financial results for the first quarter ending March 31, 2023. The company reported $231.6 million in cash, cash equivalents, and investments on its balance sheet, sufficient to fund its operating expenses until the first half of 2025. The company reported an increase in payroll and lab expenses primarily due to increased headcount and clinical trial execution, along with a decrease in professional fees. 

Adicet Bio also presented operational highlights that included progress in its allogenic gamma delta T-cell therapy development programs, specifically the engineered armored allogeneic gamma delta T cell therapy ADI-270 with preclinical proof-of-concept data; and novel CAd gamma delta T cell product candidate ADI-925 with a plan to submit an Investigational New Drug Application (IND) in the second half of 2023. Additionally, the company plans to discuss with the FDA the path forward for a potential pivotal study for ADI-001 in post-CAR T large B-cell lymphoma patients and initiate this study in the fourth quarter of 2023.

Overall, Adicet Bio remains on track to report additional data on efficacy, safety, durability and provide a regulatory update on its pivotal program, ADI-001 in Q2 2023. Although no concrete financial data on revenue or profits was reported, the progress made by Adicet Bio in developing and advancing its allogenic gamma delta T-cell therapy pipeline programs is certainly encouraging. Investors should continue to monitor the company's progress, including its discussions with the FDA in Q2 2023 and its plans to initiate a potential pivotal study in the fourth quarter of 2023.

Form 8-K - Current report - Item 2.02 Item 9.01

$ACET Reports Strong Operational Highlights for Q1 2023, Progress in Allogenic Gamma Delta T-Cell Therapy Development Programs.

Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405]

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Announcement: ACET 10-K Annual Report

Analyst Summary:
Adicet Bio, a clinical stage biotechnology company pioneering gamma delta T cell therapies for cancer, reported its financial results for Q4 and the year ended December 31, 2022. The company demonstrated strong execution in advancing its gamma delta T cell therapy pipeline and clinical proof of concept. Chen Schor, President and CEO, highlighted that the company is enrolling patients for its ongoing trial for relapsed or refractory B-cell NHL, with efficacy, durability, and safety data expected to be reported in Q2 2023. Additionally, Adicet expects to submit an IND for ADI-925, its novel CAd gamma delta T cell product candidate in H2 2023. Adicet also presented preclinical data for its four new pipeline programs at SITC Annual Meeting last November, providing additional detail on its emerging pipeline of allogeneic CAR and CAd gamma delta T cell therapy product candidates. The company’s cash and cash equivalents securities as of December 31, 2022, are expected to be sufficient to fund its operating expenses into H1 2025. 

Management Commentary:
“The strategic focus of our pipeline event has delivered positive momentum for the Adicet business, with significant achievements across our pipeline programs in 2022, including our ADI-001 program, ADI-925 IND preparation, and the appointment of Dr. Nancy Boman, a veteran biotech and pharmaceutical executive, to our team," said Chen Schor, President and CEO of Adicet Bio. 

Forward-Looking Statements:
This release contains forward-looking statements relating to the business and operations of Adicet Bio that are subject to risks and uncertainties that may cause actual results to differ. These forward-looking statements include Adicet Bio’s expected cash runway, the success and timing of its ongoing and planned clinical trials, and regulatory approvals of its product candidates. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, among others, those detailed in Adicet's Annual Report on Form 10-K filed with the SEC.

Announcement: ACET 8-K Special Filing

Announcement: ACET 8-K Special Filing

Adicet Bio Reports Progress on Cancer Therapy: Performance Analysis

Adicet Bio Reports Progress on Cancer Therapy: Performance Analysis

$ACET Reports Strong Operational Highlights for Q1 2023, Progress in Allogenic Gamma Delta T-Cell Therapy Development Programs.

$ACET Reports Strong Operational Highlights for Q1 2023, Progress in Allogenic Gamma Delta T-Cell Therapy Development Programs.

Announcement: ACET 10-K Annual Report

Announcement: ACET 10-K Annual Report

$ACET reports strong pipeline progress and financial results for Q4 2022

$ACET reports strong pipeline progress and financial results for Q4 2022

Announcement: ACET 8-K Special Filing

Announcement: ACET 8-K Special Filing