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Talaris Therapeutics, Inc. (TALS) SEC Filing 10-Q Quarterly Report for the period ending Thursday, September 30, 2021

Talaris Therapeutics, Inc.

CIK: 1827506 Ticker: TALS

Exhibit 99.1

 

Talaris Therapeutics Announces Third Quarter 2021 Financial Results and Provides Business Update  

Provided initial clinical update from its Phase 3 (FREEDOM-1) clinical trial evaluating FCR001 in living donor kidney transplant patients

Initiated Phase 2 (FREEDOM-2) clinical trial for FCR001 in delayed tolerance induction patients

BOSTON, MA, and LOUISVILLE, KY, November 12, 2021

–  Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today reported financial results for the three- and nine-month periods ended September 30, 2021, and provided an update on its business.  

 

“We made significant progress in the quarter, providing our first Phase 3 clinical update in living donor kidney transplant (LDKT) patients, and presenting additional long-term follow-up data from our Phase 2 trial in the same patient population at the 2021 American Society of Nephrology meeting,” stated Scott Requadt, Chief Executive Officer of Talaris. “Our clinical evidence to date suggests that those patients who achieve >50% T cell chimerism at 3, 6 and 12 months after the administration of FCR001 are likely to be able to be durably weaned from chronic immunosuppression at one year after transplant. We were pleased to report, in our first clinical update from the Phase 3 FREEDOM-1 trial, that all patients who have reached the three-month time point post-transplant have achieved sustained chimerism. These results continue to give us confidence that FCR001 has the potential to transform the standard of care in solid organ transplantation.”

 

Mr. Requadt continued: “In addition, we are advancing our pipeline with the initiation of our FREEDOM-2 Phase 2 trial of FCR001 to assess its potential to induce durable immune tolerance in LDKT patients who received their kidney transplant up to 12 months prior to administration of our investigational therapy. We also remain on track to initiate another Phase 2 trial in our first severe autoimmune disease indication, scleroderma, before year-end.”  

 

Corporate Highlights

 

 

Presented initial clinical update on safety and chimerism data from the Phase 3 FREEDOM-1 trial with living donor kidney transplant (LDKT) patients.

 

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FREEDOM-1 is a randomized, controlled, open-label Phase 3 registrational trial of FCR001 in 120 adult LDKT recipients in the United States. The primary endpoint of FREEDOM-1 is the proportion of LDKT recipients treated with FCR001 who are free from chronic immunosuppression (IS), without proven biopsy rejection (BPAR), at month 24 post-transplant.

 

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The initial data presented includes a total of 11 LDKT donor-recipient pairs enrolled from a total of 5 clinical sites. Five of the seven patients randomized to receive FCR001 had been dosed as of the data cut-off date and three patients were dosed at least three months prior to the data cut-off date and were evaluated for safety, chimerism, and ability to wean patients off chronic IS.

 

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All three patients dosed at least three months prior to the data cut-off date successfully achieved >50% chimerism. Chimerism is a condition whereby both the donor’s and the recipient’s hematopoietic stem cells co-exist in the recipient’s bone marrow and was correlated strongly in the Company’s Phase 2 trial with the transplant recipient’s ability to be durably weaned from chronic IS approximately one year after transplant, without subsequent graft rejection in the Company’s Phase 2 trial.

 

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Both patients dosed at least 12 months prior to the data cut-off date achieved and maintained >50% T-cell chimerism at each of the 3-, 6- and 12-month timepoints and have discontinued their use of chronic IS.

 

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The adverse events (AEs) and serious adverse events (SAEs) observed to date in the FREEDOM-1 study were consistent with kidney and stem cell transplantation involving non-myeloablative conditioning and what was observed in the Phase 2 study. No events occurred to cause the Data Safety Monitoring Board (DSMB) to stop or modify the study protocol, nor was any stopping rule triggered. Furthermore, no FCR001-dosed patients in the Phase 3 study experienced BPAR or developed donor-specific antibodies (DSA), the presence of which post-transplant predicts an increased risk for antibody-mediated rejection of the donated organ.

 


The following information was filed by Talaris Therapeutics, Inc. (TALS) on Friday, November 12, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Talaris Therapeutics, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Balance Sheets (Unaudited)
Balance Sheets (Unaudited) (Parenthetical)
Statements Of Cash Flows (Unaudited)
Statements Of Convertible Preferred Stock And Stockholders' Equity (Unaudited)
Statements Of Convertible Preferred Stock And Stockholders' Equity (Unaudited) (Parenthetical)
Statements Of Operations And Comprehensive Loss (Unaudited)
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Schedule Of Accrued Expenses (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Summary Of Future Minimum Rent Payments (Details)
Common Stock
Common Stock (Tables)
Common Stock - Additional Information (Details)
Common Stock - Schedule Of Common Stock Reserved (Details)
Convertible Preferred Stock
Convertible Preferred Stock - Additional Information (Details)
Fair Value Of Financial Assets And Liabilities
Fair Value Of Financial Assets And Liabilities (Tables)
Fair Value Of Financial Assets And Liabilities - Additional Information (Details)
Fair Value Of Financial Assets And Liabilities - Schedule Of Contingent Common Stock Liability Measured At Fair Value (Details)
Fair Value Of Financial Assets And Liabilities - Summary Of Financial Instruments Measured At Fair Value On Recurring Basis (Details)
Marketable Securities
Marketable Securities (Tables)
Marketable Securities - Summary Of Company's Investments (Details)
Nature Of Business And Liquidity
Nature Of Business And Liquidity - Additional Information (Details)
Net Loss Per Share Attributable To Common Stockholders
Net Loss Per Share Attributable To Common Stockholders (Tables)
Net Loss Per Share Attributable To Common Stockholders - Summary Of Computation Of Basic And Diluted Net Loss Per Share Attributable To Common Stockholders (Details)
Net Loss Per Share Attributable To Common Stockholders - Summary Of Potential Dilutive Securities Excluded From Calculation Of Net Loss Per Share Due To Anti-Dilutive Effect (Details)
Prepaid And Other Current Assets
Prepaid And Other Current Assets (Tables)
Prepaid And Other Current Assets - Summary Of Prepaid And Other Current Assets (Details)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Additional Information (Details)
Property And Equipment, Net - Schedule Of Property And Equipment, Net (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Schedule Of Assumptions Used To Determine The Fair Values Of Stock Options Granted (Details)
Stock-Based Compensation - Summary Of Additional Information To Stock Option Activity Involving Employees And Directors (Details)
Stock-Based Compensation - Summary Of Option Activity (Details)
Stock-Based Compensation - Summary Of Stock-Based Compensation Expense (Details)
Subsequent Events
Subsequent Events - Additional Information (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies - Additional Information (Details)

Material Contracts, Statements, Certifications & more

Talaris Therapeutics, Inc. provided additional information to their SEC Filing as exhibits

Ticker: TALS
CIK: 1827506
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-21-056466
Submitted to the SEC: Fri Nov 12 2021 7:32:01 AM EST
Accepted by the SEC: Fri Nov 12 2021
Period: Thursday, September 30, 2021
Industry: Biological Products No Disgnostic Substances

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