Last10K.com

Celularity Inc (CELU) SEC Filing 10-Q Quarterly Report for the period ending Thursday, March 31, 2022

SEC Filings

CELU Quarterly Reports

    10-Q Quarterly Report August 2022
  • 10-Q Quarterly Report May 2022
  • 10-Q Quarterly Report November 2021
    10-Q Quarterly Report August 2021

Celularity Inc

CIK: 1752828 Ticker: CELU

Exhibit 99.1

Celularity Reports First Quarter 2022 Financial Results and Provides Corporate Update

 

   

Ongoing Phase 1 study of unmodified placental-derived natural killer (NK) cell therapy candidate, CYNK-001, in acute myeloid leukemia (AML) continues enrolling new cohorts to reflect adjustments to treatment regimen and dosing as outlined in December 2021

 

   

Ongoing Phase 1 study of CYNK-001 in glioblastoma multiforme (GBM)

 

   

U.S. Food and Drug Administration (FDA) granted Fast Track designation to genetically modified placental-derived NK cell therapy candidate, CYNK-101, in first line metastatic HER2/neu positive gastric and gastroesophageal junction cancers; Phase 1/2a study is ongoing

 

   

FDA granted an Orphan Drug Designation to CYNK-101 for the treatment of gastric/gastroesophageal junction cancers

Florham Park, NJ, – May 16, 2022

– Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, today announced financial results for the first quarter ended March 31, 2022, and provided a corporate update.

“We have continued to achieve multiple transformational milestones and make significant progress this year with three ongoing Phase 1 clinical trials of two investigational drugs, CYNK-001 and CYNK-101, both of which have been granted Fast Track and Orphan Drug Designations for certain indications,” said Robert J. Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity. We expect to have data readouts for all three ongoing Phase 1 programs later this year. As such, we believe we are well-positioned to continue executing our business strategy and developing cellular therapies for cancer, infectious and degenerative diseases that leverage our proprietary placental-based technology platform.”

First Quarter Clinical and Regulatory Updates

CYNK-001 for the Treatment of AML and GBM:

 

 

CYNK-001 is Celularity’s unmodified cryopreserved human placental hematopoietic stem cell-derived NK cell therapy candidate that is enriched with CD56+/CD3- NK cells and expanded from human placental CD34+ cells. CYNK-001 is currently being investigated in two Phase 1 clinical trials, in AML and in GBM, with data readouts expected in the second half of 2022.

 

 

Celularity continues to enroll new cohorts in both arms of the Phase 1 AML study with clinical trial protocol adjustments communicated in December 2021, which include an addition of interleukin-2 (IL-2) to the treatment regimen; a fourth dose on day 21; and an increase in the dose of NK cells.

CYNK-101 for the Treatment of Gastric Cancer:

 

 

CYNK-101 is a novel allogeneic off-the-shelf human placental CD34+-derived NK cell product candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. CYNK-101 is currently being investigated in the Phase 1 portion of a Phase 1/2a clinical trial in advanced HER2+ gastric cancer.


The following information was filed by Celularity Inc (CELU) on Monday, May 16, 2022 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.

View differences made from one quarter to another to evaluate Celularity Inc's financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Celularity Inc.

Continue

Assess how Celularity Inc's management team is paid from their Annual Proxy

Definitive Proxy Statement (Form DEF 14A)
Screenshot example of actual Proxy Statement

Celularity Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors

Continue

SEC Filing Tools

Rating

Learn More
Bullish Bearish Neutral
Filter Sentiment:
All
Positive
Negative
Filter Category:
All
Financial
Revenue
Other
Filter Subcategory:
All
Expense
Product
Cash Flow
Shares
Other
Inside Celularity Inc's 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Convertible Preferred Stock And Stockholders' Equity (Deficit) (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Benefit Plans
Benefit Plans - Additional Information (Details)
Business Combinations
Business Combinations - Additional Information (Details)
Commitments And Contingencies
Commitments And Contingencies - Additional Information (Details)
Equity
Equity (Tables)
Equity - Additional Information (Details)
Equity - Summary Of The Warrants (Details)
Equity - Summary Of The Warrants (Parenthetical) (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 Aggregate Fair Values Of The Warrant Liability (Details)
Fair Value Of Financial Assets And Liabilities - Schedule Of Convertible Note Valuation Model (Details)
Fair Value Of Financial Assets And Liabilities - Schedule Of Fair Value Of Warrants Issued (Details)
Fair Value Of Financial Assets And Liabilities - Schedule Of Financial Assets And Liabilities Measured At Fair Value On A Recurring Basis (Details)
Fair Value Of Financial Assets And Liabilities - Schedule Of Reconciliation Of Contingent Consideration Obligations Measured On A Recurring Basis (Details)
Fair Value Of Financial Assets And Liabilities - Schedule Of Reconciliation Of Contingent Stock Consideration Obligation Measured On A Recurring Basis (Details)
Goodwill And Intangible Assets, Net
Goodwill And Intangible Assets, Net (Tables)
Goodwill And Intangible Assets, Net - Additional Information (Details)
Goodwill And Intangible Assets, Net - Schedule Of Carrying Values Of Goodwill Assigned To Operating Segments (Details)
Goodwill And Intangible Assets, Net - Schedule Of Intangible Assets, Net (Details)
Inventory
Inventory (Tables)
Inventory - Schedule Of Major Classes Of Inventories (Details)
Leases
Leases (Tables)
Leases - Additional Information (Details)
Leases - Impact Of Adoption Of Asc 842 (Details)
Leases - Schedule Of Cash And Non-Cash Activity Related To The Lease Liabilities (Details)
Leases - Schedule Of Future Minimum Payments Under Non-Cancelable Operating Leases (Details)
Leases - Schedule Of Lease Costs (Details)
License And Distribution Agreements
License And Distribution Agreements - Additional Information (Details)
Nature Of Business And Basis Of Presentation
Nature Of Business And Basis Of Presentation - Additional Information (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)
Property And Equipment, Net - Schedule Of Property And Equipment, Net (Parenthetical) (Details)
Related Party Transactions
Related Party Transactions - Additional Information (Details)
Revenue Recognition
Revenue Recognition (Tables)
Revenue Recognition - Additional Inforrmation (Details)
Revenue Recognition - Schedule Of Changes In Deferred Revenue From Contract Liabilities (Details)
Revenue Recognition - Schedule Of Disaggregated Revenue By Product And Services (Details)
Segment Information
Segment Information (Tables)
Segment Information - Additional Information (Details)
Segment Information - Schedule Of Financial Information By Segment (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Schedule Of Activity Related To Rsu Stock-Based Payment Awards (Details)
Stock-Based Compensation - Schedule Of Stock Option Activity (Details)
Stock-Based Compensation - Schedule Of Stock-Based Compensation Expense (Details)
Stock-Based Compensation - Schedule Of Weighted Average Grant Fair Value Of Stock Options Using Black-Scholes Option-Pricing Model (Details)
Subsequent Events
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Schedule Of Antidilutive Securities Excluded From Computation Of Diluted Weighted-Average Shares Of Common Stock Outstanding (Details)

Material Contracts, Statements, Certifications & more

Celularity Inc provided additional information to their SEC Filing as exhibits

Ticker: CELU
CIK: 1752828
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-22-020422
Submitted to the SEC: Mon May 16 2022 4:39:31 PM EST
Accepted by the SEC: Mon May 16 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations

External Resources:
Stock Quote
Social Media

Bookmark the Permalink:
https://last10k.com/sec-filings/celu/0001564590-22-020422.htm