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Celularity Inc (CELU) SEC Filing 10-Q Quarterly Report for the period ending Thursday, September 30, 2021

Celularity Inc

CIK: 1752828 Ticker: CELU

Exhibit 99.1

 

Celularity Reports Second Quarter 2021 Financial Results

 

Secured funding of approximately $138 million through merger and private placement investment in public equity (PIPE) financing

Expanded Phase 1 clinical trial to include difficult-to-treat patient population

Established multiple strategic and commercial partnerships

 

Florham Park, NJ – August 16, 2021 – Celularity Inc. (“Celularity”) (Nasdaq:CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, today reported financial results for the quarter ended June 30, 2021, and provided a summary of recent corporate highlights.

 

“This has been an exciting time for Celularity, with the achievement of multiple transformational milestones and significant progress in our unique approach to cellular medicine,” said Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity. “Most notably, this quarter marked our transition to a public company through a merger with GX Acquisition Corp., which along with a companion PIPE provided significant funds to support our work. Additionally, we made noteworthy advances in our clinical programs, including the expansion of our Phase 1 trial in patients with acute myeloid leukemia, to include difficult to treat patient populations. Beyond our program development, we forged new strategic and commercial partnerships with companies at the forefront of their respective fields that continue our legacy of pioneering new and innovative approaches to cellular medicine. We look forward to continuing to advance the field of cellular medicine and developing treatments capable of addressing significant unmet needs in cancer, autoimmune and infectious disease.”

 

Corporate Highlights

 

Celularity closed the merger with GX Acquisition Corp. (“GXGX”). Proceeds from the transaction totaled approximately $138 million, which included funds held in GXGX’s trust account and a concurrent private placement investment in public equity (PIPE) financing led by existing Celularity shareholders.
Celularity expanded its ongoing Phase 1 clinical trial of CYNK-001 in patients with acute myeloid leukemia (AML) (NCT04310592) to include patients with relapsed/refractory AML (r/r AML) in addition to its ongoing trial in patients positive for minimal residual disease (MRD).
The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Celularity’s CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, for the treatment of patients with malignant gliomas.
Celularity entered an exclusive strategic partnership with Imugene Ltd. to develop a novel oncolytic virus – allogeneic chimeric antigen receptor (CAR) T-cell immunotherapy combination for the treatment of solid tumors. The collaboration will initially explore the therapeutic potential of a combination of Imugene’s CF33-CD19 oncolytic virus (onCARlytics™) and Celularity’s placental-derived CD19 targeting CAR T-cell therapy, CYCART-19.
Celularity established a partnership to leverage Palantir’s next generation software and computational capabilities to analyze Celularity’s cellular data and accelerate research and development activities.
On July 1, 2021, Celularity announced its agreement with Arthrex whereby Arthrex would receive exclusive rights to distribute and commercialize Celularity’s placental-derived biomaterial products for orthopedics and sports medicine in the U.S. Under the terms of the agreement, Celularity will provide Arthrex with exclusive commercial distribution rights for orthopedic surgery and sports medicine and will continue to be responsible for product manufacturing and supply.

 

 

 

 

Second Quarter 2021 Financial Results

 

Revenues for the three months ended June 30, 2021, experienced a decrease of $0.3 million compared to the prior year. This was due to a decrease in product sales and rentals revenue resulting from the $24.5 million sale of the MIST/UltraMIST assets in August 2020, partially offset by (i) an increase of $0.6 million in license, royalty and other revenues related to the license arrangement with Sanuwave and (ii) an increase of $0.2 million in services revenues primarily due to higher biobanking storage revenues.

Research and development expenses for the three months ended June 30, 2021, increased $7.1 million compared to the prior year. The increase in research and development expenses was primarily due to a non-cash stock compensation charge related to the grant of fully vested senior management awards.

Selling, general and administrative expenses for the three months ended June 30, 2021, increased $21.3 million compared to the prior year, primarily due to a non-cash stock-based compensation charge related to the grant of fully vested non-employee director and senior management awards.

Net loss for the second quarter of 2021 was $64.5 million, or $2.69 per share.

 

About Celularity (Nasdaq: CELU)

 

Celularity, Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a clinical stage biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies, including unmodified natural killer (NK) cells, genetically-modified NK cells, T-cells engineered with a CAR (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs) targeting indications across cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures innovative biomaterials also derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.To learn more, visit celularity.com.

 

Forward-Looking Statements

 

This press release includes “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include, statements regarding advancing the field of cellular medicine and developing treatments for cancer, autoimmune and infectious diseases, , among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel cellular therapies, and the clinical trial and regulatory approval process; and risks associated with developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s prospectus filed with the Securities and Exchange Commission (SEC) on August 12, 2021 and other filings with the SEC. These risks and uncertainties may be amplified by the COVID- 19 pandemic. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

 

Celularity Investor Contacts:

Carlos Ramirez

Celularity Inc.

carlos.ramirez@celularity.com

 

Alexandra Roy

Solebury Trout

aroy@troutgroup.com

 

Celularity Media Contact:

Jason Braco, Ph.D.

LifeSci Communications

jbraco@lifescicomms.com

 

 

 

 

Celularity Inc.

Statement of Operations

(unaudited; in thousands, except share and per share data)

 

   Three Months Ended   Six Months Ended 
   June 30,
2021
   June 30,
2020
   June 30,
2021
   June 30,
2020
 
Net revenues                    
Product sales and rentals  $1,045   $2,074   $1,885   $4,866 
Services   1,597    1,398    2,861    2,814 
License, royalty and other   555    -    1,111    - 
Total revenues   3,197    3,472    5,857    7,680 
Operating expenses                    
Cost of revenues (excluding amortization of acquired intangible assets)                    
Product sales and rentals   869    794    1,387    1,650 
Services   571    698    1,295    1,079 
Licenses, royalties and other   -    -    -    - 
Research and development   22,911    15,804    39,901    27,566 
Selling, general and administrative   28,863    7,586    36,489    17,036 
Change in fair value of contingent consideration liability   10,048    114,738    30,704    116,463 
Amortization of acquired intangible assets   546    1,030    1,087    2,060 
Total operating expenses   63,808    140,650    110,863    165,854 
Loss from operations   (60,611)   (137,178)   (105,006)   (158,174)
Other (expense) income:                    
Interest income   129    32    269    144 
Interest expense   (817)   (924)   (1,569)   (924)
Expense related to warrant liabilities   (1,174)   (1,239)   (37,679)   (15,105)
Other (expense) income, net   (2,004)   3,698    (2,031)   3,595 
Total other (expense) income   (3,866)   1,567    (41,010)   (12,290)
Net loss before income taxes   (64,477)   (135,611)   (146,016)   (170,464)
Income tax benefit   -    7    -    (4,646)
Net loss  $(64,477)  $(135,618)  $(146,016)  $(165,818)
Per share information:                    
Net loss per share - basic and diluted  $(2.69)  $(5.66)  $(6.09)  $(6.92)
Weighted average shares outstanding - basic and diluted   23,992,184    23,955,562    23,991,129    23,954,238 

 

 

 

 

 


The following information was filed by Celularity Inc (CELU) on Monday, August 16, 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 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)
Accrued Expenses And Other Current Liabilities
Accrued Expenses And Other Current Liabilities (Tables)
Accrued Expenses And Other Current Liabilities - Schedule Of Accrued Expenses (Details)
Benefit Plans
Benefit Plans - Additional Information (Details)
Business Combinations And Disposals
Business Combinations And Disposals (Tables)
Business Combinations And Disposals - Additional Information (Details)
Business Combinations And Disposals - Schedule Of Assets And Liabilities Were Divested/Written Off (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Schedule Of Future Minimum Payments Under Non-Cancelable Operating Leases (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 Fair Value Of Warrants Issued (Parenthetical) (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)
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)
Income Taxes
Income Taxes - Additional Information (Details)
Inventory
Inventory (Tables)
Inventory - Schedule Of Major Classes Of Inventories (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)
Prepaid Expenses
Prepaid Expenses (Tables)
Prepaid Expenses - Schedule Of Prepaid Expenses (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 (Details) - Schedule Of Changes In Deferred Revenue From Contract Liabilities
Revenue Recognition (Details) - Schedule Of Disaggregated Revenue By Product And Services
Revenue Recognition (Tables)
Revenue Recognition - Additional Inforrmation (Details)
Segment Information
Segment Information (Tables)
Segment Information - Additional Information (Details)
Segment Information - Schedule Of Financial Information By Segment (Details)
Short-Term Borrowings - Related Party
Short-Term Borrowings - Related Party - Additional Information (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (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)
Summary Of Significant Accounting Policies - Schedule Of Basic And Diluted Net Income (Loss) Per Share (Details)
Ticker: CELU
CIK: 1752828
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-21-056724
Submitted to the SEC: Fri Nov 12 2021 4:38:09 PM EST
Accepted by the SEC: Fri Nov 12 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations

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