Celularity Inc 8-K, filed Nov 12, 2021
Celularity Inc (CELU)
About this 8-K
Celularity Inc filed this 8-K on November 12, 2021.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
|
|
|
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
|
|
|
|
|
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including area code:
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
|
|
|
|
|
|
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 12, 2021, Celularity Inc. issued a press release announcing its financial results as of and for the quarter ended September 30, 2021. A copy of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The information contained in this Item 2.02 and in Exhibit 99.1 to current report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit Number |
|
Description |
|
|
|
|
|
99.1 |
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
CELULARITY INC. |
|
|
|
|
|
|
|
Date: November 12, 2021 |
|
By: |
/s/ David Beers |
|
|
|
|
David Beers |
|
|
|
|
Chief Financial Officer |
2
Exhibit 99.1
Celularity Reports Third Quarter 2021 Financial Results and Corporate Update
Florham Park, NJ, – November 12, 2021 – Celularity Inc. (Nasdaq: CELU) (“Celularity”), a clinical-stage biotechnology company developing off-the-shelf, placental-derived allogeneic therapies, today announced financial results for the third quarter ended September 30, 2021 and provided a corporate update.
“We have continued to make significant progress over the past months, with the establishment of multiple strategic collaborations to further extend the potential use of our technology platform with the goal of bringing potentially transformative therapeutics to patients who require them most,” said Robert J. Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity. “Furthermore, we have advanced multiple preclinical and clinical programs targeting significant unmet medical needs, including acute myeloid leukemia and glioblastoma. We believe we are well-positioned to continue executing against our business strategy and developing cellular therapies for cancer, infectious and degenerative diseases by leveraging our proprietary placental-based platform technology.”
Third Quarter Corporate Highlights
|
|
• |
Appointed Andrew L. Pecora, M.D., F.A.C.P., C.P.E., a renowned clinician, scientist and experienced life sciences leader as President. |
|
|
• |
Entered into a research collaboration with Oncternal Therapeutics (Nasdaq: ONCT) to evaluate placental derived-cellular therapies targeting receptor-tyrosine kinase-like Orphan Receptor 1 (ROR1) in preclinical studies. The collaboration will initially explore the use of Oncternal’s ROR1-targeted chimeric antigen receptor (CAR) gene modification as part of Celularity’s CYNK natural killer cell and CyCART platforms. The partnership will also explore the use of monoclonal antibody, cirmtuzumab, in combination with Celularity’s CYNK natural killer cells. |
Third Quarter 2021 Financial Results
|
|
• |
Revenues for the three months ended September 30, 2021 increased $7.3 million compared to the prior year period. This was primarily due to an increase in license, royalty and other revenues driven by (i) recognition of previously deferred revenue as a result of the termination of the Sanuwave license agreement of $6.8 million and (ii) revenues from supply and distribution agreements recognized during the third quarter of 2021 of $1.4 million, partially offset by a decrease in product sales and rentals revenues of $0.6 million resulting from the sale of the MIST/UltraMIST assets in August 2020. |
|
|
• |
Research and development expenses for the three months ended September 30, 2021 increased $12.5 million compared to the prior year period. The increase in research and development expenses was primarily due to higher stock-based compensation expense resulting from awards granted in connection with the consummation of the business combination as well as higher clinical trial costs related to Celularity’s CYNK-001 clinical trial and higher personnel costs. |
|
|
• |
Selling, general and administrative expenses for the three months ended September 30, 2021 increased $13.3 million compared to the prior year period, primarily due to higher stock-based |
|
|
compensation expense resulting from awards granted in connection with the consummation of the business combination, and a $5.3 million charge related to an estimated legal settlement and higher personnel costs. |
|
|
• |
Net income for the third quarter of 2021 was $49.9 million, or $0.47 per share (basic) and $0.40 per share (diluted). |
Year to Date Financial Results
|
|
• |
Revenue for the nine months ended September 30, 2021, increased $5.4 million compared to the prior year period. The increase was due to an increase of $9.1 million in license, royalty and other revenues primarily driven by (i) recognition of previously deferred revenue as a result of the termination of the Sanuwave license agreement of $6.8 million and (ii) revenues from supply and distribution agreements recognized during the third quarter of 2021 of $1.4 million, partially offset by a decrease in product sales and rentals revenues of $3.6 million resulting from the sale of the MIST/UltraMIST assets in August 2020. |
|
|
• |
Research and development expenses for the nine months ended September 30, 2021 increased $24.9 million compared to the prior year period. The increase in research and development expenses was primarily due to higher stock-based compensation resulting from awards granted in connection with the consummation of the business combination, higher cell therapy process development and research expenses related to the CyCART-19 program, and higher personnel costs. |
|
|
• |
Selling, general and administrative expenses for the nine months ended September 30, 2021 increased $32.8 million compared to the prior year period, primarily due to higher stock-based compensation resulting from awards granted in connection with the consummation of the business combination , a charge related to an estimated legal settlement and higher personnel costs. |
|
|
• |
Net loss for the nine months ended September 30, 2021 was $96.1 million, or $2.00 per share (basic and diluted). |
About Celularity
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 the effects of recent strategic collaborations on Celularity’s business objectives, Celularity’s ability to advance the field of cellular medicine and develop treatments for cancer, degenerative and infectious diseases, its recent collaboration with Oncternal Therapeutics and its clinical development plans, 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 proxy statement/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.
Statements of Operations
(unaudited; in thousands, except share and per share data)
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2021 |
|
|
September 30, 2020 |
|
|
September 30, 2021 |
|
|
September 30, 2020 |
|
||||
|
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and rentals |
|
$ |
849 |
|
|
$ |
1,465 |
|
|
$ |
2,734 |
|
|
$ |
6,331 |
|
|
Services |
|
|
1,343 |
|
|
|
1,399 |
|
|
|
4,204 |
|
|
|
4,213 |
|
|
License, royalty and other |
|
|
8,430 |
|
|
|
491 |
|
|
|
9,541 |
|
|
|
491 |
|
|
Total revenues |
|
|
10,622 |
|
|
|
3,355 |
|
|
|
16,479 |
|
|
|
11,035 |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues (excluding amortization of acquired intangible assets) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and rentals |
|
|
638 |
|
|
|
271 |
|
|
|
2,025 |
|
|
|
1,921 |
|
|
Services |
|
|
923 |
|
|
|
689 |
|
|
|
2,218 |
|
|
|
1,768 |
|
|
Licenses, royalties and other |
|
|
750 |
|
|
|
73 |
|
|
|
750 |
|
|
|
73 |
|
|
Research and development |
|
|
23,765 |
|
|
|
11,217 |
|
|
|
63,666 |
|
|
|
38,783 |
|
|
Selling, general and administrative |
|
|
21,644 |
|
|
|
8,327 |
|
|
|
58,133 |
|
|
|
25,363 |
|
|
Change in fair value of contingent consideration liability |
|
|
(48,549 |
) |
|
|
(142,599 |
) |
|
|
(17,845 |
) |
|
|
(26,136 |
) |
|
Amortization of acquired intangible assets |
|
|
553 |
|
|
|
783 |
|
|
|
1,640 |
|
|
|
2,843 |
|
|
Impairment of acquired intangibles |
|
|
- |
|
|
|
129,400 |
|
|
|
- |
|
|
|
129,400 |
|
|
Total operating expenses |
|
|
(276 |
) |
|
|
8,161 |
|
|
|
110,587 |
|
|
|
174,015 |
|
|
Income (loss) from operations |
|
|
10,898 |
|
|
|
(4,806 |
) |
|
|
(94,108 |
) |
|
|
(162,980 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
55 |
|
|
|
92 |
|
|
|
324 |
|
|
|
236 |
|
|
Interest expense |
|
|
(843 |
) |
|
|
(706 |
) |
|
|
(2,412 |
) |
|
|
(1,630 |
) |
|
Loss on sale of business |
|
|
- |
|
|
|
(4,434 |
) |
|
|
- |
|
|
|
(4,434 |
) |
|
Income (expense) related to warrant liabilities |
|
|
39,937 |
|
|
|
(36,960 |
) |
|
|
2,258 |
|
|
|
(52,065 |
) |
|
Other (expense) income, net |
|
|
(109 |
) |
|
|
504 |
|
|
|
(2,140 |
) |
|
|
4,099 |
|
|
Total other income (expense) |
|
|
39,040 |
|
|
|
(41,504 |
) |
|
|
(1,970 |
) |
|
|
(53,794 |
) |
|
Net income (loss) before income taxes |
|
|
49,938 |
|
|
|
(46,310 |
) |
|
|
(96,078 |
) |
|
|
(216,774 |
) |
|
Income tax (benefit) |
|
|
- |
|
|
|
15 |
|
|
|
- |
|
|
|
(4,631 |
) |
|
Net income (loss) |
|
$ |
49,938 |
|
|
$ |
(46,325 |
) |
|
$ |
(96,078 |
) |
|
$ |
(212,143 |
) |
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share - basic |
|
$ |
0.47 |
|
|
$ |
(2.52 |
) |
|
$ |
(2.00 |
) |
|
$ |
(11.52 |
) |
|
Weighted average shares outstanding - basic |
|
|
106,369,910 |
|
|
|
18,416,078 |
|
|
|
48,071,685 |
|
|
|
18,412,761 |
|
|
Net income (loss) per share - diluted |
|
$ |
0.40 |
|
|
$ |
(2.52 |
) |
|
$ |
(2.00 |
) |
|
$ |
(11.52 |
) |
|
Weighted average shares outstanding - diluted |
|
|
123,582,822 |
|
|
|
18,416,078 |
|
|
|
48,071,685 |
|
|
|
18,412,761 |
|