GlobeNewswire Inc | Nov 12, 2021 04:05PM EST

November 12, 2021

FLORHAM PARK, N.J., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived allogeneic cell 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, including the establishment of multiple strategic collaborations to extend further the potential uses 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. Moreover, 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 our business strategy and developing cellular therapies for cancer, infectious and degenerative diseases that leverage our proprietary placental-based platform technology.

Third Quarter Corporate Highlights

-- Appointed Andrew L. Pecora, M.D., F.A.C.P., C.P.E., 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 Oncternals ROR1-targeted chimeric antigen receptor (CAR) gene modification as part of Celularitys CYNK natural killer cell and CyCART platforms. The partnership will also explore the use of monoclonal antibody, cirmtuzumab, in combination with Celularitys 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 Celularitys 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 allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using 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). These therapeutic programs target indications in 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 placentas unique biology and ready availability, it can 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 Celularitys business objectives, Celularitys 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 Celularitys competitors and industry, along with those risk factors set forth under the caption Risk Factors in Celularitys 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 Celularitys 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 Celularitys 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, SVP Investor RelationsCelularity Inc.carlos.ramirez@celularity.com

Alexandra RoySolebury Troutaroy@troutgroup.com

Celularity Media Contact:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

Three Months Ended Nine Months Ended September30,2021 September30, September30, September30, 2020 2021 2020Net revenues Product sales $ 849 $ 1,465 $ 2,734 $ 6,331 and rentalsServices 1,343 1,399 4,204 4,213 License,royalty and 8,430 491 9,541 491 otherTotal revenues 10,622 3,355 16,479 11,035 Operating expensesCost ofrevenues(excludingamortization of acquiredintangibleassets)Product sales 638 271 2,025 1,921 and rentalsServices 923 689 2,218 1,768 Licenses,royalties and 750 73 750 73 otherResearch and 23,765 11,217 63,666 38,783 developmentSelling,general and 21,644 8,327 58,133 25,363 administrativeChange in fairvalue ofcontingent (48,549 ) (142,599 ) (17,845 ) (26,136 )considerationliabilityAmortizationof acquired 553 783 1,640 2,843 intangibleassetsImpairment ofacquired - 129,400 - 129,400 intangiblesTotaloperating (276 ) 8,161 110,587 174,015 expensesIncome (loss)from 10,898 (4,806 ) (94,108 ) (162,980 )operationsOther income (expense):Interest 55 92 324 236 incomeInterest (843 ) (706 ) (2,412 ) (1,630 )expenseLoss on sale - (4,434 ) - (4,434 )of businessIncome(expense)related to 39,937 (36,960 ) 2,258 (52,065 )warrantliabilitiesOther(expense) (109 ) 504 (2,140 ) 4,099 income, netTotal otherincome 39,040 (41,504 ) (1,970 ) (53,794 )(expense)Net income(loss) before 49,938 (46,310 ) (96,078 ) (216,774 )income taxesIncome tax - 15 - (4,631 )(benefit)Net income $ 49,938 $ (46,325 ) $ (96,078 ) $ (212,143 )(loss)Per share information:Net income(loss) per $ 0.47 $ (2.52 ) $ (2.00 ) $ (11.52 )share - basicWeightedaverage shares 106,369,910 18,416,078 48,071,685 18,412,761 outstanding -basicNet income(loss) per $ 0.40 $ (2.52 ) $ (2.00 ) $ (11.52 )share -dilutedWeightedaverage shares 123,582,822 18,416,078 48,071,685 18,412,761 outstanding -diluted