Ernexa Therapeutics Inc 8-K, filed Aug 17, 2021
Ernexa Therapeutics Inc. (ERNA)
8-K
2021-08-17
For: 2021-08-16
View Original
Added on
April 06, 2026
About this 8-K
Ernexa Therapeutics Inc filed this 8-K on August 17, 2021, reporting on events of August 16, 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 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 16, 2021
(Exact Name of Registrant as Specified in its Charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of Principal Executive Offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (212 ) 582-1199
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading symbol
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Name of each exchange on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of
the Securities Exchange Act of 1934:
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.
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On August 16, 2021, we issued a press release announcing financial results for the second quarter of 2021. The full text of the press release is
furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
The information contained in this Item 2.02, including Exhibit 99.1 furnished hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18
of the Securities Exchange Act of 1934 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, or the Securities Exchange Act of 1934, except as
expressly set forth by specific reference in such filing.
| Item 9.01 |
Financial Statements and Exhibits.
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Exhibit
Number
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Exhibit Description
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Press release of Brooklyn ImmunoTherapeutics, Inc. dated August 16, 2021.
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104
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Cover Page Interactive Data File (embedded within the XBRL document)
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SIGNATURE
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, hereunto duly authorized.
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BROOKLYN IMMUNOTHERAPEUTICS, INC.
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Dated: August 17, 2021
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By:
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/s/ Howard J. Federoff
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Howard J. Federoff
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Chief Executive Officer and President
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Exhibit 99.1
Brooklyn ImmunoTherapeutics Announces Second Quarter 2021 Financial Results
NEW YORK–
August 12, 2021 – Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) (“Brooklyn”), a biopharmaceutical company focused on exploring the role that gene editing/cell and cytokine therapy can have
in treating patients with cancer, blood disorders, and monogenic diseases, today announced financial results for the quarter ended June 30, 2021.
Financial and corporate highlights for the quarter ended June 30, 2021 and subsequently include the following:
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Completed the acquisition of Novellus Therapeutics Limited (“Novellus”) in July 2021. Novellus is developing next‑generation engineered mesenchymal stem cell (“MSC”) therapies using patented mRNA-based cell reprogramming and gene editing
technologies licensed from Factor Bioscience (“Factor”).
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| • |
Raised nearly $51 million through equity line sales of common stock for general corporate purposes, including working capital to be used to enhance the development of the mRNA gene editing and cell therapies technology recently licensed from
Factor.
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| • |
Appointed Jay Sial as chief administrative officer and Kevin D’Amour, Ph.D. as chief scientific officer.
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Established a research and development center in Cambridge, Massachusetts, to pursue its mRNA-based gene editing and cellular therapies, co-locating with Factor.
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Howard Federoff, M.D., Ph.D., Brooklyn’s President and Chief Executive Officer, commented, “The second quarter advanced the evolution of Brooklyn ImmunoTherapeutics from
being a cytokine-focused immunotherapeutics company to a platform company with a pipeline of next-generation engineered cellular, gene editing and cytokine products. This was in no small measure due to the acquisition of Novellus, which enables us to
utilize the full range of the MSCs they have developed with no restriction on fields of use. By combining these with our licensed mRNA-based cell reprogramming and gene editing technology from Factor Bioscience, we believe we can create a platform
technology that will lead to a family of product candidates in varying stages of development from target selection to research and preclinical, including one in the respiratory area that is in the IND-enabling stage.”
1
“Further, we believe we are positioned to develop a variety of gene-modified products using this platform, which ultimately could help solve problems of treating certain
conditions that to date have confounded science, including potential treatments for a set of solid tumors, autoimmune disorders where inflammation is a prominent feature, and addressing multiple issues in the liver, the brain and the eye, as well as
applying that technology again to iPSCs for a multitude of applications,” continued Dr. Federoff.
“The quarter also resulted in creating a strong balance sheet and a growing in-licensed intellectual property portfolio,” said Dr. Federoff. “Following the Novellus
acquisition, we had approximately $25 million of cash on hand, which we estimate will fund our operations and expansion through the end of 2023,” Dr. Federoff continued. “We are awaiting the readout of our Phase 2b trial for neoadjuvant head and neck
cancer with our original asset, IRX-2 human-derived cytokines, during the first half of 2022. Additionally, we have multiple investigator-driven trials in a number of additional cancer types, and additional planned studies in 2022 and 2023.”
“We have made a considerable investment in ensuring that we have the right people in place, and with the addition of our new chief scientific officer Dr. Kevin D’Amour and
new chief administrative officer Jay Sial. Now it’s time for us to begin to execute on these ambitious plans that this next-generation version of Brooklyn ImmunoTherapeutics promises,” concluded Dr. Federoff.
Financial Results for Quarter Ended June 30, 2021
Operating expenses for the quarter ended June 30, 2021 were $10.1 million, as compared to operating expenses for the quarter ended June 30, 2020 of $2.0 million.
Research and development expenses increased to $5.4 million for the quarter ended June 30, 2021 compared to $1.0 million in the quarter ended June 30, 2020. Research and
development expenses increased due to upfront payments associated with licensed technology, increased clinical trial expenses, and stock-based compensation for the issuance of equity awards. Brooklyn expects research and development expenses to
continue to grow as it expands its clinical trial activities.
General and administrative expenses increased to $4.6 million in the second quarter of 2021 compared to $1.0 million during the same period in 2020. The quarter-over-quarter
increase in general and administrative expense was primarily related to increased legal, accounting and consulting fees associated with merger and acquisition activity, costs associated with being a publicly traded company, and increased stock-based
compensation resulting from the issuance of equity awards. Brooklyn expects general and administrative expenses to continue to increase in future periods as it increases its business activities and incurs costs associated with being a publicly traded
company.
2
Net loss for the quarter ended June 30, 2021 was $(27.8) million, as compared to $(3.1) million for the quarter ended June 30, 2020.
As of June 30, 2021, Brooklyn ImmunoTherapeutics had $50.2 million in cash, of which approximately $23.0 million was paid as partial consideration for the acquisition of
Novellus on July 16, 2021.
About Brooklyn ImmunoTherapeutics
Brooklyn is focused on exploring the role that cytokine, gene editing, and cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases.
Brooklyn’s most advanced program is IRX-2, a human cell-derived cytokine therapy, studying the safety and efficacy of IRX-2 in patients with head and neck cancer in Phase
2B. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.
Brooklyn has multiple next-generation cell and gene-editing therapies in preclinical development for various indications including acute respiratory distress syndrome,
solid tumor indications, as well as in vivo gene-editing therapies for rare genetic diseases. For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.com.
# # #
3
FINANCIAL TABLES FOLLOW
BROOKLYN IMMUNOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30,
2021 |
December 31,
2020 |
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ASSETS
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(unaudited)
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|||||||
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Current assets:
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||||||||
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Cash
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$
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50,164,673
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$
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1,630,455
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Tax receivable
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23,303
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-
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Prepaid expenses and other current assets
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1,753,197
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102,322
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Total current assets
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51,941,173
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1,732,777
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Property and equipment,net
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582,041
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594,106
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Right-of-use assets - operating leases
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2,767,804
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2,092,878
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Goodwill
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2,043,747
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2,043,747
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In-process research and development
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6,860,000
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6,860,000
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Security deposits and other assets
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514,881
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453,252
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Total assets
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$
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64,709,646
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$
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13,776,760
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LIABILITIES AND STOCKHOLDERS' DEFICIT
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Current liabilities:
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Accounts payable
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$
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3,679,311
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$
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1,275,223
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Accrued expenses
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1,916,126
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1,051,020
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Loans payable
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410,000
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410,000
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PPP loan, current
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309,905
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115,972
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Operating lease liabilities, current
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383,923
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273,217
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Other current liabilities
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985,233
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-
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Total current liabilities
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7,684,498
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3,125,432
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Contingent consideration
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19,290,000
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20,110,000
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Operating lease liabilities, non-current
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2,529,422
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1,905,395
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PPP loan, non-current
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-
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193,933
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Other liabilities
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22,863
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22,863
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Total liabilities
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29,526,783
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25,357,623
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Stockholders' and members' equity (deficit):
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||||||||
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Class A membership units
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-
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23,202,005
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Class B membership units
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-
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1,400,000
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Class C membership units
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-
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1,000,000
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Common units
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-
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197,873
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Common stock, $0.005 par value, 100,000,000 shares authorized, 44,707,382 issued and outstanding at June 30, 2021; no shares issued and outstanding at December 31, 2020.
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223,537
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-
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||||||
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Series A preferred stock
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781
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-
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Additional paid-in capital
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100,134,743
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-
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Accumulated deficit
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(65,176,198
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)
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(37,380,741
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)
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Total stockholders' and members' equity (deficit)
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35,182,863
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(11,580,863
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)
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Total liabilities and stockholders' and members' equity (deficit)
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$
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64,709,646
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$
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13,776,760
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4
BROOKLYN IMMUNOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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Three months ended June 30,
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Six months ended June 30,
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2021
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2020
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2021
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2020
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Operating expenses:
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||||||||||||||||
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Research and development
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5,392,777
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985,081
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6,912,410
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1,376,140
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General and administrative
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4,620,353
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1,034,120
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6,256,910
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1,657,595
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Transaction costs
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-
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-
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5,765,407
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-
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Change in fair value of contingent consideration
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-
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-
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(820,000
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)
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-
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Total operating expenses
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10,013,130
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2,019,201
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18,114,727
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3,033,735
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Loss from operations
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(10,013,130
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)
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(2,019,201
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)
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(18,114,727
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)
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(3,033,735
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)
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||||||||
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Other expenses:
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||||||||||||||||
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Loss on sale of NTN assets
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(50,000
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)
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-
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(9,648,173
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)
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-
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||||||||||
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Other expense, net
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(22,187
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)
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(14,245
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)
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(24,751
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)
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(18,923
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)
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||||||||
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Total other expenses
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(72,187
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)
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(14,245
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)
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(9,672,924
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)
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(18,923
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)
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||||||||
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Net loss
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(10,085,317
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)
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(2,033,446
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)
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(27,787,651
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)
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(3,052,658
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)
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||||||||
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Series A preferred stock dividend
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(7,806
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)
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-
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(7,806
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)
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-
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||||||||||
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Net loss attributable to common stockholders
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$
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(10,093,123
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)
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$
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(2,033,446
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)
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$
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(27,795,457
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)
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$
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(3,052,658
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)
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||||
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Net loss per common share - basic and diluted
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$
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(0.24
|
)
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$
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(0.12
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)
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$
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(0.79
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)
|
$
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(0.17
|
)
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||||
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Weighted average shares outstanding - basic and diluted
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42,448,188
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17,583,489
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35,187,292
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17,542,750
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||||||||||||
5
BROOKLYN IMMUNOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
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For the six months ended
June 30, |
||||||||
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2021
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2020
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|||||||
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Cash flows used in operating activities:
|
||||||||
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Net loss
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$
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(27,787,651
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)
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$
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(3,052,658
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)
|
||
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Adjustments to reconcile net loss to net cash used in operating activities:
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||||||||
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Depreciation and amortization
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63,485
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47,638
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||||||
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Stock-based compensation
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1,573,393
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45,468
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||||||
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Amortization of right-to-use asset
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148,702
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-
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||||||
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Transaction costs - shares to Financial Advisor
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5,765,407
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-
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||||||
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Loss on sale of NTN assets
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9,648,173
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-
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||||||
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Change in fair value of contingent consideration
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(820,000
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)
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-
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|||||
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Changes in operating assets and liabilities:
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||||||||
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Account receivable
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4,680
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-
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||||||
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Prepaid expenses and other current assets
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(1,509,284
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)
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(79,175
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)
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||||
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Security deposits and other non-current assets
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(26,909
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)
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(84,915
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)
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||||
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Accounts payable and accrued expenses
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2,844,135
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(942,836
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)
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|||||
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Operating lease liability
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(138,895
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)
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(468
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)
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||||
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Other liabilities
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-
|
10,324
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||||||
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Net cash used in operating activities
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(10,234,764
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)
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(4,056,622
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)
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||||
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Cash flows provided by (used in) investing activities:
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||||||||
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Purchase of property and equipment
|
-
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(26,177
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)
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|||||
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Purchase of NTN, net of cash acquired
|
147,262
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-
|
||||||
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Proceeds from the sale of NTN assets, net of cash disposed
|
118,594
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-
|
||||||
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Net cash provided by (used in) investing activities
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265,856
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(26,177
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)
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|||||
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Cash flows provided by financing activities:
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||||||||
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Net proceeds of common stock issued to Lincoln Park
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48,524,918
|
-
|
||||||
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Proceeds from the exercise of stock options
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10,202
|
-
|
||||||
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Proceeds from loans payable
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-
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309,905
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||||||
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Repayment of NTN's PPP Loan
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(531,994
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)
|
-
|
|||||
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Proceeds from sale of members' equity
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10,500,000
|
3,858,750
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||||||
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Net cash provided by financing activities
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58,503,126
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4,168,655
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||||||
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Net increase in cash and cash equivalents
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48,534,218
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85,856
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||||||
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Cash and cash equivalents at beginning of period
|
1,630,455
|
5,100,819
|
||||||
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Cash and cash equivalents at end of period
|
$
|
50,164,673
|
$
|
5,186,675
|
||||
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Supplemental disclosures of cash flow information:
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||||||||
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Cash paid during the period for:
|
||||||||
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Interest
|
$
|
-
|
$
|
-
|
||||
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|
||||||||
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Income taxes
|
$
|
-
|
$
|
-
|
||||
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Supplemental disclosure of non-cash investing and financing activities:
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||||||||
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Issuance of common stock for Series A preferred stock dividend
|
$
|
7,806
|
$
|
-
|
||||
|
|
||||||||
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Issuance of Common Stock for business combination
|
$
|
8,177,457
|
$
|
-
|
||||
|
|
||||||||
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Forfeiture of unvested restricted stock
|
$
|
(60
|
)
|
$
|
-
|
|||
|
|
||||||||
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Preferred shares issued in connection with reverse merger
|
$
|
781
|
$
|
-
|
||||
|
|
||||||||
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Initial measurement of ROU assets and liabilities
|
$
|
873,629
|
$
|
-
|
||||
Forward-Looking Statements
The third, fourth and fifth paragraphs of this release and the second and third paragraphs under the heading “Financial Results for Quarter Ended June 30, 2021” contain
forward-looking statements 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, which are intended to be covered by the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements are any statements that are not statements of historical fact and may be identified by terminology such as “believe,” “could,” “estimate,” “plan,” “possible,” “potential,” “project,”
“will” or other similar words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those stated or
implied in any forward-looking statement as a result of various factors, including, but not limited to, uncertainties related to: (i) the evolution of Brooklyn’s business model into a platform company focused on cellular, gene editing and cytokine
programs; (ii) Brooklyn’s ability to successfully, cost-effectively and efficiently develop its technology and products; (iii) Brooklyn’s ability to successfully commence clinical trials of any products on a timely basis or at all; (iv) Brooklyn’s
ability to successfully fund and manage the growth of its development activities; (v) Brooklyn’s ability to obtain regulatory approvals of its products for commercialization; and (vi) uncertainties related to the impact of the COVID-19 pandemic on the
business and financial condition of Brooklyn, including on the timing and cost of its clinical trials. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this communication speak
only as of the date on which they were made, and Brooklyn does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as may be
required by applicable law or regulation. Factors that may impact Brooklyn's success are more fully disclosed in Brooklyn's periodic public filings with the U.S. Securities and Exchange Commission, particularly under the heading “Risk Factors.”
Investor Relations Contact:
CORE IR
CORE IR
516-222-2560
investors@brooklynitx.com
Media Contact:
Jules Abraham
CORE IR
917-885-7378
julesa@coreir.com