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0001029125
0001029125
2023-01-19
2023-01-19
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
January 19, 2023
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Date of Report (Date of Earliest Event Reported)
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Panbela Therapeutics, Inc.
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(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-39468
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88-2805017
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(State of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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712 Vista Blvd #305
Waconia, Minnesota
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55387
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(Address of Principal Executive Offices)
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(Zip Code)
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(952) 479-1196
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(Registrant’s Telephone Number, Including Area Code)
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(Former Name or Former Address, if Changed Since Last Report.)
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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 (see General Instruction A.2. below):
☐ 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
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Trading Symbol
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Name of each exchange on which registered
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Common Stock, $0.001 par value
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PBLA
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The Nasdaq Stock Market LLC
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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.
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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 7.01.
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Regulation FD Disclosure.
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On January 19, 2023, Panbela Therapeutics, Inc. (the “Company”) issued a press release announcing that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has issued the Adoption of Commission Implementing Decision relating to the designation of ivospemin (SBP-101) as an orphan medicinal product in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA). The U.S. Food and Drug Administration previously granted orphan drug designation to SBP-101. The text of the press release is furnished as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.
The information contained in this item 7.01 and Exhibit 99.1 is being furnished, and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under Section 18. Furthermore, the information contained in this Item 7.01 and Exhibit 99.1 shall not be deemed to be incorporated by reference into the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01
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Financial Statements and Exhibits.
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Exhibit No.
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Description
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Method of Filing
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99.1
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Furnished Electronically
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report to be signed on its behalf by the undersigned hereunto duly authorized.
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Panbela Therapeutics, Inc.
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Date: January 19, 2023
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By:
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/s/ Susan Horvath
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Susan Horvath
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Chief Financial Officer
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