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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
Date of Report (Date of Earliest Event Reported)
 
Panbela Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)
 
Delaware
  
001-39468
  
88-2805017
(State of Incorporation)
  
(Commission File Number)
  
(I.R.S. Employer Identification No.)
 
712 Vista Blvd #305
Waconia, Minnesota
  
55387
(Address of Principal Executive Offices)
  
(Zip Code)
 
 
(952) 479-1196
(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 (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
  
Trading Symbol
  
Name of each exchange on which registered
Common Stock, $0.001 par value
  
PBLA
  
The Nasdaq Stock Market LLC
 
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 7.01.
Regulation FD Disclosure.
 
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
Financial Statements and Exhibits.
 
 
(d)
Exhibits.
 
Exhibit No.
  
Description
  
Method of Filing
99.1
    
Furnished Electronically
104
  
Cover Page Interactive Data File (embedded within the Inline XBRL document)
    
         
 
 
 
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.
 
Panbela Therapeutics, Inc.
Date: January 19, 2023
By:
/s/ Susan Horvath
Susan Horvath
Chief Financial Officer
 
 
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