Panbela Therapeutics, Inc.

MINNEAPOLIS, March 16, 2023 (GLOBE NEWSWIRE) — Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage enterprise establishing disruptive therapeutics for the remedy of sufferers with urgent unmet healthcare desires, nowadays gives a business enterprise update and reports economic outcomes for the quarter and complete year ended December 31, 2022. As previously announced, management is hosting earnings contact nowadays at four:30 p.m. ET.

2022 and early 2023 Highlights:

• Substantial progress was created on the conduct of the ASPIRE worldwide clinical trial studying ivospemin (SBP-101) in mixture with gemcitabine and nab-paclitaxel in the very first-line remedy of metastatic pancreatic ductal adenocarcinoma:

  • Initiated ASPIRE trial in January 2022

  • Received approval from the Australian Human Analysis Ethics Committee (HREC) to expand the ASPIRE worldwide clinical trial to Australia

  • Enrolled very first patient in South Korea

  • Enrolled very first patient in Europe

  • Enrolled very first patient in Australia

  • Received approvals to open trial web-sites in Spain, France and Italy

• An abstract for ivospemin will be presented at the American Association for Cancer Analysis (AACR), which will be held April 14-19, 2023. The perform reflects the Company’s on-going collaboration with Johns Hopkins University College of Medicine

• Closed a registered public providing yielding gross proceeds of around $15 million in Q1 of 2023

• Began Phase II Trial of CPP-1X-T for Current Onset Kind I Diabetes in January 2023, in collaboration with Indiana University and the Juvenile Diabetes Analysis Foundation

• European Medicines Agency (EMA) Committee for Orphan Medicinal Items issued the Adoption of Commission Implementing Choice relating to the designation of ivospemin as an orphan medicinal item in March 2023

• Closed a registered public providing yielding gross proceeds of around $six. million in Q4 of 2022

• Hosted an R&ampD contact joined by top specialists for a deep dive on the company’s investigational drug, ivospemin, as a polyamine metabolism modulator in ovarian cancer

• Completed the acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP)

• Presented a poster highlighting the outcomes for ivospemin as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Analysis (AACR) in April 2022

• Presented a poster highlighting the Clinical Information on Phase 1b Clinical Trial of ivospemin in Mixture with Gemcitabine and Nab-Paclitaxel in Individuals with Metastatic PDA at 2022 ASCO GI Meeting

Story continues

“During Q4 and year to date, we progressed our pipeline, which has been principally funded by means of collaborations,” mentioned Jennifer K. Simpson, PhD, MSN, CRNP, President &amp Chief Executive Officer of Panbela. “Milestones accomplished integrated very first sufferers enrolled in Australia, Europe and South Korea in our ASPIRE worldwide trial for metastatic pancreatic cancer, and EMA Orphan drug designation. Also, we bolstered our balance sheet with gross proceeds from current public offerings. As we move forward in 2023, we anticipate a constant stream of milestones to drive shareholder worth.”

Fourth Quarter ended December 31, 2022 Monetary Outcomes

Basic and administrative costs had been $1.7 million in the fourth quarter of 2022, compared to $1.three million in the fourth quarter of 2021. The boost mainly is due to severance costs connected with the acquisition of CPP.

Analysis and improvement costs had been $three.five million in the fourth quarter of 2022, compared to $two. million in the fourth quarter of 2021. The adjust is due mainly to an boost in spending on our clinical research as we expanded the ASPIRE clinical trial.

Net loss in the fourth quarter of 2022 was $four.7 million, or $five.68 per diluted share, compared to a net loss of $three.five million, or $ten.54 per diluted share, in the fourth quarter of 2021. All share and per-share amounts have been restated to reflect the 40-for-1 reverse split of our popular stock, which was helpful on January 13, 2023.

Total money was $1.three million as of December 31, 2022. Total present assets had been $1.eight million and present liabilities had been $7.eight million as of the very same date. Notes payable, plus accrued interest, on the balance sheet, the outcome of the acquisition of CPP, totaled around $7.two million. The present portion of the notes payable plus accrued interest totaled around $two. million.

Subsequent to the finish of the year, the Corporation completed a registered public providing. Gross proceeds from the raise, which closed on January 30, 2023, had been around $15 million.

Conference Contact Details

Toll No cost: 888-506-0062
International: 973-528-0011
Participant Access Code: 116790
Webcast Hyperlink: https://www.webcaster4.com/Webcast/Web page/2556/47782

Conference Contact Replay Details

Toll No cost: 877-481-4010
International: 919-882-2331
Replay Passcode: 47782
Webcast Replay: https://www.webcaster4.com/Webcast/Web page/2556/47782

About Panbela’s Pipeline
The pipeline consists of assets presently in clinical trials with an initial concentrate on familial adenomatous polyposis (FAP), very first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined improvement applications have a steady cadence of catalysts with applications ranging from pre-clinical to registration research.

Ivospemin (SBP-101)
Ivospemin is a proprietary polyamine analogue developed to induce polyamine metabolic inhibition (PMI) by exploiting an observed higher affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor development inhibition in clinical research of metastatic pancreatic cancer sufferers, demonstrating a median general survival (OS) of 14.six months and an objective response price (ORR) of 48%, each exceeding what is standard for the normal of care of gemcitabine + nab-paclitaxel suggesting prospective complementary activity with the current FDA-authorized normal chemotherapy regimen. In information evaluated from clinical research to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-associated adverse events. Really serious visual adverse events have been evaluated and sufferers with a history of retinopathy or at danger of retinal detachment will be excluded from future SBP-101 research. The security information and PMI profile observed in the preceding Panbela-sponsored clinical trials deliver help for continued evaluation of ivospemin in the ASPIRE trial.

Flynpovi ™
Flynpovi is a mixture of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and escalating polyamine export and catabolism. In a Phase three clinical trial in sufferers with sporadic massive bowel polyps, the mixture prevented &gt 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP sufferers with reduced gastrointestinal tract anatomy in the current Phase three trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP sufferers with reduced GI anatomy (sufferers with an intact colon, retained rectum or surgical pouch), showed statistically important advantage compared to each single agents (p≤0.02) in delaying surgical events in the reduced GI for up to 4 years. The security profile for Flynpovi did not considerably differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X
CPP-1X (eflornithine) is becoming created as a single agent tablet or higher dose powder sachet for quite a few indications such as prevention of gastric cancer, remedy of neuroblastoma and current onset Kind 1 diabetes. Preclinical research as effectively as Phase 1 or Phase two investigator-initiated trials recommend that CPP-1X remedy may possibly be effectively-tolerated and has prospective activity.

About Panbela
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical enterprise establishing disruptive therapeutics for sufferers with urgent unmet healthcare desires. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Additional data can be discovered at www.panbela.com. Panbela’s popular stock is listed on The Nasdaq Stock Industry LLC beneath the symbol “PBLA”.

Cautionary Statement With regards to Forward-Searching Statements
This press release includes “forward-searching statements,” such as inside the which means of the Private Securities Litigation Reform Act of 1995. Forward-searching statements can be identified by words such as: “aim,” “anticipate,” “believe,” “design,” “expect,” “feel,” “focus,” “intend,” “may,” “plan,” “potential,” “scheduled,” and “will.” All statements other than statements of historical truth are statements that must be deemed forward-searching statements. Forward-searching statements are neither historical details nor assurances of future efficiency. Instead, they are primarily based only on our present beliefs, expectations, and assumptions relating to the future of our business enterprise, future plans and techniques, projections, anticipated events and trends, the economy and other future circumstances. Since forward-searching statements relate to the future, they are topic to inherent uncertainties, dangers and alterations in situations that are tough to predict and several of which are outdoors of our manage. Our actual outcomes and economic situation may possibly differ materially and adversely from the forward-searching statements. Therefore, you must not rely on any of these forward-searching statements. Important aspects that could result in our actual outcomes and economic situation to differ materially from these indicated in the forward-searching statements incorporate, amongst other folks, the following: (i) our capability to receive added funding to execute our business enterprise and clinical improvement plans (ii) progress and accomplishment of our clinical improvement plan (iii) the influence of the present COVID-19 pandemic on our capability to conduct our clinical trials (iv) our capability to demonstrate the security and effectiveness of our item candidates: ivospemin (SBP-101) and eflornithine (CPP-1X) (v) our reliance on a third celebration for the execution of the registration trial for our item candidate Flynpovi (vi) our capability to receive regulatory approvals for our item candidates, SBP-101 and CPP-1X in the United States, the European Union or other international markets (vii) the marketplace acceptance and level of future sales of our item candidates, SBP-101 and CPP-1X (viii) the expense and delays in item improvement that may possibly outcome from alterations in regulatory oversight applicable to our item candidates, SBP-101 and CPP-1X (ix) the price of progress in establishing reimbursement arrangements with third-celebration payors (x) the impact of competing technological and marketplace developments (xi) the expenses involved in filing and prosecuting patent applications and enforcing or defending patent claims (xii) our capability to sustain the listing of our popular stock on a national securities exchange and (xiii) such other aspects as discussed in Portion I, Item 1A beneath the caption “Risk Factors” in our most current Annual Report on Kind ten-K, any added dangers presented in our Quarterly Reports on Kind ten-Q and our Present Reports on Kind eight-K. Any forward-searching statement created by us in this press release is primarily based on data presently readily available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-searching statement or causes why actual outcomes would differ from these anticipated in any such forward-searching statement, whether written or oral, whether as a outcome of new data, future developments or otherwise.

Speak to Details:

Investors:
James Carbonara
Hayden IR
(646) 755-7412
james@haydenir.com

Media:
Tammy Groene
Panbela Therapeutics, Inc.
(952) 479-1196
IR@panbela.com

Panbela Therapeutics, Inc.
Consolidated Statements of Operations and Complete Loss (unaudited)
(In thousands, except share and per share amounts)

3 months ended December 31,

Year ended December 31,

2022

2021

%
Transform

2022

2021

%
Transform

Operating costs:

Basic and administrative

$

1,661

$

1,272

30.six

%

$

six,044

$

four,587

31.eight

%

Analysis and improvement

three,463

two,049

69.

%

28,049

five,423

417.two

%

Operating loss

(five,124

)

(three,321

)

54.three

%

(34,093

)

(ten,010

)

240.six

%

Other earnings (expense):

Interest earnings

three

—

14

1

1300.

%

Interest expense

(181

)

(two

)

8950.

%

(288

)

(12

)

2300.

%

Other earnings (expense)

556

three

18433.three

%

(682

)

(602

)

13.three

%

Total other earnings (expense)

378

1

37700.

%

(956

)

(613

)

56.

%

Loss prior to earnings tax advantage

(four,746

)

(three,320

)

43.

%

(35,049

)

(ten,623

)

229.9

%

Earnings tax advantage

13

(218

)

-106.

%

116

488

-76.two

%

Net loss

(four,733

)

(three,538

)

33.eight

%

(34,933

)

(ten,135

)

244.7

%

Foreign currency translation adjustment  (loss)

(615

)

(50

)

1130.

%

626

517

21.1

%

Complete Loss

$

(five,348

)

$

(three,588

)

49.1

%

$

(34,307

)

$

(9,618

)

256.7

%

Standard and diluted net loss per share

$

(five.68

)

$

(ten.54

)

-46.1

%

$

(67.91

)

$

(34.64

)

96.

%

Weighted typical shares outstanding  – standard and diluted

832,844

335,803

148.

%

514,369

292,607

75.eight

%

Panbela Therapeutics, Inc.
Consolidated Balance Sheets (unaudited)
(In thousands, except share amounts)

December 31, 2022

December 31, 2021

ASSETS

Present assets:

Money and money equivalents

$

1,285

$

11,867

Prepaid costs and other present assets

443

91

Earnings tax receivable

49

321

Total present assets

1,777

12,279

Other noncurrent assets

three,201

593

Total assets

$

four,978

$

12,872

LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY

Present liabilities:

Accounts payable

$

two,865

$

640

Accrued costs

two,993

two,020

Accrued interest payable

325

—

Note payable

650

—

Debt, present portion

1,000

—

Total present liabilities

7,833

two,660

Debt, net of present portion

five,194

—

Total non present liabilities

five,194

—

Total liabilities

13,027

two,660

Stockholders’ (deficit) equity:

Preferred stock, $.001 par worth ten,000,000 authorized no shares issued or outstanding as of December 31, 2022 and December 31, 2021

—

—

Typical stock, $.001 par worth one hundred,000,000 authorized 1,049,644 and 335,961 shares issued and outstanding, as of December 31, 2022 and December 31, 2021, respectively

1

—

Added paid-in capital

82,285

66,240

Accumulated deficit

(91,094

)

(56,161

)

Accumulated complete earnings

759

133

Total stockholders’ (deficit) equity

(eight,049

)

ten,212

Total liabilities and stockholders’ (deficit) equity

$

four,978

$

12,872

Panbela Therapeutics, Inc.
Consolidated Statements of Money Flows (unaudited) 
(In thousands)

Year Ended December 31,

2022

2021

Money flows from operating activities:

Net loss

$

(34,933

)

$

(ten,135

)

Adjustments to reconcile net loss to net money employed in operating activities:

Create off of in method investigation and improvement (IPR&ampD)

17,737

—

Stock-primarily based compensation

1,088

1,287

Non-money interest expense

273

—

Modifications in operating assets and liabilities:

Earnings tax receivable

212

51

Prepaid costs and other present assets

(127

)

247

Deposits held for clinical trial expenses

(two,561

)

(540

)

Accounts payable

two,249

631

Accrued liabilities

786

1,214

Net money employed in operating activities

(15,276

)

(7,245

)

Money flows from investing activities:

Investment in IPR&ampD

(660

)

—

Money acquired in merger

four

—

Net money employed in investing activities

(656

)

—

Money flows from financing activities:

Proceeds from sale of popular stock,net of costs and providing expenses of $44

46

—

Proceeds from public providing of popular stock and warrants net of underwriters discount and providing expenses of $727

five,303

—

Proceeds from public providing of popular stock net of underwriters discount and providing expenses of $946

—

9,054

Proceeds from workout of warrants

five

1,042

Net money offered by financing activities

five,354

ten,096

Impact of exchange price alterations on money

(four

)

(six

)

Net adjust in money

(ten,582

)

two,845

Money and money equivalents at starting of year

11,867

9,022

Money and money equivalents at finish of year

$

1,285

$

11,867

Supplemental disclosure of money flow data:

Money paid for the duration of period for interest

$

15

$

12

Supplemental disclosure of non-money transactions:

Fair worth of popular stock, stock possibilities and stock warrants issued as consideration for asset acquisition

$

9,605

$

—