Exhibit 99.1 Panbela Provides Business Update and Reports Q4 and FY 2024 Financial Results MINNEAPOLIS, March 26, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter and full year ended December 31, 2023. As previously announced, management is hosting earnings call today at 4:30 p.m. ET. Collab ...

Panbela Therapeutics, Inc. (OTC:PBLA) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET Company Participants James Carbonara - IR Jennifer Simpson - CEO Sue Horvath - CFO Conference Call Participants Jonathan Aschoff - ROTH MKM Operator Greetings, and welcome to the Panbela Therapeutics Third Quarter 2023 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, James Carbonara, Investor Relations at Panbela. James, you ...

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements for Q3 2023, detailing financial position, operations, and cash flows [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) **Condensed Consolidated Balance Sheets (In thousands):** | Item | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------------- | :----------- | :----------- | | Cash and cash equivalents | $907 | $1,285 | | Total current assets | $1,886 | $1,777 | | Total assets | $10,628 | $4,978 | | Total current liabilities | $8,917 | $7,833 | | Total liabilities | $13,111 | $13,027 | | Total stockholders' deficit | $(2,483) | $(8,049) | - Total assets increased significantly from **$4,978 thousand** at December 31, 2022, to **$10,628 thousand** at September 30, 2023[10](index=10&type=chunk) - Stockholders' deficit improved from **$(8,049) thousand** at December 31, 2022, to **$(2,483) thousand** at September 30, 2023[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) **Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands):** | Item | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | General and administrative | $1,107 | $1,294 | $4,102 | $4,349 | | Research and development | $6,739 | $2,329 | $14,501 | $24,563 | | Operating loss | $(7,846) | $(3,623) | $(18,603) | $(28,912) | | Net loss | $(7,831) | $(4,402) | $(18,789) | $(30,198) | | Comprehensive loss | $(7,450) | $(3,675) | $(18,177) | $(28,958) | | Basic and diluted net loss per share | $(2.69) | $(257.36) | $(14.35) | $(2,255.96) | | Weighted average shares outstanding | 2,914,600 | 17,107 | 1,309,137 | 13,386 | - Net loss for the three months ended September 30, 2023, increased to **$7,831 thousand** from **$4,402 thousand** in the prior year period, primarily due to a significant increase in R&D expenses[13](index=13&type=chunk) - Net loss for the nine months ended September 30, 2023, decreased to **$18,789 thousand** from **$30,198 thousand** in the prior year period, largely due to a decrease in R&D expenses compared to 2022 which included a large IPR&D write-off[13](index=13&type=chunk) [Condensed Consolidated Statements of Stockholders' (Deficit) Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20(Deficit)%20Equity) **Changes in Stockholders' (Deficit) Equity (In thousands) for Nine Months Ended September 30, 2023:** | Item | Common Stock (Shares) | Common Stock (Amount) | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total Stockholders' (Deficit) Equity | | :-------------------------------- | :-------------------- | :-------------------- | :------------------------- | :------------------ | :------------------------------------- | :----------------------------------- | | Balance as of January 1, 2023 | 34,761 | $0 | $82,286 | $(91,094) | $759 | $(8,049) | | Proceeds from sale of Common Stock | 2,246,088 | $2 | $23,070 | $0 | $0 | $23,072 | | Net loss | 0 | $0 | $0 | $(18,789) | $0 | $(18,789) | | Foreign currency translation adjustment | 0 | $0 | $0 | $0 | $612 | $612 | | Balance as of September 30, 2023 | 2,996,334 | $3 | $106,026 | $(109,883) | $1,371 | $(2,483) | - The company's total stockholders' deficit improved from **$(8,049) thousand** at January 1, 2023, to **$(2,483) thousand** at September 30, 2023, primarily due to proceeds from common stock sales[17](index=17&type=chunk) - Common stock shares outstanding increased significantly from **34,761** to **2,996,334**, reflecting public offerings and warrant exercises, adjusted for reverse stock splits[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) **Condensed Consolidated Statements of Cash Flows (In thousands) for Nine Months Ended September 30:** | Item | 2023 | 2022 | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(22,169) | $(10,273) | | Net cash provided by (used) in investing activities | $400 | $(656) | | Net cash provided by financing activities | $21,393 | $5 | | Net change in cash | $(378) | $(10,926) | | Cash and cash equivalents at end of period | $907 | $941 | - Net cash used in operating activities more than doubled to **$22,169 thousand** in 2023 from **$10,273 thousand** in 2022, driven by increased R&D costs and long-term deposits[23](index=23&type=chunk)[117](index=117&type=chunk) - Net cash provided by financing activities significantly increased to **$21,393 thousand** in 2023, primarily from the sale of common stock and warrants, compared to **$5 thousand** in 2022[23](index=23&type=chunk)[119](index=119&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [1. Business](index=10&type=section&id=1.%20Business) - Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing disruptive therapeutics for urgent unmet medical needs, primarily utilizing pharmacotherapies to reduce or normalize increased disease-associated polyamines[26](index=26&type=chunk) - Lead candidates include ivospemin (SBP-101), licensed worldwide from the University of Florida Research Foundation, and Flynpovi™ (eflornithine and sulindac) and eflornithine (CPP-1X) alone, licensed from the Arizona Board of Regents[26](index=26&type=chunk) - The sublicense agreement to develop and commercialize Flynpovi in North America was terminated by the licensee on April 4, 2023[26](index=26&type=chunk) [2. Risks and Uncertainties](index=10&type=section&id=2.%20Risks%20and%20Uncertainties) - The company has incurred cumulative losses of **$109.9 million** since inception and a net loss of **$18.8 million** for the nine months ended September 30, 2023, with negative cash flows from operating activities of **$22.2 million**[29](index=29&type=chunk) - As of September 30, 2023, the company had cash of **$0.9 million**, a working capital deficit of **$7.0 million**, and a stockholders' deficit of **$2.5 million**, raising substantial doubt about its ability to continue as a going concern[29](index=29&type=chunk)[30](index=30&type=chunk) - Future operations are dependent on obtaining additional financing, successful development efforts, and marketing approval for product candidates, with no assurance of securing funds on acceptable terms[30](index=30&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk) [3. Basis of Presentation](index=11&type=section&id=3.%20Basis%20of%20Presentation) - The interim condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and SEC regulations, reflecting all necessary adjustments for fair presentation[32](index=32&type=chunk) - These statements do not include all information and footnotes required for complete annual financial statements and should be read in conjunction with the most recent Annual Report on Form 10-K[32](index=32&type=chunk) [4. Liquidity and Business Plan](index=11&type=section&id=4.%20Liquidity%20and%20Business%20Plan) - The company completed registered public offerings in June 2023 and January 2023, generating net proceeds of approximately **$7.7 million** and **$13.8 million**, respectively, from common stock, pre-funded warrants, and warrants[33](index=33&type=chunk)[34](index=34&type=chunk) - An additional **$1.6 million** in net proceeds was received in Q1 2023 from the ATM Program, though no sales occurred in Q2 2023[34](index=34&type=chunk) - The company requires additional capital to support current business plans and future operations, with no assurance of securing sufficient funds on acceptable terms, which could lead to scaling back operations or ceasing business[35](index=35&type=chunk)[36](index=36&type=chunk) [5. Summary of Significant Accounting Policies](index=11&type=section&id=5.%20Summary%20of%20Significant%20Accounting%20Policies) [Principles of consolidation](index=11&type=section&id=Principles%20of%20consolidation) - The condensed consolidated financial statements include assets, liabilities, and expenses of Panbela Therapeutics, Inc. and its direct and indirect subsidiaries, with all significant intercompany transactions eliminated[38](index=38&type=chunk) [Use of estimates](index=12&type=section&id=Use%20of%20estimates) - Preparation of financial statements requires management to make estimates and assumptions, which may differ from actual results, especially given current economic uncertainties[39](index=39&type=chunk) [Research and development costs](index=12&type=section&id=Research%20and%20development%20costs) - R&D costs, including clinical trial expenses, third-party services, sponsored research, manufacturing development, consulting, personnel, and intellectual property licensing, are expensed as incurred[40](index=40&type=chunk) - Clinical trial costs are accrued based on contracted amounts and milestone achievement, with estimates adjusted quarterly based on performance monitoring[41](index=41&type=chunk) - R&D costs for 2022 included a write-off of In-Process Research and Development (IPR&D) acquired from CPP[42](index=42&type=chunk) [Stock-based compensation](index=12&type=section&id=Stock-based%20compensation) - Stock-based compensation expense for employee and non-employee services is measured and recognized based on the fair value of awards at the grant date, using the Black-Scholes option pricing model[44](index=44&type=chunk)[45](index=45&type=chunk) - Compensation cost is recognized ratably over the vesting period, with performance-based awards recognized when performance is probable[44](index=44&type=chunk) [Foreign currency translation adjustments](index=13&type=section&id=Foreign%20currency%20translation%20adjustments) - Assets, liabilities, and equity transactions of Panbela Therapeutics Pty Ltd (functional currency Australian Dollar) are translated into U.S. dollars at period-end exchange rates, with revenues and expenses translated at average rates[46](index=46&type=chunk) - Resulting translation gains and losses are recorded as a component of accumulated comprehensive loss within stockholders' equity[46](index=46&type=chunk) [Comprehensive loss](index=13&type=section&id=Comprehensive%20loss) - Comprehensive loss comprises the company's net loss and the effects of foreign currency translation[47](index=47&type=chunk) [Net loss per share](index=13&type=section&id=Net%20loss%20per%20share) - Basic net loss per share is calculated by dividing net loss by the weighted-average common shares outstanding; diluted net loss per share includes potential common shares unless anti-dilutive[48](index=48&type=chunk) **Potential Shares of Common Stock Not Included in Diluted Net Loss Per Share (Anti-dilutive):** | Item | September 30, 2023 | September 30, 2022 | | :-------------------------------- | :----------------- | :----------------- | | Employee and non-employee stock options | 13,455 | 3,352 | | Common stock issuable under common stock purchase warrants | 4,068,826 | 4,538 | | Total | 4,082,281 | 7,890 | [6. Notes Payable](index=13&type=section&id=6.%20Notes%20Payable) - As of September 30, 2023, CPP had an outstanding balance of approximately **$5.4 million** (principal and interest) under the Sucampo Note, with a principal balance of **$5.2 million** bearing 5% simple interest[50](index=50&type=chunk) - Scheduled payments include **$1.0 million** plus accrued interest by January 31, 2024, 2025, and 2026, with the remaining balance due by January 31, 2027. Panbela guarantees CPP's payment obligations[50](index=50&type=chunk) - The Tillotts promissory note, with an initial principal of **$650,000**, was paid in full on January 31, 2023[52](index=52&type=chunk) [7. Stockholders' Equity](index=14&type=section&id=7.%20Stockholders'%20Equity) - In June 2023, the company completed a public offering, issuing **586,000** common shares, **1,684,000** pre-funded warrants, and **4,540,000** warrants, generating approximately **$7.7 million** in net proceeds. All pre-funded warrants were exercised by September 30, 2023[53](index=53&type=chunk) - In January 2023, another public offering issued **161,407** common shares, **61,090** pre-funded warrants, and **444,999** warrants, yielding approximately **$13.8 million** in net proceeds. All pre-funded warrants were exercised by February 3, 2023[56](index=56&type=chunk)[57](index=57&type=chunk) - The company conducted two reverse stock splits: **1-for-30** effective June 1, 2023, and **1-for-40** effective January 13, 2023, to increase per-share market price and maintain Nasdaq listing compliance[61](index=61&type=chunk)[62](index=62&type=chunk) **Shares Reserved for Future Issuance as of September 30, 2023:** | Item | Shares | | :-------------------------------- | :----- | | Stock options outstanding | 13,455 | | Shares available for grant under equity incentive plan | - | | Warrants outstanding | 4,068,826 | | Total | 4,082,281 | [8. Stock-based Compensation](index=15&type=section&id=8.%20Stock-based%20Compensation) - The company operates under the 2016 Omnibus Incentive Plan, with **12,054** stock options outstanding and no shares remaining for future awards as of September 30, 2023[64](index=64&type=chunk) - Stock-based compensation expense for the nine months ended September 30, 2023, totaled **$699 thousand**, down from **$857 thousand** in the same period of 2022[68](index=68&type=chunk)[105](index=105&type=chunk) **Stock-based Compensation Expense (in thousands) for Nine Months Ended September 30:** | Category | 2023 | 2022 | | :-------------------------------- | :----- | :----- | | General and Administrative | $554 | $697 | | Research and Development | $145 | $160 | | Total | $699 | $857 | **Stock Options Outstanding, Vested and Expected to Vest as of September 30, 2023:** | Per Share Exercise Price | Shares | Weighted Average Remaining Contractual Life (Years) | Weighted Average Exercise Price | | :----------------------- | :----- | :---------------------------------- | :------------------------------ | | $15 | 10,240 | 9.50 | $15 | | $264 | 1,150 | 7.26 | $264 | | $1,764 - $3,540 | 582 | 5.01 | $3,215 | | $3,810 - $4,908 | 498 | 5.57 | $4,493 | | $5,004 - $7,320 | 428 | 6.14 | $6,102 | | $9,720 - $18,120 | 557 | 4.81 | $12,987 | | Totals | 13,455 | 8.66 | $1,071 | [9. Gain on Sale of Intellectual Property](index=17&type=section&id=9.%20Gain%20on%20Sale%20of%20Intellectual%20Property) - On July 17, 2023, the company divested certain rights to its eflornithine pediatric neuroblastoma program, entitling it to receive up to **$9.5 million** in non-dilutive funding[70](index=70&type=chunk) - An initial payment of **$400,000** was received at closing and recognized as a gain on sale of intellectual property in Q3 2023, with future milestone payments not recognized due to uncertain probability[70](index=70&type=chunk) [10. Subsequent Events](index=17&type=section&id=10.%20Subsequent%20Events) - On November 2, 2023, the company entered into inducement offer letters with certain warrant holders, who agreed to exercise existing warrants for **2,130,000 shares** at a reduced price of **$0.78 per share**[71](index=71&type=chunk)[101](index=101&type=chunk) - In exchange, the company issued new warrants to purchase up to **4,260,000 shares** and made a cash payment of **$0.125** per existing warrant share[71](index=71&type=chunk)[101](index=101&type=chunk) - The transaction generated approximately **$1.9 million** in aggregate gross proceeds, with **$115,659** incurred in investment banking fees[71](index=71&type=chunk)[101](index=101&type=chunk) - The company agreed to file a Form S-3 registration statement for the resale of Inducement Warrant Shares and is restricted from issuing common stock or equivalents, or filing other registration statements, until stockholder approval[72](index=72&type=chunk)[102](index=102&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operations, and product development, highlighting capital needs and clinical risks [Overview](index=19&type=section&id=Overview) - Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for urgent unmet medical needs, focusing on a polyamine platform[77](index=77&type=chunk)[79](index=79&type=chunk) - Lead candidates include ivospemin (SBP-101) and Flynpovi (eflornithine (CPP-1X) and Sulindac), with exclusive worldwide licenses[78](index=78&type=chunk) - The company is engaged in sponsored research agreements with Johns Hopkins University School of Medicine and MD Anderson Cancer Center to evaluate polyamines for various diseases[79](index=79&type=chunk) [Ivospemin (SBP-101)](index=20&type=section&id=Ivospemin%20(SBP-101)) - The FDA accepted the IND application for ivospemin in 2015, and it was adopted as a USAN for SBP-101 in May 2022[80](index=80&type=chunk) - A Phase Ia/Ib study of ivospemin combined with gemcitabine and nab-paclitaxel in pancreatic cancer showed a median overall survival of **14.6 months**, with some patients demonstrating long-term survival[82](index=82&type=chunk) - The ASPIRE trial, a randomized double-blind placebo-controlled Phase II/III trial for metastatic pancreatic cancer, initiated in January 2022, has **81 sites** open in **10 countries** as of September 30, 2023, with interim analysis expected in early 2024[83](index=83&type=chunk)[85](index=85&type=chunk) - Pre-clinical studies suggest ivospemin in combination with chemotherapy may be effective in ovarian cancer, with further studies planned[86](index=86&type=chunk) [Flynpovi (eflornithine (CPP-1X) and sulindac)](index=20&type=section&id=Flynpovi%20(eflornithine%20(CPP-1X)%20and%20sulindac)) - A Phase III study of Flynpovi for familial adenomatous polyposis (FAP) failed its primary endpoint but showed statistically significant risk reductions for the need for lower gastrointestinal (LGI) surgery in a post-hoc analysis[89](index=89&type=chunk) - The FDA issued a complete response letter for the NDA, requiring additional clinical trials demonstrating an effect on a clinical endpoint[89](index=89&type=chunk) - The company regained North American rights to develop and commercialize Flynpovi for FAP in April 2023[90](index=90&type=chunk) - The PACES trial, a NCI-funded Phase III study of Flynpovi to prevent recurrence of high-risk adenomas and second primary colorectal cancers, passed a pre-planned futility analysis on June 28, 2023[91](index=91&type=chunk) [Eflornithine (CPP-1X)/eflornithine sachets (CPP-1X-S)](index=21&type=section&id=Eflornithine%20(CPP-1X)/eflornithine%20sachets%20(CPP-1X-S)) - IND applications for eflornithine were accepted by the FDA in 2009 and 2018[92](index=92&type=chunk) - A trial evaluating eflornithine sachets in STK11 mutation patients with non-small cell lung cancer is scheduled to begin, and a Phase II trial for early onset Type I diabetes opened in January 2023[93](index=93&type=chunk) - On July 17, 2023, the company divested rights to its eflornithine pediatric neuroblastoma program, receiving an initial **$400,000** payment and potential future milestone payments up to **$9.5 million**[94](index=94&type=chunk) [Financial Overview](index=21&type=section&id=Financial%20Overview) - The company incurred cumulative losses of **$109.9 million** since 2011 and a net loss of **$18.8 million** for the nine months ended September 30, 2023[96](index=96&type=chunk) - Cash and cash equivalents decreased by **$0.4 million** to **$0.9 million** as of September 30, 2023, primarily due to **$21.8 million** in negative cash flow from operations, partially offset by **$21.4 million** from financing activities[97](index=97&type=chunk) - Increased R&D costs were driven by approximately **$3.1 million** for Abraxane supply for the ASPIRE trial and an additional **$0.5 million** in prepayments for standard of care drugs[97](index=97&type=chunk) - The company needs to raise additional capital to continue operations beyond Q3 2023 and execute its business plan, with no assurance of obtaining financing on commercially reasonable terms[98](index=98&type=chunk) [Warrant Transaction After Period End](index=22&type=section&id=Warrant%20Transaction%20After%20Period%20End) - On November 2, 2023, the company received approximately **$1.9 million** in gross proceeds from warrant exercises at a reduced price of **$0.78 per share**, in exchange for issuing new warrants and a cash payment[101](index=101&type=chunk) - The company incurred **$115,659** in investment banking fees related to this transaction[101](index=101&type=chunk) - The company agreed to file a Form S-3 registration statement for the resale of the new warrant shares and is restricted from certain equity issuances or filings until stockholder approval[102](index=102&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) **Comparison of Results of Operations (in thousands):** | Item | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | % Change | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | % Change | | :-------------------------------- | :------------------------------ | :------------------------------ | :------- | :----------------------------- | :----------------------------- | :------- | | General and administrative | $1,107 | $1,294 | -14.5% | $4,102 | $4,349 | -5.7% | | Research and development | $6,739 | $2,329 | 189.4% | $14,501 | $24,563 | -41.0% | | Total operating expenses | $7,846 | $3,623 | 116.6% | $18,603 | $28,912 | -35.7% | | Other expense, net | $(4) | $(835) | -99.5% | $(353) | $(1,390) | -74.6% | | Income tax benefit | $19 | $56 | -66.1% | $167 | $104 | 60.6% | | Net Loss | $(7,831) | $(4,402) | 77.9% | $(18,789) | $(30,198) | -37.8% | [Three months ended September 30, 2023 and September 30, 2022](index=24&type=section&id=Three%20months%20ended%20September%2030,%202023%20and%20September%2030,%202022) - General and administrative (G&A) expenses decreased by **14.5%** to **$1.1 million** in Q3 2023, primarily due to reduced legal and professional services[106](index=106&type=chunk) - Research and development (R&D) expenses increased by **189.4%** to **$6.7 million** in Q3 2023, mainly due to a **$3.2 million** cost for Abraxane supply for the ASPIRE clinical trial[107](index=107&type=chunk) - Other expense, net, was approximately **$4,000** in Q3 2023, a significant reduction from **$0.9 million** in Q3 2022, due to a **$0.4 million** gain on sale of assets and interest income offsetting foreign currency exchange loss and interest expense[108](index=108&type=chunk) - Income tax benefit decreased by **66.1%** to **$19,000** in Q3 2023, primarily from refundable tax credits for R&D activities in Australia[109](index=109&type=chunk) [Nine months ended September 30, 2023 and September 30, 2022](index=24&type=section&id=Nine%20months%20ended%20September%2030,%202023%20and%20September%2030,%202022) - G&A expenses decreased by **5.7%** to **$4.1 million** for the nine months ended September 30, 2023, mainly due to lower professional services related to the CPP acquisition in 2022[110](index=110&type=chunk) - R&D expenses decreased by **41.0%** to **$14.5 million** for the nine months ended September 30, 2023, primarily due to a **$17.7 million** IPR&D write-off in Q2 2022. Excluding this, R&D increased by **$7.6 million** due to Abraxane costs and ASPIRE trial expansion[111](index=111&type=chunk) - Other expense, net, decreased by **74.6%** to **$0.4 million** for the nine months ended September 30, 2023, compared to **$1.4 million** in 2022, due to gain on asset sale and interest income offsetting foreign currency loss and interest expense[112](index=112&type=chunk)[113](index=113&type=chunk) - Income tax benefit increased by **60.6%** to **$167,000** for the nine months ended September 30, 2023, driven by increased refundable R&D tax credits in Australia due to the ASPIRE trial[114](index=114&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) **Liquidity and Capital Resources (in thousands):** | Item | September 30, 2023 | December 31, 2022 | | :-------------------------------- | :----------------- | :----------------- | | Cash | $907 | $1,285 | | Working capital (deficit) | $(7,031) | $(6,056) | **Cash Flow Data (in thousands) for Nine Months Ended September 30:** | Item | 2023 | 2022 | | :-------------------------------- | :----- | :----- | | Operating Activities | $(22,169) | $(10,273) | | Investing Activities | $400 | $(656) | | Financing Activities | $21,393 | $5 | | Net increase (decrease) in cash | $(378) | $(10,926) | [Working Capital](index=26&type=section&id=Working%20Capital) - Cash and cash equivalents decreased from **$1.3 million** at December 31, 2022, to **$0.9 million** at September 30, 2023[116](index=116&type=chunk) - The working capital deficit worsened from **$6.1 million** at December 31, 2022, to **$7.0 million** at September 30, 2023[116](index=116&type=chunk) [Cash Flows](index=26&type=section&id=Cash%20Flows) [Net Cash Used in Operating Activities](index=26&type=section&id=Net%20Cash%20Used%20in%20Operating%20Activities) - Net cash used in operating activities increased to **$21.8 million** for the nine months ended September 30, 2023, from **$10.3 million** in the prior year, primarily due to net loss, **$5.5 million** for long-term deposits with CROs, and **$3.7 million** for standard of care drug supply for the ASPIRE trial[117](index=117&type=chunk) [Net Cash Provided by Investing Activities](index=26&type=section&id=Net%20Cash%20Provided%20by%20Investing%20Activities) - Cash provided by investing activities was **$400,000** for the nine months ended September 30, 2023, primarily from the sale of intellectual property[118](index=118&type=chunk) - In the prior year, investing activities used **$656,000**, related to banker and legal costs for the CPP IPR&D acquisition[118](index=118&type=chunk) [Net Cash Provided by Financing Activities](index=26&type=section&id=Net%20Cash%20Provided%20by%20Financing%20Activities) - Net cash provided by financing activities was **$21.4 million** for the nine months ended September 30, 2023, mainly from the sale of common stock and warrants, partially offset by promissory note payments[119](index=119&type=chunk) - In the prior year, financing activities provided only **$5,000** from the exercise of stock purchase warrants[119](index=119&type=chunk) [Capital Requirements](index=26&type=section&id=Capital%20Requirements) - The company expects to incur substantial and increasing losses, generating negative net cash flows, as it continues clinical development for ivospemin and other product candidates[120](index=120&type=chunk) - Future capital needs depend on factors such as clinical trial progress, vendor payment terms, development costs for new indications, regulatory approvals, market acceptance, reimbursement arrangements, competitive developments, and patent-related costs[121](index=121&type=chunk)[129](index=129&type=chunk) - Historically, operations have been financed through equity and debt sales, but there's no assurance of obtaining additional financing on commercially reasonable terms[123](index=123&type=chunk) [Indebtedness](index=28&type=section&id=Indebtedness) - As of September 30, 2023, CPP had an outstanding principal balance of approximately **$5.2 million** on the Sucampo Promissory Note, bearing **5%** simple interest[124](index=124&type=chunk) - Panbela guarantees the full amount of the Sucampo Note, with scheduled payments of **$1.0 million** plus accrued interest due annually until January 31, 2026, and the remainder by January 31, 2027[124](index=124&type=chunk)[125](index=125&type=chunk) [Critical Accounting Estimates](index=28&type=section&id=Critical%20Accounting%20Estimates) - The accounting estimates used in the interim fiscal 2023 condensed consolidated financial statements are consistent with those described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2022[126](index=126&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as a smaller reporting company - The company is exempt from providing disclosures on market risk as it qualifies as a smaller reporting company[127](index=127&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated disclosure controls and internal control, concluding effectiveness with no material changes [Evaluation of Disclosure Controls and Procedures](index=28&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of September 30, 2023[129](index=129&type=chunk) - The internal control system provides reasonable assurance regarding the preparation and fair presentation of financial statements, with no material weaknesses identified[128](index=128&type=chunk) [Changes to Internal Control Over Financial Reporting](index=29&type=section&id=Changes%20to%20Internal%20Control%20Over%20Financial%20Reporting) - No changes in internal control over financial reporting were identified during the most recently completed fiscal quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[130](index=130&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) No legal proceedings were reported for the period - No legal proceedings were reported[132](index=132&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Updates risk factors, focusing on potential Nasdaq delisting and liquidity issues raising going concern doubts - The company's common stock has traded below **$1.00 per share** since October 16, 2023, making it ineligible for a compliance cure period if it again fails the Nasdaq Minimum Bid Price Requirement due to prior reverse stock splits[134](index=134&type=chunk) - As of September 30, 2023, the company had a stockholders' deficit of **$2,483,000**, nearing the Nasdaq Minimum Equity Rule of **$2,500,000**[135](index=135&type=chunk) - Auditors have expressed substantial doubt about the company's ability to continue as a 'going concern' due to limited financial liquidity, with cash on hand of **$0.9 million** as of September 30, 2023[140](index=140&type=chunk) - The company's continuation as a going concern is dependent on achieving positive cash flow from operations and securing external financing, with no assurance of obtaining required funding on commercially reasonable terms[142](index=142&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) No unregistered sales of equity, use of proceeds, or issuer purchases were reported - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities were reported[143](index=143&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported for the period - No defaults upon senior securities were reported[144](index=144&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable - Mine safety disclosures are not applicable[145](index=145&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by directors or officers during Q3 2023[146](index=146&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with Form 10-Q, including corporate documents, certifications, and financial statements **Key Exhibits Filed:** | Exhibit No. | Description | | :---------- | :---------- | | 3.1 | Restated Certificate of Incorporation | | 3.2 | Certificate of Amendment to Restated Certificate of Incorporation, effective June 1, 2023 | | 3.3 | Amended and Restated Bylaws | | 31.1 | Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) or 15d-14(a) | | 31.2 | Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) or 15d-14(a) | | 32.1 | Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350 | | 32.2 | Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 | | 101 | Financial statements from the quarterly report on Form 10-Q formatted in iXBRL | | 104 | Cover Page Data File (formatted as inline XBRL) |

Panbela Therapeutics, Inc. (OTC:PBLA) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants James Carbonara - Investor Relations Jennifer Simpson - Chief Executive Officer Sue Horvath - Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH MKM Operator Greetings and welcome to the Panbela Therapeutics Second Quarter 2023 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, Jam ...

PART I [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) The company's financial statements reflect a significant increase in cash and total assets as of June 30, 2023, primarily due to financing activities, while still experiencing substantial net losses. [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets increased to **$19.6 million** from **$5.0 million** at year-end 2022, driven by a rise in cash and cash equivalents to **$7.2 million**. Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 (Unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,205 | $1,285 | | Total current assets | $10,809 | $1,777 | | Total assets | $19,551 | $4,978 | | **Liabilities & Equity** | | | | Total current liabilities | $10,555 | $7,833 | | Total liabilities | $14,749 | $13,027 | | Total stockholders' equity (deficit) | $4,802 | $(8,049) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three and six months ended June 30, 2023, the company reported net losses of **$5.8 million** and **$11.0 million**, respectively, a significant reduction from 2022 primarily due to a non-recurring IPR&D write-off. Statement of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,234 | $20,028 | $7,750 | $22,236 | | Operating loss | $(5,877) | $(21,286) | $(10,745) | $(25,289) | | Net loss | $(5,833) | $(22,130) | $(10,952) | $(25,796) | | Basic and diluted net loss per share | $(7.95) | $(1,843.68) | $(22.08) | $(2,243.10) | [Condensed Consolidated Statements of Stockholders' (Deficit) Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20(Deficit)%20Equity) Stockholders' equity improved from a **$8.0 million** deficit at the start of 2023 to a positive **$4.8 million** by June 30, 2023, driven by **$23.1 million** from common stock sales. - Proceeds from the sale of common stock in the first half of 2023 amounted to **$15.4 million** in Q1 and **$7.7 million** in Q2[15](index=15&type=chunk) - The accumulated deficit increased from **$91.1 million** at the beginning of the year to **$102.0 million** by June 30, 2023, due to ongoing net losses[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operating activities was **$15.5 million**, offset by **$21.4 million** from financing activities, resulting in a **$5.9 million** increase in cash. Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,492) | $(8,680) | | Net cash used in investing activities | $0 | $(655) | | Net cash provided by financing activities | $21,412 | $0 | | **Net change in cash** | **$5,920** | **$(9,337)** | - Financing activities in H1 2023 included **$23.1 million** in proceeds from the sale of common stock and warrants, net of offering costs, and **$1.65 million** in principal payments on notes[20](index=20&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, significant accounting policies, and financial condition, highlighting its focus on therapeutics, substantial doubt about its going concern ability, and reliance on capital raises. - The company's lead candidates are ivospemin (SBP-101), Flynpovi™ (a combination of eflornithine and sulindac), and eflornithine (CPP-1X)[23](index=23&type=chunk) - The company has incurred losses of **$102.0 million** since its inception in 2011 and incurred a net loss of **$11.0 million** for the six months ended June 30, 2023, raising substantial doubt about its ability to continue as a going concern[26](index=26&type=chunk)[27](index=27&type=chunk) - The company effected a 1-for-30 reverse stock split on June 1, 2023, and a 1-for-40 reverse stock split on January 13, 2023[24](index=24&type=chunk) - In July 2023, the company divested rights to its eflornithine pediatric neuroblastoma program and is entitled to receive up to approximately **$9.5 million** in milestone-based payments, with an initial payment of **$400,000** received at closing[67](index=67&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses the company's status as a clinical-stage biopharmaceutical firm, focusing on the development of its lead candidates, ivospemin and Flynpovi, and its ongoing need for additional capital despite recent financing. - The company's ASPIRE trial, a global randomized Phase II/III study for ivospemin in metastatic pancreatic cancer, had 52 sites open in 9 countries as of June 30, 2023, with full site activation expected by mid-2023[76](index=76&type=chunk)[77](index=77&type=chunk) - The company regained North American rights to develop and commercialize Flynpovi for Familial Adenomatous Polyposis (FAP) in April 2023[84](index=84&type=chunk) - The company needs to raise additional capital to continue operations and execute its business plan beyond the third quarter of 2023[92](index=92&type=chunk) Results of Operations Comparison (in thousands) | Expense Category | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Percent Change | | :--- | :--- | :--- | :--- | | General and administrative | $2,995 | $3,053 | -1.9% | | Research and development | $7,750 | $22,236 | -65.1% | | **Total operating expenses** | **$10,745** | **$25,289** | **-57.5%** | | **Net Loss** | **$(10,952)** | **$(25,796)** | **-57.5%** | [Quantitative and Qualitative Disclosure About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk.) The company is a smaller reporting company and is therefore not required to provide the disclosure requested under this item. - As a smaller reporting company, Panbela Therapeutics, Inc. is not required to provide disclosure pursuant to Item 3[118](index=118&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2023, with no material changes to internal control over financial reporting. - The CEO and CFO concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective[120](index=120&type=chunk) - No change in internal control over financial reporting occurred during the quarter that has materially affected, or is reasonably likely to materially affect, internal controls[121](index=121&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings.) The company reported no legal proceedings. - None[124](index=124&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.Risk%20Factors.) The company highlights the risk of being delisted from Nasdaq, despite regaining compliance with the minimum bid price requirement after a reverse stock split. - The company faced a potential delisting from Nasdaq for failing to meet the minimum **$1.00** bid price requirement[126](index=126&type=chunk) - A 1-for-30 reverse stock split was effected on June 1, 2023, to address the bid price deficiency, and the company subsequently regained compliance on June 15, 2023[126](index=126&type=chunk) - A future delisting could severely harm the stock's liquidity, market price, and the company's ability to obtain financing[127](index=127&type=chunk)[131](index=131&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) The company reported no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities for the period. - None[128](index=128&type=chunk) [Defaults Upon Senior Securities](index=26&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The company reported no defaults upon senior securities. - None[128](index=128&type=chunk) [Mine Safety Disclosures](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company. - Not applicable[129](index=129&type=chunk) [Other Information](index=26&type=section&id=Item%205.%20Other%20Information.) During the three months ended June 30, 2023, no director or officer of the company adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement. - No director or officer adopted, modified, or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the quarter[130](index=130&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed with the Form 10-Q, including certificates of incorporation, bylaws, warrant agreements, securities purchase agreements, and officer certifications. - The report includes a list of exhibits filed, such as amendments to the Certificate of Incorporation, warrant agreements from the June 2023 offering, and required CEO/CFO certifications[133](index=133&type=chunk)

Panbela Therapeutics, Inc. (OTC:PBLA) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants James Carbonara - Hayden IR Jennifer Simpson - President & CEO Sue Horvath - VP & CFO Conference Call Participants Jonathan Aschoff - Roth MKM Operator Good day, and welcome to the Panbela Therapeutics first-quarter 2023 earnings call. [Operator Instructions]. It is now my pleasure to turn the floor over to your host, Mr. James Carbonara. Sir, the floor is yours. James Carbonara Thank you, oper ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission File No.: 001-39468 Panbela Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 88-2805017 (St ...

Panbela Therapeutics, Inc. (OTCQB:PBLA) Q4 2022 Earnings Conference Call March 16, 2023 4:30 PM ET Company Participants James Carbonara - Hayden IR Jennifer Simpson - Chief Executive Officer Sue Horvath - Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH MKM Operator Good day, everyone. And welcome to the Panbela Therapeutics Fourth Quarter 2022 Earnings Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions-and-c ...

PART I [Business](index=6&type=section&id=Item%201.%20Business) Panbela Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapeutics for urgent unmet medical needs, primarily in oncology, with lead assets targeting the polyamine metabolic pathway - On June 15, 2022, Panbela acquired Cancer Prevention Pharmaceuticals, Inc. (CPP), expanding its therapeutic pipeline, with consideration including common stock, options, warrants, and up to **$60 million** in contingent milestone payments[23](index=23&type=chunk) - The company's lead assets are ivospemin (SBP-101) and Flynpovi (eflornithine and sulindac), which target the polyamine pathway to suppress tumor growth and modulate the immune system[26](index=26&type=chunk) - Ivospemin has received Fast Track and Orphan Drug designations in the U.S. for pancreatic cancer, and Orphan Drug designation in Europe[27](index=27&type=chunk) - Flynpovi has received Fast Track and Orphan Drug designations for Familial Adenomatous Polyposis (FAP) in both the U.S. and Europe[30](index=30&type=chunk) - The company relies on third-party manufacturers for its product candidates and does not own or operate any manufacturing facilities[150](index=150&type=chunk) [Clinical Trials Overview](index=7&type=section&id=Clinical%20Trials%20Overview) The company is actively enrolling patients in the ASPIRE trial for ivospemin in metastatic pancreatic cancer and planning a Phase III registration trial for Flynpovi in FAP, alongside supporting various investigator-initiated trials - The ASPIRE trial is a randomized, double-blind, placebo-controlled study of ivospemin combined with gemcitabine and nab-paclitaxel for previously untreated metastatic pancreatic cancer, enrolling **600 subjects** globally with an interim analysis expected in early 2024[33](index=33&type=chunk)[34](index=34&type=chunk) - A Phase III registration trial for Flynpovi in Familial Adenomatous Polyposis (FAP) is being designed with a North American partner and is scheduled to begin in the second half of 2023, fully funded by the partner[28](index=28&type=chunk)[42](index=42&type=chunk) - The PACES trial, a Phase III study funded by the NCI, is evaluating Flynpovi to prevent the recurrence of high-risk adenomas and colorectal cancers in colon cancer survivors[41](index=41&type=chunk) - Multiple trials are evaluating single-agent eflornithine for indications including relapsed refractory neuroblastoma, STK11 mutant non-small cell lung cancer, and recent-onset Type 1 diabetes[43](index=43&type=chunk) [Disease Background and Market Opportunity](index=10&type=section&id=Disease%20Background%20and%20Market%20Opportunity) The company targets several diseases with significant unmet medical needs, including pancreatic cancer, Familial Adenomatous Polyposis (FAP), ovarian cancer, colorectal cancer, and neuroblastoma - Pancreatic Ductal Adenocarcinoma (PDA) is a major unmet medical need, with median overall survival for untreated metastatic patients ranging from **8.5 to 11.1 months** with standard chemotherapy regimens[44](index=44&type=chunk) - Familial Adenomatous Polyposis (FAP) is a rare genetic condition affecting approximately **1 in 10,000 individuals** in the U.S., leading to a nearly **100% lifetime risk** of colorectal cancer by age 40 if untreated, with no currently approved pharmacotherapeutic treatments[52](index=52&type=chunk)[57](index=57&type=chunk) - Ovarian cancer is the fifth leading cause of cancer deaths among women, with a five-year survival rate of approximately **29%** for metastatic disease[58](index=58&type=chunk) [Proprietary Technology and Mechanism of Action](index=14&type=section&id=Proprietary%20Technology%20and%20Mechanism%20of%20Action) The company's therapeutic strategy involves resetting the dysregulated polyamine pathway, which is critical for cancer cell proliferation and immune evasion - The company's assets target the polyamine metabolic pathway, which is dysregulated in many cancers and is essential for cell proliferation and immune modulation[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk) - Ivospemin is a polyamine analogue designed to be taken up by pancreatic cancer cells, disrupting their polyamine balance and inducing programmed cell death (apoptosis)[72](index=72&type=chunk)[73](index=73&type=chunk) - Flynpovi offers a dual-mechanism approach: eflornithine irreversibly inhibits ornithine decarboxylase (ODC) to block new polyamine synthesis, while sulindac increases polyamine catabolism and export[76](index=76&type=chunk)[82](index=82&type=chunk)[86](index=86&type=chunk) [Government Regulation](index=29&type=section&id=Government%20Regulation) The company's products are subject to extensive regulation by the FDA in the U.S. and similar agencies abroad, covering all stages from research and development to post-approval marketing - Pharmaceutical product development is a multi-year process requiring preclinical tests and adequate and well-controlled clinical trials (typically Phase I, II, and III) to establish safety and effectiveness before FDA approval[155](index=155&type=chunk)[160](index=160&type=chunk) - The company has received Fast Track Designation for ivospemin and Flynpovi, which facilitates development and expedites the review of drugs for serious conditions with unmet medical needs[134](index=134&type=chunk)[168](index=168&type=chunk) - The company has obtained U.S. and European Orphan Drug Status for its key product candidates, which provides incentives like tax credits, fee waivers, and a seven-year period of U.S. market exclusivity upon approval[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks, including a history of negative cash flow, substantial doubt about its ability to continue as a "going concern," and uncertainties in clinical development and third-party reliance - The company is a pre-revenue entity with a history of negative operating cash flow, and its auditors have expressed substantial doubt about its ability to continue as a "going concern"[200](index=200&type=chunk)[202](index=202&type=chunk) - Additional capital is required to fund operations beyond the third quarter of 2023, and failure to secure financing could force the company to delay or terminate development programs[205](index=205&type=chunk)[268](index=268&type=chunk) - The integration of the recently acquired CPP may be more difficult, costly, or time-consuming than expected, and the anticipated benefits may not be fully realized[223](index=223&type=chunk) - Clinical trials are expensive, lengthy, and their outcomes are highly uncertain, with unfavorable results potentially delaying or preventing regulatory approval[227](index=227&type=chunk) - The company relies on third-party CROs to conduct clinical trials and third-party suppliers for manufacturing, which limits direct control over timing, cost, and quality[235](index=235&type=chunk)[236](index=236&type=chunk) [Properties](index=49&type=section&id=Item%202.%20Properties) The company does not own or lease any real property, conducting its business functions on a distributed basis with employees working from home - The company does not lease or own any real property and all employees currently work from their homes[273](index=273&type=chunk) [Legal Proceedings](index=49&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, Panbela Therapeutics, Inc. is not a party to any material legal proceedings - The company is not currently party to any material legal proceedings[274](index=274&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=49&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is listed on the Nasdaq Capital Market under the symbol "PBLA", with **277 holders of record** as of March 13, 2023, and no anticipated cash dividends in the foreseeable future - Common stock is listed on the Nasdaq Capital Market under the symbol **"PBLA"**[277](index=277&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future[278](index=278&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=49&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For the year ended December 31, 2022, Panbela reported a net loss of **$34.9 million**, primarily due to a **$17.7 million** non-cash write-off of in-process research and development (IPR&D) and increased clinical trial costs, leading to a significant decrease in cash position and substantial doubt about its going concern ability Operating Expenses and Net Loss | | Year Ended December 31, | | Percent Change | | :--- | :--- | :--- | :--- | | | **2022 (in thousands)** | **2021 (in thousands)** | | | **General and administrative** | $6,044 | $4,587 | 31.8% | | **Research and development** | $28,049 | $5,423 | 417.2% | | **Total operating expenses** | $34,093 | $10,010 | 240.6% | | **Net Loss** | **($34,933)** | **($10,135)** | **244.7%** | - The significant increase in R&D expenses in 2022 was primarily due to a one-time, non-cash write-off of approximately **$17.7 million** for In-Process Research and Development (IPR&D) acquired from CPP, along with increased costs for the ivospemin randomized trial[324](index=324&type=chunk) Liquidity and Capital Resources | Liquidity and Capital Resources | December 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $1,285 | $11,867 | | **Working capital** | ($6,056) | $9,619 | - Net cash used in operating activities increased to **$15.3 million** in 2022 from **$7.2 million** in 2021, reflecting higher net losses and changes in operating assets and liabilities[328](index=328&type=chunk)[330](index=330&type=chunk) - Subsequent to year-end, in January 2023, the company raised gross proceeds of approximately **$15.0 million** from a public offering and **$1.6 million** from its ATM facility, with these funds expected to support operations into the third quarter of 2023[333](index=333&type=chunk)[334](index=334&type=chunk) [Controls and Procedures](index=60&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2022, with no material changes identified - Management concluded that as of December 31, 2022, the company's disclosure controls and procedures were effective[353](index=353&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[357](index=357&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=61&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) The company's executive officers are Jennifer K. Simpson, Ph.D., President and CEO, and Susan Horvath, VP and CFO, with a classified Board of Directors having extensive industry experience and an adopted code of ethics - The executive leadership consists of Jennifer K. Simpson, Ph.D., as President and Chief Executive Officer, and Susan Horvath as Vice President and Chief Financial Officer[362](index=362&type=chunk)[363](index=363&type=chunk) - The Board of Directors is divided into three classes, with directors typically serving three-year terms[364](index=364&type=chunk) - The company has adopted a code of ethics and business conduct applicable to all directors, officers, and employees[373](index=373&type=chunk) [Executive Compensation](index=64&type=section&id=Item%2011.%20Executive%20Compensation) For fiscal year 2022, CEO Jennifer K. Simpson's total compensation was **$694,324** and CFO Susan Horvath's was **$423,459**, with cash incentive bonuses approved based on performance milestones Summary Compensation Table | Name and Principal Positions | Year | Salary ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | **Jennifer K. Simpson** | 2022 | 506,000 | 188,324 | 694,324 | | President and Chief Executive Officer | 2021 | 476,609 | 182,422 | 1,196,733 | | **Susan Horvath** | 2022 | 320,000 | 103,459 | 423,459 | | Chief Financial Officer and Vice President of Finance | 2021 | 302,200 | 99,620 | 557,078 | - No new equity awards were granted to named executive officers during fiscal 2022[379](index=379&type=chunk) - For 2022 performance, the Compensation Committee approved cash bonus payments at **74.44% of target** for the CEO and **80.83% of target** for the CFO, paid in the first quarter of 2023[384](index=384&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=68&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of December 31, 2022, **100,556 shares** were underlying outstanding stock options, with **50,511 shares** remaining available for future issuance, and Lind Global Fund II LP was the only beneficial owner of **5% or more** of the company's stock Equity Compensation Plan Information | Plan Category | Securities to Be Issued Upon Exercise | Weighted-Average Exercise Price ($) | Securities Remaining Available for Future Issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 100,556 | $145.50 | 50,511 | - As of March 13, 2023, Lind Global Fund II LP was the only reported beneficial owner of more than **5%** of the company's common stock, with ownership of **6.0%**[400](index=400&type=chunk)[402](index=402&type=chunk) - All directors and current executive officers as a group (8 persons) beneficially owned **130,187 shares**, representing less than **1%** of outstanding shares as of March 13, 2023[400](index=400&type=chunk)[402](index=402&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=69&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) The company disclosed a **$350,000** separation agreement with Jeffrey E. Jacob and a consulting agreement with former Chief Medical Officer Dr. Suzanne Gagnon for approximately **$72,000** in 2022, with the Board determining four members as independent directors - Following the CPP acquisition, a separation agreement was made with Jeffrey E. Jacob (now a Panbela director) for a total payment of **$350,000**, due upon a material financing or by June 15, 2024[403](index=403&type=chunk) - The company has a consulting contract with former Chief Medical Officer Dr. Suzanne Gagnon, under which she was paid approximately **$72,000** in 2022[405](index=405&type=chunk) - The Board of Directors has determined that Messrs. Donovan, Fratamico, Mathiesen, and Schemel are "independent directors" under Nasdaq rules[412](index=412&type=chunk) [Principal Accounting Fees and Services](index=72&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Cherry Bekaert LLP served as the independent registered public accounting firm for fiscal years 2022 and 2021, with total fees billed at **$130,375** and **$107,850** respectively, all pre-approved by the Audit Committee Audit Fees and Services | | Year Ended December 31, 2022 ($) | Year Ended December 31, 2021 ($) | | :--- | :--- | :--- | | **Audit Fees** | $124,800 | $105,500 | | **Audit-Related Fees** | $5,575 | $2,350 | | **Total** | **$130,375** | **$107,850** | PART IV [Exhibits, Financial Statements Schedules](index=73&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statements%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the annual report, including the Merger Agreement with CPP, corporate governance documents, and various agreements Financial Statements [Report of Independent Registered Public Accounting Firm](index=77&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The independent auditor, Cherry Bekaert LLP, issued an opinion on the fair presentation of the consolidated financial statements but highlighted substantial doubt about the company's ability to continue as a going concern and identified the CPP asset purchase accounting as a critical audit matter - The auditor's report expresses substantial doubt about the Company's ability to continue as a going concern, citing recurring losses and negative cash flows from operations[427](index=427&type=chunk) - The accounting for the acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP) was identified as a Critical Audit Matter, particularly the judgment involved in classifying it as an asset acquisition and valuing the in-process research and development (IPR&D)[431](index=431&type=chunk)[432](index=432&type=chunk)[433](index=433&type=chunk) [Consolidated Financial Statements](index=79&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements for the year ended December 31, 2022, show a significant deterioration in financial position, with total assets decreasing to **$5.0 million** and a stockholders' deficit of **$8.0 million**, alongside a net loss of **$34.9 million** Consolidated Balance Sheet Data | Consolidated Balance Sheet Data (in thousands) | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,285 | $11,867 | | Total current assets | $1,777 | $12,279 | | Total assets | $4,978 | $12,872 | | Total current liabilities | $7,833 | $2,660 | | Total liabilities | $13,027 | $2,660 | | Total stockholders' (deficit) equity | ($8,049) | $10,212 | Consolidated Statement of Operations Data | Consolidated Statement of Operations Data (in thousands) | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Operating loss | ($34,093) | ($10,010) | | Net loss | ($34,933) | ($10,135) | | Basic and diluted net loss per share | ($67.91) | ($34.64) | [Notes to Consolidated Financial Statements](index=83&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide critical details, including the substantial doubt about the company's going concern ability, the accounting for the CPP acquisition which resulted in a **$17.7 million** R&D expense, outstanding debt of approximately **$6.4 million** to Sucampo GmbH, and equity transactions including a **1-for-40 reverse stock split** - The acquisition of CPP was accounted for as an asset acquisition, with the purchase consideration allocated to the assets acquired, and the in-process research and development (IPR&D) asset of **$17.7 million** was immediately expensed upon closing[493](index=493&type=chunk)[496](index=496&type=chunk) - As of December 31, 2022, the company had approximately **$6.4 million** in principal and interest outstanding under a promissory note to Sucampo GmbH and **$0.7 million** to Tillotts Pharma AG[497](index=497&type=chunk)[498](index=498&type=chunk) - Effective January 13, 2023, the company implemented a **1-for-40 reverse stock split** of its common stock, with all share and per-share data in the report retroactively adjusted[452](index=452&type=chunk)[512](index=512&type=chunk) - The company has license agreements with the University of Florida Research Foundation for ivospemin and the University of Arizona for Flynpovi, which include obligations for royalties and potential milestone payments[500](index=500&type=chunk)[502](index=502&type=chunk)[503](index=503&type=chunk)

Financial Data and Key Metrics Changes - General and administrative expenses increased to $1.3 million in Q3 2022 from $0.9 million in Q3 2021, primarily due to services and personnel costs related to the acquisition of Cancer Prevention Pharmaceuticals [23] - Research and development expenses rose to $2.3 million in Q3 2022 from $1.3 million in Q3 2021, driven by increased spending on clinical studies for the ASPIRE trial [24] - Net loss for Q3 2022 was $4.4 million or $0.21 per diluted share, compared to a net loss of $2.1 million or $0.16 per diluted share in Q3 2021 [26] - Total cash was approximately $0.9 million as of September 30, 2022, excluding gross proceeds of approximately $6 million from a public offering [26] - Total current assets were $1.8 million and current liabilities were $8 million as of the end of the quarter [27] Business Line Data and Key Metrics Changes - The company is focusing on the ASPIRE trial, which has approximately 95 planned sites across the U.S., Europe, Australia, and South Korea, with significant site openings expected by year-end [6][7] - The trial sample size is 600 patients, with an anticipated 36 months for complete enrollment and an interim analysis expected in early 2024 [8] Market Data and Key Metrics Changes - The company is expanding its clinical trials internationally, with recent approvals for trial sites in Spain, France, and Italy [6] - The registration trial for familial adenomatous polyposis (FAP) is anticipated to begin mid-2023, funded by One-Two Therapeutics [9] Company Strategy and Development Direction - The company aims to enhance shareholder value by executing against its milestones and advancing its clinical development programs [21] - The focus remains on delivering effective treatments for pancreatic cancer and other cancers with limited treatment options [7] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about recent approvals and the progress made in Q3, indicating a strong commitment to advancing clinical trials and enhancing stockholder value [21] - The company is optimistic about the upcoming interim analysis and the potential for positive outcomes from ongoing trials [8] Other Important Information - The acquisition of Cancer Prevention Pharmaceuticals resulted in approximately $8 million in debt and accrued interest on the balance sheet [28] - The company projects that cash from the recent capital raise will sustain operations into Q1 2023, focusing on value-driving initiatives [32] Q&A Session Summary Question: How will the data from the Phase I trials be released? - Management indicated that the data will be focused on peer-reviewed journals, and press releases will follow once the journals are available for public viewing [34]