This Quarterly Report and other publicly available documents, including any documents incorporated herein and therein by reference, contain, and our officers and representatives may from time to time make, “forward-looking statements,” including within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. When used in the following discussion, the words “anticipates,” “intends,” “believes,” “expects,” “plans,”” seeks,” “estimates,” “likely,” “may,” “would,” “will,” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding (i) our plans to initiate a randomized clinical trial; and (ii) our estimates of additional funds that may be required to complete our development plan and obtain necessary approvals.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially and adversely from the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) our lack of diversification and the corresponding risk of an investment in our Company; (ii) potential deterioration of our financial condition and results due to failure to diversify; (iii) our ability to successfully complete acquisitions and integrate operations for new product candidates; (iv) our ability to obtain additional capital, on acceptable terms or at all, required to implement our business plan; (v) final results of our Phase I clinical trial; (vi) progress and success of our randomized Phase II/III clinical trial; (vii) our ability to demonstrate safety and effectiveness of our product candidate; (viii) our ability to obtain regulatory approvals for our product candidate in the United States, the European Union, or other international markets; (ix) the market acceptance and future sales of our product candidate; (x) the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidate; (xi) the rate of progress in establishing reimbursement arrangements with third-party payors; (xii) the effect of competing technological and market developments; (xiii) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xiv) our ability to maintain our listing on a national securities exchange (xv) such other factors as discussed in Part I, Item 1A under the caption “Risk Factors” in our most recent Annual Report on Form 10-K, any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.

Any forward-looking statement made by us in this Quarterly Report is based on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement or reasons why actual results would differ from those anticipated in any such forward-looking statement, whether written or oral, whether as a result of new information, future developments or otherwise.

Overview

We existPanbela Therapeutics, Inc. (“Panbela” and together with its direct and indirect subsidiaries, “we,” “us,” “our,” and the “Company”) is a clinical stage biopharmaceutical company developing disruptive therapeutics for the primary purposetreatment of advancing the commercial development of our proprietary polyamine analogue in solid tumorspatients with an initial focus on pancreatic cancer.urgent unmet medical needs.

WeOn June 15, 2022, Panbela completed the previously announced strategic business reorganization and acquisition of Cancer Prevention Pharmaceuticals, Inc. (“CPP”) pursuant to the agreement and plan of merger, dated as of February 21, 2022 (the “Merger Agreement”), by and among Panbela, CPP and Panbela Research, Inc. (formerly known as Panbela Therapeutics, Inc., “Panbela Research”), among others. Pursuant to the terms of the Merger Agreement, (i) Canary Merger Subsidiary I, Inc. (“Merger Sub I”), then a wholly-owned subsidiary of Panbela, which was itself a wholly-owned subsidiary of Panbela Research, merged with and into Panbela Research (the “First Merger”), with Panbela Research surviving the First Merger, and (ii) Canary Merger Subsidiary II, Inc., then a wholly-owned subsidiary of Panbela, merged with and into CPP (the “Second Merger” and, together with the First Merger, the “Mergers”), with CPP surviving the Second Merger. As a result of the Mergers, each of Panbela Research and CPP became a wholly owned subsidiary of Panbela. In addition, in connection with the consummation of the Mergers, “Panbela Therapeutics, Inc.” was renamed “Panbela Research, Inc.” and “Canary Merger Holdings, Inc.” was renamed “Panbela Therapeutics, Inc.”

Our lead candidates are ivospemin (SBP-101) for which we have exclusively licensed the worldwide rights to this compound, which has been designated as SBP-101, from the University of Florida Research Foundation, Inc. and Flynpovi (eflornithine (CPP-1X) and Sulindac). Flynpovi is delivered in an oral form. The Company has an exclusive worldwide license to commercialize Flynpovi from the Arizona Board of Regents of the University of Arizona.

Ivospemin (SBP-101)

In August 2015, the Food and Drug Administration (“FDA”)FDA accepted our Investigational New Drug (“IND”) application for our SBP-101ivospemin product candidate. In May of 2022 we were notified that the United States Adopted Names (“USAN”) had adopted ivospemin as a USAN for SBP-101. The USAN information on ivospeminwas posted on the USAN Web site (www.ama-assn.org/go/usan).

We have completed an initial clinical trial of SBP-101ivospemin in patients with previously treated locally advanced or metastatic pancreatic cancer. This was a Phase I, first-in-human, dose-escalation, safety study. From January 2016 through September 2017, we enrolled twenty-nine patients into six cohorts, or groups, in the dose-escalation phase of the Phase I trial. No drug-related bone marrow toxicity or peripheral neuropathy was observed at any dose level. In addition to being evaluated for safety, 23 of the 29 patients were evaluable for preliminary signals of efficacy prior to or at the eight-week conclusion of their first cycle of treatment using the Response Evaluation Criteria in Solid Tumors (“RECIST”), the currently accepted standard for evaluating change in the size of tumors.

In 2018, we began enrolling patients in our second clinical trial, a Phase Ia/Ib study of the safety, efficacy and pharmacokinetics of SBP-101ivospemin administered in combination with two standard-of-care chemotherapy agents, gemcitabine and nab-paclitaxel. A total of 25 subjects were enrolled in 4four cohorts to evaluate the dosage level and schedule. An additional 25 subjects were enrolled in the expansion phase of the trial. Interim results were presented in January of 2022. Best response in evaluable subjects (cohorts 4 and Ib N=29) was a CR in 1 (3%), PR in 13 (45%), SD in 10 (34%) and PD in 5 (17%). One subject did not have post baseline scans with RECIST tumor assessments. Median PFS, now final at 6.5 months, may have been negatively impacted by drug dosing interruptions to evaluate potential toxicity. Median overall survival in Cohort 4 + Phase Ib was 12.0 months when data was presented in January 2022 and is now final at 14.6 months. Two patients from cohort 2 have demonstrated long term survival. One at 30.3 months (final data) and one at 33.0 months and still alive at data base lock on March 18, 2022. Seven subjects are still alive at database lock, one from cohort 2 and six from cohort 4 plus Ib.

In January of 2022, the Company announced the initiation of a new clinical trial. Referred to as ASPIRE, the trial is a Phase II/III randomized double-blind placebo-controlled trial in combination with gemcitabine and nab-paclitaxel, a standard pancreatic cancer treatment regimen in patients previously untreated for metastatic pancreatic cancer. The trial will be conducted globally at approximately 6095 sites in the United States, Europe and Asia - Pacific. The company announced the first patient enrolled in the trial in Australia in August of 2022. In September, the company announced that they had obtained regulatory approval to open sites in Spain, France and Italy. On March 31, 2023 there were 45 sites open in 7 countries.

While opening of clinical sites in the United States and the rest of the world has been slower than originally anticipated, due in part to resource fatigue in the medical community, the Company expects all countries and sites to be open by mid-2023.

The trial was originally designed as a Phase II/III with a smaller initial sample size (150) to support the events required for interim analysis based on progression-free survival (PFS) and a primary endpoint of overall survival. In response to European and FDA regulatory feedback, the study was amended to include the total trial sample size (600) and the design modified to utilize overall survival as the primary endpoint to be examined at interim analysis. PFS will also be analyzed to provide additional efficacy evidence. This amendment was supported by the final data from the Phase Ia/Ib first line metastatic pancreatic trial which completed enrollment in December of 2020. The study will enroll 600 subjects and is anticipated to take 36 months for complete enrollment with the interim analysis available in early 2024.

In early April 2022,2023, the Company announced a poster presentation highlighting the results for SBP-101ivospemin as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research.Research Annual Conference The poster concludes that the ivospemin chemotherapy treatment of C57Bl/6 mice injected with VDID8+ ovarian cancer with SBP-101cells significantly prolonged survival and decreased overall tumor burden. The results suggest that SBP-101ivospemin in combination with standard of care chemotherapy may have a role in the clinical management of ovarian cancer, and the Company intends to continue pre-clinical and clinical studies in ovarian cancer.

Additional clinical trials may be required for FDA or other country approvals. The cost and timing of additional clinical trials isare highly dependent on the nature and size of the trials.

Pending AcquisitionFlynpovi (eflornithine (CPP-1X) and sulindac)

As previously announced, on February 21, 2022, Panbela entered intoIn 2009, the FDA accepted our IND application for the combination product, Flynpovi, product candidate.

In a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc. (“CPP”), a private clinical stage company developing therapeutics to reducePhase III study, the riskefficacy and recurrencesafety of cancer and rare diseases, for athe combination of stockeflornithine and future milestone payments. The combined entity will have an expanded pipeline; areas of initial focus includesulindac known as Flynpovi, as compared with either drug eflornithine or sulindac alone, in adults with familial adenomatous polyposis (FAP)(“FAP”) was conducted. A total of 171 patients underwent randomization. Disease progression occurred in 18 of 56 patients (32%) in the Flynpovi group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], first-line metastatic pancreatic0.39 to 1.32) for Flynpovi as compared with sulindac (p = 0.29) and 0.66 (95% CI, 0.36 to 1.23) for Flynpovi as compared with eflornithine. In a post-hoc analysis, none of the patients in the Flynpovi arm progressed to a need for lower gastrointestinal (“LGI”) surgery for up to 48 months compared with 7 (13.2%) and 8 (15.7%) patients in the sulindac and eflornithine (CPP-1X) arms. These data corresponded to risk reductions for the need for LGI surgery approaching 100% between Flynpovi and either monotherapy with HR = 0.00 (95% CI, 0.00–0.48; p = 0.005) for Flynpovi versus sulindac and HR = 0.00 (95% CI, 0.00–0.44; p = 0.003) for Flynpovi versus eflornithine. Given the statistical significance of the LGI group, a new drug application (“NDA”) was filed with the FDA. As the study failed to meet the primary endpoint, and the NDA was based on the results of an exploratory analysis, a complete response letter was issued. To address this deficiency concern, the Company must submit the results of one or more adequate and well-controlled clinical trials which demonstrate an effect on a clinical endpoint.

In April of 2023 the Company regained the North American rights to develop and commercialize Flynpovi in patients with FAP, as a result of the termination of the licensing agreement between CPP and One-Two Therapeutics Assets Limited

We also have an ongoing double-blind placebo-controlled trial of Flynpovi to prevent recurrence of high-risk adenomas and second primary colorectal cancers in patients with stage 0-III colon or rectal cancer, neoadjuvant pancreatic cancer,Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (“PACES”). The purpose of this study is to assess whether the combination of eflornithine and sulindac (compared to corresponding placebos) has efficacy against colorectal cancer prevention and ovarian cancer.lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas one cm or greater, multiple adenomas, any adenomas >/= 0.3 cm, total advanced colorectal events, or total colorectal events. The combined development programs boast a steady cadence of catalysts with programs ranging from pre-clinical to registration studies. The obligations of each of Panbela and CPP to consummate the transactions contemplatedPACES trial is funded by the definitive agreement remain subjectNational Cancer Institute (“NCI”) in collaboration with Southwest Oncology Group (“SWOG”).

Eflornithine (CPP-1X)/eflornithine sachets (CPP-1X-S)

In 2009 and 2018, the FDA accepted our IND applications for eflornithine.

There are trials evaluating eflornithine sachets in relapsed refractory neuroblastoma supported by the Children’s Oncology Group (“COG”) /NCI (ongoing) and STK11 mutation patients with non-small cell lung cancer scheduled to approval ofbegin this year. For eflornithine tablets, a Phase II trial in early onset Type I diabetes was opened on January 11, 2023 in collaboration with Indiana University and the issuance of securities in the transactions by Panbela’s stockholders, and satisfaction of other customary closing conditions. If approved, the closing is expected to occur in the second quarter of 2022.Juvenile Diabetes Research Foundation (“JDRF”).

Financial Overview

On January 13, 2023, the Company's Board of Directors approved the implementation of a reverse stock split at a ratio of one-for-forty (1:40) shares of the Company's common stock. The reverse stock split was effective as of January 13, 2023. All share and per share amounts of our common stock presented have been retroactively adjusted to reflect the one-for-forty reverse stock split.

We have incurred losses of $59.8$96.2 million since 2011. For the three months ended March 31, 2022,2023, we incurred a net loss of $3.7$5.1 million. We also incurred negative cash flows from operating activities of approximately $4.5$9.7 million for this period. We expect to continue to incur substantial losses, which will generate negative net cash flows from operating activities, as we continue to pursue research and development activities and commercialize.

Our cash was approximately $7.4$5.2 million and $11.9$1.3 million as of March 31, 20222023 and December 31, 2021,2022, respectively. A decreaseAn increase of $4.5$3.9 million in cash for the three months ended March 31, 20222023 was due to $13.7 million net financing activities offset in part by approximately $9.7 million negative cash flow from operationsoperations. Due to drug shortages of Abraxane, which included $2.6 millionis utilized in addition to fund long term deposits held byivospemin for the CRO leading our randomized trial. This cash balance is expected, due to the increased spending on our newcurrent randomized clinical trial, the Company has explored all avenues to be sufficient to sustain operations intoprocure supply and prepayments of approximately $2.0 million were required well in advance of delivery and is reflected in the fourth quarterperiods cash used in operations. Net financing activities included a registered public offering of 2022.common stock, prefunded warrants, and warrants with net proceeds of approximately $13.7 million. The Company also sold common stock through its at-the market sales arrangement, with net proceeds of approximately $1.6 million. In the same period, the Company also recorded $1.6 million in loan repayments.

We will need to raise additional capital to continue our operations and execute our business plan past the fourthsecond quarter of 2022,2023, including completing required future trials and pursuing regulatory approvals in the United States, the European Union, and other international markets. We historicallyHistorically we have financed our operations principally from the sale of equity securities and debt. While we have been successful in the past in obtaining the necessary capital to support our operations and we are likely to seek additional financing through similar means, there is no assurance that we will be able to obtain additional financing under commercially reasonable terms and conditions, or at all. This risk would increase if our clinical data were not positive or if economic or market conditions deteriorate.

If we are unable to obtain additional financing when needed, we would need to scale back our operations, taking actions which may include, among other things, reducing use of outside professional service providers, reducing staff or staff compensation, significantly modifying, or delaying the development of our SBP-101 product candidate, licensecandidates, licensing to third parties the rights to commercialize our SBP-101 product candidate for pancreatic cancercandidates, or other applications that we would otherwise seek to pursue, or cease ceasing operations.

The Company has not experienced any significant disruptions to our operations as a result of the COVID-19 pandemic. Recruitment and enrollment in our Phase Ia/Ib trial was paused for a brief time in April and May of 2020. DrugThe drug product was delayed induring early 2022, but we had adequate supply to initiate our randomized Phase II/III clinical trial and experienced no product related disruptions to our clinical trials. The Company was not required to change management practices as it was decentralized prior to the COVID-19 pandemic.

Results of Operations

Comparison of the results of operations (in thousands):

Research and development (“R&D”) and general and administrative (“G&A”) expenses include non-cash share-based compensation expense resulting from our issuance of stock options. We expense the fair value of equity awards over their vesting periods. The terms and vesting schedules for share-based awards vary by type of grant and the employment status of the grantee. The awards granted through March 31, 20222023 vest upon performance or time-based conditions. We expect to record additional non-cash share-based compensation expense in the future, which may be significant.

The following table summarizes the stock-based compensation expense in our statements of comprehensive loss:

General and administrative expense

Our G&A expenses increased 56.3%decreased 24.7% to $1.4 million in the first quarter of 2023, down from $1.8 million in the first quarter of 2022, up from $1.1 million in the first quarter of 2021.2022. The increasedecrease is primarily associated withrelated to reduced legal and other costs associated with the Company’s proposedcompleted merger with CPP.of CPP in 2022.

Research and development expense

Our R&D expenses increased 100.9%58.9% to $3.5 million in the first quarter of 2023, up from $2.2 million in the first quarter of 2022, up from $1.1 million in the first quarter of 2021.2022. The increase is due primarily to increased clinical trial costs related to our new randomizedsites and subject enrollments in the ASPIRE Randomized Phase II/III trial in the first quarter of 2022.2023.

Other income (expense), net

Other expense, net, was approximately $0.3 million for the three months ended March 31, 2023. Other expenses in the three months ended March 31, 2023 are related to foreign currency exchange loss on the intercompany receivable balance and interest expense on two promissory notes.

Other income, net, was approximately $0.3 million for the three months ended March 31, 2022. Other expense, net, was $0.1 million for the three months ended March 31, 2021. The net income (expense) in both periods is composed primarily of a foreign currency exchange gain (loss) on the intercompany receivable balance.

Income tax benefit

Income tax benefit decreased to $29,000 for the three months ended March 31, 2022 down from $116,000 foris related to foreign currency exchange gain on the three months ended March 31, 2021. Our income tax benefit is derived primarily from refundable tax credits associated with our R&D activities conducted in Australia, these activities are down significantly as we wrap up the Phase Ia/Ib trial.intercompany receivable balance.

Liquidity and Capital Resources

The following table summarizes our liquidity and capital resources as of March 31, 20222023 and December 31, 20212022 and our cash flow data for the three months ended March 31, 20222023 and 2021.2022. It is intended to supplement the more detailed discussion that follows (in thousands):

Working Capital

Our total cash and cash equivalents were $7.4$5.2 million and $11.9$1.3 million as of March 31, 20222023 and December 31, 2021,2022, respectively. We had $4.5$9.7 million in current liabilities and a working capital deficit of $1.9 million as of March 31, 2023, compared to $7.8 million in current liabilities and working capital deficit of $3.4 million as of March 31, 2022, compared to $2.7 million in current liabilities and working capital of $9.6$6.0 million as of December 31, 2021.2022. Working capital is defined as current assets less current liabilities.

Cash Flows

Net Cash Used in Operating Activities

Net cash used in operating activities was approximately $9.7 million in the three months ended March 31, 2023 compared to approximately $4.5 million in the three months ended March 31, 2022 compared to approximately $2.0 million in the three months ended March 31, 2021.2022. The net cash used in each of these periods primarily reflects the net loss for these periods and is partially offset by the effects of changes in operating assets and liabilities. For the quarter ended March 31, 2022,2023, cash used in operating activities also included $2.6$5.5 million to fund long term deposits held by the CRO leading our randomized trial. The increase in the quarter to Net Deposits held by our CRO was offset by an increase in Accounts Payable. Also reflected in the increased cash used in operations is approximately $2.0 for prepayment of drug supply.

Net Cash Provided by Financing Activities

NoNet cash provided by financing activities was approximately $13.7 million for the three months ended March 31, 2023, with no cash provided by financing activities for the three months ended March 31, 2022 and net cash provided by financing activities was approximately $1.0 million for the three months ended March 31, 2021.2022. The cash provided for the three months ended March 31, 20212023 represents the proceeds from the exercisesale of common stock, prefunded warrants duringand warrants, partially offset by the quarter.payment and payoff of promissory notes.

Capital Requirements

As we continue to pursue our operations and execute our business plan, including wrapping up our current Phase 1the completion of the clinical trialdevelopment plan for our initial product candidate, SBP-101,ivospemin, in pancreatic cancer, planning for required future trials and pursuing regulatory approvals in the United States, the European Union and other international markets, we expect to continue to incur substantial and increasing losses, which will continue to generate negative net cash flows from operating activities.

Our future capital uses and requirements depend on numerous current and future factors. These factors include, but are not limited to, the following:

To date, we have used primarily equity financings and convertible debt to fund our ongoing business operations and short-term liquidity needs, and we expect to continue this practice for the foreseeable future. As of March 31, 2022,2023, we did not have any existing credit facilities under which we could borrow funds.

We will need to obtain additional funds to continue Historically we have financed our operations principally from the sale of equity securities and execute our business plans including completion of required future trials and pursuing regulatory approvals in the United States, the European Union and other international markets.debt. While we have been successful in the past in obtaining the necessary capital to support our operations and havewe are likely to seek additional financing through similar future plans to obtain additional financing,means, there is no assurance that we will be able to obtain additional financing under commercially reasonable terms and conditions, or at all. This risk would increase if our clinical data were inconclusive or not positive or economic conditions worsened in the market as a whole or in the pharmaceutical or biotechnology markets individually.

If we are unable to obtain additional financing when needed, we will likely need to reduce our operations by taking actions which may include, among other things, reducing use of outside professional service providers, reducing staff size or staff compensation, significantly modifying or delaying the development of , licensing rights to third parties, including the right to commercialize for patients with pancreatic cancer, or other applications that we would otherwise seek to pursue, or discontinuing operations entirely.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the interests of our current stockholders could be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our current stockholders. If we issue preferred stock, it could affect the rights of our stockholders or reduce the value of our common stock. Specific rights granted to future holders of preferred stock may include voting rights, preferences as to dividends and liquidation, conversion and redemption rights, sinking fund provisions, and restrictions on our ability to merge with or sell our assets to a third party. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any of these events could adversely affect our ability to achieve our regulatory approvals and commercialization goals and harm our business.

Our future success is dependent upon our ability to obtain additional financing, the success of our current Phase 1 clinical trial and required future trials, our ability to obtain marketing approval for our SBP-101 product candidate in the United States, the European Union and other international markets. If we are unable to obtain additional financing when needed, if our Phase 1 clinical trial is not successful, if we do not receive regulatory approval required for future trials or if once these studies are concluded, we do not receive marketing approval for our SBP-101 product candidate, we would not be able to continue as a going concern and would be forced to cease operations. The interim financial statements included in this report have been prepared assuming that we will continue as a going concern and do not include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties.

Indebtedness

CPP issued to Sucampo GmbH (“Lender”) an Amended and Restated Promissory Note (the “Note”) on June 15, 2022 for the principal sum of approximately $6.2 million (the “Principal”). The note bears simple interest on any outstanding Principal at a rate of 5% per annum. All unpaid Principal, together with any then unpaid and accrued interest, is payable as follows: (i) $1.0 million, plus all interest accrued but unpaid on or before each of January 31, 2023, January 31, 2024, January 31, 2025 and January 31, 2026; and (ii) all remaining Principal plus accrued but unpaid interest on or before January 31, 2027. The Company made the scheduled January 31, 2023 payment of $1.0 million plus accrued interest. The outstanding principal balance on March 31, 2023 was approximately $5.2 million. Accrued and unpaid interest as of March 31, 2023 totaled approximately $42,000.

Panbela has provided a Guarantee of payment in favor of the Lender for the full amount of the Note issued to the Lender.

As of March 31, 2022 and December 31, 2021 we had no debt obligations.2023, the outstanding balance on the amended promissory note with a former development partner, Tillotts Pharma AG was paid in full.

Critical Accounting Policies and Estimates

Our significant accounting policies and estimates are set forth in the notes accompanying the condensed consolidated financial statements included in this document. The accounting policies and estimates used in preparing our interim fiscal 20222023 condensed consolidated financial statements are the same as those described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021.2022.

As a smaller reporting company, we are not required to provide disclosure pursuant to this item.

Evaluation of Disclosure Controls and Procedures

Our management is responsible for establishing and maintaining adequate internal control over financial reporting for the Company. As of the date of this filing, management has not identified any material weaknesses, but believes that it does have a significant deficiency in that it has insufficient personnel resources within the accounting function to fully segregate the duties over financial transaction processing and reporting. Management has mitigated this deficiency primarily through greater involvement in the review and monitoring of financial transaction processing and reporting by executive and senior management.

We believe that our internal control system provides reasonable assurance to our management and Board of Directors regarding the preparation and fair presentation of published financial statements. All internal controls over financial reporting, no matter how well designed, have inherent limitations, including the possibility of human error and the circumvention or overriding of controls. Therefore, even effective internal controls over financial reporting can provide only reasonable assurance with respect to financial statement preparation and presentation. Further, because of changes in conditions, the effectiveness of internal controls over financial reporting may vary over time.

As of the end of the period covered by this quarterly report, the Company’s management conducted an evaluation, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, pursuant to Rules 13a-15 and 15d-15 of the Exchange Act. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of March 31, 2022,2023, our disclosure controls and procedures were effective in ensuring that information relating to the Company required to be disclosed in the reports that we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, including ensuring that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Changes to Internal Control Over Financial Reporting

We have not identified any change in our internal control over financial reporting during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

None.

ThereOther than noted below there have been no material changes to the risk factors included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021.2022.

We could be delisted from Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital.

During the first quarter of 2023, we cured previously identified minimum bid price and minimum stockholders’ equity deficiencies and regained compliance with all applicable listing standards of The Nasdaq Stock Market LLC (“Nasdaq”). However, on April 14, 2023, we received a notification letter from the Listing Qualifications Department (the “Staff”) of Nasdaq indicating that for 30 business days, our common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (“Minimum Bid Price Requirement”). The Nasdaq notification has no immediate effect on the listing or trading of our common stock on Nasdaq. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we have an initial compliance period of 180 calendar days, or until October 11, 2023, to regain compliance with the Minimum Bid Price Requirement. During the compliance period, our shares of common stock will continue to be listed and traded on The Nasdaq Capital Market. To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days or such longer period as may be required in the Staff’s discretion during the 180-calendar day grace period. Further, if our common stock has a closing bid price of $0.10 or less for ten consecutive business days, then the Staff may proceed with immediate delisting, subject to a limited opportunity for a hearing.

We intend to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq, including by effecting a reverse stock split. At our annual meeting of stockholders to be held on May 25, 2023, we are asking stockholders to approve a proposed amendment to our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our outstanding common stock at a reverse stock split ratio ranging from any whole number between 1-for-5 and 1-for-100, subject to and as determined by our Board of Directors. If the reverse stock split proposal is not approved by our stockholders, then we will be unable to complete a reverse stock split, and our common stock will be delisted from the Nasdaq Capital Market if our bid price does not improve. Even if a reverse stock split is approved and effected, it is not a guarantee that we will ultimately regain compliance with the applicable requirements for continued listing.

If, for any reason, Nasdaq were to delist our securities from trading on The Nasdaq Capital Market and we were unable to obtain listing on another reputable national securities exchange, a reduction in some or all of the following may occur, each of which could materially adversely affect our stockholders:

In addition, if we cease to be listed on The Nasdaq Capital Market, we may have to pursue trading on a less recognized or accepted market, such as the over the counter markets, our stock may be traded as a “penny stock”, which would make transactions in our stock more difficult and cumbersome, and we may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive investments with higher associated risks, such that existing or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock. This may also cause the market price of our common stock to further decline.

None.

None.

Not applicable.

None.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.