Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations.

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,”“intends,” “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 ability to obtain additional funding to complete a randomized clinical trial; (ii) progress and success of our Phase 1 clinical trial; (iii) the impact of the current COVID-19 pandemic on our ability to complete enrollment in future clinical trials and procure the active ingredient; (iv) our ability to demonstrate the safety and effectiveness of our SBP-101 product candidate (v) our ability to obtain regulatory approvals for our SBP-101 product candidate in the United States, the European Union or other international markets; (vi) the market acceptance and level of future sales of our SBP-101 product candidate; (vii) the cost and delays in product development that may result from changes in regulatory oversight applicable to our SBP-101 product candidate; (viii) the rate of progress in establishing reimbursement arrangements with third-party payors; (ix) the effect of competing technological and market developments; (x) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xi) 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 exist for the primary purpose of advancing the commercial development of our proprietary polyamine analogue in solid tumors with an initial focus on pancreatic cancer.

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. (“UFRF”).UFRF.

In August 2015, the Food and Drug Administration (“FDA”)FDA accepted our Investigational New Drug (“IND”) application for our SBP-101 product candidate.

We haveIn 2017 we completed an initial clinical trial of SBP-101 in patients with previously treated locally advanced or metastatic pancreatic cancer. This was a Phase 1, first-in-human, dose-escalation, monotherapy safety study. From January 2016 through September 2017, we enrolled twenty-nine patients into six cohorts (cohorts 5a and 5b while the same dose, were separated as the result of different manufacturing lots) in the dose-escalation phase of the Phase 1 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. Eight of the 23 patients (35%) had SDstable disease (“SD”) and 15 of 24 (65%) had PD.progressive disease (“PD”). It should be noted that of the 15 patients with PD, six came from cohorts one and two and are considered to have received less than potentially therapeutic doses of SBP-101. We also noted that 28 of the 29 patients had follow-up blood tests measuring the Tumor Marker CA 19-9 associated with pancreatic ductal adenocarcinoma. Eleven of these patients (39%) had reductions in the CA 19-9 levels, as measured at least once after the baseline assessment. Seven of the remaining 17 patients who showed no reduction in CA 19-9 came from cohorts one and two.

In 2018December of 2020 we began enrollingcompleted enrollment of patients in our second clinical trial, a Phase 1a/1b study of the safety, efficacy and pharmacokinetics of SBP-101 administered in combination with two standard-of-care chemotherapy agents, gemcitabine and nab-paclitaxel. A total of 25 subjects were enrolled in 4 cohorts in the Phase 1a portion of the trial to evaluate the dosage level and schedule. Preliminary results were presented in a poster at the American Society of Clinical Oncology - GI conference (“ASCO-GI”) in January 2020. The poster reflected safety and efficacy results, as of a December 31, 2019 cutoff, from evaluable patients in cohorts 2 and 3 (N=13) which showed manageable toxicity, an objective response rate of 62% and a disease control rate of 85%, with several patients still ongoing at the reporting cutoff. An additional 25 subjects were enrolled in the expansion phaseor Phase 1b portion of the trial. Enrollment was completedOn June 4, 2021, we announced the presentation of interim clinical data from our Phase 1 combination therapy study, “SBP-101, a polyamine metabolic inhibitor, administered in Decembercombination with gemcitabine and nab-paclitaxel (“G+A”), shows signals of 2020.efficacy as first-line treatment for subjects with metastatic pancreatic ductal adenocarcinoma (“PDA”),” at the American Society of Clinical Oncology (“ASCO”) Annual Meeting held June 4-8, 2021. 

After Phase 1b enrollmentSBP-101 was completed, some patientswell-tolerated when administered at doses and schedules tested in combination with G+A in subjects with previously untreated metastatic PDA. The most common Grade ≥3 adverse events (“AEs”) related to any study medication were neutropenia in 20 subjects (19 attributed to G+A and 1 attributed to all 3) and elevated liver function tests (“LFTs”) in 15 subjects (5 attributed to SBP-101 and 10 attributed to all 3). SBP-101-related increases in LFTs were asymptomatic in all but 2 subjects and reversed in all but 1 subject when SBP-101 administration was interrupted and dose-reduced or discontinued. Six subjects experienced vision AEs (3 possibly related to SBP-101, 1 related to gemcitabine and 2 related to all 3 based on principal investigator assessment. All were considered by the trial were notedsponsor to have complaints of serious visual adverse effects. Visual changes were not seen in the SBP-101 monotherapy study. After consultationbe possibly related to SBP-101; 5 subjects had findings consistent with our Data Safety Monitoring Board (“DSMB”) we determined that SBP-101 would not be administered to ongoing patients in the trial while additional safety information is analyzed. Patients continued with the standard drug regimen and all other trial activities also continued. Panbela conferred with the FDA regarding this plan to continue the trial but hold dosing of SBP-101 in ongoing patients until we could learn more. Because of our plan to withhold SBP-101, the FDA issued a partial clinical hold for the impacted study. On April 15, 2021, the Company announced that, subsequent to providing our evaluation and response to the FDA, the FDA has lifted the partial clinical hold. The Company has agreed to include in the design of all futureretinopathy. Future studies the exclusion ofwill exclude patients with a history of retinopathy or at risk of retinal detachment and scheduled ophthalmologic monitoring for all patients. Additionally, in future dose-finding studies screening for retinal toxicity will be included. These considerations will be reflected in the randomized clinical trial that the Company is planning to initiate in the middle of 2021.

Interim efficacy was reported for 29 response-evaluable subjects in Cohort 4 + Phase 1b as well as for 7 subjects in Cohort 2.  Eleven subjects in Cohort 4 + Phase 1b had treatment with SBP-101 interrupted to evaluate retinal toxicity. The dose level in Cohort 4 + Phase 1b was the same as Cohort 2; however, the dose schedule was altered. The dose interruption may confound final efficacy results fromfor Cohort 4 + Phase 1b. In Cohort 2 (N=7), the full study will be presented asobjective response rate (“ORR”) was 71%, and the disease control rate (“DCR”) was 100% by RECIST criteria (SD or better for ≥ 16 weeks). Median progression free survival (“PFS”) in Cohort 2 was 5.6 months and median overall survival (“OS”) was 10.3 months. In Cohort 4 + Phase 1b (N=29), the ORR was 48%, DCR was 70%, and PFS was 5.2 months; median OS has not been reached in Cohort 4 + Phase 1b to date. Subsequent to the release of this data in our poster at ASCO, one subject with a poster presentation at the ASCO Annual Meetingpartial response converted to be held June 4-8, 2021.a complete response (“CR”) and one subject while non-CR by RECIST criteria had no evidence of disease.

Additional clinical trials will be required for FDA or other country approvals ifThe Company believes that the interim results of the front-line clinical trial of our SBP-101 product candidate justify continued development. Additional clinical trials will be required for FDA or other country approvals. We expect to begin a randomized clinical trial of SBP-101 administered in combination with two standard-of-care chemotherapy agents, gemcitabine and nab-paclitaxel for first line treatment of metastatic PDA in the second half of 2021. The cost and timingexpected duration of additionalthis randomized clinical trialstrial is highly dependent on the nature and size of the trials.trial which is still in planning at this time.

We are also exploring SBP-101 for neo-adjuvant treatment in appropriate patients. There is also preclinical data to suggest that SBP-101 may have potential therapeutic uses for cancers other than pancreatic. In February 2021, we entered into a research agreement with the Johns Hopkins University School of Medicine. The collaboration is intended to focus on the further development of Panbela’s investigative agent SBP-101, including activity in cell lines outside of pancreatic cancer, biomarkers informing diagnostics and potential combination with checkpoint inhibitors. We expect these efforts will yield preclinical data to inform future development in the second half of this year.

Financial Overview

We have incurred losses of $48.3$50.5 million since 2011. For the threesix months ended March 31,June 30, 2021, we incurred a net loss of $2.3$4.4 million. We also incurred negative cash flows from operating activities of approximately $1.9$3.7 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 SBP-101 product candidate.

Our cash was approximately $8.1$6.4 million and $9.0 million as of March 31,June 30, 2021 and December 31, 2020, respectively.

A decrease of $0.9$2.6 million in cash for the threesix months ended March 31,June 30, 2021 was due to negative cash flow from operations of approximately $1.9$3.7 million offset in part from funds generated from the exercise of warrants.

Other than the temporary pause in enrollment during April and May of 2020 in our current clinical trial, the Company has not experienced any significant disruptions to our operations as a result of the COVID-19 pandemic. Recruitment and enrollment were resumed in May of 2020 and completed in December of 2020. The Company was not required to change management practices as it was decentralized prior to the COVID-19 pandemic.

Based on anticipated use of cash we expect the proceeds of the sale of equity securities that occurred in September of 2020 and July of 2021 will be sufficient to fund our expected operations into the secondfirst quarter of 2022.2023, however there can be no assurance to this estimate. We will need to obtain additional funds to continue our operations and execute our current business plans, including completing required future trials and pursuing regulatory approvals in the United States, the European Union and other international markets, and laboratory studies to explore potential indications in other cancer types. We historically 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 have similar future plans to obtain additional financing, 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 worsen in the market as a whole or in the pharmaceutical or biotechnology markets individually.

Results of Operations

Comparison of the results of operations (in thousands):

General and administrative (“G&A”) expenses consist primarily of salaries, incentive compensation and other employee benefits, including stock-based compensation. Other G&A expenses include professional fees for accounting and tax, legal services, insurance, and costs associated with being a publicly traded company including directors and officer’s liability insurance premiums.

Research and development (“R&D”) expenses consist primarily of clinical and generalregulatory costs, costs incurred under agreements with contract research organizations, pre commercial manufacturing and administrative (“stability testing and employee compensation related expenses.

R&D and G&A”)&A expenses include non-cash share-basedstock-based compensation expense resulting frombecause of our issuanceissuances 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, 2021September 30, 2020 vest upon performance orand 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:loss for:

Three months ended June 30, 2021 and June 30, 2020

General and administrative expense

OurFor the three months ended June 30, 2021 and 2020 G&A expenses increased 145.5% to $1.1were $1.2 million in the first quarter of 2021, up from $0.5and $0.7 million, in the first quarter of 2020.respectively. The increase reflects increased salaries associated with additional headcount and market based adjustmentsis due to base salaries; accrued incentive compensation; increased stockhigher employee compensation expense and increasedincremental costs associated with maintaining theour Nasdaq listing of our common stock on a national exchange, including increased D&O insurance premiums and additionalsuch as investor relations costs.and insurance.

Research and development expense

OurFor the three months ended June 30, 2021 and 2020 R&D expenses increased 83.8% to $1.1were $1.0 million in the first quarter of 2021, up from $0.6and $0.4 million, in the first quarter of 2020.respectively. The increase iswas primarily due primarily to increased manufacturing costs of active ingredienthigher spending on preclinical research and clinical trial costs in the first quarter of 2021.pre commercial manufacturing.

Other expense,income (expense), net

Other expense, net, was $0.1 million and $1.0 million$152,000 for the three months ended March 31,June 30, 2021 and 2020, respectively. The net expense in both periods is composed primarily the result of a foreign currency exchange loss onloss. The net other income of approximately $0.6 million in the intercompany receivable balance.three months ended June 30, 2020 is primarily a foreign exchange gain.

Income tax benefit

Income tax benefit remained flat at $0.1 millionincreased to $192,000 for the three months ended March 31,June 30, 2021 up from $40,000 during the three months ended June 30, 2020. Our income tax benefit is derived primarily from refundable tax credits associated with our R&D activities conducted in Australia which were increased in the quarter.

Six months ended June 30, 2021 and March 31,June 30, 2020

General and administrative expense

For the six months ended June 30, 2021 and 2020 G&A expenses were $2.4 million and $1.1 million, respectively. The increase is due to higher employee compensation expense and incremental costs associated with our Nasdaq listing such as investor relations and insurance.

Research and development expense

For the six months ended June 30, 2021 and 2020 R&D expenses were $2.0 million and $1.0 million, respectively. The increase was due primarily to increased spending on the current clinical trial.

Other income (expense), net

Other expense, net, was $276,000 and $193,000 for the six months ended June 30, 2021 and June 30, 2020 respectively and is primarily the result of a foreign currency exchange loss.

Income tax benefit

Income tax benefit increased to $308,000 for the six months ended June 30, 2021 up from $133,000 during the six months ended June 30, 2020. Our income tax benefit is derived primarily from refundable tax credits associated with our R&D activities conducted in Australia.

Liquidity and Capital Resources

The following table summarizes our liquidity and capital resources as of March 31,June 30, 2021 and December 31, 2020 and our cash flow data for the threesix months ended March 31,June 30, 2021 and 2020.It2020. It is intended to supplement the more detailed discussion that follows (in thousands):

Working Capital

Our total cash was $8.1$6.4 million and $9.0 million as of March 31,June 30, 2021 and December 31, 2020, respectively. We had $1.3$1.4 million in current liabilities and working capital of $7.5$5.8 million as of March 31,June 30, 2021, compared to $1.4 million in current liabilities and working capital of $8.4 million as of December 31, 2020.

Cash Flows

Net Cash Used in Operating Activities

Net cash used in operating activities was approximately $1.9$3.7 million in the threesix months ended March 31,June 30, 2021 compared to $1.1$2.0 million in the threesix months ended March 31,June 30, 2020. 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.liabilities and non-cash stock compensation expense.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $1.0 million for the threesix months ended March 31,June 30, 2021 and net cash usedprovided in financing activities was $26,000$1.8 million for the threesix months ended March 31,June 30, 2020. The cash provided for the threesix months ended March 31,June 30, 2021 represents the proceeds from the exercise of warrants during the quarter.first half of 2021. Cash provided for the six months ended June 30, 2020 was the result of a private sale of common stock and warrants.

On July 2, 2021 the company sold 3,333,334 shares of common stock, which provided incremental cash of approximately $9.0 million.

Capital Requirements

As we continue to pursue our operations and execute our business plan, including the wrapping up our current Phase 1 clinical trial and initiating a randomized trial for our initial product candidate, SBP-101, 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,June 30, 2021, we did not have any existing credit facilities under which we could borrow funds.

We expect that we will have increases in expenditures in order to continue our efforts to grow our business, complete our Phase 1a clinical trial and begin the next clinical trial for our SBP-101 product candidate. We also have begun to invest in additional R&D efforts on mechanism of action, biomarkers, additional indications in other cancer types and the possibility of SBP-101 to act as a sensitizing agent for certain immunotherapies. The exact amounts and timing of any expenditure may vary significantly from our current intentions. We will need to obtain additional funds to continue our operations 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. While we have been successful in the past in obtaining the necessary capital to support our operations, and have similar future plans to obtain additional financing, 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 reduce staff compensation, significantly modifying or delaying the development of our SBP-101 product candidate, licensing rights to third parties, including the right to commercialize our SBP-101 product candidate 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

As of March 31,June 30, 2021 and December 31, 2020 we had no debt obligations.

Critical Accounting Policies and Estimates

Our significant accounting policies are set forth in the notes accompanying the condensed consolidated financial statements included in this document. The accounting policies used in preparing our interim fiscal 2021 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, 2020.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

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,June 30, 2021, 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.

Other than as 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, 2020.

Our business is subject to risks arising from epidemic diseases, such as the 2020 outbreak of the COVID-19 illness.

The outbreak of COVID-19, which was declared in March 2020 by the World Health Organization to be a pandemic, has spread across the globe and is impacting worldwide economic activity. A pandemic, including COVID-19, or other public health epidemic poses the risk that we or our employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to the spread of the disease within these groups or due to shutdowns that may be requested or mandated by governmental authorities. During the second quarter of 2020 we paused enrollment in our clinical trial for 6 weeks to allow the health care systems involved in the trial time to focus resources on responding to the pandemic. We continued to treat patients previously enrolled. Once enrollment was restarted in May 2020, we experienced no further delays. This delay did not have a material effect on the completion of enrollment or costs of the clinical trial. During the course of the pandemic, health care facilities have limited our ability to conduct on site patient data monitoring for our clinical trial, these visits are now successfully conducted remotely as necessary. We also experienced a delay, approximately 30 to 60 days, early in the pandemic, in the manufacturing of our active ingredient. We believe our supply of drug is adequate and we do not expect this delay to disrupt the current trial or anticipated new trial to be initiated in 2021.

While we have not, to date experienced any significant disruptions as a result of the pandemic, we are unable to estimate the future impact that COVID-19 could have on our operations. The continued spread of COVID-19, limited availability of approved vaccines and measures taken by governmental authorities in light of the same may slow potential enrollment of clinical trials and reduce the number of eligible patients for our clinical trials. The pandemic could also disrupt the supply chain and the manufacture or shipment of both drug substance and finished drug product for our product candidates for preclinical testing and clinical trials and adversely impact our business, financial condition or results of operations. We often attend and present clinical updates at various medical and investor conferences throughout the year. The COVID-19 outbreak has caused, and is likely to continue to cause, cancellations or reduced attendance of these conferences and we may need to seek alternate methods to present clinical updates and to engage with the medical and investment communities. The COVID-19 outbreak and mitigation measures may also have an adverse impact on global economic conditions which could have an adverse effect on our business and financial condition and our potential to conduct financings on terms acceptable to us, if at all. The extent to which the COVID-19 outbreak impacts our results will depend on future developments that are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity of the virus and the actions to contain its impact.

DespiteThe Company did experience a continuing rising level of infections in India, the Company has been able to complete certain manufacturing studies with respect to its active ingredient. As of the date hereof, the Company has not experienced anymodest delay in receiptshipment of the active ingredient from its supplier in India. The Company is closely monitoringIndia to the situationUnited States as a result of increased COVID-19 cases in India in the first half of 2021. The product was received early July 2021 for filling and believes it has adequate supplylabeling. To the extent possible the spread of the active ingredient. TheDelta variant is being considered in our assumptions as the Company anticipatesplans for a new clinical trial to be initiated, likely to be conducted in many different locations, in the second half of 2021. At this time no material disruption to the initiation of the new trial which is to be initiated in 2021.anticipated.

During the three months ended March 31, 2021, the Company issued 193,607 shares of common stock as a result of exercises of outstanding warrants. Of the shares of common stock issued, 188,607 shares were issued pursuant to net, cashless, exercises of warrants to purchase 531,140 shares and the remaining 5,000 shares were issued for $25,000 cash. The shares were issued in reliance on an exemption from registration set forth in Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) to “accredited investors,” as defined in Rule 501 of Regulation D of the SEC, without the use of any general solicitation or advertising to market or otherwise offer the securities for sale. None, of the shares issued have been registered under the Securities Act or applicable state securities laws and none may be offered or sold in the United States absent registration under the Securities Act, or an exemption from such registration requirements.

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.