# DiaMedica Therapeutics Inc.: Form 10-Q for the period ended Sep 30, 2021

- Company: [DiaMedica Therapeutics Inc.](/companies/dmac.md) (CIK 1401040)
- Form: 10-Q
- Filed: 2021-11-10
- Accepted by EDGAR: Nov 10, 2021, 16:35 ET
- Period: 2021-09-30
- Accession: 0001437749-21-026175
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1401040/000143774921026175/dmtp20210930_10q.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1401040/000143774921026175/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2021-09-30.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Research and development | 3 months, 2021-07-01 to 2021-09-30 | $2.3m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 9 months, 2021-01-01 to 2021-09-30 | $6.9m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months, 2021-07-01 to 2021-09-30 | −$3.4m | us-gaap:OperatingIncomeLoss |
| Operating income | 9 months, 2021-01-01 to 2021-09-30 | −$10.4m | us-gaap:OperatingIncomeLoss |
| Income tax | 3 months, 2021-07-01 to 2021-09-30 | $7.0k | us-gaap:IncomeTaxExpenseBenefit |
| Income tax | 9 months, 2021-01-01 to 2021-09-30 | $21.0k | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months, 2021-07-01 to 2021-09-30 | −$3.5m | us-gaap:NetIncomeLoss |
| Net income | 9 months, 2021-01-01 to 2021-09-30 | −$10.3m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2021-07-01 to 2021-09-30 | −$0.18 | us-gaap:EarningsPerShareBasicAndDiluted |
| Diluted EPS | 9 months, 2021-01-01 to 2021-09-30 | −$0.55 | us-gaap:EarningsPerShareBasicAndDiluted |
| Operating cash flow | 9 months, 2021-01-01 to 2021-09-30 | −$9.4m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 9 months, 2021-01-01 to 2021-09-30 | $15.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | at 2021-09-30 | $16.2m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2021-09-30 | $48.5m | us-gaap:AssetsCurrent |
| Total assets | at 2021-09-30 | $48.7m | us-gaap:Assets |
| Current liabilities | at 2021-09-30 | $1.6m | us-gaap:LiabilitiesCurrent |
| Shareholders' equity | at 2021-09-30 | $47.0m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 27,973 characters.

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is based upon accounting principles generally accepted in the United States of America and discusses the financial condition and results of operations for DiaMedica Therapeutics Inc. and its subsidiaries for the three and nine months ended September 30, 2021 and 2020.

This discussion should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this report and our Annual Report on Form 10-K for the year ended December 31, 2020, which includes additional information about our critical accounting policies and practices and risk factors. The following discussion contains forward-looking statements that involve numerous risks and uncertainties. Our actual results could differ materially from the forward-looking statements as a result of these risks and uncertainties. See “*Cautionary Note Regarding Forward-Looking Statements”* for additional cautionary information.

### Business Overview

We are a clinical stage biopharmaceutical company primarily focused on developing novel treatments for neurological disorders and kidney diseases. Currently, our primary focus is on developing DM199, a proprietary recombinant KLK1 protein for the treatment of acute ischemic stroke (AIS). We plan to advance DM199, our lead drug candidate, through required clinical studies, including our ReMEDy2 pivotal Phase 2/3 trial which we initiated in September 2021 to evaluate the safety and efficacy of DM199 for the treatment of AIS and which was granted Fast Track Designation by the FDA also in September 2021, to create shareholder value by establishing its clinical and commercial potential as a therapy for AIS.

DM199 is a recombinant form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) produced primarily in the kidneys, pancreas and salivary glands, that plays a critical role in the regulation of local blood flow and vasodilation (the widening of blood vessels which decreases blood pressure) in the body, as well as an important role in inflammation and oxidative stress (an imbalance between potentially damaging reactive oxygen species, or free radicals, and antioxidants in the body). We believe DM199 has the potential to treat a variety of diseases where healthy functioning requires sufficient activity of KLK1 and its system, the kallikrein-kinin system.

Our DM199 product candidate is in clinical development as follows:

#### AIS Phase 2/3 ReMEDy2 Study

Our ReMEDy2 is a Phase 2/3 adaptive design, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of DM199 for the treatment of AIS, and evaluating the effects of DM199 on both physical recoveries post AIS and the rate of recurrent AIS, as two separate independent, primary endpoints, with each statistically powered for success.

In April 2021, we submitted an IND application to the FDA detailing a proposed protocol for this clinical study. The protocol was developed, in part, based upon written responses from the U.S. Food and Drug Administration (FDA) following a Type B Pre-IND meeting request. The FDA accepted our IND in May 2021, allowing us to proceed with this pivotal Phase 2/3 study which we have named ReMEDy2. This clinical study follows our Phase 2 study in AIS patients that demonstrated an improvement in stroke outcomes and reduction in severe stroke recurrence. The ReMEDy2 study is intended to evaluate whether DM199, a recombinant form of KLK1, can improve both physical recoveries and the rate of recurrent ischemic stroke at three-months in the group of AIS patients who currently have no treatment option other than supportive care.

In September 2021, we announced the initiation of the first site for our ReMEDy2 trail, which is an adaptive design, randomized, double-blind, placebo-controlled trial targeted to enroll approximately 350 patients at 75 sites in the United States. Patients enrolled in the study will be treated with either DM199 or placebo within 24 hours of the onset of AIS symptoms. The study excludes patients treated with tissue plasminogen activator (tPA) and those with large vessel occlusions. The study population is representative of the 80% of AIS patients who do not have treatment options today, primarily due to the short treatment windows for treatment by tPA or mechanical thrombectomy. As a result of the COVID-19 pandemic and the recent resurgence in cases caused by the Delta and other variants, clinical trials are experiencing delays and stoppages in site activations and enrollment due to staffing and other resource shortages. We also have experienced site activation and enrollment delays as we begin our ReMEDy2 trial primarily as a result of the prevalence of the Delta variant in the United States. We anticipate that the COVID-19 pandemic, and variants of COVID-19, will likely continue to adversely affect our ability to initiate new clinical trial sites and complete enrollment in our clinical trials.

On September 30, 2021, we announced that the FDA had granted Fast Track Designation to DM199 for the treatment of AIS, and on November 8, 2021, we announced that the FDA had accepted our amended protocol adding stroke recurrence as a second independent primary endpoint to the ReMEDy2 trial.

#### REDUX Clinical Study

In October 2019, the FDA accepted our Phase 2 clinical study protocol for the treatment of CKD caused by rare or significant unmet diseases. The study named REDUX, Latin for restore, is a multi-center, open-label investigation targeting enrollment of approximately 90 participants with mild or moderate CKD (Stage II or III) and albuminuria, who are being enrolled in three equal cohorts. The study is being conducted in the United States at 13 sites and is focused on participants with CKD. Cohort 1 is focused on non-diabetic, hypertensive African Americans (AA) with Stage II or III CKD. African Americans are at greater risk for CKD than Caucasians, and those African Americans who have the APOL1 gene mutation are at an even higher risk. Cohort 2 is focused on participants with IgA Nephropathy (IgAN). Cohort 3, which was added after the completion of our August 2020 public offering, is focused on diabetic kidney disease (DKD) participants with Type 2 diabetes mellitus with CKD, hypertension and albuminuria. The study will evaluate two dose levels of DM199 within each cohort. Study participants receive DM199 by subcutaneous injection twice weekly for 95 days. The primary study endpoints include safety, tolerability, blood pressure, albuminuria and kidney function, which will be evaluated by changes from baseline in estimated glomerular filtration rate (eGFR) and albuminuria, as measured by the urinary albumin-to-creatinine (UACR) ratio. Participant enrollment and dosing for this study commenced in December 2019.

In June 2021, we announced interim results indicating that DM199 is demonstrating clinically meaningful improvements in kidney function in Cohorts 1 and 2, as measured by simultaneously stabilizing eGFR and decreasing UACR. In participants who were hypertensive (Cohorts 1 and 3), DM199 also reduced blood pressure by clinically significant levels and importantly, there was no effect on participants who were not hypertensive (Cohort 2). We reported the following preliminary data:

- AA: Decrease in UACR -27% in moderate to severe albuminuria (baseline UACR \>500) (n=6), Increase in eGFR +2 ml/min (n=12) and decrease in blood pressure -8/-3 mmHg;
- IgAN: Decrease in UACR -33% (P=0.002) (baseline UACR\>500) (n=11) and eGFR and blood pressure were stable (n=16); and
- DKD: eGFR and UACR levels were stable and blood pressure decreased significantly by -5/1 mmHg (n=28)

DM199 was safe and well tolerated across all cohorts, with no DM199 related severe adverse events (SAEs) or discontinuations due to drug-related adverse events (AEs). AEs were generally mild to moderate in severity, with the most common being local injection site irritation that resolved.

As of October 31, 2021, we had enrolled 78 subjects, including 22 African American subjects into Cohort 1, 23 subjects with IgAN into Cohort 2 and completed enrollment with 33 subjects with Type 2 diabetes, hypertension and albuminuria into Cohort 3. Enrollment in Cohort 1 has been discontinued as the total number of African American subjects, including subjects in Cohorts 2 and 3, has reached our goal of enrolling 30 African American subjects for our safety analysis. Accordingly, currently we are only continuing to enroll subjects with IgAN into Cohort 2. Throughout the third quarter of 2021 and the date of this report, we have continued to experience slower than expected enrollment in Cohort 2 of the REDUX study as the surge in the Delta variant of COVID-19 occurring in the summer of 2021 has caused the restoration of certain restrictions and elevated concerns of potential safety issues for study site staff and study subjects. We are monitoring the effects of the recent surge in COVID-19 infections related to the Delta and other variants and we will provide an update on the anticipated completion of Cohort 2 when we are able to reasonably do so.

### Financial Overview

We have not generated any revenues from product sales. Since our inception, we have financed our operations from public and private sales of equity, including most recently our September 2021 private placement which generated $29.9 million in net proceeds, after offering expenses, the exercise of warrants and stock options, interest income on funds available for investment and government grants.

We have incurred losses in each year since our inception. Our net losses were $10.3 million and $8.1 million for the nine months ended September 30, 2021 and 2020, respectively. As of September 30, 2021, we had an accumulated deficit of $79.3 million. Substantially all of our operating losses resulted from expenses incurred in connection with the development of our DM199 product candidate, our primary research and development (R&D) activities, and general and administrative (G&A) support costs associated with our operations.

We expect to continue to incur significant expenses and increased operating losses for at least the next several years. However, in the near term, we anticipate that our expenses will increase as we:

- begin enrolling subjects in our pivotal ReMEDy2 Phase 2/3 study of DM199 for AIS;
- complete our ongoing REDUX Phase 2 study of DM199 for CKD;
- provide G&A support for our operations; and
- maintain, expand and protect our intellectual property portfolio.

While we expect our rate of future negative cash flow per month will vary due to the timing of expenses incurred, we expect our current cash and marketable securities resources will be sufficient to allow us to begin enrolling subjects in our Phase 2/3 study in patients with AIS, complete the remaining cohort in our REDUX Phase 2 study in patients with CKD and to otherwise fund our currently planned operations for at least the next twelve months from the date of issuance of these condensed consolidated financial statements. However, the amount and timing of future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, including enrollment in our clinical studies, the potential expansion of our current development programs, potential new development programs, related G&A support and the effects of the COVID-19 pandemic. We may require significant additional funds earlier than we currently expect and there is no assurance that we will not need or seek additional funding prior to such time. We may elect to raise additional funds even before we need them if market conditions for raising additional capital are favorable.

### Overview of Expense Components

#### Research and Development Expenses

R&D expenses consist primarily of fees paid to external service providers such as contract research organizations; contractual obligations for clinical development including clinical sites, outside nursing services and laboratory testing, and preclinical studies; development of manufacturing processes, costs for production runs of DM199; salaries, benefits, and share-based compensation and other personnel costs.

At this time, due to the risks inherent in the clinical development process and the clinical stage of our product development programs, we are unable to estimate with any certainty the costs we will incur in the continued development of DM199 or any of our preclinical development programs. Although as previously discussed, we have experienced a delay and expect to continue to experience a delay in the timing of costs incurred in the REDUX study as a result of the COVID-19 pandemic, we do not expect to experience a significant overall increase in costs. We intend to continue to assess the effect of the pandemic on our REDUX and ReMEDy2 studies by monitoring the continued spread of new variants of the COVID-19 virus, actions implemented to combat the virus, the availability, adoption and effectiveness of vaccines and the number of people vaccinated. Our R&D expenses have remained relatively stable during the third quarter of 2021 as compared to prior year periods as the increased costs for the preparation and initiation of our ReMEDy2 clinical study are offset by cost reductions in our REDUX trial as it nears completion. We expect that our R&D expenses will increase in the future as sites are activated and enrollment increases in the ReMEDy2 clinical study and as we incur costs to support the conduct of the ReMEDy2 clinical study. The process of conducting clinical studies necessary to obtain regulatory approval and manufacturing scale-up to support expanded development and potential future commercialization is costly and time consuming. Any failure by us or delay in completing clinical studies, manufacturing scale-up or in obtaining regulatory approvals could lead to increased R&D expenses and, in turn, have a material adverse effect on our results of operations.

#### General and Administrative Expenses

G&A expenses consist primarily of salaries and related benefits, including share-based compensation related to our executive, finance, business development and support functions. G&A expenses also include insurance, rent and utilities, travel expenses, patent costs and professional fees for auditing, tax and legal services. We expect our G&A expenses will continue to increase in the future as we expand our development and operating activities.

We have instituted a number of procedural changes related to protecting the health and safety of our employees in response to the COVID-19 pandemic. Our office was closed in the second quarter of 2020 and remained closed through the first quarter of 2021 and our employees worked remotely. In the second quarter of 2021, we opened our office and allowed, but did not require, employees to work in the office two days of each week. This policy remained in effect through the third quarter of 2021. Non-essential travel continues to be on hold and we encourage our employees to interact with each other and vendors through audio and video conferencing. We did not incur significant additional G&A expenses during the three and nine months ended September 30, 2021 related to these changes, or the COVID-19 pandemic, nor do we expect to incur significant additional G&A expenses related to the COVID-19 pandemic going forward. Provided conditions related to COVID-19 do not deteriorate, we expect to continue to work on a modified in-person/remote schedule and restrict non-essential travel for the foreseeable future.

#### Other (Income) Expense

Other (income) expense consists primarily of interest income and foreign currency exchange gains and losses. In past years, governmental assistance – research incentives, which were associated with the ReMEDy Phase 2 stroke study, were a significant component of this line item.

### Results of Operations

#### Comparison of the Three and Nine Months ended September 30, 2021 and 2020

The following table summarizes our unaudited results of operations for the three and nine months ended September 30, 2021 and 2020 (in thousands):

| Operating expenses: | Three Months Ended September 30, 2021 | 2020 | Nine Months Ended September 30, 2021 | 2020 |
| --- | ---: | ---: | ---: | ---: |
| Research and development | $2,332 | $2,158 | $6,894 | $5,107 |
| General and administrative | 1,084 | 1,161 | 3,506 | 3,324 |
| Total other (income) expense, net | 27 | (128) | (75) | (359) |

#### Research and Development Expenses

R&D expenses increased slightly to $2.3 million for the three months ended September 30, 2021, up from $2.2 million for the three months ended September 30, 2020. R&D expenses increased to $6.9 million for the nine months ended September 30, 2021, compared to $5.1 million for the nine months ended September 30, 2020, an increase of $1.8 million. The increase for the nine month comparison was primarily due to a number of factors including costs incurred for our pivotal ReMEDy2 clinical study, increased year-over-year costs related to manufacturing process development and increased personnel costs associated with adding staff to support R&D operations. These increases were partially offset by decreased costs incurred for our earlier ReMEDy Phase 2 stroke study, which completed in the prior year, and our REDUX study as the number of enrollments declined in the later stages of the study.

#### General and Administrative Expenses

G&A expenses were $1.1 million for the three months ended September 30, 2021, down from $1.2 million for the three months ended September 30, 2020. G&A expenses increased to $3.5 million for the nine months ended September 30, 2021, up $0.2 million from $3.3 million for the nine months ended September 30, 2020. The increase for the nine month comparison was primarily due to increased professional services costs and increased personnel costs to support our expanding clinical programs. These increases were partially offset by reduced non-cash, share based compensation costs.

### Liquidity and Capital Resources

The following tables summarize our liquidity and capital resources as of September 30, 2021 and December 31, 2020, and our sources and uses of cash for each of the nine month periods ended September 30, 2021 and 2020, and is intended to supplement the more detailed discussion that follows (in thousands):

| Liquidity and Capital Resources | September 30, 2021 | December 31, 2020 |
| --- | ---: | ---: |
| Cash, cash equivalents and marketable securities | $48,097 | $27,507 |
| Total assets | 48,664 | 28,095 |
| Total current liabilities | 1,624 | 2,028 |
| Total shareholders’ equity | 47,036 | 26,014 |
| Working capital | 46,913 | 25,893 |

18

| Cash Flow Data Cash flow provided by (used in): | Nine Months Ended September 30, 2021 | 2020 |
| --- | ---: | ---: |
| Operating activities | $(9,448) | $(6,169) |
| Investing activities | (11,848) | (16,801) |
| Financing activities | 30,106 | 28,884 |
| Net increase in cash and cash equivalents | $8,810 | $5,914 |

### Working Capital

We had cash and cash equivalents of $16.2 million, marketable securities of $31.9 million, current liabilities of $1.6 million and working capital of $46.9 million as of September 30, 2021, compared to $7.4 million in cash and cash equivalents, marketable securities of $20.1 million, $2.0 million in current liabilities and $25.9 million in working capital as of December 31, 2020. The increases in our combined cash, cash equivalents and marketable securities and in our working capital are due to net proceeds from our September 2021 private placement, partially offset by cash used in operating activities during the quarter ended September 30, 2021.

### Cash Flows

#### Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2021 was $9.4 million compared to $6.2 million for the nine months ended September 30, 2020. This increase relates primarily to the increase in the net loss, partially offset by non-cash share-based compensation and the effects of the changes in operating assets and liabilities.

#### Investing Activities

Investing activities consist primarily of purchases and maturities of marketable securities. Net cash used in investing activities was $11.8 million for the nine months ended September 30, 2021 compared to net cash used in investing activities of $16.8 million for the nine months ended September 30, 2020. The decrease results from the timing of purchases and maturities of marketable securities.

#### Financing Activities

Financing activities consist primarily of net proceeds from the sale of common shares in the current year period. Net cash provided by financing activities was $30.1 million for the nine months ended September 30, 2021 compared to $28.9 million for the nine months ended September 30, 2020. This increase was due to our September 2021 private placement.

On September 26, 2021, we issued and sold in a private placement an aggregate 7,653,060 common shares at a purchase price of $3.92 per share to ten accredited investors resulting in gross proceeds of $30.0 million and net proceeds to us of $29.9 million, after deducting offering expenses.

### Capital Requirements

Since our inception, we have incurred losses while advancing the R&D of our DM199 product candidate. We have not generated any revenues from product sales and do not expect to do so for at least three to five years. We do not know when, or if, we will generate any revenues from product sales of our DM199 product candidate or any future product candidate. We do not expect to generate any revenue from product sales unless and until we obtain regulatory approval. We expect to continue to incur substantial operating losses until such time as any future product sales, royalty payments, licensing fees and/or milestone payments are sufficient to generate revenues to fund our continuing operations. We expect our operating losses to increase in the near term as we continue the research, development and clinical studies of, and seek regulatory approval for, our DM199 product candidate. In the long-term, subject to obtaining regulatory approval of our DM199 product candidate or any future product candidate and in the absence of the assistance of a strategic partner, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution.

Accordingly, and notwithstanding the receipt of $29.9 million in net proceeds from our September 2021 private placement, we expect we will need substantial additional capital to further our R&D activities, planned clinical studies, regulatory activities and otherwise develop our product candidate, DM199, or any future product candidates, to a point where they may be commercially sold. Although we are striving to achieve these plans, there is no assurance these and other strategies will be achieved or that additional funding will be obtained on favorable terms or at all. While we expect our rate of future negative cash flow per month will vary due to our clinical activities and the timing of expenses incurred, we expect our current cash, cash equivalents and marketable securities resources will be sufficient to allow us to fund our planned operations for at least the next twelve months from the date of issuance of these condensed consolidated financial statements. However, the amount and timing of future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, including the initiation of new sites and enrollment in our clinical studies, the potential expansion of current development programs, potential new development programs, the effects of the COVID-19 pandemic on our clinical programs and operations, and related G&A support. We may require significant additional funds earlier than we currently expect and there is no assurance that we will not need or seek additional funding prior to such time, especially if market conditions for raising additional capital are favorable.

Since our inception, we have financed our operations from public and private sales of equity, the exercise of warrants and stock options, interest income on funds available for investment, and government incentive grants, and we expect to continue this practice for the foreseeable future. We do not have any existing credit facilities under which we could borrow funds. We may seek to raise additional funds through various sources, such as equity or debt financings, or through strategic collaborations and license agreements. We can give no assurances that we will be able to secure additional sources of funds to support our operations, or if such funds are available to us, that such additional financing will be sufficient to meet our needs or on terms acceptable to us. This is particularly true if our clinical data is not positive or economic and market conditions deteriorate.

To the extent we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our shareholders will be diluted. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. The availability of financing will be affected by our clinical data and other results of scientific and clinical research; the ability to attain regulatory approvals; market acceptance of our product candidates; the state of the capital markets generally with particular reference to pharmaceutical, biotechnology and medical companies; the status of strategic alliance agreements; and other relevant commercial considerations.

If adequate funding is not available when needed, we may be required to scale back our operations by taking actions that may include, among other things, implementing cost reduction strategies, such as reducing use of outside professional service providers, reducing the number of our employees or employee compensation, modifying or delaying the development of our DM199 product candidate; licensing to third parties the rights to commercialize our DM199 product candidate for AIS, CKD or other indications that we would otherwise seek to pursue, or otherwise relinquishing significant rights to our technologies, future revenue streams, research programs or product candidates or granting licenses on terms that may not be favorable to us; and/or divesting assets or ceasing operations through a merger, sale, or liquidation of our company.

### Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements (as defined by applicable SEC regulations) that could have a current material effect or that are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.

### Critical Accounting Policies and Estimates

There have been no material changes to our critical accounting policies and estimates from the information provided in “*Part II. Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies,”* included in our annual report on Form 10-K for the fiscal year ended December 31, 2020.

## Controls and procedures

As filed, 1,962 characters.

### Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the United States Securities Exchange Act of 1934, as amended (Exchange Act)) that are designed to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered in this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of such period to provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and 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 in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the three months ended September 30, 2021 that has materially affected or is reasonably likely to materially affect our internal control over financial reporting.

Filed Nov 10, 2021.
Source: SEC EDGAR, the filing index for accession 0001437749-21-026175. Last ingested by Listed: Oct 24, 2026, 15:09 ET. No prices; not investment advice.