Workflow
Aclaris Therapeutics(ACRS)
icon
Search documents
Aclaris Therapeutics shares torpedo on underwhelming dermatitis trial results
Proactive Investors· 2024-01-10 18:03
About this content About Andrew Kessel Andrew is a financial journalist with experience covering public companies in a wide breadth of industries, including tech, medicine, cryptocurrency, mining and retail. In addition to Proactive, he has been published in a Financial Times-owned newsletter covering broker-dealer firms and in the Columbia Misourian newspaper as the lead reporter focused on higher education. He got his start with an internship at Rolling Stone magazine.  Read more About the publisher Pr ...
Aclaris Therapeutics Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis
Newsfilter· 2024-01-10 12:00
- ATI-1777 2% BID Achieved a Statistically Significant Result in the Primary Efficacy Endpoint at Week 4 - - Minimal Systemic Exposure Supports "Soft" Topical JAK Inhibitor Approach - - ATI-1777 Was Well Tolerated - WAYNE, Pa., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced top-line results from its Phase 2b study of ATI-1777, an investigationa ...
Are Medical Stocks Lagging Aclaris Therapeutics (ACRS) This Year?
Zacks Investment Research· 2024-01-04 16:20
The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Is Aclaris Therapeutics (ACRS) one of those stocks right now? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Aclaris Therapeutics is a member of our Medical group, which includes 1077 different companies and currently sits at #5 in the Zacks Sector Rank. The Zacks Sector Rank gauges the st ...
Aclaris Therapeutics(ACRS) - 2023 Q3 - Quarterly Report
2023-11-05 16:00
7 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37581 Aclaris Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 46-0571712 (State or Othe ...
Aclaris Therapeutics(ACRS) - 2023 Q2 - Quarterly Report
2023-08-06 16:00
PART I. FINANCIAL INFORMATION This section provides the company's unaudited financial statements and management's analysis of its financial condition and operations [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Aclaris Therapeutics' unaudited condensed consolidated financial statements for Q2 and H1 2023, including balance sheets and cash flows [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to $235.6 million, driven by reduced cash and marketable securities Condensed Consolidated Balance Sheet Data (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $31,150 | $45,277 | | Total current assets | $132,935 | $231,550 | | **Total Assets** | **$235,649** | **$254,596** | | Total current liabilities | $22,829 | $21,938 | | **Total Liabilities** | **$55,899** | **$56,975** | | **Total Stockholders' Equity** | **$179,750** | **$197,621** | [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total revenue increased to $4.4 million, but rising R&D expenses led to a net loss of $57.7 million for H1 2023 Statement of Operations Highlights (in thousands, except per share data) | Metric | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Total Revenue | $4,397 | $2,981 | | Research and development | $47,862 | $33,085 | | Total costs and expenses | $66,130 | $42,882 | | Loss from operations | $(61,733) | $(39,901) | | **Net Loss** | **$(57,729)** | **$(39,321)** | | Net loss per share | $(0.84) | $(0.62) | [Unaudited Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased to $179.8 million due to net loss, partially offset by stock issuance and compensation - Total stockholders' equity decreased from **$197.6 million** on Dec 31, 2022, to **$179.8 million** on June 30, 2023[23](index=23&type=chunk) - The decrease was driven by a net loss of **$57.7 million** (sum of Q1 and Q2 net losses), partially offset by **$26.7 million** in net proceeds from an at-the-market stock sale and **$13.3 million** in stock-based compensation[23](index=23&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $47.0 million, with a net decrease in cash of $14.1 million for H1 2023 Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(47,007) | $(40,635) | | Net cash provided by investing activities | $6,136 | $8,709 | | Net cash provided by financing activities | $26,744 | $72,841 | | **Net (decrease) increase in cash** | **$(14,127)** | **$40,915** | | Cash and cash equivalents at end of period | $31,150 | $68,264 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's focus on immuno-inflammatory diseases, liquidity, fair value adjustments, and segment reporting - The company is a clinical-stage biopharmaceutical firm focused on immuno-inflammatory diseases[30](index=30&type=chunk) - As of June 30, 2023, the company had **$210.8 million** in cash, cash equivalents, and marketable securities and believes this is sufficient to fund operations for more than 12 months[31](index=31&type=chunk)[33](index=33&type=chunk) - The fair value of the contingent consideration liability related to the Confluence acquisition decreased by **$2.3 million** during the first six months of 2023, primarily due to ceasing the pursuit of zunsemetinib for hidradenitis suppurativa[54](index=54&type=chunk) - In April 2023, the company sold **3.4 million shares** of common stock for gross proceeds of **$27.5 million** through its at-the-market (ATM) facility[64](index=64&type=chunk) - The company recorded licensing revenue of **$2.3 million** from its agreement with Eli Lilly for the six months ended June 30, 2023[82](index=82&type=chunk) - The company operates in two segments: Therapeutics, which focuses on drug development, and Contract Research, which provides laboratory services[90](index=90&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operational results, and clinical program progress, confirming sufficient capital for over 12 months [Development Programs](index=28&type=section&id=Development%20Programs) The company provides updates on zunsemetinib, ATI-1777, and ATI-2138 clinical trials, including expected data readouts - **Zunsemetinib (oral MK2 inhibitor):** Topline data for the Phase 2b trial in rheumatoid arthritis is expected in Q4 2023. Topline data for the Phase 2a trial in psoriatic arthritis is expected in H1 2024[100](index=100&type=chunk)[103](index=103&type=chunk) - **ATI-1777 (topical JAK 1/3 inhibitor):** Topline data for the Phase 2b trial in mild to severe atopic dermatitis is expected in H2 2023[106](index=106&type=chunk) - **ATI-2138 (oral ITK/JAK3 inhibitor):** A Phase 1 trial in healthy volunteers was completed, with data supporting progression to Phase 2 development in ulcerative colitis. Data is expected to be reported in September 2023[108](index=108&type=chunk) - The company has ceased development of zunsemetinib for moderate to severe hidradenitis suppurativa after a Phase 2a study failed to meet its primary or secondary endpoints[104](index=104&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) Total revenue increased to $4.4 million, but higher R&D and G&A expenses led to a larger operating loss Comparison of Results of Operations (in thousands) | Line Item | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Total revenue | $4,397 | $2,981 | $1,416 | | Research and development | $47,862 | $33,085 | $14,777 | | General and administrative | $17,107 | $12,174 | $4,933 | | **Loss from operations** | **$(61,733)** | **$(39,901)** | **$(21,832)** | Research & Development Expenses by Program (Six Months Ended June 30, in thousands) | Program | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Zunsemetinib | $15,450 | $11,318 | $4,132 | | ATI-1777 | $5,292 | $5,866 | $(574) | | ATI-2138 | $6,631 | $2,267 | $4,364 | | ATI-2231 | $520 | $3,089 | $(2,569) | - A bad debt expense of **$1.0 million** was recorded for the three and six months ended June 30, 2023, due to the bankruptcy filing of EPI Health[86](index=86&type=chunk)[121](index=121&type=chunk)[169](index=169&type=chunk) [Liquidity and Capital Resources](index=48&type=section&id=Liquidity%20and%20Capital%20Resources) The company held $210.8 million in cash and marketable securities, believing it has sufficient funds for over 12 months - The company had cash, cash equivalents, and marketable securities of **$210.8 million** as of June 30, 2023[175](index=175&type=chunk) - Management believes existing cash is sufficient to fund operations for a period greater than 12 months from the date of the 10-Q issuance[190](index=190&type=chunk) Cash Flow Summary (Six Months Ended June 30, in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(47,007) | $(40,635) | | Net cash provided by investing activities | $6,136 | $8,709 | | Net cash provided by financing activities | $26,744 | $72,841 | - In April 2023, the company sold **3.4 million shares** of common stock for gross proceeds of **$27.5 million** under its ATM facility[179](index=179&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=56&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate sensitivity, but it expects no material effect due to short-term investments - The primary market risk is interest rate sensitivity on cash equivalents and marketable securities, but the company does not expect a **10%** change in rates to have a material effect due to the short-term nature of its portfolio[199](index=199&type=chunk) - The company does not believe that inflation has had a material effect on its business, financial condition, or results of operations during the six months ended June 30, 2023[200](index=200&type=chunk) [Item 4. Controls and Procedures](index=56&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes - Based on an evaluation as of June 30, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[203](index=203&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[204](index=204&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings or aware of any pending actions - The company is not currently a party to any material legal proceedings[212](index=212&type=chunk) [Item 1A. Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) The company reports no material changes to its risk factors since its 2022 Annual Report on Form 10-K - There have been no material changes to the company's risk factors since its 2022 Annual Report on Form 10-K[213](index=213&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=59&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[213](index=213&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Certificate of Amendment to the Certificate of Incorporation, certifications by the CEO and CFO, and XBRL data files
Aclaris Therapeutics(ACRS) - 2023 Q1 - Earnings Call Transcript
2023-05-08 15:56
Financial Data and Key Metrics Changes - The company ended Q1 2023 with cash, cash equivalents, and marketable securities of $204 million, down from $230 million at year-end 2022 [36] - The net loss for Q1 2023 was $28.2 million, compared to $18.8 million in Q1 2022, primarily due to advancements in ongoing clinical programs [37] - Total revenue for the quarter was $2.5 million, an increase from $1.5 million in the prior year's quarter, driven by higher licensing revenue [37] Business Line Data and Key Metrics Changes - The Phase 2a trial of ATI-450 in hidradenitis suppurativa (HS) did not meet primary or secondary efficacy endpoints, but provided valuable safety and pharmacodynamic data [10][18] - The Phase 2b study of ATI-1777 in atopic dermatitis is ongoing, with an expanded protocol to include mild patients, and top-line results are now expected in the second half of 2023 [14][35] - The company is advancing its Phase 1 clinical asset ATI-2138 and plans to initiate a Phase 2a proof-of-concept study in ulcerative colitis [12][34] Market Data and Key Metrics Changes - The company is positioned in the immune-inflammatory disease space, which has seen significant transactions, indicating a competitive landscape with opportunities for shareholder value creation [7] - The competitive landscape in atopic dermatitis is evolving, with the company focusing on differentiators for ATI-1777 [76] Company Strategy and Development Direction - The company aims to complete and report results from ongoing trials in rheumatoid arthritis and psoriatic arthritis, while exploring the MK2 mechanism in other indications [39] - The leadership team emphasizes a fiscally prudent approach to executing clinical programs, with a focus on advancing key assets [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of ATI-450, noting that the drug's performance in HS does not raise red flags for the upcoming rheumatoid arthritis study [43] - The team remains optimistic about the potential of ATI-450 and is focused on timely reporting of ongoing trials [39] Other Important Information - The company completed chronic toxicology studies for ATI-450, with no issues of concern identified [25] - The data safety monitoring committee for the rheumatoid arthritis trial has not raised any safety concerns to date [34] Q&A Session Summary Question: Read-through from HS to RA study and CK levels - Management expressed confidence in the safety profile of ATI-450, indicating no red flags and a positive outlook for the RA study [43][44] Question: Atopic dermatitis enrollment challenges - Management acknowledged enrollment challenges due to a mild winter and noted that expanding criteria to include mild patients should enhance recruitment [45] Question: Choice of ulcerative colitis as first indication - Management highlighted the attractiveness of ATI-238 in ulcerative colitis and the competitive landscape in inflammatory bowel disease [46] Question: CK elevations compared to other therapies - Management noted that asymptomatic CK elevations are common and not a concern among clinicians, with no evidence of significant pathology [49][50] Question: CNS adverse events in HS study - Management indicated that the etiology of CNS events like dizziness and headache remains unclear, but they are generally transient [55][56] Question: Discontinuation rates in RA study - Management stated that discontinuation rates in the RA study are tracking at or below those seen in competitive studies [59][60]
Aclaris Therapeutics(ACRS) - 2023 Q1 - Quarterly Report
2023-05-07 16:00
7 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37581 Aclaris Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 46-0571712 (State or Other Ju ...
Aclaris Therapeutics(ACRS) - 2022 Q4 - Annual Report
2023-02-22 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 Commission file number 001-37581 ACLARIS THERAPEUTICS, INC. Incorporated under the Laws of the I.R.S. Employer Identification No. State of Delaware 46-0571712 640 Lee Road, Suite 200 Wayne, PA 19087 (484) 324-7933 Securities registered pursuant to Section 12(b) of the Act: Title of Each Class: Tradin ...
Aclaris Therapeutics (ACRS) Presents at the 41st Annual J.P. Morgan Healthcare Conference -- Slideshow
2023-01-12 16:44
EMPOWERING PATIENTS THROUGH KINOME INNOVATION 41st Annual J.P. Morgan Healthcare Conference January 2023 ...
Aclaris Therapeutics(ACRS) - 2022 Q3 - Quarterly Report
2022-11-07 16:00
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements and notes for the period ended September 30, 2022 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets grew to $267.6 million while total liabilities decreased, boosting stockholders' equity to $219.8 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $61,653 | $27,349 | | Total current assets | $256,573 | $205,032 | | **Total assets** | **$267,632** | **$251,211** | | **Liabilities & Equity** | | | | Total current liabilities | $19,789 | $22,931 | | **Total liabilities** | **$47,794** | **$53,870** | | **Total stockholders' equity** | **$219,838** | **$197,341** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net loss narrowed year-over-year for both the third quarter and nine-month period, driven by higher licensing revenue Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $19,018 | $1,659 | $21,999 | $5,260 | | Research and development | $23,656 | $13,976 | $56,741 | $29,711 | | Total costs and expenses | $39,892 | $21,954 | $82,774 | $72,090 | | Loss from operations | $(20,874) | $(20,295) | $(60,775) | $(66,830) | | **Net loss** | **$(19,952)** | **$(21,146)** | **$(59,273)** | **$(68,061)** | | Net loss per share | $(0.30) | $(0.35) | $(0.92) | $(1.23) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Financing activities provided $72.8 million in cash, contributing to a net cash increase of $34.3 million for the nine-month period Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(48,452) | $(35,059) | | Net cash provided by (used in) investing activities | $9,926 | $(158,456) | | Net cash provided by financing activities | $72,830 | $225,054 | | **Net increase in cash and cash equivalents** | **$34,304** | **$31,539** | | Cash and cash equivalents at end of period | $61,653 | $53,602 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, segment information, and a significant licensing agreement with Eli Lilly - The company believes its existing cash, cash equivalents, and marketable securities of **$248.1 million** are sufficient to fund operations for more than 12 months from the report's issuance date[23](index=23&type=chunk)[25](index=25&type=chunk) - In August 2022, the company entered into a non-exclusive patent license agreement with Eli Lilly and Company, recognizing **$17.6 million in licensing revenue** and recording **$7.3 million in related licensing expenses** during Q3 2022[76](index=76&type=chunk)[78](index=78&type=chunk) - The company operates in two reportable segments: **Therapeutics**, focused on developing therapies for immuno-inflammatory diseases, and **Contract Research**, which provides laboratory services[84](index=84&type=chunk) - The fair value of the contingent consideration liability related to the Confluence acquisition **decreased by $2.4 million** during the first nine months of 2022, primarily due to higher discount rates[41](index=41&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes financial performance, clinical program progress, and confirms sufficient liquidity for the next 12 months [Clinical Programs](index=32&type=section&id=Clinical%20Programs) The company provides updates on its key clinical trials, with topline data for several programs expected in 2023 - **Zunsemetinib:** Topline data for the Phase 2b trial in rheumatoid arthritis and the Phase 2a trial in psoriatic arthritis are expected in the **second half of 2023**[105](index=105&type=chunk)[106](index=106&type=chunk)[109](index=109&type=chunk) - **ATI-1777:** Topline data from the Phase 2b trial for moderate to severe atopic dermatitis is expected in the **first half of 2023**[113](index=113&type=chunk) - **ATI-2138:** A Phase 1 single ascending dose (SAD) trial was completed and the company plans to initiate a Phase 1 multiple ascending dose (MAD) trial for ulcerative colitis by the **end of 2022**[115](index=115&type=chunk)[118](index=118&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) A significant increase in licensing revenue drove Q3 2022 results, offsetting higher R&D expenses from clinical trial activities - Licensing revenue increased to **$17.9 million in Q3 2022** from $0.2 million in Q3 2021, primarily due to the upfront and milestone payments from the Eli Lilly agreement[162](index=162&type=chunk) Research & Development Expenses by Program (Nine Months Ended Sep 30, in thousands) | Program | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Zunsemetinib | $21,500 | $12,532 | $8,968 | | ATI-1777 | $9,220 | $1,894 | $7,326 | | ATI-2138 | $4,060 | $3,330 | $730 | | ATI-2231 | $4,397 | $333 | $4,064 | | **Total R&D Expenses** | **$56,741** | **$29,711** | **$27,030** | - The fair value of the contingent consideration liability **decreased by $2.4 million** in the first nine months of 2022, compared to an increase of $22.1 million in the same period of 2021[181](index=181&type=chunk) [Liquidity and Capital Resources](index=54&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $248.1 million in cash and equivalents, deemed sufficient to fund operations for over 12 months - The company had cash, cash equivalents, and marketable securities totaling **$248.1 million** as of September 30, 2022[184](index=184&type=chunk) - In April 2022, the company raised gross proceeds of **$75.0 million** by selling 4.8 million shares of common stock through its at-the-market facility[54](index=54&type=chunk)[187](index=187&type=chunk) - Management believes existing capital is **sufficient to fund operating and capital expenditure requirements** for more than 12 months from the date of the report[207](index=207&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=63&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk from interest rate fluctuations is considered immaterial to its financial condition - The company's main market risk is interest rate sensitivity on its investment portfolio, but it is **not expected to have a material effect** due to the short-term, low-risk nature of the securities[216](index=216&type=chunk) [Controls and Procedures](index=63&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of September 30, 2022[221](index=221&type=chunk) - **No changes occurred** during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[221](index=221&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=66&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is **not currently a party** to any material legal proceedings[226](index=226&type=chunk) [Risk Factors](index=66&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's previously disclosed risk factors have occurred - The company's risk factors have **not changed materially** from those described in its 2021 Annual Report on Form 10-K[227](index=227&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the reporting period - There were **no unregistered sales of equity securities** to report for the period[229](index=229&type=chunk) [Exhibits](index=66&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including required certifications and corporate documents