BRISBANE, Calif., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced the pricing of an underwritten public offering of 25,035,000 shares of its common stock and pre-funded warrants to purchase 18,379,861 shares of common stock. The shares of common stock are being sold at a price of $2.88 ...

Target Levels of Active Drug Achieved in Healthy Volunteers with Oral Twice-Daily Dosing; Supportive Impact on Pharmacodynamic Biomarker of Complement Activity ANX1502 Generally Well Tolerated Across Cohorts with No Serious Adverse Events Tablet Formulation of ANX1502 Expected to Advance into Proof-of-Concept Study in Patients with Cold Agglutinin Disease (CAD) in 2024 BRISBANE, Calif., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (NASDAQ:ANNX), a clinical-stage biopharmaceutical company developing a ne ...

[PART I—FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section details Annexon, Inc.'s unaudited condensed consolidated financial statements and management's financial analysis [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Annexon, Inc.'s unaudited financial statements as of September 30, 2023, report a net loss of **$32.5 million** for Q3 and **$106.3 million** for nine months, with assets at **$203.8 million** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$203.8 million** as of September 30, 2023, from **$285.1 million** at year-end 2022, primarily due to reduced cash and investments Condensed Consolidated Balance Sheet Data (in thousands) | Account | September 30, 2023 (Unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $133,159 | $140,020 | | Short-term investments | $32,112 | $102,637 | | Total current assets | $169,169 | $248,098 | | **Total assets** | **$203,816** | **$285,096** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $17,170 | $22,360 | | Total liabilities | $46,977 | $53,902 | | Accumulated deficit | $(544,608) | $(438,262) | | **Total stockholders' equity** | **$156,839** | **$231,194** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for Q3 2023 was **$32.5 million**, and **$106.3 million** for the nine months, with operating expenses remaining stable quarterly but increasing year-to-date Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $27,893 | $27,862 | $90,489 | $83,966 | | General and administrative | $6,888 | $8,207 | $23,225 | $24,938 | | **Total operating expenses** | **$34,781** | **$36,069** | **$113,714** | **$108,904** | | Loss from operations | $(34,781) | $(36,069) | $(113,714) | $(108,904) | | **Net loss** | **$(32,482)** | **$(35,054)** | **$(106,346)** | **$(107,564)** | | Net loss per share | $(0.43) | $(0.51) | $(1.42) | $(2.21) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$97.7 million** for the nine months ended September 30, 2023, offset by **$72.9 million** from investing and **$17.9 million** from financing activities Cash Flow Summary for Nine Months Ended September 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(97,665) | $(89,170) | | Net cash provided by investing activities | $72,886 | $102,058 | | Net cash provided by financing activities | $17,926 | $122,800 | | **(Decrease) increase in cash, cash equivalents and restricted cash** | **$(6,853)** | **$135,688** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage biopharmaceutical operations, liquidity, accounting policies, and an accumulated deficit of **$544.6 million** as of September 30, 2023 - The company has experienced losses since inception, with an accumulated deficit of **$544.6 million** as of September 30, 2023[27](index=27&type=chunk) - Management projects that existing cash, cash equivalents, and short-term investments of **$165.3 million** will fund operating expenses and capital expenditure requirements for at least twelve months from the issuance date of the financial statements[27](index=27&type=chunk)[28](index=28&type=chunk) - In July 2022, the company raised net proceeds of **$122.5 million** through a private placement of common stock, pre-funded warrants, and common warrants[54](index=54&type=chunk) - During the first quarter of 2023, the company sold **2,646,458 shares** of common stock under its 2021 ATM program, generating net proceeds of approximately **$17.5 million**[56](index=56&type=chunk)[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing complement medicines, with key programs like ANX005 and ANX007, and details financial results including increased R&D expenses and liquidity projections [Overview](index=19&type=section&id=Overview) Annexon is a clinical-stage biopharmaceutical company focused on C1q-targeting complement medicines, advancing pipeline programs like ANX005, ANX007, and ANX1502 - The company is focused on stopping the classical complement pathway by targeting C1q to treat inflammatory-related diseases[79](index=79&type=chunk) - Key Pipeline Updates: - **ANX005 (GBS):** Phase 3 trial has achieved target enrollment, with data anticipated in the first half of 2024 - **ANX007 (GA):** Showed statistically significant protection from vision loss in a Phase 2 trial; regulatory interactions for Phase 3 are ongoing, with an update expected by year-end 2023; EMA granted PRIME designation - **ANX1502 (Autoimmune):** Phase 1 trial results in healthy volunteers are expected by year-end 2023[80](index=80&type=chunk)[81](index=81&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Q3 2023 R&D expenses were flat at **$27.9 million**, while nine-month R&D increased **8%** to **$90.5 million** due to ANX005 manufacturing costs Comparison of Operating Expenses for the Three Months Ended September 30 (in thousands) | Expense Category | 2023 | 2022 | Dollar Change | | :--- | :--- | :--- | :--- | | Research and development | $27,893 | $27,862 | $31 | | General and administrative | $6,888 | $8,207 | $(1,319) | Comparison of Operating Expenses for the Nine Months Ended September 30 (in thousands) | Expense Category | 2023 | 2022 | Dollar Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $90,489 | $83,966 | $6,523 | 8% | | General and administrative | $23,225 | $24,938 | $(1,713) | (7%) | - The **8%** increase in R&D expenses for the nine-month period was mainly driven by a **$6.6 million** increase in contract manufacturing for the pivotal stage of ANX005 development, partially offset by a **$6.2 million** decrease in clinical outside services costs due to the completion of the ARCHER trial in GA[98](index=98&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, Annexon had **$165.3 million** in cash and investments, projected to fund operations into Q2 2025, with **$82.0 million** available via ATM program - The company's existing cash, cash equivalents, and short-term investments of **$165.3 million** are expected to fund operations into the second quarter of 2025[110](index=110&type=chunk) - The company has an active at-the-market (ATM) program with **$82.0 million** available for future sales of common stock as of September 30, 2023[111](index=111&type=chunk) Historical Cash Flows for Nine Months Ended September 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(97,665) | $(89,170) | | Net cash provided by investing activities | $72,886 | $102,058 | | Net cash provided by financing activities | $17,926 | $122,800 | [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that as of the end of the period, the company's disclosure controls and procedures are effective[119](index=119&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[120](index=120&type=chunk) [PART II—OTHER INFORMATION](index=29&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section outlines legal proceedings, significant risk factors, and other material information impacting the company [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may face ordinary course litigation - As of the filing date, Annexon is not party to any material legal proceedings[121](index=121&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including limited operating history, substantial losses, need for financing, and dependence on early-stage product development and regulatory approvals - The company is a clinical-stage biopharmaceutical company with a limited operating history, significant losses since inception, and anticipates continued losses[123](index=123&type=chunk) - Substantial additional financing is required to achieve goals, and failure to obtain it could force delays or termination of development programs[123](index=123&type=chunk) - The business is heavily dependent on the successful development, regulatory approval, and commercialization of its early-stage clinical product candidates[123](index=123&type=chunk) - The company relies on third-party suppliers for manufacturing and faces risks if these suppliers fail to comply with regulations or provide sufficient quantities[123](index=123&type=chunk) [Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements](index=30&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%2C%20Financial%20Condition%20and%20Capital%20Requirements) The company has a limited operating history, significant accumulated deficit of **$544.6 million**, and requires substantial additional financing to fund operations into Q2 2025 - The company has incurred significant operating losses since inception, with a net loss of **$106.3 million** for the nine months ended September 30, 2023, and an accumulated deficit of **$544.6 million**[127](index=127&type=chunk) - The company will require substantial additional financing, and its current capital of **$165.3 million** is expected to fund operations only into the second quarter of 2025; failure to raise more capital could force delays or termination of product development[128](index=128&type=chunk)[129](index=129&type=chunk) [Risks Related to Our Business](index=33&type=section&id=Risks%20Related%20to%20Our%20Business) Business success depends on developing and commercializing early-stage product candidates, facing risks from clinical trial delays, patient enrollment, adverse effects, and reliance on third-party manufacturers - The company's business is heavily dependent on the successful development and regulatory approval of its product candidates, which are in early stages of clinical development and based on a novel therapeutic approach (C1q inhibition)[140](index=140&type=chunk)[141](index=141&type=chunk) - Clinical trials may face substantial delays or failures due to issues with generating preclinical data, regulatory disagreements, patient recruitment, or unforeseen safety events[155](index=155&type=chunk) - The company relies completely on third-party contract manufacturers for its product supply and does not have its own manufacturing capabilities, making it vulnerable to supply disruptions and compliance failures[200](index=200&type=chunk) [Risks Related to Intellectual Property](index=52&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Commercial success depends on intellectual property protection, facing risks of infringement claims, patent invalidation, and breaches of trade secret confidentiality agreements - The company may face allegations of infringing third-party patent rights, which could lead to costly litigation, substantial damages, and limitations on its ability to commercialize products[242](index=242&type=chunk)[243](index=243&type=chunk) - The company's ability to compete depends on maintaining its intellectual property; patents may not issue, or issued patents may be challenged, invalidated, or circumvented[248](index=248&type=chunk)[249](index=249&type=chunk) - The company relies on confidentiality agreements to protect trade secrets, but these may be breached, and it may not have adequate remedies, potentially impairing its competitive position[262](index=262&type=chunk) [Risks Related to Government Regulation](index=59&type=section&id=Risks%20Related%20to%20Government%20Regulation) Approved products face extensive ongoing regulatory scrutiny, potential penalties for non-compliance, and challenges from healthcare legislation and fraud and abuse laws impacting pricing and reimbursement - Approved products will remain subject to extensive ongoing regulatory requirements for manufacturing (cGMP), labeling, and promotion, with potential for penalties or withdrawal of approval for non-compliance[279](index=279&type=chunk)[280](index=280&type=chunk)[282](index=282&type=chunk) - Enacted and future healthcare legislation, including the ACA and the Inflation Reduction Act (IRA), may increase the difficulty and cost of obtaining marketing approval and could negatively affect product pricing and reimbursement[285](index=285&type=chunk)[289](index=289&type=chunk) - Business operations and relationships with healthcare professionals and third-party payors are subject to fraud and abuse laws (e.g., the Anti-Kickback Statute), which could lead to significant penalties if violations are found[299](index=299&type=chunk)[300](index=300&type=chunk) [Risks Related to Our Common Stock](index=63&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The company's common stock price is volatile, influenced by reduced disclosure as a smaller reporting company, significant insider ownership, potential future dilution, and no dividend policy - The company's common stock price has been and could continue to be subject to substantial volatility due to clinical trial results, regulatory announcements, and broader market conditions[301](index=301&type=chunk) - As of September 30, 2023, executive officers, directors, and 5%+ stockholders beneficially owned a majority of the outstanding voting stock, enabling them to exert significant control over matters requiring stockholder approval[313](index=313&type=chunk) - The company does not intend to pay dividends, so a return on investment will depend on the appreciation of the stock price[326](index=326&type=chunk)

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 June 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 001-39402 ANNEXON, INC. (Exact name of Registrant as specified in its Charter) Delaware 27-5414423 (State or other jurisdiction of in ...

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 001-39402 ANNEXON, INC. (Exact name of Registrant as specified in its Charter) Delaware 27-5414423 (State or other jurisdiction of i ...

GAME-CHANGING MEDICINES FOR COMPLEMENT- MEDIATED DISEASES INVESTOR PRESENTATION MARCH 2023 Nasdaq: ANNX Forward-Looking Statements This p ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 001-39402 ANNEXON, INC. (Exact name of Registrant as specified in its Charter) Delaware 27-5414423 (State or other jurisdiction of incorp ...

GAME-CHANGING MEDICINES FOR COMPLEMENT- MEDIATED DISEASES JANUARY 2023 Nasdaq: ANNX Forward-Looking Statements This p ...

[PART I—FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents Annexon, Inc.'s unaudited condensed consolidated financial statements, highlighting **$269.5 million** in cash and investments, a **$403.9 million** accumulated deficit, and **$122.6 million** from a July 2022 private placement Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2022 ($) | December 31, 2021 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $210,658 | $74,843 | | Short-term investments | $58,861 | $167,872 | | Total current assets | $274,777 | $247,693 | | Total assets | $312,722 | $287,040 | | **Liabilities & Equity** | | | | Total liabilities | $52,120 | $55,131 | | Total stockholders' equity | $260,602 | $231,909 | | Accumulated deficit | $(403,879) | $(296,315) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2022 ($) | | :--- | :--- | :--- | | Research and development | $27,862 | $83,966 | | General and administrative | $8,207 | $24,938 | | **Net loss** | **$(35,054)** | **$(107,564)** | | Net loss per share | $(0.51) | $(2.21) | - The company has experienced losses since inception, with an accumulated deficit of **$403.9 million** as of September 30, 2022. Operations have been funded primarily through stock issuances[28](index=28&type=chunk) - In July 2022, the company closed a private placement of common stock and warrants, resulting in net proceeds of approximately **$122.6 million**. Management projects that current cash is sufficient to support operations for at least the next 12 months[29](index=29&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage biopharmaceutical business, pipeline progress, and financial performance, noting a net loss increase to **$107.6 million** and a liquidity boost from a **$122.6 million** private placement extending cash runway into H2 2025 - Annexon is a clinical-stage biopharmaceutical company focused on a new class of complement medicines targeting C1q for autoimmune, neurodegenerative, and ophthalmic disorders[105](index=105&type=chunk) - The company is advancing a pipeline of five product candidates: ANX005 (IV for GBS, wAIHA, HD, ALS), ANX007 (intravitreal for GA), ANX009 (subcutaneous for LN), ANX105 (monoclonal antibody), and ANX1502 (oral small molecule)[108](index=108&type=chunk)[110](index=110&type=chunk) Financial Results Comparison (in thousands) | Metric | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | Research and development | $83,966 | $72,849 | | General and administrative | $24,938 | $20,406 | | **Net loss** | **$(107,564)** | **$(92,952)** | - As of September 30, 2022, the company had **$269.5 million** in cash, cash equivalents, and short-term investments, which is expected to fund operations into the second half of 2025[136](index=136&type=chunk)[146](index=146&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) R&D expenses increased by **$11.1 million** (15%) to **$84.0 million**, driven by clinical trial and personnel costs, while G&A expenses rose by **$4.5 million** (22%) to **$24.9 million** due to personnel and professional services R&D Expense Breakdown - Nine Months Ended Sep 30 (in thousands) | Expense Category | 2022 ($) | 2021 ($) | Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Clinical and nonclinical outside services | $39,640 | $30,608 | $9,032 | 30% | | Compensation and personnel-related | $21,740 | $18,031 | $3,709 | 21% | | Contract manufacturing | $12,553 | $14,464 | $(1,911) | (13%) | | **Total R&D Expenses** | **$83,966** | **$72,849** | **$11,117** | **15%** | G&A Expense Breakdown - Nine Months Ended Sep 30 (in thousands) | Expense Category | 2022 ($) | 2021 ($) | Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Compensation and personnel-related | $12,579 | $9,622 | $2,957 | 31% | | Consulting and professional services | $9,653 | $8,673 | $980 | 11% | | **Total G&A Expenses** | **$24,938** | **$20,406** | **$4,532** | **22%** | [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity, primarily from equity sales, was boosted by a **$122.6 million** July 2022 private placement, bringing cash and investments to **$269.5 million** and extending funding into H2 2025, with a **$100.0 million** ATM program available - On July 11, 2022, the company completed a private placement of common stock and warrants, resulting in net proceeds of approximately **$122.6 million** after fees and expenses[148](index=148&type=chunk) - Based on the current operating plan, existing cash and investments are expected to fund operations and capital requirements into the second half of 2025[146](index=146&type=chunk) - The company has a **$100.0 million** at-the-market (ATM) offering program established in August 2021, but no shares have been sold under this program as of September 30, 2022[147](index=147&type=chunk) Historical Cash Flows (in thousands) | Activity | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(89,170) | $(77,789) | | Net cash provided by (used in) investing activities | $102,058 | $(121,933) | | Net cash provided by financing activities | $122,800 | $847 | [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are foreign currency exchange and interest rate fluctuations, with foreign currency exposure deemed immaterial and interest rate risk on short-term investments not expected to materially impact financial results - The company's primary market risks are foreign currency exchange risk and interest rate risk[155](index=155&type=chunk)[156](index=156&type=chunk) - Foreign currency risk from operations in Australia is not considered material[155](index=155&type=chunk) - Interest rate risk is associated with cash and cash equivalents (**$210.7 million**) and short-term investments (**$58.9 million**). However, due to the short-term nature of these holdings, a 10% change in interest rates is not expected to have a material impact[156](index=156&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of September 30, 2022, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[157](index=157&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended September 30, 2022, that materially affected, or are reasonably likely to materially affect, internal controls[158](index=158&type=chunk) [PART II—OTHER INFORMATION](index=31&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may become involved in ordinary course litigation - As of the filing date, the company is not party to any material legal proceedings[162](index=162&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including its clinical-stage status, history of losses, need for substantial financing, dependence on product candidate success, clinical trial delays, supply chain reliance, competition, and public health crises - The company is a clinical-stage biopharmaceutical company with a limited operating history, significant losses since inception, and no products approved for commercial sale[164](index=164&type=chunk)[165](index=165&type=chunk) - Substantial additional financing will be required to achieve goals, and failure to obtain it could force delays or termination of development programs[164](index=164&type=chunk)[167](index=167&type=chunk) - The business is heavily dependent on the successful development, regulatory approval, and commercialization of its product candidates, which are in early stages of clinical development[164](index=164&type=chunk)[181](index=181&type=chunk) - The company relies on third-party suppliers for manufacturing and intends to do so for commercial supplies, creating risk related to compliance, quality, and supply chain stability[164](index=164&type=chunk)[255](index=255&type=chunk) - Public health crises like the COVID-19 pandemic have caused and could continue to cause interruptions in clinical trial activities, staff shortages, and supply chain issues[164](index=164&type=chunk)[188](index=188&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Details the July 11, 2022 private placement of common stock and warrants, and confirms no material change in the planned use of proceeds from the July 2020 IPO - On July 11, 2022, the company sold an aggregate of **9,013,834 shares** of common stock, pre-funded warrants to purchase **24,696,206 shares**, and common warrants to purchase **8,427,508 shares** in a private placement[422](index=422&type=chunk) - There has been no material change in the planned use of proceeds from the company's IPO, which was declared effective on July 23, 2020[423](index=423&type=chunk) [Defaults Upon Senior Securities](index=74&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[423](index=423&type=chunk) [Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[423](index=423&type=chunk) [Other Information](index=74&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this period - None[423](index=423&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Quarterly Report on Form 10-Q, including certifications from executive officers and Inline XBRL documents for financial reporting - The report includes required certifications from the Principal Executive Officer (31.1) and Principal Financial Officer (31.2) as exhibits[425](index=425&type=chunk) - Inline XBRL files (Instance, Schema, Calculation, Definition, Label, Presentation) are included as exhibits 101.INS through 101.PRE[425](index=425&type=chunk)[427](index=427&type=chunk)