Ventyx Biosciences(VTYX)
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Ventyx Biosciences(VTYX) - 2024 Q1 - Quarterly Report
2024-05-09 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2024 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: 001-40928 Ventyx Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 83-2996852 | | ...
Ventyx Biosciences(VTYX) - 2024 Q1 - Quarterly Results
2024-05-09 20:06
Exhibit 99.1 Ventyx Biosciences Reports First Quarter 2024 Financial Results and Highlights Recent Corporate Progress Phase 2a trials of CNS-Penetrant NLRP3 Inhibitor VTX3232 to initiate in H2 2024 in patients with early Parkinson's disease and in participants with obesity with certain additional cardiovascular risk factors Cash, cash equivalents and marketable securities of $302.6 million as of March 31, 2024 are expected to fund planned operations into at least the second half of 2026 Ventyx to host confe ...
Ventyx Biosciences(VTYX) - 2023 Q4 - Annual Report
2024-02-27 21:15
Financial Performance - The company reported a net loss of $193.0 million for the year ended December 31, 2023, compared to a net loss of $108.4 million for the year ended December 31, 2022, reflecting an increase in losses of $84.5 million[523]. - The accumulated deficit as of December 31, 2023, was $419.2 million, indicating significant ongoing financial challenges[523]. - The company has incurred net losses since inception and expects to continue doing so for the foreseeable future[551]. - The company has not generated any revenue from product sales since its inception and does not expect to do so for the foreseeable future[530]. - The company has not generated any revenue and does not expect to until regulatory approval and commercialization of product candidates[545]. Research and Development Expenses - Total research and development expenses increased to $175.8 million in 2023 from $87.7 million in 2022, marking an increase of approximately $88.0 million[539]. - The primary contributors to the increase in research and development expenses included costs associated with the Phase 1 and Phase 2 trials for VTX958 (approximately $51.2 million) and the Phase 2 trial for VTX002 (approximately $15.0 million)[540]. - The company plans to initiate a Phase 3 trial of VTX002 in ulcerative colitis in the second half of 2024, following positive results from a Phase 2 trial[521]. - The company expects to report topline results from the Phase 2 trial of VTX958 in Crohn's disease in mid-2024[521]. General and Administrative Expenses - General and administrative expenses rose to $32.2 million in 2023 from $25.4 million in 2022, an increase of $6.8 million primarily due to higher personnel costs and stock-based compensation[541]. - The company anticipates increased general and administrative expenses as it expands operations and complies with public company requirements[536]. Cash Flow and Liquidity - Net cash used in operating activities was $166.5 million for 2023, compared to $98.8 million in 2022, driven by a net loss of $193.0 million[552][553]. - Net cash provided by investing activities was $100.9 million in 2023, mainly from $373.7 million in proceeds from maturities of marketable securities[554]. - Net cash provided by financing activities was $53.3 million in 2023, primarily from $48.4 million in net proceeds from common stock issuance[556]. - As of December 31, 2023, the company had cash, cash equivalents, and marketable securities totaling $252.2 million, excluding restricted cash of $1.0 million[543]. - As of December 31, 2023, the company had cash, cash equivalents, and marketable securities totaling $252.2 million, down from $356.6 million in 2022, primarily invested in U.S. Treasury and corporate debt securities[572]. - Short-term liquidity needs related to operating leases are approximately $2.2 million, while long-term needs are about $15.6 million[549]. - The company anticipates needing substantial additional funding for ongoing operations and product development, with no committed external sources of funds[550]. Market and Compliance Risks - The company ceased to be an "emerging growth company" and a "smaller reporting company" as of December 31, 2023, due to its market value exceeding $700 million as of June 30, 2023[567][568]. - The loss of EGC and smaller reporting company status is expected to increase the company's public compliance costs[569]. - The company is exposed to market risk related to interest rate changes, particularly affecting its short-term available-for-sale marketable securities[572]. - A hypothetical change of 100 basis points in foreign currency exchange rates would be immaterial to the company's financials[573]. Stock-Based Compensation - The company recognizes stock-based compensation expense based on the fair value of equity awards estimated using the Black-Scholes option pricing model[566].
Ventyx Biosciences(VTYX) - 2023 Q4 - Annual Results
2024-02-27 21:08
Exhibit 99.1 Ventyx Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Corporate Progress Ventyx to host virtual investor event on March 11 th to provide clinical updates on our NLRP3 portfolio and from the open-label extension of the VTX002 Phase 2 trial in ulcerative colitis Cash, cash equivalents and marketable securities of $252.2 million as of December 31, 2023 are expected to fund operations into at least H2 2025 SAN DIEGO, February 27, 2024 (GLOBE NEWSWIRE) ...
Ventyx Biosciences(VTYX) - 2023 Q3 - Quarterly Report
2023-11-09 21:20
Financial Performance - The company reported a net loss of $54.0 million for the three months ended September 30, 2023, compared to a net loss of $30.5 million for the same period in 2022, representing an increase of 77.3%[113]. - The accumulated deficit reached $372.4 million as of September 30, 2023, indicating significant ongoing financial challenges[97]. - The company has not generated any revenue from product sales since its inception and does not expect to do so in the foreseeable future[105]. - Total operating expenses for the three months ended September 30, 2023, were $57.9 million, up from $31.4 million in the same period of 2022, marking an increase of 84.0%[113]. - Net cash used in operating activities was $114.9 million for the nine months ended September 30, 2023, primarily due to a net loss of $146.2 million[135]. Research and Development - Research and development expenses increased to $49.8 million for the three months ended September 30, 2023, from $25.5 million in the same period of 2022, reflecting a growth of 95.3%[114]. - The company incurred research and development expenses of $133.7 million for the nine months ended September 30, 2023, compared to $57.6 million for the same period in 2022, reflecting an increase of 132.5%[108]. - Research and development expenses increased by approximately $76.2 million for the nine months ended September 30, 2023, compared to the same period in 2022, primarily due to costs associated with clinical trials for VTX958 and VTX002[121]. - The company plans to conduct an interim efficacy analysis for VTX958 in Crohn's disease in Q1 2024, with full topline data expected later in 2024[95]. - Positive results were announced from the Phase 2 trial of VTX002 in ulcerative colitis, with a Phase 3 trial expected to be initiated in 2024[95]. General and Administrative Expenses - The company expects significant increases in general and administrative expenses as it expands operations and prepares for potential commercialization of product candidates[111]. - General and administrative expenses rose to $23.9 million for the nine months ended September 30, 2023, up from $17.0 million in 2022, reflecting increased personnel costs and professional service fees[122]. - General and administrative expenses for the three months ended September 30, 2023, were $8.2 million, an increase of $2.2 million from $6.0 million in 2022[117]. Cash and Funding - As of September 30, 2023, the company had cash, cash equivalents, and marketable securities totaling $300.8 million, excluding restricted cash of $1.0 million[134]. - Net cash provided by investing activities was $54.8 million for the nine months ended September 30, 2023, mainly from proceeds of $298.7 million from maturities of marketable securities[137]. - Net cash provided by financing activities was $52.7 million for the nine months ended September 30, 2023, attributed to net proceeds from the issuance of common stock under the Sales Agreement[139]. - The company anticipates needing substantial additional funding for ongoing operations and product development, with cash resources expected to last into 2025[128]. - Net cash provided by financing activities was $178.1 million for the nine months ended September 30, 2022, primarily from $176.5 million in net proceeds from common stock issuance[140]. Accounting and Reporting - The company has not made material changes to its critical accounting policies and estimates during the nine months ended September 30, 2023[142]. - The aggregate market value of shares held by non-affiliate stockholders exceeded $700 million on the last business day of the second quarter of 2023, leading to a change in filer status[146]. - The company will cease to be classified as an emerging growth company effective December 31, 2023, due to its large accelerated filer status[145]. - The company will no longer qualify as a smaller reporting company effective December 31, 2023, impacting its reporting requirements[147]. - The company evaluates long-lived assets for impairment whenever events indicate that the carrying value may not be recoverable[143]. - Assumptions and estimates used for cash flow evaluations in impairment assessments are subject to judgment and may lead to material changes in asset values[144]. - The company has elected to take advantage of the extended transition period for complying with new accounting standards as an emerging growth company[145]. - Recent accounting pronouncements that may impact financial positions are disclosed in the quarterly report[149]. - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[150].
Ventyx Biosciences, Inc. (VTYX) Business Update Conference (Transcript)
2023-11-08 04:30
Ventyx Biosciences, Inc. (NASDAQ:VTYX) Business Update Conference Call Summary Company Overview - **Company**: Ventyx Biosciences, Inc. - **Ticker**: NASDAQ:VTYX - **Date of Call**: November 7, 2023 Key Points Industry and Company Focus - The call focused on the results of the Phase 2 trial of the TYK2 inhibitor VTX958 in plaque psoriasis and provided a business update on ongoing clinical trials and product development [5][6][22]. Clinical Trial Results - The Phase 2 trial of VTX958 in plaque psoriasis achieved its primary and all key secondary endpoints, but did not meet expectations for a best-in-class efficacy profile [5][11]. - A higher-than-anticipated discontinuation rate was observed, with 22% of patients discontinuing at the 225-milligram BID dose and 21% at the 300-milligram BID dose, compared to 16% on placebo [10]. - The trial enrolled 220 participants and was a 16-week randomized, double-blind, placebo-controlled study [8][9]. - The primary endpoint of PASI-75 was achieved by 49% of patients in the 300-milligram BID group, but the overall efficacy was disappointing [11][12]. Decisions on Trials - The company decided to terminate the Phase 2 trial of VTX958 in plaque psoriasis and psoriatic arthritis due to the lack of compelling efficacy data [6][16][17]. - The ongoing Phase 2 trial of VTX958 in Crohn's disease will continue, with an interim efficacy analysis planned for the first quarter of 2024 [17][18]. Financial Position - Ventyx reported having over $300 million in cash, cash equivalents, and marketable securities as of the end of the third quarter, with a cash runway expected to extend into 2025 [24][36]. Future Developments - The company is committed to providing updates on the ongoing Phase 2 trial of VTX958 in Crohn's disease and expects to deliver several important portfolio updates in the first quarter of 2024 [22][25]. - VTX002, an S1P1 modulator for ulcerative colitis, is viewed as a potential best-in-disease oral agent, with updates expected in early 2024 [23][49]. Safety and Adverse Events - Most adverse events in the psoriasis trial were mild or moderate, with no serious adverse events related to the study drug [13]. - A case of colon cancer was reported but deemed unrelated to the drug [43]. Strategic Insights - The company acknowledges a higher unmet need in Crohn's disease and a less competitive landscape for oral agents, which supports the continuation of the trial in this indication [29][35]. - The management expressed confidence in the pharmacokinetic data and the potential for VTX958 to exhibit preferential biodistribution to gastrointestinal tissue [18][32]. Conclusion - While the results from the psoriasis trial were disappointing, Ventyx remains optimistic about its broader portfolio and the potential for upcoming data to inform future development strategies [25][66].
Ventyx Biosciences(VTYX) - 2023 Q2 - Earnings Call Transcript
2023-08-13 15:11
Start Time: 16:30 January 1, 0000 5:23 PM ET Ventyx Biosciences, Inc. (NASDAQ:VTYX) Q2 2023 Earnings Conference Call August 10, 2023, 16:30 PM ET Company Participants Raju Mohan - Founder and CEO Marty Auster - CFO Bill Sandborn - President and Chief Medical Officer Conference Call Participants Michael Yee - Jefferies Alex Thompson - Stifel Vikram Purohit - Morgan Stanley Derek Archila - Wells Fargo Chris Shibutani - Goldman Sachs Emily Bodnar - H.C. Wainwright Sam Slutsky - LifeSci Capital Operator Good af ...
Ventyx Biosciences(VTYX) - 2023 Q2 - Quarterly Report
2023-08-10 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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: 001-40928 Ventyx Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 83-2996852 (State o ...
Ventyx Biosciences(VTYX) - 2023 Q1 - Earnings Call Transcript
2023-05-14 17:55
Ventyx Biosciences, Inc. (NASDAQ:VTYX) Q1 2023 Earnings Conference Call May 11, 2023 6:00 PM ET Company Participants Raju Mohan - Founder & Chief Executive Officer Marty Auster - Chief Financial Officer Bill Sandborn - President & Chief Medical Officers Conference Call Participants Michael Yee - Jefferies Yasmeen Rahimi - Piper Sandler Derek Archila - Wells Fargo Alex Thompson - Stifel Chris Shibutani - Goldman Sachs Emily Bodnar - H.C. Wainwright Sam Slutsky - LifeSci Capital Operator Good afternoon, ladie ...
Ventyx Biosciences(VTYX) - 2023 Q1 - Quarterly Report
2023-05-11 20:21
[PART I—FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements.) This section presents Ventyx Biosciences, Inc.'s unaudited condensed consolidated financial statements for Q1 2023, showing a net loss of $38.9 million and total assets of $389.2 million [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2023, shows total assets of $389.2 million, an increase from $371.4 million, primarily due to marketable securities, with stockholders' equity rising to $371.6 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **$389,169** | **$371,400** | | Cash and cash equivalents | $63,669 | $64,819 | | Marketable securities | $313,246 | $291,794 | | **Total Liabilities** | **$17,551** | **$17,505** | | **Total Stockholders' Equity** | **$371,618** | **$353,895** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2023, the company reported a net loss of $38.9 million, or $(0.68) per share, primarily due to a significant increase in research and development expenses to $35.4 million Statement of Operations Summary (in thousands, except per share data) | Metric | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $35,437 | $17,409 | | General and administrative | $7,115 | $5,338 | | **Total operating expenses** | **$42,552** | **$22,747** | | Loss from operations | $(42,552) | $(22,747) | | Interest income | $(3,622) | $(132) | | **Net loss** | **$(38,931)** | **$(22,732)** | | **Net loss per share** | **$(0.68)** | **$(0.45)** | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity increased to $371.6 million, primarily driven by $48.4 million in net proceeds from an at-the-market stock offering, partially offset by the net loss - The company raised **$48.4 million** in net proceeds from an at-the-market offering during the quarter[23](index=23&type=chunk) - Stock-based compensation expense for the quarter was **$6.6 million**[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $30.9 million, while financing activities provided $48.6 million, largely from a stock offering, ending the period with $63.7 million in cash Cash Flow Summary (in thousands) | Activity | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(30,921) | $(12,726) | | Net cash used in investing activities | $(18,895) | $(16,503) | | Net cash provided by financing activities | $48,646 | $86 | | **Net decrease in cash and cash equivalents** | **$(1,150)** | **$(29,101)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, fair value measurements, the $48.4 million ATM stock offering, lease obligations, and a breakdown of $6.6 million in stock-based compensation expenses - The company is a clinical-stage pharmaceutical company developing a pipeline of small molecule product candidates for inflammatory diseases[28](index=28&type=chunk) - In February 2023, the company sold 1,176,470 shares of common stock through its at-the-market (ATM) Sales Agreement for aggregate gross proceeds of **$50.0 million**, resulting in net proceeds of approximately **$48.4 million**[54](index=54&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $3,214 | $1,195 | | General and administrative | $3,353 | $2,249 | | **Total** | **$6,567** | **$3,444** | [Item 2. 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 Q1 2023 financial results, highlighting clinical pipeline advancements, an increased net loss of $38.9 million due to higher R&D, and a strong liquidity position of $376.9 million expected to fund operations into 2025 [Overview](index=21&type=section&id=Overview) Ventyx is a clinical-stage biopharmaceutical company developing small molecule candidates for inflammatory diseases, with lead programs VTX958, VTX002, and NLRP3 inhibitors, anticipating continued operating losses - The lead candidate, VTX958, is actively enrolling in three Phase 2 trials for psoriasis, psoriatic arthritis, and Crohn's disease, with topline data from the psoriasis trial expected in **Q4 2023**[84](index=84&type=chunk) - Topline data from the Phase 2 trial of VTX002 in ulcerative colitis is expected in the **second half of 2023**[84](index=84&type=chunk) - The company incurred a net loss of **$38.9 million** for the three months ended March 31, 2023, and had an accumulated deficit of **$265.2 million**[86](index=86&type=chunk) [Financial Operations Overview](index=22&type=section&id=Financial%20Operations%20Overview) This section details financial operations, noting no revenue, with R&D expenses increasing by $18.0 million to $35.4 million due to clinical trials, and G&A expenses rising by $1.8 million Research and Development Expenses by Program (in thousands) | Program | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :--- | :--- | :--- | | VTX958 | $15,672 | $5,568 | | VTX002 | $8,455 | $3,880 | | VTX2735 | $270 | $3,340 | | Unallocated R&D | $11,040 | $4,621 | | **Total R&D** | **$35,437** | **$17,409** | - The **$18.0 million** net increase in R&D expenses was primarily driven by a **$10.1 million** increase in costs for VTX958 trials and a **$4.6 million** increase for the VTX002 trial[104](index=104&type=chunk) - General and administrative expenses increased by **$1.8 million**, mainly due to a **$1.1 million** increase in stock-based compensation and a **$0.3 million** increase in other compensation-related expenses[105](index=105&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2023, the company had $376.9 million in cash and marketable securities, bolstered by $48.4 million from an ATM offering, expected to fund operations into 2025 - As of March 31, 2023, the company had cash, cash equivalents and marketable securities of **$376.9 million**[107](index=107&type=chunk) - In February 2023, the company received approximately **$48.4 million** in net proceeds from the sale of common stock through its Sales Agreement[107](index=107&type=chunk) - The company expects its current cash, cash equivalents, and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into **2025**[111](index=111&type=chunk) [Cash Flows](index=27&type=section&id=Cash%20Flows) Net cash used in operating activities increased to $30.9 million, while investing activities used $18.9 million, and financing activities provided $48.6 million, primarily from a stock offering Summary of Net Cash Flow Activity (in thousands) | Activity | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :--- | :--- | :--- | | Operating activities | $(30,921) | $(12,726) | | Investing activities | $(18,895) | $(16,503) | | Financing activities | $48,646 | $86 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Ventyx is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Ventyx is not required to provide quantitative and qualitative disclosures about market risk[128](index=128&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2023, 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[130](index=130&type=chunk) - There were no material changes in the company's internal control over financial reporting during the quarter ended March 31, 2023[131](index=131&type=chunk) [PART II—OTHER INFORMATION](index=29&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not aware of any pending legal proceedings expected to materially impact its financial position or results of operations - The Company is not aware of any pending legal proceedings that would reasonably be expected to have a material impact on the Company's financial position or results of operations[52](index=52&type=chunk)[133](index=133&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including a history of losses, need for financing, dependence on product candidate success, uncertain clinical development, regulatory approval, intellectual property, and stock price volatility [Risks Related to Our Business](index=30&type=section&id=Risks%20Related%20to%20Our%20Business) This section details business risks, including a history of significant losses (accumulated deficit of $265.2 million), need for future capital, dependence on early-stage product candidates, and intense competition - The company has a history of significant operating losses, with an accumulated deficit of **$265.2 million** as of March 31, 2023, and expects to continue incurring losses for the foreseeable future[136](index=136&type=chunk)[138](index=138&type=chunk) - The business is entirely dependent on the success of its product candidates, which are still in early stages of clinical development and may never receive regulatory approval or be successfully commercialized[143](index=143&type=chunk) - The company faces significant competition from other biotechnology and pharmaceutical companies, such as **BMS**, that have substantially greater resources and experience[172](index=172&type=chunk)[173](index=173&type=chunk)[175](index=175&type=chunk) [Risks Related to Government Regulation](index=62&type=section&id=Risks%20Related%20to%20Government%20Regulation) This section highlights risks from the lengthy and unpredictable FDA approval process, compliance with federal and state healthcare laws, and potential adverse impacts from healthcare reform measures like the Inflation Reduction Act of 2022 - The FDA regulatory approval process is lengthy, time-consuming, and unpredictable, and the company has no prior experience submitting an NDA[285](index=285&type=chunk) - The company is subject to numerous federal and state healthcare laws, including the Anti-Kickback Statute and False Claims Act, and non-compliance could result in significant civil and criminal penalties[313](index=313&type=chunk) - Healthcare reform, including the **Inflation Reduction Act of 2022**, could lead to stricter coverage criteria and downward pressure on pricing, which may adversely affect the ability to sell products profitably[331](index=331&type=chunk)[336](index=336&type=chunk) [Risks Related to Intellectual Property](index=73&type=section&id=Risks%20Related%20to%20Intellectual%20Property) This section outlines intellectual property risks, including challenges in obtaining and maintaining patent protection, potential infringement lawsuits, and increased uncertainties and costs due to changes in U.S. patent law - The company's success relies on obtaining and maintaining sufficient patent protection, but the patent process is uncertain and issued patents may not adequately protect against competitors[342](index=342&type=chunk)[343](index=343&type=chunk) - The company may be sued for infringing on the intellectual property rights of third parties, which could be costly and time-consuming and could prevent or delay the development or commercialization of its product candidates[369](index=369&type=chunk) - Changes in U.S. patent law, such as the **America Invents Act**, have increased the uncertainties and costs surrounding the prosecution and enforcement of patents[377](index=377&type=chunk)[378](index=378&type=chunk) [Risks Related to Our Common Stock](index=85&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) This section details risks for investors, including stock price volatility, potential dilution from future equity offerings, no anticipated dividends, and significant control by executive officers and directors - The market price of the company's common stock is likely to be volatile, with its closing price ranging from a low of **$11.95** to a high of **$46.65** between March 31, 2022, and March 31, 2023[395](index=395&type=chunk) - The company will need to raise additional capital, which may result in future equity offerings that could cause substantial dilution to existing investors[398](index=398&type=chunk) - As of March 31, 2023, executive officers and directors beneficially owned a significant portion of the outstanding stock, enabling them to exert significant control over matters requiring stockholder approval[407](index=407&type=chunk) [General Risk Factors](index=89&type=section&id=General%20Risk%20Factors) This section covers general risks, including the company's status as an "emerging growth company" and "smaller reporting company," costs of being public, internal control failures, and vulnerability to unfavorable global economic conditions - The company is an "emerging growth company" and a "smaller reporting company," which allows it to rely on exemptions from certain disclosure requirements, potentially making its common stock less attractive to investors[418](index=418&type=chunk)[422](index=422&type=chunk) - Failure to establish and maintain effective internal controls over financial reporting could lead to a loss of investor confidence and a significant decline in the stock price[425](index=425&type=chunk) - Unfavorable global economic conditions and instability in the financial services industry could adversely affect the company's business, financial condition, and ability to raise capital[430](index=430&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=93&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered equity sales and no material change in the planned use of $158.8 million net proceeds from its October 2021 IPO - The company had no sales of unregistered securities during the reported period[440](index=440&type=chunk) - There has been no material change in the planned use of the approximately **$158.8 million** in net proceeds from the company's Initial Public Offering on October 25, 2021[441](index=441&type=chunk) [Item 3. Defaults Upon Senior Securities](index=93&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The company reports no defaults upon senior securities during the period - None[442](index=442&type=chunk) [Item 4. Mine Safety Disclosures](index=93&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not Applicable[443](index=443&type=chunk) [Item 5. Other Information](index=93&type=section&id=Item%205.%20Other%20Information.) The company reports no other information for this period - None[444](index=444&type=chunk) [Item 6. Exhibits](index=94&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and required officer certifications - The report includes a list of filed exhibits, such as corporate governance documents and required officer certifications[446](index=446&type=chunk)