| --- | --- | --- | --- | --- | |--------------------------------------------------------------|-------|--------------|-------|-------------| | Operating expenses: | | March \n2024 | 31, | 2023 | | Research and development | $ | 33,776 | $ | 24,395 | | General and administrative | | 7,283 | | 5,636 | | Total operating expenses | | 41,059 | | 30,031 | | Loss from operations | | (41,059 ) | | (30,031 ) | | Interest and other income, net | | 1,998 | | 980 | | Net loss | $ | (39,061 ) | $ | (29,051 ) | | Other ...

REDWOOD CITY, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (NASDAQ:BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on May 1, 2024, the compensation committee of Biomea's board of directors granted 8 new employees non-qualified stock options to purchase an aggregate of 80,250 shares of the Company's c ...

Exhibit 99.1 Biomea Fusion Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights • In 2023, reported Phase 2 data (COVALENT-111) in type 2 diabetes patients supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells. o After just a 4-week treatment period in type 2 diabetes patients, who had previously failed standard of care (HbA1c > 7.0% and < 10%), BMF-219 demonstrated continued glycemic control ...

Custom Scaffold Creation: We create novel chemical scaffolds using a computational platform to exploit the unique structural elements of a specific target protein. We then screen these scaffolds with in-house technologies to select the optimal candidates for further construction and design. This evaluation process is intended to increase the probability of having multiple targeted compounds that can advance through the discovery process and into the clinic. · Molecule Optimization/Refinement: Using our prop ...

There’s a simple reason why short-squeeze stocks to buy represent a powerful catalyst: they’re intuitive and easier to engage.Buying something and hoping that it appreciates in value represents an organically sensible strategy. It’s the reason why people collect everything from baseball cards to luxury Swiss watches. Stated differently, it doesn’t take much to explain the rationale behind short-squeeze stocks to buy.On the other hand, shorting a stock represents an incredibly complex affair by comparison. F ...

Three Clinical Data Sets from the Dose Escalation Phase of COVALENT-111 to be Presented at the 17th Annual ATTD Conference Highlighting BMF-219's Novel Mechanism of Action in Patients with Type 2 Diabetes Patients in COVALENT-111 are displaying improved glycemic control while off therapy out to Week 26 following the 28-day treatment with BMF-219, supporting enhanced pancreatic islet function as the mechanism of actionBMF-219 was generally well tolerated with no serious adverse events and no adverse event-re ...

Financial advisors rarely if ever recommend speculative stocks because they don’t want to get sued. Let’s be real here. And I’m not interested in any drama either. These are extremely risky ideas and you should assume a greater probability of losing than winning.That being said, humans are humans. We say one thing when we really mean another. In this context, speculative stocks represent a siren call. Allow me to use blunt language: it’s legalized gambling. Whether you live in San Francisco, California or M ...

We may be required to protect our patents through procedures created to attack the validity of a patent at the USPTO. The USPTO hears post-grant proceedings, including post grant review (PGR), inter partes review (IPR), and derivation proceedings. An adverse determination in any such submission or proceeding could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position. Because of a lower evidentiary standard in USPTO proceedings compare ...

Clinical Development and Trial Progress - The company's lead product candidate, BMF-219, demonstrated a significant reduction in HbA1C by 3.5% in preclinical studies for diabetes treatment, outperforming liraglutide which showed a 1.7% reduction at Day 29[122] - BMF-219 showed consistent on-target inhibition and anti-proliferative effects in various menin-dependent cancer cell lines, including AML, DLBCL, CLL, and MM[122] - The Phase 1/1b clinical trial (COVALENT-102) for BMF-219 in NSCLC, CRC, and PDAC patients with KRAS mutations was initiated in October 2022[123] - Initial clinical data from the Phase 2 portion of COVALENT-111 showed that 40 patients were enrolled, with T2DM patients in Cohorts 2 and 3 having median A1c levels of 7.9% and 7.8% at baseline[125] - BMF-219 was generally well tolerated in COVALENT-111, with no dose reductions, serious adverse events, or severe adverse events reported[126] - Initial topline data from the Phase 1 trial (COVALENT-101) revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients with menin-dependent mutations treated at Dose Level 4[127] - The company's lead product candidate, BMF-219, is in clinical development for selected liquid tumors, solid tumors, and type 2 diabetes, with limited clinical data from a small patient population[225] - The company's second product candidate, BMF-500, received IND clearance from the FDA in May 2023 and is preparing to enter clinical development[225] - The company's lead product candidate, BMF-219, has not yet completed clinical testing, and its success depends on factors such as regulatory approvals, manufacturing capabilities, and market acceptance[256] - The company has received IND clearance for BMF-500, another development candidate, but its clinical development and commercialization remain uncertain[256] - Preclinical and clinical development is a lengthy and expensive process, with potential delays due to regulatory, manufacturing, or patient enrollment challenges[258][259][260] - The company's clinical trials may face delays or difficulties in patient enrollment and retention, which could delay regulatory submissions or marketing approvals[234] - The company's product candidates may initially seek approval for second or later lines of therapy, with potential for earlier line therapy approval depending on clinical data[237] - The company's preclinical studies and clinical trials are subject to uncertainty, and successful preclinical studies and early clinical trials may not predict the success of later trials[233] - Interim or preliminary clinical trial data may change as more patient data becomes available, potentially impacting regulatory approval and commercialization[311] Financial Performance and Funding - The company reported a net loss of $53.9 million for the six months ended June 30, 2023, compared to a net loss of $33.6 million for the same period in 2022[128] - Research and development expenses increased by $22.4 million during the six months ended June 30, 2023, primarily due to increased clinical and manufacturing activities for BMF-219 and BMF-500[134] - The company had an accumulated deficit of $185.5 million as of June 30, 2023, and expects to continue incurring significant losses for the foreseeable future[128] - Net cash used in operating activities was $25.4 million during the six months ended June 30, 2022, primarily due to a net loss of $33.6 million[140] - Net cash provided by financing activities was $163.0 million during the six months ended June 30, 2023, with $161.8 million from the public offering of common stock and $1.2 million from stock option exercises[142] - The company has $223.3 million in cash, cash equivalents, restricted cash, and investments as of June 30, 2023, which is expected to fund operations for at least one year[216] - The company has incurred significant net losses since inception and expects to continue incurring losses for the foreseeable future[208] - The company may need to raise additional funds through equity or debt financing, which could dilute existing stockholders or impose restrictive covenants[216] - The company's expenses are expected to increase significantly as it continues clinical trials and seeks marketing approval for BMF-219 and BMF-500[216] - The company's ability to generate revenue depends on successful completion of clinical trials, regulatory approval, and commercialization of product candidates[211] - The company's ability to generate product revenue depends on the successful clinical development and commercialization of BMF-219, BMF-500, and future candidates, which is not expected for many years[256] - The company's ability to use net operating loss (NOL) carryforwards to offset future taxable income is limited to 80% of current year taxable income under U.S. tax law[357] Regulatory and Market Risks - The company faces significant translational risk as product candidates advance in clinical development, with no guarantee of success in later-stage trials[211] - The company's ability to generate revenue depends on the successful development and commercialization of its product candidates, which may not occur for several years, if ever[229] - The company's product candidates, if approved, will face competition from existing and future therapies, with key competitive factors including potency, selectivity, safety, price, and reimbursement availability[244] - The company's product candidates may face challenges in market acceptance due to potential undesirable side effects or unexpected characteristics in preclinical or clinical trials[244][245] - Regulatory approval delays or denials could significantly impact the company's ability to commercialize its product candidates[257][262] - The company's competitors may obtain regulatory approval more rapidly, develop more effective drugs, or have greater financial resources and expertise[242] - The company's novel approach to drug discovery and development, including its FUSION™ System, is unproven and may not yield commercially viable product candidates[254] - The company's FUSION System is being used to build a pipeline of novel covalent small molecule product candidates, but the system is unproven and may not enable the development of a successful pipeline[226] - The company faces competition from Kura Oncology's KO-539 and Syndax Pharmaceuticals' SNDX-5613, both of which target menin through non-covalent inhibition and are in clinical development[241] - The company estimates the incidence and prevalence of target patient populations for BMF-219 and BMF-500 based on third-party sources, but these estimates may be inaccurate or based on imprecise data[239] - The market opportunities for BMF-219 and BMF-500 are limited to patients ineligible for or failing prior treatments, with potential inaccuracies in target patient population estimates[267][268] - The company faces significant competition from pharmaceutical and biotechnology companies, including those developing covalent binders and targeted therapies for genetically-defined cancers and metabolic diseases[270][271][272] - Adverse events or side effects from the company's covalent small molecule product candidates could hinder regulatory approval, market acceptance, and commercial potential[275][276] - The company may face challenges in recruiting and retaining qualified personnel, establishing clinical trial sites, and acquiring necessary technologies due to competition[273] - The COVID-19 pandemic or similar outbreaks could materially impact the company's preclinical studies and clinical trials[279] - Market acceptance of the company's precision medicine product candidates depends on factors such as clinical indications, perceived advantages, side effects, and cost of treatment[281][282] - The company's ability to commercialize product candidates depends on coverage and reimbursement from government and private payors, which may not be adequate[284][286] - Regulatory approval processes are lengthy, unpredictable, and may require additional data, potentially delaying or preventing commercialization[291][292][294] - The company may incur substantial liabilities from product liability lawsuits, which could limit commercialization efforts[287][288] - The company lacks experience in commercializing product candidates and may face challenges in building an effective sales and marketing organization[289][290] - The company may seek orphan drug designation (ODD) for eligible product candidates, but there is no guarantee of success. ODD is granted for rare diseases affecting fewer than 200,000 individuals annually in the U.S.[295] - Even with ODD, the company may not secure or maintain orphan drug exclusivity due to competition, broader indications, or manufacturing challenges[296] - Fast Track designation does not guarantee faster development, regulatory review, or approval, and the FDA may withdraw the designation if data no longer supports it[298] - Accelerated approval requires post-marketing confirmatory trials, and failure to meet FDA requirements could result in expedited withdrawal of approval[299] - Priority review designation aims for a 6-month FDA review cycle, but it does not guarantee approval or expedited processes[301] - Regulatory disruptions, such as government shutdowns, can delay FDA reviews and approvals, impacting the company's business[303] - The company faces risks of product liability claims, which could result in significant financial and reputational damage[320] - The company lacks commercialization experience and may need to develop or outsource sales, marketing, and distribution capabilities[322] - Regulatory approval for product candidates requires lengthy and costly preclinical and clinical trials, with no guarantee of success[323] - Only a small percentage of drugs in development successfully complete FDA or foreign regulatory approval processes, which could materially adversely affect the company's business, results of operations, and prospects[325] - Orphan Drug Designation (ODD) in the U.S. provides financial incentives, including grant funding for clinical trials, tax advantages, and user-fee waivers, and grants seven years of exclusivity for the first FDA-approved product for a specific disease[327] - Breakthrough Therapy designation may not result in a faster development process, review, or approval compared to conventional FDA procedures, and does not assure ultimate FDA approval[329] - Accelerated approval by the FDA does not guarantee a faster development or regulatory review process and does not increase the likelihood of regulatory approval[330] - Regulatory approval in one jurisdiction does not guarantee approval in others, and delays in one jurisdiction may negatively impact approval processes in others[333] - The FDA's ability to review and approve new products can be affected by factors such as government budget levels, personnel retention, and statutory changes, leading to fluctuating review times[334] - Post-approval regulatory obligations may include costly post-market studies, surveillance, or clinical trials, and failure to comply could result in penalties, restrictions, or product recalls[336] - Changes in healthcare laws and regulations could prevent or delay marketing approval, restrict post-approval activities, and affect the company's ability to profitably sell approved products[337] - Regulatory approval of product candidates in one jurisdiction does not guarantee approval in other jurisdictions[366] - Changes in FDA funding or government shutdowns could delay regulatory reviews and impact the company's ability to access capital markets[368] - The company's product candidates are subject to comprehensive regulation by the FDA and other agencies, which could delay or prevent commercialization[369] - Healthcare legislative measures aimed at reducing costs could materially adversely affect the company's business and operations[370] - Misconduct by employees, contractors, or vendors could result in regulatory sanctions and reputational damage[372] - Violations of healthcare laws and regulations could lead to significant penalties, including fines, disgorgement, and exclusion from federal healthcare programs[373] Operational and Strategic Risks - The company's resource allocation decisions may impact its ability to capitalize on more profitable product candidates or indications[214] - The company is subject to various risks and uncertainties, including unforeseen expenses, delays, and complications in product development[205] - The company had 94 full-time employees as of June 30, 2023, with 71 engaged in research and development activities[352] - Future financial performance depends on the company's ability to effectively manage growth, including hiring new employees and engaging third-party service providers to develop and commercialize product candidates[354] - The company's operations and those of its contractors are vulnerable to natural and man-made disasters, which could significantly disrupt operations and increase costs[355] - The company relies on third-party manufacturers outside the U.S., including in China, exposing it to risks such as supply disruptions, increased costs, and foreign currency fluctuations[359] - The company depends on single-source suppliers for key materials, exposing it to risks of supply disruptions, price increases, and delays[365]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements for Q1 2023, reporting a **net loss of $29.1 million** and **$86.7 million** in cash and equivalents Key Financial Data (Q1 2023 vs Q1 2022) | Financial Metric | Three Months Ended March 31, 2023 (in millions, except per share data) | Three Months Ended March 31, 2022 (in millions, except per share data) | | :--- | :--- | :--- | | Research and development expense | $24.4 million | $11.4 million | | General and administrative expense | $5.6 million | $5.1 million | | Net loss | $(29.1) million | $(16.4) million | | Net loss per share | $(0.98) | $(0.56) | Balance Sheet Highlights (as of March 31, 2023) | Account | Amount (in thousands) | | :--- | :--- | | Cash, cash equivalents, and restricted cash | $86,651 | | Total assets | $112,638 | | Total liabilities | $29,509 | | Accumulated deficit | $(160,621) | | Total stockholders' equity | $83,129 | - The company believes its existing financial resources, including proceeds from an April 2023 public offering, are sufficient to fund operations for at least **one year** past the issuance date of the financial statements[433](index=433&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's lead drug candidates, BMF-219 and BMF-500, significant R&D expense increases, and liquidity, noting **$161.8 million** from a recent offering will fund operations for at least one year - The company's lead product candidate, **BMF-219**, is a covalent inhibitor of menin being developed for menin-dependent diseases including acute leukemia, KRAS solid tumors, and type 2 diabetes mellitus (T2DM)[495](index=495&type=chunk)[501](index=501&type=chunk) - The company's second development candidate, **BMF-500**, a covalent inhibitor of FLT3, received FDA clearance in May 2023 for a Phase 1 study in patients with relapsed or refractory acute leukemia[498](index=498&type=chunk) Research and Development Expense Breakdown (in thousands) | Cost Category | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :--- | :--- | :--- | | External costs | $16,161 | $6,193 | | Personnel-related expenses | $6,377 | $3,817 | | Facilities and other | $1,857 | $1,340 | | **Total R&D Expenses** | **$24,395** | **$11,350** | - In April 2023, the company completed a public offering, selling 5,750,000 shares of common stock for net proceeds of approximately **$161.8 million**[499](index=499&type=chunk)[521](index=521&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$86.7 million** cash and investments, with foreign currency risk deemed immaterial - The company's primary market risk is interest rate sensitivity. As of March 31, 2023, it held **$86.7 million** in cash, cash equivalents, restricted cash, and investments[533](index=533&type=chunk) - Due to the short-term maturities of its cash equivalents, management asserts that an immediate **10% relative change** in interest rates would not have a material effect on their fair market value[533](index=533&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's 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 concluded that as of March 31, 2023, the company's disclosure controls and procedures were **effective** at a reasonable assurance level[170](index=170&type=chunk) - There were **no material changes** to the company's internal control over financial reporting during the first quarter of 2023[171](index=171&type=chunk) PART II. OTHER INFORMATION [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 litigation may arise in the ordinary course of business - As of the report date, the company is **not a party to any material legal proceedings**[175](index=175&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section outlines key risks including limited operating history, need for capital, unproven drug development, dependence on BMF-219, lengthy regulatory pathways, reliance on third parties, intellectual property challenges, and common stock volatility [Risks Related to Our Limited Operating History, Business, Financial Condition, Results of Operations, and Need for Additional Capital](index=29&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%2C%20Business%2C%20Financial%20Condition%2C%20Results%20of%20Operations%2C%20and%20Need%20for%20Additional%20Capital) The company faces challenges from its limited operating history, lack of revenue, significant net losses, and the need for substantial additional capital, exacerbated by financial market instability - The company is a clinical-stage entity with a **limited operating history**, **no products approved** for sale, and has **never generated revenue**[177](index=177&type=chunk)[178](index=178&type=chunk) - The company has incurred significant net losses since inception, totaling **$160.6 million** in accumulated deficit as of March 31, 2023, and expects these losses to continue and increase[181](index=181&type=chunk)[184](index=184&type=chunk) - **Substantial additional funding is required** to continue operations. Failure to raise capital could force the company to delay, reduce, or eliminate development programs[147](index=147&type=chunk)[148](index=148&type=chunk) - Adverse developments in the financial services industry, such as the failure of Silicon Valley Bank (SVB), could **negatively affect access to funding** and the financial stability of its partners and suppliers[156](index=156&type=chunk)[157](index=157&type=chunk) [Risks Related to Product Development](index=35&type=section&id=Risks%20Related%20to%20Product%20Development) The company's unproven covalent small molecule strategy, high dependence on BMF-219, lengthy and uncertain drug development, and competitive landscape pose significant product development risks - The company's approach of developing covalent small molecule therapies is **novel and unproven**, and may not lead to marketable products[163](index=163&type=chunk)[164](index=164&type=chunk) - The business is **substantially dependent on BMF-219**. Failure to advance BMF-219 would materially harm the company[197](index=197&type=chunk)[198](index=198&type=chunk) - Preclinical and clinical drug development is a **lengthy, expensive, and uncertain process**. Programs may experience delays or fail, which would adversely affect the ability to commercialize products[3](index=3&type=chunk)[5](index=5&type=chunk) - The company faces **substantial competition** from major pharmaceutical and biotechnology companies, including Kura Oncology and Syndax Pharmaceuticals, which are developing non-covalent menin inhibitors[27](index=27&type=chunk)[29](index=29&type=chunk) - Product candidates may cause **significant adverse events or toxicities**, which could prevent regulatory approval or limit commercial potential[34](index=34&type=chunk)[35](index=35&type=chunk) [Risks Related to Regulatory Process and Other Legal Compliance Matters](index=47&type=section&id=Risks%20Related%20to%20Regulatory%20Process%20and%20Other%20Legal%20Compliance%20Matters) The company faces lengthy, unpredictable regulatory approval processes, extensive post-approval obligations, and complex healthcare compliance laws, including data privacy, with significant penalties for non-compliance - The regulatory approval processes of the FDA and comparable foreign authorities are **lengthy, time-consuming, and inherently unpredictable**, with no guarantee of success[70](index=70&type=chunk)[71](index=71&type=chunk)[73](index=73&type=chunk) - Even if regulatory approval is received, the company will be subject to **extensive and ongoing regulatory obligations**, including potential post-marketing studies and restrictions (REMS)[94](index=94&type=chunk)[101](index=101&type=chunk) - The company's operations are subject to various healthcare laws and regulations, including anti-kickback, fraud and abuse, and false claims laws, which could expose it to **significant penalties if violated**[113](index=113&type=chunk)[114](index=114&type=chunk) - The company is subject to stringent and changing laws related to data privacy and security, such as HIPAA and the CCPA, and failure to comply could result in **significant fines and liability**[116](index=116&type=chunk)[117](index=117&type=chunk)[121](index=121&type=chunk) [Risks Related to Reliance on Third Parties](index=57&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) The company's heavy reliance on third-party CROs, CMOs, and single-source suppliers for preclinical, clinical, and manufacturing activities creates risks related to control, quality, compliance, and supply chain continuity - The company **depends on third parties**, such as CROs and medical institutions, to conduct and support its preclinical studies and clinical trials[205](index=205&type=chunk)[206](index=206&type=chunk) - **Reliance on third parties for manufacturing creates risks** related to cGMP compliance, quality control, and supply chain continuity, as the company does not own its manufacturing facilities[213](index=213&type=chunk)[214](index=214&type=chunk)[215](index=215&type=chunk) - The company depends on **single-source suppliers** for some ingredients and materials, exposing it to risks of supply disruptions, price increases, and delays[220](index=220&type=chunk)[221](index=221&type=chunk)[223](index=223&type=chunk) - Future collaborations or strategic alliances are subject to **numerous risks**, including the partner not dedicating sufficient resources, potential disputes, and termination of agreements[227](index=227&type=chunk)[230](index=230&type=chunk) [Risks Related to Intellectual Property](index=61&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's commercial success hinges on obtaining and enforcing intellectual property rights, facing risks of patent challenges, infringement claims, and limited patent terms - The company's ability to successfully commercialize its products depends on its ability to obtain, maintain, and enforce patent protection, which is **highly uncertain** in the biotechnology field[238](index=238&type=chunk)[239](index=239&type=chunk)[240](index=240&type=chunk) - Issued patents may be **challenged, invalidated, or held unenforceable** in court or before patent offices, potentially resulting in claims being narrowed[244](index=244&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk) - The company may become involved in **expensive and time-consuming lawsuits** to protect its patents or may be sued by third parties for infringing their intellectual property rights[263](index=263&type=chunk)[282](index=282&type=chunk)[285](index=285&type=chunk) - **Patent terms are limited** and may expire before or shortly after a product is commercialized, opening the door to generic competition[271](index=271&type=chunk) [Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business](index=55&type=section&id=Risks%20Related%20to%20Employee%20Matters%2C%20Managing%20Our%20Growth%20and%20Other%20Risks%20Related%20to%20Our%20Business) The company's success depends on retaining key personnel and managing growth, facing risks from business disruptions, limitations on NOL carryforwards, and geopolitical factors affecting its China operations - The company is **highly dependent on its key personnel**, including its CEO and COO[128](index=128&type=chunk)[129](index=129&type=chunk) - As of March 31, 2023, the company had **86 full-time employees** and expects to grow its organization, which will impose significant responsibilities on management[132](index=132&type=chunk)[133](index=133&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards to offset future taxable income may be **limited** under Section 382 of the Internal Revenue Code if an "ownership change" occurs[140](index=140&type=chunk)[141](index=141&type=chunk) - A portion of product development and manufacturing sourcing occurs in China, exposing the company to **risks from trade wars, political unrest, or operational disruptions** at third-party manufacturers[203](index=203&type=chunk)[204](index=204&type=chunk) [Risks Related to Our Common Stock](index=70&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The company's common stock faces high volatility, potential dilution from future offerings, significant influence from principal stockholders, and no anticipated dividends, limiting returns to stock appreciation - The trading price of the company's common stock has been and is likely to be **highly volatile** due to factors such as clinical trial results, regulatory decisions, and market conditions[303](index=303&type=chunk)[309](index=309&type=chunk) - Raising additional capital through equity offerings will cause **dilution to existing stockholders**[311](index=311&type=chunk)[315](index=315&type=chunk) - As of March 31, 2023, executive officers, directors, and their affiliates beneficially own approximately **30% of the company's voting stock**, enabling them to exert **significant influence** over stockholder matters[318](index=318&type=chunk) - The company has **never paid dividends** and does not anticipate doing so in the foreseeable future; any return to stockholders will be limited to stock value appreciation[319](index=319&type=chunk)[321](index=321&type=chunk) [General Risk Factors](index=74&type=section&id=General%20Risk%20Factors) General risks include securities litigation, public company costs, internal control challenges, reduced reporting as an 'emerging growth company,' cybersecurity threats, and geopolitical instability - The company will continue to incur **significant costs** and management attention to comply with public company requirements under the Sarbanes-Oxley Act and SEC regulations[340](index=340&type=chunk)[342](index=342&type=chunk) - As an "emerging growth company," the company takes advantage of certain exemptions from reporting requirements, which may make its stock **less attractive to investors**[354](index=354&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk) - The company is **vulnerable to cybersecurity incidents** which could compromise sensitive data, disrupt programs, and result in significant financial, legal, and reputational harm[394](index=394&type=chunk)[395](index=395&type=chunk)[397](index=397&type=chunk) - **Geopolitical risks**, such as the military conflict between Russia and Ukraine, could adversely impact the company's business, financial condition, and clinical trials through market volatility and sanctions[408](index=408&type=chunk)[409](index=409&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=80&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period, and no material change in the planned use of IPO proceeds - There were **no unregistered sales** of equity securities in the period[411](index=411&type=chunk) - There has been **no material change** in the planned use of proceeds from the company's IPO[413](index=413&type=chunk) [Item 3. Defaults Upon Senior Securities](index=81&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - **None**[414](index=414&type=chunk) [Item 4. Mine Safety Disclosures](index=81&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - **None**[414](index=414&type=chunk) [Item 5. Other Information](index=81&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this period - **None**[415](index=415&type=chunk) [Item 6. Exhibits](index=82&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and required CEO/CFO certifications - Lists exhibits filed with the report, including **corporate governance documents** and required **CEO/CFO certifications** under Sarbanes-Oxley Sections 302 and 906[417](index=417&type=chunk)[418](index=418&type=chunk)[419](index=419&type=chunk)