Workflow
89bio(ETNB)
icon
Search documents
89Bio (ETNB) 2025 Conference Transcript
2025-05-14 18:40
Summary of 89Bio (ETNB) Conference Call Company Overview - **Company**: 89Bio - **Focus**: Development of picocefermin, an FGF21 analog for treating NASH (Non-Alcoholic Steatohepatitis) and severe hypertriglyceridemia (SHTG) [3][52] Key Points on FGF21 and NASH - **Mechanism of Action**: FGF21 is a unique FGF21 analog that addresses metabolic dysregulation, liver fat reduction, and fibrosis directly [3][4][6] - **Clinical Efficacy**: FGF21 shows benefits in fibrosis improvement as early as 24 weeks, compared to other drugs that may take longer [6][10] - **Market Dynamics**: Recent successful drug approvals in the NASH space have increased confidence in the market, with a shift towards more potent second-generation products [7][10] Competitive Landscape - **Recent Deals**: GSK's acquisition of Boston Pharmaceuticals' efemulsipherman for $800 million validates interest in the NASH market and the FGF21 mechanism [11][12] - **Market Potential**: The F4 cirrhotic population represents the highest unmet need and pricing power in the NASH market [13][14] Differentiating Characteristics of Pegosafirman - **Dosing and Administration**: Pegosafirman can be dosed once a week or every two weeks, with a favorable tolerability profile compared to competitors [18][21][23] - **Efficacy Data**: In phase 2 studies, pegosafirman showed a 20% placebo-adjusted delta in fibrosis improvement, with a relative risk benefit of 3.5 [18][19][20] - **Tolerability**: Lower rates of gastrointestinal adverse events compared to other FGF21 agents, which is crucial for patient compliance [21][22] Physician and Patient Perspectives - **Physician Preferences**: Key criteria include fibrosis benefit, tolerability, and the ability to address steatohepatitis [27][28][30] - **Patient Preferences**: Patients prioritize dosing convenience, adverse event profiles, and affordability [32][33] Market Strategy and Future Outlook - **Targeting Endocrinologists**: As the market evolves, endocrinologists are expected to play a significant role in treating NASH, especially with the approval of GLP-1s [34][35] - **Market Size**: The F4 space alone could exceed $5 billion, indicating significant potential for multiple successful players [38] Combination Therapies - **Potential Combinations**: The combination of FGF21 with GLP-1s could yield synergistic benefits, but safety and tolerability will be critical factors [49][50] Severe Hypertriglyceridemia (SHTG) Strategy - **Target Population**: Patients with triglycerides above 500 mg/dL, often with metabolic dysfunction, represent a significant market opportunity [52][53] - **Efficacy in SHTG**: Phase 2 studies showed a 57% to 63% reduction in triglycerides, positioning pegosafirman as a second-line therapy for refractory patients [54][55] Conclusion - **Overall Outlook**: 89Bio is well-positioned in the NASH and SHTG markets with a differentiated product profile and a strong focus on patient and physician needs, supported by promising clinical data and market validation through recent industry deals [56]
89bio to Participate in Upcoming Investor Conferences
Globenewswire· 2025-05-06 20:05
Company Overview - 89bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardiometabolic diseases [3] - The company is headquartered in San Francisco and is dedicated to creating best-in-class treatments for patients lacking optimal options [3] Product Development - 89bio is currently in Phase 3 trials for its lead candidate, pegozafermin, targeting metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis and severe hypertriglyceridemia (SHTG) [3] - Pegozafermin is a fibroblast growth factor 21 (FGF21) analog utilizing glycoPEGylated technology to enhance biological activity through an extended half-life [3] Investor Engagement - The company will participate in the BofA Securities 2025 Health Care Conference on May 14, 2025, at 1:40 PM ET [1] - Additionally, 89bio will be present at the RBC Capital Markets Global Healthcare Conference on May 20, 2025, at 9:30 AM ET [2] - Webcasts of these fireside chats will be available on the investor section of 89bio's website, with replays accessible for approximately 30 days post-conference [2]
89bio(ETNB) - 2025 Q1 - Quarterly Report
2025-05-02 20:30
PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for Q1 2025 show total assets increased to $685.0 million due to a public offering, while net loss rose to $71.3 million from increased R&D expenses [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $685.0 million by March 31, 2025, primarily due to a rise in cash and cash equivalents, significantly boosting stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $315,396 | $126,060 | | Marketable securities | $323,384 | $313,895 | | Total current assets | $682,944 | $476,450 | | **Total assets** | **$685,031** | **$478,685** | | **Liabilities & Equity** | | | | Total current liabilities | $37,884 | $36,129 | | Total liabilities | $79,573 | $77,896 | | Total stockholders' equity | $605,458 | $400,789 | | **Total liabilities and stockholders' equity** | **$685,031** | **$478,685** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for Q1 2025 increased to $71.3 million due to higher R&D expenses, though net loss per share decreased to $0.49 due to more shares outstanding Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | P&L Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $64,394 | $47,428 | | General and administrative | $11,515 | $9,849 | | Total operating expenses | $75,909 | $57,277 | | Loss from operations | $(75,909) | $(57,277) | | **Net loss** | **$(71,275)** | **$(51,681)** | | **Net loss per share, basic and diluted** | **$(0.49)** | **$(0.54)** | | Weighted-average shares outstanding | 146,365,115 | 95,846,740 | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity significantly increased to $605.5 million by March 31, 2025, primarily driven by $269.9 million from a public offering, partially offset by net loss - In Q1 2025, the company issued common stock and pre-funded warrants in a public offering, raising net proceeds of **$269.9 million**[16](index=16&type=chunk) - The increase in equity was offset by a net loss of **$71.3 million** and other comprehensive loss of **$0.2 million** for the quarter[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $71.7 million in Q1 2025, but a $268.9 million inflow from financing activities led to a net increase in cash to $315.4 million Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(71,737) | $(39,720) | | Net cash used in investing activities | $(7,833) | $(79,898) | | Net cash provided by financing activities | $268,906 | $21,030 | | **Net change in cash and cash equivalents** | **$189,336** | **$(98,588)** | | **Cash and cash equivalents at end of period** | **$315,396** | **$217,573** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes confirm the company's clinical-stage focus on pegozafermin, an accumulated deficit of $895.8 million, and sufficient cash of $638.8 million for at least one year, alongside key financial commitments - The company is a clinical-stage biopharmaceutical company developing pegozafermin for MASH and SHTG[21](index=21&type=chunk) - As of March 31, 2025, the company had an accumulated deficit of **$895.8 million** but believes its cash, cash equivalents, and marketable securities of **$638.8 million** are sufficient to fund operations for at least one year[23](index=23&type=chunk)[24](index=24&type=chunk) - In February 2025, the company raised net proceeds of approximately **$269.9 million** from an underwritten public offering[62](index=62&type=chunk) - The company has a term loan facility for up to **$150.0 million**, with **$35.0 million** drawn as of March 31, 2025; access to the **$30.0 million** Tranche 2 is not anticipated[56](index=56&type=chunk) [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 advancement of pegozafermin in Phase 3 trials, a $17.0 million increase in R&D expenses, and $638.8 million in cash, which is deemed sufficient for at least one year of operations [Overview](index=20&type=section&id=Overview) The company is a clinical-stage biopharmaceutical firm developing pegozafermin, with Phase 3 trials for MASH and SHTG progressing and commercial supply preparations underway - Lead product candidate, pegozafermin, is in Phase 3 development for MASH and SHTG[76](index=76&type=chunk) - The Phase 3 ENLIGHTEN program for MASH is enrolling patients, with topline data for the F2-F3 cohort expected in **H1 2027** and the F4 cohort in **2028**[78](index=78&type=chunk)[80](index=80&type=chunk) - The Phase 3 ENTRUST trial for SHTG has completed enrollment, with topline data expected in **Q1 2026**[79](index=79&type=chunk)[81](index=81&type=chunk) - A collaboration with BiBo is in place to construct a production facility for pegozafermin's commercial supply[82](index=82&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q1 2025 R&D expenses increased by $17.0 million to $64.4 million, driven by Phase 3 MASH trials, while G&A expenses also rose Change in Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Research and development** | **$64,394** | **$47,428** | **$16,966** | | Clinical development | $33,795 | $17,924 | $15,871 | | Contract manufacturing | $19,057 | $21,351 | $(2,294) | | Personnel-related expenses | $10,673 | $7,733 | $2,940 | | **General and administrative** | **$11,515** | **$9,849** | **$1,666** | [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $638.8 million in cash and equivalents, bolstered by a $269.9 million public offering, sufficient to fund operations for at least one year - The company had cash, cash equivalents, and marketable securities of **$638.8 million** as of March 31, 2025[96](index=96&type=chunk) - In February 2025, a public offering raised net proceeds of **$269.9 million**[100](index=100&type=chunk) - Existing cash is expected to fund operations for at least one year from the filing date of the 10-Q[105](index=105&type=chunk) - The company does not anticipate meeting the condition to access Tranche 2 (**$30.0 million**) of its Term Loan Facility[106](index=106&type=chunk) [Contractual Obligations and Commitments](index=30&type=section&id=Contractual%20Obligations%20and%20Commitments) The company has significant future financial commitments, including $35.0 million in outstanding debt, potential $65.0 million milestone payments to Teva, and a $13.5 million payment to BiBo for a production facility - Obligated to pay Teva up to **$65.0 million** upon achievement of specified commercial milestones for pegozafermin[118](index=118&type=chunk) - A remaining **$13.5 million** is payable to BiBo for a production facility upon achieving a certain milestone[119](index=119&type=chunk) - The outstanding principal of **$35.0 million** under the Loan Agreement matures on October 1, 2028[117](index=117&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes in its market risk from the information provided in its Annual Report on Form 10-K for the year ended December 31, 2024 - There have been no material changes in market risk since the last Annual Report on Form 10-K[122](index=122&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025 - Management concluded that disclosure controls and procedures were effective as of March 31, 2025[124](index=124&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[125](index=125&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[128](index=128&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including dependence on pegozafermin's success, clinical and regulatory uncertainties, capital needs, reliance on third-party manufacturers, competition, and intellectual property disputes [Risks Related to Business and Industry](index=34&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) Risks include the company's dependence on pegozafermin, the uncertain and costly nature of clinical trials, the need for additional capital, reliance on third-party manufacturers, and intense competition - The company is a clinical-stage biopharmaceutical company with a history of net losses and its business depends entirely on the success of pegozafermin[131](index=131&type=chunk)[136](index=136&type=chunk) - The company will require substantial additional capital to finance operations, which may not be available on acceptable terms[140](index=140&type=chunk) - Reliance on third-party manufacturers, including BiBo in China, exposes the company to supply chain, geopolitical, and regulatory risks like the proposed BIOSECURE Act[147](index=147&type=chunk)[148](index=148&type=chunk)[154](index=154&type=chunk) - The company faces substantial competition from other companies developing therapies for MASH and SHTG, some with greater resources[163](index=163&type=chunk) [Risks Related to Regulatory Approvals](index=54&type=section&id=Risks%20Related%20to%20Regulatory%20Approvals) Significant regulatory risks include the uncertainty of pegozafermin's approval, potential post-market issues, and the limitations of expedited designations, compounded by FDA disruptions and evolving requirements - Pegozafermin has not received regulatory approval, and the process is lengthy, expensive, and uncertain[189](index=189&type=chunk)[193](index=193&type=chunk) - Even if approved, pegozafermin could face post-market difficulties, including potential revocation of approval if harmful side effects are discovered[192](index=192&type=chunk) - Breakthrough Therapy and PRIME designations do not guarantee a faster review or ultimate approval[195](index=195&type=chunk)[196](index=196&type=chunk) - Disruptions at the FDA and other government agencies, including policy changes and budget constraints, could negatively affect the review of regulatory submissions[199](index=199&type=chunk) [Risks Related to Intellectual Property](index=61&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Intellectual property risks include the uncertainty of patent protection, reliance on a critical license from Teva, and the potential for costly litigation to defend or enforce IP rights - Success depends on the ability to obtain and maintain intellectual property protection for products and technologies, which is highly uncertain[209](index=209&type=chunk)[213](index=213&type=chunk) - The company relies on a license from Teva for the glycoPEGylation technology essential for pegozafermin; termination of this license would materially harm the business[217](index=217&type=chunk) - The company may become involved in expensive and unsuccessful lawsuits to protect its intellectual property or defend against infringement claims from third parties[220](index=220&type=chunk)[223](index=223&type=chunk) [Risks Related to Ownership of Our Common Stock](index=67&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Risks to common stock ownership include significant price volatility, potential depression from substantial share sales, and dilution from future equity offerings - The price of the company's common stock may be volatile and fluctuate significantly due to clinical developments, competitor news, and market trends[225](index=225&type=chunk) - Sales of a substantial number of shares, or the perception of such sales, could depress the stock price[226](index=226&type=chunk) - Raising additional capital through equity offerings may cause significant dilution to existing stockholders[229](index=229&type=chunk) [General Risk Factors](index=69&type=section&id=General%20Risk%20Factors) General risks include substantial control by insiders, inherent limitations of internal controls, and exclusive forum provisions that may limit stockholders' judicial options - Directors, executive officers, and holders of **5%** or more of the stock have substantial control over the company[232](index=232&type=chunk) - The company's disclosure and internal controls have inherent limitations and may not prevent all errors or fraud; failure to maintain effective controls could harm investor confidence[233](index=233&type=chunk)[235](index=235&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards may be limited, and a potential tax assessment from Israeli authorities could impact NOLs and financial condition[239](index=239&type=chunk)[240](index=240&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[242](index=242&type=chunk) [Other Information](index=72&type=section&id=Item%205.%20Other%20Information) The company states that none of its directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the first quarter of 2025 - No directors or executive officers adopted or terminated a Rule 10b5-1 trading plan during the three months ended March 31, 2025[245](index=245&type=chunk) [Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, forms of warrants, and officer certifications - The report includes a list of all exhibits filed, such as the Certificate of Incorporation, Bylaws, forms of warrants, and officer certifications required by the SEC[247](index=247&type=chunk)
89bio(ETNB) - 2025 Q1 - Quarterly Results
2025-05-01 20:05
[89bio First Quarter 2025 Financial Results and Corporate Updates](index=1&type=section&id=89bio%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Updates) [Recent Highlights and Anticipated Milestones](index=1&type=section&id=Recent%20Highlights%20and%20Anticipated%20Milestones) 89bio advances global Phase 3 MASH trials with data expected by 2028, significantly enhancing its financial position - **Topline histology data** from ENLIGHTEN-Fibrosis expected **1H 2027**, and ENLIGHTEN-Cirrhosis in **2028**[2](index=2&type=chunk)[4](index=4&type=chunk) - The Phase 3 ENTRUST trial for SHTG is **fully enrolled**, with **topline data expected in Q1 2026**[2](index=2&type=chunk)[10](index=10&type=chunk) - Pegozafermin shows potential for **fibrosis improvement and MASH resolution**, supported by a *Hepatology* meta-analysis[3](index=3&type=chunk) - The company concluded Q1 2025 with **$638.8 million in cash and equivalents** following a **$287.5 million gross proceeds equity offering**[2](index=2&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) Three global Phase 3 trials are actively enrolling, with MASH histology data expected by 2028 and SHTG data by Q1 2026 [Metabolic dysfunction-associated steatohepatitis (MASH)](index=1&type=section&id=Metabolic%20dysfunction-associated%20steatohepatitis%20(MASH)) ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials are actively enrolling globally, with histology data expected by 2028 - The Phase 3 ENLIGHTEN-Fibrosis (F2-F3 MASH) and ENLIGHTEN-Cirrhosis (F4 MASH) trials are **actively enrolling patients globally**[3](index=3&type=chunk)[4](index=4&type=chunk) - **Topline histology data** is anticipated in **1H 2027** for ENLIGHTEN-Fibrosis and in **2028** for ENLIGHTEN-Cirrhosis[4](index=4&type=chunk) - Trials are designed with **FDA and EMA alignment** to support **accelerated approval** via histology data, while collecting outcomes for full approval[5](index=5&type=chunk) [Severe Hypertriglyceridemia (SHTG)](index=2&type=section&id=Severe%20Hypertriglyceridemia%20(SHTG)) The global Phase 3 ENTRUST trial for SHTG is fully enrolled, with topline data expected in Q1 2026 - The global Phase 3 ENTRUST trial is **fully enrolled**[2](index=2&type=chunk) - **Topline data** from the ENTRUST trial is expected in **Q1 2026**[10](index=10&type=chunk) - ENTRUST is a **52-week trial** evaluating **weekly pegozafermin doses (30 mg and 20 mg)** versus placebo[10](index=10&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Q1 2025 saw 89bio secure **$287.5 million** from an equity offering and implement a flexible global manufacturing strategy - A **follow-on equity offering** in Q1 2025 generated **$287.5 million in gross proceeds**[10](index=10&type=chunk) - The company holds a **$150 million credit facility** with K2 HealthVentures, with **$35 million drawn**[10](index=10&type=chunk) - A **flexible, global manufacturing strategy** is implemented with alternative suppliers to mitigate risks[3](index=3&type=chunk)[10](index=10&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Q1 2025 saw 89bio report a **$71.3 million net loss** due to increased expenses, while maintaining a **$638.8 million cash position** - As of March 31, 2025, **cash, cash equivalents, and marketable securities totaled approximately $638.8 million**[6](index=6&type=chunk) Key Financial Metrics | Financial Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change Driver | | :--- | :--- | :--- | :--- | | **R&D Expenses** | $64.4 | $47.4 | Increased clinical development for Phase 3 MASH trials and higher personnel costs | | **G&A Expenses** | $11.5 | $9.8 | Increased personnel-related expenses due to higher headcount | | **Net Loss** | $71.3 | $51.7 | Higher R&D and G&A expenses | [Financial Statements](index=5&type=section&id=Financial%20Statements) Unaudited Q1 2025 financial statements show a **$71.3 million net loss**, **$685.0 million total assets**, and **$605.5 million stockholders' equity** [Condensed Consolidated Statement of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) The statement details a **net loss of $71.3 million** for Q1 2025, driven by **$75.9 million in total operating expenses** | (In thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $64,394 | $47,428 | | General and administrative | $11,515 | $9,849 | | **Total operating expenses** | **$75,909** | **$57,277** | | Loss from operations | $(75,909) | $(57,277) | | Interest income and other, net | $6,038 | $6,556 | | **Net loss** | **$(71,275)** | **$(51,681)** | | Net loss per share, basic and diluted | $(0.49) | $(0.54) | | Weighted-average shares outstanding | 146,365,115 | 95,846,740 | [Condensed Consolidated Balance Sheet Data](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) The balance sheet shows **total assets of $685.0 million** as of March 31, 2025, with **cash and equivalents at $638.8 million** | (In thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $638,780 | $439,955 | | **Total assets** | **$685,031** | **$478,685** | | Total current liabilities | $37,884 | $36,129 | | **Total liabilities and stockholders' equity** | **$685,031** | **$478,685** |
89bio Reports First Quarter 2025 Financial Results and Corporate Updates
Globenewswire· 2025-05-01 20:05
Core Insights - 89bio, Inc. is advancing its clinical-stage biopharmaceutical development, focusing on therapies for liver and cardiometabolic diseases, particularly targeting metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG) [11] Clinical Trials - The Phase 3 ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials are designed to support accelerated approval for treating patients with MASH, with topline data expected in 1H 2027 and 2028, respectively [1][5] - The ENTRUST trial for SHTG has been fully enrolled, with topline data anticipated in 1Q 2026 [1][5] - Pegozafermin has been recognized in a meta-analysis as one of the most effective agents for fibrosis improvement and MASH resolution, highlighting its potential in the market [2] Financial Position - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling approximately $638.8 million, an increase from $439.9 million at the end of 2024 [7][15] - The company completed a follow-on equity offering in 1Q 2025, generating gross proceeds of $287.5 million [4] - A $150 million credit facility with K2 HealthVentures has been established, with $35 million drawn down [4] Expenses and Losses - Research and development expenses for Q1 2025 were $64.4 million, up from $47.4 million in Q1 2024, primarily due to increased clinical development costs [8] - General and administrative expenses rose to $11.5 million in Q1 2025 from $9.8 million in Q1 2024, driven by higher personnel-related costs [9] - The net loss for Q1 2025 was reported at $71.3 million, compared to a net loss of $51.7 million in Q1 2024, attributed to higher R&D and G&A expenses [10]
89bio: A Buy With Strong Market Opportunity In MASH And SHTG
Seeking Alpha· 2025-04-18 08:46
Core Viewpoint - 89bio, Inc. (NASDAQ: ETNB) is initiated with a Buy rating due to its promising lead candidate, pegozafermin, which has potential in addressing two challenging medical indications [1] Company Summary - 89bio, Inc. is focused on developing pegozafermin, a drug that may provide solutions for difficult medical conditions [1]
Is Creative Medical Technology Holdings, Inc. (CELZ) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2025-03-25 14:40
Group 1 - Creative Medical Technology Holdings, Inc. (CELZ) is currently outperforming its peers in the Medical sector with a year-to-date performance increase of approximately 14.3%, compared to the sector average gain of 5% [4] - CELZ has a Zacks Rank of 2 (Buy), indicating a positive outlook based on earnings estimates and revisions [3] - The Zacks Consensus Estimate for CELZ's full-year earnings has increased by 9.4% over the past quarter, reflecting improving analyst sentiment [4] Group 2 - CELZ is part of the Medical - Biomedical and Genetics industry, which includes 509 stocks and currently ranks 74 in the Zacks Industry Rank [6] - The Medical - Biomedical and Genetics industry has seen an average gain of 6% year-to-date, indicating that CELZ is performing better than the industry average [6] - Another stock in the same industry, 89BIO (ETNB), has also shown strong performance with a year-to-date increase of 17% and a Zacks Rank of 2 (Buy) [5][6]
Is 89BIO (ETNB) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2025-03-06 15:40
Company Performance - 89BIO (ETNB) has returned 10.5% year-to-date, outperforming the average gain of 7.4% for Medical stocks [4] - The Zacks Consensus Estimate for ETNB's full-year earnings has increased by 38% over the past quarter, indicating improving analyst sentiment [3] - Eton Pharmaceuticals, Inc. (ETON) has also shown strong performance with a year-to-date return of 13.9% and a consensus EPS estimate increase of 33.8% over the past three months [4][5] Industry Context - 89BIO is part of the Medical - Biomedical and Genetics industry, which consists of 510 companies and currently ranks 66 in the Zacks Industry Rank [6] - The average gain for the Medical - Biomedical and Genetics industry so far this year is 7.8%, with 89BIO outperforming this average [6] - The Medical group, which includes 1012 companies, is currently ranked 3 within the Zacks Sector Rank [2]
89bio to Participate in the Leerink Partners Global Healthcare Conference
Globenewswire· 2025-03-03 21:05
SAN FRANCISCO, March 03, 2025 (GLOBE NEWSWIRE) -- 89bio, Inc. (the “Company” or “89bio”) (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the Company’s Management will participate in a fireside chat at the Leerink Partners Global Healthcare Conference on Monday, March 10, 2025 at 4:20 PM EST and participate in one-on-one investor meetings. The webca ...
89bio price target lowered by $8 at H.C. Wainwright, here's why
Thefly· 2025-02-28 16:16
Group 1: IPOs and Secondary Offerings - Basel Medical (BMGL) is conducting an IPO priced at $4.00 for 2.205 million shares [1] - Intelligent Living Application Group (ILAG) is executing a spot secondary offering priced at $0.58 for 1.035 million shares [1] - SiriusPoint (SPNT) is also conducting a spot secondary offering priced at $14.00 for 4.107 million shares [1] - Luda Technology (LUD) is launching an IPO priced at $4.00 for 2.5 million shares [3] - LZ Technology (LZMH) is conducting an IPO priced at $4.00 for 1.8 million shares [3] - Webus International (WETO) is executing an IPO priced at $4.00 for 2 million shares [5] Group 2: Large Secondary Offerings - Keurig Dr Pepper (KDP) is conducting a spot secondary offering priced at $32.80 for 73 million shares [5] - CCC Intelligent Solutions (CCCS) is executing a spot secondary offering priced at $10.38 for 42 million shares [6] - Life Time Group (LTH) is also conducting a spot secondary offering priced at $30.40 for 23 million shares [7]