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89bio(ETNB) - 2025 FY - Earnings Call Transcript
2025-06-11 16:20
89Bio (ETNB) FY 2025 Conference June 11, 2025 11:20 AM ET Speaker0 Great. Good morning, everyone. Thanks so much for joining us. I'm really pleased to be joined by Rohan Palikar, CEO of eighty nine Bio. Thank you so much. Speaker1 Andrea, great to be here. Thanks for having us. Speaker0 Yeah. Maybe to start, let's just talk about the NASH space, the evolution. There have been so many developments, both on the clinical side as well as the approved drug last year. How do you see the NASH space evolving from h ...
89bio to Participate in Goldman Sachs 46th Annual Global Healthcare Conference
Globenewswire· 2025-06-04 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 aims to provide best-in-class treatment options for patients lacking optimal therapies [3] Key Developments - The company will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025, at 11:20 AM EDT [1] - Management will also engage in one-on-one investor meetings during the conference [1] Product Focus - 89bio is advancing its lead candidate, pegozafermin, through Phase 3 clinical development for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG) [3] - Pegozafermin is a fibroblast growth factor 21 (FGF21) analog utilizing glycoPEGylated technology to enhance biological activity and extend half-life [3]
89Bio (ETNB) 2025 Conference Transcript
2025-05-20 14:32
89Bio (ETNB) 2025 Conference May 20, 2025 09:30 AM ET Speaker0 Brian Abraham, senior biotech analyst at RBC Capital Markets. Our next feature company is eighty nine Bio represented by their CEO, Brohan. Thanks so much for joining us. Speaker1 Nice to be here, Brian. Thanks for having us. Speaker2 Kicking things off to set the stage, there's obviously been a Speaker0 lot of developments in the FGF21 space. Speaker2 You guys are one of always been one of the leaders. Speaker0 What's the latest on some of the ...
89Bio (ETNB) 2025 Conference Transcript
2025-05-14 18:40
89Bio (ETNB) 2025 Conference May 14, 2025 01:40 PM ET Speaker0 This joining us on this, our second day of Bank of America's twenty twenty five health care conference here in Las Vegas. My name is Jason Zemanski. I'm one of SMID cap analysts here at the bank, And I'm so pleased to have join me on stage, Rohan Palakkar. Thank you so much for joining us. Speaker1 Great to be here, Jason. Thanks for having us. Well, Speaker0 maybe let's start broadly, especially for those newer to the story. What about FGF21 ma ...
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]