Metsera Announces Positive Phase 1 Data of First-in-Class Once-Monthly Amylin Candidate MET-233i
19-day observed half-life supports once-monthly dosing as monotherapy and potential first-in-category monthly GLP-1 + Amylin combination Well-tolerated with no safety signals
Company to host conference call and webcast today at 8:00 A.M. ET
NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), today announced positive topline data from the Phase 1 clinical trial of MET-233i, an ultra-long acting amylin analog engineered for class-leading durability, potency, and combinability with Metsera's fully-biased monthly GLP-1 receptor agonist candidate, MET-097i. In the study, MET-233i demonstrated up to 8.4% mean placebo-subtracted weight loss at Day 36, a 19-day observed half-life supporting once-monthly dosing, and a favorable tolerability profile with no safety signals.
'We are excited by these impressive results from MET-233i, which demonstrate exceptional efficacy with no safety signals, and enable the potential first monthly multi-NuSH combination,' said Steve Marso, M.D., Chief Medical Officer of Metsera. 'We observed five-week body weight loss comparable to that of leading GLP-1-based medicines, and we identified efficacious starting doses with placebo-like tolerability. These data position MET-233i as a potential best-in-class amylin and support a category-leading profile in combination with MET-097i.'
The randomized, placebo-controlled, double-blind Phase 1 trial was designed to evaluate the pharmacokinetics, efficacy, and safety of subcutaneous MET-233i in 80 participants with overweight or obesity without type 2 diabetes. MET-233i was evaluated at single doses from 0.15 mg to 2.4 mg, and multiple doses from 0.15 mg to 1.2 mg given once weekly over five weeks without titration. The trial population was broadly balanced in gender between MET-233i and placebo and had a mean baseline body mass index of approximately 32.
Topline results from the Phase 1 trial include:
Dose-linear pharmacokinetics with an observed half-life of 19 days from dose to 50% of Cmax. This represents the most durable pharmacokinetic profile of any known amylin analog and supports the potential for once-monthly dosing with simplified titration. MET-233i's exposure profile after multiple doses matched that of MET-097i, supporting combinability as a potential first-in-category once-monthly multi-NuSH combination. These data further substantiate HALO™, Metsera's proprietary, novel peptide stabilization and lipidation platform technology.
Body weight loss up to 8.4%. Body weight loss was dose-dependent, ranging up to a placebo-subtracted mean of 8.4% at Day 36 after five weekly doses of 1.2 mg, with individual responses as high as 10.2%. In the single ascending dose (SAD) portion of the trial, substantial weight loss was maintained more than four weeks after dosing, supported by the ultra-long pharmacokinetics observed for MET-233i.
Favorable tolerability results. Gastrointestinal adverse events in the multiple ascending dose (MAD) portion of the trial were all mild, dose-dependent, and primarily confined to the first week of dosing, implying rapid onset of tolerance despite a three-fold accumulation of exposure over five weeks. Anticipated starting doses of 0.15 mg and 0.3 mg demonstrated tolerability results comparable to placebo in both the SAD and the MAD portions of the trial.
No safety signals. There were no severe or serious adverse events observed in the SAD or MAD portion of the trial to date.
'Amylin agonism has emerged as a central therapeutic mechanism for metabolic diseases, but candidates in development have been limited to weekly dosing,' said Professor Carel le Roux, Director of the Metabolic Medicine Group and Chair in Experimental Pathology at University College Dublin. 'The durability and efficacy of MET-233i in this trial, along with its combinability with Metsera's GLP-1 RA, make it the potential first monthly multi-NuSH combination candidate for patients seeking greater levels of well-tolerated weight loss with a more convenient dosing schedule.'Next StepsBased on these positive topline data, Metsera is rapidly advancing MET-233i as a monotherapy and in combination with MET-097i:
An ongoing monotherapy trial evaluates 12 weekly doses of MET-233i with dose titration, followed by an exposure-matched monthly dose at week 13. Topline data from this trial are expected in late 2025.
Metsera has extended an ongoing co-administration trial of MET-233i and MET-097i to twelve weeks, with topline data expected by year-end 2025 or early 2026.
The Company also expects to report topline clinical data from its ultra-long acting GIP receptor agonist, MET-034i, in combination with MET-097i, in late 2025. We anticipate that MET-034i will be the third peptide engineered with Metsera's HALO™ platform to enter clinical testing.Conference Call and Webcast InformationMetsera will host a conference call and webcast today, June 9, 2025, at 8:00 A.M. Eastern Time to discuss the Phase 1 clinical trial of MET-233i. A live webcast of the call and a replay will be available on the Events page in the Investors & News section of the Metsera website at investors.metsera.com. To access the call by phone, participants should visit this link to receive dial-in details: https://register-conf.media-server.com/register/BI658482ecfbdb4146996744dd3d86c481.
About MET-233i MET-233i is an ultra-long acting, subcutaneously injectable monthly amylin analog engineered for class-leading durability, potency, and combinability in solution with Metsera's fully-biased, ultra-long acting GLP-1 RA candidate MET-097i, with matched solubility parameters and observed half-lives. MET-233i is being explored in clinical studies as a monotherapy and in combination with MET-097i. Metsera is developing the combination of MET-233i and MET-097i via the FDA biologic pathway with the intent to pursue the combination's regulatory approval in the United States under a BLA.About Metsera's HALO™ peptide stabilization and lipidation platformHALO™ is Metsera's novel peptide stabilization and lipidation platform technology that enables peptides to bind simultaneously to albumin and to a drug target, designed to facilitate a half-life approaching that of albumin and exceeding that of other NuSH peptides. This ultra-long half-life may enable monthly dosing, improved tolerability, and improved scalability.About Metsera, Inc.Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin, non-incretin and combination therapies with potential best-in-class profiles to address multiple therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape. Metsera was founded in 2022 and is based in New York City. For more information, please visit us at www.metsera.com and follow us on LinkedIn and X.
Metsera may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors & News section of its website at investors.metsera.com. In addition, you may sign up to automatically receive email alerts and other information about the Company by using the 'Email Alerts' option on the Investors & Media page and submitting your email address.
Forward Looking StatementsThis press release includes 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to the timelines, design and results of the Company's clinical trials and data releases; the Company's product candidate pipeline and milestone events; potential benefits of treatment with the Company's product candidates; and anticipated market opportunity and strategy. When used herein, words including 'anticipate,' 'believe,' 'can,' 'continue,' 'could,' 'designed,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, our limited operating history; our ability to generate revenue or become profitable; failure to obtain additional capital when needed on acceptable terms or at all; raising additional capital may cause dilution to our stockholders or require us to relinquish rights to our technologies or product candidates; our dependence on the success of our product candidates; risks associated with preclinical and clinical development; difficulties or delays in the commencement or completion, or the termination or suspension, of clinical trials; our ability to timely enroll patients in our clinical trials; if our current or future product candidates are associated with side effects, adverse events or other properties or safety risks; risks associated with the regulatory approval processes of the FDA and comparable foreign authorities; risks associated with conducting clinical trials and preclinical studies outside of the United States; our reliance on third parties to conduct clinical trials and preclinical studies; our reliance on third parties for the manufacture and shipping of our product candidates; risks associated with our license and collaboration agreements and future strategic alliances; significant competition in our industry; product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated; our success is dependent on our ability to attract and retain highly qualified management and other clinical and scientific personal; if we or our licensors are unable to obtain, maintain, defend and enforce patent or other intellectual property protection for our current or future product candidates or technology; risks associated with our common stock and the other important factors discussed under the caption 'Risk Factors' in its filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which are accessible on the SEC's website at www.sec.gov and the Investors section of the Company's website at investors.metsera.com. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause the Company's views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.
Contact:Jono EmmettMetseramedia@metsera.com
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December 31, 2024 Assets Current assets: Cash and cash equivalents $ 54,310 $ 105,140 Restricted cash 1,138 1,116 Accounts receivable, net 8,119 4,706 Prepaid expenses and other current assets 10,020 8,205 Investments 26,393 — Total current assets $ 99,980 $ 119,167 Internal-use software, property and equipment, net 1,557 2,920 Goodwill and other intangible assets, net 126,055 126,456 Operating lease right-of-use assets 3,985 5,107 Payment-dependent notes receivable 9,604 7,412 Other assets, noncurrent 1,664 2,444 Total assets $ 242,845 $ 263,506 Liabilities and stockholders' equity Current liabilities: Accounts payable 2,744 1,941 Accrued compensation and benefits 13,600 13,430 Accrued expenses and other current liabilities 6,765 6,310 Operating lease liabilities, current 2,032 3,463 Total current liabilities $ 25,141 $ 25,144 Payment-dependent notes payable 9,604 7,412 Operating lease liabilities, noncurrent 3,231 3,694 Warrant liabilities 296 192 Other liabilities, noncurrent 329 322 Total liabilities $ 38,601 $ 36,764 Commitments and contingencies Stockholders' equity (1): Common stock, $0.0001 par value; 133,333 shares authorized; 12,411 and 12,427 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively 1 1 Treasury stock, at cost; 10 shares as of both June 30, 2025 and December 31, 2024, respectively (625 ) (625 ) Additional paid-in capital 575,676 570,606 Accumulated other comprehensive income 1,193 572 Accumulated deficit (375,724 ) (346,972 ) Total Forge Global Holdings, Inc. stockholders' equity $ 200,521 $ 223,582 Noncontrolling Interest 3,723 3,160 Total stockholders' equity $ 204,244 $ 226,742 Total liabilities and stockholders' equity $ 242,845 $ 263,506 Expand (1) Amounts have been adjusted to reflect the Reverse Stock Split. Expand FORGE GLOBAL HOLDINGS, INC. Unaudited Consolidated Statements of Operations (In thousands of U.S. dollars, except share and per share data) Three Months Ended Six Months Ended June 30, 2025 March 31, 2025 June 30, 2024 June 30, 2025 June 30, 2024 Revenues: Marketplace revenue $ 18,597 $ 15,997 $ 11,679 $ 34,594 $ 20,199 Custodial administration fees 9,142 9,299 10,603 18,441 21,325 Total revenues $ 27,739 $ 25,296 $ 22,282 $ 53,035 $ 41,524 Transaction-based expenses: Transaction-based expenses (155 ) (192 ) (256 ) (347 ) (285 ) Total revenues, less transaction-based expenses $ 27,584 $ 25,104 $ 22,026 $ 52,688 $ 41,239 Operating expenses: Compensation and benefits 27,193 29,491 28,784 56,684 58,627 Technology and communications 4,667 4,349 2,649 9,016 5,709 Professional services 1,204 2,332 1,605 3,536 3,822 General and administrative 2,144 2,254 2,508 4,398 7,570 Advertising and market development 1,528 1,215 1,243 2,743 2,333 Acquisition-related transaction costs 1,988 — — 1,988 — Depreciation and amortization 909 986 1,781 1,895 3,597 Rent and occupancy 786 946 1,107 1,732 2,242 Total operating expenses $ 40,419 $ 41,573 $ 39,677 $ 81,992 $ 83,900 Operating loss $ (12,835 ) $ (16,469 ) $ (17,651 ) $ (29,304 ) $ (42,661 ) Interest and other income: Interest income 803 1,042 1,495 1,845 3,204 Change in fair value of warrant liabilities (294 ) 191 2,280 (103 ) 6,727 Other income, net 76 54 94 130 170 Total interest and other (expense) income $ 585 $ 1,287 $ 3,869 $ 1,872 $ 10,101 Loss before provision for income taxes $ (12,250 ) $ (15,182 ) $ (13,782 ) $ (27,432 ) $ (32,560 ) Provision for income taxes 189 1,016 258 1,205 474 Net loss $ (12,439 ) $ (16,198 ) $ (14,040 ) $ (28,637 ) $ (33,034 ) Net income (loss) attributable to noncontrolling interest $ 141 $ (26 ) $ (316 ) $ 115 $ (686 ) Net loss attributable to Forge Global Holdings, Inc. $ (12,580 ) $ (16,172 ) $ (13,724 ) $ (28,752 ) $ (32,348 ) Net loss per share attributable to Forge Global Holdings, Inc. common stockholders: Diluted $ (1.01 ) $ (1.29 ) $ (1.13 ) $ (2.30 ) $ (2.67 ) Weighted-average shares used in computing net loss per share attributable to Forge Global Holdings, Inc. common stockholders: Basic 12,474 12,534 12,179 12,503 12,112 Diluted 12,474 12,534 12,179 12,503 12,112 Expand FORGE GLOBAL HOLDINGS, INC. Unaudited Consolidated Statements of Cash Flows (In thousands of U.S. dollars) Three Months Ended Six Months Ended June 30, 2025 March 31, 2025 June 30, 2024 June 30, 2025 June 30, 2024 Cash flows from operating activities: Net loss $ (12,439 ) $ (16,198 ) $ (14,040 ) (28,637 ) $ (33,034 ) Adjustments to reconcile net loss to net cash used in operations: Share-based compensation 3,436 6,519 7,859 9,955 17,326 Depreciation and amortization 746 941 1,781 1,687 3,597 Amortization of right-of-use assets 509 613 662 1,122 1,305 Loss on impairment of long lived assets — — — — 186 Allowance for doubtful accounts 99 170 107 269 216 Change in fair value of warrant liabilities 294 (191 ) (2,280 ) 103 (6,727 ) Other (6 ) 4 — (2 ) (10 ) Changes in operating assets and liabilities: Accounts receivable (2,365 ) (1,317 ) 923 (3,682 ) (673 ) Prepaid expenses and other assets (1,523 ) 506 (5,353 ) (1,017 ) (4,228 ) Accounts payable 363 461 (1,004 ) 824 62 Accrued expenses and other liabilities 100 396 (4,636 ) 496 (1,854 ) Accrued compensation and benefits 4,004 (3,833 ) 2,041 171 (1,926 ) Operating lease liabilities (990 ) (904 ) (491 ) (1,894 ) (1,046 ) Net cash used in operating activities $ (7,772 ) $ (12,833 ) $ (14,431 ) $ (20,605 ) $ (26,806 ) Cash flows from investing activities: Maturity of investments and term deposits 14,673 534 6,559 15,207 6,559 Purchases of investments and term deposits (19,397 ) (22,012 ) — (41,409 ) — Purchases of property and equipment (100 ) (51 ) (267 ) (151 ) (667 ) Net cash provided by (used in) investing activities $ (4,824 ) $ (21,529 ) $ 6,292 $ (26,353 ) $ 5,892 Cash flows from financing activities: Proceeds from exercise of options 47 26 235 73 461 Taxes withheld and paid related to net share settlement of equity awards (170 ) (679 ) (1,135 ) (849 ) (3,437 ) Share buyback $ (4,139 ) $ — $ — $ (4,139 ) $ — Cash paid for fractional shares related to stock split $ (4 ) $ — $ — $ (4 ) $ — Net cash used in financing activities $ (4,266 ) $ (653 ) $ (900 ) $ (4,919 ) $ (2,976 ) Effect of changes in currency exchange rates on cash and cash equivalents $ 711 $ 358 $ (78 ) 1,069 (331 ) Net decrease in cash and cash equivalents (16,151 ) (34,657 ) (9,117 ) $ (50,808 ) $ (24,221 ) Cash, cash equivalents and restricted cash, beginning of the period $ 71,599 $ 106,256 $ 130,681 $ 106,256 $ 145,785 Cash, cash equivalents and restricted cash, end of the period $ 55,448 $ 71,599 $ 121,564 $ 55,448 $ 121,564 Reconciliation of cash, cash equivalents and restricted cash to the amounts reported within the consolidated balance sheets Cash and cash equivalents 54,310 70,472 120,475 54,310 120,475 Restricted cash 1,138 1,127 1,089 1,138 1,089 Total cash, cash equivalents and restricted cash, end of the period $ 55,448 $ 71,599 $ 121,564 $ 55,448 $ 121,564 Expand FORGE GLOBAL HOLDINGS, INC. Unaudited Reconciliation of GAAP to Non-GAAP Results (In thousands of U.S. dollars) June 30, 2025 March 31, 2025 June 30, 2024 June 30, 2025 June 30, 2024 Net loss attributable to Forge Global Holdings, Inc. $ (12,580 ) $ (16,172 ) $ (13,724 ) $ (28,752 ) $ (32,348 ) Add: Interest expense, net (803 ) (1,042 ) (1,495 ) (1,845 ) (3,204 ) Provision for income taxes 189 1,016 258 1,205 474 Depreciation and amortization 909 986 1,781 1,895 3,597 Net loss attributable to noncontrolling interest 141 (26 ) (316 ) 115 (686 ) Loss or impairment on long lived assets — — — — 186 Share-based compensation expense 3,436 6,519 7,859 9,955 17,326 Change in fair value of warrant liabilities 294 (191 ) (2,280 ) 103 (6,727 ) Acquisition-related transaction costs 1,988 — — 1,988 — Other 993 — $ — 993 $ — Adjusted EBITDA $ (5,433 ) $ (8,910 ) $ (7,917 ) $ (14,343 ) $ (21,382 ) Expand Three Months Ended Six Months Ended June 30, 2025 March 31, 2025 June 30, 2024 June 30, 2025 June 30, 2024 Net loss attributable to Forge Global Holdings, Inc. $ (12,580 ) $ (16,172 ) $ (13,724 ) $ (28,752 ) $ (32,348 ) Add: Change in fair value of warrant liabilities 294 (191 ) (2,280 ) 103 (6,727 ) Income tax (expense) benefit of adjustment (4 ) 13 48 (4 ) 108 Adjusted net loss attributable to Forge Global Holdings, Inc. $ (12,290 ) $ (16,350 ) $ (15,956 ) $ (28,653 ) $ (38,967 ) Weighted average shares - basic and diluted 12,474 12,534 12,179 12,503 12,112 EPS - basic and diluted $ (1.01 ) $ (1.29 ) $ (1.13 ) $ (2.30 ) $ (2.67 ) Adjusted EPS - basic and diluted $ (0.99 ) $ (1.30 ) $ (1.31 ) $ (2.30 ) $ (3.22 ) Expand Amounts may not recalculate due to rounding SUPPLEMENTAL FINANCIAL INFORMATION Unaudited KEY OPERATING METRICS (In thousands of U.S. dollars) Key Business Metrics Forge monitors the following key business metrics to help evaluate its business, identify trends affecting its business, formulate business plans, and make strategic decisions. The tables below reflect period-over-period changes in Forge's key business metrics, along with the percentage change between such periods. Forge believes the following business metrics are useful in evaluating its business: Trades are defined as the total number of orders executed by Forge on behalf of private investors and shareholders. Increasing the number of orders is critical to increasing Forge's revenue and, in turn, to achieving profitability. Volume is defined as the total sales value for all securities traded through the Forge marketplace, which is the aggregate value of the issuer company's equity attributed to both the buyer and seller in a trade and as such a $100 trade of equity between buyer and seller would be captured as $200 volume for Forge. Although Forge typically captures a commission on each side of a trade, Forge may not in certain cases due to factors such as the use of a third-party broker by one of the parties or supply factors that would not allow Forge to attract sellers of shares of certain issuers. Volume is influenced by, among other things, the pricing and quality of Forge's services as well as market conditions that affect private company valuations, such as increases in valuations of comparable companies at IPO. Net Take Rates are defined as Forge's marketplace revenues, less markets-related transaction-based expenses, divided by Volume. These represent the percentage of fees earned by the Forge marketplace on any transactions executed from the commission Forge charged on such transactions less transaction-based expenses, which is a determining factor in Forge's revenue. The Net Take Rate can vary based upon the service or product offering and is also affected by the average order size and transaction frequency. Total Custodial Accounts are defined as Forge clients' custodial accounts that are established on Forge's platform and billable. These relate to Forge's Custodial Administration fees revenue stream and are an important measure of Forge's business as the number of Total Custodial Accounts is an indicator of Forge's future revenues from certain account maintenance, transaction and cash administration fees. Assets Under Custody is the reported value of all client holdings held under Forge's agreements, including cash submitted to Forge by the responsible party. These assets can be held at various financial institutions, issuers and in Forge's vault. As the custodian of the accounts, Forge collects all interest and dividends, handles all fees and transactions and any other considerations for the assets concerned. Fees are earned from the overall maintenance activities of all assets and are not charged on the basis of the dollar value of Assets Under Custody, but Forge believes that Assets Under Custody is a useful metric for assessing the relative size and scope of its business. Custodial Client Cash, previously called Custodial Cash Balance, is a component of Assets Under Custody representing the value of cash held on behalf of clients held under Forge's agreements. These assets are held at various financial institutions. Fees are earned from the administration activities performed with respect to these balances. The amount of Custodial Client Cash is a determining factor in Forge's revenue. Please note that starting in the first quarter of 2025, Forge has added Custodial Client Cash as a key business metric for its custody solution as cash administration fee revenue is highly correlated to this metric. Custodial Client Cash has been provided as a metric in Forge's quarterly supplemental information furnished with the SEC since the third quarter of 2022 and was previously called Custodial Cash Balance. Forge has not adjusted methodology, assumptions, or otherwise changed any aspects of this metric and it is comparable to prior period presentations of Custodial Cash Balance in Forge's quarterly supplemental information. Custodial Client Cash represents the value of cash held on behalf of clients held under Forge's custody solution agreements. Forge believes that disclosing Custodial Client Cash provides investors with valuable insight into custody solution revenue as cash administration fees currently make up the majority of Forge's custodial administration fee revenue. Cash administration fees are based on prevailing interest rates and custodial client cash balances. Forge has included Custodial Client Cash balances for all periods presented to facilitate comparability and trend analysis.
