# EDGAR Filing Document

**Accession Number:** 0002040807
**File Stem:** 0000950170-25-099185
**Filing Date:** 2025-7
**Character Count:** 23220
**Document Hash:** b6fec1a940d211038fa49ae1d5bd9e9a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-099185.hdr.sgml**: 20250728

**ACCESSION NUMBER**: 0000950170-25-099185

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250728

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250728

**DATE AS OF CHANGE**: 20250728

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Metsera, Inc.
- **CENTRAL INDEX KEY:** 0002040807
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42489
- **FILM NUMBER:** 251155822

**BUSINESS ADDRESS:**
- **STREET 1:** 3 WORLD TRADE CENTER
- **STREET 2:** 175 GREENWICH STREET
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10007
- **BUSINESS PHONE:** (212) 784-6595

**MAIL ADDRESS:**
- **STREET 1:** 3 WORLD TRADE CENTER
- **STREET 2:** 175 GREENWICH STREET
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10007

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## **FORM** 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** July 28, 2025<br>

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METSERA, INC.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-42489 | 92-0931552 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 3 World Trade Center <br>175 Greenwich Street |  |  |
| New York**,** New York |  | 10007 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 212 784-6595<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock, par value $0.00001 per share | MTSR | The Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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## **Item 2.02 Results of Operations and Financial Condition.** 
On July 28, 2025, Metsera, Inc. announced financial results for the three and six months ended June 30, 2025, as well as a business update. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

## **Item 9.01 Financial Statements and Exhibits.** 
(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1\* | [<u>Press Release, dated July 28, 2025.</u>](mtsr-ex99_1.htm) |
| 104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document |

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\* Furnished herewith.

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **METSERA, INC.** |
| Date: | July 28, 2025 | By:  | /s/ Matthew Lang |
|  |  |  | Matthew Lang<br>*Chief Legal Officer and Secretary* |

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## Exhibit 99.1

**Exhibit 99.1**

![img124768095_0.jpg](img124768095_0.jpg)

**Metsera Reports Second Quarter 2025 Financial Results and Continued Portfolio Progress**

*MET-097i (fully biased once-monthly GLP-1 RA) VESPER-1 and interim VESPER-3 data release expected in September 2025; Phase 3 initiation on track for late 2025*

*MET-233i (once-monthly amylin analog) delivered class-leading Phase 1 results including 8.4% five-week weight loss and 19-day half-life; 12-week monotherapy data expected in late 2025*

*MET-233i + MET-097i 12-week co-administration data expected by year-end 2025 or early 2026*

*Oral peptide programs on track; four-week data for selected lead (MET-097o or MET-224o) expected in late 2025*

*$530.9 million cash and cash equivalents support runway into 2027*

**NEW YORK, July 28, 2025** – Metsera, Inc. (Nasdaq: MTSR), a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today reported second quarter 2025 financial results and continued portfolio progress.

"The second quarter of 2025 saw rapid progress across our category-leading pipeline of ultra-long acting, combinable injectable and oral nutrient-stimulated hormone analogs," said Whit Bernard, Chief Executive Officer. "We reported positive Phase 1 data from MET-233i, our first-in-class once-monthly amylin candidate, demonstrating exceptional efficacy with favorable tolerability, and enabling a potential first-in-category monthly multi-NuSH combination. Additionally, we completed enrollment in the VESPER-2 and -3 studies with MET-097i ahead of schedule, enabling an accelerated release of interim VESPER-3 tolerability data in tandem with VESPER-1. We remain on track to deliver all of our committed clinical milestones, including initiation of a global Phase 3 program for MET-097i in late 2025."

**<u>Pipeline Highlights and Upcoming Milestones</u>**

**MET-097i: VESPER-1 and interim VESPER-3 data release expected in September 2025; Phase 3 initiation on track for late 2025.**

• MET-097i is a fully biased, monthly, ultra-long acting, subcutaneously injectable GLP-1 receptor agonist (RA) which has demonstrated highly competitive body weight loss and excellent tolerability in clinical trials.

• The VESPER program includes three ongoing Phase 2b trials designed to further evaluate the differentiated profile of MET-097i and enable rapid transition into Phase 3 clinical trials. All three trials (VESPER-1, VESPER-2, and VESPER-3) are fully enrolled and on track.

• We expect to release topline data from VESPER-1 together with interim data from the titration phase of VESPER-3 in September 2025. Combined, these data will inform the weekly dosing regimens we plan to investigate in Phase 3 trials.

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• We expect to release topline 28-week results from the monthly dosing portion of VESPER-3 by year-end 2025 or in early 2026.

• We are on track to initiate the Phase 3 program of MET-097i in late 2025.

**MET-233i: Delivered class-leading Phase 1 results, including 8.4% five-week weight loss and 19-day observed half-life; 12-week monotherapy data expected in late 2025** 

• MET-233i is a monthly, ultra-long acting, subcutaneously injectable amylin analog in ongoing clinical trials as a monotherapy and co-administered with MET-097i.

• In June, we presented five-week weight loss, tolerability, and pharmacokinetic data for MET-233i monotherapy, positioning MET-233i as a first-in-class monthly amylin analog with potentially best-in-class efficacy and placebo-like tolerability.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•In these data, MET-233i demonstrated mean placebo-subtracted weight loss up to 8.4% at Day 36, and placebo-like tolerability on candidate starting doses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•MET-233i also demonstrated a 19-day observed half-life and matched pharmacokinetics to MET-097i, enabling a potential first-in-category monthly multi-NuSH combination with MET-097i.

• We expect to announce topline 12-week data from the MET-233i monotherapy trial in late 2025.

**MET-233i + MET-097i: 12-week co-administration data expected by year-end 2025 or in early 2026**

• We expect to announce topline 12-week data from the MET-233/097 co-administration trial by year-end 2025 or in early 2026.

**Oral peptide platform: MET-097o program and alternate candidate MET-224o on track; four-week topline data for selected lead expected in late 2025.**

• MET-097o and MET-224o are oral, fully biased, ultra-long acting GLP-1 receptor agonists in development for the treatment of obesity and overweight.

• Preliminary four-week weight loss, tolerability, and pharmacokinetic data for the selected lead candidate are expected in late 2025.

**Additional key pipeline programs: Combination and prodrug candidates continue to advance, with multiple clinical milestones expected in late 2025 and early 2026.**

• Preliminary data from co-administration of MET-034, an ultra-long acting GIP RA (Metsera's third HALO™-engineered peptide in clinical testing), with MET-097i are expected in late 2025.

• IND-enabling studies progressing for MET-815, a prodrug of MET-097i with potential for quarterly maintenance dosing; clinical trial initiation planned for year-end 2025 or early 2026.

**<u>Second Quarter 2025 Financial Results</u>**

**Cash Position**: Cash and cash equivalents were $530.9 million as of June 30, 2025, compared to $352.4 million as of December 31, 2024. Based on current operating plans, we estimate our existing cash and cash equivalents will be sufficient to fund projected operating expenses, working capital and capital expenditure needs into 2027.

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**R&D Expenses**: Research and development (R&D) expenses for the three and six months ended June 30, 2025, were $60.5 million and $117.7 million, respectively, compared to $20.9 million and $38.7 million for the three and six months ended June 30, 2024, respectively. The increases in R&D expense were driven by product candidate development costs related to our preclinical, clinical and contract manufacturing as well as increases in personnel-related expenses, including stock-based compensation, to support our ongoing research and development activities.

**G&A Expenses**: General and administrative (G&A) expenses for the three and six months ended June 30, 2025, were $11.5 million and $20.1 million, respectively, compared to $5.6 million and $9.7 million for the three and six months ended June 30, 2024, respectively. The increases in G&A expenses primarily related to personnel-related expenses, including stock-based compensation, as well as professional fees and other costs associated with being a public company.

**Net Loss**: Net loss was $68.7 million and $145.3 million, respectively, for the three and six months ended June 30, 2025, compared to $26.7 million and $46.6 million for the three and six months ended June 30, 2024, respectively. Net loss for the three and six months ended June 30, 2025, consisted of R&D and G&A expenses totaling $72.0 million and $137.8 million, respectively, and a change in fair value of contingent consideration of a benefit of $0.9 million and an expense of $13.2 million, respectively. Net cash used in operating activities for the six months ended June 30, 2025 was $113.3 million.

**About Metsera** 

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 Statements**

This 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 and design of the Company's clinical and pre-clinical trials and data releases; the Company's product candidate pipeline and milestone events; potential benefits of treatment with the Company's product candidates; anticipated market opportunity and strategy; and the Company's future financial results and cash flow projections. 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

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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 our Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, once available, 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 Emmett

Metsera

<u>media@metsera.com</u>

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| | | |
|:---|:---|:---|
| **METSERA, INC.** | **METSERA, INC.** | **METSERA, INC.** |
| **CONDENSED CONSOLIDATED BALANCE SHEETS** | **CONDENSED CONSOLIDATED BALANCE SHEETS** | **CONDENSED CONSOLIDATED BALANCE SHEETS** |
| **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** |
|  | **As of** | **As of** |
|  | **(unaudited)** |  |
|  | **June 30,** | **December 31,** |
|  | **2025** | **2024** |
| **Assets** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $530919 | $352447 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 7157 | 6686 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 538076 | 359133 |
| Property and equipment, net | 248 | 57 |
| Operating lease right-of-use asset | 1042 | 1385 |
| Intangible assets and goodwill | 98737 | 90413 |
| Other assets | 1557 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $639660 | $450988 |
| **Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $22912 | $20837 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses and other current liabilities | 37556 | 17877 |
| &nbsp;&nbsp;&nbsp;&nbsp;Note payable with related parties |  | 8387 |
| &nbsp;&nbsp;&nbsp;&nbsp;Due to related parties | 300 | 392 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities, current | 740 | 714 |
| &nbsp;&nbsp;&nbsp;&nbsp;Contingent consideration, current | 40800 | 19100 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 102308 | 67307 |
| Deferred tax liabilities | 8496 | 7780 |
| Operating lease liabilities, noncurrent | 324 | 701 |
| Contingent consideration, noncurrent | 79300 | 87850 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 190428 | 163638 |
| Redeemable convertible preferred stock, par value $0.00001 per share |  | 540857 |
| Stockholders' equity (deficit): |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Preferred stock, par value $0.00001 per share |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Common stock, par value $0.00001 per share | 1 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Additional paid-in capital | 838119 | 2479 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive income (loss) | 13561 | 1160 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accumulated deficit | (402449) | (257146) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity (deficit) | 449232 | (253507) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $639660 | $450988 |

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| | | | | |
|:---|:---|:---|:---|:---|
| **METSERA, INC.** | **METSERA, INC.** | **METSERA, INC.** | **METSERA, INC.** | **METSERA, INC.** |
| **CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS** | **CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS** | **CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS** | **CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS** | **CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS** |
| **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** |
|  | **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** |
|  | **For the three months<br>ended June 30,** | **For the three months<br>ended June 30,** | **For the six months<br>ended June 30,** | **For the six months<br>ended June 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Acquired in-process research and development | $— | $— | $— | $90 |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 60511 | 20855 | 117697 | 38668 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 11482 | 5643 | 20085 | 9718 |
| &nbsp;&nbsp;&nbsp;&nbsp;Change in fair value of contingent consideration | (870) | 1507 | 13150 | 592 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 71123 | 28005 | 150932 | 49068 |
| Loss from operations | (71123) | (28005) | (150932) | (49068) |
| Other income (expense): |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest expense | (39) | (27) | (140) | (27) |
| &nbsp;&nbsp;&nbsp;&nbsp;Foreign exchange loss | (2958) | (17) | (4547) | (18) |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest income | 5405 | 1063 | 10316 | 1956 |
| Loss before income taxes | (68715) | (26986) | (145303) | (47157) |
| Income tax benefit |  | 258 |  | 549 |
| Net loss | $(68715) | $(26728) | $(145303) | $(46608) |
| Net loss per share of common stock, basic and diluted | $(0.66) | $(1.86) | $(1.62) | $(3.31) |
| Weighted-average shares of common stock outstanding, basic and diluted | 104879649 | 14367751 | 89719624 | 14102215 |

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