[8-K] HomeStreet, Inc. Reports Material Event

Rhea-AI Filing Summary

Alvotech’s July 2025 Form 6-K details governance, commercial, regulatory and financing actions since its Q1 report.

• Governance: Six directors re-elected; veteran executive Linda Jónsdóttir appointed CFO; COO Faysal Kalmoua exits board and management.
• Commercial: Advanz Pharma partnership broadened to three new biosimilars (milestones up to €160 m) and separate AVT10 (Cimzia) deal; global Keytruda biosimilar co-development with Dr. Reddy’s.
• M&A: Acquired Swiss packager Ivers-Lee and Xbrane’s Swedish R&D team plus Cimzia candidate for c.SEK 275 m.
• Pipeline: CHMP positive opinion for AVT06 (Eylea); AVT23 (Xolair) study shows therapeutic equivalence.
• Manufacturing risk: FDA pre-approval inspection (26 Jun–4 Jul) issued Form 483 citing operational, documentation and quality control deficiencies; detailed response submitted 25 Jul.
• Financing: Oversubscribed SDR IPO (SEK 39 m) and institutional placement (SEK 750 m) add >3,000 new holders; term-loan amendment folds second tranche, trims margin to SOFR+6.0%, facility now $1.081 bn, cash $152 m.

New capital and partnerships enhance growth prospects, but regulatory remediation is critical for near-term BLA approvals.

Positive

• €160 m milestone expansion of Advanz Pharma partnership covering three new biosimilars
• Global Keytruda biosimilar collaboration with Dr. Reddy’s broadens high-value oncology pipeline
• CHMP positive opinion for AVT06 and successful AVT23 efficacy study de-risk European approvals
• SEK 789 m equity raises were oversubscribed, adding >3,000 shareholders and improving liquidity
• Term-loan amendment lowers interest by 50 bp and simplifies capital structure, reducing financing costs

Negative

• FDA Form 483 cites multiple manufacturing and documentation deficiencies that could delay four pending BLAs
• Executive turnover with COO departure may disrupt operational continuity during critical remediation phase

Insights

Pharmaceutical Equity Analyst

TL;DR – Strong deals and financing offset by FDA Form 483 risk; net impact neutral.

Commercial wins with Advanz (€160 m milestones) and Dr. Reddy’s expand the oncology & autoimmune pipeline while Ivers-Lee adds downstream capacity. SEK 789 m of fresh equity plus a 50 bp interest cut strengthen liquidity and reduce cash burn. However, the Form 483 covers multiple quality-system gaps tied to four BLAs; approval timing for AVT02/03/05/06 now depends on FDA classification, creating binary regulatory risk. Overall, strategic momentum is positive but valuation upside is capped until inspection issues are fully resolved.

Regulatory Risk Analyst

TL;DR – Form 483 elevates approval risk; remediation plan is submitted but outcome uncertain.

The inspection observations span manufacturing controls, documentation and lab practices—areas often requiring re-inspection. While management claims some issues are historical, FDA follow-up could delay launch-ready assets and trigger additional costs. Positive CHMP feedback on AVT06 underscores EU progress, yet U.S. revenue inflection depends on clearing the Form 483. Investors should monitor FDA’s classification letter (OAI, VAI or NAI) and potential impact on 2025–26 launch schedules.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

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

HOMESTREET, INC.

(Exact name of registrant as specified in its charter)

Washington

001-35424

91-0186600

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

601 Union Street, Ste. 2000, Seattle, WA 98101

(Address of principal executive offices) (Zip Code)

(206) 623-3050

(Registrant’s telephone number, including area code)

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:

Title of each class			Trading Symbol(s)			Name of each exchange on which registered
Common Stock, No Par Value			HMST			Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Act or Rule 12b-2 of the Exchange Act.

☐			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 12(a) of the Exchange Act.

Item 7.01 Regulation FD Disclosure

The information provided pursuant to this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any filing or other document filed by the Company pursuant to the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing or document. The information provided pursuant to this Item 7.01 shall instead be deemed “furnished.”

HomeStreet, Inc. ("HomeStreet") is hereby furnishing a second quarter 2025 slide presentation that executive management intends to use in meetings with institutional investors and industry analysts. The slide presentation is included as Exhibit 99.1 to this report and will be available on HomeStreet's investor relations web site at http://ir.homestreet.com. The presentation includes forward looking statements within the meaning of the Exchange Act, the Securities Act, and the rules under each of those statutes. Please refer to the second page of the presentation, which includes a list of factors that could cause the results to materially differ from forward looking statements set forth therein. A more complete discussion of these and other relevant risks is set forth in the registrant’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024, Form 10-Q for the quarter ended March 31, 2025 and our other filings made from time to time with the Securities Exchange Commission.

Item 9.01			Financial Statements and Exhibits
(d)			Exhibits.
Exhibit 99.1			HomeStreet, Inc. Second Quarter 2025 slide presentation
Exhibit 104			Cover Page Interactive Data File (embedded within with Inline XBRL)

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.

Date: July 28, 2025

HomeStreet, Inc.
By:						/s/ John M. Michel
						John M. Michel
						Executive Vice President and Chief Financial Officer

FAQ

What regulatory setback did Alvotech (ALVO) disclose in the July 2025 6-K?

The FDA issued a Form 483 after a 26 Jun–4 Jul pre-approval inspection of the Reykjavik plant, noting quality-system deficiencies.

How much capital did Alvotech raise through recent share offerings?

Alvotech raised SEK 39 m via an SDR IPO and SEK 750 m through a private placement in June 2025.

What are the financial terms of the amended term-loan facility?

Post-amendment, the entire $1.081 bn facility bears SOFR + 6.0% cash interest, 50 bp lower than before, maturing July 2029.

Which pipeline assets received positive European feedback?

AVT06 (biosimilar to Eylea) received a positive CHMP opinion, and AVT23 (Xolair) met its primary endpoint in a confirmatory study.

What is the potential value of the expanded Advanz Pharma partnership?

The agreement includes up to €160 m in development and commercial milestones plus revenue sharing.