[8-K] Civista Bancshares, 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

Civista Bancshares, Inc.

(Exact name of Registrant as Specified in Its Charter)

Ohio			001-36192	34-1558688
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
100 East Water Street
Sandusky, Ohio				44870
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (419) 625 - 4121

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

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 shares, no par value		CIVB		The Nasdaq Stock Market LLC

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. ☐

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

On July 22, 2025, the Board of Directors (the “Board”) of Civista Bancshares, Inc. (the “Company”) adopted and approved amendments to the Company’s Amended and Restated Code of Regulations as permitted by Section 11.01 thereof (as so amended, the “Second Amended Regulations”). The amendments include revisions to reflect developments in the Ohio General Corporation Law (the “OGCL”), as well as other technical, clarifying and modernizing revisions. The following is a summary of the amendments:

•Section 2.01 has been amended to clarify that the Board has the authority to fix an alternate date for the annual meeting of shareholders;

•Section 4.04 has been amended to replace a legacy provision to reflect the customary authority of boards of directors of Ohio corporations and other public companies to determine the compensation payable to directors for services rendered and expenses incurred;

•Section 6.01 has been amended to memorialize the Board’s existing practice of requiring the election of a Lead Independent Director, in lieu of a Vice Chairperson of the Board, whenever the Chairperson of the Board does not qualify as “independent” under applicable exchange rules;

•Section 8.01 has been amended to update the provisions governing the indemnification of directors and officers to conform to current standards and requirements under the OGCL and to incorporate a customary advancement of expenses provision that reflects the current standards and conditions under the OGCL;

•Section 9.01 has been amended to eliminate the requirement to issue physical stock certificates to represent shares of the Company and, instead, to allow for the shares of the Company to be represented solely in uncertificated (book-entry) form; and

•Other updates and clarifying, conforming and modernizing changes have been made to various provisions, including updates and changes to reflect the use of telephonic, video and other communication equipment in connection with meetings of shareholders and directors, the adoption of gender-neutral terminology and current officer titles.

The foregoing summary of the amendments to the Company’s Amended and Restated Code of Regulations does not purport to be a complete summary and is qualified in its entirety by reference to the full text of the Second Amended Regulations, which is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number Description

3.1 Second Amended and Restated Code of Regulations of Civista Bancshares, Inc., dated July 22, 2025

104 Cover Page Interactive File-the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

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.

			Civista Bancshares, Inc.
Date:	July 28, 2025	By:	/s/ Ian Whinnem
			Ian Whinnem, 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.