ORGO files 8-K disclosing press release and Phase 3 ReNu data

Rhea-AI Filing Summary

Organogenesis Holdings, Inc. filed a Form 8-K reporting a material event that includes a press release dated September 25, 2025 and referenced data from Phase 3 randomized controlled trials (ReNu) dated the same day. The filing indicates the press release and trial data are provided as part of the 8-K's disclosures and that the interactive cover page data are embedded in the Inline XBRL document. The filing is signed by Lori Freedman, Chief Administrative and Legal Officer.

The filing text supplied here contains no actual trial results, financial figures, forward-looking statements, or additional narrative about the ReNu data, and therefore does not disclose outcomes, metrics, or impacts on operations or finances.

Positive

• Public disclosure of Phase 3 RCT data for ReNu dated September 25, 2025
• Timely press release accompanies the 8-K, signaling management followed disclosure protocols

Negative

• No trial results or numerical efficacy/safety data are included in the supplied filing text
• No financial or operational impact metrics are disclosed, preventing investor assessment of materiality

Insights

Corporate filings analyst

TL;DR: The 8-K announces a press release and Phase 3 data release without presenting results.

The filing formally records a material event via a press release dated September 25, 2025 and notes that Phase 3 RCT data for ReNu were provided on that date. This is the standard route to ensure timely public disclosure under reporting rules.

Because no numerical results or financial impacts are present in the supplied text, investors cannot assess material effects from this filing alone; follow-up disclosure or access to the referenced press release and trial data will be required to evaluate significance over the coming days.

Clinical development advisor

TL;DR: Phase 3 data availability is potentially important but the filing here contains no efficacy or safety numbers.

The 8-K identifies that Phase 3 randomized controlled trial data for the product named ReNu were released on September 25, 2025. Publication of Phase 3 data is a key milestone in clinical development because it typically contains efficacy and safety outcomes that drive regulatory and commercial decisions.

Since the supplied filing text does not include trial endpoints, sample sizes, or results, stakeholders should review the referenced press release and full trial dataset when available; near-term investor impact depends entirely on the concrete trial outcomes disclosed there.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

What did Organogenesis (ORGO) report in the 8-K dated September 25, 2025?

The 8-K reports a press release dated September 25, 2025 and references data from Phase 3 randomized controlled trials (ReNu) provided on that date.

Does the 8-K include Phase 3 trial results for ReNu (ORGO)?

No. The supplied filing text references the Phase 3 data but does not include trial results, metrics, or outcomes.

Who signed the 8-K for Organogenesis (ORGO)?

The filing is signed by Lori Freedman, identified as Chief Administrative and Legal Officer.

Is there financial information or guidance in this 8-K for ORGO?

No. The provided content contains no financial figures, guidance, or statements about financial impact.

Where can investors find the detailed Phase 3 data referenced by ORGO?

The 8-K indicates a press release and embedded Inline XBRL cover page, but investors must access the referenced press release and associated trial materials to review detailed data.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 09/25/2025 - 05:00 PM Learn about SEC filing dates

NASDAQ false 0001661181 0001661181 2025-09-25 2025-09-25

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): September 25, 2025

ORGANOGENESIS HOLDINGS INC.

(Exact Name of Registrant as specified in its charter)

Delaware		001-37906		98-1329150
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

85 Dan Road Canton, MA		02021
(Address of principal executive offices)		(Zip Code)

(781) 575-0775

(Registrant’s telephone number, including area code)

Not Applicable

(Registrant’s name or former address, if change 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
Class A Common Stock, $0.0001 par value		ORGO		Nasdaq Capital Market

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 pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On September 25, 2025, Organogenesis Holdings Inc. (the “Company”) issued a press release announcing an update on its second Phase 3 randomized controlled trial (“RCT”) of ReNu, a cryopreserved amniotic suspension allograft (“ASA”) for the management of symptoms associated with knee osteoarthritis (“OA”). A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by this reference.

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), 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, or the Exchange Act, except as expressly set forth by specific reference in any such filing.

Item 8.01. Other Events.

As noted in Item 7.01 above, the Company announced an update on its second Phase 3 RCT of ReNu, a cryopreserved ASA for the management of symptoms associated with knee OA on September 25, 2025.

This second Phase 3 trial was a fully enrolled 594 patient trial and was a prospective, double-blind, multicenter, saline-controlled, parallel group, RCT of ReNu ASA, for the treatment of subjects with mild to severe symptomatic knee OA. Patients were randomized to receive a single intra-articular (“IA”) injection of either saline control or ReNu.

This second Phase 3 RCT of ReNu did not achieve statistical significance for its primary endpoint, despite the ReNu results demonstrating a numerical improvement in baseline pain reduction over the first Phase 3 trial. Baseline pain reduction at six months for ReNu was -6.9 for the second Phase 3 study compared to -6.0 in the first Phase 3 study. Additionally, the ReNu results continued to demonstrate a favorable safety profile.

The primary endpoint for the study was the difference between ReNu and Saline groups in the reduction in knee pain at six months assessed by the Western Ontario and McMaster Universities Arthritis Index (“WOMAC”) pain scale. The study data demonstrated a numerical improvement of -0.5 favoring ReNu (p=0.0393 one-sided p-value, compared to p=0.023 target threshold). The first Phase 3 trial achieved improvement of -0.7 favoring ReNu, which was statistically significant (p=0.0177, one sided p-value, compared to p=0.023 target threshold). Additional data from the Phase 3 RCTs is included as Exhibit 99.2 and is incorporated herein by reference.

The Company plans to request a pre-Biologics License Application (“BLA”) meeting with the FDA by the end of October 2025 to discuss the BLA submission pathway, including potentially using the combined efficacy analysis from both Phase 3 studies of ReNu to support a BLA approval.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “intend,” “seek,” “anticipate,” “believe,” “expect,” “estimate,” “potential” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements concern, and these risks and uncertainties include, among others: the risks and uncertainties inherent in clinical development; the FDA may require additional evidence for ReNu before we can submit a BLA or get a BLA approved, which we may not be able to obtain; that other clinical trials of ReNu may produce different results; the likelihood and timing of possible regulatory approval and commercial launch of ReNu; determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to develop or commercialize ReNu; ongoing regulatory obligations and oversight impacting ReNu; unforeseen safety issues resulting from the administration of ReNu in patients; competing products and product candidates that may be superior to our products and product candidates; uncertainty of market acceptance and commercial success of ReNu and the impact of studies (whether conducted by us or others and whether mandated or voluntary) on the commercial success of ReNu; our ability to manufacture and manage supply components for ReNu; the availability and extent of reimbursement of ReNu from third-party payers, including private payer healthcare and insurance programs and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers, including local coverage determinations by Medicare Part A/B Medicare Administrative Contractors; new policies and procedures adopted by such payers; unanticipated expenses; the costs of developing, producing, and selling ReNu; our ability to meet our sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2024 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated September 25, 2025
99.2		Data from Phase 3 RCTs of ReNu dated September 25, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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

Organogenesis Holdings Inc.
By:		/s/ Lori Freedman
Name:		Lori Freedman
Title:		Chief Administrative and Legal Officer

Date: September 25, 2025