# EDGAR Filing Document

**Accession Number:** 0001360214
**File Stem:** 0001493152-25-015054
**Filing Date:** 2025-9
**Character Count:** 22433
**Document Hash:** 9f91288cc7558758e93b3bff61dfd647
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-015054.hdr.sgml**: 20250926

**ACCESSION NUMBER**: 0001493152-25-015054

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20250924

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Unregistered Sales of Equity Securities

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250926

**DATE AS OF CHANGE**: 20250926

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** HARROW, INC.
- **CENTRAL INDEX KEY:** 0001360214
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 450567010
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35814
- **FILM NUMBER:** 251345408

**BUSINESS ADDRESS:**
- **STREET 1:** 1A BURTON HILLS BLVD
- **STREET 2:** SUITE 200
- **CITY:** NASHVILLE
- **STATE:** TN
- **BUSINESS PHONE:** 615.733.4731

**MAIL ADDRESS:**
- **STREET 1:** 1A BURTON HILLS BLVD
- **STREET 2:** SUITE 200
- **CITY:** NASHVILLE
- **STATE:** TN

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** HARROW HEALTH, INC.
- **DATE OF NAME CHANGE:** 20181228

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Imprimis Pharmaceuticals, Inc.
- **DATE OF NAME CHANGE:** 20120301

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** TRANSDEL PHARMACEUTICALS INC
- **DATE OF NAME CHANGE:** 20070912

?xml version='1.0' encoding='ASCII'?

**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 24, 2025**

**HARROW, INC.**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-35814** | **45-0567010** |
| (State or other jurisdiction<br> of incorporation) | (Commission<br> File Number) | (IRS Employer<br> Identification No.) |

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| | |
|:---|:---|
| **1A Burton Hills Blvd., Suite 200** |  |
| **Nashville, Tennessee** | **37215** |
| (Address of principal executive offices) | (Zip Code) |

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Registrant's telephone number, including area code: **(615) 733-4730**

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| |
|:---|
| **Not Applicable** |
| (Former Name or Former Address, if Changed Since Last Report) |

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

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| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name on exchange on which registered |
| Common Stock, $0.001 par value per share | HROW | The Nasdaq Stock Market LLC |
| 8.625% Senior Notes due 2026 | HROWL | The Nasdaq Stock Market LLC |
| 11.875% Senior Notes due 2027 | HROWM | The Nasdaq Stock Market LLC |

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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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Act of 1934: Emerging growth company ☐

If any 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 1.01 Entry Into a Material Definitive Agreement.**

On September 8, 2025, Harrow, Inc., a Delaware corporation (the "<u>Company</u>"), reported that it had entered into a non-binding indication of interest ("<u>IOI</u>") to acquire the equity interests in Melt Pharmaceuticals, Inc., a Delaware corporation ("<u>Melt</u>"), not already owned by the Company. Consistent with the IOI, on September 24, 2025, the Company entered into an Agreement and Plan of Merger (the "<u>Merger Agreement</u>") by and among the Company, Harrow Acquisition Sub, Inc., a Delaware corporation and wholly owned subsidiary of the Company, Melt, and D. Brad Osborne, as stockholder representative. As of June 30, 2025, the Company owned approximately 45% of Melt's outstanding equity and also had a mid-single digit royalty on future net sales of Melt's primary product (MELT-300). Certain officers and directors of the Company, including Mark L. Baum, the Company's Chairman and Chief Executive Officer, and Andrew R. Boll, the Company's President and Chief Financial Officer, own additional equity interests in Melt, and Mr. Baum serves on the board of directors of Melt.

Given the ownership interests in Melt and other relationships of the Company's management with Melt, the Merger Agreement and the transactions contemplated thereby were negotiated and approved by a special committee of the Company's Board of Directors comprised of independent directors (the "<u>Independent Committee</u>"). The Independent Committee consulted with independent legal counsel at Dykema Gossett PLLC and received a fairness opinion from Lake Street Capital Markets, LLC with respect to the transactions.

Under the terms of the Merger Agreement and related milestone payment agreement, the Company agreed to acquire the remaining equity interests of Melt in exchange for an initial cash payment of approximately $4.3 million at closing, and contingent consideration consisting of cash and Company equity upon achievement of (i) U.S. Food and Drug Administration ("<u>FDA</u>") approval of the MELT-300 product candidate, (ii) coding and reimbursement of the MELT-300 product candidate, and (iii) various one-time sales milestones, as follows:

● Upon FDA approval of MELT-300, the Company shall pay an aggregate amount in cash of approximately $87.2 million.

● Upon receipt of pass-through status awarded and J-Code (or any other similar designation) issued by the Center for Medicare & Medicaid Services for MELT-300 the Company shall issue an aggregate of approximately 1,112,000 shares of the Company's common stock, par value $0.001 per share (" <u>Common Stock</u> ").

● Upon achievement of various annual net sales milestones ranging from $100.0 million to $1.0 billion per year, the Company shall make one-time cash payments that in the aggregate may total up to approximately $261.0 million if all annual net sales milestones are achieved.

The regulatory and commercial milestones must be achieved, if at all, on or before December 31, 2035.

The Merger Agreement includes representations and warranties and covenants of the parties customary for a transaction of this nature. Until the earlier of the termination of the Merger Agreement and the effective time of the acquisition, Melt has agreed to operate its business in the ordinary course and has agreed to certain other operating covenants. In addition, Melt has agreed to use reasonable best efforts to obtain approval of the Merger Agreement and the transactions contemplated thereby by the requisite Melt stockholders needed for approval.

The closing of the Melt acquisition is subject to certain customary closing conditions, including the approval of the requisite stockholders of Melt, the continued accuracy of representations and warranties and performance of covenants, and the absence of any material adverse effect.

The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Merger Agreement and related milestone payment agreement, which the Company expects to file as an exhibit to its Quarterly Report on Form 10-Q for the three months ending September 30, 2025.

**Item 3.02 Unregistered Sales of Equity Securities.**

To the extent applicable, the disclosure included in Item 1.01 of this Current Report on Form 8-K with respect to the potential issuance of Common Stock in the Melt acquisition is incorporated by reference into this Item 3.02. If the applicable milestone is reached, the Common Stock would be issued to Melt stockholders pursuant to the exemption from the registration requirements provided in Section 4(a)(2) of the Securities Act of 1933, as amended (the "<u>Securities Act</u>") for transactions by an issuer not involving any public offering. Accordingly, the Common Stock issuable to Melt stockholders has not been registered under the Securities Act and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act.

*This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, including statements regarding the Melt acquisition. These statements are based on currently available operating, financial, economic and other information, and are subject to a number of significant risks and uncertainties. A variety of factors, many of which are beyond our control, could cause actual future results to differ materially from those projected in the forward-looking statements. Specific factors that might cause such a difference include, but are not limited to: changes in market conditions, negotiation of final transaction documents, changes in operations, business, financial or other conditions relevant to the planned transactions, and other execution risks related to the completion of the transactions described herein, as well as other risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and its other filings with the Securities and Exchange Commission (the "SEC"). We believe these forward-looking statements are reasonable; however, you should not place undue reliance on any forward-looking statements, which are based on current expectations. Furthermore, forward-looking statements speak only as of the date they are made. If any of these risks or uncertainties materialize, or if any of our underlying assumptions are incorrect, we may not be able to complete the potential transactions on terms expected or at all, and our actual results may differ significantly from those expected or implied by our forward-looking statements. These and other risks are detailed in our filings with the SEC. We do not undertake any obligation to publicly update or revise these forward-looking statements after the date of this Current Report on Form 8-K to reflect future events or circumstances, except as required by applicable law. We qualify any and all of our forward-looking statements by these cautionary factors.*

**Item 8.01. Other Events**

On September 26, 2025, the Company issued a press release announcing the entry into the Merger Agreement. A copy of the press release is attached to this Current Report on Form 8-K as <u>Exhibit 99.1</u> and is incorporated by reference herein.

**Item 9.01. Financial Statements and Exhibits**

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| | |
|:---|:---|
| **(d)** | **Exhibits** |
| 99.1 | [Press Release of Harrow, Inc., dated as of September 26, 2025](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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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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| | | |
|:---|:---|:---|
|  | **HARROW, INC.** | **HARROW, INC.** |
| Dated: September 26, 2025 | By: | */s/ Andrew R. Boll* |
|  |  | Andrew R. Boll |
|  |  | President and Chief Financial Officer |

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## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Harrow to Acquire Melt Pharmaceuticals**

**NASHVILLE, Tenn., September 26, 2025** – Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that it has entered into an agreement to acquire **Melt Pharmaceuticals, Inc.**, a clinical-stage pharmaceutical company pioneering non-opioid, non-IV therapies for sedation for medical procedures in the hospital, outpatient, and in-office settings. The closing of this acquisition is subject to customary closing conditions, including approval by Melt stockholders, excluding Harrow and Harrow-affiliated parties.

Melt's lead investigational therapy, **MELT-300**, is a patented, sublingually delivered formulation of a fixed dose of midazolam (3mg) and ketamine (50mg) designed to provide rapid, predictable sedation and analgesia without the need for intravenous administration. This innovative approach has the potential to transform patient experiences across a wide range of office-based and outpatient procedures and address the healthcare system's growing demand to reduce exposure to opioids.

<u>In November 2024</u>, Melt announced positive topline results from its pivotal LOUISE (<u>L</u>ower <u>O</u>pioid <u>U</u>se and <u>I</u>mprove the <u>S</u>edation <u>E</u>xperience) Phase 3 Study, which demonstrated that MELT-300 was statistically superior to both sublingual midazolam alone (P=0.009) and placebo (P=<0.0001) in providing successful procedural sedation. In addition, the proportion of patients requiring rescue sedation was nearly twice as high for sublingual midazolam compared with MELT-300 (P=0.003).

The LOUISE Phase 3 Study was conducted under a <u>Special Protocol Assessment ("SPA") agreement</u> with the U.S. Food and Drug Administration ("FDA"), which confirmed the study design would adequately support a future regulatory submission. Further, results from a recently completed cardiac safety study indicated that MELT-300 did not alter normal heart rhythm, supporting the therapy's safety profile.

Harrow plans to submit a New Drug Application ("NDA") to the FDA in 2027, with a potential U.S. commercial launch in 2028.

**Strategic Rationale**

● **Immediately Accretive Launch**: Harrow, through its ImprimisRx subsidiary, has successfully marketed the MKO Melt®, a compounded sublingual sedation product widely used by ophthalmologists for more than a decade, with the product used in over *500,000* cataract surgeries. This long-standing, positive experience, by over 700 U.S. ophthalmologists, provides a strong foundation of physician trust and market familiarity with this mode of sedation delivery. Upon FDA approval of MELT-300, Harrow intends to ensure customer access to an FDA-approved product and discontinue the MKO Melt.

● **Market Opportunity**: Entry into the multi-billion-dollar U.S. procedural sedation market. MELT-300's novel formulation has the potential to replace and/or supplement IV sedation in medical interventions, with applications in ophthalmic surgery and potential label expansion opportunities into tens of millions of other procedures annually, including claustrophobia during MRIs, sedation for colonoscopies, dental procedures, gastroenterology procedures, and other interventions.

HROW Acquires Melt Pharmaceuticals

Septemeber 26, 2025

● **Added Diversification**: Strengthens Harrow's perioperative portfolio of surgical solutions and diversifies Harrow's business as MELT-300 is utilized outside of its core US ophthalmic business.

● **Operational Synergies**: Harrow's existing commercial and regulatory infrastructure provides the scale to accelerate Melt's market introduction and potential to replace opioid-based intravenous sedation during the more than 4,000,000 annual U.S. cataract surgeries.

● **Improved Patient Experience**: MELT-300's under-the-tongue delivery, using Catalent's ZYDIS® oral dissolving tablet technology – which is used in over 35 FDA-approved products – offers a less invasive, needle-free, non-opioid option that could reduce anxiety, improve comfort, and simplify care.

● **Expanded Accessibility**: Enables physicians to perform procedures comfortably in office and outpatient settings, reducing reliance on operating rooms.

● **Global Application**: The MELT 300 product candidate has patents issued in North America, Australia, Europe, Asia, and the Middle East. Harrow intends to identify suitable development and commercialization partners to make this technology available outside the U.S. market.

"We are excited to welcome Melt Pharmaceuticals *back* into the Harrow family. This acquisition represents another important step in our mission to deliver innovative, patient-focused ophthalmic disease management solutions that go beyond the limitations of traditional care," said Mark L. Baum, Chief Executive Officer of Harrow. "MELT-300 has the potential to redefine the standard of care for millions of patients by providing a convenient, non-opioid alternative for procedural sedation. By reducing reliance on opioids, MELT-300 not only addresses a critical public health need but also opens the door to significant market expansion opportunities across a wide range of medical procedures. With this acquisition, Harrow continues to strengthen its pipeline of transformative therapies and reinforces our commitment to improving outcomes for patients and providers alike."

Larry Dillaha, MD, Chief Executive Officer of Melt Pharmaceuticals, added, "Sedation hasn't changed much over the past few decades. Having demonstrated the clinical superiority of the MELT-300 drug candidate over its individual components, including midazolam, we believe the standards of care for sedation will change when the MELT-300 drug candidate is FDA-approved. By re-joining Harrow, we gain the resources and expertise needed to accelerate our programs and bring MELT-300 closer to the patients and physicians who need it most. Together, we are committed to transforming the state of the art in the massive US and global procedural sedation market."

**About Harrow**

Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and retina diseases. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit <u>harrow.com</u>.

HROW Acquires Melt Pharmaceuticals

Septemeber 26, 2025

**About Melt Pharmaceuticals**

Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-IV, non-opioid, sedation, and analgesia therapeutics for human medical procedures in the hospital, outpatient, and in-office settings. Melt intends to seek regulatory approval through the FDA's 505(b)(2) regulatory pathway for its proprietary, patented small-molecule product candidates, where possible. Melt's core intellectual property is the subject of multiple granted patents in North America, Europe, Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed business in 2019. To learn more about Melt, please visit their website, www.meltpharma.com.

**<br> Forward-Looking Statements**

This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks, including litigation matters, and other uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at <u>sec.gov</u>. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

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| | |
|:---|:---|
| **Contacts:** |  |
| **Investors:** | **Media:** |
| Mike Biega | Silvana Guerci-Lena |
| Vice President of Investor Relations and Communications | Powers & Company |
| <u>mbiega@harrowinc.com</u> | <u>silvana@powers-co.com</u> |
| 617-913-8890 | 508-808-8993 |

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