6-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of May 2023

001-36345

(Commission File Number)

GALMED PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

16 Tiomkin St.

Tel Aviv 6578317, Israel

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover

Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

On May 4, 2023, Galmed Pharmaceuticals Ltd. (the “Company”) entered into a definitive agreement (the “Agreement”) for a $1.5 million equity investment in OnKai Inc. (“OnKai”), a US-based technology company developing an AI-based platform to advance healthcare for underserved populations across the United States by facilitating alignment between healthcare stakeholders. The Company led an investment round of $6 million (the “Investment Round”) in OnKai.

The signing of the definitive agreement follows an announcement that the Company made in January 2023 that it had entered into a non-binding termsheet for an equity investment in OnKai. The Agreement provides that the Company will invest $1.5 million in exchange for series seed preferred shares of OnKai (which is in addition to a $1.5 million investment that was made by the Company in OnKai through a Simple Agreement for Future Equity and which will convert at a 15% discount into series seed preferred shares upon consummation of the Investment Round). Following the Investment Round, the Company will hold approximately 18% of the outstanding share capital of OnKai on an as-converted and fully diluted basis.

The Agreement further provides that the Company shall have the right to appoint a member to OnKai’s board of directors. Initially, it is contemplated that Allen Baharaff will serve as a board member of OnKai while continuing to serve as CEO of the Company. Under the terms of the Agreement, during the three year period following the closing of the Investment Round the Company shall have the right to merge with OnKai subject to the approval of the boards of directors of each of the Company and OnKai and applicable law and based on valuations that will be prepared by an independent valuator elected jointly by the Company and OnKai and approved by OnKai’s board of directors. The Agreement and other transaction documentation further contemplate, among other things, that the Company is granted certain customary pre-emptive rights as well as registration rights, first refusal rights, co-sale rights and broad based weighted average anti-dilution rights, a board seat, and certain customary protective provisions. The closing of the Investment Round is subject, among other things, to customary closing conditions.

In connection with the Agreement, the Company’s wholly-owned subsidiary, Galmed Research and Development Ltd. (“GRD”), entered into a services agreement (the “Services Agreement”) with OnKai. The Services Agreement provides that GRD shall on a non-exclusive basis (i) provide support services to OnKai relating to finance, business development, strategic planning, execution and others; and (ii) lend its experience to OnKai in building a strategy and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis (i) take part in plan preparation to serve GDR’s vision of developing drugs for the underserved population and (ii) when relevant, design a process on the clinical trial dashboard that could potentially serve GDR’s future trial.

On May 4, 2023, the Company issued a press release entitled “Galmed Pharmaceuticals forms a Strategic Partnership with OnKai”. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

This Report does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. Any securities that may be offered related to the Investment Round have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements.

Cautionary Note Regarding Forward-Looking Statements

The information in this Form 6-K may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed’s objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed intends, expects, projects, believes or anticipates will or may occur in the future, including statements relating to the Investment Round, including as to the entry into of definitive documents and consummation of the Investment Round described above. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Galmed’s actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. Galmed discusses many of these risks in its Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023 in greater detail under the heading “Risk Factors” and elsewhere in the Annual Report, in our Report on Form 6-K filed with the SEC on March 30, 2023 and this press release. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to Galmed or persons acting on its behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this Report. Galmed undertakes no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

This Form 6-K is incorporated by reference into the Company’s Registration Statements on Form S-8 (Registration No. 333-206292 and 333-227441) and the Company’s Registration Statement on Form F-3 (Registration No. 333-254766).

Exhibit Index

Exhibit No.	Description
99.1	Press Release, dated May 4, 2023

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, thereunto duly authorized.

	Galmed Pharmaceuticals Ltd.
Date: May 4, 2023	By:	/s/ Allen Baharaff
		Allen Baharaff
		President and Chief Executive Officer

EX-99.1

Exhibit 99.1

Galmed Pharmaceuticals forms a Strategic Partnership

with OnKai

TEL AVIV, Israel, May 4, 2023 /PRNewswire/ — Galmed Pharmaceuticals Ltd. (GLMD) reported today the execution of a definitive agreement for a $3M equity investment in OnKai Inc., leading an investment round of $6M. The agreement provides Galmed with a minority, but a strategic stake in Onkai. Concurrently, a strategic partnership agreement is being signed to advance both companies by leveraging their complementary knowledge and experience in their respective fields.

OnKai, a US-based technology company, combines public healthcare and medical innovation experience with complex process digitalization, design thinking, and software development to create an AI-powered digital platform that facilitates health equity in underserved communities across the US.

The platform holds significant potential value for both the pharmaceutical and biotech industries by facilitating a new pool of potentially 80M underserved patients to participate in clinical trials.

At its core, the collaboration empowers local clinics and healthcare professionals serving underserved communities to make a substantial contribution to clinical studies. This enables pharmaceutical companies to fulfill their scientific and regulatory obligations, which necessitate access to a diverse and representative patient populace.

Galmed is strategically positioning itself for future clinical trials by leveraging OnKai’s cutting-edge platform. Through the platform, Galmed intends to overcome the growing challenges of competitiveness in patient recruitment, improving the planning and execution of its upcoming clinical trials, resulting in more efficient trials.

Through this partnership, the companies intend to facilitate faster clinical trial enrollment and provide patients with access to novel medications, such as orphan drugs, and opportunities to participate in otherwise inaccessible clinical trials as a therapeutic option.

Noam Smetana, CEO of OnKai, stated: “Galmed’s investment serves as a catalyst to prepare OnKai to service the pharma industry. We fully intend to leverage Galmed’s experience and knowledge to best serve clinical trials alongside the underserved population.” Mr. Smetana continued: “OnKai’s grid and relationships with local clinics in underserved communities enable access to the minority patients that are essential to clinical trials. We see this as a win for patients as we bring innovative research and potential therapies to people who do not have access while providing a better representation of these populations in the drug development process.”

Allen Baharaff, Co-founder, President, and CEO of Galmed noted: “The strategic collaboration with Onkai is intended to provide Galmed with a unique opportunity to take part in what we view as a much-needed disruptor in the industry and one which we believe can really make a difference. “

Allen Baharaff emphasized that “Over time, the vision with the OnKai technology is to be able to create a portfolio of trials with multiple partners and with the leverage of non-dilutive resources, while at the same time, creating a significant impact in underserved communities. The opening of OnKai’s platform to Galmed provides it with a tighter relationship with foundations and patient advocacy organizations. This is intended to play a key role in pursuing orphan indications combined with other sources of non-dilutive financing. It is exciting to join hands with a team that brings decades of experience in innovations, local clinics, healthcare professionals, charities, and pharma companies. We believe this type of integration is mandatory to improve the quality and efficiency of drug development and clinical trials.”

About Galmed Pharmaceuticals Ltd.

We are a biopharmaceutical company focused on the development of Aramchol. Historically, we have focused almost exclusively on developing Aramchol for the treatment of liver disease. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.

About OnKai Inc.

OnKai, Inc. is a digital health company for enhancing sustainable health equity through delivering the Smart Grid, the first AI-based platform that bridges the gaps in healthcare by aligning HCPs and clinics in underserved communities with foundations, service providers, pharma companies, and other industry stakeholders.

https://onkai.co/

Forward-Looking Statements:

Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, our ability to identify, evaluate and complete any strategic alternative that yields value for our shareholders; the timing and cost of our any pre-clinical or clinical trial, for our product candidates; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol or any other product candidate; our expectations regarding the commercial market for non-alcoholic steato-hepatitis, or NASH, in patients or any other targeted indication; third-party payor reimbursement for Aramchol or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; the development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy; our ability to maintain the listing of our ordinary share on The Nasdaq Capital Market; and our expectations regarding licensing, acquisitions and strategic operations. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023 in greater detail under the heading “Risk Factors.” Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

CONTACT: For further information: Guy Nehemya, Chief Operating Officer, Galmed Pharmaceuticals Ltd., investor.relations@galmedpharma.com, +972-3-693-8448