Galmed Pharmaceuticals Ltd 6-K, filed Jun 1, 2023

Galmed Pharmaceuticals Ltd. (EOCN)

6-K 2023-06-01 For: 2023-06-01

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Added on April 06, 2026

About this 6-K

Galmed Pharmaceuticals Ltd filed this 6-K on June 1, 2023.

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	As of			As of
	March 31,			December 31,
	2023			2022
	Unaudited			Audited
Assets

Current assets
Cash and cash equivalents	$	1,672		$	2,016
Short term deposit		754			-
Restricted Cash		114			114
Marketable debt securities		9,726			11,769
Other receivables		568			825
Total current assets		12,834			14,724

Right of use assets		176			223
Property and equipment, net		105			114
Investment in convertible loan		1,676			1,500
Total non-current assets		1,957			1,837

Total assets	$	14,791		$	16,561

Liabilities and stockholders’ equity

Current liabilities
Trade payables	$	2,266		$	2,560
Other payables		535			534
Total current liabilities		2,801			3,094

Non-current liabilities
Lease obligation	$	-		$	44
Total non-current liabilities		-			44

Ordinary shares par value NIS 0.01 per share; Authorized 20,000,000; Issued and outstanding: 1,680,232 shares as of March 31, 2023 and December 31, 2022*)		70			70
Additional paid-in capital		200,435			200,138
Accumulated other comprehensive loss		(645	)		(745	)
Accumulated deficit		(187,870	)		(186,040	)
Total stockholders’ equity		11,990			13,423

Total liabilities and stockholders’ equity	$	14,791		$	16,561

	Three months ended
	March 31,
	2023			2022
Research and development expenses	$	1,083		$	4,796

General and administrative expenses		919			1,296

Total operating expenses		2,002			6,092

Financial (income) expense, net		(172	)		51

Net loss	$	1,830		$	6,143

Basic and diluted net loss per share*)	$	1.09		$	3.67

Weighted-average number of shares outstanding used in computing basic and diluted net loss per share*)		1,680,232			1,672,566

	Three months ended
	March 31,
	2023			2022
Net loss	$	1,830		$	6,143
Other comprehensive loss:
Net unrealized loss (gain) on available for sale securities		(100	)		445
Comprehensive loss	$	1,730		$	6,588

							Accumulated
					Additional		other
	Ordinary shares				paid-in		Comprehensive			Accumulated
	Shares*)		Amount		capital		loss			Deficit			Total
Balance - December 31, 2022		1,680,232	$	70	$	200,138	$	(745	)	$	(186,040	)	$	13,423
Stock-based compensation		-		-		297		-			-			297
Unrealized profit from marketable debt securities		-		-		-		100			-			100
Net loss		-		-		-		-			(1,830	)		(1,830	)
Balance - March 31, 2023		1,680,232	$	70	$	200,435	$	(645	)	$	(187,870	)	$	11,990

							Accumulated
					Additional		other
	Ordinary shares				paid-in		Comprehensive			Accumulated
	Shares*)		Amount		capital		loss			Deficit			Total
Balance - December 31, 2021		1,672,566	$	70	$	198,772	$	(171	)	$	(168,174	)	$	30,497
Stock-based compensation		-		-		457		-			-			457
Unrealized loss from marketable debt securities		-		-		-		(445	)		-			(445	)
Net loss		-		-		-		-			(6,143	)		(6,143	)
Balance - March 31, 2022		1,672,566	$	70	$	199,229	$	(616	)	$	(174,317	)	$	24,366

	1.	In February 2022, the Company granted options to purchase 24 ordinary shares of the Company to one of its officers. The options are exercisable at $1.61 per share, have a 10-year term and vest over a period of four years.

	2.	In November 2022, the Company’s board of directors approved the repricing of outstanding options to purchase an aggregate of 64,559 ordinary shares held by the Company’s employees and directors to $5.70 per share and extended their terms for one year following the date of termination of an optionee’s employment or service with the Company or affiliate.

		On March 23, 2023, the Company received a ruling from the Israel Tax Authority (“ITA”) confirming the repricing. This repricing was accounted for as a modification of a share-based payment award and increased the. The incremental compensation expense recognized as a result of the modification during the period ended December 31, 2023 was approximately $0.1 million.

	1.	On May 4, 2023, the Company entered into a definitive agreement (the “Agreement”) for a $1.5 million equity investment in 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 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.

	2.	On May 15, 2023 the Company effected a reverse share split of the Company’s ordinary shares at the ratio of 1-for-15, such that each fifteen (15) ordinary shares, par value NIS 0.01 per share, shall be consolidated into one (1) ordinary share, par value NIS 0.15. As a result, all share and per share amounts were adjusted retroactively for all periods presented in these financial statements.

	●	the timing and cost of our planned PSC clinical trial and our pivotal Phase 3 ARMOR trial, or the ARMOR Study, if re-initiated, for our product candidates, Aramchol and Amilo-5MER, or for any other pre-clinical or clinical trials;

	●	completion and receiving favorable results of our planned PSC clinical trial and the ARMOR Study (if re-initiated) for Aramchol or any other 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, Amilo-5MER or any other product candidate in the countries in which we seek to market the product;

	●	our ability to achieve favorable pricing for Aramchol, Amilo-5MER or any other product candidate;

	●	our expectations regarding the commercial market for PSC, non-alcoholic steato-hepatitis, or NASH, in patients or any other targeted indication;

	●	third-party payor reimbursement for Aramchol, Amilo-5MER 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 expectations regarding licensing, acquisitions and strategic operations;

	●	current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and

	●	our ability to maintain the listing of our ordinary share on The Nasdaq Capital Market;

	Three months ended March 31,
	2023			2022
	(unaudited)
	(In thousands, except per share data)
Research and development expenses		1,083			4,796
General and administrative expenses		919			1,296
Total operating expenses		2,002			6,092
Financial expense (income), net		(172	)		51
Net loss		1,830			6,143
Other comprehensive loss:		(100	)		445
Comprehensive loss		1,730			6,588
Basic and diluted net loss per share*)	$	1.09		$	3.67

	●	the progress and costs of our pre-clinical studies and other research and development activities;

	●	the regulatory pathway of Aramchol, Amilo-5MER or any other product candidate;

	●	the scope, prioritization and number of our research and development programs;

	●	the amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect to Aramchol or any other product candidtate;

	●	the costs of the development and expansion of our operational infrastructure;

	●	the costs and timing of obtaining regulatory approval for Aramchol, Amilo-5MER or any other product candidate;

	●	the ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under our potential future licensing agreements;

	●	the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

	●	the costs and timing of securing manufacturing arrangements for clinical or commercial production;

	●	the costs of contracting with third parties to provide sales and marketing capabilities for us;

	●	the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;

	●	the magnitude of our general and administrative expenses;

	●	any cost that we may incur under future in- and out-licensing arrangements relating to Aramchol, Amilo-5MER or any other product candidate;

	●	market conditions;

	●	our ability to maintain the listing of our orindary share on The Nasdaq Capital Market; and

	●	the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above.

Exhibit No.		Description

99.1		Press Release, dated June 1, 2022

	Galmed Pharmaceuticals Ltd.

Date: June 1, 2023	By:	/s/ Allen Baharaff
		Allen Baharaff
		President and Chief Executive Officer

	●	Initiated a new clinical program to evaluate its lead compound, Aramchol meglumine for the treatment of Primary Sclerosing Cholangitis (PSC), a rare disease for which there is no approved treatment;
	●	Phase 2 proof of concept PSC study to be conducted in collaboration with the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health Virginia Commonwealth University;
	●	Formed a strategic partnership with Onkai, Inc., leading an investment round of $6 million in Onkai, an AI-powered digital platform that facilitates health equity in underserved communities across the US, Enabling faster and diverse enrollment to clinical trials.
	●	The Company is discontinuing its evaluation of strategic alternatives; and
	●	Nasdaq notified the Company that it regained compliance with the Nasdaq minimum bid price rule.

	●	Cash and cash equivalents, short term deposit, restricted cash and marketable debt securities totaled $12.2 million as of March 31, 2023, compared to $13.8 million at December 31, 2022.
	●	Net loss amounted to $1.8 million, or $1.09 per share, for the three months ended March 31, 2023, compared to a net loss of $6.1 million, or $3.67 per share, for the three months ended March 31, 2022.
	●	Research and development expenses amounted to approximately $1.1 million for the three months ended March 31, 2023, compared to approximately $4.8 million for the three months ended March 31, 2022. The decrease resulted primarily from a decrease in clinical trial expenses.
	●	General and administrative expenses amounted to approximately $0.9 million for the three months ended March 31, 2023, compared to approximately $1.3 million for the three months ended March 31, 2022. The decrease in general and administrative expenses for the three months ended March 31, 2023 resulted primarily from a decrease in share based compensation and professional services expenses.
	●	Financial income, net amounted to approximately $0.2 million for the three months ended March 31, 2023, compared to financial expense of $0.05 million for the three months ended March 31, 2022.

	Three months ended
	March 31,
	2023			2022
Research and development expenses	$	1,083		$	4,796

General and administrative expenses		919			1,296

Total operating expenses		2,002			6,092

Financial (income) expense, net		(172	)		51

Net loss	$	1,830		$	6,143

Basic and diluted net loss per share*)	$	1.09		$	3.67

Weighted-average number of shares outstanding used in computing basic and diluted net loss per share*)		1,680,232			1,672,566