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Tel Aviv, Israel, August 4, 2022 /PRNewswire/ – Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of Aramchol™, an oral treatment for non-alcoholic steatohepatitis or NASH, fibrosis and other fibrotic indications, for today’s commercial update and three to six months Reported financial results. June 30, 2022.
Recent developments
- By focusing research and development on advancing Aramcol for new anti-fibrotic indications, ARMOR has reached its goal of terminating the open-label portion of the study.
- Implement a cost reduction plan that includes reducing headcount and full-time positions and discontinuing any non-essential research and development activities.
- It is not possible to assess the continuation of the development of Aramchol and Amilo-5MER and predict when and if the enrollment portion of the ARMOR study will begin.
- Continue to explore strategic options and structure to best optimize resources to maximize shareholder value and achieve goals.
Financial Summary – Second Quarter 2022 versus Second Quarter 2021:
- Total of cash and cash equivalents, restricted cash and marketable debt securities 22.5 million dollars such as June 30, 2022In comparison 34.9 million dollars as if December 31, 2021.
- A net loss has occurred 3.7 million dollarsOr 0.15 dollars In stock, expired for three months. June 30, 2022compared to net loss 8.4 million dollarsOr 0.33 dollars In stock, expired for three months. June 30, 2021.
- Research and development costs approx 2.6 million dollars It has been over for three months June 30, 2022Compared to approx 7.0 million dollars It has been over for three months June 30, 2021. The decrease was primarily due to lower clinical trial costs associated with the discontinuation of the open-label portion of the ARMOR study.
- General and administrative expenses approx 1.1 million dollars It has been over for three months June 30, 2022Compared to approx 1.4 million dollars It has been over for three months June 30, 2021. The reduction of general and administrative expenses for three months has ended June 30, 2022 It is mainly due to the reduction of professional service costs.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. It is a biopharmaceutical company developing clinical-grade drugs for liver, metabolic and infectious diseases.
Forward-looking statements:
This press release may contain forward-looking statements. Forward-looking statements may include, but are not limited to, Galmed’s objectives, plans and strategies, as well as statements, other than historical facts, about what Galmed intends, expects, projects or believes to be the activities, events or developments. It is predicted to happen or likely to happen in the future. These statements are often defined as “believes,” “expects,” “may,” “expects,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” projects, “positions,” “strategy” and Such forward-looking statements are based on management’s experience and understanding of historical trends, current conditions, future developments and other assumptions and assessments believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Galmad’s actual activities or results to differ materially from those anticipated in forward-looking statements, including, but not limited to: the timing and cost of Galmad’s pivotal Phase 3 ARMOR trial, or the ARMOR study or any other preclinical or clinical trial; experiments; completing and receiving favorable results from the ARMOR study for Aramcol or any other preclinical or clinical trial; Impact of COVID-19; regulatory action by Aramcol or the FDA or EMA with respect to another product candidate; commercial launch and future sales of Aramchol or other future products or product candidates; Ability to comply with all applicable post-market regulatory requirements for Aramchol or other product candidate in countries where Galmed intends to market the product. Galmed’s ability to price competitively for Aramchol or any other product candidate; Galmed’s prospects regarding commercialization or other indications for NASH patients; payment of a third-party payer to Aramcol or another product candidate; Gambed’s assumptions regarding expected capital requirements and Gambed’s additional financing needs; market adoption of Aramcol 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; Galmed’s expectations regarding the use and approval, licensing, acquisitions and strategic transactions of Aramcol or any other product candidate for additional indications or combination therapy; Galmed’s ability to maintain a listing of its common stock on the Nasdaq Capital Market; and the outcome of any assessment of Galmed’s strategic options. More detailed information about the risks and uncertainties facing Galmed is available under the heading “Risk Factors” in Galmed’s most recent annual Form 20-F filing with the SEC. May 2, 2022, and other filings that Galmed has made and may make in the future with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed’s current views on future events, and Galmed undertakes no obligation to update or revise any forward-looking statements and specifically disclaims any obligation. , due to new information, future events or any other reason.
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Galmed Pharmaceuticals Ltd. |
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Consolidated balance sheets |
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US dollars in thousands, except for data sharing and shared data |
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such as |
such as |
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June 30, |
December 31st, |
|||||||
2022 |
2021 |
|||||||
Properties |
||||||||
Current assets |
||||||||
Cash and cash |
$ |
1,980 |
2,884 |
|||||
Limited cash |
114 |
114 |
||||||
Marketable debt securities |
20,422 |
31,931 |
||||||
Another recipient |
614 |
1,125 |
||||||
Total current assets |
23,130 |
36,054 |
||||||
Right to use property |
315 |
406 |
||||||
Property and equipment, net |
130 |
145 |
||||||
Total non-current assets |
445 |
551 |
||||||
Total assets |
$ |
23,575 |
$ |
36,605 |
||||
Liabilities and stockholders’ equity |
||||||||
Recently, Ada |
||||||||
Commercial paid |
$ |
2,089 |
$ |
4,871 |
||||
Other accounts payable |
640 |
1,008 |
||||||
Total current liabilities |
2,729 |
5,879 |
||||||
Non-current liabilities |
||||||||
Operating lease liabilities, current portion net |
$ |
134 |
$ |
229 |
||||
Total non-current liabilities |
134 |
229 |
||||||
Ordinary shares 0.01 NIS per shekel; Authorized 300,000,000; |
||||||||
25,088,414 shares as of June 30, 2022 and December 31, 2021 |
70 |
70 |
||||||
Additional paid up capital |
199,675 |
198,772 |
||||||
Accumulated other general loss |
(982) |
(171) |
||||||
accumulated deficit |
(178,051) |
(168,174) |
||||||
Total stockholders’ equity |
20,712 |
30,497 |
||||||
Total liabilities and stockholders’ equity |
$ |
23,575 |
$ |
36,605 |
The accompanying notes are an integral part of the interim consolidated financial statements.
Galmed Pharmaceuticals Ltd. |
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Enhanced Operating Instructions (Unknown) |
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US dollars in thousands, except for data sharing and shared data |
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Three months passed |
Six months passed |
|||||||||||||||
June 30, |
June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Research and development costs |
2,580 |
7,036 |
7,376 |
14,416 |
||||||||||||
General and administrative expenses |
1,150 |
1,376 |
2,446 |
3,128 |
||||||||||||
Total operating expenses |
3,730 |
8,412 |
9,822 |
17,544 |
||||||||||||
Financial expenditure (income), net |
4 |
(16) |
55 |
(243) |
||||||||||||
Net loss |
$ |
3,374 |
$ |
8,396 |
$ |
9,877 |
$ |
17,301 |
||||||||
Basic and diluted net loss per share |
$ |
0.15 |
$ |
0.33 |
$ |
0.39 |
$ |
0.72 |
||||||||
The weighted average number of shares used |
||||||||||||||||
Calculation of basic and net loss per share |
25,088,414 |
25,083,914 |
25,088,414 |
24,099,132 |
Galmed Pharmaceuticals Ltd. |
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Consolidated Statements of Cash Flows (Unrecognized) |
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Thousands of US dollars |
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Six months passed |
||||||||
June 30, |
||||||||
2022 |
2021 |
|||||||
Cash flow from operating activities |
||||||||
Net loss |
$ |
(9,877) |
$ |
(17,301) |
||||
Adjustments required to reconcile net loss with net cash used in operating activities |
||||||||
Depreciation and depreciation |
18 |
21 |
||||||
Stock-based compensation expense |
903 |
943 |
||||||
Reimbursement of premium payments on marketable debt securities |
35 |
126 |
||||||
Interest income from short term deposits |
– |
(7) |
||||||
Loss (Gain) on Realization of Marketable Debt Securities |
201 |
(19) |
||||||
Financial costs |
(42) |
– |
||||||
Changes in assets and liabilities; |
||||||||
Reduction in other accounts |
511 |
325 |
||||||
Reduction of trade fees |
(2,782) |
(1,417) |
||||||
Additions (deductions) in other accounts |
(330) |
412) |
||||||
Net cash used in business activities |
(11,363) |
(16,917) |
||||||
Cash flow from investment activities |
||||||||
Purchase of property and equipment |
(3) |
(8) |
||||||
Investment is available for sale securities. |
(7,831) |
|||||||
Sales (investment) in short-term deposits, net |
– |
2,005 |
||||||
Securities offered for sale from sale consideration |
10,462 |
6,359 |
||||||
Net cash used in investment activities |
10,459 |
525 |
||||||
Cash flow from financing activities |
||||||||
Derived from the practice of options |
|
– |
||||||
|
|
Issuance of ordinary shares, net cost |
||||||
– |
17,368 |
Net cash provided in financial activities |
||||||
– |
17,368 |
Increase (decrease) in cash and cash equivalents and cash balances |
||||||
(904) |
976 |
Cash and cash and restricted cash at the beginning of the period |
||||||
2,998 |
7,060 |
Cash and cash and restricted cash at the end of the period |
$ |
2,094 |
||||
$ |
||||||||
8,036 |
Disclosure of additional cash flow information: |
Cash from interest |
$ |
138 |
||||
$ |
||||||||
347 |
Non-monetary transactions: |
Right-of-use assets acquired in lieu of new operating lease liabilities, net |
$ |
– |
$ 530
Size represents less
$1.Source Galmed Pharmaceuticals Ltd.
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