CITING THE MANY FDA ADVERSE EFFECTS TO KEYSTONE DENTAL - CHECK-CAP FOUNDER STRONGLY RECOMMENDS VOTING AGAINST THE KEYSTONE DENTAL MERGER ALSO RECOMMENDS VOTING FOR THE SYMETRYX BOARD NOMINEES
This action by the FDA could potentially harm Keystone's business, financial condition and results of operations and, as a result, negatively impact your investment.
TORONTO, Dec. 8, 2023 /PRNewswire/ - Further to its news release of November 28, 2023, Symetryx continues to urge its fellow Check-Cap Ltd. ("Check-Cap") (NASDAQ: CHEK) shareholders to VOTE AGAINST the Keystone Dental and FOR the Symetryx slate of highly qualified and independent director nominees. See Symetryx Today Issues Open Letter to Shareholders In Regard to the Upcoming Annual General Meeting (newswire.ca)
Keystone Dental ("Keystone") reported on November 22nd through a 6K filling with the Securities and Exchange Commission (the "SEC") under Check-Cap's SEC filing page, the following: On November 6, 2023, Keystone received a deficiency letter from the U.S. Food and Drug Administration (the "FDA") regarding its Paltop Short Implants in which the FDA requests additional information and raises certain concerns regarding Keystone's submission to the FDA.
While Keystone indicates it intends to proactively engage the FDA on this issue and present information to the agency, there is no guarantee that the FDA will agree with Keystone's determination that a new filing submission was not needed for these products. If the FDA determines that a new filing submission was needed for one or more of the referenced implant bodies, Keystone may be subject to enforcement action and/or it may be required to cease marketing the applicable product and withdraw or recall the subject product from the marketplace until a new submission is made and clearance is obtained (which may not happen in a timely manner or at all), issue corrective communications, or pay fines. This action by the FDA could potentially harm Keystone's business, financial condition and results of operations and, as a result, negatively impact your investment.
Keystone Dental may indeed be required by the FDA to make a new filing submission and provide clinical data to support the continued marketing of their product.
It is further worth noting hundreds of adverse events have been reported by Keystone Dental on implants to the FDA every year from 2019 until today. These large number of adverse events may drive clinicians to choose other brands with fewer concerns. See the FDA's website for information on the events reported by the FDA: See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm (and enter Keystone Dental to view the negative reports).
Symetryx is pleased to see that other stakeholders agree that the transaction with Keystone Dental DOES NOT provide the maximum value for shareholders. We once again urge all shareholders to reject the Keystone transaction by voting AGAINST Proposal #1, the Keystone transaction, and to support the Symetryx Board nominees by voting FOR each. Only with a new, independent Board do we believe, that we shareholders will have the best opportunity to realize the full value of our investment and not give it away to Keystone's investors.
Symetryx has engaged Mackenzie Partners, Inc. to act as an advisor in this matter, we welcome shareholders to reach out to share their views or should they seek clarification on our own. Mackenzie Partners can be reached at 1-800-322-2885 or [email protected]
Sincerely,
Symetryx Corporation
THIS ANNOUCEMENT CONTAINS OUR CURRENT VIEWS ON THE VALUE OF SECURITIES OF CHECK-CAP AND CERTAIN ACTIONS THAT ITS BOARD OF DIRECTORS MIGHT TAKE TO ENHANCE THE VALUE OF ITS COMMON STOCK. OUR VIEWS ARE BASED ON OUR OWN ANALYSES OF PUBLICLY AVAILABLE INFORMATION AND ASSUMPTIONS WE BELIEVE TO BE REASONABLE. THERE CAN BE NO ASSURANCE THAT THE INFORMATION WE CONSIDERED AND ANALYZED IS ACCURATE OR COMPLETE. SIMILARLY, THERE CAN BE NO ASSURANCE THAT OUR ASSUMPTIONS ARE CORRECT. THE ACTUAL PERFORMANCE AND RESULTS OF CHECK-CAP MAY DIFFER MATERIALLY FROM OUR ASSUMPTIONS AND ANALYSES.
THIS ANNOUNCEMENT ALSO REFERENCES THE SIZE OF SYMETRYX'S CURRENT HOLDINGS OF CHECK-CAP. SYMETRYX'S VIEWS AND OUR HOLDINGS COULD CHANGE AT ANY TIME. WE MAY TAKE ANY OF THESE OR OTHER ACTIONS REGARDING CHECK-CAP WITHOUT UPDATING THIS ANNOUNCEMENT OR PROVIDING ANY NOTICE WHATSOEVER OF ANY SUCH CHANGES (EXCEPT AS OTHERWISE REQUIRED BY LAW). WE MAY SELL SOME OR ALL OF OUR CHECK-CAP SHARES AT ANY TIME WITHOUT NOTICE.
FORWARD-LOOKING STATEMENTS:
Certain statements contained in this announcement are forward-looking statements including, but not limited to, statements that are predications of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties. Due to such risks and uncertainties, actual events or results or actual performance may differ materially from those reflected or contemplated in such forward-looking statements. Forward-looking statements can be identified by the use of the future tense or other forward-looking words such as "believe," "might, "expect," "anticipate," "intend," "plan," "estimate," "should," "could," "may," "will," "objective," "projection," "forecast," "continue," "strategy," "position" or the negative of those terms or other variations of them or by any comparable terminology.
Important factors that could cause actual results to differ materially from the expectations set forth in this announcement include, among other things, the factors identified in the public filings of Check-Cap and other information generally available in the market. Such forward-looking statements should therefore be construed considering such factors, and Symetryx is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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