8-K
AIxCrypto Holdings, Inc. (AIXC)
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
Dateof Report (Date of earliest event reported): April29, 2022
QualigenTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-37428 | 26-3474527 |
|---|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (Commission<br><br> <br>File<br> Number) | (I.R.S.<br> Employer<br><br> <br>Identification<br> No.) |
2042 Corte Del Nogal, Carlsbad, California 92011
(Address of principal executive offices) (Zip Code)
(760) 918-9165
(Registrant’s telephone number, including area code)
n/a
(Former name or former address, if changed since last report)
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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title<br> of each class | Trading<br> Symbol | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $.001 per share | QLGN | The<br> Nasdaq Capital Market of The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act (§230.405 of this chapter) or Rule 12b-2 of the Exchange Act (§240.12b-2 of this chapter).
Emerging growth company ☐
If an 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 ☐
Item1.01. Entry into a Material Definitive Agreement.
On April 29, 2022, Qualigen Therapeutics, Inc. (the “Company”) entered into a Series B Preferred Share Purchase Agreement (the “Series B Purchase Agreement”) with NanoSynex Ltd., a company established under the laws of the State of Israel (“NanoSynex”), pursuant to which it will acquire 381,786 newly authorized Series B preferred shares of NanoSynex, nominal value NIS 0.01 per share (the “Preferred B Shares”) for a total purchase price of $600,000, subject to certain closing conditions described in the Series B Purchase Agreement.
Also on April 29, 2022, the Company entered into a Share Purchase Agreement (the “Series A-1 Purchase Agreement”) with Alpha Capital Anstalt (“Alpha”), pursuant to which it will acquire 2,232,861 Series A-1 preferred shares, nominal value NIS 0.01 each (the “Series A-1 Shares”) of NanoSynex from Alpha in exchange for 3,500,000 shares of Company common stock and pre-funded warrants to purchase 2,432,203 shares of Company common stock, subject to certain closing conditions described in the Series A-1 Purchase Agreement.
Subject to the satisfaction of the applicable closing conditions set forth in the Series B Purchase Agreement and Series A-1 Purchase Agreement, the Company will acquire an approximate 53% interest in the voting securities of NanoSynex.
As a condition to the Series B Purchase Agreement, the Company has agreed to, among other things, enter into a Master Agreement for the Operational and Technological Funding of NanoSynex (the “Funding Agreement”), pursuant to which the Company will agree to fund NanoSynex up to an aggregate of approximately $10.4 million over the following three years, subject to NanoSynex’s achievement of certain performance milestones specified in the Funding Agreement and the satisfaction of other terms and conditions described in the Funding Agreement.
The Company will receive in exchange for any payment made to NanoSynex under the Funding Agreement one or more promissory notes (which may contain convertible features) with a face value equal to the amount paid by the Company to NanoSynex upon satisfaction of the applicable performance milestones. Any promissory notes issued to the Company by NanoSynex under the Funding Agreement will bear interest at a rate of 9.00% per annum on the principal balance from time to time outstanding under the promissory note. The principal and interest under any promissory note issued to the Company under the Funding Agreement will be due and payable upon the sooner to occur of: (i) five years from the date of the particular promissory note; (ii) the acquisition by any person or entity of all or substantially all of the share capital of NanoSynex, through share purchase, issuance of shares or merger of NanoSynex or the purchase of all or substantially all of the assets of NanoSynex; or (iii) the initial public offering of NanoSynex. If at any time, the Company’s ownership of the share capital of NanoSynex on an issued and outstanding basis falls or is reasonably expected to fall below 50.1%, solely as a result of the exercise of existing or future options (or an equivalent instrument) or as a result of issuance of restricted, shares, restricted stock units (or an equivalent instruments), the Company, in its sole discretion, may elect to convert all or any portion of the outstanding principal amount into shares of NanoSynex’s most senior class of preferred shares existing immediately prior to such conversion, subject to the terms and conditions described in the promissory notes so that, following such conversion, the Company will regain 50.1% ownership of NanoSynex’s issued and outstanding share capital.
The Company will also have the right to appoint two directors to the NanoSynex’s board of directors and has elected to designate Michael Poirier, the Company’s Chairman and Chief Executive Officer, and Shishir Sinha, the Company’s Chief Operating Officer and Senior Vice President, Diagnostics, to serve in such positions. The Company has the right to appoint a third director, thereby giving it majority control of NanoSynex’s board of directors, after the Company has funded nine months of operations following the Closing of the Series B Purchase Agreement, pursuant to the Funding Agreement.
As a condition to the Series A-1 Purchase Agreement, the Company has agreed to, among other things, provide Alpha with certain registration rights and has agree to file, within 30 days of the closing, a registration statement (the “Resale Registration Statement”) with the United States Securities and Exchange Commission (the “Commission”) covering the resale of all of the shares of the Company’s common stock (including the common stock underlying the pre-funded warrant) to be issued to Alpha under the Series A-1 Purchase Agreement. The Company will agree to use its commercially reasonable efforts to cause the Resale Registration Statement to become effective as soon as reasonably practicable.
The foregoing description of the Series B Purchase Agreement, the Series A-1 Purchase Agreement and the Funding Agreement is a summary only, does not purport to be complete and is qualified in its entirety by the full text of the Series B Purchase Agreement, the Series A-1 Purchase Agreement and the Funding Agreement (attached as an exhibit to the Series B Purchase Agreement), copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending March 31, 2022.
The representations, warranties and covenants contained in the Series B Purchase Agreement and Series A-1 Purchase Agreement described in Item 1.01 of this Current Report on Form 8-K are not intended to be a source of factual, business or operational information about the Company; were made only for purposes of such agreements and as of specific dates; were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the parties, including being qualified by disclosures for the purpose of allocating contractual risk between the parties instead of establishing matters as facts; and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors or security holders. Accordingly, investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the parties.
Item7.01. Regulation FD Disclosure.
On May 3, 2022, the Company issued a press release announcing the signing of the Series B Purchase Agreement and Series A-1 Purchase Agreement. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Such exhibit and the information set forth therein shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
Item9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit<br><br> <br>No. | Description |
|---|---|
| 99.1 | Press Release dated May 3, 2022 issued by Qualigen Therapeutics, Inc. |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
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.
| QUALIGEN<br> THERAPEUTICS, INC. | ||
|---|---|---|
| Date:<br> May 4, 2022 | By: | /s/ Michael S. Poirier |
| Michael<br> S. Poirier, Chairman and Chief Executive Officer |
Exhibit 99.1
Qualigen Therapeutics to Acquire Majority Stake in Diagnostics Technology Company NanoSynex
Companiesto Collaborate in the Development of Innovative Diagnostics Platform to Combat “Superbugs”, a Rising Global Health Crisis
CARLSBAD, Calif., May 3, 2022 (GLOBE NEWSWIRE) – Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces it has entered into definitive agreements to acquire a majority stake in NanoSynex Ltd., an Israeli-based developer of next generation diagnostics technology.
NanoSynex’s technology is an Antimicrobial Susceptibility Testing (AST) platform that aims to provide clinical laboratories worldwide with a rapid, accurate and personalized test for bacterial infections, with the goal of quickly matching the correct antibiotics to treat a patient’s particular infection. Antibiotic misuse and overuse have given rise to antibiotic resistant bacteria, commonly known as superbugs, which the World Health Organization has called one of the top ten global public health threats facing humanity. NanoSynex’s AST platform aims to enable better targeting of antibiotics for their most suitable uses to ultimately result in faster and more efficacious treatment, hence reducing hospitals mortality and morbidity rates.
Deaths associated with antimicrobial resistance have been on the rise, which is believed to be due in no small part to antibiotic overuse or misuse. A systematic analysis published in the Lancet estimates that antimicrobial resistance caused 1.2 million deaths worldwide in 2019 and an additional estimated 4.95 million deaths were linked to antimicrobial resistance.^1^
Michael Poirier, Qualigen’s Chairman and CEO, commented, “We look forward to collaborating with the dynamic team at NanoSynex to help develop and commercialize this potentially game-changing technology. Qualigen is committed to investing in people and products that can position us ahead of the next global health crisis where rapid deployment of diagnostic tools is critical. Acquiring a majority stake in NanoSynex will provide us with the opportunity to leverage our long-standing diagnostics development, regulatory and commercial expertise as we expand our footprint as a diversified life sciences company.”
“We are proud to join in Qualigen’s mission to develop innovative diagnostics. NanoSynex and Qualigen share the same goal to provide clinicians with the solutions they need to treat patients more readily, accurately, and effectively. Together with Qualigen, we believe we will revolutionize patient care.” said Diane Abensur Bessin, Co-Founder and Chief Executive Officer of NanoSynex.
Qualigen’s purchase of the controlling interest in NanoSynex will be primarily comprised of a stock-for-stock acquisition with NanoSynex’s controlling shareholder, as well as an initial $600,000 cash investment in NanoSynex, and is subject to certain closing conditions. Subject to the closing of the transactions, Qualigen expects to consolidate the financial results of NanoSynex, and provide future milestone-based funding leading to the commercialization of this technology. Qualigen envisions future synergy of its proprietary, results-proven FastPack^®^diagnostics platform with the innovative NanoSynex technology, further strengthening the Company’s diagnostics business which has seen a resurgence post Covid lockdown.
^1^https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
AboutQualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack^®^ System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The investigational compounds within Qualigen’s RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions.
For more information about Qualigen Therapeutics, Inc., please visit www.qualigeninc.com.
AboutNanoSynex
NanoSynex is a MedTech company that aims at providing new solutions to improve testing quality, patient outcomes, and reduce healthcare costs by speeding up diagnostic processes. NanoSynex is focused on the development and commercialization of a rapid innovative Antimicrobial Susceptibility Test (AST). The technology is based on a purely phenotypic approach and uses a microfluidic disposable test card platform and method that optimizes bacterial growth. This disruptive development was born from exciting research discoveries at the lab of Professor Shulamit Levenberg, former Dean of the Technion Institute of Technology – Biomedical Engineering Faculty.
For more information about NanoSynex, please visit www.nanosynex.com.
Forward-LookingStatements
This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. These statements include those related to the satisfaction of closing conditions in connection with the proposed transaction with NanoSynex and the Company’s prospects and strategy for its diagnostics business and development of its therapeutic drug candidates. Actual events or results may differ from the Company’s expectations. For example, there can be no assurance that the closing conditions for the NanoSynex transaction will be satisfied or that the Company will be able to maintain its diagnostic sales and marketing engine without interruption following the expiration of the distribution agreement with Sekisui Diagnostics, compete with others in this industry or expand market demand and/or market share for its diagnostics product, nor can there be any assurance that the Company will be able to successfully develop any drugs (including QN-302, QN-247 and RAS-F); that preclinical development of the Company’s drugs (including QN-302, QN-247 and RAS-F, and the deprioritized infectious-disease drug candidate QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (or Fast Track designation or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company’s owned and in-licensed patent applications; that such patents, if any, and the Company’s currently owned and in-licensed patents would prevent competition; or that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company’s prospective therapeutic products (including QN-302, QN-247 and RAS-F, and QN-165). The Company’s stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company’s business can be found in the Company’s prior filings with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available at www.sec.gov.
The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
Source: Qualigen Therapeutics, Inc.