PROSPECTUS |
Filed
pursuant to Rule 424(b)(4)
Registration
No. 333-272623 |
Qualigen
Therapeutics, Inc.
14,724,058
Shares of Common Stock
11,972,754
Pre-Funded Warrants to Purchase up to 11,972,754 Shares of Common Stock
11,972,754
Shares of Common Stock Underlying the Pre-Funded Warrants
We
are offering on a “reasonable best efforts” basis 14,724,058 million shares of common stock, par value $0.001 per share
(the “common stock”) at a public offering price of $0.13 per share.
We
are also offering pre-funded warrants (the “pre-funded warrants”) to purchase up to an aggregate of 11,972,754 shares of
common stock to those purchasers whose purchase of shares of common stock in this offering would result in the purchaser, together with
its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our
outstanding common stock immediately following the consummation of this offering, in lieu of shares of common stock that would result
in beneficial ownership in excess of 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock. Each pre-funded
warrant is exercisable for one share of our common stock, has an exercise price of $0.001 per share and an indefinite term. For each
pre-funded warrant that we sell, the number of shares of common stock we are offering will be reduced on a one-for-one basis. Each pre-funded
warrant is being sold at the public offering price of $0.13 per share minus the exercise price of $0.001.
There
is no established trading market for the pre-funded warrants, and we do not expect a market to develop. In addition, we do not intend
to list the pre-funded warrants on Nasdaq, any other national securities exchange or any other trading system. Without an active trading
market, the liquidity of the pre-funded warrants may be limited.
We
have engaged Univest Securities, LLC (whom we refer to herein as the “Placement Agent”) to act as our exclusive placement
agent in connection with the securities offered by this prospectus. The Placement Agent has no obligation to buy any of the securities
from us or to arrange for the purchase or sale of any specific number or dollar amount of securities but has agreed to use its reasonable
best efforts to arrange for the sale of the securities offered by this prospectus. We have agreed to pay the Placement Agent a fee based
upon the aggregate gross proceeds raised in this offering. See “Plan of Distribution.”
Pursuant
to this prospectus, we are also offering the shares of common stock issuable upon the exercise of pre-funded warrants offered hereby.
The
shares of our common stock and pre-funded warrants being offered will be sold in a single closing (or in multiple closings with the same
terms, but all of which closings would occur by no later than September 9, 2024). We will deliver all securities to be issued in connection
with this offering delivery versus payment (DVP)/receipt versus payment (RVP) upon receipt of investor funds received by us. Accordingly,
neither we nor the Placement Agent have made any arrangements to place investor funds in an escrow account or trust account since the
Placement Agent will not receive investor funds in connection with the sale of the securities offered hereunder. Because there is no
minimum number of securities or minimum aggregate amount of proceeds for this offering to close, we may sell fewer than all of the securities
offered hereby, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient
to pursue the business goals outlined in this prospectus. Because there is no escrow account and there is no minimum offering amount,
investors could be in a position where they have invested in our company, but we are unable to fulfill our objectives due to a lack of
interest in this offering. Also, any proceeds from the sale of securities offered by us will be available for our immediate use, despite
uncertainty about whether we would be able to use such funds to effectively implement our business plan. The offering of the shares of
our common stock and pre-funded warrants will terminate no later than September 9, 2024 unless the offering is fully subscribed before
that date or we decide to terminate the offering (which we may do at any time in our discretion) before that date; however, the shares
of our common stock underlying the pre-funded warrants will be offered on a continuous basis pursuant to Rule 415 under the Securities
Act of 1933, as amended (the “Securities Act”).
Our
common stock is listed on The Nasdaq Capital Market under the symbol “QLGN.” The last reported sales price of our common
stock on The Nasdaq Capital Market on September 4, 2024 was $0.1836 per share. We do not intend to list the pre-funded warrants on any
national securities exchange or other nationally recognized trading system.
| |
Per Share | | |
Per Pre-Funded Warrant | | |
Total | |
Public offering price | |
$ | 0.13 | | |
$ | 0.129 | | |
$ | 3,470,585.55 | |
Placement Agent Fees(1) | |
$ | 0.004 | | |
$ | 0.004 | | |
$ | 104,117.57 | |
Proceeds, before expenses, to us | |
$ | 0.126 | | |
$ | 0.125 | | |
$ | 3,366,467.98 | |
(1) |
Upon
the closing of this offering, we will pay the Placement Agent a cash placement commission equal to 3.0% of the aggregate gross proceeds
to us from the sale of the shares of Common Stock, or pre-funded warrants in lieu thereof, sold in this offering. See “Plan
of Distribution” for a complete description of compensation payable to the Placement Agent. |
An
investment in our securities involves significant risks. You should carefully consider the risk factors beginning on page 10 of this
prospectus before you make your decision to invest in our securities.
Neither
the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the
accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
Delivery
of the shares of our common stock, pre-funded warrants is expected to be made on or about September 6, 2024.
Sole
Placement Agent
Univest
Securities, LLC
The
date of this prospectus is September 5, 2024
TABLE
OF CONTENTS
Neither
we nor the placement agent has authorized anyone to provide any information or to make any representations other than those contained
in or incorporated by reference in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have
referred you. We and the placement agent take no responsibility for, and can provide no assurance as to the reliability of, any other
information that others may give you. This prospectus is an offer to sell only the shares of common stock offered hereby, but only under
circumstances and in jurisdictions where it is lawful to do so. The information contained in or incorporated by reference in this prospectus
or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of shares
of our shares of common stock. Our business, financial condition, results of operations and prospects may have changed since that date.
To
the extent there is a conflict between the information contained in this prospectus, on the one hand, and the information contained in
any document incorporated by reference filed with the Securities and Exchange Commission, or the SEC, before the date of this prospectus,
on the other hand, you should rely on the information in this prospectus. If any statement in a document incorporated by reference is
inconsistent with a statement in another document incorporated by reference having a later date, the statement in the document having
the later date modifies or supersedes the earlier statement.
No
action is being taken in any jurisdiction outside the United States to permit a public offering of our shares of common stock or possession
or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside
the United States are required to inform themselves about and to observe any restrictions as to this public offering and the distribution
of this prospectus applicable to that jurisdiction.
Unless
otherwise indicated, information contained in this prospectus concerning our industry and the markets in which we operate, including
our general expectations and market position, market opportunity and market share, is based on information from our own management estimates
and research, as well as from industry and general publications and research, surveys and studies conducted by third-parties. Management
estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and
knowledge, which we believe to be reasonable. Our management estimates have not been verified by any independent source, and we have
not independently verified any third-party information. In addition, assumptions and estimates of our and our industry’s future
performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in
“Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and
estimates. See “Risk Factors” and “Information Regarding Forward-Looking Statements.”
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to the registration
statement of which this prospectus is a part were made solely for the benefit of the parties to such agreement, including, in some cases,
for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or
covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such
representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
We
may also provide a prospectus supplement or post-effective amendment to the registration statement to add information to, or update or
change information contained in, this prospectus. You should read both this prospectus and any applicable prospectus supplement or post-effective
amendment to the registration statement together with the additional information to which we refer you in the sections of this prospectus
entitled “Where You Can Find More Information.”
PROSPECTUS
SUMMARY
This
summary highlights information contained elsewhere in or incorporated by reference into this prospectus. This summary does not contain
all of the information that you should consider before deciding to invest in our securities. You should carefully read this entire prospectus
and the documents and reports incorporated by reference into this prospectus before making an investment decision, including the information
presented under the headings “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements
and Industry Data and Market Information” in this prospectus and the historical financial statements and the notes thereto
incorporated by reference into this prospectus. You should pay special attention to the information contained under the caption titled
“Risk Factors” in this prospectus, in our most recent Annual Report on Form 10-K, in any subsequent Quarterly Reports on
Form 10-Q and in our other reports filed from time to time with the Securities and Exchange Commission, which are incorporated by reference
into this prospectus, before deciding to buy our securities. In this prospectus, the terms “Qualigen Therapeutics, Inc.,”
the “Company,” “we,” “our,” “ours” and “us”
refer to Qualigen Therapeutics. Inc. and (as to time periods when it had one or more subsidiaries) its subsidiaries.
Overview
We
are an early-clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Our business now consists
of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS).
In
addition, on April 11, 2024, we entered into a Co-Development Agreement (the “Co-Development Agreement”) with Marizyme, Inc.
(“Marizyme”). The Co-Development Agreement contemplated that we would invest an aggregate of $800,000 in Marizyme in April
2024 (the “Funding Payment”) and pay Marizyme a $200,000 Exclusivity Fee (Provided, that if the parties so agree the total
Funding Payment can be increased from time to time to up to a total of $1,500,000.) To date our Funding Payment investment has been $500,000,
and in July 2024 we have advanced an additional $1,250,000 pursuant to an 18% demand promissory note, and in August 2024 we amended the
Co-Development Agreement to increase the total Funding Payment to up to a total of $1,750,000. The Funding Payment is designed to provide
financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult
patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts
used in coronary artery bypass grafting surgery. In return for the Funding Payment we will receive quarterly a 33% payment in the nature
of royalties on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the
amount of the Funding Payment cash provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been
launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States.
The
Exclusivity Fee entitled us to an exclusivity period until May 31, 2024 (the “Exclusivity Period”) for purposes of proposing
and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business. The Exclusivity Period
has ended, and we do not intend to expand the Exclusivity Period.
Our
lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding
affinity to G4s prevalent in cancer cells (such as pancreatic cancer). Such binding could, by stabilizing the G4s against DNA “unwinding,”
help inhibit cancer cell proliferation. QN-302 is currently undergoing a Phase 1a clinical trial at START Midwest in Grand Rapids, Michigan,
and HonorHealth in Scottsdale, Arizona.
Our
Pan-RAS program, which is currently at the preclinical stage, consists of a family of RAS oncogene protein-protein interaction inhibitor
small molecules believed to inhibit or block mutated RAS genes’ proteins from binding 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. The investigational compounds
within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF, upstream of the KRAS, HRAS and NRAS
effector pathways.
On
May 22, 2020, we completed a “reverse recapitalization” transaction with Qualigen, Inc. (not to be confused with the Company);
pursuant to which our merger subsidiary merged with and into Qualigen, Inc. with Qualigen, Inc. surviving as a wholly owned subsidiary
of the Company. The Company, which had previously been known as Ritter Pharmaceuticals, Inc., was renamed Qualigen Therapeutics, Inc.,
and the former stockholders of Qualigen, Inc. acquired, via the recapitalization, a substantial majority of the shares of the Company.
Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,”
commenced trading on Nasdaq, on a post-reverse-stock-split adjusted basis, under the ticker symbol “QLGN” on May 26, 2020.
We are no longer pursuing the gastrointestinal disease treatment business on which Ritter Pharmaceuticals, Inc. had focused before the
reverse recapitalization transaction.
On
July 20, 2023, we sold our Qualigen, Inc. subsidiary, which contained our former FastPack® diagnostics business to Chembio
Diagnostics, Inc., an American subsidiary of French diagnostics provider Biosynex, S.A. The aggregate net purchase price for Qualigen,
Inc. was $5.4 million in cash, of which $450,000 was being held in escrow to satisfy certain Company indemnification obligations until
January 20, 2025. On June 4, 2024, the $450,000 escrow account was settled early and liquidated by mutual agreement of the Company and
the buyer (Chembio). In exchange for the early settlement, $350,000 was paid to the Company, and $100,000 was paid to Chembio.
This settlement resulted in a $100,000 loss from discontinued operations in the second quarter of 2024.
We
own a minority interest in NanoSynex, Ltd. (“NanoSynex”), a privately-held microbiologics diagnostic company domiciled in
Israel. NanoSynex’s technology is for Antimicrobial Susceptibility Testing that 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. On May 26, 2022, we acquired a 52.8% interest in NanoSynex from our related party Alpha Capital Anstalt (“Alpha”)
and NanoSynex, and entered into a Master Agreement for the Operational and Technological Funding of NanoSynex with NanoSynex (the “NanoSynex
Funding Agreement”). On July 20, 2023, we entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex
Amendment”), pursuant to which we agreed to, in exchange for eliminating all future NanoSynex Funding Agreement obligations for
us to invest further cash in NanoSynex (except for obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000
on or before March 31, 2024), surrender 281,000 Series B Preferred Shares of NanoSynex held by us, resulting in our ownership in NanoSynex
being reduced from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex; in addition, we agreed to surrender
approximately $3.0 million of promissory notes which NanoSynex had issued to us under the Funding Agreement. On November 22, 2023 we
further agreed to eliminate our obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000 on or before March
31, 2024, by instead surrendering shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex
voting equity from approximately 49.97% to 39.90%.
Product
Pipeline
QN-302
We
exclusively in-licensed the global rights to the G-Quadruplex (“G4”) selective transcription inhibitor platform from University
College London (“UCL”) in January 2022. The licensed technology comprises lead compound QN-302 (formerly known as SOP1812)
and back-up compounds that target regulatory regions of cancer genes that down-regulate gene expression in multiple cancer pathways.
Developed by Dr. Stephen Neidle and his group at UCL, the G4 binding concept is derived from nucleic acid research conducted over more
than over 30 years, including research on G4s, which are higher order DNA and RNA structures formed by sequences containing guanine-rich
repeats. G4s are overrepresented in telomeres (a region of repetitive DNA sequences at the end of a chromosome) as well as promoter sequences
and untranslated regions of many oncogenes. Their prevalence is therefore significantly greater in cancer cells compared to normal human
cells.
G4-selective
small molecules such as QN-302 and backup compounds target the regulatory regions of cancer genes, which have a high prevalence of enriched
G4s. Stable G4-QN-302 complexes can be impediments to replication, transcription or translation of those cancer genes containing G4s,
and the drugs’ binding to G4s are believed to stabilize the G4s against possible “unwinding.” G4 binders like QN-302
could be efficacious in a variety of cancer types with a high prevalence of G4s.
We
believe that QN-302 has the potential to demonstrate superior efficacy and activity against pancreatic ductal adenocarcinoma (“PDAC”),
which represents 98% of pancreatic cancers. Pancreatic cancer is the tenth most common cancer in men and the seventh most common in women,
but it is the fourth leading cause of cancer deaths in men and the third leading cause in women; it accounts for about 3% of all cancers
in the United States but is responsible for about 8% of all cancer-related deaths. It has one of the lowest rates of survival of all
cancer types.
In-vitro
and in-vivo studies have shown that G4 stabilization by QN-302 resulted in inhibition of target gene expression and cessation
of cell growth in various cancers, including PDAC. In in-vitro studies, QN-302 was potent in inhibiting the growth of several
PDAC cell lines at low nanomolar concentrations. Similarly, in in-vivo studies, QN-302 showed a longer survival duration in a
KPC genetic mouse model for pancreatic cancer than gemcitabine (the current standard of care for PDAC) has historically shown. Additional
preclinical in-vivo studies suggest activity in gemcitabine-resistant PDAC. Data further demonstrated that QN-302 had significant
anti-tumor activity in three patient-derived PDAC xenograft models. Early safety indicators in pancreatic cancer mouse in-vivo models
suggest no significant adverse toxic effects at proposed therapeutic doses.
On
January 9, 2023, the U.S. Food and Drug Administration (“FDA”) granted Orphan Drug Designation (“ODD”) to QN-302
for the indication of pancreatic cancer. ODD provides advantages to pharmaceutical companies that are developing investigational drugs
or biological products that show promise in treating rare diseases or conditions that affect fewer than 200,000 people in the United
States, including seven-year marketing exclusivity and eligibility to receive regulatory support and guidance from the FDA in the design
of an overall drug development plan.
There
are also economic advantages to receiving ODD, including a 25% federal tax credit for expenses incurred in conducting clinical research
on the orphan designated product within the United States. Tax credits may be applied to the prior year or applied to up to 20 years
of future taxes. ODD recipients may also have their Prescription Drug User Fee Act (PDUFA) application fees waived, a potential savings
of around $3.2 million (as of fiscal year 2023) for applications requiring covered clinical data, and may qualify to compete for research
grants from the Office of Orphan Products Development that support clinical studies.
On
August 1, 2023 we announced that the FDA had cleared our investigational new drug (“IND”) application for QN-302, and on
November 1, 2023 the first patient in our Phase 1a clinical trial for QN-302 was dosed at START Midwest in Grand Rapids, Michigan.
We
will require additional cash resources to be able to continue and complete this Phase 1a clinical trial.
Pan-RAS
(formerly referred to as RAS or RAS-F)
In
July 2020 we entered into an exclusive worldwide in-license agreement with the University of Louisville Research Foundation, Inc. (“UofL”)
for the intellectual property covering the “RAS” family of pan-RAS inhibitor small molecule drug candidates, which are believed
to work by blocking RAS mutations directly, thereby inhibiting tumor formation (especially in pancreatic, colorectal and lung cancers).
Pursuant to the license agreement, we will seek to identify and develop a lead drug candidate from the compound family and, upon commercialization,
will pay UofL royalties in the low-to-mid-single-digit percentages on net sales of Pan-RAS inhibitor licensed products. The license agreement
with UofL for Pan-RAS was amended in March 2021 and June 2023.
RAS
is the most common oncogene in human cancer. Activating mutations in one of the three human RAS gene isoforms (KRAS, HRAS or NRAS) are
present in about one-fourth to one-third of all cancers. For example, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas,
52% of colon cancers, and 32% of lung adenocarcinomas. For these three cancer types, cancers with mutant KRAS are diagnosed in more than
170,000 people each year in the United States and cause more than 120,000 deaths. Drugs that target signaling downstream of RAS are available;
however, such drugs have shown disappointing clinical durability because RAS is a “hub” that activates multiple effectors,
so drugs that block a single pathway downstream may not account for the many other activated pathways.
We
also had a sponsored research agreement with UofL for Pan-RAS research; that agreement expired in December 2023.
On
February 15, 2024, we entered into a License and Sublicense Agreement with Pan-RAS Holdings, Inc., a New York corporation (“Pan-RAS
Holdings”), which contemplated an exclusive out-license of our Pan-RAS drug development program, including our rights under the
UofL license agreement, Pan-RAS Holdings. Although the License and Sublicense Agreement called for a closing by March 16, 2024, the License
and Sublicense Agreement was in essence structured as a 30-day option in favor of Pan-RAS Holdings. At the contemplated closing, Pan-RAS
Holdings would have paid us an upfront fee of $1,000,000 in cash. In addition, Pan-RAS Holdings would have become responsible to pay
on our behalf our in-license royalty obligations to UofL, as and when required. Finally, if the contemplated closing had occurred, Pan-RAS
Holdings would have been required to pay to us for our own account, on a semiannual basis, royalties equal to 1.0% of net sales of any
RAS products. We would have owed certain amounts to UofL under our in-license agreement from them, if, as and when we received any Non-Royalty
Sublicensing Income from Pan-RAS Holdings.
Pan-RAS
Holdings did not effectuate the closing by March 16, 2024, and we and they voluntarily terminated the License and Sublicense Agreement
effective as of March 16, 2024.
Previous
Programs
We
have discontinued all of our efforts as to the following programs, and we do not plan to resume them:
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1. |
QN-247
(formerly referred to as ALAN or AS1411-GNP) – an oligonucleotide aptamer-based, nucleolin-inhibiting anticancer drug
candidate, consisting of QN-165 conjugated with gold nanoparticles. |
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2. |
QN-165
(formerly referred to as AS1411) – an oligonucleotide aptamer-based drug candidate for the potential broad-spectrum
treatment of infectious diseases such as COVID-19. |
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3. |
Selective
Target Antigen Removal System (STARS) – a therapeutic blood-filtering device product concept, which would be designed
to remove circulating tumor cells, viruses, inflammation factors and immune checkpoints. |
Research
and Development
For
research and development of our drug candidates, we have historically leveraged the scientific and technical resources and laboratory
facilities of UofL and UCL, through technology licensing, sponsored research, and other consulting agreements. We have engaged contract
research organizations (“CROs”) and clinical sites for the Phase 1a clinical trial of QN-302. We intend to focus our internal
research and development on oversight of these CROs. We currently have no internal research and development facilities.
Regulatory
Matters
We
have obtained FDA clearance/approval for our QN-302 Phase 1a clinical trial. We have not obtained FDA or other regulatory approval for
any other drug candidate.
United
States—FDA Drug Approval Process
The
research, development, testing, and manufacture of product candidates are extensively regulated by governmental authorities in the United
States and other countries. In the United States, the FDA regulates drugs under the Food, Drug and Cosmetics Act and its implementing
regulations.
The
steps required to be completed before a drug may be marketed in the United States include, among others:
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preclinical
laboratory tests, animal studies, and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice
(“GLP”) regulations; |
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submission
to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin and
for which progress reports must be submitted annually to the FDA; |
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approval
by an independent institutional review board (“IRB”) or Ethics Committee (“EC”) at each clinical trial site
before each trial may be initiated; |
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adequate
and well-controlled human clinical trials, conducted in accordance with applicable IND regulations, Good Clinical Practices (“GCP”),
and other clinical trial related regulations, to establish the safety and efficacy of the drug for each proposed indication to the
FDA’s satisfaction; |
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submission
to the FDA of a New Drug Application (“NDA”) and payment of user fees for FDA review of the NDA (unless a fee waiver
applies); |
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satisfactory
completion of an FDA pre-approval inspection of one or more clinical trial site(s) at which the drug was studied in a clinical trial(s)
and/or of us as a clinical trial sponsor to assess compliance with GCP regulations; |
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satisfactory
completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the drug is produced to assess
compliance with current GMPs regulations; |
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agreement
with the FDA on the final labeling for the product and the design and implementation of any required Risk Evaluation and Mitigation
Strategy; and |
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FDA
review and approval of the NDA, including satisfactory completion of an FDA advisory committee review, if applicable, based on a
determination that the drug is safe and effective for the proposed indication(s). |
Preclinical
tests include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies. The conduct of the preclinical
tests and formulation of the compounds for testing must comply with federal regulations and requirements, including GLP regulations.
The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of
an IND application, which must become effective before human clinical trials may begin. We cannot be certain that submission of an IND
application will result in the FDA allowing clinical trials to begin.
Clinical
trials necessary for product approval are typically conducted in three sequential phases, but the phases may overlap or be combined.
The study protocol and informed consent information for study subjects in clinical trials must also be approved by an IRB for each institution
where the trials will be conducted, and each IRB must monitor the study until completion. Study subjects must provide informed consent
and sign an informed consent form before participating in a clinical trial. Clinical testing also must satisfy the extensive GCP regulations
for, among other things, informed consent and privacy of individually identifiable information.
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Phase
1—Phase 1 clinical trials involve initial introduction of the study drug in a limited population of healthy human volunteers
or patients with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption,
metabolism and distribution of the study drug in humans, evaluate the side effects associated with increasing doses, and, if possible,
to gain early evidence of effectiveness. |
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Phase
2—Phase 2 clinical trials typically involve administration of the study drug to a limited patient population with a specified
disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side
effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information before beginning larger and more
expensive Phase 3 clinical trials. |
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Phase
3—Phase 3 clinical trials typically involve administration of the study drug to an expanded patient population to further evaluate
dosage, to provide substantial evidence of clinical efficacy and to further test for safety, generally at multiple geographically
dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the study drug
and to provide an adequate basis for product approval. Generally, adequate and well-controlled Phase 3 clinical trials are required
by the FDA for approval of an NDA. |
The
FDA has various programs, including fast track designation, breakthrough therapy designation, priority review and accelerated approval,
which are intended to expedite or simplify the process for the development, and the FDA’s review of drugs (e.g., approving
an NDA on the basis of surrogate endpoints subject to post-approval trials). Generally, drugs that may be eligible for one or more of
these programs are those intended to treat serious or life-threatening diseases or conditions, those with the potential to address unmet
medical needs for those disease or conditions, and/or those that provide a meaningful benefit over existing treatments. For example,
a sponsor may be granted FDA designation of a drug candidate as a “breakthrough therapy” if the drug candidate is intended,
alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical
evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant
endpoints, such as substantial treatment effects observed early in clinical development. If a drug is designated as breakthrough therapy,
the FDA will take actions to help expedite the development and review of such drug. Moreover, if a sponsor submits an NDA for a product
intended to treat certain rare pediatric or tropical diseases or for use as a medical countermeasure for a material threat, and that
meets other eligibility criteria, upon approval such sponsor may be granted a priority review voucher that can be used for a subsequent
NDA. From time to time, we anticipate applying for such programs where we believe we meet the applicable FDA criteria. A company cannot
be sure that any of its drugs will qualify for any of these programs, or even if a drug does qualify, that the review time will be reduced.
The
results of the preclinical studies and of the clinical studies, together with other detailed information, including information on the
manufacture and composition of the drug, are submitted to the FDA in the form of an NDA requesting approval to market the product for
one or more proposed indications. The testing and approval process requires substantial time, effort and financial resources. Unless
the applicant qualifies for an exemption, the filing of an NDA typically must be accompanied by a substantial “user fee”
payment to the FDA. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety
and efficacy of the product in the proposed patient population to the satisfaction of the FDA. After an NDA is accepted for filing, the
FDA substantively reviews the application and may deem it to be inadequate, and companies cannot be sure that any approval will be granted
on a timely basis, if at all. The FDA may also refer the application to an appropriate advisory committee, typically a panel of clinicians,
for review, evaluation and a recommendation as to whether the application should be approved, but is not bound by the recommendations
of the advisory committee.
Before
approving an NDA, the FDA usually will inspect the facility or the facilities at which the drug is manufactured and determine whether
the manufacturing and production and testing facilities are in compliance with cGMP regulations.
Once
issued, the FDA may withdraw product approval if, among other things, ongoing regulatory requirements are not met, certain defects exist
in the NDA, or safety or efficacy problems occur after the product reaches the market.
Intellectual
Property
Information
regarding our (in-licensed) issued patents and pending patent applications, as of December 31, 2023, is as follows (excluding patents
and pending patent applications which pertain to programs which we have discontinued). As of that date we did not have any directly-owned
issued patents and pending patent applications.
Subject Matter | |
Issued | | |
Pending | | |
Geographic Scope | |
Patent Term | |
In-Licensed Patents | |
| | |
| | |
| |
| |
University College London (UCL) | |
| | | |
| | | |
| |
| | |
QN-302 | |
| 3 | | |
| 10 | | |
U.S., Europe, Australia, Canada, China, Hong Kong, India, Japan, Korea, Russia | |
| 2030-2040 | |
University of Louisville | |
| | | |
| | | |
| |
| | |
Pan-RAS | |
| 0 | | |
| 12 | | |
U.S., Europe, Australia, Canada, China, Hong Kong, India, Israel, Japan, Korea, Mexico, Russia, South Africa | |
| 2039 | * |
TOTAL | |
| 3 | | |
| 22 | | |
| |
| | |
*Anticipated
patent term
Human
Capital Management
As
of September 4, 2024, we had 3 employees, all of whom were full-time. None of our employees are represented by a labor union or covered
by a collective bargaining agreement.
Diversity
& Inclusion. With respect to our employees overall, 33% are women and none are people of color.
Going
Concern Qualification
Our
working capital deficiency, stockholders’ deficit, and recurring losses from operations raise substantial doubt about our ability
to continue as a going concern. As a result, our independent registered public accounting firm included an explanatory paragraph in its
report on our financial statements for the year ended December 31, 2023 with respect to this uncertainty. Our ability to continue as
a going concern will require us to obtain additional funding.
Corporate
Information
Ritter
Pharmaceuticals, Inc. (our predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural
Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc. On May
22, 2020, upon completing the “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals, Inc. was
renamed Qualigen Therapeutics, Inc. and Qualigen, Inc. became a wholly-owned subsidiary of the Company. On July 20, 2023 we sold Qualigen,
Inc. to Chembio Diagnostics, Inc., an American subsidiary of French diagnostics provider Biosynex S.A.
Our
principal executive offices are located at 5857 Owens Avenue, Suite 300, Carlsbad, CA 92008. Our telephone number is (760) 452-8111.
Our corporate website address is www.qlgntx.com. Our website and the information contained on, or that can be accessed through,
our website will not be deemed to be incorporated by reference in, and are not considered part of, this prospectus. You should not rely
on our website or any such information in making your decision whether to purchase our securities.
We
are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage
of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
The
Offering
Securities
we are offering |
14,724,058
shares of common stock together, or (in the alternative for applicable purchasers, pre-funded warrants to purchase up to 11,972,754
shares of common stock). The shares of common stock being sold with the pre-funded warrants must initially be purchased together
as units in this offering but are immediately separable and will be issued separately in this offering. Each pre-funded warrant has
an exercise price of $0.001 per share, is immediately exercisable, and will be exercisable until exercised in full. We are also registering
the issuance of shares of our common stock issuable upon exercise of the pre-funded warrants. |
|
|
|
We
are offering to those purchasers whose purchase of common stock in this offering would otherwise result in the purchaser, together
with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%)
of our outstanding common stock immediately following the closing of this offering, in lieu of purchasing common stock, pre-funded
warrants to purchase up to an aggregate of 11,972,754 shares of our common stock. Each pre-funded warrant is exercisable for one
share of our common stock. The purchase price of each pre-funded warrant is equal to the price at which a share of common stock is
being sold to the public in this offering, minus $0.001. We are also registering the issuance of up to 11,972,754 shares of our common
stock issuable upon exercise of the pre-funded warrants. For each pre-funded warrant that we sell, the number of shares of common
stock that we are offering will be reduced on a one-for-one basis. |
|
|
Common
stock outstanding immediately before this offering |
12,297,981
shares |
|
|
Public
offering price |
$0.13
per share of common stock or, in the alternative, $0.129 per pre-funded warrant. |
|
|
Common
stock outstanding immediately after this offering |
Up
to 27,022,039 shares, assuming no exercise of the pre-funded warrants issued in this offering. |
|
|
Use
of proceeds |
The
net proceeds from this offering will be approximately $3.1 million (based on a public offering price of $0.13 per share, or, in the
alternative, $0.129 per pre-funded warrant), after deducting the Placement Agent fee and estimated offering expenses payable by us,
and assuming no sale of any pre-funded warrants in this offering.
We
intend to use the net proceeds from the sale of the securities offered by us pursuant to this prospectus for our operations and for
other general corporate purposes, which may include, but are not limited to: i) payment on an accelerated basis of the $2,000,000
Senior Note issued in July 2024 (“July Senior Note”); ii) advancement of our clinical trial and preclinical studies;
iii) general working capital; iv) possible expansion of our relationship with Marizyme, Inc. under the Co-Development Agreement,
and v) possible future acquisitions.
|
Risk
Factors |
See
“Risk Factors” and other information appearing elsewhere in this prospectus and in the documents incorporated by reference
for a discussion of factors you should carefully consider before deciding whether to invest in our securities. |
|
|
Lock-up |
We
have agreed, subject to certain exceptions and without the approval of the Placement Agent and purchasers of our securities in this
offering, not to (1) issue, enter into any agreement to issue or announce the issuance or proposed issuance of, any shares of common
stock (or securities convertible into or exercisable for common stock) or file any registration statement, including any amendments
or supplements for a period of 180 days following the closing of the offering of the shares and (2) enter into a variable rate transaction
for a period of 180 days following the closing of this offering. Our directors and officers have agreed not to offer, sell, pledge
or otherwise transfer or dispose of any of our securities for 180 days following the closing of the offering of the shares. See “Plan
of Distribution” for more information. |
The
Nasdaq
Capital
Market listing symbol |
“QLGN.”
There is no established trading market for the pre-funded warrants and we do not expect a market to develop. In addition, we do not
intend to apply for the listing of the pre-funded warrants on any national securities exchange or other trading market. Without an
active trading market, the liquidity of the pre-funded warrants will be limited. |
The
number of shares of common stock to be outstanding after this offering is based on 9,613,899 shares of common stock outstanding on June
30, 2024 plus 2,684,082 shares issued from then through September 4, 2024, does not give effect to the shares of common stock issuable
upon exercise of the pre-funded warrants issued in this offering and excludes:
|
● |
337,286
shares of common stock issuable upon the exercise of options outstanding as of June 30, 2024, at a weighted average exercise price
of $38.92 per share; |
|
|
|
|
● |
4,741,957
shares of common stock issuable upon the exercise of warrants outstanding as of June 30, 2024, at a weighted average exercise price
of $0.48 per share; |
|
|
|
|
● |
4,218,978
shares of common stock issuable under the 2022 Debenture, the 2024 Alpha Debenture and the 2024 Chen Debenture (as defined below)
as of June 30, 2024, based on the conversion price of $0.26 per share as of June 30, 2024; |
|
|
|
|
● |
418,429
shares of common stock available for future issuance under the 2020 Plan (as defined below) as of June 30, 2024; and |
|
|
|
|
● |
100,000
shares of common stock issuable under the ESPP (as defined below), which has been temporarily suspended. |
Unless
otherwise indicated, all information in this prospectus gives effect to the 1-for-10 reverse stock split effectuated on November 23,
2022.
RISK
FACTORS
Investing
in our common stock and pre-funded warrants involves a high degree of risk. Before investing in our common stock and pre-funded warrants,
you should consider carefully the risks and uncertainties discussed under “Risk Factors” in our latest annual
report on Form 10-K and subsequent quarterly reports on Form 10-Q and current reports on Form 8-K, which are incorporated by reference
herein in their entirety. You should carefully consider each of the following risks, together with all other information set forth in
this prospectus and incorporated by reference herein, including our consolidated financial statements and the related notes, before deciding
to buy our common stock and pre-funded warrants. If any of the following risks actually occurs, our business could be harmed. In that
case, the trading price of our common stock could decline, and you may lose all or part of your investment.
This
prospectus and the documents incorporated by reference herein also contain forward-looking statements that involve risks and uncertainties.
Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors,
including the risks faced by us described below and elsewhere in this prospectus. See “Cautionary Note Regarding Forward-Looking
Statements” for information relating to these forward-looking statements.
Risks
Related to this Offering
The
price of our common stock may be highly volatile.
The
market price of our securities, like that of many other research and development public pharmaceutical and biotechnology companies, has
been highly volatile and the price of our common stock may be volatile in the future due to a wide variety of factors, including:
|
● |
announcements
by us or others of results of pre-clinical testing and clinical trials; |
|
● |
our
quarterly operating results and performance; |
|
● |
developments
or disputes concerning patents or other proprietary rights; |
|
● |
mergers
or acquisitions or disposition; |
|
● |
litigation
and government proceedings; |
|
● |
adverse
legislation or regulatory matters; |
|
● |
changes
in government regulations; |
|
● |
our
available working capital; |
|
● |
failure
of our common stock to continue to be listed or quoted on a national exchange or market system, such as Nasdaq or the New York Stock
Exchange |
|
● |
economic
and other external factors; and |
|
● |
general
market conditions. |
Since
January 1, 2024, the closing stock price of our common stock has fluctuated between a high of $0.58 per share to a low of $0.17 per share.
On September 4, 2024, the last reported sales price of our common stock on The Nasdaq Capital Market was $0.1836 per share. The fluctuation
in the price of our common stock has sometimes been unrelated or disproportionate to our operating performance. In addition, potential
dilutive effects of future sales of shares of common stock, options and warrants by us, as well as the potential sale of common stock
by the holders of options, warrants and the Debenture could have an adverse effect on the market price of our shares.
Any
failure to develop or maintain effective internal controls over financial reporting or difficulties encountered in implementing or improving
our internal controls over financial reporting could harm our operating results and prevent us from meeting our reporting obligations.
Effective
internal controls, particularly those related to financial reporting, are necessary for us to produce reliable financial reports. If
we cannot provide reliable financial reports, our business and operating results could be harmed, investors could lose confidence in
our reported financial information, and the trading price of our common stock could drop significantly. In addition, investors relying
upon this misinformation could make an uninformed investment decision, and we could be subject to sanctions or investigations by the
SEC or other regulatory authorities or to stockholder class action securities litigation.
In
connection with the audit of our financial statements as of and for the year ended December 31, 2022, our management determined that
the material weakness identified in connection with the 2021 audit had not been fully remediated and resulted in adjustments to the accounting
treatment related to convertible debt, the business combination and goodwill impairment during the 2022 audit, which resulted in the
late filing of the 2022 Annual Report.
In
connection with the audit of our financial statements as of and for the year ended December 31, 2023, our management identified material
weaknesses in our internal control over financial reporting related to limited accounting personnel and resources resulting in lack of
segregation of duties, and to the fact that we have not designed and implemented effective Information Technology General Controls related
to access controls to financing accounting systems.
We
intend to continue to take steps to enhance our internal controls, including implementing additional internal procedures and utilizing
well-established external consulting resources with experience and expertise in U.S. GAAP and public company accounting and reporting
requirements.
If
we are unable to remediate the material weaknesses and achieve and maintain effective internal control over financial reporting and effective
disclosure controls, our business could be adversely affected.
Our
failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock, which would limit the ability
of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market and negatively
impact our ability to raise capital.
If
we fail to satisfy the continued listing requirements of Nasdaq, Nasdaq may take steps to delist our common stock. Such a delisting would
likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when
you wish to do so.
We
have in the past been in noncompliance with other Nasdaq’s continued listing rules. For example, on November 23, 2022, we effected
a 1-for-10 reverse stock split of our outstanding common stock to cure our noncompliance, for a period of more than 30 consecutive business
days, with Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share.
In
addition, on April 20, 2023, we received a notification letter from the Listing Qualifications Department of Nasdaq indicating that,
as a result of our delay in filing our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, we were not in compliance
with the timely filing requirements for continued listing under Nasdaq Listing Rule 5250(c)(1). We regained compliance with this listing
rule by filing our Annual Report on Form 10-K on May 2, 2023.
On
May 23, 2024, the Company received written notice (the “Delist Notice”) from Nasdaq indicating the Company’s continued
non-compliance with the minimum bid price requirement, pursuant to Listing Rule 5550(b)(2).
On
November 20, 2023, the Company received a letter (the “Bid Price Deficiency Notice”) from Nasdaq notifying the Company that,
because the closing bid price for its common stock has been below $1.00 per share for 30 consecutive business days, it no longer complies
with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed
securities to maintain a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”), and Listing Rule 5810(c)(3)(A)
provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for a period of 30 consecutive business
days.
Additionally,
the Delist Notice states that since the Company had not yet filed its Form 10-Q for the period ended March 31, 2024, it no longer complied
with Listing Rule 5250(c)(1), and that this matter serves as a separate and additional basis for delisting the Company’s securities
from The Nasdaq Stock Market. We regained compliance with this listing rule by filing our Quarterly Report on Form 10-Q on July 2, 2024.
Further,
on November 21, 2023, the Company also received a letter from Nasdaq notifying the Company that it did not comply with the $2,500,000
minimum stockholders’ equity requirement, as set forth in Listing Rule 5550(a)(2) (the “Equity Rule”). On January 12,
2024, Nasdaq granted the Company an extension of time until May 21, 2024, to regain compliance with the Equity Rule. The Company has
not done so to date. As such, the Delist Notice states that this matter also serves as a separate and additional basis for delisting
the Company’s securities from The Nasdaq Stock Market.
On
July 16, 2024, the Company attended a hearing before the Nasdaq Hearings Panel (the “Panel”) regarding the Company’s
potential delisting from The Nasdaq Stock Market due to non-compliance with the Bid Price Rule and the shareholder equity requirement
pursuant to the Equity Rule. On August 2, 2024, the Company received the Panel decision which granted the Company until October 31, 2024
to regain compliance with the Bid Price Rule and the Equity Rule. If the Company is unable to regain compliance with the listing standards
of the Nasdaq Capital Market by October 31, 2024, the Company’s securities may be delisted from The Nasdaq Stock Market.
Losing
our Nasdaq listing would seriously harm us, by undermining our ability to raise capital and decreasing our attractiveness to possible
merger partners. Also, if our common stock were to be delisted from Nasdaq, it would have a material negative impact on the actual and
potential liquidity of our securities, as well as a material negative impact on our ability to raise future capital. If, for any reason,
Nasdaq were to delist our common stock from trading on its exchange and we were unable to obtain listing on another national securities
exchange or take action to restore our compliance with the Nasdaq continued listing requirements, a reduction in some or all of the following
may occur, each of which could have a material adverse effect on our stockholders:
|
● |
the
liquidity of our common stock; |
|
● |
the
market price of our common stock; |
|
● |
our
ability to obtain financing for the continuation of our operations; |
|
● |
the
number of institutional and general investors that will consider investing in our securities; |
|
● |
the
number of market makers in our common stock; |
|
● |
the
availability of information concerning the trading prices and volume of our common stock; and |
|
● |
the
number of broker-dealers willing to execute trades in shares of our common stock. |
Further,
we would likely become a “penny stock”, which would make trading of our common stock much more difficult.
Investors
will experience immediate and substantial dilution as a result of this offering and may suffer substantial dilution related to issued
stock warrants and options.
Investors
will incur immediate and substantial dilution as a result of this offering. After giving effect to this offering for aggregate gross
proceeds of $3.47 million, based on a public offering price of $0.13 per share, assuming no sale of pre-funded warrants in this
offering, and after deducting estimated offering expenses payable by us, investors in this offering can expect immediate dilution of
$0.18 per share of common stock. See “Dilution.”
As
of June 30, 2024, we had outstanding options to purchase 337,286 shares of common stock, at a weighted average exercise price of $38.92,
and warrants to purchase 4,741,957 shares of common stock, at a weighted average exercise price of $0.48.
In
addition, the 8% Senior Convertible Debenture which we issued on December 21, 2022 to Alpha Capital Anstalt (“Alpha”) in
the aggregate principal amount of $3,300,000 for a purchase price of $3,000,000 (“the 2022 Debenture”) is convertible, at
any time, and from time to time, at the holder’s option, into shares of our common stock, subject to the terms and conditions described
in the 2022 Debenture, and, subject to the terms and conditions described in the 2022 Debenture, we may elect to pay all or a portion
of the $110,000 Monthly Redemption Amount (as defined in the 2022 Debenture) and/or interest required by the 2022 Debenture in shares
of our common stock. On July 13, 2023, we obtained stockholder approval, for purposes of complying with Nasdaq Listing Rule 5635(d),
the issuance to Alpha of more than 20% of our issued and outstanding common stock pursuant to the terms and conditions of (a) the 2022
Debenture, and (b) our common stock purchase warrant dated December 22, 2022 issued to Alpha. After the first two monthly redemptions,
we may elect to pay all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal
to the lesser of (i) the then conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the 2022
Debenture) for the five consecutive trading days ending on the trading day that is immediately before the applicable Monthly Redemption
Date (such average, the “VWAP Price”), subject to the Equity Conditions (as defined in the 2022 Debenture) having been satisfied.
As of August 19, 2024, the remaining principal balance of $394,921 as of June 30, 2024 had been fully converted into 1,518,931 shares
of common stock at $0.26 per share, and there were no additional shares of common stock issuable under the 2022 Debenture.
In
addition, on April 12, 2024, we issued to Yi Hua Chen (“Chen”) an 8% Convertible Debenture (the “2024 Chen Debenture”)
in the aggregate principal amount of $1,100,000 for a purchase price of $1,000,000. The 2024 Chen Debenture matures no later than December
31, 2024, and is convertible, at any time, and from time to time, at Chen’s option, into shares of our common stock, at $0.6111
per share, subject to adjustment as described in the 2024 Chen Debenture. The 2024 Chen Debenture accrues interest on its outstanding
principal balance at the rate of 8% per annum, which interest is payable at maturity. Additionally, we issued a 5-year common stock purchase
warrant (the “2024 Chen Warrant”) to Chen to purchase up to 1,800,032 shares of our common stock at a price of $0.26 per
share, subject to adjustment as described in the 2024 Chen Warrant. Both the 2024 Chen Debenture and the 2024 Chen Warrant include a
beneficial ownership blocker of 9.99%, which may only be waived by Chen upon 61 days’ notice to us. Chen has executed a waiver
relinquishing its rights to receive prior notice of, and to participate in, this offering, and waived any provision of the 2024 Chen
Debenture that would otherwise result in the acceleration of the maturity date upon the completion of this offering to a date earlier
than December 31, 2024.
On
July 12, 2024, we issued a senior note to an institutional investor pursuant to a certain securities purchase agreement (“2024
Senior Note Agreement”) dated July 5, 2024, providing for the Company to issue to the investor at par a Senior Note with the following
characteristics and terms, against the investor’s loan of $2,000,000 in cash: (a) an original principal amount of $2,000,000, (b)
unsecured, (c) nonconvertible, (d) scheduled maturity date of July 8, 2025, (e) interest at the rate of 18% per annum, (f) requirement
for partial prepayments from a percentage of any future Company financings, and (g) otherwise, principal and interest on the senior note
not payable until maturity. Pursuant to the 2024 Senior Note Agreement, which also required resignations and appointments by the Company’s
Board of Directors, on July 5, 2024, Richard David, Sidney Emery, Kurt Kruger, and Ira Ritter each resigned from their respective positions
as members of the Company’s Board of Directors, effective July 12, 2024. The Company’s Board of Directors appointed Campbell
Becher, Robert Lim, and Cody Price to serve as directors on the Board, effective July 12, 2024.
Between
May 16, 2024 and July 12, 2024, we issued a total of 1,599,924 shares of common stock to Alpha who partially exercised a warrant for
shares of Company common stock at $0.26 per share.
We
also have an incentive compensation plan for our management, employees and consultants and an employee stock purchase plan, which has
been temporarily suspended. We have granted, and expect to grant in the future, options to purchase shares of our common stock to our
directors, employees and consultants. To the extent that options are exercised, our stockholders will experience dilution and our stock
price may decrease.
The
sale, or even the possibility of a sale, of the shares of common stock underlying these options, warrants and the 2022 Debenture (and
the 2024 Alpha Debenture, the 2024 Chen Debenture, the 2024 Alpha Warrant and the 2024 Chen Warrant) could have an adverse effect on
the market price for our securities or on our ability to obtain future financing.
If
the offering price of the common stock in this offering is lower than the current exercise price of certain of our outstanding warrants
with anti-dilution price protection provisions, then, as a result of this offering, such outstanding warrants will have their exercise
prices reduced to the offering price.
If
the offering price of the common stock in this offering is lower than $0.26 per share, which is the current lowest exercise price among
our outstanding warrants with anti-dilution price protection provisions, then, as a result of this offering, such warrants, which, before
this offering, are exercisable for up to 3,674,792 shares of our common stock, will have their exercise prices reduced to at least the
offering price per share in this offering. These warrants include: (i) warrants issued to Alpha and other holders in May 2020 which,
before this offering, are exercisable for up to 74,668 shares of our common stock, (ii) a common stock purchase warrant issued to Alpha
in December 2022 which, before this offering, is exercisable for up to 900,076 shares of our common stock (the “2022 Warrant”),
(iii) the 900,016-shares 2024 Alpha Warrant, and (iv) the 1,800,032-shares 2024 Chen Warrant.
If
the offering price of the common stock in this offering is lower than the current conversion price of the Debentures issued to Alpha
and Chen, then, as a result of this offering, such conversion price will be reduced to the offering price and therefore the number of
shares of common stock issuable upon full conversion of the Debentures will increase.
Since
the offering price of the common stock in this offering is lower than $0.6111 per share, which is the current conversion price of the
2024 Alpha Debenture and the 2024 Chen Debenture, then this offering could be considered a “Dilutive Issuance” (as defined
below) and the conversion price of the Debentures shall be reduced to equal the offering price per share in this offering. As a result,
the number of shares of common stock issuable upon full conversion of the Debentures will increase. The offering price of the common
stock in this offering is $0.13. Thus, the 2024 Alpha Debenture and the 2024 Chen Debenture will be convertible into approximately 12,692,308
shares of common stock instead of the 2,700,048 shares of common stock the 2024 Alpha Debenture and the 2024 Chen Debenture are convertible
into before this offering.
Our
shares of common stock are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell
shares to raise money or otherwise desire to liquidate their shares.
Our
common stock has from time to time been “thinly-traded,” meaning that the number of persons interested in purchasing our
common stock at or near ask prices at any given time may be relatively small or non-existent. This situation is attributable to a number
of factors, including the fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional
investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of
such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend
the purchase of our shares until such time as we become more seasoned and viable. As a consequence, there may be periods of several days
or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady
volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give stockholders
any assurance that a broader or more active public trading market for our common shares will develop or be sustained, or that current
trading levels will be sustained.
We
do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, our stockholders’ ability
to achieve a return on their investment will depend on appreciation in the price of our common stock.
We
have never declared or paid cash dividends on our common stock and do not anticipate paying any cash dividends to holders of our common
stock in the foreseeable future. Consequently, our stockholders must rely on sales of their common stock after price appreciation, which
may never occur, as the only way to realize any future gains on their investments. There is no guarantee that shares of our common stock
will appreciate in value or even maintain the price at which our stockholders have purchased their shares.
Upon
our dissolution, our stockholders may not recoup all or any portion of their investment.
Our
working capital deficiency, stockholders’ deficit, and recurring losses from operations raise substantial doubt about our ability
to continue as a going concern. As a result, our independent registered public accounting firm included an explanatory paragraph in its
report on our financial statements for the year ended December 31, 2023 with respect to this uncertainty. Our ability to continue as
a going concern will require us to obtain additional funding.
In
the event of our liquidation, dissolution or winding-up, whether voluntary or involuntary, the proceeds and/or our assets remaining after
giving effect to such transaction, and the payment of all of our debts and liabilities, including the Debentures, will be distributed
to the holders of common stock on a pro rata basis. There can be no assurance that we will have available assets to pay to the holders
of common stock, or any amounts, upon such a liquidation, dissolution or winding-up. In this event, our stockholders could lose some
or all of their investment.
Our
board of directors can, without stockholder approval, cause preferred stock to be issued on terms that adversely affect holders of our
common stock.
Under
our Amended and Restated Certificate of Incorporation (as amended, the “Certificate of Incorporation”), our board of directors
is authorized to issue up to 15,000,000 shares of preferred stock, of which none are issued and outstanding as of the date of this prospectus.
Also, our board of directors, without stockholder approval, may determine the price, rights, preferences, privileges and restrictions,
including voting rights, of those shares. If our board of directors causes shares of preferred stock to be issued, the rights of the
holders of our common stock would likely be subordinate to those of preferred holders and therefore could be adversely affected. Our
board of directors’ ability to determine the terms of preferred stock and to cause its issuance, while providing desirable flexibility
in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third
party to acquire a majority of our outstanding common stock. Preferred shares issued by our board of directors could include voting rights
or super voting rights, which could shift the ability to control the Company to the holders of the preferred stock. Preferred stock could
also have conversion rights into shares of our common stock at a discount to the market price of our common stock, which could negatively
affect the market for our common stock. In addition, preferred stock would have preference in the event of liquidation of the Company,
which means that the holders of preferred stock would be entitled to receive the net assets of the Company distributed in liquidation
before the holders of our common stock receive any distribution of the liquidated assets.
Our
management will have broad discretion over the use of the net proceeds from this offering and we may use the net proceeds in ways with
which you disagree, or which do not produce beneficial results.
We
currently intend to use the net proceeds from this offering for our operations and for other general corporate purposes, including, but
not limited to, our internal research and development programs, payment on an accelerated basis of the $2,000,000 Senior Note issued
in July 2024, possible strategic initiatives with Marizyme regarding DuraGraft, general working capital and possible future acquisitions
(see “Use of Proceeds”). We have not allocated specific amounts of the net proceeds from this offering for any of the foregoing
purposes. Accordingly, our management will have significant discretion and flexibility in applying the net proceeds of this offering.
You will be relying on the judgment of our management with regard to the use of these net proceeds, and you will not have the opportunity,
as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the net proceeds
will be invested in a way that does not yield a favorable, or any, return for us or our stockholders. The failure of our management to
use such funds effectively could have a material adverse effect on our business, financial condition, and results of operation.
This
is a best efforts offering; no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe
is required for our business.
The
Placement Agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering. The Placement
Agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar
amount of the securities. There is no required minimum number of securities that must be sold as a condition to completion of this offering.
Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, Placement
Agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth in this
prospectus. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received
by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to
pursue the business goals outlined in this prospectus. Thus, we may not raise the amount of capital we believe is required for our business
and may need to raise additional funds, which may not be available or available on terms acceptable to us. Despite this, any proceeds
from the sale of securities offered by us will be available for our immediate use, and because there is no escrow account and no minimum
offering amount in this offering, investors could be in a position where they have invested in us, but we are unable to fulfill our objectives
due to a lack of interest in this offering.
There
is no public market for the pre-funded warrants being offered in this offering.
There
is no established public trading market for the pre-funded warrants being offered in this offering, and we do not expect a market to
develop. In addition, we do not intend to apply to list the pre-funded warrants on any securities exchange or nationally recognized trading
system. Without an active market, the liquidity of the pre-funded warrants will be extremely limited.
Holders
of the pre-funded warrants will not have rights of holders of our shares of common stock until such pre-funded warrants are exercised.
The
pre-funded warrants in this offering do not confer any rights of share ownership on their holders, but rather merely represent the right
to acquire shares of our common stock at a fixed price. Until holders of pre-funded warrants acquire shares of our common stock upon
exercise of the pre-funded warrants, as applicable, holders of pre-funded warrants will have no rights with respect to our shares of
common stock underlying such pre-funded warrants.
If
we do not maintain a current and effective registration statement relating to the common stock issuable upon exercise of the pre-funded
warrants being offered in this offering, holders will be able to exercise such warrants on a “cashless” basis and we may
not receive any additional funds upon the exercise of such warrants.
If
we do not maintain a current and effective registration statement relating to the common stock issuable upon exercise of the pre-funded
warrants being offered in this offering, such warrants may be exercised by way of a “cashless” exercise, meaning that the
holder would not pay a cash purchase price upon exercise, but instead would receive upon such exercise the net number of shares of our
common stock determined according to the formula set forth in the warrant. Accordingly, we may not receive any additional funds upon
the exercise of such warrants.
Purchasers
who purchase our securities in this offering pursuant to a securities purchase agreement may have rights not available to purchasers
that purchase without the benefit of a securities purchase agreement.
In
addition to rights and remedies available to all purchasers in this offering under federal securities and state law, the purchasers that
enter into a securities purchase agreement will also be able to bring claims of breach of contract against us. The ability to pursue
a claim for breach of contract provides those investors with the means to enforce any covenants uniquely available to them under the
securities purchase agreement.
There
is no assurance that we and Marizyme will agree to any expanded relationship, or that any expanded relationship which is agreed to would
be favorable to us.
Under
the Co-Development Agreement with Marizyme, we were entitled to an exclusivity period (the “Exclusivity Period”) until May
31, 2024 for purposes of proposing and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft
business. The Exclusivity Period has ended, and we do not intend to expand the Exclusivity Period. The co-development relationship with
Marizyme could increase Funding Payments, a revised payback structure to us in respect of past or future Funding Payments, etc. However,
we and Marizyme have not reached and may not ever reach any such agreement for an expanded relationship.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the information incorporated herein by reference contain forward-looking statements by Qualigen Therapeutics, Inc. that
involve risks and uncertainties and reflect our judgment as of the date of this prospectus. These statements generally relate to future
events or our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain
words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” or “continue” or the negative of these words or other similar
terms or expressions that concern our expectations, strategy, plans or intentions. Such forward-looking statements may relate to, among
other things, potential future development, testing and launch of products and product candidates. Actual events or results may differ
from our expectations due to a number of factors.
These
forward-looking statements include, but are not limited to, statements about:
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our
ability to procure sufficient working capital to continue and complete the development, testing and launch of our prospective drug
products; |
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our
ability to successfully develop any drugs; |
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our
ability to progress our drug candidates through preclinical and clinical development; |
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our
ability to obtain the requisite regulatory approvals for our clinical trials and to begin and complete such trials according to any
projected timeline; |
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our
ability to complete enrollment in our clinical trials as contemplated by any projected timeline; |
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the
likelihood that future clinical trial data will be favorable or that such trials will confirm any improvements over other products
or lack negative impacts; |
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our
ability to successfully commercialize any drugs; |
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the
likelihood that patents will issue on our in-licensed patent applications; |
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our
ability to protect our intellectual property; and |
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our
ability to compete. |
By
their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare,
regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur
on longer or shorter timelines than anticipated. In light of the significant uncertainties in these forward-looking statements, you should
not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each
forward-looking statement contained in this prospectus, we caution you that forward-looking statements are not guarantees of future performance
and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate
may differ materially from the forward-looking statements contained in this prospectus. In addition, even if our results of operations,
financial condition and liquidity, and the development of the industry in which we operate, are consistent in some future periods with
the forward-looking statements contained in this prospectus, they may not be predictive of results or developments in other future periods.
Any forward-looking statement that we make in this prospectus speaks only as of the date of this prospectus, and we disclaim any intent
or obligation to update these forward-looking statements beyond the date of this prospectus, except as required by law. This caution
is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
In
addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any forward-looking statements.
Future
filings with the Securities and Exchange Commission (the “SEC”), future press releases and future oral or written statements
made by us or with our approval, which are not statements of historical fact, may also contain forward-looking statements. Because such
statements include risks and uncertainties, many of which are beyond our control, actual results may differ materially from those expressed
or implied by such forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we
undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they
are made.
You
should also consider carefully the statements under the section titled “Risk Factors” in this prospectus, and documents incorporated
herein by reference including the sections titled “Business,” “Risk Factors” and “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” incorporated by reference from our most recent Annual Report on
Form 10-K and in our Quarterly Reports on Form 10-Q, as well as any amendments thereto, filed with the SEC, which address additional
factors that could cause our actual results to differ from those set forth in the forward-looking statements and could materially and
adversely affect our business, operating results and financial condition. All subsequent written and oral forward-looking statements
attributable to us or persons acting on our behalf are expressly qualified in their entirety by the applicable cautionary statements.
USE
OF PROCEEDS
We
estimate that net proceeds from this offering will be approximately $3.1 million (based on a public offering price of $0.13 per share)
after deducting estimated Placement Agent fees and estimated offering expenses payable by us, and assuming no sale of any pre-funded
warrants in this offering.
We
intend to use the net proceeds from the sale of the securities offered by us pursuant to this prospectus for our operations and for other
general corporate purposes for advancement of our clinical trial and preclinical studies, payment on an accelerated basis of the $2,000,000
Senior Note issued in July 2024, possible expansion of our relationship with Marizyme regarding DuraGraft under the Co-Development Agreement,
general working capital and possible future acquisitions. We have not determined the amount of net proceeds to be used specifically for
such purposes and, as a result, management will retain broad discretion over the allocation of net proceeds. The occurrence of unforeseen
events or changed business conditions could result in the application of the net proceeds from this offering in a manner other than as
described in this prospectus. Pending their uses, we intend to invest the net proceeds of this offering in interest-bearing bank accounts
or in short-term, interest-bearing, investment-grade securities.
DIVIDEND
POLICY
We
have not paid cash dividends on our common stock, and we do not anticipate that we will declare or pay dividends on our common stock
in the foreseeable future. Payment of dividends, if any, is within the sole discretion of our board of directors and will depend, among
other factors, upon our earnings, capital requirements and our operating and financial condition. To the extent we have any earnings,
we likely will retain earnings to pay down debt, or expand corporate operations and not use such earnings to pay dividends.
CAPITALIZATION
The
following table sets forth our cash, total long-term liabilities and capitalization as of June 30, 2024 on:
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an
actual basis; and |
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on
an as adjusted basis, to give effect to this offering for aggregate gross proceeds of $3.47 million, based the offering price
of $0.13 per share of common stock and $0.129 per pre-funded warrant, , and after deducting the Placement Agent fees and other estimated
offering expenses payable by us. |
You
should read this capitalization table together with the section titled “Use of Proceeds” in this prospectus, and the section
titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated
financial statements and the related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023, and Form
10-Q for the quarter ended June 30, 2024 which are incorporated by reference in this prospectus.
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At June 30, 2024 | |
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Actual (unaudited) | | |
As Adjusted (unaudited) | |
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Cash | |
$ | 118,685 | | |
$ | 3,172,033 | |
Total Liabilities | |
| 4,812,273 | | |
| 4,812,273 | |
Stockholders’ equity: | |
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Qualigen Therapeutics, Inc. stockholders’ equity (deficit): | |
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Common stock, $0.001 par value; 225,000,000 shares authorized; 9,613,899 shares issued and outstanding as of June 30, 2024 | |
| 47,514 | | |
| 62,238 | |
Additional paid-in capital | |
| 116,086,316 | | |
| 119,124,940 | |
Accumulated other comprehensive income | |
| — | | |
| — | |
Accumulated deficit | |
| (120,411,693 | ) | |
| (120,411,693 | ) |
Total stockholders’ deficit | |
| (4,277,863 | ) | |
| (1,224,515 | ) |
Total capitalization | |
$ | 534,410 | | |
$ | 3,587,758 | |
The
number of shares of common stock to be outstanding after this offering set forth in the table above is based on 9,613,899 shares of common
stock outstanding on June 30, 2024, does not give effect to the shares of common stock issuable upon exercise of the pre-funded warrants
issued in this offering and excludes:
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337,286
shares of common stock issuable upon the exercise of options outstanding as of June 30, 2024, at a weighted average exercise price
of $38.92 per share; |
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4,741,957
shares of common stock issuable upon the exercise of warrants outstanding as of June 30, 2024, at a weighted average exercise price
of $0.48 per share; |
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4,218,978
shares of common stock issuable under the 2022 Debenture, the 2024 Alpha Debenture and the 2024 Chen Debenture as of June 30, 2024,
based on the conversion price of $0.26 per share as of June 30, 2024; |
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418,429
shares of common stock available for future issuance under the Company’s 2020 Stock Incentive Plan (the “2020 Plan”)
as of June 30, 2024; and |
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100,000
shares of common stock issuable under the Company’s 2021 Employee Stock Purchase Plan (the “ESPP”), which has been
temporarily suspended. |
DILUTION
Purchasers
of common stock or pre-funded warrants in this offering will experience immediate dilution to the extent of the difference between the
public offering price per share of common stock in this offering and the net tangible book value per share of common stock immediately
after this offering.
Our
net tangible book value as of June 30, 2024 was approximately $(4.3) million, or $(0.44) per share of common stock. Net tangible book
value per share is determined by dividing the net of total tangible assets less total liabilities, by the aggregate number of shares
of common stock outstanding as of June 30, 2024.
After
giving further effect to this offering for aggregate gross proceeds of $3.47 million, based on a public offering price of $0.13
per share, and after deducting the estimated offering expenses payable by us, our as adjusted net tangible book value as of June 30,
2024 would have been $(1,224,515) or $(0.05) per share of common stock. This represents an immediate increase in the net tangible
book value of $0.39 per share to our existing stockholders and an immediate dilution in net tangible book value of $0.18 per share to
new investors purchasing securities in the offering. The calculations set forth in this section only reflect direct shares and pre-funded
warrants.
The
table below illustrates this dilution on a per-share basis.
Public offering price per share of common stock | |
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$ | 0.13 | |
Net tangible book value per share as of June 30, 2024 | |
$ | (0.44 | ) | |
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Increase in net tangible book value per share attributable to existing stockholders | |
$ | 0.39 | | |
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As adjusted net tangible book value per share as of June 30, 2024, after giving effect to this offering | |
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$ | (0.05 | ) |
Dilution per share to new investors purchasing securities in this offering | |
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$ | 0.18 | |
The
above table excludes:
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337,286
shares of common stock issuable upon the exercise of options outstanding as of June 30, 2024, at a weighted average exercise price
of $38.92 per share; |
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4,741,957
shares of common stock issuable upon the exercise of warrants outstanding as of June 30, 2024, at a weighted average exercise price
of $0.48 per share; |
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4,218,978
shares of common stock issuable under the 2022 Debenture, the 2024 Alpha Debenture and the 2024 Chen Debenture as of June 30, 2024,
based on the conversion price of $0.26 per share as of June 30, 2024; |
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418,429
shares of common stock available for future issuance under the 2020 Plan as of June 30, 2024; and |
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100,000
shares of common stock issuable under the ESPP, which has been temporarily suspended. |
The
above table also excludes 2,541,931 shares issued from July 1, 2024 through August 19, 2024 from exercises of warrants listed above and
voluntary conversions of the 2022 Debenture into common stock.
To
the extent that options or warrants are exercised, new options are issued under our 2020 Plan, shares are issued under the 2024 Alpha
Debenture, the 2024 Chen Debenture, the 2024 Alpha Warrant or the 2024 Chen Warrant, or we issue additional shares of common stock in
the future, there may be further dilution to investors participating in this offering. In addition, we may choose to raise additional
capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or
future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these
securities could result in further dilution to our stockholders.
Because
there is no minimum offering amount required as a condition to the closing of this offering, the dilution per share to purchasers in
the offering may be more than that indicated above in the event that the actual number of shares sold, if any, is less than the maximum
number of shares of our common stock we are offering.
DESCRIPTION
OF CAPITAL STOCK
The
following description of the terms of our securities is not complete and is qualified in its entirety by reference to our Certificate
of Incorporation, and our amended and restated bylaws (the “Bylaws”), both of which are filed as exhibits to our Annual Report
on Form 10-K.
Under
our Certificate of Incorporation and Bylaws, we are authorized to issue 240,000,000 shares of capital stock, consisting of 225,000,000
shares of common stock, par value $0.001 per share, and 15,000,000 shares of preferred stock, $0.001 par value per share, including 7,000
shares that have been designated as Series Alpha Preferred Stock. As of September 4, 2024, there were 12,297,981 shares of our common
stock outstanding and no shares of our Series Alpha Preferred Stock outstanding.
Common
Stock
Pursuant
to the terms of our Certificate of Incorporation, the holders of common stock are entitled to one vote per share on all matters to be
voted upon by the stockholders, except on matters relating solely to terms of preferred stock. Subject to preferences that may be applicable
to any outstanding preferred stock, the holders of common stock will be entitled to receive ratably such dividends, if any, as may be
declared from time to time by our Board of Directors out of funds legally available therefor. In the event of liquidation, dissolution
or winding up, the stockholders will be entitled to share ratably in all assets remaining after payment of liabilities, subject to prior
distribution rights of preferred stock, if any, then outstanding. The holders of our common stock will have no preemptive or conversion
rights or other subscription rights. There will be no redemption or sinking fund provisions applicable to our common stock.
Preferred
Stock
Pursuant
to the terms of our Certificate of Incorporation, our Board of Directors has the authority to issue preferred stock in one or more classes
or series and to fix the designations, powers, preferences and rights, and the qualifications, limitations or restrictions thereof, including
dividend rights, conversion right, voting rights, terms of redemption, liquidation preferences and the number of shares constituting
any class or series, without further vote or action by the stockholders.
The
issuance of shares of preferred stock, or the issuance of rights to purchase such shares, may decrease the amount of earnings and assets
available for distribution to the holders of common stock, could adversely affect the rights and powers, including voting rights, of
the common stock, and could have the effect of delaying, deterring or preventing a change of control of us or an unsolicited acquisition
proposal.
Stock
Options
As
of September 4, 2024, we had outstanding options to acquire 336,996 shares of our common stock, having a weighted-average exercise price
of $38.94 per share.
Warrants
As
of September 4, 2024, we had outstanding warrants (including the 2022 Warrant, the 2024 Alpha Warrant and the 2024 Chen Warrant) to purchase
an aggregate of 3,700,212 shares of our common stock, having a weighted-average exercise price of $0.43 per share.
If
the offering price of the common stock in this offering is lower than $0.26 share, which is the current lowest exercise price among our
outstanding warrants with anti-dilution price protection provisions, as a result of this offering, certain of our outstanding warrants,
which are exercisable for up to 3,674,792 shares of our common stock, will have their exercise prices reduced to at least the offering
price per share in this offering. These warrants include: (i) warrants issued to Alpha and other holders in May 2020 which, before this
offering, are exercisable for up to 74,668 shares of our common stock, (ii) 900,076 shares remaining on the 2022 Warrant, (iii) the 900,016-shares
2024 Alpha Warrant, and (iv) the 1,800,032-shares 2024 Chen Warrant.
2024
Debenture - Alpha
On
February 27, 2024, upon our receipt of a cash purchase price payment of $500,000 (less expenses), we issued to Alpha an 8% Convertible
Debenture (the “2024 Alpha Debenture”) in the principal amount of $550,000. The 2024 Alpha Debenture matures no later than
December 31, 2024 and is convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the
Company, at $0.6111 per share, subject to adjustment as described in the 2024 Alpha Debenture. Except in respect of an Exempt Issuance,
the 2024 Alpha Debenture contains a “ratchet” antidilution provision, with an $0.1164 floor. Accordingly, if the offering
price of the common stock in this offering is lower than the current conversion price, then this offering could be considered a “Dilutive
Issuance” and the conversion price of the 2024 Alpha Debenture shall be reduced to equal the offering price per share in this offering.
The 2024 Alpha Debenture accrues interest on its outstanding principal balance at the rate of 8% per annum, payable at maturity. In connection
with this issuance, we also issued to Alpha the 2024 Alpha Warrant - a 5-year common stock purchase warrant to purchase (at $0.26 per
share) 900,016 shares of our common stock. We also granted to Alpha an option (the “2024 Option”), exercisable until July
1, 2024, to purchase from us additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of $1,100,000
(and with a proportional number of accompanying common stock warrants of like tenor, up to a total of 1,800,032 additional warrants).
On April 8, 2024, Alpha assigned the 2024 Option to Yi Hua Chen (“Chen”). Alpha has executed a waiver relinquishing its rights
to receive prior notice of, and to participate in, this offering, and waived any provision of the 2024 Alpha Debenture that would otherwise
result in the acceleration of the maturity date upon the completion of this offering to a date earlier than December 31, 2024.
2024
Debenture - Chen
On
April 11, 2024, Chen exercised the Alpha Option in full, and on April 12, 2024 Chen paid the Company a cash exercise/purchase price of
$1,000,000. Upon such payment, we issued to Chen an 8% Convertible Debenture (the “2024 Chen Debenture”) in the principal
amount of $1,100,000. The 2024 Chen Debenture matures no later than December 31, 2024 and is convertible, at any time, and from time
to time, at Chen’s option, into shares of common stock of the Company, at $0.6111 per share, subject to adjustment as described
in the 2024 Debenture. Except in respect of an Exempt Issuance, the 2024 Chen Debenture contains a “ratchet” antidilution
provision, with an $0.1164 floor. Accordingly, if the offering price of the common stock in this offering is lower than the current conversion
price, then this offering could be considered a “Dilutive Issuance” and the conversion price of the 2024 Chen Debenture shall
be reduced to equal the offering price per share in this offering. The 2024 Chen Debenture accrues interest on its outstanding principal
balance at the rate of 8% per annum, payable at maturity. Pursuant to the terms of the Alpha Option as exercised by Chen, on April 12,
2024 we also issued to Chen the 2024 Chen Warrant - a common stock purchase warrant, exercisable until February 27, 2029, to purchase
1,800,032 shares of our common stock at $0.26 per share. Chen has executed a waiver relinquishing its rights to receive prior notice
of, and to participate in, this offering, and waived any provision of the 2024 Chen Debenture that would otherwise result in the acceleration
of the maturity date upon the completion of this offering to a date earlier than December 31, 2024.
Registration
Rights
In
December 2022, pursuant to the terms of the 2022 Securities Purchase Agreement, we entered into a registration rights agreement with
Alpha (the “Registration Rights Agreement”), pursuant to which we agreed to file one or more registration statements, as
necessary, and to the extent permissible, to register under the Securities Act the resale of the remaining shares (underlying the 2022
Debenture and the 2022 Warrant) not otherwise registered under the Company’s registration statement on Form S-3 (File No. 333-266430).
The Registration Rights Agreement requires that the Company file, within 30 days after signing, a resale registration statement and use
commercially reasonable efforts to cause the resale registration statement to be declared effective by the SEC on or before the 60th
calendar day following the date of signing of the Registration Rights Agreement (or 120 days if such registration statement is
subject to full review by the SEC). We filed a resale registration statement on Form S-3 pursuant to the requirements of the Registration
Rights Agreement on December 2022 (File Number 333-269088), which registration statement was declared effective by the SEC on January
5, 2023. On September 1, 2023, we filed a Post-Effective Amendment No. 1 to Form S-3 on Form S-1 (File No. 333-269088), which Post-Effective
Amendment was declared effective by the SEC on September 7, 2023. On May 1, 2024, we filed a Post-Effective Amendment No. 2 to Form S-1
on Form S-3 (File No. 333-269088), which Post-Effective Amendment was declared effective by the SEC on May 2, 2024.
We
granted Alpha “piggyback” registration rights for the shares underlying the 2024 Alpha Debenture and the 2024 Alpha Warrant.
Similarly, Chen has “piggyback” registration rights for the shares underlying the 2024 Chen Debenture and the 2024 Chen Warrant.
Alpha and Chen have the contractual right (if not waived by them) to require us to, in the registration statement of which this Prospectus
is a part, register for resale up to all of such underlying shares.
Anti-Takeover
Effects of Delaware Law and Our Certificate of Incorporation and Bylaws
The
provisions of Delaware law and our Certificate of Incorporation and Bylaws could discourage or make it more difficult to accomplish a
proxy contest or other change in our management or the acquisition of control by a holder of a substantial amount of our voting stock.
It is possible that these provisions could make it more difficult to accomplish, or could deter, transactions that stockholders may otherwise
consider to be in their best interests or in our best interests. These provisions are intended to enhance the likelihood of continuity
and stability in the composition of our board of directors and in the policies formulated by the board of directors and to discourage
certain types of transactions that may involve an actual or threatened change of our control. These provisions are designed to reduce
our vulnerability to an unsolicited acquisition proposal and to discourage certain tactics that may be used in proxy fights. Such provisions
also may have the effect of preventing changes in our management.
Delaware
Statutory Business Combinations Provision. We are subject to the anti-takeover provisions of Section 203 of the Delaware General
Corporation Law (the “DGCL”). Section 203 prohibits a publicly-held Delaware corporation from engaging in a “business
combination” with an “interested stockholder” for a period of three years after the date of the transaction in which
the person became an interested stockholder, unless the business combination is, or the transaction in which the person became an interested
stockholder was, approved in a prescribed manner or another prescribed exception applies. For purposes of Section 203, a “business
combination” is defined broadly to include a merger, asset sale or other transaction resulting in a financial benefit to the interested
stockholder, and, subject to certain exceptions, an “interested stockholder” is a person who, together with his or her affiliates
and associates, owns, or within three years prior, did own, 15% or more of the corporation’s voting stock.
Election
and Removal of Directors. Except as may otherwise be provided by the DGCL, any director or the entire board of directors may be removed,
with or without cause, at an annual meeting or a special meeting called for that purpose, by the holders of a majority of the shares
then entitled to vote at an election of directors, provided a quorum is present. Vacancies on our board of directors resulting from the
removal of directors and newly created directorships resulting from any increase in the number of directors may be filled solely by the
affirmative vote of a majority of the remaining directors then in office (although less than a quorum) or by the sole remaining director.
This system of electing and removing directors may discourage a third party from making a tender offer or otherwise attempting to obtain
control of us, because it generally makes it more difficult for stockholders to replace a majority of our directors. Our Certificate
of Incorporation and Bylaws do not provide for cumulative voting in the election of directors.
Advance
Notice Provisions for Stockholder Proposals and Stockholder Nominations of Directors. Our Bylaws provide that, for nominations to
the board of directors or for other business to be properly brought by a stockholder before a meeting of stockholders, the stockholder
must first have given timely notice of the proposal in writing to our Secretary. For an annual meeting, a stockholder’s notice
generally must be delivered not less than 90 days or more than 120 days before the anniversary of the previous year’s annual meeting.
Special
Meetings of Stockholders. Special meetings of the stockholders may be called at any time only by the board of directors, the Chairman
of the board of directors, the Chief Executive Officer or the President, subject to the rights of the holders of any series of preferred
stock then outstanding.
Blank-Check
Preferred Stock. Our board of directors is authorized to issue, without stockholder approval, preferred stock, the rights of which
will be determined at the discretion of the board of directors and that, if issued, could operate as a “poison pill” to dilute
the stock ownership of a potential hostile acquirer to prevent an acquisition that our board of directors does not approve.
Transfer
Agent
The
transfer agent and registrar for our common stock is Equiniti Trust Company. Its address is P.O. Box 64945, Saint Paul, MN 55164-0945
and its telephone number is (800) 468-9716.
Listing
Our
common stock is listed on The Nasdaq Capital Market under the symbol “QLGN.”
DESCRIPTION
OF SECURITIES WE ARE OFFERING
Common
Stock
The
material terms and provisions of our common stock are described under the section titled “Description of Capital Stock” on
page 21.
Pre-Funded
Warrants
The
following summary of certain terms and conditions of the pre-funded warrants is not complete and is subject to, and qualified in its
entirety by, the provisions of pre-funded warrant, the form of which is filed as an exhibit to the registration statement of which this
prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of pre-funded warrant for
a complete description of the terms and conditions of the pre-funded warrants.
General
The
term “pre-funded” refers to the fact that the purchase price of the pre-funded warrants in this offering includes almost
the entire exercise price that will be paid under the pre-funded warrants, except for a nominal remaining exercise price of $0.001. The
purpose of the pre-funded warrants is to enable investors that may have restrictions on their ability to beneficially own more than 4.99%
(or, at the election of the holder, 9.99%) of our outstanding common stock following the consummation of this offering the opportunity
to invest capital into the Company without triggering their ownership restrictions, by receiving pre-funded warrants in lieu of shares
of our common stock which would result in such ownership of more than 4.99% (or, at the election of the holder, 9.99%), and receiving
the ability to exercise their option to purchase the shares underlying the pre-funded warrants at a nominal price at a later date.
Form
The
pre-funded warrants will be issued as individual warrant agreements to the investors. You should review the form of pre-funded warrant,
filed as an exhibit to the registration statement of which this prospectus forms a part, for a complete description of the terms and
conditions applicable to the pre-funded warrants.
Exercisability
The
pre-funded warrants are exercisable at any time after their original issuance and will be exercisable until exercised in full. The pre-funded
warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice
accompanied by payment in full by wire transfer or cashier’s check drawn on a United States bank for the number of shares of our
common stock purchased upon such exercise (except in the case of a cashless exercise as described below). A holder (together with its
affiliates) may not exercise any portion of the pre-funded warrant to the extent that the holder would own more than 4.99% (or, at the
election of the holder, 9.99%) of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior
notice from the holder to us, the holder may increase or decrease such beneficial ownership limitation, provided that the limitation
in no event exceeds 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as
such percentage ownership is determined in accordance with the terms of the pre-funded warrants. No fractional shares of common stock
will be issued in connection with the exercise of a pre-funded warrant. In lieu of fractional shares, we will pay the holder an amount
in cash equal to the fractional amount multiplied by the exercise price or round up to the next whole share of common stock.
Duration
and Exercise Price
The
exercise price per whole share of our common stock purchasable upon the exercise of the pre-funded warrants is $0.001 per share of common
stock. The pre-funded warrants will be immediately exercisable and may be exercised at any time until the pre-funded warrants are exercised
in full. The exercise price of the pre-funded warrants is subject to appropriate adjustment in the event of certain stock dividends and
distributions, stock splits, stock combinations, reclassifications or similar events affecting our common stock.
Cashless
Exercise
If,
at any time after the issuance of the pre-funded warrants, the holder exercises its pre-funded warrants and a registration statement
registering the issuance of the shares of common stock underlying the pre-funded warrants under the Securities Act is not then effective
(or the prospectus contained therein is not available for the issuance of shares of common stock underlying the pre-funded warrants),
then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise
price, the holder shall instead receive upon such exercise (either in whole or in part) only the net number of shares of common stock
determined according to a formula set forth in the pre-funded warrants. Notwithstanding anything to the contrary, in the event we do
not have or maintain an effective registration statement, there are no circumstances that would require us to make any cash payments
or net cash settle the pre-funded warrants to the holders.
Transferability
Subject
to applicable laws, the pre-funded warrants and all right thereunder are transferable, in whole or in part, at the option of the holder
upon surrender of the pre-funded warrant to us together with the appropriate instruments of transfer and funds sufficient to pay any
transfer taxes payable upon the making of such transfer.
Exchange
Listing
There
is no established trading market for the pre-funded warrants, and we do not plan on applying to list the pre-funded warrants on The Nasdaq
Capital Market any other national securities exchange or any other nationally recognized trading system.
Fundamental
Transactions
In
the event of a fundamental transaction, as described in the pre-funded warrants and generally including any reorganization, recapitalization
or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets,
our consolidation or merger with or into another person, the acquisition of 50% or more of our outstanding voting power of the common
equity, or any person or group becoming the beneficial owner of 50% or more of the voting power represented by our outstanding common
equity, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and amount
of securities, cash or other property that the holders would have received had they exercised the pre-funded warrants immediately before
such fundamental transaction without regard to any limitations on exercise contained in the pre-funded warrants.
Rights
as a Stockholder
Except
by virtue of such holder’s ownership of shares of our common stock, the holder of a pre-funded warrant does not have the rights
or privileges of a holder of our common stock, including any voting rights, until the holder exercises the pre-funded warrant.
PLAN
OF DISTRIBUTION
Univest
Securities, LLC has agreed to act as our exclusive placement agent in connection with this offering subject to the terms and conditions
of the placement agency agreement dated September 5, 2024. The Placement Agent is not purchasing or selling any of the securities offered
by this prospectus, nor is it required to arrange the purchase or sale of any specific number or dollar amount of securities but has
agreed to use its reasonable best efforts to arrange for the sale of all of the securities offered hereby. Therefore, we may not sell
the entire amount of securities offered pursuant to this prospectus. We will enter into a securities purchase agreement directly with
certain investors, at the investor’s option, who purchase our securities in this offering. Investors who do not enter into a securities
purchase agreement shall rely solely on this prospectus in connection with the purchase of our securities in this offering.
Alpha
and Chen have participation rights, under their Debentures, which (if not waived by them) would entitle them to purchase in this offering
up to all of the Securities.
We
will deliver the securities being issued to the investors upon receipt of such investor’s funds for the purchase of the securities
offered pursuant to this prospectus. We will deliver the securities being offered pursuant to this prospectus upon closing (or, if there
are multiple closings (which would in any event be upon with the same terms, and all of which closings would occur by no later than September
10, 2024) we will deliver such securities upon the applicable closing in which the particular investor participates). We expect this
offering to be completed not later than two (2) business days following the commencement of this offering and we will deliver all securities
to be issued in connection with this offering delivery versus payment (DVP)/receipt versus payment (RVP) upon receipt of investor funds
received by us. We expect to deliver the securities being offered pursuant to this prospectus on or about September 6, 2024.
We
have agreed to indemnify the Placement Agent and specified other persons against specified liabilities, including liabilities under the
Securities Act, and to contribute to payments the Placement Agent may be required to make in respect thereof.
Fees
and Expenses
We
have engaged Univest Securities, LLC as our exclusive placement agent in connection this offering. This offering is being conducted on
a “best efforts” basis and the Placement Agent has no obligation (nor does any placement agent syndicate member have any
obligation) to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of securities.
We have agreed to pay the Placement Agent (inclusive of any placement agent syndicate members) a cash fee equal to 3% of the gross proceeds
of the offering, and a number of common stock purchase warrants, of like tenor as the pre-funded warrants except that the exercise price
will be 120% of the sale price for common stock in this offering and the exercisability period will not begin until six months after
the date of this offering, equal to 3% of the number of shares of common stock and pre-funded warrants sold in this offering (the “Placement
Agent Warrants”). The Placement Agent Warrants are subject to a one hundred eighty (180) day lock-up period during which they will
not be exercisable and will expire five years after the Closing Date. Pursuant to FINRA Rule 5110(e)(1)(A), any Placement Agent compensation
consisting of securities will not be sold, transferred, assigned, pledged, or hypothecated, and will not be the subject of any hedging,
short sale, derivative, put, or call transaction that would result in the effective economic disposition of the securities for a period
of 180 days beginning on the date of commencement of sales of the public equity offering, except as provided in FINRA Rule 5110(e)(2).
We have agreed to pay the Placement Agent a fee based on the aggregate proceeds as set forth in the table below:
| |
Per Share | | |
Per Pre-Funded Warrant | | |
Total | |
Public offering price | |
$ | 0.13 | | |
$ | 0.129 | | |
$ | 3,470,585.55 | |
Placement Agent Fees | |
$ | 0.004 | | |
$ | 0.004 | | |
$ | 104,117.57 | |
Proceeds, before expenses, to us | |
$ | 0.126 | | |
$ | 0.125 | | |
$ | 3,366,467.98 | |
We
have also agreed to reimburse the Placement Agent at closing (or, if there are multiple closings (which would in any event be upon the
same terms, and all of which closings would occur by no later than September 10, 2024) at the last such closing) (i) for legal and other
expenses incurred by them in connection with the offering in an aggregate amount up to $125,000. We estimate the total expenses payable
by us for this offering, excluding the Placement Agent fees and expenses, will be approximately $100,000.
The
Placement Agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions
received by it and any profit realized on the resale of the shares sold by it while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act. As an underwriter, the Placement Agent would be required to comply with the requirements
of the Securities Act and the Exchange Act, including, without limitation, Rule 415(a)(4) under the Securities Act and Rule 10b-5 and
Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares by the Placement
Agent acting as principal. Under these rules and regulations, the Placement Agent:
|
● |
may
not engage in any stabilization activity in connection with our securities; and |
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● |
may
not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted
under the Exchange Act, until it has completed its participation in the distribution. |
Listing
Our
common stock is listed on The Nasdaq Capital Market under the trading symbol “QLGN.” We do not plan to list the pre-funded
warrants on the Nasdaq Capital Market or any other securities exchange or trading market.
Right
of First Refusal
We
have agreed to grant the Representative for the 18-month period following the closing of this offering, a right of first refusal to provide
investment banking services to us on an exclusive basis in all matters for which investment banking services are sought by us. In accordance
with FINRA Rule 5110(g)(6)(A)(i), such right of first refusal shall not have a duration of more than three years from the commencement
of sales of this offering or the termination date of the engagement between us and the underwriter.
Tail
Financing
Subject
to certain exceptions set forth in the Letter of Engagement dated as of April 12, 2024, issued by Univest to the Company (the “Letter
of Engagement”), if the Company terminates the Letter of Engagement and subsequently completes any public or private financing
(other than pursuant to the exercise or conversion of any derivative securities which were outstanding on April 12, 2024), at any time
during the eighteen (18) months after terminating the Letter of Engagement, with any investors contacted by Univest, then Univest shall
be entitled to receive the compensation set forth above unless the Company has a pre-existing and documented business relationship with
the respective investor.
Lock-Up
Agreements
Our
directors and officers have entered into lock-up agreements. Under these agreements, these individuals agreed, subject to specified exceptions,
not to sell or transfer any shares of common stock or securities convertible into, or exchangeable or exercisable for, common stock during
a period ending 180 days after the completion of this offering, without first obtaining the written consent of the Placement Agent. Specifically,
these individuals agreed, in part, subject to certain exceptions, not to:
|
● |
offer
for sale, sell, pledge, or otherwise transfer or dispose of (or enter into any transaction or device that is designed to, or could
be expected to, result in the transfer or disposition by any person at any time in the future of) any shares of common stock or securities
convertible into or exercisable or exchangeable for common stock; |
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enter
into any swap or other derivatives transaction that transfers to another, in whole or in part, any of the economic benefits or risks
of ownership of shares of common stock; or |
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make
any demand for or exercise any right or cause to be filed a registration statement, including any amendments thereto, with respect
to the registration of any of our securities. |
No
Sales of Similar Securities
We
have agreed, subject to certain exceptions, not to issue, enter into any agreement to issue or announce the issuance or proposed issuance
of, any shares of common stock (or securities convertible into or exercisable for common stock) or, subject to certain exceptions, file
any registration statement, including any amendments or supplements thereto (other than the prospectus supplement, registration statement
or amendment to the registration statement relating to the securities offered hereunder and a registration statement on Form S-8), until
90 days after the completion of this offering. We have also agreed not to enter into a variable rate transaction (as defined in the securities
purchase agreement) for 180 days after the completion of this offering.
Discretionary
Accounts
The
Placement Agent does not intend to confirm sales of the securities offered hereby to any accounts over which it has discretionary authority.
Other
Activities and Relationships
The
Placement Agent and certain of its affiliates are full service financial institutions engaged in various activities, which may include
securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment,
hedging, financing and brokerage activities. The Placement Agent and certain of its affiliates may in the future perform various commercial
and investment banking and financial advisory services for us and our affiliates, for which they would receive customary fees and expenses.
In
the ordinary course of their various business activities, the Placement Agent and certain of its affiliates may make or hold a broad
array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including
bank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involve
securities and/or instruments issued by us and our affiliates. If the Placement Agent or its affiliates have a lending relationship with
us, they routinely hedge their credit exposure to us consistent with their customary risk management policies. The Placement Agent and
its affiliates may hedge such exposure by entering into transactions that consist of either the purchase of credit default swaps or the
creation of short positions in our securities or the securities of our affiliates, including potentially the common stock offered hereby.
Any such short positions could adversely affect future trading prices of the common stock offered hereby. The Placement Agent and certain
of its affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or express
independent research views in respect of such securities or instruments and may at any time hold, or recommend to clients that they acquire,
long and/or short positions in such securities and instruments.
The
foregoing does not purport to be a complete statement of the terms and conditions of the placement agency agreement or the securities
purchase agreement, copies of which are attached to the registration statement of which this prospectus is a part. See “Where You
Can Find More Information.”
LEGAL
MATTERS
The
validity of the securities being offered will be passed upon for us by Sichenzia Ross Ference Carmel LLP, New York, New York. The Placement
Agent is being represented by Sullivan & Worcester LLP, New York, New York in connection with this offering.
EXPERTS
The
consolidated financial statements of Qualigen Therapeutics, Inc. as of December 31, 2023 and 2022 and for each of the two years in the
period ended December 31, 2023, incorporated in this prospectus by reference from the Company’s Annual Report on Form 10-K for
the year ended December 31, 2023 have been audited by Baker Tilly US, LLP, an independent registered public accounting firm, as stated
in their report thereon (which report includes an explanatory paragraph regarding the existence of substantial doubt about the Company’s
ability to continue as a going concern), incorporated herein by reference, and have been incorporated in this prospectus and registration
statement in reliance upon such report and upon the authority of such firm as experts in accounting and auditing.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to “incorporate by reference” into this prospectus the information we file with the SEC, which means that we
can disclose important information to you by referring you to those documents. Any information referenced this way is considered to be
part of this prospectus, and any information that we file later with the SEC will automatically update and, where applicable, supersede
this information. We incorporate by reference the following documents that we have filed with the SEC (other than, in each case, documents
or information deemed to have been furnished and not filed in accordance with the SEC’s rules):
|
(1) |
Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the SEC on April 8, 2024; |
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(2) |
Our
Periodic Report on Form 10-Q for the period ended March 31, 2024, as filed with the SEC on July 2, 2024 and Our Periodic Report on
Form 10-Q for the period ended June 30, 2024, as filed with SEC on August 14, 2024; |
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(3) |
Our
Current Reports on Form 8-K filed with the SEC on February 22, 2024, February 27, 2024, March 28, 2024, April 16, 2024, May 30, 2024,
July 11, 2024, July 15, 2024, July 15, 2024, July 18, 2024 and August 5, 2024; and |
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(4) |
the
description of our common stock, which is registered under Section 12 of the Exchange Act, in our registration statement on Form
8-A, filed with the SEC on June 15, 2015, as updated by Exhibit 4.9 to Amendment No. 1 to our Annual Report on Form 10-K for the
fiscal year ended December 31, 2022, filed on July 7, 2023. |
Additionally,
all documents filed by us with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after (i) the date of the initial
filing of the registration statement and before effectiveness of the registration statement, and (ii) the date of this prospectus and
before the termination or completion of any offering hereunder, shall be deemed to be incorporated by reference into this prospectus
from the respective dates of filing of such documents, except that we do not incorporate any document or portion of a document that is
“furnished” to the SEC, but not deemed “filed.”
We
undertake to provide without charge to each person (including any beneficial owner) who receives a copy of this prospectus, upon written
or oral request, a copy of all of the preceding documents that are incorporated by reference (other than exhibits, unless the exhibits
are specifically incorporated by reference into these documents). We will provide to each person, including any beneficial owner, to
whom a prospectus is delivered, a copy of any or all of the reports or documents that we incorporate by reference in this prospectus
contained in the registration statement (except exhibits to the documents that are not specifically incorporated by reference) at no
cost to you, by writing or calling us at: Qualigen Therapeutics. Inc., Attn: Corporate Secretary, 5857 Owens Avenue, Suite 300, Carlsbad,
California 92008, telephone number: (760) 452-8111.
Any
statements contained in a document incorporated by reference in this prospectus shall be deemed to be modified, superseded or replaced
for purposes of this prospectus to the extent that a statement contained in this prospectus (or in any other subsequently filed document
which also is incorporated by reference in this prospectus) modifies, supersedes or replaces such statement. Any statement so modified,
superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a part of this prospectus. Statements
contained in this prospectus and any document incorporated by reference as to the contents of any contract, agreement or other document
referred to are not necessarily complete, and in each instance, reference is made to the copy of the contract, agreement or other document
filed as an exhibit to the registration statement or any incorporated document, each statement being so qualified by this reference.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed with the SEC a registration statement on Form S-1 under the Securities Act for the shares of common stock and pre-funded warrants,
and the shares of common stock issuable upon exercise of the pre-funded warrants being offered by this prospectus. This prospectus, which
is part of the registration statement, does not contain all of the information included in the registration statement and the exhibits.
For further information about us and the common stock and pre-funded warrants offered by this prospectus, you should refer to the registration
statement and its exhibits. References in this prospectus to any of our contracts or other documents are not necessarily complete, and
you should refer to the exhibits attached to the registration statement for copies of the actual contract or document. Additionally,
we file annual, quarterly and current reports, proxy statements and other information with the SEC.
The
SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file
electronically with the SEC, including us, at http://www.sec.gov. We make available, free of charge, on our website at www.qlgntx.com,
our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports and statements
as soon as reasonably practicable after they are filed with the SEC. The contents of our and the SEC’s websites are not part of
this prospectus, and the reference to our and the SEC’s websites do not constitute incorporation by reference into this prospectus
of the information contained at those sites, other than documents we file with the SEC that are specifically incorporated by reference
into this prospectus.
PROSPECTUS
14,724,058
Shares of Common Stock
11,972,754
Pre-Funded Warrants to Purchase up to 11,972,754 Shares of Common Stock
11,972,754
Shares of Common Stock Underlying the Pre-Funded Warrants
Sole
Placement Agent
Univest
Securities, LLC
September
5, 2024
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