Qualigen Therapeutics, Inc. Reports Third Quarter 2022 Financial Results and Provides Corporate Update
Q3 2022 FastPack ® sales increased approximately 25% year-over-year
Company continues to execute on and advance core therapeutic programs
CARLSBAD, Calif., Nov. 15, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN Qualigen Therapeutics, Inc.), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces its financial results for the third quarter ended September 30, 2022, and provides an update on its therapeutic pipeline and other corporate developments.
Corporate and Financial Highlights For Q3 2022 and to Date:
Diagnostics Business
Sales of FastPack increased approximately 25% year-over-year from Q3 2021
NanoSynex development advances on track to hit important milestones in 2023
Therapeutics Pipeline
Encouraging preclinical in vivo and in vitro data presented at the National Cancer Institute’s Fourth RAS Initiative Symposium
Data underscoring QN-302’s potential safety, tolerability, and efficacy in pancreatic cancer presented at American Academy of Cancer Research’s (AACR) Pancreatic Cancer meeting
Scientific Advisory Board (SAB) of oncology experts for lead therapeutic program QN-302 held initial meeting
In vivo readout of QN-247 demonstrated robust efficacy and no safety signal in triple negative breast cancer model
Corporate
Shareholders approved reverse stock split to satisfy Nasdaq continued listing qualifications.
Michael Poirier, Qualigen’s Chairman and CEO commented, “We continue to execute on our business plan as we advance both our therapeutics pipeline and diagnostics business. We are pleased that our revenue from FastPack has increased substantially since we resumed full responsibility for the sales and marketing of FastPack from our former sales and marketing partner, Sekisui Diagnostics. In this sluggish market, these sales results year-over-year show the strength of our flagship diagnostics business, and we are looking forward to continued successful results.
“Within therapeutics, our preparations for an IND submission for our lead therapeutics program QN-302 are all on-track. Additionally, we are working diligently to advance our discovery program in RAS. A close look at the oncology market shows that RAS is garnering increased investment and attention as it now appears to be a viable approach to potentially treating various cancers. We have been making steady progress with our RAS program and believe it to be a vital component of our therapeutics pipeline. The validation we have received by both the National Cancer Institute and the American Association for Cancer Research (AACR) are early indicators of that progress and we look forward to providing further updates at the appropriate time. We are also encouraged by the positive QN-247 readout results and believe there are opportunities to assess which indications merit further development.
“Finally, we are pleased that our shareholders have authorized the reverse stock split to secure our continued listing on Nasdaq. In the meantime, we maintain our focus on execution of upcoming milestones and look forward to providing scientific and business updates as appropriate,” concluded Mr. Poirier.
Third Quarter Financial Highlights
Revenues for the three months ended September 30, 2022, were $1.4 million compared to approximately $1.2 million in the same quarter of the previous year. All revenues generated during the quarter were from product sales of diagnostics. Importantly, since assuming full responsibility for sales and marketing from Sekisui, year over year FastPack sales increased approximately 25%.
For the three months ended September 30, 2022, Qualigen reported a net loss of approximately $4.1 million, or $0.10 per share, compared to a net loss of approximately $3.0 million, or $0.10 per share, for the corresponding period in 2021.
Research and development costs include therapeutic and diagnostic research and product development costs. Research and development costs decreased from $2.1 million for the three months ended September 30, 2021 to $1.7 million for the three months ended September 30, 2022. Of the $1.7 million of research and development costs for the three months ended September 30, 2022, $0.9 million (56%) was attributable to therapeutics and $0.8 million (44%) was attributable to diagnostics. Of the $2.1 million of research and development costs for the three months ended September 30, 2021, $1.7 million (83%) was attributable to therapeutics and $0.4 million (17%) was attributable to diagnostics.
The decrease in therapeutics research and development costs during the three months ended September 30, 2022 compared to the three months ended September 30, 2021 was primarily due to an increase of $0.4 million in pre-clinical research costs for QN-302, which we acquired in January 2022, offset by a $0.5 million decrease in pre-clinical research costs related to the potential application of QN-165 for the treatment of COVID-19 (which has since been deprioritized to a non-core program), a decrease of $0.4 million in pre-clinical research costs for QN-247, a $0.1 million decrease in legal expenses and a $0.1 decrease in preclinical research costs for RAS.
The increase in diagnostics research and developments costs during the three months ended September 30, 2022 compared to the three months ended September 30, 2021 was due primarily to an increase of $0.5 million of research and development expenses related to NanoSynex, offset by a $0.1 million reduction in research and development expenses related to the supply agreement with Prediction Biosciences.
As of September 30, 2022, Qualigen Therapeutics had $6.6 million in cash. The Company believes its cash is sufficient to fund its anticipated operations into the third quarter of 2023.
About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack® System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. The investigational compounds within our RAS family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). In addition to our oncology drug pipeline, we have an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions.
For more information about Qualigen Therapeutics, Inc., please visit www.qualigeninc.com.
Forward-Looking Statements
This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's prospects and strategy for its diagnostics business and development of its therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that the Company will be able to continue to maintain its diagnostic sales and marketing engine without interruption following the expiration of its distribution agreement with Sekisui Diagnostics, compete with others in this industry or expand market demand and/or market share for its diagnostics products, nor can there be any assurance that the Company will be able to bring the NanoSynex diagnostics technology to market or successfully develop any drugs (including QN-302, RAS and QN-247); that preclinical development of the Company's drugs (including QN-302, RAS and QN-247, and the deprioritized infectious-disease drug candidate QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (or Fast Track designation or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's currently owned and in-licensed patents would prevent competition; or that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, RAS and QN-247, and QN-165). The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fail to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K, all of which are available at www.sec.gov.
The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
Source: Qualigen Therapeutics, Inc.
QUALIGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS
(Unaudited)
|
| For the Three Months Ended |
|
| For the Nine Months Ended |
| ||||||||||
|
| 2022 |
|
| 2021 |
|
| 2022 |
|
| 2021 |
| ||||
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Net product sales |
| $ | 1,441,065 |
|
| $ | 1,155,065 |
|
| $ | 3,593,628 |
|
| $ | 3,693,842 |
|
License revenue |
|
| — |
|
|
| — |
|
|
| — |
|
|
| 478,654 |
|
Total revenues |
|
| 1,441,065 |
|
|
| 1,155,065 |
|
|
| 3,593,628 |
|
|
| 4,172,496 |
|
EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
| 1,278,029 |
|
|
| 993,120 |
|
|
| 3,206,553 |
|
|
| 3,112,224 |
|
General and administrative |
|
| 2,618,021 |
|
|
| 2,756,323 |
|
|
| 8,177,627 |
|
|
| 8,582,361 |
|
Research and development |
|
| 1,688,096 |
|
|
| 2,083,315 |
|
|
| 5,059,067 |
|
|
| 10,091,155 |
|
Sales and marketing |
|
| 239,865 |
|
|
| 130,217 |
|
|
| 683,291 |
|
|
| 402,347 |
|
Total expenses |
|
| 5,824,011 |
|
|
| 5,962,975 |
|
|
| 17,126,538 |
|
|
| 22,188,087 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
| (4,382,946 | ) |
|
| (4,807,910 | ) |
|
| (13,532,910 | ) |
|
| (18,015,591 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME, NET |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on change in fair value of warrant liabilities |
|
| 321,300 |
|
|
| 1,763,936 |
|
|
| 1,019,342 |
|
|
| 4,299,000 |
|
Interest income, net |
|
| 4,631 |
|
|
| 6,801 |
|
|
| 15,763 |
|
|
| 36,863 |
|
Other income, net |
|
| 1,139 |
|
|
| 702 |
|
|
| 795 |
|
|
| 3,596 |
|
Total other income, net |
|
| 327,070 |
|
|
| 1,771,439 |
|
|
| 1,035,900 |
|
|
| 4,339,459 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE PROVISION FOR INCOME TAXES |
|
| (4,055,876 | ) |
|
| (3,036,471 | ) |
|
| (12,497,010 | ) |
|
| (13,676,132 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROVISION FOR INCOME TAXES |
|
| — |
|
|
| 1,011 |
|
|
| 6,173 |
|
|
| 2,146 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
| (4,055,876 | ) |
|
| (3,037,482 | ) |
|
| (12,503,183 | ) |
|
| (13,678,278 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interest |
|
| (230,767 | ) |
|
| — |
|
|
| (234,883 | ) |
|
| — |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to Qualigen Therapeutics, Inc. |
| $ | (3,825,109 | ) |
| $ | (3,037,482 | ) |
| $ | (12,268,300 | ) |
| $ | (13,678,278 | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
| $ | (0.10 | ) |
| $ | (0.10 | ) |
| $ | (0.33 | ) |
| $ | (0.48 | ) |
Weighted—average number of shares outstanding, basic and diluted |
|
| 39,444,058 |
|
|
| 29,026,211 |
|
|
| 37,154,623 |
|
|
| 28,683,972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
| $ | (4,055,876 | ) |
| $ | (3,037,482 | ) |
| $ | (12,503,183 | ) |
| $ | (13,678,278 | ) |
Foreign currency translation adjustment |
|
| 88,523 |
|
|
| — |
|
|
| 154,063 |
|
|
| - |
|
Other comprehensive loss |
|
| (3,967,353 | ) |
|
| (3,037,482 | ) |
|
| (12,349,120 | ) |
|
| (13,678,278 | ) |
Comprehensive loss attributable to noncontrolling interest |
|
| (230,767 | ) |
|
| — |
|
|
| (234,883 | ) |
|
| — |
|
Comprehensive loss attributable to Qualigen Therapeutics, Inc. |
| $ | (3,736,586 | ) |
| $ | (3,037,482 | ) |
| $ | (12,114,237 | ) |
| $ | (13,678,278 | ) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
QUALIGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
| September 30, |
| December 31, | ||||
|
| 2022 |
| 2021 | ||||
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash |
| $ | 6,618,141 |
|
| $ | 17,538,272 |
|
Accounts receivable, net |
|
| 603,291 |
|
|
| 822,351 |
|
Inventory, net |
|
| 1,481,524 |
|
|
| 1,055,878 |
|
Prepaid expenses and other current assets |
|
| 1,692,472 |
|
|
| 1,379,896 |
|
Total current assets |
|
| 10,395,428 |
|
|
| 20,796,397 |
|
Restricted cash |
|
| 5,624 |
|
|
| — |
|
Right-of-use assets |
|
| 1,479,618 |
|
|
| 1,645,568 |
|
Property and equipment, net |
|
| 311,531 |
|
|
| 204,216 |
|
Intangible assets, net |
|
| 5,852,074 |
|
|
| 171,190 |
|
Goodwill |
|
| 4,896,223 |
|
|
| — |
|
Other assets |
|
| 18,334 |
|
|
| 18,334 |
|
Total Assets |
| $ | 22,958,832 |
|
| $ | 22,835,705 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
| $ | 596,039 |
|
| $ | 886,224 |
|
Accrued expenses and other current liabilities |
|
| 1,471,327 |
|
|
| 1,793,901 |
|
R&D grant liability |
|
| 905,603 |
|
|
| — |
|
Deferred revenue, current portion |
|
| 102,640 |
|
|
| 135,063 |
|
Operating lease liability, current portion |
|
| 198,373 |
|
|
| 134,091 |
|
Short term debt-related party |
|
| 941,261 |
|
|
| — |
|
Warrant liabilities |
|
| 666,000 |
|
|
| 1,686,200 |
|
Total current liabilities |
|
| 4,881,243 |
|
|
| 4,635,479 |
|
Operating lease liability, net of current portion |
|
| 1,365,459 |
|
|
| 1,542,564 |
|
Deferred revenue, net of current portion |
|
| 60,521 |
|
|
| 92,928 |
|
Deferred tax liability |
|
| 736,000 |
|
|
| - |
|
Total liabilities |
|
| 7,043,223 |
|
|
| 6,270,971 |
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Qualigen Therapeutics, Inc. stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 225,000,000 shares authorized; 42,110,182 and 35,290,178 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively |
|
| 42,110 |
|
|
| 35,290 |
|
Additional paid-in capital |
|
| 108,967,248 |
|
|
| 101,274,073 |
|
Accumulated other comprehensive income |
|
| 154,063 |
|
|
| — |
|
Accumulated deficit |
|
| (97,012,929 | ) |
|
| (84,744,629 | ) |
Total Qualigen Therapeutics, Inc. stockholders’ equity |
|
| 12,150,492 |
|
|
| 16,564,734 |
|
Noncontrolling interest |
|
| 3,765,117 |
|
|
| — |
|
Total Stockholders’ Equity |
|
| 15,915,609 |
|
|
| 16,564,734 |
|
Total Liabilities & Stockholders’ Equity |
| $ | 22,958,832 |
|
| $ | 22,835,705 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
