Qualigen Therapeutics CEO Michael Poirier Provides Letter to Shareholders

Rhea-AI Summary

Qualigen Therapeutics (Nasdaq: QLGN) announced a shift to full control of its diagnostics business following the expiration of its agreement with Sekisui Diagnostics. This transition is expected to boost revenue and profit margins from its FastPack diagnostics system. The company is also advancing its therapeutic pipeline, notably developing QN-302 for pancreatic cancer, which has shown promise in preclinical studies. Qualigen aims to enhance shareholder value through strategic investments and by diversifying its offerings in diagnostics and therapeutics.

Positive

• Qualigen will regain 100% revenue from FastPack diagnostics after April 1, 2022.
• Projected increase in revenue and per-unit profit margins for diagnostics.
• Acquired exclusive rights to QN-302 for pancreatic cancer treatment, a significant advancement in the therapeutic pipeline.
• Strong preclinical results for QN-302 demonstrating anti-tumor activity.

Negative

• No guarantees that increased revenue and margins will materialize post-agreement expiration.
• Development timelines for therapeutic candidates may face delays or challenges.

CARLSBAD, Calif., Feb. 22, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation and diagnostics, today issues the following Letter to Shareholders:

To Our Valued Shareholders:

As we close out the second month of 2022, I am excited for what lies ahead for our company. The last 45 days have helped to realize the well-constructed strategy of Qualigen, and the next several months will continue to bring opportunities that will impact our company significantly.

Looking forward, we are confident that our diagnostics business is about to become stronger. The commercial agreement for FastPack with our partner Sekisui Diagnostics, LLC will soon expire and, I’m pleased to announce that Qualigen will begin to benefit from 100% of the revenue generated from those sales. As a result, we expect to see an increase in our revenue and per-unit profit margins from our flagship diagnostics business. We remain grateful to Sekisui for a strong collaboration and partnership over the last several years and are prepared for Qualigen to resume full commercial responsibility as of April 1, 2022.

Qualigen will assume all commercial activities and distribution management for its diagnostics unit in the U.S. and international markets. In anticipation of this change, we have been ramping up our diagnostics sales and marketing activities and production capabilities, without significantly impacting our spend. We are ensuring that the resources are firmly in place to facilitate a smooth transition. Once the license expires, we do not expect any interruption to our diagnostics sales and marketing engine as we will continue to leverage established partnerships with our various distributors in both the US and abroad.

We will continue to explore potential opportunities within the diagnostics arena to create new revenue streams to add shareholder value. This includes reviewing potential add-on technologies and products for acquisition or licensing that can further strengthen our diagnostics business. The last two years under the shadow of COVID-19 have demonstrated the importance of rapid, accurate and convenient diagnostics testing, areas where Qualigen has excelled over the last 20 years. As a company, we want to be prepared from a technological and operational standpoint for when the next global need arises and to position Qualigen for success in fast-growing market segments.

We believe that the focus on keeping Qualigen diversified, that is, continuing to build value from our commercialized medical diagnostics, while seeking to develop new and innovative treatments for rare and Orphan cancers, represents an advantageously differentiated business model. The expected increase in diagnostics revenue and per unit margin will allow us to continue to conduct our business and drive the development of our early-stage cancer therapeutic pipeline assets.

Our dual focus on diagnostics and therapeutics drove the decision to acquire exclusive rights to our new lead therapeutic G4-selective transcription inhibitor program, QN-302, from the University College London (UCL), a top ten worldwide academic institution, for the potential treatment of pancreatic cancer, and other potential indications. We are particularly pleased to be discussing this recent in-license from UCL for exclusive worldwide rights and the positive news we have already received around it during this time of year. February is Rare Disease Month, and February 28, 2022, Rare Disease Day. Thus, we find it fitting to launch our development efforts of QN-302 for pancreatic cancer during a time designed to raise additional awareness around devastating rare cancers and other rare diseases.

Pancreatic cancer is a rare disease. According to the American Cancer Society, each year an estimated 60,430 Americans are diagnosed with pancreatic cancer, with more than 48,220 dying from the disease each year? -- the highest mortality rate of all major cancers. Currently there are few viable treatment options for pancreatic cancer, including surgery, radiation therapy and chemotherapy, which may extend survival or relieve symptoms, but seldom produce a cure. Surgical removal of the tumor is possible in less than 20% of patients diagnosed with pancreatic cancer because detection is often in late stages and has spread beyond the pancreas. Adjuvant treatment with chemotherapy (and sometimes radiation) may lower the risk of recurrence. For advanced disease, chemotherapy (sometimes along with a targeted drug therapy) may lengthen survival.¹

For that reason, we are pleased about the opportunity to develop a potential new approach to treating pancreatic cancer. Professor Stephen Neidle, a globally recognized leader in this space, and his team at the UCL developed a portfolio of small molecules that target regions of cancer genes that have a disproportionately high number of G4s. Preclinical studies show that the investigational QN-302 selectively binds to G4s, forming a complex that may prevent the G4 structures from “unwinding” at the cancer cells’ key regulatory regions. In theory, by preventing such “unwinding,” QN-302 may inhibit transcription – which has already been seen in preclinical modeling through strong anti-tumor activity in multiple tumor types, including pancreatic cancer animal models - without apparent toxicity at proposed therapeutic doses. Further, preclinical studies suggest encouraging anti-tumor activity against chemotherapy-resistant tumors.

We were therefore thrilled to welcome Professor Neidle as a consultant to Qualigen as we prepare to initiate IND-enabling studies for QN-302. As we announced this month, Dr. Neidle will serve to help build scientific understanding regarding data results, including authorship and presentation to the scientific community. As announced last week, we are already off to a strong start with three abstracts accepted to the prestigious American Association for Cancer Research (AACR) conference in April, where Professor Neidle will present regarding QN-302. We look forward to sharing the data from these abstracts at the time of the AACR conference.

As we make progress on our lead therapeutic program QN-302, we continue to invest in our QN-247 and RAS-F pipeline programs. We remain cautiously optimistic by the therapeutic potential of these assets as their differentiated mechanisms fit well within our strategy to treat rare Orphan cancers like acute myeloid leukemia. To accomplish this, we are further strengthening our collaboration with the University of Louisville while working to identify cost-saving efficiencies within our third-party vendor networks. Our RAS-F platform will benefit from an operationally streamlined process to identify and advance promising leads for further preclinical development, and from these efforts we anticipate opportunities to present promising new data at future conferences.

We are off to a strong start for the year, with exciting new diagnostics opportunities and a clear path forward for our lead therapeutics program. We continue to develop our pipeline in Orphan oncology, including our QN-247 and RAS-F programs, and anticipate multiple reportable milestones throughout the year. As a priority, we will continue to carefully manage our cash in order to both maximize shareholder value and support business opportunities.

We are grateful to the many shareholders who have made the journey with us, and we look forward to successfully continuing that journey in the months and years to come, and to providing updates along the way.

Sincerely,
Michael Poirier
CEO
Qualigen Therapeutics

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for cancer, as well as maintaining and expanding its core FDA-cleared FastPack^® System, which has been used successfully in diagnostics for 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. QN-247 inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The compounds within Qualigen’s RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. Such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions.

For more information about Qualigen Therapeutics, Inc., please visit www.qualigeninc.com.

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 the development of therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance we will recognize an increase in revenue and per unit profit margin following the expiration of our commercial agreement with Sekisui Diagnostics, LLC; that the Company will successfully develop any drugs (including QN-302, QN-247 and RAS-F); that preclinical development of the Company's drugs (including QN-302, QN-247 and RAS-F, and the deprioritized infectious-disease drug candidate QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will receive the necessary regulatory approvals to 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 inlicensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, QN-247 and RAS-F, and QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available at www.sec.gov.

The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Relations:

David Kugelman
Atlanta Capital Partners, LLC
(404) 856-9157 or (866) 692-6847 Toll Free - U.S. & Canada
dk@atlcp.com

Tony Schor
Investor Awareness, Inc.
(847) 971-0922
tony@investorawareness.com

Media:

Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com

Source: Qualigen Therapeutics, Inc.

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¹ https://pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts/

FAQ

What does the press release from Qualigen Therapeutics (QLGN) announce?

The press release outlines Qualigen's transition to full control of its diagnostics business and advancements in its therapeutic pipeline, including QN-302.

When will Qualigen regain full commercial responsibility for its diagnostics?

Qualigen will regain full commercial responsibility for its diagnostics business on April 1, 2022.

What is QN-302 and its relevance in the press release?

QN-302 is a therapeutic candidate for pancreatic cancer, and its development was highlighted as a significant achievement for Qualigen.

How does Qualigen plan to increase shareholder value?

Qualigen aims to enhance shareholder value by regaining full revenue from diagnostics and advancing its therapeutic programs.

What are the expected impacts of the changes in Qualigen's diagnostics business?

The changes are expected to improve revenue and profit margins for Qualigen's diagnostics segment.