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
