CARLSBAD, Calif., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (“Qualigen” or “the Company,” Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today issued the following letter to its stockholders:
To our Valued Stockholders:
I am excited to update you on our significant accomplishments for 2022 and to review our priorities for the coming months. The year 2022 was one in which we faced significant macro-environmental headwinds, including supply chain shortages and higher interest rates affecting our industry. Despite this, we have remained focused on achieving our therapeutic pipeline and diagnostic business goals. I am very pleased that the team delivered on major milestones both within budget and timelines.
Advanced lead program QN-302 toward IND submission and Phase 1 clinical trials
In advancing our cancer therapeutics pipeline, our activities centered around our lead program, QN-302, a small molecule G-Quadruplex (G4) selective transcription inhibitor with strong binding affinity to G4s that are expressed in cancer cells. At the start of 2022, we in-licensed exclusive worldwide rights to QN-302 from the University College of London, one of the leading pharmacology institutions in the world, and we have made continuous progress developing this small molecule compound for the potential treatment of pancreatic cancer and other G4-targeted advanced solid tumors. Over the course of the year, we have kept you apprised of key IND-enabling activities on the path to achieve our most significant near-term milestone – becoming clinical stage by initiating a Phase 1 clinical trial in the second half of 2023.
At the end of December 2022, upon our request, we received Pre-IND feedback from the U.S. Food and Drug Administration (FDA). This feedback has been instructive in our activities to help us prepare our Investigational New Drug (IND) submission, which we remain on track to file with the FDA in the first half of 2023. Following clearance of the IND submission, we intend to initiate a Phase 1 clinical trial, for which we look forward to providing more detailed information at the appropriate time.
In the meantime, we are very pleased that QN-302 was granted Orphan Drug Designation (ODD) for the treatment of pancreatic cancer by the FDA just a couple of weeks ago.
We believe that the ODD designation serves as confirmation that our lead program has the potential to address the fourth deadliest cancer in the United States with high unmet medical need. The advantages to us of the ODD designation include a 25% tax credit for expenses incurred in the development of QN-302, the potential to qualify to compete for Office of Orphan Products Development research grants, and a waiver on the application fees of potentially $3.2 million (as of fiscal year 2023) for applications requiring covered clinical data.
We are encouraged by the strong body of research that we have built with our collaborators and partners regarding QN-302’s utility as a potential best-in-class G4 selective transcription inhibitor with ODD potential for multiple cancer indications. Over the past year, we presented data at major scientific conferences including the American Association of Cancer Research (AACR) on the design and structure of QN-302 and promising in vitro and in vivo efficacy and safety in models of target cancers, including G4-expressing tumors such as pancreatic cancer. Importantly, we also presented at AACR’s Specialty Pancreatic Cancer Conference on additional safety data as well as the potential to use a genetic biomarker, S100P, of which research will be built upon to target and monitor select patient groups in the clinic.
Lastly, we are focused on executing on our strategy to secure non-dilutive funding for various QN-302 development efforts. Upon execution of a potential agreement at a future time, we would ensure all derivative intellectual property be exclusively owned by Qualigen Therapeutics.
Expanded RAS discovery efforts to target KRAS G12D and G12C
In parallel with our QN-302 development, we continue to advance the efforts in our RAS therapeutic platform, with the goal of identifying a lead compound to enter IND-enabling studies. As part of these activities, we have been actively submitting data to scientific conferences for presentation and publication. Last May, two of our abstracts were featured in the American Society for Clinical Oncology’s (ASCO) Annual Meeting Abstract Book. Recently, in October 2022, our collaborator presented two posters on efficacy in two cancer types at the National Cancer Institute’s 4th Annual RAS Symposium, a gathering of worldwide RAS experts. Invitations to present data at these key scientific venues provided validation that our development approach has merit within the oncology research community.
As with QN-302, we believe that our RAS platform also has ODD potential for multiple indications of high unmet medical need. We look forward to informing you with more news as we achieve additional milestones.
Development partners sought for QN-247 program
In August 2022, we reported that QN-247, our nanoparticle-oligonucleotide conjugate program targeting nucleolin-expressing malignancies, demonstrated a robust efficacy signal and showed no adverse events or toxicities at the tested therapeutic dose in an animal model for Triple Negative Breast Cancer (TNBC), a rare, highly aggressive and difficult to treat form of breast cancer. Moreover, QN-247 demonstrated a favorable safety profile with stable body weights throughout the study. Qualigen believes the encouraging efficacy and safety results in TNBC animal model warrant further investigation. As a result, we are seeking partners to help advance this program into IND-enabling studies, as we focus our therapeutics resources on the development of QN-302 and our RAS platform.
NanoSynex Progressing Antimicrobial Susceptibility Testing platform
Leveraging our diagnostics know-how, in May 2022, we announced our majority investment in private Israeli diagnostics developer NanoSynex, which is developing an Antimicrobial Susceptibility Testing (AST) platform that aims to provide clinical laboratories with a rapid, accurate and personalized test for bacterial infections, with the goal of quickly matching the correct antibiotics to treat a patient’s particular infection. It is widely known that antibiotic misuse and overuse have given rise to antibiotic resistant bacteria, commonly known as superbugs, which the World Health Organization has called one of the top ten global public health threats facing humanity. NanoSynex’s AST platform is designed to enable better targeting of antibiotics for their most suitable uses to ultimately result in faster and more efficacious treatment, hence reducing hospital mortality and morbidity rates.
Based on our ongoing discussions with NanoSynex’s management, it is encouraging to see that they remain on track and within budget toward commercializing their proprietary AST. To that end, NanoSynex has already completed development of its latest system design, which is composed of disposable test cards, a benchtop reader and real-time data analysis software.
We continue to weather the storm of difficult markets in a challenging macro environment. Thanks to you, our valued stockholders, we were able to regain Nasdaq compliance in December 2022 from our reverse stock split.
We understand that it is imperative that we continually evaluate the allocation of our financial resources and exercise judicious stewardship in order to reach our development goals and create long-term value.
Austerity Measures
Accordingly, in January of this year, we implemented a range of austerity measures designed to extend our cash runway as we execute on our priorities. These measures included, but are not limited to, a reduction in force wherein 14% of all our staff were laid off, providing an estimated $1.1 million in annual savings along with temporary base salary reductions for our executive team. As a result of these changes, certain executive responsibilities were reassigned by expanding the role of our current President and Chief Strategy Officer, Amy Broidrick, to become President, Chief Strategy and Operating Officer effective as of February 16, 2023. As a result of these changes, the Company’s current cash balance is expected to fund operations into the third quarter of 2023, including the IND package for QN-302 and discovery efforts for a lead RAS candidate.
As we announced last week, Benedict Abugan has been promoted to Vice President, Diagnostics and Corporate Communications. Mr. Abugan has been with Qualigen for more than 20 years in a variety of roles with increasing responsibility across scientific and business functions. We are very pleased that he has accepted these additional duties, and look forward to realizing the benefits of his leadership.
We are off to a strong start for the year as we continue to achieve milestones on our exciting cancer therapeutics pipeline and diagnostics business and partnerships. We are on track to create stockholder value as we march down a clear path toward becoming a clinical stage therapeutics company in the near-term. While these times remain uncertain, we are very confident that Qualigen is moving in the right direction in executing our strategy and advancing our lead cancer therapeutic program toward the clinic and delivering value to our FastPack customers and stakeholders. We will continue to execute on our milestones that blaze the pathway forward and we believe that our prudent management of our cash reserves will help us to successfully weather this storm. We are grateful to our many stockholders who have loyally stood by us as we steadfastly execute on our long-range operating plan. We look forward to providing more updates as they develop, and to communicate with our valued stockholders and stakeholders along the way.
Sincerely,
Michael Poirier
Chief Executive Officer and Chairman
Qualigen Therapeutics
About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, while also commercializing diagnostics. 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 Qualigen’s 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 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, including statements related to the development of QN-302, including the anticipated timing for our IND application submission, and the Company’s other 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 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). The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available at www.sec.gov.
The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
Source: Qualigen Therapeutics, Inc.
