NeOnc Technologies Completes $18.5 Million Financing, Advances Phase II Clinical Trials for Enhanced Method of Delivering Novel Therapeutics to the Brain Under FDA Fast-Track Status

Rhea-AI Summary

NeOnc Technologies has completed an $18.5 million financing round, increasing its post-money valuation by 214% to approximately $220 million. This funding supports Phase I and II clinical trials of its NEO™ technology for brain cancer treatment, which has shown promising results in overcoming the blood-brain barrier. The financing includes $4.5 million in new equity investment and converts $14 million of debt to equity, eliminating all short-term debt. NeOnc's intellectual property portfolio comprises 135 patents, and the company has secured FDA Fast-Track and Orphan Drug statuses for its leading candidates, enhancing the therapeutic potential and market opportunities. The global CNS and brain tumor drug markets are projected to grow significantly, providing promising prospects for NeOnc's innovative therapies.

Positive

• Completed $18.5 million financing, raising post-money valuation to $220 million.
• Increased valuation by 214% from previous funding round.
• Eliminated $14 million in short-term debt through equity conversion.
• Secured FDA Fast-Track and Orphan Drug statuses for leading candidates.
• Promising Phase I and II clinical trial results for NEO™ technology.

Negative

• No notable negative aspects were identified in the press release.

Financial Analyst

The recent financing round of $18.5 million for NeOnc Technologies Holdings, Inc. marks a significant boost in the company's financial stability and growth prospects. The conversion of $14 million in debt to equity not only cleans up the balance sheet by eliminating short-term liabilities but also reflects strong investor confidence. The post-money valuation surged to $220 million, up by 214% from the previous funding round. This is a notable increase, possibly indicating positive reception of the company's technological advancements and market potential.

One noteworthy aspect is the issuance of Class A common stock at $12 per share, which sets a clear market value for the equity. The company's cumulative equity raised since inception now totals over $31 million and this financial health could support a listing on a national stock exchange, potentially broadening the investor base and improving liquidity for current shareholders.

From an investor's perspective, the successful raising of funds and conversion of debt to equity is generally positive, enhancing the company's balance sheet and offering a solid foundation for future development. However, the real test lies in the upcoming clinical trial outcomes and subsequent regulatory approvals, which will ultimately determine the sustainability and growth of the company's market value.

Medical Research Analyst

NeOnc Technologies' progress in Phase I and II clinical trials for treating brain cancer represents a significant milestone in the medical field. Overcoming the blood-brain barrier is one of the critical challenges in treating brain disorders and NeOnc's NEO™ platform technology presents a novel approach to this problem. The FDA Fast-Track designation for their lead drug candidates is particularly promising, as it can expedite the drug development process, potentially leading to earlier market entry.

The mention of NEO212™ as a potential treatment for both primary brain tumors and brain metastasis suggests that the drug could have broad applications, which is advantageous in terms of both market potential and patient impact. Furthermore, the OD status, which provides exclusive marketing rights and other incentives, enhances the company's competitive position significantly.

Nevertheless, the clinical trials' success is imperative. While early studies have indicated the viability of their drug delivery method, the scalability and real-world efficacy remain to be validated through these ongoing trials. Investors should keep a close watch on trial results and FDA communications for a clearer picture of the drug's approval prospects and market potential.

Market Research Analyst

The biotechnology sector, particularly companies developing treatments for central nervous system (CNS) disorders, holds substantial growth potential. NeOnc’s targeted approach to improving existing brain cancer treatments through their NEO™ platform is well-positioned within this expanding market. With the global CNS treatment market projected to grow to $166.5 billion by 2028 and the brain tumor drug market expected to reach $3.7 billion by 2030, NeOnc's innovations could capture significant market share if clinical trials are successful.

The company's strategic research partnerships, extensive patent portfolio and the acquisition of FDA Fast-Track and Orphan Drug statuses are strategic advantages that could accelerate both market entry and adoption. However, competition in the biotech space is intense and maintaining a competitive edge will require continuous innovation and successful clinical outcomes.

From a market perspective, NeOnc’s advancements hold promise, but investors should be mindful of the competitive landscape and the inherent risks in biotech investments, particularly those in the clinical trial stages. Monitoring the progression of their trials and subsequent market activities will provide further guidance on the company's growth trajectory.

• New investment and debt conversion by new and existing investors sets company’s post-money valuation at approximately $220 million, up 214% from previous funding round.
  
• Financing supports further expansion of NeOnc’s NEO™ platform technology that has produced a patent portfolio of novel drug candidates and delivery methods for more effectively passing the blood brain barrier.
• Two Phase II and one Phase I clinical studies advance after several published studies indicate NEO™ drug viability as a delivery vehicle for chemotherapeutics and ability to beneficially effect brain cancer treatment.
  

WESTLAKE VILLAGE, Calif., June 26, 2024 (GLOBE NEWSWIRE) --  NeOnc Technologies Holdings, Inc., a clinical-stage medical biotechnology company, has completed a $18.5 million financing to support the ongoing development and Phase I and II clinical studies of its novel drug and delivery methods designed to address the persistent challenges with overcoming the blood-brain barrier.

The financing secured $4.5 million in new equity investment from existing and new investors. It also converted to equity all outstanding notes held by lenders along with accounts payable to University of Southern California (USC) totaling $14 million, thereby eliminating all outstanding short-term debt. The transactions were completed with the issuance of Class A common stock priced at $12 per share.

The financing sets NeOnc’s post-money valuation at approximately $220 million, an increase of 214% from the previous $10 million equity funding the company announced in February of last year. It brings the total amount of committed equity since inception to more than $31 million.

The new financing supports further development and expansion of NeOnc’s NEO™ platform technology that has generated an extensive patent portfolio. Secured under exclusive worldwide rights from USC, NeOnc’s intellectual property portfolio includes 135 U.S. and international patents issued and patents pending.

The company believes the funding also provides the financial and net equity requirements for a potential direct listing on a national stock exchange.

“We believe this latest funding round and debt conversion demonstrates the strong confidence in our technology and future growth prospects expressed by both new and existing investors, as well as by our strategic research partners at USC,” stated NeOnc executive chairman, Amir Heshmatpour. “It underscores our commitment to fortifying our financial position as we complete our current clinical trials. It also opens the door to a number of options we now enjoy for accessing the capital markets that would be most favorable to our investors and invested management team.”

According to NeOnc’s founder, CEO and CSO, Thomas Chen, M.D., Ph.D.: “Most importantly, the funding supports our mission of improving and extending the lives of brain cancer patients by developing therapies that maximize the effectiveness and delivery of current standard-of-care drugs for brain cancer.”

Dr. Chen is a widely respected neurosurgery professor and medical expert who brings to NeOnc more than 30 years of medical and clinic research experience. A board-certified neurosurgeon, he is also currently the director of Surgical Neuro-Oncology at USC. He was recognized last year for his achievements by the American Health Council with its coveted Best in Medicine Award.

NeOnc’s proprietary biotechnology breakthroughs are the result of more than a decade of research and development by Dr. Chen and his accomplished medical and scientific teams. Dr. Chen has been leading the company’s Phase I and II clinical trials.

Metastases to the brain are the most common brain tumors in adults and this develops in nearly 30% of patients with solid tumors. Traditional cytotoxic drugs have had a limited role in the management of these cancers and no standard systemic therapy exists.

“We believe one of our lead drug candidates, NEO212™, could have a meaningful impact on solid tumor patients who develop uncontrolled brain metastasis and who are often excluded from traditional clinical trials,” noted Dr. Chen. “We also believe that NEO212 may have the potential to treat primary brain tumors as well as potentially work with systemic therapy to improve outcomes in patients who develop brain metastasis.”

By enabling greater penetration of the blood-brain barrier, Dr. Chen believes the company’s NEO technology can turn existing FDA-approved drugs into more effective treatments across a full range of central nervous system (CNS) disorders. The company is currently developing several additional proprietary chemotherapy agents that have demonstrated positive effects in laboratory tests on other various types of cancers.

NeOnc has secured FDA Fast-Track status for its leading drug candidates that supports its clinical trials. FDA grants Fast-Track status when a drug is shown to treat a serious condition and provides an unmet medical need or therapy that may be potentially better than other available therapies. The criteria includes if the drug will impact survival and day-to-day functioning, or if left untreated, the disease will progress from a less severe condition to a more serious one.

The drug must also show superior effectiveness, significant decrease in serious side effects and the ability to improve the diagnosis of a serious condition. Additionally, it must demonstrate a decrease in clinically significant toxicity over available therapies, and an ability to address emerging or anticipated public health needs.

NeOnc has also secured the FDA’s classification as an Orphan Drug (OD). OD status is granted by the FDA to a substance that shows promise in treating, preventing or diagnosing an “orphan disease;” that is, diseases that currently affect less than 200,000 people. OD status provides a seven-year window of exclusive marketing rights, fee reductions, and additional tax incentives. The FDA gathers and shares information from Patient-Focused Drug Development (PFDD) meetings which companies like NeOnc can use in its drug development.

OD status also provides a more streamlined clinical trial process, including not having to perform Phase I safety studies, binding, placebo, and randomization criteria. Once sufficient effectiveness and safety data is shown, a New Drug Application (NDA) can be submitted for a Fast-Track review by the FDA.

“In consultation with the FDA under OD and Fast-Track status, we expect to collect sufficient data that demonstrates the important therapeutic value of our lead drug candidates,” added Dr. Chen. “We believe our novel intranasal delivery approach makes a study in a pediatric population, in particular, easier than other methods. Radiation and chemotherapy for children with high-grade gliomas is complex, time consuming and prognosis remains poor. All this underscores the importance of developing effective therapies that are less invasive and more tolerant for pediatric and other challenged populations.”

The NEO drug development platform addresses a global CNS treatment market that is projected to grow at a 9.4% CAGR to $166.5 billion by 2028. The global brain tumor drug market is projected to expand at a 10.2% CAGR to reach $3.7 billion by 2030.

Driving this growth is an increasing incidence of such diseases with the aging population. However, radiation therapy still accounts for 38% of the brain cancer treatment market, with drug treatment remaining second to radiation therapy mostly due to current inefficiencies of drug delivery.

About NeOnc Technologies Holdings
NeOnc Technologies is a privately held clinical stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood-brain barrier.

The company’s NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials, and are advancing under FDA Fast-Track and Investigational New Drug (IND) status.

The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.

For more about NeOnc and its pioneering technology, visit neonctech.com.  
  
Important Cautions Regarding Forward-Looking Statements 
All statements other than statements of historical facts included in this press release are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). Generally, such forward-looking statements include statements regarding our expectations, possible or assumed future actions, business strategies, events, or results of operations, including statements regarding our expectations or predictions or future financial or business performance or conditions and those statements that use forward-looking words such as "projected," "expect," "possibility" and "anticipate," or similar expressions. The achievement or success of the matters covered by such forward-looking statements involve significant risks, uncertainties, and assumptions. Actual results could differ materially from current projections or implied results. 

NeOnc Technologies Holding, Inc. (the "Company") cautions that statements and assumptions made in this news release constitute forward-looking statements without guaranteeing future performance. Forward-looking statements are based on estimates and opinions of management at the time statements are made. The information set forth herein speaks only as of the date hereof. The Company and its management are under no obligation, and expressly disclaim any obligation, to update, alter, or otherwise revise any forward-looking statements following the date of this news release, whether because of new information, future events, or otherwise, except as required by law. 

NeOnc Company Contact: 
Patrick Walters, COO 
NeOnc Technologies Holdings, Inc. 
Email Contact 

NeOnc Investor Relations: 
Ron Both or Grant Stude
CMA Investor Relations 
Tel (949) 432-7566 
Email Contact 

NeOnc Media Contact: 
Tim Randall 
CMA Media Relations 
Tel (949) 432-7572 
Email Contact 

FAQ

What recent funding did NeOnc Technologies secure?

NeOnc Technologies secured $18.5 million in recent financing.

How has NeOnc Technologies' valuation changed after the recent funding?

NeOnc Technologies' post-money valuation increased by 214% to approximately $220 million.

What phases of clinical trials is NeOnc Technologies advancing with the new funding?

NeOnc Technologies is advancing its Phase I and II clinical trials with the new funding.

What is NeOnc Technologies' approach to overcoming the blood-brain barrier?

NeOnc Technologies uses its NEO™ platform technology to effectively deliver therapeutics across the blood-brain barrier.

Which FDA statuses has NeOnc Technologies secured for its leading candidates?

NeOnc Technologies has secured FDA Fast-Track and Orphan Drug statuses for its leading candidates.

What is the market outlook for NeOnc Technologies' treatments?

The global CNS treatment market and brain tumor drug market are projected to grow significantly, providing promising prospects for NeOnc's treatments.