1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Capital Structure
3. Valuation
Discussion
Symbol
NUOX
Sector
Health Care
Subsector
Pharmaceuticals
Offer Range
—
Shares Offered
2.86M
Shares Outstanding Pre-IPO
13.43M
16.29M
$149.9M
17.6%
Implied Upside vs Midpoint
Description
We are a clinical-stage biopharmaceutical company developing innovative oxygen therapeutic solutions for the treatment of diseases where hypoxia, or lack of oxygen, plays a critical role. Our product candidate is NanO2, the API of which is dodecafluoropentane. NanO2™ is administered intravenously as an emulsified liquid, containing nano-sized droplets that after entering the body, due to the human body temperature, convert to a gas, which enables them to deliver more oxygen than when in the liquid state. Due to the fact that the size of the NanO2 particle is approximately 30 times smaller in diameter than a red blood cell, the NanO2 particle can partition into tissue, deliver oxygen and further facilitate oxygen transfer from red blood cell to tissue. The focus of our clinical research and development to date has been on the administration of NanO2 to treat acute ischemic stroke, GBM, ARDS, and sickle cell anemia. In each of these diseases or conditions, lack of oxygen plays a critical role in either weakening the effectiveness of standard treatment or directly causing mortality or morbidity. Stroke patients experience reduced blood flow to the brain, which results in hypoxia and causes localized brain death. NanO2 is designed to maintain the oxygenation of the brain tissue until blood flow is restored. ARDS is a respiratory condition in which patients’ lungs are compromised, and they cannot imbibe enough oxygen through normal inhalation. Radiation therapy, a common treatment of solid tumor cancers such as GBM, relies on oxygen to generate oxygen free radicals to kill tumor cells. However, most tumors are hypoxic or low oxygen, which makes radiation therapy less effective. NanO2 is being developed as a radiation therapy sensitizer providing an oxygenate supplement to facilitate oxygen free radical generation. NanO2 has been administered in patients with acute ischemic stroke and GBM in two separate completed Phase I/IIa human clinical trials. The FDA has allowed Phase IIb human clinical trials for NanO2 in both stroke and GBM. NanO2 received orphan drug designation status for the treatment of GBM in 2015 and sickle cell anemia in 2016. The granting of an orphan drug designation does not shorten the duration of the regulatory review and approval process nor does it guarantee regulatory approval. The first applicant of an NDA to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to seven-year exclusive marketing period in the United States for that product for that indication. At this time, no pharmaceutical treatments have been approved for the treatment of hypoxia of tissues affected by acute ischemic stroke, GBM or ARDS. Multiple neuroprotective agents for the treatment of stroke have failed clinical trials. Similarly, oxygen therapy to treat tissue hypoxia, such as in cancerous tumors or ARDS, is also lacking or very limited in efficacy. The low oxygenation of tissues affected by acute ischemic stroke, GBM and ARDS are believed to contribute to the associated morbidities and mortalities of these diseases or conditions. By targeting and treating the low oxygenation of tissues affected by acute ischemic stroke, GBM and ARDS, we believe that our therapy addresses an important and largely unmet medical need using a non-surgical, non-invasive treatment that has the potential to significantly improve a patient’s quality of life. We have completed an open-label Phase Ib/IIa human clinical trial of NanO2 for the treatment of GBM in 11 patients in Australia, and a randomized, placebo-controlled Phase Ib/IIa clinical trial of NanO2 in the United States for the treatment of acute ischemic stroke in 24 patients. We have completed enrollment and treated 93 patients in a Phase IIb clinical trial of NanO2 in the United States for the treatment of GBM and are now in the follow up period. This trial has been partially funded by the National Cancer Institute. The University of Glasgow has commenced an investigator initiated Phase IIb clinical trial administering NanO2 that we supply to stroke patients in the United Kingdom. To date, seventeen (17) patients have been treated. In the second quarter of 2025, we also commenced dosing patients in a Phase Ib trial administering NanO2 to respiratory distress patients in Canada, which is expected to be followed by a Phase II clinical trial for ARDS patients. Health Canada has already agreed to allow the Phase II clinical trial to be conducted. To date, the first and second cohorts of this Phase Ib trial have been completed, and a total of twelve (12) patients have been treated. In April 2026, we announced positive preliminary results from the second cohort, with the results demonstrating stronger oxygenation signals with dose escalation. Our intention is to use the net proceeds from this offering to complete all three trials, as well as to conduct our planned Phase II ARDS trial, and to commence preparation for a pivotal Phase III GBM trial. We have also received allowance to commence a prospective, randomized, double-blind, placebo controlled Phase II clinical trial of NanO2 in the United States for the treatment of patients with high-grade glioma. In addition, an IND has been allowed by the FDA, for a phase 2 trial in MI. We have safety data from the two separate completed Phase Ib/IIa human clinical trials of NanO2 as well as safety data from our Phase IIb GBM clinical trial, the investigator sponsored Phase IIb stroke trial, and our Phase Ib respiratory distress trial. The two completed Phase Ib/IIa human clinical trials enrolled a small number of patients and may not be representative of a larger trial population. In the Phase Ib/IIa stroke trial, there were eight (8) SAEs that occurred in four (4) patients. None of the SAEs were determined to be related to NanO2. These eight (8) SAEs included: abdominal pain, cerebrovascular accident, confusional state, depression, cardiac pacemaker replacement, pneumonia, and migraine. In the Phase Ib/IIa GBM trial, there were a total of nine (9) SAEs, none of which were unexpected. These nine (9) SAEs occurred in five (5) patients. These nine (9) SAEs included: atypical pneumonia, radiation necrosis, motor dysfunction, pyrexia, platelet count decrease, and syncope. Out of the nine (9) SAEs, six (6) SAEs that occurred in three (3) patients were determined to be unrelated or unlikely related to NanO2, which included atypical pneumonia, pyrexia, and syncope. Three (3) SAEs that occurred in three (3) patients were determined to be possibly or probably related to NanO2, consisting of radiation necrosis, motor dysfunction, and platelet count decrease. In the ongoing Phase IIb GBM trial, as of July 6, 2026, there have been forty-nine (49) SAEs that occurred in twenty-five (25) patients. These SAEs consist of: anorectal infection, brain oedema, necrosis, central nervous system necrosis, embolism, hemiparesis, fall, dizziness, seizure, mental status changes, pulmonary embolism, platelet count decrease, muscular weakness, peripheral swelling, deep vein thrombosis, type 2 diabetes mellitus, pancytopenia, intracranial hemorrhage, cerebral hemorrhage, hypoxia, pneumonia, pneumonitis, hydrocephalus, febrile neutropenia, pleural effusion, small intestinal obstruction, and device related infection. Of the forty-nine (49) SAEs, forty-seven (47) SAEs in twenty-five (25) patients were determined to be unrelated or unlikely be related to NanO2 or placebo. These forty-seven (47) SAEs consisted of: anorectal infection, brain oedema, necrosis, central nervous system necrosis, embolism, fall, dizziness, seizure, mental status changes, pulmonary embolism, platelet count decrease, muscular weakness, peripheral swelling, deep vein thrombosis, type 2 diabetes mellitus, pancytopenia, intracranial hemorrhage, cerebral hemorrhage, hypoxia, pneumonia, pneumonitis, hydrocephalus, febrile neutropenia, pleural effusion, small intestinal obstruction, and device related infection. Of the forty-nine (49) SAEs, two (2) SAEs, consisting of hemiparesis and mental status changes, in two (2) patients were determined to possibly be related to NanO2 or placebo, both of which resolved without sequelae. None of the foregoing SAEs are unexpected. However, since the Phase IIb GBM trial is randomized and placebo controlled, it is blinded and a final determination regarding the cause of the SAEs has not been made. In June 2025, an investigator sponsored multicenter, single blind, randomized, placebo controlled Phase IIb trial of NanO2 to treat patients with large vessel occlusion strokes was commenced in the United Kingdom by NHS Greater Glasgow and Clyde’s Queen Elizabeth University Hospital. The National Institute for Health and Care Research, or NIHR, awarded a grant to physicians at the University of Glasgow and NHS Greater Glasgow and Clyde’s Queen Elizabeth University Hospital to lead the execution of a 150-subject trial in ischemic stroke in the United Kingdom. To date, seventeen (17) patients have been treated. As of July 6, 2026, there have been three (3) SAEs. Two (2) of the SAEs, ischemic stroke and subarachnoid haemorrhage, were determined to be not related to NanO2 or placebo. The other SAE, hypotension, was determined to be related to NanO2 or placebo. None of the foregoing SAEs are unexpected. However, based on regulation in the United Kingdom, a SUSAR report was still submitted for the hypotension SAE. Since the Phase IIb stroke trial is randomized and placebo controlled, it is blinded and a final determination regarding the cause of the SAEs has not yet been made. In June 2025, we commenced the EXTEND Phase Ib respiratory distress trial, which is an open label, dose escalation trial with three cohorts, each of which has six (6) patients. Dosing of the first and second cohorts has been completed and, to date, two (2) SAEs, upper GI bleeding and chronic obstructive pulmonary disease, were reported in one (1) patient in cohort 1 and one (1) patient in cohort 2. Neither of these SAEs were determined to be related to NanO2 and both resolved without sequelae. The API in NanO2 is dodecafluoropentane, which was originally developed as a contrast agent and has been administered to approximately 2,000 patients for use as a contrast agent. The contrast agent was approved in the European Union, or EU. While we are not seeking approval of dodecafluoropentane as an API in a contrast agent in the EU or the United States, we believe that the prior approval of dodecafluoropentane as an API in a contrast agent in the EU is relevant because it supports our belief that NanO2, with dodecafluoropentane as an API, is likely to be well tolerated in a broad population. To date, we have been funded by $21.4 million in private financing and $10.8 million of non-dilutive funding from granting agencies. In addition, we have been granted an additional $1.7 million of non-dilutive funding that has not yet been received. An additional $2.0 million in grant funding has been awarded to our third-party collaborators to conduct trials for which we will supply NanO2. Granting agencies include the National Institutes of Health, or the NIH; the Department of Defense, or the DoD; and Biomedical Advanced Research and Development Authority, or BARDA, in the United States; as well as the NIHR in the United Kingdom. Included in the $2.0 million in grant funding that has been awarded to our third-party collaborators is a grant by the NIHR of $1.4 million to investigating physicians to conduct a Phase IIb trial of NanO2 in approximately 150 stroke patients in the United Kingdom. We are a clinical development biopharmaceutical company with a limited operating history. We have no products approved for commercial sale. We have a history of operating losses and expect to continue to incur substantial losses for the foreseeable future. Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern. Our cash and the proceeds of this offering will only fund our operations for a limited time. We expect that the net proceeds from this offering will only be sufficient to allow us to fully fund our currently active trials, to conduct our planned Phase II ARDS trial, and to commence preparation for a pivotal Phase III GBM trial, but that we will need to raise additional funding in order to complete the future trials that are needed in order to submit a filing application with the FDA for our product candidate. We will need to raise additional capital to fund our planned clinical trials and development and commercialization efforts. --- We were originally formed as NuvOx Pharma, L.L.C., an Arizona limited liability company, in March 2008. On December 29, 2022, we formed NuvOx Therapeutics, Inc. by filing a Certificate of Incorporation with the Secretary of State of the State of Delaware, and, effective as of January 31, 2023, NuvOx Pharma, L.L.C. converted from an Arizona limited liability company into a Delaware corporation, NuvOx Therapeutics, Inc. Our principal executive offices are located at 1635 E. 18th Street, Tucson, AZ 85719, and our telephone number is (520) 624-6688. Our website address is http://www.nuvoxtherapeutics.com.
Post-IPO economic shares by class.
| Class | Shares | % Economic |
|---|---|---|
Common Stock (listed) 1 vote per share · none | 13.1M | 80.4% |
Series A-1 Preferred Stock 1 vote per share on an as-converted basis · 1-for-1 | 847.86K | 5.2% |
Series A-2 Preferred Stock 1 vote per share on an as-converted basis · 1-for-1 | 2.35M | 14.4% |
| Total economic shares | 16.29M | 100% |