MALVERN, Pa., Feb. 21, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s fourth quarter and full year 2024 financial results and provide a business update at 8:30 a.m. ET on Wednesday, March 5, 2025.
Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 5045393 Webcast: Available on the events section of the Ocugen investor site.
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Key Points: – Acquiring FibroGen’s China operations for $160M secures rights to anemia drug roxadustat. – The sale extends cash runway to 2027 and funds key drug development. – Roxadustat leads in China, but faces generic competition and regulatory scrutiny.
AstraZeneca (AZN) has announced a $160 million acquisition of FibroGen’s (FGEN) China business, securing regional rights to the oral anemia drug roxadustat. This deal strengthens AstraZeneca’s footprint in the Chinese pharmaceutical market while providing FibroGen with a much-needed financial boost.
The relationship between AstraZeneca and FibroGen surrounding roxadustat dates back over a decade. Initially, AstraZeneca held broader rights to the HIF-PH inhibitor but returned control in the U.S. and select other markets last year. However, the company maintained an interest in China and South Korea, where the drug is marketed under the brand name Evrenzo.
With this acquisition, AstraZeneca will pay an enterprise value of $85 million, in addition to $75 million of net cash currently held by FibroGen’s Chinese operations. The transaction is expected to close in mid-2025, at which point FibroGen plans to use the proceeds to repay a term loan facility managed by Morgan Stanley Tactical Value, simplifying its capital structure.
For FibroGen, this sale represents a crucial financial lifeline. Entering 2024, the company held $121.1 million in cash and equivalents. The proceeds from this transaction, coupled with loan repayment, should extend FibroGen’s cash runway into 2027. The move allows the company to refocus on developing FG-3246, a CD46-targeting antibody-drug conjugate, and FG-3180, a companion PET imaging agent for metastatic castration-resistant prostate cancer (mCRPC).
“This deal bolsters our company on several fronts,” said FibroGen CEO Thane Wettig. “It strengthens our financial position, meaningfully extending our cash runway, and enables us to continue progressing key clinical development programs.”
Roxadustat is a leading treatment for anemia in chronic kidney disease in China, and regulatory bodies are considering its approval for chemotherapy-induced anemia. Despite its dominance, the drug faces increasing competition, as Chinese regulators approved a generic version from CSPC Pharmaceutical last summer. Several other companies are also seeking approval for their own generic versions.
China remains a crucial market for AstraZeneca, though the company has recently encountered challenges, including a slowdown in sales and an ongoing investigation into its former China head, Leon Wang, over potential tax violations. Nevertheless, AstraZeneca CEO Pascal Soriot remains optimistic, stating in a recent earnings call that “longer term, we see continuous opportunity for growth in China.”
While today’s deal secures AstraZeneca’s position in China, FibroGen retains the rights to roxadustat in other markets, including the U.S., where it has faced regulatory setbacks. The drug was rejected by the FDA in 2021 for chronic kidney disease and later failed a Phase 3 anemia trial in 2023. However, FibroGen is still evaluating development plans for anemia associated with lower-risk myelodysplastic syndrome, with hopes of meeting with the FDA in the second quarter to discuss potential next steps.
As the transaction moves forward, both AstraZeneca and FibroGen are positioning themselves for long-term growth, with AstraZeneca reinforcing its presence in China’s expanding pharmaceutical sector and FibroGen securing the resources to pursue future drug development.
Combination therapy with oxylanthanum carbonate plus tenapanor led to greater reductions in urinary phosphate excretion than either drug alone
LOS ALTOS, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the publication of preclinical data describing the benefits of combination treatment of oxylanthanum carbonate (OLC) and tenapanor on phosphate management in the American Society of Nephrology (ASN) journal, Kidney360.
The publication, entitled “Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rats,” examines the potential synergistic benefits of a combination of OLC, a phosphate binder, with tenapanor, a sodium/hydrogen exchanger 3 (NHE3) inhibitor, on urinary phosphate excretion. Data demonstrated sizeable reductions in urinary phosphate excretion (a proxy for intestinal phosphate absorption) in response to both OLC monotherapy and the combination of OLC with tenapanor.
“With approximately 75% of patients receiving maintenance dialysis failing to meet serum phosphate targets set by international Kidney Disease Improving Global Outcomes (KDIGO) guidelines, we must explore new approaches to improve control of hyperphosphatemia” said Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Stanford University School of Medicine. “Based on the results of this pre-clinical study, we believe that OLC, an investigational phosphate binder, when used alone or in combination with tenapanor, could improve control of hyperphosphatemia in patients receiving maintenance dialysis who are either unresponsive to currently available phosphate binders or intolerant to their associated adverse effects, high pill burden, and poor palatability.”
“We’re excited by these preclinical data showing a synergistic treatment effect from the combination of OLC and tenapanor. OLC, with its low pill burden and more palatable formulation, could complement tenapanor, significantly enhancing patient adherence and clinical outcomes,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Further studies in patients with end-stage kidney disease and hyperphosphatemia will be required to understand the most effective and best tolerated OLC-containing regimens, as we aim to improve long-term control of hyperphosphatemia and prevent its myriad complications.”
Key Findings:
Treatment with tenapanor alone (0.15 mg/kg) led to 12.5% lower mean urinary phosphate excretion compared to the vehicle in rats fed a high phosphorus diet.
A pooled analysis of monotherapy with OLC (0.75%, 1.5%, and 3%) demonstrated a 17.7% reduction in urinary phosphate excretion compared to vehicle.
Treatment with tenapanor in combination with OLC demonstrated a more pronounced 41.3% reduction in urinary phosphate excretion compared to vehicle.
The combination of OLC and tenapanor was synergistic and statistically significant (p=0.009 for 0.75% OLC + tenapanor and p=0.010 for 1.5% OLC + tenapanor).
About Oxylanthanum Carbonate (OLC)
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1Reason Research, LLC 2022 survey. Results here. 2 Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2023-2030 3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM 4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.
GeoVax Advances GEO-MVA to Strengthen U.S. and Global Readiness
ATLANTA, GA, February 19, 2025 – The confirmation of a fourth case of Clade 1 Mpox in New York underscores the urgent need for a stronger and more diversified vaccine supply chain. GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, is calling for immediate action to expand vaccine production and ensure timely distribution.
The spread of Clade 1 Mpox, a highly virulent and transmissible strain with a fatality rate ranging from 3% – 10%, is raising alarms across the public health community. While the virus has been a persistent threat in Africa, its increasing presence in Europe and the United States signals a critical moment in the fight against the disease. Over the last 4 months, confirmed cases of Clade 1 Mpox have been reported in California, Georgia, New Hampshire, and New York. However, the nation remains heavily dependent on a single non-U.S. vaccine manufacturer of the preferred Mpox vaccine, based on Modified Vaccinia Ankara (MVA), leaving the U.S. and global markets vulnerable to supply chain disruptions, limited accessibility, and potential vaccine shortages at a time when demand is surging.
Current Supply Chain Inadequate for Global Mpox Response
The current reliance on a single supplier for the preferred Mpox vaccine presents numerous challenges, particularly as the outbreak grows:
Supply chain instability – Depending on a single foreign manufacturer introduces geopolitical and logistical risks that could delay vaccine availability during critical outbreaks.
Insufficient production capacity – African health agencies have requested 20 million doses in 2025 to curb the spread of the virus, yet only 2–5 million doses are expected to be available.
High costs and limited access – At as much as $270 per dose in the U.S., the preferred product for vaccination against Mpox can be prohibitively expensive for many, creating a barrier to widespread vaccination efforts.
Inability to respond swiftly to emerging strains – Current stockpiles, which were depleted during the 2022 outbreak, are likely inadequate to combat the increasing spread of Clade 1, leaving public health officials struggling to contain the outbreak.
GeoVax’s GEO-MVA: A Critical Additional-Source Solution
In response to these pressing concerns, GeoVax is advancing development of GEO-MVA, an alternative MVA based vaccine in the fight against Mpox. GeoVax is also further addressing vaccine availability with plans to transition manufacturing of GEO-MVA, once authorized, to an advanced MVA manufacturing platform with the potential to offer significant advantages over the currently utilized Chicken Embryo Fibroblast (CEF) manufacturing platform, a complicated manufacturing process highly dependent on the availability of Specific Pathogen Free (SPF) chicken eggs. GEO-MVA’s innovative MVA production process, once implemented, should enable:
Scalability for global demand – Rapid, high-volume manufacturing to meet urgent vaccination needs.
Flexibility to utilize existing vaccine manufacturing facilities vs need to construct new ones.
Lower cost and increased accessibility – The advanced technology behind GeoVax’s MVA manufacturing platform should help reduce production costs, making vaccination programs more affordable worldwide.
Eliminate the need for SPF eggs whose availability can be negatively impacted by supply disruptions such as those related to avian flu outbreaks.
Strengthening U.S. biosecurity – Unlike the current MVA vaccine, which is produced overseas, GEO-MVA can be manufactured within the U.S., reducing reliance on foreign supply chains.
Enhanced pandemic preparedness – A diversified vaccine supply ensures greater resilience in response to future outbreaks, preventing disruptions in availability.
GeoVax has established strategic partnerships with OXB (France) and ProBioGen (Berlin) to support production scale up, while also actively engaging with U.S. and international health agencies to potentially expedite regulatory approvals and secure funding to bring GEO-MVA to market and eventually transition production to the next generation MVA manufacturing process. GeoVax recently completed cGMP (current Good Manufacturing Practice) manufacturing of the GEO-MVA drug substance and is currently in the process of fill-finish, with anticipated availability of clinical vialed material by mid-year.
A Call to Action: Strengthening the Global Response
With the growing threat of Clade 1 Mpox, it is imperative to diversify vaccine manufacturing capabilities and ensure the U.S. and global health agencies have access to multiple suppliers. GeoVax urges policymakers and regulators to take decisive action:
Increase federal funding and policy support to expedite the availability of GEO-MVA as an alternative Mpox vaccine.
Expedite regulatory approvals to bring GEO-MVA to market as quickly as possible.
Enhance collaboration with global health organizations to ensure equitable vaccine distribution, particularly in underserved regions.
“We cannot afford to wait for another pandemic-level crisis before addressing vaccine shortages and supply chain vulnerabilities,” said David Dodd, Chairman & CEO of GeoVax. “The emergence of Clade 1 Mpox in the U.S. is a clear warning sign. Immediate action is needed to strengthen vaccine supply and access. GEO-MVA, along with our efforts towards establishing our next generation MVA manufacturing platform, represents critical solutions to ensure we are better prepared for future outbreaks.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,810,000 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.87 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 20, 2025, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering are expected to be $2,715,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds received from the private placement to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.
The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; (viii) the completion of the offering and (ix) the satisfaction of customary closing conditions related to the offering, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
GeoVax’s Vaccine Development Programs Align with Anticipated HHS Focus on Vaccine Safety, Diversification and Domestic Biosecurity
ATLANTA, GA, February 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in vaccine and immunotherapy development, congratulates Robert F. Kennedy, Jr. on his confirmation as Secretary of the U.S. Department of Health and Human Services (HHS). RFK Jr.’s appointment provides a significant opportunity for healthcare innovation, transparency, and public trust, reinforcing national priorities such as vaccine safety, diversified vaccine platforms, and strengthened domestic manufacturing. GeoVax stands ready to support these initiatives by delivering next-generation vaccines and advanced vaccine manufacturing technology that enhance biosecurity, public health resilience, and vaccine confidence.
GeoVax’s Commitment to a Robust, Transparent and Secure Vaccine Future
GeoVax’s mission aligns closely with the new administration’s policy priorities, particularly in reducing reliance on foreign pharmaceutical supply chains, increasing vaccine safety and durability, and ensuring access for underserved populations. The Company’s proprietary Modified Vaccinia Ankara (MVA) platform offers a promising alternative to other vaccine technologies such as mRNA, providing broad-spectrum, durable immunity across multiple infectious diseases via a recognized safe vaccine platform.
Key initiatives supporting the goals for vaccine safety and transparency include:
Diversified Vaccine Development – GeoVax’s GEO-CM04S1, a next-generation COVID-19 vaccine, and GEO-MVA, a dual-purpose Mpox and smallpox vaccine, align with the advocacy for alternative vaccine platforms beyond mRNA. These vaccines are designed to offer long-term immunity with a well-documented safety profile.
Transparency as a Pillar of Public Trust – As David Dodd, Chairman and CEO of GeoVax, has emphasized, restoring trust in vaccines requires clear communication, open regulatory processes, and full transparency regarding safety, efficacy, and potential risks. GeoVax supports the call for greater industry accountability and public engagement, ensuring that vaccine development aligns with the highest standards of ethical science.
Strengthening U.S. Biosecurity – GeoVax’s anticipated domestic vaccine manufacturing capabilities reinforce the bipartisan legislative commitment to reducing dependence on foreign pharmaceutical supply chains, thereby enhancing national pandemic preparedness.
Ethical Vaccine Development & Public Confidence – GeoVax embraces open regulatory processes, rigorous safety standards, and public access to data, ensuring confidence in its vaccines. These principles align with the call for increased scrutiny and transparency in vaccine development and approval.
Equitable Access & Global Preparedness – With cost-effective, scalable technology that does not require ultra-cold storage, GeoVax’s vaccines are well-suited for domestic and global distribution, ensuring broad access to critical immunizations, particularly for immunocompromised and underserved communities.
David Dodd: “Transparency is the Key to Restoring Vaccine Trust”
Reflecting on the challenges of vaccine hesitancy, David Dodd has been a vocal advocate for transparency in vaccine development and regulatory processes. In a recent op-ed, he emphasized: “Trust in vaccines has become a critical battleground for public health. Addressing public concerns openly and honestly is the only way to bridge the growing divide between science and skepticism. Transparency is a necessity, not an option. GeoVax remains committed to clear communication, scientific integrity, and ensuring that public confidence in vaccines is based on facts, not fear.” (https://www.genengnews.com/topics/translational-medicine/a-call-to-action-building-vaccine-trust-through-transparency/)
This perspective directly supports the stated goals of strengthening public trust, reducing regulatory opacity, and ensuring vaccine safety through independent oversight. GeoVax’s proactive approach to transparent vaccine development is a model for responsible biotech leadership.
A New Era for U.S. Healthcare and Pandemic Preparedness
RFK Jr.’s confirmation as HHS Secretary provides a renewed opportunity in support of vaccine diversification, transparency, and strategic biomanufacturing initiatives. GeoVax’s innovative vaccine pipeline supports these goals, positioning the Company as a vital partner in safeguarding national and global public health.
GeoVax’s vaccine development strategy builds upon successful national initiatives, such as Operation Warp Speed and Project NextGen, by prioritizing pandemic preparedness and biosecurity resilience. Through continued engagement with federal agencies and global health organizations, the Company seeks to accelerate vaccine development, expand domestic manufacturing, and enhance pandemic response efforts.
David Dodd, Chairman and CEO of GeoVax, stated: “Secretary Kennedy’s confirmation presents an opportunity to redefine public health with greater emphasis on safety, accessibility, and innovation. GeoVax proudly supports the commitment to reducing dependence on foreign pharmaceutical supply chains, diversifying vaccine technology, and restoring trust in public health solutions. We stand ready to collaborate with HHS and other healthcare stakeholders to advance a safer, more resilient healthcare future.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Nutriband is partnering with Kindeva Drug Delivery to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.
ORLANDO, Fla., Feb. 13, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has signed an addendum to the Commercial Development and Clinical Supply Agreement for its lead product, Aversa™ Fentanyl, that it has in place with its partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.
Nutriband and Kindeva have revised their agreement to formalize their exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments.
Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants.
Nutriband’s abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products.
The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1
1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
Key Points: – AbbVie and Xilio Therapeutics announce a partnership to develop innovative tumor-activated immunotherapies, including masked T-cell engagers. – Xilio will receive $52 million upfront and is eligible for up to $2.1 billion in milestone payments and royalties. – The collaboration aims to enhance the effectiveness of immunotherapy while minimizing systemic side effects.
AbbVie and Xilio Therapeutics have entered a strategic collaboration to advance next-generation tumor-activated immunotherapies, a move that could significantly impact the oncology space. The partnership will focus on developing masked T-cell engagers (TCEs), a cutting-edge approach designed to precisely target tumors while reducing the systemic toxicity often associated with immunotherapies.
Under the terms of the agreement, Xilio will receive an upfront payment of $52 million, with the potential to earn up to $2.1 billion in milestone payments and royalties if the collaboration yields successful drug candidates. This deal highlights the growing interest in tumor-selective therapies as biopharmaceutical companies seek to refine cancer treatments for better efficacy and safety.
Immunotherapy has revolutionized cancer treatment over the past decade, with checkpoint inhibitors and CAR-T therapies offering promising results. However, many of these treatments come with serious side effects, such as cytokine release syndrome and immune-related toxicities, which can limit their widespread use. Tumor-activated therapies, like those being developed through the AbbVie-Xilio collaboration, aim to overcome these challenges by ensuring immune system activation occurs predominantly at the tumor site rather than throughout the body.
This strategy aligns with a broader industry trend where major pharmaceutical companies are investing heavily in precision oncology. Companies such as Bristol Myers Squibb, Merck, and Roche are also exploring targeted immune therapies, with some already advancing their own masked TCE platforms.
AbbVie’s decision to partner with Xilio follows similar collaborations between biotech startups and large pharmaceutical firms. Smaller biotech companies often bring innovative drug discovery capabilities, while established players like AbbVie provide the resources and expertise needed to navigate clinical development and regulatory approval.
The move also positions AbbVie competitively in the immuno-oncology space, where it faces increasing competition from global drugmakers. The company has been expanding its oncology pipeline following the success of Imbruvica and Venclexta, and this partnership could strengthen its position in the next generation of cancer therapeutics.
Meanwhile, Xilio Therapeutics, a biotech firm specializing in tumor-selective treatments, stands to gain significant financial backing and research support through this agreement. Its proprietary technology platform, which develops highly potent, tumor-activated biologics, has the potential to redefine immunotherapy approaches for solid tumors.
With oncology continuing to be one of the most lucrative and rapidly evolving fields in biotech, tumor-activated immunotherapies are poised to become a major focus of drug development. The potential to minimize toxicity while enhancing efficacy makes these therapies particularly appealing for both patients and healthcare providers.
If successful, the AbbVie-Xilio collaboration could lead to groundbreaking advancements in cancer treatment, opening doors for future partnerships and expanding the role of tumor-targeted biologics in oncology.
The AVERSA™ transdermal abuse deterrent technology is protected by a broad international intellectual property portfolio with patents already issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia
February 07, 2025 08:45 ET
ORLANDO, Fla., Feb. 07, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on February 3, 2025 for patent application 18/369,241, “Abuse and Misuse Deterrent Transdermal Systems” which covers its Aversa™ abuse deterrent technology. The receipt of a Notice of Allowance means that the USPTO is expected to issue a U.S. patent for this application after administrative processes have been completed.
The expected issuance of this patent further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa™ abuse deterrent technology. This technology can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband’s lead product under development is Aversa™ Fentanyl, an abuse deterrent fentanyl transdermal system, with the potential to become the first and only abuse deterrent pain patch on the market.
Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products.
The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1
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1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
Patient treated in procedure, conducted at Mass General Transplant Center and in collaboration with partner eGenesis, was recently released from hospital
Investigational therapy tegoprubart targets CD40 ligand (CD40L) with potential to improve both safety and efficacy compared to standard of care immunosuppression regimens
IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a key component of the immunosuppression therapy regimen in a patient who recently received a transplanted kidney from a genetically modified pig. The procedure was performed on January 25, 2025, by surgeons at Massachusetts General Hospital (MGH) in collaboration with our partner eGenesis. In December 2024, MGH received Food and Drug Administration (FDA) approval to proceed with this transplant and plans to perform two additional xenotransplants this year, further advancing the field of xenotransplantation. Following the successful transplant, the patient was discharged from the hospital and is now off dialysis for the first time in over two years.
“This second kidney xenotransplant conducted at MGH represents another important milestone in the effort to consider new strategies in transplantation and immunosuppression to address the global organ shortage crisis. We are grateful to the patient, the team at MGH, and our partner eGenesis for supporting tegoprubart’s central role in these landmark procedures,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Blocking the CD40 Ligand is a critical component of the immunosuppression regimen for effective translation of organ transplant from nonhuman primates into humans. Our anti-CD40L antibody tegoprubart represents a novel approach to immunosuppression therapy with the potential to improve safety and efficacy and enable patients to live longer with their transplanted organs.”
Similar to the first-ever kidney xenotransplant, also conducted at MGH in March 2024, tegoprubart is being administered to the current patient investigationally as part of a regimen designed to prevent the body from rejecting the transplanted pig organ. Tegoprubart is designed to block CD40L and has been shown to inhibit multiple costimulatory receptors including CD40 and CD11, key components of how immune cells communicate with one another. Based on extensive prior research, tegoprubart has been observed to be generally safe and well-tolerated in multiple potential indications, including for the prevention of rejection following kidney allotransplantation.
“I would like to thank Eledon for their work supporting this historic xenotransplant. Immunosuppression presents one of the greatest challenges for transplantation in both human and non-human organs. The need for advancements in immunosuppressive medications is critical for advancing our field and improving the quality of life for transplant patients everywhere,” said Dr. Leonardo Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital.
Tegoprubart was also used as a cornerstone component of the chronic immunosuppression regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human, performed at the University of Maryland Medical Center in September 2023. Currently, tegoprubart is being evaluated in three global clinical studies for the prevention of organ rejection in patients receiving kidney transplants and in a separate investigator sponsored trial for the prevention of islet transplant rejection in patients with type 1 diabetes (T1D). Eledon recently announced initial data from this investigator-initiated islet transplant trial, conducted by the research team at the University of Chicago Medicine Transplant Institute, that demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.
The Company plans to report updated interim clinical trial from its ongoing Phase 1b and long-term safety and efficacy extension studies in kidney transplant this summer, topline results from its Phase 2 BESTOW kidney transplant trial in the fourth quarter of 2025, and longer-term follow up results from the investigator-led islet transplant clinical trial at UChicago Medicine Transplant Institute later this year.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Company had $98.8 million in cash as of December 31, 2024; existing cash expected to fund planned operations into the first quarter of 2026
Company is debt-free after repaying mortgage on facilities
TNX-102 SL fibromyalgia FDA PDUFA goal date is August 15, 2025
$10.1 million in net sales from migraine products in 2024
CHATHAM, N.J., Feb. 07, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, recently announced selected preliminary operating results for the year ended December 31, 2024, and certain preliminary financial condition information as of December 31, 2024.
Preliminary Full Year 2024 Financial Results1
The Company had approximately $98.8 million in cash and cash equivalents as of December 31, 2024.
Net cash used in operating activities was approximately $60.9 million, compared to $102.0 million for the prior year.
Capital expenditures was approximately $0.1 million, compared to $29.1 million for the prior year.
Net operating loss was approximately $126.6 million, which includes non-cash impairment charges of approximately $59.0 million, compared to net operating loss of $116.7 million for the prior year.
The Company announced that net revenue from the sale of its marketed products was approximately $10.1 million, compared to $7.8 million for the prior year.
On February 3, 2025, the Company repaid a mortgage (Loan and Guaranty Agreement) with JGB Capital and related parties that was secured by two facilities and the Company is now debt-free.
The Company expects that its cash resources at December 31, 2024, and the gross proceeds of approximately $30.4 million raised from sales under its at-the-market facility in the first quarter of 2025, will be sufficient to fund its planned operations into the first quarter of 2026.
The cash runway is expected to fund the company beyond the August 15, 2025 Prescription Drug User Fee Act (PDUFA) goal date assigned by the U.S. Food and Drug Administration (FDA) for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia.
1The above information is preliminary financial information for the year ended December 31, 2024 and subject to completion. The unaudited, estimated results for the year ended December 31, 2024 are preliminary and were prepared by the Company’s management, based upon its estimates, a number of assumptions and currently available information, and are subject to revision based upon, among other things, quarter and year-end closing procedures and/or adjustments, the completion of the Company’s consolidated financial statements and other operational procedures. This preliminary financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods. However, the Company has not completed its financial closing procedures for the year ended December 31, 2024, and its actual results could be materially different from this preliminary financial information, which preliminary information should not be regarded as a representation by the Company or its management as to its actual results for the year ended December 31, 2024. In addition, EisnerAmper LLP, the Company’s independent registered public accounting firm, has not audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information. During the course of the preparation of the Company’s financial statements and related notes as of and for the year ended December 31, 2024, the Company may identify items that would require it to make material adjustments to this preliminary financial information. As a result, prospective investors should exercise caution in relying on this information and should not draw any inferences from this information. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles and reviewed by the Company’s auditors.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
James J. Ferguson, MD, FACC, FAHA, joins as Chief Medical Officer
Extensive experience provides strong support for advancing specialized cardiovascular assets, including leading the late-stage clinical development of tecarfarin and other business development opportunities
PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company focused on the development of specialized cardiovascular therapies, with the late-stage asset tecarfarin, a new Vitamin K antagonist, today announced a leadership transition appointing James J. Ferguson, MD, FACC, FAHA, as its new Chief Medical Officer, effective immediately. Dr. Ferguson is a distinguished medical expert with over 25 years of leadership in the cardiovascular field and deep expertise in clinical development. Dr. Ferguson will lead the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline.
Dr. Ferguson replaces Douglas W. Losordo, MD. Cadrenal thanks Dr. Douglas Losordo for his contributions to advancing the development of our tecarfarin program.
“We welcome Dr. Ferguson to our team and are confident that he will play a critical role in driving the late-stage clinical development of tecarfarin and the prioritization of indications. Dr. Ferguson brings expertise and strong relationships with cardiovascular clinical and scientific thought leadership, which will be instrumental as we prepare for late-stage clinical development of our tecarfarin program,” said Quang X. Pham, Chief Executive Officer, Cadrenal Therapeutics, Inc.
Dr. Ferguson joins Cadrenal after serving as Chief Medical Officer at Matinas BioPharma. Previously, Dr. Ferguson was Head of U.S. Cardiovascular Medical Affairs at Amgen and held several senior positions at AstraZeneca, including Vice President of US Cardiovascular Medical and Scientific External Relations, Therapeutic Area Vice President of Cardiovascular Global Medical Affairs, and US Development brand leader for BRILINTA.
“I’m truly honored to be joining Cadrenal at this exciting and transformative time. I look forward to advancing the late-stage clinical development of tecarfarin and bringing forward the first innovation in vitamin K-targeted anticoagulation in 70 years. This product could have a truly meaningful impact for patients in whom there continues to be major unmet medical needs with standard warfarin therapy,” said Dr. Ferguson.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing specialized therapeutics for rare cardiovascular conditions. The Company is developing tecarfarin, a vitamin K antagonist (VKA) designed to be a better and safer anticoagulant than warfarin for individuals with implanted cardiac devices. Cadrenal strives to improve outcomes and reduce major adverse events for these patients. Although warfarin is widely used off-label for several rare cardiovascular diseases, extensive clinical and real-world data have shown it to have significant serious side effects. With its innovation, Cadrenal aims to meet the unmet needs of this patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges.
Cadrenal is pursuing a product in a pipeline approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted left ventricular assist devices (LVADs). In 2025, the Company plans to initiate a pivotal Phase 3 trial evaluating tecarfarin versus warfarin for LVAD patients. The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).
Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus to build a pipeline of specialized cardiovascular therapies. For more information, visit www.cadrenal.com and connect with us on LinkedIn.
Safe Harbor
Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the contributions to be made by Dr. Ferguson including leading the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline, as well as advancing other indications in rare cardiovascular conditions requiring chronic anticoagulation; playing a critical role in driving the late-stage clinical development of tecarfarin and the prioritization of indications; Dr. Ferguson’s expertise and strong relationships with cardiovascular clinical and scientific thought leadership being instrumental as the Company prepares for the for late-stage clinical development of our tecarfarin programs; advancing the late-stage clinical development of tecarfarin and bringing forward the first innovation in vitamin K-targeted anticoagulation in 70 years; the product having a truly meaningful impact for patients in whom there continues to be major unmet medical needs with standard warfarin therapy; the Company striving to improve outcomes and reduce major adverse events for patients; the Company aiming to meet the unmet needs of the patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges; and the Company initiating in 2025 a pivotal Phase 3 trial evaluating tecarfarin versus warfarin for LVAD patients. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to derive benefits from the contributions expected to be made by Dr. Ferguson; the ability to initiate the pivotal Phase 3 clinical trial for tecarfarin in LVAD patients in 2025 and provide improved outcomes; the ability to enter into collaborations with development partners; the ability of tecarfarin to provide a safer alternative to LVAD patients and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Results from the Phase 1 single ascending dose study support proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection
TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses
TNX-1500 showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses supporting monthly dosing for future efficacy trials
TNX-1500 was generally well-tolerated with a favorable safety profile
Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product
CHATHAM, N.J., Feb. 06, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced positive topline results from its Phase 1, single ascending dose trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy participants. The objectives of the Phase 1 trial were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support dosing in a planned Phase 2 trial in kidney transplant recipients.
“There remains a significant need for new agents with improved activity and safety to prevent transplant rejection and treat autoimmune diseases,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “First generation anti-CD40L mAb therapy, particularly ruplizumab (a.k.a., humanized 5c8 or BG9588) showed activity in modulating autoimmunity and rejection in allo- and xeno-transplantation but was limited by an increased risk of thrombosis.1-3 Tonix created TNX-1500, a next generation anti-CD40L mAb, by reengineering the Fc region of ruplizumab, to preserve activity with improved safety. The results of the Phase 1 study indicate that TNX-1500 has met these design objectives. We believe the results of this study and our prior animal studies4,5 indicate that TNX-1500 is potentially best-in-class among next-generation anti-CD40L mAbs in development.”
Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals said, “Topline results from the TNX-1500 Phase 1 study showed TNX-1500 at the 10 mg/kg and 30 mg/kg doses blocked both the primary and secondary antibody responses to a test antigen. The pharmacokinetic data support monthly dosing at doses of 10 mg/kg or above. Based on these findings, we are eager to advance this promising candidate into a Phase 2 efficacy study. We believe TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden relative to current immunosuppressive regimens.”
Methods and Topline Results
Dosing: TNX-1500 solution was infused i.v. over a period of one hour to achieve doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg. Participants were observed in the clinic for one day and followed with periodic clinic visits to Day 120.
Keyhole Limpet Hemocyanin (KLH) Challenge: To evaluate the immune modulation potency of TNX-1500, participants received an antigen challenge with KLH (Immucothel®) administered subcutaneously (SC) on Day 2 and Day 29 of the study.
Disposition: A total of 26 participants were enrolled in three Cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg). A total of 24 participants completed the study and two discontinued early (one placebo participant was lost to follow-up and one on TNX-1500 withdrew consent).
Tolerability: TNX-1500 was generally well-tolerated with a favorable safety and tolerability profile. The only treatment-emergent adverse event (TEAE) occurring in ≥ 3 participants among all TNX-1500 groups was aphthous ulcer, occurring in one participant each in the 3 mg/kg, 10 mg/kg, and 30 mg/kg groups; all were rated as mild, possibly related, and resolved in 2-10 days. There were no TEAEs assessed as related to KLH administration. No TEAEs led to study discontinuation and there were no serious adverse events. There were no thromboembolic events, which were prespecified as TEAEs of special interest.
Pharmacodynamics: TNX-1500 at 10 mg/kg and 30 mg/kg blocked both the primary and secondary anti-KLH Ab responses, evidenced by the mean Ab level at all sampled timepoints (through Day 120) being below the lower limit of quantitation (400 µg/L). TNX-1500 at 3 mg/kg blocked the primary response to KLH Day 2 challenge and reduced the peak secondary response to KLH Day 29 challenge by approximately two thirds (69%) relative to the peak response to placebo.
Pharmacokinetics: The mean (SD) half-life of TNX-1500 was: 3 mg/kg, 19.6 (9.29) days; 10 mg/kg, 37.8 (5.46) days; and 30 mg/kg, 33.7 (4.83) days.
Tonix plans to discuss these results with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 1 meeting. Pending alignment with the FDA, a Phase 2 study of TNX-1500 in kidney transplant recipients will be pursued.
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts. 4,5
*TNX-1500 is an investigational new biologic and is not approved for any indication
Lassiter G, et al. Am J Transplant. 2023;23(8):1171-1181. doi: 10.1016/j.ajt.2023.03.022.
Miura S, et al. Am J Transplant. 2023;23(8):1182-1193. doi: 10.1016/j.ajt.2023.03.025.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the U.S. National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrance only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
