Tinnitus

Hamilton, Bermuda, April 30, 2025 (GLOBE NEWSWIRE) -- Management to host conference call today, April 30, at 8:00 a.m. EDT RNA delivery business progressing with platform development, new applications and collaborations Plans to partially spin off RNA delivery business Cash used in operations more than halved in 2024 - finished year with shareholders’ equity of $6.6 million Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (OTCQB:CYTOF), a company dedicated to developing and commercializing RNA delivery technology for targets beyond the liver, today provided a business update and reported its full year 2024 financial results. "Altamira made great progress in its core business of RNA delivery in 2024," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman, and CEO. "The successful testing of our xPhore platform with circular RNA, an emerging and very potent RNA modality, was just one major achievement among many others. We look forward to developing and supplying innovative nanoparticles to partners in pharma and biotech for the safe and effective delivery of various types of RNA molecules to targets beyond the liver. To maximize the potential of our RNA delivery business, we took the first steps towards partially spinning it off to private equity investors. We intend to complete this process in the coming months.” RNA Delivery In 2024, Altamira made further progress with the development of its peptide based xPhore™ nanoparticle platform. The technology allows for extrahepatic RNA delivery, in particular to sites of inflammation, a hallmark of cancer, inflammatory and autoimmune diseases. Once inside target cells, the nanoparticles disassemble and release their RNA payload at substantially higher rates than lipid nanoparticles (LNPs), the current industry standard. In August 2024, part of the Company’s expanding research and development team moved to the Switzerland Innovation Park in Allschwil near Basel. At the new location, the Company has access to modern and well-equipped lab facilities to support its growing activities. The key focus for the development activities has been on nanoparticle formulation and process development for nanoparticle manufacturing. Important progress was achieved with the development and refinement of analytical methods, the reproducibility of manufacturing and stability of the nanoparticles. Further, the xPhore™ platform was successfully tested also for circular mRNA (circRNA). In vitro experiments demonstrated successful transfection of cells and significantly higher protein expression than with linear mRNA, based on which the Company filed a provisional patent application with the United States Patent Office (USPTO). CircRNA has been attracting substantial interest in drug development thanks to enhanced protein expression and greater stability compared to linear mRNA. Altamira is pursuing with the RNA delivery business a ‘picks and shovels’ strategy based on the licensing of its xPhore™ platform technology to partners in the biotech and pharma industry for use in their own RNA drug product development programs. The platform is adapted for the specific requirements of different RNA modalities: OligoPhore™ for oligonucleotides, SemaPhore™ for linear mRNA, and CycloPhore™ for circRNA. To date, the Company has set up collaborations with three partners, of which two were initiated in 2024: With Belgium-based Univercells Group Altamira is evaluating the use of the SemaPhore platform for the delivery of mRNA vaccines. Thanks to lower mRNA loss during cell entrance, the nanoparticles may allow for using lower doses and thus result in potentially more effective and efficient vaccines. With an undisclosed partner in the radiopharmaceutical sector Altamira will test in vitro and in vivo the use of nanoparticles with a certain payload in conjunction with one of the partner’s proprietary radiopharmaceuticals for cancer treatment. Radiopharmaceutical therapy uses tiny amounts of radioactive compounds which find their way to a tumor through the bloodstream and bind to a tumor-specific receptor. Altamira expects to sign up at least two more partners in the course of 2025. The Company intends to grow the RNA delivery business, which it operates through its Swiss subsidiary Altamira Therapeutics AG (“ATAG”), by involving private equity investors for its funding. Altamira aims to spin off a majority of ATAG’s share capital and has initiated the process for the legal and organizational carve-out of the entity. Legacy Assets Altamira made further progress also with its non-core activities (“legacy assets”). The Company’s associate Altamira Medica AG (“Medica”), which commercializes Bentrio®, a drug free, preservative free nasal spray for the treatment of allergic rhinitis, agreed with two of its international distributors on the expansion of their exclusive distribution territories (Southeast Asia, parts of Scandinavia). Marketing approval for Mainland China is expected for 2025. With the USPTO’s allowance of a patent covering the composition of Bentrio®, a major milestone was reached for the intended US commercialization. Bentrio® has already been cleared by the FDA and shall be marketed in the US through a licensing partner; discussions are ongoing. In Europe, Medica is in the process of transitioning Bentrio® from a Class I to a Class IIa medical device under the new EU Medical Device Regulation (MDR). Partnering discussions are also ongoing regarding AM-125, a patented nasal spray for the treatment of acute vestibular syndrome (AVS), a very frequent type of dizziness, which may be developed also for various other disorders of the central nervous system. AM-125 is a reformulation of betahistine, a histamine analog, which in the traditional oral formulation is the standard of care treatment for vertigo in many countries around the world, but currently not approved in the US. Further legacy assets intended for partnering include AM-111, a cell-penetrating peptide for the treatment of acute hearing loss, which has orphan drug designation and is in Phase 3 clinical development, as well as AM-102, an oral small molecule for the treatment of tinnitus (preclinical stage). Full Year 2024 Financial Results and Outlook Following the partial divestiture of the Bentrio® business in November 2023, related activities were reclassified and reported as discontinued operations for the time up to the transaction. Continuing operations comprise the RNA delivery development programs as well as those related to AM-125. Total operating loss from continuing operations increased from $6.6 million in 2023 to $6.9 million in 2024. Research and development expenses were $3.7 million in 2024 vs. $3.4 million in 2023. General and administrative expenses decreased from $3.5 million in 2023 to $3.2 million in 2024. Net finance expense decreased from $1.5 million in 2023 to $0.8 million in 2024 primarily as the Company incurred no more interest expenses (2023: $1.1 million). The Company’s share of the loss of its 49% associate Altamira Medica amounted to $0.8 million in 2024 vs. $44 thousand in 2023; the latter related only to the period from the sale of 51% of Medica’s share capital in November to year-end. The Company’s net loss for 2024 was $8.5 million compared with $4.3 million in the previous year. In 2023, discontinued operations contributed a profit of $3.8 million, reflecting an accounting gain of $5.8 million on the partial sale of Medica. Cash used in operations decreased from $12.8 million in 2023 to $6.1 million in 2024. Investing activities consumed $0.1 million in cash in 2024, after having provided $1.6 million in 2023, reflecting mainly the Medica transaction. Financing activities provided $6.5 million of cash inflow in 2024 vs. $11.8 million in 2023. Cash and cash equivalents on December 31, 2024, rose to $1.0 million from $0.7 million at December 31, 2023. Shareholders’ equity was $6.6 million at the end of 2024 vs. $7.7 million at December 31, 2023. The Company continued to have no financial debt outstanding. Upon completion of the planned partial spin-off of its ATAG subsidiary, Altamira expects its operating expenses to decrease significantly. The Company expects to fund its operations from its cash position, proceeds from the sale of ATAG shares to private equity investors, the partnering or divestiture of legacy assets as well as from the provision of services for affiliates. Altamira intends to update its financial guidance as and when material new information will become available, notably on the planned partial spin-off of ATAG. FY2024 Investor Webcast Details Altamira’s Senior Management will hold an investor call today, Wednesday, April 30, 2025, at 8:00 a.m. EDT to present its business update and the Company’s full-year 2024 results. Event: Altamira Therapeutics Full Year 2024 Financial Results and Business Update Call Date: Wednesday, April 30, 2025 Time: 8:00 am EDT Webcast URL: https://edge.media-server.com/mmc/p/7t3h98aw Registration for Call https://register-conf.media-server.com/register/BI95acee4618c44d05a56b78125b22638d Click on the call link and complete the online registration form. Upon registering you will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details. Select a method for joining the call. Dial-In: A dial in number and unique PIN are displayed to connect directly from your phone. Call Me: Enter your phone number and click “Call Me” for an immediate callback from the system. The call will come from a US number. Dial-In: A dial in number and unique PIN are displayed to connect directly from your phone. Call Me: Enter your phone number and click “Call Me” for an immediate callback from the system. The call will come from a US number. The call will be in listen-only mode. Conference Call Replay A replay of the call will be available after the live event and accessible through the webcast link: https://edge.media-server.com/mmc/p/7t3h98aw Consolidated Statement of Profit or Loss and Other Comprehensive Income/(Loss) For the Years Ended December 31, 2024 and 2023 (in US$) (1) Amounts have been re-presented from those previously published to reflect the change in the Company’s presentation currency from Swiss francs to US dollars. (2) Weighted average number of shares outstanding: 2024: 2,832,299; 2023: 491,258. Consolidated Statement of Financial Position As of December 31, 2024 and 2023 (in US$) (1) Amounts have been re-presented from those previously published to reflect the change in the Company’s presentation currency from Swiss francs to US dollars. About Altamira Therapeutics Altamira Therapeutics (OTCQB:CYTOF) is developing and supplying peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (xPhore™ platform). The versatile delivery platform is suited for different RNA modalities, including siRNA, mRNA and circRNA, and made available to pharma or biotech companies through out-licensing. The Company has two proprietary flagship programs based on xPhore™ and siRNA payloads: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. In addition, Altamira holds a 49% stake (with additional economic rights) in Altamira Medica AG, which owns its commercial-stage legacy asset Bentrio®, an OTC nasal spray for allergic rhinitis. Further, the Company is in the process of partnering / divesting its inner ear legacy assets. Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/ Forward-Looking Statements This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the success of strategic transactions, including licensing or partnering, with respect to Altamira’s legacy assets, Altamira’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the clinical utility of Altamira’s product candidates, the timing or likelihood of regulatory filings and approvals, Altamira’s intellectual property position and Altamira’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira’s Annual Report on Form 20-F for the year ended December 31, 2024, and in Altamira’s other filings with the Securities Exchange Commission (“SEC”), which are available free of charge on the SEC’s website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira or to persons acting on behalf of Altamira are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. Investor Contact: Hear@altamiratherapeutics.com

91.5% of patients experienced clinically meaningful reductions in tinnitus after 12 weeks of treatment with Lenire. 220 patients were analyzed, making the paper one of the largest real-world analyses of tinnitus patients ever published in a peer-reviewed scientific journal. Real-world outcomes in this paper are consistent with the results of Lenire's large-scale clinical trials. CHICAGO, April 28, 2025 /PRNewswire/ -- Nature Communications Medicine has published the first peer reviewed, real-world analysis of U.S. patients treated with Lenire, the only FDA approved tinnitus treatment device of its kind. Tinnitus afflicts an estimated 25 million American adults and is commonly described as "ringing" in the ears. Continue Reading Lenire Real World Evidence Published in Nature Communications Medicine (PRNewsfoto/Neuromod Devices) Results in the paper titled: "Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting" reported 91.5% of tinnitus patients had a clinically significant reduction in tinnitus. These real-world results are consistent with Lenire's clinical trial results that were instrumental in Lenire being granted De Novo approval by the FDA in March 2023 The paper is available at Nature Communications Medicine: Bimodal neuromodulation is the simultaneous stimulation of two nerves for therapeutic purposes. Lenire plays audio tones via headphones while delivering mild energy pulses to the surface of the tongue to treat tinnitus. Under the care of an audiologist with tinnitus expertise, patients typically use the device at home for two 30-minute sessions daily for an average of 12 weeks. Real World Lenire Outcomes Consistent with Clinical Trials The paper, co-authored by audiologist Emily E. McMahan, Au. D., of the Alaska Hearing and Tinnitus Center (AHTC) and Professor Hubert Lim, Ph. D., from the University of Minnesota, analyzed the results of 220 patients with moderate or worse tinnitus who were treated with Lenire at AHTC between May 2023 and June 2024. This analysis is one of the largest ever conducted of real-world patients following their treatment for tinnitus with a medical device. After an interim check-up after six weeks of treatment with Lenire, 78% had a clinically meaningful reduction in tinnitus. After 12-weeks 91.5% of patients had a clinically meaningful reduction in tinnitus, which demonstrates the effectiveness of a typical treatment protocol with Lenire in a real-world clinical setting.1,5,6 AHTC's results are the first of a series of planned, real-world evidence publications that have been compiled with a base of thousands of patients treated with Lenire. "Publication of this data in Nature Communications Medicine underscores how effective Lenire can be for tinnitus patients when they receive guidance from an experienced tinnitus care professional," said audiologist and AHTC founder, Emily E. McMahan, Au. D. "I am confident we have entered an important new era of tinnitus care". FDA Approval in March 2023 was facilitated by Lenire's controlled, TENT-A3 clinical trial. The results were published in Nature Communications, a journal from the same portfolio. The paper remains in the 99th percentile of more than 250,000 tracked Nature articles.2 TENT-A3 included 112 trial participants and demonstrated Lenire's clinical superiority to sound-only therapy, a widely used treatment for tinnitus.2,5 Nearly 89 percent of trial participants said they would recommend Lenire as a tinnitus treatment.2 "To achieve real-world positive results that are better than what were observed in our previous controlled clinical trial that led to FDA authorization for the Lenire treatment is a major advancement for the tinnitus field," said Neuromod Chief Scientific Officer and University of Minnesota Professor, Hubert Lim, Ph.D. "Publication of Lenire's real-world data in a top-tier scientific journal further validates Lenire's bimodal neuromodulation as a treatment option for tinnitus patients." According to Neuromod Devices founder and CEO, Dr. Ross O'Neill, who was Lenire's principal inventor, "Fifteen percent of the global adult population experiences tinnitus, with many seeking better treatment options. These results show Lenire is successful treating tinnitus in real-world clinical settings". "As scientists and medical professionals, we are committed to evidence-based technology. Part of our DNA at Neuromod is working closely with a passionate network of tinnitus care experts. We train and qualify clinicians and provide ongoing support to help continuously improve clinical best practices and patient outcomes." Lenire is available through specialized tinnitus clinics in the United States of America and Europe. Lenire is also a treatment option through the US Department of Veterans Affairs. References and Notes Mc Mahan, E., and Lim, H., Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting Commun Med (2025). Boedts, M. Beuchner, A. et al. Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial. Nature communications (2024) US VA Benefits Report Fiscal Year 2024: As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone's day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories. Clinically meaningful reduction in tinnitus is defined as at least 7-points of improvement on the THI scale for the paper. About Neuromod Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specializes in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit . About Lenire® Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials. Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for therapeutic purposes. The tinnitus treatment device that was used in the study, known as Lenire, was developed by Neuromod Devices. It consists of wireless (Bluetooth ®) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip®. The device's settings can be configured to provide treatment with different combinations of audio and electrical stimuli. The timing, intensity and delivery of the stimuli are controlled by an easy-to-use handheld controller that each participant is trained to use prior to continuing treatment from home. Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an Audiologist or ENT Surgeon, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician. Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo Approval Grant by the US FDA. About Tinnitus Tinnitus, which is commonly known as 'ringing in the ears', is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans are currently living with tinnitus.3 Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 3.2 million veterans compensated in 2024.4 About Audiologist Emily E. McMahan Au. D. Audiologist Emily E. McMahan, Au. D. the owner of Alaska Hearing and Tinnitus Center. Dr. McMahan specializes in Diagnostic Hearing & Hearing Management as well as Tinnitus and Tinnitus Management. Dr. McMahan holds Board Certification in Audiology through the American Board of Audiology. She is a Fellow of the American Academy of Audiology and the Academy of Doctors of Audiology. Dr. McMahan is past-President of Audiology Practice Standards Organization (APSO) which is a nationwide group dedicated to creating a national standard of care for the profession of Audiology. SOURCE Neuromod Devices WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Researchers discovered new mutations in the GLA gene, the underlying cause of Fabry disease, but noted that all of them may be amenable to Galafold (migalastat) chaperone therapy, an approved treatment to slow or prevent organ function decline in Fabry patients, a new study reports.Clinical manifestations of these novel Fabry-causing mutations were detailed in the study. The researchers reported that each patient experienced involvement in multiple organs.“This study further enriches the Fabry disease GLA mutation database and deepens our understanding of GLA mutations and the structure and function of the [Gal A] protein,” the team wrote.Additionally, a model developed by the scientists may predict patients’ responses to Galafold treatment, per the study.The study, “Pathogenicity of novel GLA gene missense mutations in Fabry disease and the therapeutic impact of migalastat,” was published in the Journal of Advanced Research.In Fabry, mutations in the GLA gene affect alpha-galactosidase A, or alpha-Gal A, an enzyme needed to break down certain fatty molecules, including globotriaosylceramide, known as Gb3. Because people with Fabry produce very little or an abnormal version of alpha-Gal A, these fatty molecules build up to toxic levels in various tissues and organs, causing disease symptoms.There are two types of Fabry, dependent on the impact of the GLA mutation and its effect on alpha-Gal A activity. The classic form of the condition, which is more severe, is marked by less than 1% of alpha-Gal A activity, with symptoms arising in childhood. In comparison, the late-onset form is characterized by more than 1% of alpha-Gal A activity, with symptoms usually emerging in adulthood.When new GLA mutations are discovered, it’s essential to understand their impact on alpha-Gal A function and, in turn, on Fabry patients.Here, a research team in China retrospectively screened the clinical data of 163 Fabry patients, looking for new GLA mutations and examining their effect on disease development.Of the 95 different GLA mutations detected, 12 had not been previously reported. Nine of these were considered to definitely cause Fabry because they led to a shortened version of alpha-Gal A, which would be rapidly degraded. The remaining three were missense mutations, meaning they caused a change in a single amino acid — which serve as the building blocks of proteins — within an intact alpha-Gal A enzyme.The researchers then focused on the Fabry patients with missense mutations, as these specific genetic changes may still allow for the production of a partially functional enzyme. That makes these individuals suitable candidates for treatment with Galafold, an oral chaperone therapy approved for adults with Fabry carrying certain GLA mutations.Galafold works by stabilizing the abnormal alpha-Gal A enzyme, allowing it to reach lysosomes, the cell’s recycling centers, where it boosts Gb3 clearance. The therapy has been shown to help manage symptoms in people with Fabry.All of the patients with this type of mutation were men, with an average age of 14.75 years at onset and 29.5 at diagnosis.The man in the first case, found to have a p.W44G mutation, experienced hand and foot pain, a lack of sweat, and benign skin lesions during childhood. He also had symptoms of dizziness, heart palpitations, left heart enlargement, episodic ankle swelling, and diarrhea. The patient was given pain medications but not enzyme replacement therapy (ERT). Prediction analysis also suggested that this mutation was highly pathogenic, or disease-causing.The second patient, carrying a p.S65N mutation, also experienced hand and foot pain and a lack of sweat since childhood. As he aged, other symptoms emerged, including benign skin lesions, high blood pressure, and mild tinnitus, or ringing in the ears. At 31, he underwent a kidney biopsy due to unexplained proteinuria, or high levels of protein in the urine, that revealed scarring. Genetic tests confirmed Fabry, and he was treated with ERT. His mutation was deemed low pathogenic, indicating a mild impact on the enzyme.In the third case, the patient had a p.G260W mutation. Unexplained proteinuria was discovered during a routine medical examination at age 32, with a subsequent kidney biopsy revealing damage. After being diagnosed with Fabry via genetic and alpha-Gal A enzyme testing, he was started on ERT, which significantly reduced his lyso-Gb3 levels. His mutation was considered highly pathogenic.The team then created human kidney cell lines (HEK-293) harboring each mutation to investigate their impact on GLA gene expression (activity), alpha-Gal A protein expression (production), and enzyme activity. The model was designed to work at different mutation sites.The GLA gene expression levels of all of the mutations were significantly lower than those of unmutated control cells, the researchers found. The low pathogenic p.S65N mutation showed the highest expression across all of the mutations. Likewise, alpha-Gal A expression and its activity were significantly lower in all, with the p.S65N mutation showing the most residual enzyme activity at 43.75% of normal.All cell lines were exposed to Galafold, with treatment significantly increasing the expression and activity of all the mutant alpha-Gal A enzymes, particularly in the p.S65N mutant, which reached as high as 80.7% of normal, according to the scientists.“[Galafold] intervention increased the enzymatic activity in the disease models with the novel missense mutations, as well as [meeting] the amenable mutation criteria for GLA gene mutations applicable to [Galafold],” the research team concluded.