DNMT3B

HAMILTON, BERMUDA , Jan. 08, 2024 (GLOBE NEWSWIRE) -- Altamira Therapeutics to Present at 3rd Annual mRNA-Based Therapeutics Summit Altamira’s two flagship programs, AM-401 and AM-411, designed for KRAS-driven cancer and rheumatoid arthritis, serve to demonstrate the technology’s capability to enhance therapeutic efficacy HAMILTON, BERMUDA Jan. 8, 2023 (GLOBE NEWSWIRE) -- Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq: CYTO), a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets, announced today that it will be presenting at the 3rd Annual mRNA-Based Therapeutics Summit, being held January 23-25 at the JW Marriott Hotel, Berlin. Covadonga Pañeda, Ph.D., the Company's Chief Operating Officer, will give a presentation at the conference titled, "Delivery of therapeutic RNA in inflammation and cancer using peptide-based nanoparticles”. In addition, she will participate in the panel discussion on “Tissue specific targeting of mRNA to increase therapeutic efficacy.” "There is a strong and growing interest in the use of mRNA for highly targeted treatment of a broad range of human diseases, based on the unique ability of mRNA to promote expression of specific proteins,” Dr. Pañeda commented. “However, even the most powerful mRNA therapeutic is useless if it is not delivered safely and effectively into target cells, which has remained one of the key challenges for non-hepatic targets to date. Thanks to our SemaPhore platform we are able to deliver therapeutic mRNA, in an efficient and safe manner, to tissues harboring a tumor or suffering from acute or chronic inflammation, restricting the therapeutic effect of the drug to the site where it is needed." SemaPhore™, Altamira’s peptide-based delivery platform for mRNA, has been successfully tested so far in vivo in models of osteoarthritis (WNT16, DNMT3B), atherosclerosis (p27Kip1), aortic aneurysm (SOD2), and tumor microenvironment (ZBTB46). About Altamira Therapeutics Altamira Therapeutics (Nasdaq: CYTO) is developing and supplying peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (OligoPhore™ / SemaPhore™ platforms). The Company currently has two flagship siRNA programs using its proprietary delivery technology: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. The versatile delivery platform is also suited for mRNA and other RNA modalities and made available to pharma or biotech companies through out-licensing. In addition, Altamira holds a 49% stake (with additional economic rights) in 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 (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). 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, 2022, 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.

HAMILTON, BERMUDA, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Company hosts 1H 2023 Financial Results and Business Update call today at 8 a.m. ET First research collaboration with biopharmaceutical company initiated for OligoPhore™ platform Partnering discussions for legacy assets progressing with conclusion of clinical development program and opening of IND as key milestones for Bentrio® and AM-125 Significant strengthening of shareholders’ equity and balance sheet Altamira Therapeutics Ltd. (NASDAQ:CYTO) ("Altamira" or the "Company"), a company dedicated to addressing unmet medical needs, today provided a business update and reported its first half 2023 financial results. "We continue progressing with the strategic repositioning toward becoming a leading provider of innovative RNA delivery technology," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman, and CEO. "We have achieved great strides in enhancing awareness and visibility of our OligoPhore™ / SemaPhore™ platforms for extrahepatic RNA delivery and efficient endosomal release; as a result, we recently entered into our first collaboration with a biopharmaceutical company. We look forward to working with Heqet Therapeutics, in the framework of this first collaboration, on their mission to develop treatments for cardiac regeneration, applying RNA with our OligoPhore™ platform. We are excited to see interest in our technology growing steadily and remain confident about the potential to develop further partnerships with biopharmaceutical companies. "Meanwhile, we have reached important clinical and regulatory milestones in our legacy programs in OTC consumer health and inner ear therapeutics," Mr. Meyer added. "Our clinical trial with Bentrio in seasonal allergic rhinitis met the primary endpoint, adding further to our set of compelling efficacy data. In addition, the FDA cleared an IND for our AM-125 investigational drug in acute vestibular syndrome. These milestones are important elements in our ongoing partnering discussions.” “As part of our strategic pivot, we have adapted our organization, downsized activities especially in clinical development, and reallocated resources from our legacy programs towards our RNA delivery projects. This has allowed for a significant reduction in expense levels. At the same time, we have managed to significantly improve our shareholders’ equity position while reducing financial liabilities.” RNA Delivery Technology Altamira has continued to make progress with the further development of the RNA delivery technology around its OligoPhore™ / SemaPhore™ platforms, which are based on a patented peptide for delivery of RNA in nanoparticles to extrahepatic tissues and efficient endosomal release inside target cells. Two in vivo studies performed by independent research groups at Washington University School of Medicine (St. Louis, MO) using our SemaPhore™ platform provided further external validation of the technology. In a preprint, one research group presented animal data showing restriction of tumor growth with nanoparticles based on SemaPhore™ and ZBTB46 mRNA. Enforced ZBTB46 expression following treatment with the nanoparticles resulted in an immunostimulatory tumor microenvironment and restricted tumor growth. The effect was significantly potentiated when the treatment was combined with anti-PD1 immune checkpoint inhibition, suggesting that ZBTB46 mRNA delivered by SemaPhore™ nanoparticles could be an effective adjuvant therapy with immunotherapy in cancer management. Meanwhile, the other research group presented results from an animal study with DNMT3B mRNA nanoparticles based on Altamira's SemaPhore™ delivery technology at the Osteoarthritis Research Society International World Congress in Denver (CO). Local (intra-articular) administration of the nanoparticles to mice with meniscal injury resulted in strong induction of DNMT3B protein as well as significantly reduced bone sclerosis, cartilage degeneration, and synovitis (inflammation of the connective tissue lining the inside of a joint capsule). Functional studies showed significantly decreased pain sensitivity and improved weight bearing in active treated mice compared to controls. At the same time, the Company advanced work on its two flagship development programs AM-401, for the treatment of KRAS-driven tumors, and AM-411, for the treatment of rheumatoid arthritis; targeting NF-kB, aiming for an IND submission in 2024. Altamira plans to out-license the two programs either following the IND or after a Phase 1 clinical trial at the latest. Importantly, the Company filed a provisional patent application relating to single polyvalent siRNA sequences which as part of AM-401 can target different KRAS mutations (polyKRASmut). If granted, the patent would extend IP coverage for the program to 2043. In line with the Company’s strategy of leveraging the OligoPhore™/SemaPhore™ through out-licensing and partnering rather than commercializing its own drug products, Altamira has significantly expanded its business development activities. This includes the engagement of Maria Grunwald, PhD, MBA, a highly experienced business developer based in Boston, as Senior Business Advisor. On July 5, 2023 the Company announced that it entered into a collaboration and option agreement with Heqet Therapeutics s.r.l. (“Heqet”), a biotech spin-out from King’s College London. Under the terms of the agreement, Heqet will test nanoparticles based on Altamira’s OligoPhore™ delivery platform and comprising certain non-coding RNAs (ncRNAs) in the regeneration of damaged heart tissue following myocardial infarction in animal models. Upon successful conclusion of the experiments, Heqet will, under certain conditions, have the option to negotiate with Altamira for a license to use the Company’s technology and intellectual property to translate its findings into the development of therapeutics for cardiac regeneration. Bentrio® Nasal Spray On May 24, 2023, Altamira announced positive results from the randomized controlled NASAR clinical trial evaluating Bentrio® nasal spray in patients with seasonal allergic rhinitis (SAR). The NASAR trial enrolled 100 SAR patients in Australia who were randomized at a 1:1 ratio to receive either Bentrio® or saline nasal spray for two weeks via self-administration three times per day, or as needed. For eligibility, patients had to have a baseline reflective Total Nasal Symptom Score (rTNSS) of at least 5 points out of 12, referring to the worst level of nasal congestion, sneezing, nasal itching, and rhinorrhea (runny nose) within the past 24 hours averaged over a one-week treatment-free run-in period. The primary efficacy endpoint was defined as the difference in the average rTNSS over the subsequent 2-week treatment period between Bentrio® and saline nasal spray, the current standard of care in drug-free SAR management. The rTNSS decreased in the Bentrio® group from 6.9 points in the pre-treatment period to an average of 5.0 points over the 14-day treatment period (i.e. -1.9 points), while the saline spray group showed a decrease from 6.9 to 6.2 points (i.e. -0.8 points). The reduction in nasal symptoms conferred by Bentrio® was thus 2.4 times larger than with saline nasal spray. The difference in rTNSS reduction of 1.1 points in favor of Bentrio® was statistically significant in the ANCOVA model (LSmeans; p = 0.012; 95% confidence interval -2.0 to -0.3), and the study thus met the primary efficacy endpoint. 63.3% of Bentrio®-treated study participants rated treatment efficacy as either good or very good vs. 29.2% of saline-treated participants. 73.5% of Bentrio®-treated study participants rated tolerability of the treatment as either good or very good vs. 85.5% of saline-treated participants. The Company expects to release further results from the NASAR trial shortly and to submit an article for publication in a peer-reviewed medical journal. The data read-out from the NASAR trial completes the Bentrio® development program in allergic rhinitis. Previous clinical trials demonstrated the safety, tolerability and efficacy of Bentrio in patients exposed to grass pollen or house dust mites under controlled conditions and the extended nasal residence time of more than three hours in human volunteers. The accumulated data suggest that Bentrio®, based on a drug-free and preservative-free formulation, can help to effectively reduce the most common symptoms of allergic rhinitis similar to the reduction observed in response to medicated nasal sprays, but without the tolerability issues frequently experienced with the use of such sprays. On July 20, 2023, Altamira announced that it entered into an exclusive agreement with Pharma Nordic AS for the marketing and distribution of Bentrio® in Norway and potentially further Scandinavian countries. The collaboration agreement will allow Pharma Nordic to market and commercialize Bentrio® in Norway beginning in the first quarter of 2024, and, subject to meeting certain milestones, also in Sweden, Finland, and Denmark later on. Discussions with potential marketing and distribution partners for the US and other key markets have continued to move forward and are still ongoing at this time. In the context of these partnering discussions, it has suspended preparations for launching the product in the US on its own and minimized marketing and sales activities in Europe. Inner Ear Therapeutics On June 29, 2023, the FDA completed its review of Altamira’s IND application for AM-125 (betahistine nasal spray) in acute vestibular syndrome (AVS) and concluded that the proposed Phase 2 clinical trial with AM-125 in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV), the most common type of vertigo, may proceed. The regulatory clearance opened the way for the clinical evaluation of AM-125 also in the United States. An earlier Phase 2 clinical trial conducted in Europe (the TRAVERS trial) demonstrated that a four-week treatment course with AM-125 in AVS patients, following surgical removal of a tumor behind the inner ear, was well tolerated and helped to accelerate vestibular compensation enabling patients to regain balance and recover faster. The new Phase 2 trial is designed to demonstrate AM-125’s tolerability and clinical utility also in BPPV. As previously announced, Altamira intends to divest or partner the AM-125 program for further development and commercialization in the context of its strategic pivot to RNA delivery technology. To this end, the Company has initiated discussions with a number of potential partners based on a structured approach. First Half 2023 Financial Results and Financial Guidance Revenues for the first half of 2023 were CHF 0.1 million compared to CHF 0.3 million for the first half of 2022, reflecting the waning of SARS-CoV-2 infections and, more importantly, the aforementioned strategic decision to temporarily reduce commercial activities around Bentrio® in anticipation of partnering transactions for key markets. Total operating loss for the first six months of 2023 was CHF 4.6 million compared with CHF 8.4 million for the first six months of 2022, a reduction of 45.5%. The improvement was primarily driven by lower expenditures for research and development (CHF 2.3 million vs. CHF 3.6 million) as clinical trials wound down, and for marketing and sales (CHF 0.2 million vs. CHF 2.1 million) as commercial activities were reduced. General and administrative expenses slightly increased in the first half of 2023 to CHF 2.2 million from CHF 2.1 million in the first half of 2022 as higher costs related to capital market projects outweighed reductions in administrative expenditures. Net loss for the first half of 2023 was CHF 5.4 million compared with CHF 8.2 million for the first half of 2022. Financial liabilities decreased from CHF 5.9 million at the end of 2022 to CHF 3.1 million at June 30, 2023. Shareholders’ equity improved at the same time from CHF -8.3 million to CHF -1.8 million. Cash and cash equivalents on June 30, 2023 totaled CHF 50 thousand compared with CHF 15 thousand at December 31, 2022. In early July 2023 Altamira raised $5.0 million in equity through the public offering of 11,111,112 common shares (or pre-funded warrants) at $0.45 each and 11,111,112 warrants with an exercise price of CHF 0.40 and a 5-year duration. The transaction yielded net proceeds of CHF 3.7 million. The Company expects its total cash need in 2023 to be in the range of CHF 12 to 14 million and in the 12 months from the issuance date of these financial statements to be in the range of CHF 12 to 14 million. First Half 2023 Investor Conference Call & Webcast Details Altamira management will hold an investor teleconference today, Tuesday, September 12, 2023, at 8:00 a.m. ET to discuss its business update and first half 2023 results. Founder, Chairman, and CEO Thomas Meyer and COO Covadonga Pañeda will deliver prepared remarks followed by a Q&A session where they will address questions from investors and analysts. Event: Altamira Therapeutics First Half 2023 Financial Results and Business Update CallDate: Tuesday, September 12thTime: 8am ET (5am PT) Access: Toll Free: 888-506-0062International: 973-528-0011Participant Access Code: 500382Webcast URL: https://www.webcaster4.com/Webcast/Page/2797/48993 Investors can begin accessing the webcast 15 minutes before the call, where an operator will register your name and organization. The call will be in listen-only mode. A replay of the call will be available 30 minutes after the live call via the Investors section of the Altamira website at https://ir.altamiratherapeutics.com/. Replay Access:Toll Free replay number: 877-481-4010International: 919-882-2331Replay Passcode: 48993Expiration: September 26, 2023, 11:59 PM ET Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income or Loss (unaudited) For the Six Months Ended June 30, 2023 and 2022 (in CHF) SIX MONTHS ENDED JUNE 30 2023 2022 Revenue 105,469 290,798 Cost of Sales (212,181) (1,192,232)Gross profit (106,712) (901,434)Other operating income 111,405 255,820 Research and development (2,261,154) (3,563,883)Sales and marketing (160,936) (2,129,881)General and administrative (2,168,953) (2,076,383)Operating loss (4,586,350) (8,415,761)Finance expense (861,118) (377,985)Finance income 37,018 509,143 Loss before tax (5,410,450) (8,284,603)Income tax gain/(loss) (10,596) 46,085 Net loss attributable to owners of the Company (5,421,046) (8,238,518)Other comprehensive income: Items that will never be reclassified to profit or loss Remeasurement of defined benefit liability, net of taxes of CHF 0 (28,847) 209,526 Items that are or may be reclassified to profit or loss Foreign currency translation differences, net of taxes of CHF 0 137,747 (63,477)Other comprehensive income, net of taxes of CHF 0 108,900 146,049 Total comprehensive loss attributable to owners of the Company (5,312,146) (8,092,469) Condensed Consolidated Interim Statement of Financial Position (unaudited) As of June 30, 2023 and December 31, 2022 (in CHF) JUNE 30, DECEMBER 31, 2023 2022 ASSETS Non-current assets Property and equipment 1 1 Right-of-use assets 387,737 445,827 Intangible assets 3,893,681 3,893,681 Other non-current financial assets 192,958 194,263 Total non-current assets 4,474,377 4,533,772 Current assets Inventories 270,503 11,644 Trade receivables 31,813 6,525 Other receivables 756,234 755,987 Prepayments 374,376 709,266 Derivative financial instruments 247,090 270,176 Cash and cash equivalents 49,569 15,395 Total current assets 1,729,585 1,768,993 Total assets 6,203,962 6,302,765 EQUITY AND LIABILITIES Equity Share capital 1,590,801 236,011 Share premium 15,560,642 192,622,406 Other reserves 871,633 258,044 Accumulated deficit (19,847,641) (201,431,272)Total shareholders’ equity attributable to owners of the Company (1,824,565) (8,314,811) Non-current liabilities Loan 930,561 - Non-current lease liabilities 287,808 343,629 Employee benefits 381,362 336,206 Deferred income 932,200 932,200 Deferred tax liabilities 129,291 125,870 Total non-current liabilities 2,661,222 1,737,905 Current liabilities Loan 2,130,340 5,869,797 Current lease liabilities 118,229 117,856 Trade and other payables 1,964,139 4,914,404 Accrued expenses 1,154,598 1,977,614 Total current liabilities 5,367,305 12,879,671 Total liabilities 8,028,527 14,617,576 Total equity and liabilities 6,203,962 6,302,765 About Altamira TherapeuticsAltamira (Nasdaq: CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic targets (OligoPhore™ / SemaPhore™ delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and is planned to be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or out-licensing its legacy assets in allergology and viral infection (Bentrio® OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). 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 StatementsThis 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 the continued commercialization of Bentrio and success of strategic transactions, including licensing or partnering, with respect to Bentrio or any other legacy assets, Altamira’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira’s 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, 2022, 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.

Management will host an investor conference call today, May 16th, at 8 a.m. Eastern Company is advancing OligoPhore™ / SemaPhore™ platform for extrahepatic RNA delivery and efficient endosomal release; expects first research collaborations with biopharmaceutical companies in 2023 Filed IND submission with FDA for AM-125 in acute vestibular syndrome ‘Showcase' RNA development programs AM-401 and AM-411 progressing in KRAS-driven cancers and rheumatoid arthritis, targeting INDs in 2024 Divestiture or partnering of legacy assets remains a key strategic focus Top-line data from full NASAR trial with Bentrio in seasonal allergic rhinitis expected in the second quarter HAMILTON, BERMUDA / ACCESSWIRE / May 16, 2023 / Altamira Therapeutics Ltd. (NASDAQ:CYTO) ("Altamira" or the "Company"), a company dedicated to addressing unmet medical needs, today provided a business update and reported its full year 2022 financial results ended December 31, 2022. "We continue to make good progress on our journey to become a leading provider of innovative RNA delivery technology," stated Thomas Meyer, Altamira Therapeutics' founder, Chairman, and CEO. "Our OligoPhore / SemaPhore platforms are designed to address two major challenges in the development of RNA therapeutics. The first is delivery to tissues and organs other than the liver, for example for the treatment of cancers, autoimmune, or inflammatory disorders. The second is the effective and rapid release of the RNA payloads within target cells. We are excited to see interest in our technology growing steadily and, accordingly, we are confident we will enter into our first collaboration agreements this year with biopharmaceutical companies. "At the same time, we are fast approaching important clinical and regulatory milestones with our legacy programs in OTC consumer health and in inner ear therapeutics," Mr. Meyer added. "This month, we expect to receive top-line data from the recently completed NASAR trial with Bentrio in seasonal allergic rhinitis. We just submitted an Investigational New Drug (IND) filing to the Food and Drug Administration (FDA) for AM-125 in acute vestibular syndrome on which we expect to receive comments or clearance in the weeks ahead. "These milestones will be important elements in our strategy to divest or partner the legacy programs as the second step in our transformation to become a leading pure-play technology platform company in RNA delivery technology. Through this process, we expect to unlock the intrinsic value of our legacy businesses. While it has taken longer than initially expected, we look forward to major progress and its conclusion this year." RNA Delivery Technology Update Altamira has been making good progress with its strategic pivot to RNA delivery technology around its OligoPhore / SemaPhore platforms. The technology is based on a patented peptide for delivery of RNA in nanoparticles to extrahepatic tissues and efficient endosomal release inside target cells. It has been successfully tested in numerous animal disease models with both siRNA (short interfering RNA) and mRNA (messenger RNA). Recently, additional promising data were reported: At the 2023 Osteoarthritis Research Society International (OARSI) World Congress held in March in Denver, a Washington University research group presented data from a mouse model of meniscal injury. Systemic delivery of DNA-methyltransferase 3 beta (DNMT3B) mRNA with SemaPhore nanoparticles significantly reduced bone sclerosis, cartilage degeneration, and synovitis (inflammation of the connective tissue lining the inside of a joint capsule) compared to controls. In addition, functional studies showed significantly decreased pain sensitivity and improved weight bearing. In a March 2023 article preprint, another Washington University research group presented data from a mouse model of sarcoma and metastatic breast cancer. Systemic delivery of ZBTB46 (zinc finger and BTB domain containing 46) mRNA with SemaPhore nanoparticles promoted anti-tumor components in the tumor microenvironment and resulted in the restriction of tumor growth. When the nanoparticle treatment was combined with an anti-PD1 immune checkpoint inhibitor, significant synergistic effects in the control of tumor growth were observed, generating long-term complete remission of tumor mass in many of the treated animals. Since 2022, Altamira has stepped up its efforts to present and promote its OligoPhore / SemaPhore platforms at international conferences and its business development activities targeted at potential partners in the biopharmaceutical industry. In general, consistent with its capital efficient RNA business model, the Company plans to focus on providing its nanoparticle technology to licensees rather than develop and commercialize its own drug products. Concurrently, the Company continued the development work on its two ‘showcase' development programs with the OligoPhore platform for siRNA delivery - AM-401 for the treatment of KRAS-driven tumors and AM-411 for the treatment of rheumatoid arthritis (NF-kB). In February 2023, Altamira expanded its intellectual property estate by filing a provisional patent application relating to single polyvalent siRNA sequences which as part of AM-401 can target different KRAS mutations (polyKRASmut). If granted, the patent would extend IP coverage for the program to 2043. Altamira aims to advance both AM-401 and AM-411 to an IND filing with the FDA in 2024 and plans to out-license them either following the IND or after a Phase 1 clinical trial at the latest. Bentrio® Nasal Spray The clinical development program for Bentrio, the Company's novel drug-free nasal spray for protection against harmful airborne particles such as allergens, is nearly complete. In February 2023, data from three clinical studies were presented at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Antonio, TX. In two randomized controlled crossover studies, Bentrio was shown to provide effective protection for patients in both seasonal and perennial allergic rhinitis under controlled exposure to grass pollen and house dust mites, respectively, for several hours. These positive outcomes were corroborated by a third study which demonstrated in healthy volunteers that Bentrio has a significantly longer nasal residence time within the nasal cavity and, compared to a classic saline nasal spray (3.5 hours vs. 1 hour), provides wider distribution and coverage therein. The data read-out from the NASAR trial in Australia will complete the Altamira development program in allergic rhinitis. The study enrolled 100 patients suffering from seasonal allergic rhinitis who were treated for two weeks either with Bentrio or with a classic saline nasal spray as the current standard of care in drug-free treatments. In January 2023, the Company reported that an interim analysis based on the data from the first 53 NASAR participants showed a statistically significant reduction of nasal symptoms with Bentrio vs. the control as well as good tolerability and safety. The results from the complete trial are expected to become available in the month of May. In contrast, the outcomes from the COVAMID trial with Bentrio in 160 patients suffering from acute COVID-19 which were reported in January 2023, were inconclusive under the specific test conditions. Although a trend for faster and more pronounced reduction in nasal viral load and symptoms was observed with Bentrio vs. the untreated controls, the differences were not deemed statistically significant. Altamira considers that the more benign outcomes from the Omicron variant resulted in more pronounced spontaneous recovery, and treatment may have started too late in the trial (about 4.5 days after infection). As previous studies with Bentrio on cultured human nasal epithelia cells exposed to various types of viruses had shown best results from prophylactic treatment application, the Company concluded that Bentrio is best used right before or while being exposed to virus particles. No further studies in viral infection are ongoing or planned. As part of its strategic pivot to a pure-play RNA delivery technology company, Altamira initiated discussions last year with several well-established OTC consumer health companies for partnering on Bentrio for North America, Europe, and other key international markets. These discussions and related due diligence have extended into 2023 and are still ongoing at this point. In the context of these partnering discussions, the Company suspended preparations for launching the product in the US on its own and minimized marketing and sales activities in Europe. Meanwhile, the Company's existing distribution partners launched Bentrio in several Asian geographies, including Singapore, Malaysia, Indonesia, the Philippines, and Hong Kong. Inner Ear Therapeutics In June 2022, the Company announced positive top-line data from its Phase 2 TRAVERS trial with AM-125, a patented nasal spray formulation of betahistine for the treatment of acute vestibular syndrome (AVS). Detailed results were published in a peer-reviewed article in Otology & Neurotology, one of the leading journals in scientific and clinical inner ear research, in April 2023. AVS is characterized by the sudden onset of continuous vertigo lasting days to weeks and may be associated with nausea, head motion intolerance, and unstable balance. The randomized, double-blind, placebo-controlled TRAVERS trial enrolled a total of 124 patients, at more than 10 study sites across Europe, who suffered from AVS following surgery for the removal of a tumor. The trial demonstrated good tolerability of AM-125. Further, administration of AM-125 resulted in a dose- and time-dependent improvement in balance, and signs and symptoms of vestibular dysfunction. Based on the positive outcomes from TRAVERS, the Company filed an IND application this past week with the FDA. The IND, if granted, would allow conducting clinical trials with AM-125 in the US as well. The submission includes the protocol for a Phase 2 trial in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV), which is the most common type of vertigo and characterized by repeated episodes of vertigo produced by changes in the head position relative to gravity. A recently published meta-analysis shows statistically significant improvement in dizziness handicap for BPPV patients when treated with oral betahistine over the standard of care procedure alone. By avoiding the fast metabolism after oral intake, intranasal delivery of AM-125 achieves higher bioavailability of betahistine (5-to-29 times higher). In the context of its strategic pivot to RNA delivery technology, Altamira intends to divest or partner the AM-125 program for further development and commercialization that includes the implementation of a Phase 2 clinical study. To this end, the Company has initiated discussions with a number of potential partners and expects to intensify such efforts following now that the IND has been submitted. Full Year 2022 Financial Results Revenues for the full year of 2022 were CHF 0.3 million compared to CHF 0.1 million for the full year of 2021. The 2022 revenues exclude a non-refundable upfront license fee of CHF 0.9 million from Nuance Pharma related to the marketing and distribution of Bentrio in Mainland China, Hong Kong, Macau and South Korea which was deferred for revenue recognition.[1] Total operating loss for the full year of 2022 was CHF 26.1 million, or CHF 13.7 million before a one-time non-cash write-off (impairment) of capitalized development expenditures for the AM-125 project based on impairment testing under IFRS, compared with CHF 16.8 million for the full year of 2021. Research and development expenses for the full year of 2022 were CHF 19.7 million, or CHF 7.3 million before the aforementioned one-time non-cash write-off (impairment) of capitalized development expenditures for the AM-125 project, compared with CHF 8.4 million for the full year of 2021. General and administrative expenses for the full year of 2022 were CHF 3.6 million compared with CHF 4.9 million for the full year of 2021. Net loss for the full year of 2022 was CHF 26.5 million, or CHF 14.1 million before the aforementioned one-time non-cash write-off (impairment) of capitalized development expenditures for the AM-125 project, compared with CHF 17.1 million for the full year of 2021. Cash and cash equivalents on December 31, 2022 totaled CHF 15 thousand compared with CHF 1.0 million at December 31, 2021. [1]Revenue recognition for the upfront payment is deferred until transfer of production to Nuance, which will occur 4 years after Nuance obtaining the first national registration of Bentrio® in the territory or upon Nuance's cumulative orders for Bentrio® reaching a contractually defined minimum quantity of Bentrio® from the Company, whichever comes later. The upfront payment was incorrectly recorded as revenue in the Unaudited Condensed Consolidated Interim Financial Statements of the Company as of June 30, 2022 and for the six months ended June 30, 2022, furnished with the Securities and Exchange Commission on November 30, 2022.The Company will reflect the adjustment in the comparatives included in the June 30, 2023 financial statements, and will reflect the adjustment in restated financial statements as of June 30, 2022 and for the six months ended June 30, 2022 to be filed with a Form 6-K/A at a later date. In April 2023, the convertible loan issued to Altamira 14 months earlier by FiveT Investment Management was converted by the lender into common shares, resulting in a reduction in financial liabilities of CHF 5.6 million. The Company expects its additional cash need for FY 2023 to be in the range of CHF 15 million to 17 million, which it intends to fund through a combination of the planned divestiture or partnering of its legacy assets, equity offerings, debt financings, and grants. During the first four months of 2023, Altamira raised CHF 4.5 million from share issuances under the "at the market" program with A.G.P. and the equity line with Lincoln Capital Partners. Further, in early May 2023, the Company raised CHF 2.5 million through a convertible loan provided by FiveT Investment Management. The loan bears interest at the rate of 10% per annum and matures 22 months from May 4, 2023. FY2022 Investor Teleconference Details Altamira management will hold an investor call today, Tuesday, May 16, 2023, at 8:00 a.m. ET to discuss its business update and full-year 2022 results. The presentation will be available via teleconference or webcast with audio . Date: Tuesday, May 16, 2023 Time: 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) Webcast URL: Toll-free dial-in number: 888-506-0062 International dial-in number: 973-528-0011 Participant Access Code: 250106 Conference Call Replay A replay of the call will be available after the live event and archived for two weeks until Tuesday, May 30, 2023. Toll-free dial-in number: 877-481-4010 International dial-in number: 919-882-2331 Replay Passcode: 48448 Consolidated Statement of Profit or Loss and Other Comprehensive Income/(Loss) For the Years Ended December 31, 2022 and 2021 (in CHF) 2022 20211) Revenue 305,616 63,882 Cost of Sales (1,443,855 ) (2,240,554 ) Gross profit (1,138,239 ) (2,176,672 ) Other operating income 709,449 214,217 Research and development (19,677,756 ) (8,360,821 ) Sales and marketing (2,381,384 ) (1,498,218 ) General and administrative (3,644,549 ) (4,946,576 ) Operating loss (26,132,479 ) (16,768,070 ) Interest income 969 3,219 Interest expense (911,869 ) (189,695 ) Foreign currency exchange gain/(loss), net 54,645 328,641 Revaluation gain/(loss) from derivative financial instruments 451,131 (410,918 ) Transaction costs (1,137 ) - Loss before tax (26,538,740 ) (17,036,823 ) Income tax gain/(loss) 10,329 (21,620 ) Net loss attributable to owners of the Company (26,528,411 ) (17,058,443 ) Other comprehensive income/(loss): Items that will never be reclassified to profit or loss Remeasurements of defined benefit liability, net of taxes of CHF 0 441,277 264,984 Items that are or may be reclassified to profit or loss Foreign currency translation differences, net of taxes of CHF 0 61,046 772 Other comprehensive income/(loss), net of taxes of CHF 0 502,323 265,756 Total comprehensive loss attributable to owners of the Company (26,026,088 ) (16,792,687 ) Basic and diluted loss per share (29.13 ) (25.76 ) 1) Revised 2) Weighted average number of shares outstanding: 2022: 910,723; 2021: 662,314. Consolidated Statement of Financial Position As of December 31, 2022 and 2021 (in CHF) December 31, 2022 December 31, 20211) ASSETS Non-current assets Property and equipment 1 1 Right-of-use assets 445,827 564,714 Intangible assets 3,893,681 14,314,877 Other non-current financial assets 194,263 199,105 Total non-current assets 4,533,772 15,078,697 Current assets Inventories 11,644 839,221 Trade receivables 6,525 21,746 Other receivables 755,987 917,833 Prepayments 709,266 996,910 Derivative financial instruments 270,176 0 Cash and cash equivalents 15,395 984,191 Total current assets 1,768,993 3,759,901 Total assets 6,302,765 18,838,598 EQUITY AND LIABILITIES Equity Share capital 236,011 149,643 Share premium 192,622,406 188,511,476 Foreign currency translation reserve 258,044 62,069 Accumulated deficit (201,431,272 ) (175,686,937 ) Total shareholders' (deficit)/equity attributable to owners of the Company (8,314,811 ) 12,704,528 Non-current liabilities Derivative financial instruments 0 1,233 Non-current lease liabilities 343,629 461,485 Employee benefit liability 336,206 668,319 Deferred income 932,200 0 Deferred tax liabilities 125,870 142,484 Total non-current liabilities 1,737,905 1,273,521 Current liabilities Loan 5,869,797 0 Current lease liabilities 117,856 114,251 Trade and other payables 4,914,404 3,697,723 Accrued expenses 1,977,614 1,048,575 Total current liabilities 12,879,671 4,860,549 Total liabilities 14,617,576 6,134,070 Total equity and liabilities 6,302,765 18,838,598 1) Revised About Altamira Therapeutics Altamira Therapeutics (Nasdaq:CYTO) is dedicated to developing and commercializing RNA delivery technology for extrahepatic targets (OligoPhore™ / SemaPhore™ platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and is planned to be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or out-licensing its legacy assets in allergology and viral infection (Bentrio® OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: 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 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' 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 the continued commercialization of Bentrio and success of strategic transactions, including licensing or partnering, with respect to Bentrio or any other legacy assets, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' 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 Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2022, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: . 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 Therapeutics or to persons acting on behalf of Altamira Therapeutics 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 Therapeutics 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. CONTACT: Hear@altamiratherapeutics.com 800-460-0183 SOURCE: Altamira Therapeutics View source version on accesswire.com: