HAMILTON, BERMUDA / ACCESSWIRE / April 12, 2022 / 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 second half and full 2021 financial results.
Altamira in 2021 laid the groundwork to transform the Company through its Trasir acquisition to enter RNA therapeutics — which it believes to be one of the most exciting and dynamic fields in medicine – as signaled by its adoption of a new name and ticker symbol. As the Company repositions around RNA therapeutics, it also continues to progress towards upcoming key catalysts with its (non-RNA) legacy programs.
“We are progressing preclinical development of AM-401 for treatment of KRAS-driven cancer as the first indication for our OligoPhore delivery platform with siRNAs,” stated Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO. “In our legacy business, we are laying the foundations for long-term growth with our drug-free Bentrio nasal spray through partnering with international distributors, as well as advancing our AM-125 nasal spray for vertigo treatment towards important milestones this year.
“In February, we completed patient enrollment in Part B of our Phase 2 “TRAVERS” clinical trial with AM-125. In March, we completed enrollment in our house dust mite (HDM) challenge study testing Bentrio. We remain on track to release top-line results for both studies during 2Q-22. In parallel, we initiated our “COVAMID” clinical trial with Bentrio in acute COVID-19 and have been seeing rapid enrollment so far.
“As we are moving towards important clinical and regulatory milestones with our legacy programs, we have been preparing for the second step of our transformation, the planned divestiture or spin-off of our legacy business targeted for the second half of 2022,” Mr. Meyer added. “With that step, Altamira shall become an RNA therapeutics focused company with disruptive prospects, while unlocking the intrinsic value of our legacy business.”
Strategic Repositioning Around RNA Therapeutics
In June 2021, Altamira entered the field of RNA therapeutics through the share-based acquisition of Trasir Therapeutics Inc. (“Trasir”). Trasir is a pioneer in the development of nanoparticles for extrahepatic nucleic acid delivery, that is of RNA molecules to targets outside the liver. The Company’s proprietary peptide-based technology platforms, OligoPhore and SemaPhore, enable the safe and effective delivery of siRNA (small interfering ribonucleic acid) and mRNA (messenger ribonucleic acid), respectively, into target cells using systemic or local administration. The technology has been successfully tested in numerous animal disease models, including indications in various types of cancer and inflammatory diseases. Altamira has selected KRAS-driven cancers, which may affect the pancreas, lungs or colorectum, among others, as the first indication for drug development. Under project code AM-401, the Company is aiming for an FDA IND in 2023 to initiate a clinical proof-of-concept study in humans.
Since the acquisition of Trasir, Altamira has expanded its RNA activities and resources. Dr. Samuel Wickline, Trasir’s founder who became the Company’s Chief Scientific Officer, was recently joined in the leadership team by Dr. Covadonga Pañeda, Altamira’s new Chief Development Officer. The Company intends to leverage its OligoPhore / SemaPhore platform through out-licensing to other biopharmaceutical companies and has already initiated corresponding business development activities.
Continued Development of Bentrio and Early Commercialization
Within its legacy business, Altamira has made good progress with Bentrio, its novel drug-free nasal spray for protection against airborne viruses and allergens that is now being commercialized in Germany and other European countries under the CE mark as an “over the counter” product. Following positive results from its first clinical trial in allergic rhinitis in 2Q-21, which showed a significant reduction in nasal symptoms over four hours of controlled exposure to grass pollen in a challenge chamber compared to no protection, it initiated two further studies. In Canada, the Company has initiated an HDM challenge study with allergic rhinitis patients, which is expected to read out in 2Q-22. In the US, HDM allergens are the second most common source of sensitization right after plant-related allergens (e.g. pollen / hay fever) and may be present all year long. Meanwhile, in Australia, Altamira has a larger study (“NASAR”) ongoing in patients who are naturally exposed to seasonal allergens in which study participants receive Bentrio or a saline nasal spray control over two weeks. The Company expects the NASAR trial to read out in 4Q-22 / 1Q-23.
In viral infection, Altamira has demonstrated in vitro on human nasal epithelia cells that Bentrio lowers infectious viral titers when applied prior to or after infection with SARS-CoV-2 not only in the wild type, but also the Delta and Omicron variants. Similar effects in the same type of assay were also shown in H1N1 influenza virus infection, further confirming the broad protective scope of Bentrio. The Company’s plans for clinical testing of Bentrio in COVID-19 were delayed in 2021 as it waited for regulatory approval in India, however it was able to start the randomized controlled COVAMID trial in Bulgaria in March 2022. Enrollment has been progressing swiftly so far, and Altamira may complete the study in 3Q-2022.
In 3Q-21 the Company launched Bentrio in Germany and Austria, first via online pharmacies and, from late Q4-21 also through “brick and mortar” pharmacies. Sales in 2021 reached CHF 0.1 million, with the product launch and adoption slowed by various regulatory restrictions on direct-to-consumer marketing for use against SARS-CoV-2 and the lack of specific clinical evidence. In 1Q-22, Bentrio revenues continued to grow, reaching approximately 2.5x their FY 2021 level. To drive further growth of its Bentrio activities, Altamira established an “OTC Consumer Health” business unit, which will be headed from May 2022 by the accomplished industry veteran Jean Lachance.
The German speaking European countries have been serving as the Company’s test markets. It plans to market and distribute Bentrio through established distributors leveraging their strong presence in OTC consumer health markets world-wide rather than on its own. It has already entered into marketing and distribution agreements for more than 20 international markets so far, primarily in Asia and MENA countries. Altamira also aims to partner Bentrio for North America, Europe, and other markets. To date, Bentrio has been cleared for sale in the countries of the European Union, Switzerland, UK, Singapore and Malaysia. The Company has received the first orders from distributors and expects revenues from Bentrio supplies to accelerate following further marketing clearances and respective product launches. In addition, under the agreement with Nuance covering China and several other Asian markets, Altamira received an upfront payment of USD $1 million, and it may receive development and commercial milestones of up to USD $22.5 million and, upon production transfer, a staggered royalty on net sales at a high-single to low-double-digit percentage.
For accessing the US market, the Company filed with the FDA in October 2021 a 510(k) application for premarket clearance of Bentrio in the allergy indication. The review of the submission is still ongoing at this point.
Advancing AM-125 Towards Read-Out from Proof-of-Concept Study in Vertigo
Development of Altamira’s AM-125 program for the treatment of vertigo in 2021 was still impacted by COVID-19 related intermittent slowdowns in recruitment for the TRAVERS Phase 2 clinical trial. In March 2022, the Company was able to complete enrollment into Part B of the trial, which recruited 75 patients with acute vertigo following neurosurgery. Top-line data from the trial are expected for 2Q-2022.
An interim analysis of Part A of the trial had demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125 (1 mg, 10 mg and 20 mg). At the highest dose of 20 mg (taken 3x daily), AM-125-treated patients demonstrated, on average, a 2.6-fold improvement in Tandem Romberg test performance from baseline to six weeks, compared to those who received placebo (balance was maintained for 9.2 seconds vs. 3.5 seconds, respectively [least square mean], p-value < 0.001). This positive outcome was supported by similar improvements in additional efficacy measures, including additional objective as well as clinician- and patient-reported outcomes.
Altamira is currently preparing the submission of an IND to the FDA for the next steps in the clinical development of AM-125. The product is an intranasal formulation of betahistine, which has been widely used for decades in tablet form as a vestibular stimulant and standard of care in vertigo treatment and management around the world, with the US being a notable exception. Vestibular dysfunction affects more than one third of the U.S. population 40 years of age and older. Because of its ability to circumvent first-pass metabolism, AM-125 has been shown to have 5-to-29 times higher bioavailability than orally administered betahistine. Even without a US market, worldwide sales of oral betahistine are approximately $450 million. Altamira intends to pursue partnering opportunities with AM-125.
Second Half 2021 Financial Results
In the second half of 2021 ended Dec. 31, 2021, the Company recorded its first 2021 revenues of CHF 0.1 million from its launch of Bentrio last summer through online pharmacies in Germany and Austria.
Total operating expenses for the second half of 2021 were CHF 8.9 million compared with CHF 3.0 million for the second half of 2020.
In the context of the Company’s repositioning, it has deprioritized its development programs in tinnitus (Keyzilen®), hearing loss (Sonsuvi®) and antipsychotic induced weight gain (AM-201) and has written off all related intangible assets.
Full Year 2021 Financial Results
In 2021, the Company recorded its first and total revenue of CHF 0.1 million from the launch of Bentrio last summer through online pharmacies in Germany and Austria.
Total operating expenses for the full year of 2021 were CHF 15.4 million compared to CHF 5.5 million for the full year of 2020.
During the first quarter of 2022, the Company raised CHF 5 million from FiveT Investment Management Ltd. through a convertible loan agreement. The loan is convertible into common shares of the Company at USD $1.9458 per share. It carries an interest rate of 10% p.a. and will mature on February 8, 2023, if not converted by FiveT or prepaid by Altamira. In addition, the Company received an upfront payment of USD $1 million from Nuance Pharma.
The Company expects its total cash requirements for FY 2022 to be in the range of CHF 11 to 13 million, for which it can draw upon its cash position as well as further issuances of common shares under its equity line with Lincoln Park Capital and its “at-the-market” program with A.G.P. Additional sources of funding may arise from the planned spin-off or divestiture of its (non-RNA) legacy assets.
FY2021 Investor Teleconference Details
Altamira management will hold an investor call Today, Tuesday, April 12, 2022, 8:00 a.m. ET to discuss its second-half and full-year 2021 results. The presentation will be available via teleconference or webcast with audio and presenter-controlled slides.
Conference Call Replay
A replay of the call will be available after the live event and archived for two weeks until Tuesday, April 26, 2022.
About Altamira Therapeutics
Altamira Therapeutics (NASDAQ:CYTO) is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; commercial) or for the treatment of vertigo (AM-125; Phase 2), and therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®; Phase 3). Founded in 2003, it is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/.
Consolidated Statement of Profit or Loss and Other Comprehensive Income/(Loss)
For the Years Ended December 31, 2021 and 2020
(in CHF)
| 2021 | 2020 | |||||||
|
Revenue
|
63,882 | – | ||||||
|
Cost of Sales
|
(2,240,554 | ) | – | |||||
|
Gross profit
|
(2,176,672 | ) | – | |||||
|
Other operating income
|
460,710 | 174,475 | ||||||
|
Research and development
|
(8,939,037 | ) | (2,862,979 | ) | ||||
|
Sales and marketing
|
(1,498,218 | ) | – | |||||
|
General and administrative
|
(4,946,576 | ) | (2,594,662 | ) | ||||
|
Operating loss
|
(17,099,793 | ) | (5,283,166 | ) | ||||
|
Interest income
|
3,219 | 258 | ||||||
|
Interest expense
|
(189,695 | ) | (135,151 | ) | ||||
|
Foreign currency exchange gain/(loss), net
|
328,641 | (333,553 | ) | |||||
|
Revaluation gain/(loss) from derivative financial instruments
|
(410,918 | ) | (2,250,222 | ) | ||||
|
Transaction costs
|
– | (219,615 | ) | |||||
|
Loss before tax
|
(17,368,546 | ) | (8,221,449 | ) | ||||
|
Income tax gain/(loss)
|
(21,620 | ) | 21,284 | |||||
|
Net loss attributable to owners of the Company
|
(17,390,166 | ) | (8,200,165 | ) | ||||
|
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
|
264,984 | (26,118 | ) | |||||
|
Items that are or may be reclassified to profit or loss
|
||||||||
|
Foreign currency translation differences, net of taxes of CHF 0
|
772 | 88,862 | ||||||
|
Other comprehensive income/(loss), net of taxes of CHF 0
|
265,756 | 62,744 | ||||||
|
Total comprehensive loss attributable to owners of the Company
|
(17,124,410 | ) | (8,137,421 | ) | ||||
|
Basic and diluted loss per share
|
(1.31 | ) | (1.36 | ) | ||||
Consolidated Statement of Financial Position
As of December 31, 2021 and 2020
(in CHF)
| December 31, 2021 |
December 31, 2020 |
|||||
|
ASSETS
|
||||||
|
Non-current assets
|
||||||
| Property and equipment | 1 | 46,636 | ||||
| Right-of-use assets | 564,714 | – | ||||
| Intangible assets | 14,314,877 | 9,115,410 | ||||
| Other non-current financial assets | 199,105 | 20,001 | ||||
| Total non-current assets | 15,078,697 | 9,182,047 | ||||
| Current assets | ||||||
| Inventories | 839,221 | – | ||||
| Trade receivables | 21,746 | – | ||||
| Other receivables | 917,833 | 80,861 | ||||
| Prepayments | 996,910 | 277,589 | ||||
| Cash and cash equivalents | 984,191 | 11,258,870 | ||||
| Total current assets | 3,759,901 | 11,617,320 | ||||
| Total assets | 18,838,598 | 20,799,367 | ||||
| EQUITY AND LIABILITIES | ||||||
| Equity | ||||||
| Share capital | 149,643 | 114,172 | ||||
| Share premium | 188,511,476 | 177,230,300 | ||||
| Foreign currency translation reserve | 62,069 | 61,297 | ||||
| Accumulated deficit | (176,018,660 | ) | (160,635,879) | |||
| Total shareholders’ (deficit)/equity attributable to owners of the Company | 12,704,528 | 16,769,890 | ||||
| Non-current liabilities | ||||||
| Derivative financial instruments | 1,233 | 6,318 | ||||
| Non-current lease liabilities | 461,485 | – | ||||
| Employee benefit liability | 668,319 | 867,376 | ||||
| Deferred tax liabilities | 142,484 | 125,865 | ||||
| Total non-current liabilities | 1,273,521 | 999,559 | ||||
| Current liabilities | ||||||
| Loan | – | 523,920 | ||||
| Derivative financial instruments | – | 310,439 | ||||
| Current lease liabilities | 114,251 | – | ||||
| Trade and other payables | 3,697,723 | 762,453 | ||||
| Accrued expenses | 1,048,575 | 1,433,106 | ||||
| Total current liabilities | 4,860,549 | 3,029,918 | ||||
| Total liabilities | 6,134,070 | 4,029,477 | ||||
| Total equity and liabilities | 18,838,598 | 20,799,367 | ||||
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 approval and timing of commercialization of AM-301, 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, 2021, and in Altamira Therapeutics’ other filings with the SEC, which are available free of charge on the Securities Exchange Commission’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 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:
Investors@altamiratherapeutics.com
800-460-0183
SOURCE: Altamira Therapeutics
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