|This one could swing quickly, look at the chart setup.
M&A activity in the RNA sector is strong.
See list of near-term catalysts below
Good day everyone and welcome to all of our new members,
Altamira Therapeutics Ltd. (NASDAQ: CYTO) is a biopharma company developing RNA therapeutics for unmet medical needs.
Current price $.81/share (at market close 5-18-22)
Following the acquisition of Trasir Therapeutics Inc. last year CYTO is focusing on RNA therapeutics and its OligoPhore™ / SemaPhore™ platform for extrahepatic RNA delivery (more on that below). The company continues to progress towards upcoming key catalysts with its (non-RNA) legacy programs as well.
While the company recorded nominal Revenues of $100K in 2021, they have indicated that Q122 revenues have exceeded that figure by 2.50X. Their product Bentrio, an over-the-counter nasal spray treatment for allergies and viruses (more on that below), is gaining commercial success, developing sales channels across the globe. The company is considering a spin-off, licensing or sale of that product to help fund their RNA therapeutics, a sector they believe will be more lucrative.
I want to look briefly at the CYTO pipeline but would urge you to visit the company website and investor deck found there to get detailed information.
CYTO pipeline of RNA therapy:
Altamira is developing OligoPhore™ / SemaPhore™ as a versatile platform for safe and effective delivery of nucleic acid payloads such as siRNA (small interfering ribonucleic acid), mRNA (messenger ribonucleic acid) into target cells, using systemic or local administration.
Delivery into target cells and tissues has proved to be a major challenge and the RNA payload that becomes available within the cells has been reported at 1-2%. CYTO wants to leverage their platform through collaborations with other biopharmaceutical companies and the out-licensing of technology for other indications.
CYTO is becoming an RNA delivery platform company.
According to Researchandmarkets.com, the market for mRNA vaccines and therapeutics was $46.7B in 2021 and will grow to $101.3B in 2026 representing a CAGR of 16.8%. The market for siRNA, over the same period will grow from $4.9B to $11.0B.
The company has initiated a preclinical development program and is aiming for FDA IND in 2023 to be followed by clinical proof-of-concept study.
Recent M&A activity in the RNA biopharma sector:
Tidal Therapeutics (mRNA delivery, preclinical stage), acquired in 2021 by Sanofi for $160M upfront + up to $310M milestone payments.
Translate Bio (mRNA delivery), recently acquired by Sanofi for $3.2B
Dicerna (specializing in hepatic delivery), recently acquired by Novo for $3B
The CYTO legacy pipeline (the company may divest or spin off these products):
Bentrio is a novel drug-free nasal spray for protection against airborne viruses and allergens now being commercialized in Germany and other European countries as an “over the counter” product. The company is currently involved in Bentrio allergen studies in Canada and Australia with results expected over the next few quarters.
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.
In recent updates the company said its COVAMID studies for the treatment of Covid-19 with Bentrio in Bulgaria have reached the midpoint of patient enrollment and the same study in North Macedonia has been approved for extended clinical study. CYTO expects to report results in both studies in Q322.
To date, Bentrio has been cleared for sale in the countries of the European Union, Switzerland, UK, Singapore, and Malaysia and is currently generating revenues in those areas. 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 and that application is still under FDA review.
The AM-125 program for the treatment of vertigo is currently in the TRAVERS Phase 2b clinical trial. In March this year, the company was able to complete enrollment in the trial, which recruited 75 patients with acute vertigo following neurosurgery. Top-line data from the trial are expected for 2Q-2022.
The product is an intranasal formulation of betahistine, a standard of care in vertigo treatment and management around the world, except in the US. Even without a US market, worldwide sales of oral betahistine are approximately $450 million. CYTO is currently preparing the submission of an IND to the FDA for the next steps in the clinical development of AM-125.
Keyzilen® (AM-101) for the treatment of acute inner ear tinnitus and Sonsuvi® (AM-111) for the treatment of acute inner ear hearing loss have both been evaluated in Phase 3 trials but will require further clinical testing.
Near term potential catalysts for CYTO:
Expect read-outs on house dust mite challenge Bentrio study with allergic rhinitis patients in the current, second quarter of 2022.
Top line data from AM-125 TRAVERS Phase 2 is anticipated in the current, second quarter of 2022.
Preparing the submission of an IND to the FDA for the next steps in the clinical development of the AM-125 program for vertigo.
Seasonal allergic rhinitis NASAR clinical Bentrio trial is expected to report top line data in fourth quarter of 2022 or first quarter of 2023.
COVAMID trial with Bentrio in acute COVID-19 may be completed in 3Q 2022.
In the RNA-based business, plan to submit an IND to the FDA in 2023 for KRAS-driven cancer treatment using RNA therapeutics.
Expected FDA feedback on Bentrio 510(k) submission.
FYE is December 31.
52-week high is $4.58/share
Outstanding 15.2M shares
Float 13.5M shares
Book value (mrq) $.85/share
Market cap $11.4M
When I look at the chart below, with the double bottom formed, along with the fact that CYTO shares are currently priced below their book value, I see what looks to be an oversold opportunity.
We will have more on CYTO in an updated report soon.
The Traders News Group