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
Do we disclose any information to outside parties?
What information do we collect?
We collect information from you when you subscribe to our newsletter or fill out a form on one of our social platforms. This includes your email address and or mobile phone number.
When registering on our site, as appropriate, you may be asked to enter your: e-mail address and or mobile number.
What do we use your information for?
When we collect your email or mobile number it is used for one purpose to send you the information you requested about small cap stocks. Please read our disclaimer carefully before viewing our emails.
Your information, whether public or private, will not be sold, exchanged, transferred, or given to any other company for any reason whatsoever, other than for the express purpose of delivering the information on small cap stocks that you requested.
We send periodic emails
The email address you provide may be used to send you information, the small cap stock reports you requested, respond to inquiries, and/or other requests or questions.
How do we protect your information?
We implement a variety of security measures to maintain the safety of your personal information when you enter, submit, your email address. We use secure third parties to send email and sms messages to you.
Because we value your privacy we have taken the necessary precautions to be in compliance with the California Online Privacy Protection Act.
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
Please Note: TNS LLC and its employees are not a registered investment advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operators owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D. TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results.
In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The owners and operators of this publication have been compensated twenty five thousand dollars cash via bank wire by legends media llc for this weeks distributed opinions on cyto. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.
TNS LLC is not affiliated with any exchange, electronic quotation system, the Securities Exchange Commission or FINRA. TNS LLC is not a Broker/Dealer and does not engage in high frequency trading.
To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.