(Source 1)(Source 2)
Current Challenges with RNA Delivery
- Delivery into target cells and tissues has proved to be a major challenge as RNA is inherently unstable and tends to show poor cellular uptake
- Various delivery technologies have been developed to address these challenges
- Despite substantial progress with delivery of RNA therapeutics to the liver, other target tissues and organs have remained difficult to reach
- Another challenge has been the low amount of RNA payload that becomes available within the cells, which has been reported at 1-2% only
- These challenges have clearly prevented more widespread adoption of RNA therapeutics
Solution: CYTO’s Peptide-Based Nanoparticles
OligoPhore™ /SemaPhore™ technology enabling safe and effective delivery of RNA payloads with systemic administration:
- Stability: RNA complexed in nanoparticle format for, and only released inside of cells after uptake
- Extrahepatic delivery: not sequestered in liver, but permeates inflamed pathological tissues
- Endosomal escape: pH-dependent nanoparticle disassembly, followed by full release of RNA into cytoplasm
- Selectivity: silences molecular targets in diseased tissues only
- Safety: no cellular or adaptive immune responsivity to nanoparticle components or RNA after multiple serial doses, and no organ toxicities in mice
RNA Therapeutics Growth Strategy: Two Pillars
1. Developing RNA therapeutics to clinical proof of concept for technology platform
- KRAS-driven cancers as first indication for drug development (project AM-401)
- KRAS mutations present in approximately 25% of tumors, one of the most common gene mutations linked to cancer, driving 32% of lung cancers, 40% of colorectal cancers, and 85% to 90% of pancreatic cancer cases (MD Anderson).
- Initiated a preclinical development program
- Aiming for IND in 2023 to be followed by clinical proof-of-concept study
2. Leverage technology platform through partnering
- Aim to leverage platform through collaborations with other biopharmaceutical companies and the out-licensing of technology for other indications
- Intend to become a delivery platform company
RNA BioPharma Sector Being Revalued: Increasing Capital Flows and Active M&A 12
- 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
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Bentrio Is A Novel, Drug-free Nasal Spray
Test-marketed in Germany and Austria in 2H-21. New, growing distribution covers 20+ countries - actively aiming for global.
Protects as a physical barrier the nasal mucosa
Traps airborne particles through electrostatic effects
Humidifies the nasal mucosa and thus aids its functionality
Protects for ≥ 3 hours Gel designed for extended nasal residence time
Bentrio Commercialization
- 3Q 2021 Bentrio launched commercially in Germany and Austria, via online pharmacies
- Distribution in “brick and mortar” pharmacies starting in late 4Q 2021
- Created OTC Consumer Health business unit to support further growth, headed by Big Brand (OTC cough & cold / allergy) industry veteran Jean Lachance starting in May
- Sequential Q/Q revenue growth
- First distributor orders received – sales ramping up as function of national clearances / approvals and market launches
- Key collaborations with Nuance Pharma (China) and Wellesta (India, Southeast Asia)
- $1M upfront received from Nuance, development and commercial milestones up to $22.5M and, upon production transfer, staggered royalty on net sales at high-single to low-double-digit percentage.
More from the company presentation here.
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And right now, CYTO has 4 must-know potential catalysts. Here's what you need to know:
No. 1 CYTO Potential Catalyst - Another Low Float Breakout Idea
According to the Yahoo Finance website, CYTO has a low float.
The website reports this profile to have approximately 13.53Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility.
With so few shares available for trading, other potential catalysts (like big news) could spark a vertical move in the short-term.
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No. 2 CYTO Potential Catalyst - A Pair Of Major Distribution Agreements Announcements
Since the turn of the new year, CYTO has been dropping big news announcements.
Here are two to focus in on immediately in terms of distribution agreements:
Altamira Therapeutics and Nuance Pharma Enter Into Exclusive Licensing and Distribution Agreement for Bentrio in China and Additional Asian Markets
- Nuance Pharma to develop and commercialize Bentrio™ nasal spray in Chinese Mainland, Hong Kong, Macau and South Korea
- Altamira to receive up to $23.5Mn in upfront and milestone payments during initial phase of supply Bentrio™ to Nuance
- Altamira to receive royalties on sales following start of local production of Bentrio™ by Nuance
HAMILTON, BERMUDA / ACCESSWIRE / March 4, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, announced today that it has entered into an exclusive licensing and distribution agreement (the "Agreement") for Bentrio™, its nasal spray for protection against airborne viruses and allergens, with Nuance Pharma Ltd. ("Nuance") in Chinese Mainland, Hong Kong, Macau and South Korea (the "Territory").
...
"We are excited to greatly expand the distribution of Bentrio and further enlarge our footprint in Asia through this strategic collaboration with Nuance," said Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "As a fast growing, well capitalized company with a growing portfolio of products specifically for the treatment of respiratory disorders, Nuance is an ideal commercialization partner for this important and dynamic region. We are looking forward to working with the Nuance team to launch Bentrio."
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Read the full article here.
Altamira Therapeutics and Wellesta Expand Bentrio Marketing and Distribution Agreement to Include Two Additional Markets
HAMILTON, BERMUDA / ACCESSWIRE / February 9, 2022 /Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that the geographic scope of its existing marketing and distribution agreement (the "Agreement") for Bentrio™ with Wellesta Holding Pte Ltd ("Wellesta") has been expanded. In addition to India, Indonesia, Malaysia, Singapore, Taiwan and Vietnam, Wellesta will now also promote and sell Bentrio™ in the Philippines and Morocco upon registration of the product with the regulatory agencies in those two countries.
"The Philippines and Morocco, with populations of approximately 110Mn and 37Mn, respectively, represent two attractive new markets for Bentrio," said Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "Wellesta has proven to be a strong commercialization partner for us, and we look forward to continuing to work with its well experienced team."
Having already obtained marketing clearances for Bentrio™ in Malaysia and Singapore, Wellesta is now making preparations and procedures for registration in the other six countries covered by the Agreement.
Read the full article here.
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No. 3 CYTO Potential Catalyst - Receiving Regulatory Approval To Expand Trial In Macedonia
Altamira Receives Regulatory Approval from the Ministry of Health to Expand COVAMID Trial for Bentrio in Acute CV-19 into North Macedonia
Extending clinical study will complement the ongoing trial in Bulgaria
Reaffirms it expects to complete the study in 3Q-22 subject to sufficient CV-19 incidence
HAMILTON, BERMUDA / ACCESSWIRE / May 5, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has received regulatory approval from the North Macedonia Ministry of Health to extend the COVAMID clinical investigation of its Bentrio™ nasal spray in patients with acute CV19 into the Republic of North Macedonia. North Macedonia is a sovereign nation, which borders Bulgaria to the west and has a population of 2.1 million.
COVAMID is a randomized, placebo controlled clinical trial to evaluate the ability of Bentrio nasal spray to reduce the SCV2 viral load in the nose, alleviate CV19 signs and symptoms, and decrease the frequency of CV-19 related hospital admissions. In the COVAMID trial, 136 confirmed (via a positive PCR test) CV19 patients will be randomized at a 2:1:1 ratio to receive for 10 days either Bentrio, a placebo (Bentrio minus its key mineral component), or no treatment, followed by a 10-day observation phase.
"Extending our study into North Macedonia strengthens our ability to meet our recruitment objectives for the COVAMID trial," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "We are pleased to further expand the number of study sites in accordance with our initial plans and to increase the overall recruitment potential. Subject to sufficient CV-19 cases, we continue to expect completion of the COVAMID trial in 3Q 2022."
Last month, the Company announced that it had reached the midpoint for enrollment in its COVAMID clinical trial. Based on a blinded interim analysis to confirm the validity of statistical assumptions, Altamira will complete enrollment at 136 or expand to up to 180 subjects.
Read the full article here.
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No. 4 CYTO Potential Catalyst - Positive In Vitro Efficacy Data For Bentrio Adds To Growing Body Of Evidence
Altamira Therapeutics Reports Positive In Vitro Efficacy Data for Bentrio Nasal Spray in Protecting Against SCV2 Omicron Variant
HAMILTON, BERMUDA / ACCESSWIRE / March 11, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced positive efficacy data from testing its Bentrio™ nasal spray in vitro against the Omicron variant of the SCV2 virus.
Bentrio™ is a drug-free nasal spray for protection against airborne viruses and allergens, which has previously shown positive outcomes in vitro against the original SCV2 virus and its Delta variant.
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"The latest set of in vitro data add to the growing body of evidence suggesting Bentrio's potential protective effects against SCV2," commented Thomas Meyer, Altamira Therapeutic's founder, Chairman and CEO. "Importantly, they provide further confirmation that Bentrio appears to be effective across virus variants, suggesting broad applicability. We are pleased that Bentrio achieved very encouraging results, not only against the particularly infectious Delta variant, but also against the highly transmissible Omicron variant."
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Read the full article here.
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CYTO Recap - 4 Potential Catalysts For Your New Nasdaq Breakout Idea
No. 1 - Another Low Float Breakout Idea
No. 2 - A Pair Of Major Distribution Agreements Announcements
No. 3 - Receiving Regulatory Approval To Expand Trial In Macedonia
No. 4 - Positive In Vitro Efficacy Data For Bentrio Adds To Growing Body Of Evidence
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Coverage is officially initiated on CYTO. When you have time, do this:
