Half Year 2023 Altamira Therapeutics Ltd Earnings Call

Speaker 1: Good morning and welcome to the Altamira Therapeutics first half 2023 Financial Results and Business Update Conference call. On today's caller Thomas Meyer Altamira Therapeutics Founder, Chairman and Chief Executive Officer and Covidanga Paneta Chief Operating Officer.

Speaker 1: Earlier today, Altamira Therapeutics issued a news release with the first half 2023 financial results as well as a comprehensive business update.

Speaker 1: The release is available on the company's website at ir.altamiratherapeutics.com and has been filed with the SEC.

Speaker 1: During today's call, the company will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Speaker 1: These include statements that address future operating, financial or business performance, or our strategies or expectations.

Speaker 1: 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.

Speaker 1: These risks and uncertainties include, but are not limited to, the timing and conduct of our clinical trials, the clinical utility of our product candidates, the timing or likelihood of regulatory filings and approvals, our intellectual property position and our financial position, as well as those described in the risk factor section in our annual report on Form 6K and future filings with the Securities and Exchange Commission.

Speaker 1: In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing its views as of any subsequent date.

Speaker 1: While it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so even when its views change.

Speaker 1: With that, I will hand the call over to Thomas Meyer.

Speaker 2: Thank you, operator.

Speaker 2: Hello everyone and thank you for joining our first half of 2023 Financial Results and Business Update Call.

Speaker 2: Together with our Chief Operating Officer, Kobadonga Pannida, I'm pleased to be providing an update on the advancements that we have made during the first half of this year, which includes updates on our clinical activities, recent strategic partnerships, positioning our legacy business for future opportunities, corporate developments that make us a stronger company today, as well as our financials.

Speaker 2: We will then address questions that we receive from investors. For investors right now, macroeconomic uncertainty continues to prevail on a global scale. And also there is softening in many areas, labor, consumer demand, housing markets. I still believe in the resilience of our economy.

Speaker 2: In the biotech sector, what we are seeing is a sense of renewed optimism.

Speaker 2: Many companies within our industry continue to make positive strides.

Speaker 2: What's more, the future looks promising thanks to exciting new discoveries and development, making this an opportune time to strengthen product offerings and pipelines through strategic partnerships and acquisitions. We continue to make headway in our RNA therapeutics business this year. This has been a process of repositioning the company that we initiated last year to generate long-term shareholder value.

Speaker 2: The evolution of our company includes leveraging our various pipeline assets, which we have been very transparent and methodical about.

Speaker 2: RNA-based therapeutics represent a highly attractive and promising market.

Speaker 2: In fact, a light-market research estimates that sales of RNA-based therapeutics based on RNA interference and antisense oligonucleotides are expected to reach $25.1 billion by 2030.

Speaker 2: Given that the corresponding figure for 2021 was just $4.9 billion, the industry is registering a compound annual growth rate of 17.6%. And this is only one part of the market and opportunity, as it does not even include any sales of mRNA therapeutics.

Speaker 2: RNA-based therapeutics hold vast promise for addressing numerous diseases that presently lack optimal or viable treatment options.

Speaker 2: And thus...

Speaker 2: Our focus in the long term is to hone in on tools for RNA delivery through therapeutic targets beyond the liver and efficient endosomal releases inside target cells.

Speaker 2: With regards to our legacy assets centered on OTC consumer health and inner ear therapeutics.

Speaker 2: We have achieved significant milestones in the clinical and regulatory domains.

Speaker 2: Notably, our clinical trial featuring Bentrio for seasonal allergic rhinitis successfully met its primary endpoint.

Speaker 2: Adding to the existing body of compelling efficacy data.

Speaker 2: In addition, we were pleased to report that the FDA cleared an investigational new drug, IMD, or AM125 drug, which targets acute Westerbork syndrome.

Speaker 2: These milestones are important elements in our ongoing partnering discussions.

Speaker 2: Our intent is to divest or partner our legacy assets, venture and AM125, for further development and commercialization in the context of our strategic pivot to RNA delivery technology.

Speaker 2: To this end, our discussions are ongoing and we'll provide you with updates as they become more concrete material.

Speaker 2: Concurrently, we achieved significant strides in elevating awareness and recognition of our oligo4 semaphore platforms, particularly in the realm of extra hepatic RNA delivery and efficient endosomal release.

Speaker 2: We recently announced our collaboration with Hequitt Therapeutics to pursue the development of cardiac regeneration treatments.

Speaker 2: Harnessing the power of RNA through our OligoForum platform.

Speaker 2: This serves as an encouraging testament to the growing interest in our technology, and we hold a strong conviction regarding the potential for forging additional partnerships with other biopharmaceutical companies.

Speaker 2: And now I will pass the call over to our Chief Operating Officer, Kawadonga Panita, who will talk more about that and our RNA programs.

Speaker 3: Cola?

Speaker 4: Thanks Thomas and good morning everyone.

Speaker 4: Altamira's progress in advancing RNA delivery technology through our oligo4 and semaphore platforms is meaningful.

Speaker 4: These platforms are built upon a patented peptide designed to deliver RNA in nanoparticles to tissues beyond the liver and efficiently release them into target cells.

Speaker 4: Recently, we received further external validation of this technology through two in vivo studies conducted by independent research teams at Washington University of Madison and San Diego.

Speaker 4: In one study, the research team shared animal data showing that nanoparticles based on our SAMA4 platform loaded with ZTB46 mRNA efficiently restrained tumor growth.

Speaker 4: What's more important is that the introduction of ZB-TB46 mRNA specifically into the tumours of treated animals prompt the creation of an immune stimulating environment around the tumor, further limiting its growth.

Speaker 4: This effect was notably enhanced when combined with anti-PD-1 immune checkpoint inhibition of TuneIn stopping as she uses the

Speaker 4: indicating that set BtB46 mRNA delivered by semaphore nanoparticles could serve as a valuable supplementary therapy alongside immunotherapy for cancer management.

Speaker 4: This exciting development highlights the potential of our technology in the field of cancer treatment.

Speaker 4: In a second study, researchers administered nanoparticles based on semaphore loaded with an mRNA encoding for DMMT-BB, a protein known to be involved in cartilage on a sezum.

Speaker 4: directly into the joints, that is, in particular, administration of mice with meniscal injuries.

Speaker 4: The outcome was quite promising.

Speaker 4: There was a robust increase in DNMT3B protein levels, and the mice experienced significant reduction in bone sclerosis, cartilage degeneration, and sinovitis.

Speaker 4: In addition, the functional assessment revealed that the treated mice showed significantly decreased pain sensitivity and improved weight bearing in the active treated mice compared

Speaker 4: The research serves as a testament of the potential of RNA therapy and we couldn't be prouder of their achievements.

Speaker 4: These findings also bolster on wavering commitment to advancing RNA therapy and underscore the significant impact that it can have on improving healthcare outcomes.

Speaker 4: Together with our partners and researchers, we remain steadfast in our mission to harness the power of RNA for the betterment of patients worldwide.

Speaker 4: At the same time, we advanced the work on our two flagship development programs, AM401, for the treatment of K-res-driven tumors and AM411 for the treatment of bromothoate arthritis, targeting NF-kappaB.

Speaker 4: aiming for an IND submission in 2024. We plan to out-license the two programs either following IND or after a Phase 1 clinical trial at the latest.

Importantly, we find the provisional patent application related to the single polyvalent fRNA sequences, which is part of AM401, can target different K-breath mutations.

We call this polykaryote.

If granted, the patent would extend IP coverage for the programs to 2042.

In line with our strategy of leveraging oligo4, semaphore, throughout licensing and partnering, rather than commercializing our own products, we have significantly expanded our business development activities.

This includes the engagement of Maria Gurnewald, PhD, a highly experienced business developer based in Boston as a senior business advisor.

As Thomas mentioned earlier, on July 5th, 2023, we announced that we were entering into a collaboration and option agreement with Hecate Therapeutics.

A biotech spinout from King's College, London.

Our collaboration centers on the testing of nanoparticles utilizing our innovative oligo4 delivery platform combined with specific non-coding RNA for the purpose of regenerating damaged heart tissue post-myocardial infarction in animal models.

Should this experiment yield successful outcomes, HECET will have an option under certain conditions to initiate negotiations with Aljameirah for a license.

granting access to our technology and intellectual property.

This in turn would enable HEC-CAT to advance their discoveries into the development of therapeutics for cardiac regeneration.

The potential of cardiac muscle regeneration remains a topic of great interest to the global scientific and medical community, given the substantial complications and elevated mortality rates associated with myocardial and dupart

We firmly believe that Altamira's peptide-based oligo4 platform, tailored for RNA delivery, possesses the capacity to serve as a secure and efficient conduit for controlled localized cardiac regeneration.

In late May, we shared some exciting news about an article published in the International Journal of Molecular Sciences.

This paper, titled, Peptide-based Nanoparticles for Systemic Extrapatric Delivery of Therapeutic Nucleotides, was authored by researchers from the University of Washington, St. Louis, the University of California, Los Angeles, and our very own Chief Scientific Advisor, Samuel Wickley.

who discuss the challenges when trying to safely and efficiently deliver important RNA molecules to cells outside the liver.

These RNA molecules have great potential for treating various diseases. The difficulties lie in their natural instability and getting them inside cells.

While there are some delivery methods that work well for liver-related conditions, there aren't as effective for other parts of the body.

Additionally, even when one manages to get RNA into cells, getting it out of the endosome and into the right part of the cell can be tricky.

In recent years, science made tremendous strides in understanding how cells react to RNA treatments, but major challenges have remained for diseases that aren't liver related.

That's where our peptide nanoparticles like Oligophore and Semaphore come into play. They offer a promising way to deliver RNA treatments to diseases beyond the liver and ensure they get where they are needed. I will now turn back the call to Thomas.

Thank you, Koval.

Now let's discuss our legacy assets, the Bentrio drug-free nasal spray and our AM125 beta-histine nasal spray for vertigo.

In the month of May, we shared exciting findings from the randomized controlled Nazar clinical trial, evaluating benchionesal sprain patients with seasonal vertic retinitis, short SAR, and a

To study efficacy of Bencio, there's another trial enrolled 100 patients in Australia who are randomized at a one to one ratio to receive either Bencio or saline nasal spray for two weeks via self-administration three times per day or as needed.

For legibility, patients had to have baseline reflective total nasal symptom score, RTNSS,

at least five points out of 12 referring to the worst level of nasal congestion, sneezing, nasal itching and renal area.

which is a runny nose, within the past 24 hours averaged over a one-week treatment-free running period. The primary efficacy endpoint was defined as the difference in the average RTNSS over the subsequent two-week treatment period between Bentrio and saline nasal spray, which is the current standard of care when it comes to drug-free allergic rhinitis management.

The Nazar results demonstrated for Bancho a statistically significant and highly relevant clinical improvement in efficacy over saline nasal spray.

The improvement from baseline was 1.9 points in the RTNSS, which was 1.1 points or 2.4 balls larger than saline.

Both outcomes came in well above the minimal clinically important difference of 0.28 points.

The next questions are about the RNA activities and they will be answered by doctor upon eat out.

The first one is.

If your platforms are truly exceptional how come that you still need to make a lot of efforts to make it known.

Caller please.

Okay.

They feel the bar in Ethiopia.

Instant evolution on drug and biotech companies that are continuously assessing different technologies to ascertain the best option to play with all our Eagle Jacks.

Up to now.

Fields has been extremely focused in lipid nanoparticle or LNP.

L M P.

Great.

The progress achieved with Alan piece would be spectacular the technology is very powerful however.

This technology has also limitations, especially when it comes to delivering arnie to target tissues beyond the liver.

Regarding the release of the army cargo with same target itself.

Give them their good performance liver delivery a lot of efforts have been made to modify Alan piece in a way that they reach also.

Non hepatic tissue.

Success has been rather limited so far and in addition, there are quite few intellectual property issues that come with this technology.

For pharma and biotech companies have started to explore a tentative.

I think that we've made great asset.

Within relatively short period of time to increase the visibility of our technology with them, especially also be young scientists exactly.

We are very pleased that we have been invited to more of a more industry Symposia conference Dr Technology.

Most recent example is sort of a participation into our Nancy Dixon deliberately content.

Well, we are moderating a panel on the future of Arnie therapeutics outside the liver and sharing assertion RNA coordination Jackie.

In parallel to increasing our visibility we have been engaging in Nicaragua.

That business development discussions with biotech and pharma company.

So as these discussions we can draw on them show potential partner as the large <unk>.

Amount of data.

Second collaboration that's been just the stock.

Based on our growing pipeline.

To enter into collaborations.

Yeah.

Okay. Thank you and.

The second question to you is the following.

Holland Wells will you start making money on the RNA business.

There are two main parts the army business start generating money.

Besides these two collaborations with companies that seek to use our technology to deliver there arnie cargo.

Milestones coupled with these deals.

So this is about granting access to Oliver for the kind of attack.

Longer term this will be the key driver for us.

The second is too.

Out licensing other two flagship program, saying for one nameplate.

Sure.

I already mentioned.

We expect to partner them either at your filing in R&D next year or after please one typically such transactions include some upfront payments milestones.

Well, that's all the ounces.

Okay. Thank you Colo the nexen.

A question is about with our venture program.

There are quite many nasal sprays available for treating hay fever, since you want to partner venture or the obvious question is what could be the appeal of such a product to one of those larger OTC companies.

Well, it's certainly true that there are quite a few offerings out there for suffers so allergic rhinitis importantly, there is no cure for it except for desensitization, which is allergen specific immunotherapy.

Most suffers seek to manage the symptoms by ease of trying to prevent or reduce exposure to allergens or by seeking to relief than freak.

Frequently antihistamines are used either in foremost tablets or nasal sprays.

They block or reduce the action of Histamines.

Just a bunch of releases when under attack from allergens.

So truck based option is to use of corticosteroid sprays, which seek to reduce the inflammatory response.

And then there are seawater of saline nasal sprays, which helped to rinse the nasal cavity and eliminate the allergists. This is a very popular drug free option.

Now as always there are some kind of trade off involved with.

Many of these treatment options.

So some of the drug based treatments, especially older antihistamines can make you feel drowsy.

Then drug based treatments, usually contain some preservatives, which may provoke some stinging or burning sensation.

Major way out your nasal mucosa.

Well, most tryst nasal mucosa, it's very important for the natural line of defense of the nose.

And then would you struck sometimes they take a while to start acting which may be an issue. For example, if you unexpectedly get exposure to allergens and we'd like to protect yourself a S. A P.

On the other hand to say like nasal sprays are usually well tolerated does there a physiological so they topped the drug based options on that account.

The tradeoff is that there are sick as he is lower.

This is the rinsing and so you.

This seawater drain off relatively quickly and you would need to reapply frequently which is not that practical.

Now for venture we are seeing an attractive positioning allowing for significant product differentiation. So venture as a triple mode of action rapid onset and several hours of nasal residents time. So its efficacy is approaching that of Medicaid and nasal sprays yet.

Yet its safety and Tolerability similar to seawater nasal spray so in short.

We considered a benches and attractive product for the management of allergic rhinitis offering strong clinically relevant efficacy rapid onset and favorable tolerability and safety profile.

We believe this is quite compelling and we are happy to have received patient feedback supporting this.

Both in the context of our clinical trials.

And also from patient testimonials.

So this is the end of the Q&A session. So please.

As have been good questions.

I hope he could have answered them well.

I believe we've covered all the highlights thoroughly today, so I will simply thank everyone for attending this morning's call and wish you a terrific day ahead. Thank you very much.

This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.