Half Year 2024 Altamira Therapeutics Ltd Earnings Call
I'm going to make a video on the next episode of the video, and I'll see you in the next video.
Good morning, and welcome to the Altamera Therapeutics first half, 2024, and business update conference call on today's call, our Thomas Meyer, Altamera's founder, Chairman and Chief Executive Officer, and Covadonga Paneda, Altamera's Chief Operating Officer.
Speaker Change: Earlier today, Altamera issued a news release with the first half 2024 financial results, as well as comprehensive business update. The release is available on the company's website at www.altamera.parapudix.com and has been found with the SEC.
Speaker Change: During today's call, the company will be making forward looking statements within the meaning of the private securities litigation reform act of 1995. These include statements that address future operating, financial, or business performance, or its strategies or expectations.
Speaker Change: Forward-looking statements are based on management's courage, expectations, and beliefs in involved significant risks and uncertainties that could cause actual results, developments, and business decisions to differ materially from those contemplated by these statements.
Speaker Change: These risks and uncertainties include, but are not limited to, the timing and conduct of our clinical trials, the clinical unity of our product candidate, the timing or likelihood of regulatory filings.
Speaker Change: and approvals are intellectual property positions and are financial positions, as well as those describes in the risk factor section in our annual report on form 20F and future filings with the Securities and Exchange Commission.
Speaker Change: 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 Change: While it may elect to update these future forward-looking statements as some point in the future, it's specifically this claims any obligation to do so even if it's used change. With that, I'll hand the call over to Altamir Therapeutic CEO, Thomas Meyer, please begin.
Thomas Meyer: Thank you, operator. Hello everyone and thank you for joining our first off 2024 financial results and business update call.
Speaker Change: I will kick off the call by providing an overview of recent corporate developments.
Speaker Change: Our Chief Operating Officer, Covadonga Paneda, will then discuss the progress in our new core business of RNA delivery.
Speaker Change: Finally, I will discuss our financials and outlook for 2024 before opening the call for any questions.
Covadonga Paneda: In 2021, we entered the field of RNA delivery through the acquisition of tracer therapeutics and initiated our strategic repositioning around tracer's exciting peptide-based nanoparticle technology for extraivatic RNA delivery.
Covadonga Paneda: Looking back, this was definitely the right decision to take. Also, it has taken us longer than expected to harness the potential of the tracet technology, which we now call our oligophore and Semaphore platforms.
Covadonga Paneda: I'm pleased to say that we have made great progress and continue to gain momentum with our RNA delivery programs.
Covadonga Paneda: This shows in various forms.
Speaker Change: Fresh and vivo data, recently published in Nature Immunology, a top ranking scientific journal, show dramatic reductions in cancer grows, following treatment with CBTB 46M RNA, delivered with our Semaphore nanoparticle technology.
Speaker Change: Development of both the Oleg of War and the Semaphore platforms, as well as of our A.M. for 1 and A.M. for 11 flagship programs in key rest-driven cancers, and in our three the slightest is progressing.
Speaker Change: Benefitting from our new access to the lab space at the Switzerland Innovation Park in the Basel area.
Speaker Change: At the same time, we are evaluating our platforms for using cardiac regeneration and mRNA vaccines in joint projects with two partners.
Speaker Change: Through our business development activities, we are exploring and discussing additional exciting collaboration opportunities with other pharma and biotech companies.
Speaker Change: While we progress with our innate delivery activities, we keep working towards completion of our strategic repositioning, by divesting or licensing out our legacy assets.
Speaker Change: We already divested part of our venture and nasal spray business by retaining a 49% stake and additional economics.
Speaker Change: from the share of licensing revenues and in case of a sale, we will still participate significantly in the upside of this business.
Speaker Change: The main focus of our current partnering activities is on AM 125, our BEDA ST nasal spray for the treatment of where to go.
Speaker Change: In connection with the repositioning, we have also been optimizing our cost structure, significantly reducing the cash burn rate and contributing to this further simplifying the group structure.
Speaker Change: Ultimately, the goal will be to have a much different business model.
Speaker Change: Compared to the development of drug products, we expect to operate a much less capital intense business based on revenues from contract development and revenue streams from licensing rights to RNA delivery technology.
Speaker Change: Last week, we raised in a public offering of common chairs, gross proceeds of $4 million. To strengthen our financial position and support the ongoing transition to the new business model.
Speaker Change: The shares were issued together with Warrens, which could provide us with up to $8 million in additional cash upon reaching certain development in business milestones.
Speaker Change: Following the summary, I'm handing the call over to Covadonga Paneda, our CEO will provide you with a more detailed update on our RNA delivery business.
Speaker Change: Thanks Thomas, and good morning everyone. It's our exciting times to work in the R&B.
Covadonga Paneda: Research and Development Activities in Alta Merit's core business RNA delivery builds on our peptide base, oligophore and semaphore nanoparticle platforms continue to progress.
Speaker Change: The key focus during the first half of the year has been a nanoparticle formulation and profit development around the platforms.
Speaker Change: as well as on the evaluation and development of nanoparticles for delivery of specific SIRNA and mRNA payloads for partners.
Speaker Change: and for two flagship programs, A and 411, A and 411, the treatment of K-Vastor in cancers and rheumatoid arthritis respectively.
Speaker Change: Evidence for the effectiveness and versatility of Baltimore's RNA delivery platforms keeps growing, as shown by two recent scientific publications.
Speaker Change: A research group from Washington University presented in a pre-print form of publication, the result.
Speaker Change: of a study showing that administration of SOG2 and Mourane delivered systemically with semaphore nanoparticles to mice with abdominal or tick onerism or A-A-A.
Speaker Change: resulted in a significant reduction in our dilation, delayed rupture and promoted a significant improvement in survival weight.
Speaker Change: A.A.A. is an inflammatory disease involving oxidative stress, caused by excessive levels of reactive oxygen species.
Speaker Change: which was solved in abnormal enlargement of the abdominal order and tractor made a life rest.
Speaker Change: In the second study published in Nature Immunology, San Francisco was evaluated as a delivery vehicle for mRNA in the context of cancer.
Speaker Change: Here, another research group from Washington University showed a systemic administration of CB, TB, 46M RNA with Semaphore, non-apodicals, two mouse models of Sarcoma and metastatic breast cancer.
Speaker Change: Results that contain the ABP-46 expression, restored immunosumentary tumor microenvironment, and highly significant reduction in tumor growth.
Speaker Change: When CBTB 46M RNA nanoparticles were combined with an immune checkpoint inhibitor treatment, such as NTPD1, L-Compwave and more pronounced.
Speaker Change: showing that an anti-PD-1 response involves the anti-PD responses that are common-modeled and in the anti-PD-1 refractory breast cancer model generating long-term complete remission of tumor in many of the treated animals.
Speaker Change: Extended monotherapy with the CBCP-46 nanoparticles produced complete remission, even in the most respiratory-20P-1 treatment.
Speaker Change: My Swiss Arcoma eliminated, so treatment did not develop additional tumours following repeated challenge, indicating the development of a protective immunological memory.
Speaker Change: Meanwhile, all from our zone development work has resulted in significant enhancement of nanoparticles stability, which has been one of the key challenges in handling and transport of RNA through formulation.
Speaker Change: Thanks to its news world process production method, the company obtained formulations of oligophore nanoparticles that are stable in liquid form when stored at 4 degrees for a period of at least one month.
Speaker Change: These formulations were in addition able to withstand shaking stress without significant statistical chemical changes. The ability of the manifold relations to maintain their attributes through shaking stress is essential for transportation and one of the key limitations of lipid nanoparticles.
Speaker Change: the most common tables are in a delivery vehicle.
Speaker Change: Focusing on our proprietary development programs A and 401 and A and 401 and A and 401 11. I'll tell me our files during the first half of 2024. Several patent applications with the U.S. patent and trademark office.
Speaker Change: This aim to complete the existence, lecture, or property, and extend direction of protection.
Speaker Change: For AFO01, covered with different K-Rest mutations in cancer treatment with non-aparticles, comprising the oligoport platform, and a single SIR and ASEquin, Policative Assmute, is stopped.
Speaker Change: In vitro data, confirmed the ability of polycairous mute SIRNA to knock down cairous carrying the following mutation.
Speaker Change: Chitwapsi, Chitwapsi, Chitwapsi
Speaker Change: G12R, G12A, and A146G, which account for the majority of the KLS mutations in pancreatic, colorectal, and non-small cell loan cancer.
Speaker Change: for AM411, coverage of nanoparticles comprising a sourness sequence is targeting the p65 protein at component of the NFCAPA in beta transcription factor and only go for a search.
Speaker Change: Activation of P65 has been observed in multiple types of cancer, as well as in many planetary diseases. For instance,
Speaker Change: P665 is a well-known key check point in rheumatoid arthritis inflammation and SARS-Rubyglych, key biological part of this that become dysregulated in rheumatoid arthritis.
Speaker Change: The company aims to advance both A and 401 and A and 411 towards an investigational new drug application filing in the SDA in 2020-26.
Speaker Change: and to outlides them either following the IND or after phase 1 clinical trial at the latest.
Speaker Change: Assamera is pursuing a picks and shovels strategy with the RNA delivery business. This strategy is based on the licensing of its platform technology to partners in the biotic and pharma industry for the use with their own RNA payload.
Speaker Change: refers to such collaborations have been set up.
Speaker Change: with Hecketsu Epidics, a spin-off from King's College London, as from here it's working a nanoparticles based on the oligoport platform and comprising certain non-coding RNAs for the regeneration of damaged heart tissue following myocardial infection in an animal model.
Speaker Change: with Badgeum-based Universal Scoop out-smair as evaluating the use of the Semaphore platform for delivery of mRNA vaccine.
Speaker Change: Thanks to lower mRNA loss during cell entrance, the nanoparticles may allow for using lower doses and thus results in potentially more effective and efficient vaccines.
Speaker Change: The Pompositive Outcome for Obsessive Alluations, Art Humea and its partners in tend to discuss and negotiate licensing agreements.
Speaker Change: So it's business development activity as the company is pursuing additional collaboration of the changes with other formats and biotech.
Speaker Change: and Covadonga Paneda.
Speaker Change: In August 2024, part of a company's expanding research and development team moved to Switzerland Innovation Park in Auschwill near Bottle.
Speaker Change: At the new location, the company has access to modern and well-equipped last facility to support its government activity.
Speaker Change: I will now turn the call back to Tom.
Speaker Change: Thanks, Covadonga.
Speaker Change: I will discuss now our two main legacy assets, the Venture or Drug Free Nays of Spray for Allege and our aim 125 that is T-Nays of Spray for Rodego and other disorders of the central nervous system.
Speaker Change: Our associate, Altamira Medikayji, made further progress in implementing its growth strategy with Benchill. A drug free, reserved for free, is a spray for the treatment of allergic unites.
Speaker Change: We are very pleased that Medica agreed with two of its international distributors to expand their exclusive distribution territories.
Speaker Change: With Neil's former, to extend the territory across South East and East Asia, under the amended agreement.
Speaker Change: New York's territory will expand from China, Hong Kong, Macau and South Korea to also include Singapore, Malaysia, Thailand, the Philippines in Indonesia, Vietnam and Taiwan, was a combined population of greater than 613 million people.
Speaker Change: New York has been marketing ventures since late 2022 in Hong Kong, and recently submitted the request for marketing approval for mainland China.
Speaker Change: We expect news to launch Ventura in May, on China in 2025, and this huge market to become a key growth driver in the years ahead.
Speaker Change: Medical will be entitled to a milestone payment of $1 million upon Chinese marketing approval.
Speaker Change: With Pharma Nordic to extend the territory from Norway to also include Sweden and Denmark, which together have a population of 16.5 million people.
Speaker Change: For a monolithic launch venture was successfully no wait in 2024 and it tends to introduce product Sweden and Denmark in 2025.
Speaker Change: Scandinavia is a very interesting market for nasal sprays in general.
Speaker Change: The two licensed territory expansions are a strong mutual vote of confidence by the parkers. And we look forward to further growing the venture franchise with them.
Speaker Change: Meanwhile, discussions and negotiations for the marketing and distribution of venture in the US, Europe and other key markets are on goal.
Speaker Change: with our second nasal spray program A125 for the Tribunal of the Q-Dvestable Syndrome, ABS and potentially other disorders of the central nerve system.
Speaker Change: We continue to work towards partnering of the asset.
Speaker Change: A125 has been developed to help acutely visit patients get back on their feet more quickly
Speaker Change: The drug product is a reformation of better histine, a histamine analogue, which in the traditional oral formulation is the standard of care treatments where to go in many countries around the world.
Speaker Change: A Phase II clinical trial in Europe demonstrated that a four-week treatment course was AM-125 and AVS patients was well-polarated and helped to accelerate vestibular compensation, enabling patients to regain balance and recover faster.
Speaker Change: In the U.S., they're all about his scene, exceptionally has not been marketed for decades and no comparable product exists.
Speaker Change: Automere received in summer 2023 IND clearance from the FDA for a phase 2 clinical trial in benign proxistinal positional vertical BPPV, which is the most frequent type of ADS.
Speaker Change: BPPV accounts for 17 to 42% of all diagnosed vertical cases.
Speaker Change: U.S. healthcare costs associated with diagnosis of PPPV alone approach $2 billion per year.
Speaker Change: Now a few words about the simplification of our corporate structure.
Speaker Change: Since the partial divestiture of the venture business in late 2023, we have continued our efforts to streamline our group structure and align it with our strategic positioning around the RNA delivery platforms.
Speaker Change: In the first half of 2024, we transferred our Irish subsidiary.
Speaker Change: To Altamira Medical AG, emerge two of our subsidiaries in Basel.
Speaker Change: to the combined entity which is called Altamira Surputi's AG and which continues to serve as the core operating subsidiary.
Speaker Change: Following this restructuring, the ultimate aircraft comprises the parent company of the mayor of Sirpudix Limited
Speaker Change: in Hamilton, Bermuda, and its subsidiaries, Alpamero Seputic, A.G. in Basel.
Speaker Change: Altamiya Supurix Inc in Newark, Delaware, Hotel Anom in Basel as well as the associated company Altamiya America AG.
Speaker Change: This means that we are no longer using the name of forest medical.
Speaker Change: Upon the partnering licensing out of A125, which is currently concentrated in our Autolanum AG subsidiary, we expect to do one more final step of simplification.
Speaker Change: Now, turning to our financials.
Speaker Change: Before reviewing our financial results for the first part of 2024, I would like to note that the financial statements are presented for the first time in U.S. dollars, rather than Swiss francs.
Speaker Change: Further, I need to highlight that the income statement for the first half of 2023 has been revised retrospectively due to the partial divestiture of the Benchew business.
Speaker Change: The Venture activities are reported now as discontinued operations.
Speaker Change: Continuing operations does comprise the RNA delivery development programs, as well as those related to a month 25.
Speaker Change: Overall, we were pretty much on track with expenses in the first half of 2024.
Speaker Change: Total operating loss from continuing operations was $3.9 million in the period, compared against the $3.6 million in the first half of 2020.
Speaker Change: 2023.
Speaker Change: The increase was primarily related to higher expenditures on the research and development which increased 32.6% to 2 million dollars.
Speaker Change: This was partially compensated by lower general and administrative expenses, which decreased 11.7% to 2 million dollars.
Speaker Change: Net loss from continuing operations reached $4.3 million in the first half of 2024, which was 4% lower than in the corresponding reporting period in 2023.
Speaker Change: Finance expands decreased markedly from 0.9 million to 0.2 million dollars. On the other hand, the company recorded a pro-rater loss of its associate company, all to mere medical of 0.2 million dollars.
Speaker Change: In the first half of 2023, there was no such impact as ultramaramedic that was deconsolidated and classified as associate only upon its partial deficit in November 2023.
Speaker Change: The company's net loss for the first half of 2024, amounted to $4.3 million, which was 27% lower than the $5.9 million and was recorded in the first half of 2023.
Speaker Change: During the first six months of 2023, the company had recorded an after-tax loss of $1.4 million from this continued operation. There was no such loss recorded in the first half of 2024.
Speaker Change: work
Speaker Change: Turning to the ball and cheat.
Speaker Change: here.
Speaker Change: We are not seeing major changes compared to December 31st, 2023.
Speaker Change: Cheryl the equity amounted to 6.3 million out of June 30, 2024 compared with 7.7 million dollars at year and 2023. There was no financial debt outstanding at either time point.
Speaker Change: [inaudible]
Speaker Change: Cash used in operations, decreased from 8.4 million in the first half of 2023 to 3.2 million dollars in the first half of 2024.
Speaker Change: Financing activities provided $8.4 million dollars in the first six months of 2023 versus $2.5 million in the first six months of 2024.
Speaker Change: Cash and Cash Equivalence.
Speaker Change: On June 30, 2024, totaled 65,000 compared with 55,000 at June.
Speaker Change: 30s, 20, 23.
Speaker Change: At the mirror expects total cash needs in 2024 to be in the range of 5.8 to 7 million dollars, which is slightly lower than initially budgeted.
Speaker Change: During the third quarter of 2024, the company raised 0.7 million dollars from share issuances under the 2022 commitment purchase agreement with Lincoln Park Capital Fund.
Speaker Change: In addition, last week received gross proceeds of $4 million net $3.3 million upfront from a public offering of common shares.
Speaker Change: and pre-funded warrants in new of common shares, which have two types of milestone linked common share warrants attached.
Speaker Change: These milestones are defined as positive by the distribution data for our aim for one and aim for 11 nanoparticles.
Speaker Change: which we seek to obtain in the course of 2025.
Speaker Change: The NG into one or more agreements relating to the further development and commercialization for AM411
Speaker Change: which we seek to obtain as mentioned upon opening of an I&D by the FDA in 2026 or completion of a phase 1 clinical trial at the latest.
Speaker Change: Both Meyer stones will be very significant for the company could provide additional funding of up to $8 million.
Speaker Change: It is, however, to be noted that it can be no guarantee that the warrants will be exercised by their holders.
Speaker Change: With the current cash, as well as expected proceeds from RNA delivery project revenues, our associate of the mere medical, the part ring of AM-125, as well as from other sources, we consider our cash needs to be covered for the next 12 months.
Speaker Change: With this, let me conclude with a brief summary and some perspectives.
Speaker Change: At the beginning of today's presentation, I mentioned the growing momentum in our new core business of RNA delivery.
Speaker Change: It is very exciting to see the significant progress that we have been making over the past few months and quarters in our R&D.
Speaker Change: I'm really proud of the great achievements of our strong and highly motivated or an 18, both with SRNA and mRNA applications.
Speaker Change: Progress in the latter is particularly noteworthy since MRA formulation and delivery are generally considered to be challenging.
Speaker Change: Not a leaf due to such challenges, the use of mRNA for sub-pudix has barely begun.
Speaker Change: We have just scratched the surface of something that will become a very powerful approach in human matters.
Speaker Change: From our business development contacts, we are seeing a very significant potential for our oligo-4 and several four platforms.
Speaker Change: We certainly still have some way to go with our R&D. That will soon be much more in vivo work with the distribution being a key focus for our activities.
Speaker Change: I'm glad that going forward, we can benefit from work from the well equipped lapses facilities at the Switzerland Innovation Park, as well as from our growing network of specialized external service providers.
Speaker Change: As for our legacy assets, I will associate the mere medical keeps executing on its growth strategy.
Speaker Change: The expect to see a significant increase in the revenues in 2025 from distributors. Driven, body anticipated launches in mainland China, Southeast Asia, Sweden and Denmark, as well as certain other countries.
Speaker Change: Given the strong efficacy, good for ability of venturing, allergy, we see a good partnering in the potential and also key markets.
Speaker Change: Meanwhile, we're positioning a 1-25 for partnering as an innovative, reformulated drug product with significant sales potential in Berkiko, but also in other disorders of the central nervous system.
Speaker Change: In short, we look forward to advancing our project towards important new milestones and to updating you with further reports about our progress.
Speaker Change: With that, I would now like to turn the call back to the operator to open the lines for questions.
Speaker Change: Certainly, as a reminder to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again.
Speaker Change: [inaudible]
Speaker Change: I'm going to get in there.
Speaker Change: and our first question.
Speaker Change: i
Speaker Change: Again, Hunter Diamond of Diamond Equity, your line is open hunter.
Speaker Change: Yes, congratulations on the results. Most of my questions were answered, but...
Speaker Change: My question relates to the venture of distribution in Sweden and Denmark now it's been launched in Norway. Can you discuss the marketing approach in Norway or partnerships to replicate the success of that in Norway within the new markets?
Speaker Change: Hi Hunter. Yeah, Farman Odek is pursuing here.
Speaker Change: We're a good strategy.
Speaker Change: They are actually working with a network of physicians.
Speaker Change: So this is a color colleges and the E&T physicians so too.
Speaker Change: Familiarized them with the product. At the same time, they have a Salesforce set calling on the pharmacies. They have also been using social media quite extensively. And just one example was that
Speaker Change: Tik Tok event, so which was just a three minute something like that, which generated within three or four days about 700,000 views and 500 or 600 comments.
Speaker Change: So it's...
Speaker Change: It's an approach that plays on various levels.
Speaker Change: Now, Pharma Nordic has pretty detailed plans here, also for Sweden and Denmark. I mean, each country, of course, is a little bit different, however, they're all Scandinavian, and so therefore, they're also benefits here from.
Speaker Change: Applying, let's say, marketing materials and experiences to the other countries.
Speaker Change: So the whole team there is...
Speaker Change: I'm pretty motivated to get going.
Speaker Change: Great. Thank you and the second question I don't know how much of it relates to you, but maduro, Matt I'm sure you know some of these large mrna companies have cut their R&D budgets is there any effect on your business or any thoughts on that like how it affects smaller enterprises related to larger companies, maybe it's a benefit to smaller businesses.
Speaker Change: <unk>.
Speaker Change: Theres less R&D at larger corporations.
Speaker Change: Yes, well I think there is still a lot a lot.
Speaker Change: Of <unk> and activity yet.
Speaker Change: Companies like mother or not.
Speaker Change: I mean, I'm suddenly not the right person here to comment on multiyear enough.
R&D plans whatsoever, I mean, what I can say is simply that.
Speaker Change: Mrna the use of mrna here for therapeutics.
Speaker Change: And of course also vaccines still holds tremendous potential.
I would rather see this a little bit here as focusing strategy I mean of course, you can pursue many different projects at the same time.
Speaker Change: But it requires obviously certain resources now what we see here is clearly the upside.
Speaker Change: Mrna.
Speaker Change: You can really.
Speaker Change: You boost here certain biological activities and when you think of small molecules.
Speaker Change: The majority vast majority of small molecules, they inhibit or block things.
Speaker Change: And for.
Endesa Rene: For that you can use <unk> RNA Endesa Rene has set a very good potential now for small molecules to actually enhance our boost certain activity that has been always very.
Endesa Rene: Very very big challenge and now with mrna you can do this in a very targeted.
Endesa Rene: And specific fashion and thats going to really revolutionize.
Endesa Rene: It's not just me, saying this.
Endesa Rene: Are they not.
Endesa Rene: The most.
Endesa Rene: Let's say.
Endesa Rene: Uh huh.
Endesa Rene: Knowledgeable person to comment on this but this is clearly what we feel what we hear at conferences.
Endesa Rene: Mrna.
Endesa Rene: That's going to be.
Endesa Rene: Bright future.
Endesa Rene: I think what we have read or heard here about some.
Endesa Rene: Program adjustments.
Endesa Rene: Is not.
Endesa Rene: Deviating at all from the long term trend.
Endesa Rene: That is going on.
Endesa Rene: Great exactly I just was curious because you are more immersed in the area for conferences.
Speaker Change: I was just wondering your take on it okay. Thank you for taking my questions I'll open the line for other questions Youre welcome. Thank you.
Speaker Change: And again as a reminder to ask a question. Please press star one on your telephone and wait.
Speaker Change: For your name to be announced.
Speaker Change: I am showing no further questions. We will now turn the call back over to management for any concluding remarks.
Speaker Change: Yes. Thank you I'll, let Tony I believe for you have covered all major topics today. So I will simply thank everyone for attending this morning's call.
Speaker Change: For the questions and I will wish you a terrific. Thank.
Thank you.
Speaker Change: Goodbye.
Speaker Change: And this concludes today's conference call. Thank you for participating you may now disconnect.
Speaker Change: Okay.
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