Scinai Immunotherapeutics Ltd. (NASDAQ:SCNI) Q2 2024 Results Conference Call August 20, 2024 11:00 AM ET
Company Participants
Liat Halpert – Head of Business Development
Amir Reichman – CEO
Liat Halpert
Good morning, everyone. And welcome to Scinai Immunotherapeutics Investor Webinar. My name is Liat Halpert, and I’m Head of Business Development at Scinai. Thank you for joining us. Today, Mr. Amir Reichman, Scinai’s CEO, will present our Q2 financial results and provide a business update of our activities in 2024, including an update about our R&D pipeline development, our CDMO business unit and our upcoming strategic milestones. I want to remind everyone that this recording will be available later on our website at www.scinai.com/investorrelations in one word.
And now for some housekeeping. In this webinar, we will contain projections or other forward-looking statements regarding future events or the future performance of the company. These statements are only predictions, and Scinai can’t guarantee that they will occur. Actual results may differ from those projected. For more information, please refer to our forward-looking statement section at the start of this presentation. At the end of this presentation, we will allow for a Q&A session. Anyone who has a question is invited to submit it through the system. I will collect the questions and will present the most popular ones to Amir at the end of his presentation. We will try to answer all questions even those that have not been addressed on the live session by posting them on our Web site alongside a link to this recording. The presentation will last 40 minutes. And in the end of it, we will allow for 20 minutes. And now please let me introduce Mr. Amir Reichman, Scinai’s CEO. Amir, the stage is yours.
Amir Reichman
Thank you very much, Liat, for the nice introduction. And for the sake of housekeeping here is the safe harbor statement. It’s going to be also available on our Web site, together with the recording. So thank you, everybody, for joining us today. Let me introduce Scinai, our Q2 2024 financial results and provide some business updates. So who are we, Scinai Immunotherapeutics? We are a biotechnology company located in Jerusalem, Israel, with a mission to building a healthier and happier world by developing, manufacturing and commercializing innovative inflammation and immunology biological products primarily for the treatment of autoimmune and infectious diseases. And here, you can see the teams, one of the holiday year celebrations. Scinai Immunotherapeutics is a biotech start-up company with two business units, as you can see on the screen in front of you. An innovative R&D unit, discovering novel VHH antibodies under a research agreement with the Max Planck Society in Germany, and developing those antibodies in its facility in Israel under an exclusive license from the Max Planck. The second business unit is a drug development service unit, CDMO, providing services to early stage biological drug development projects for customers in Israel and plans to expand in the future also to serve customers from Europe and the United States.
Our executive team is highly experienced with pharmaceutical drug development and manufacturing. Myself — I myself had the experience as a former entrepreneur, who was one of the founders of the company that traded on the NASDAQ until 2017 and was acquired by Mitsubishi Tanabe Pharma for $1.1 billion. I then earned an MBA degree with the Wharton School of Penn University before spending five more years with Novartis North America in the United States, an additional six years with GSK in Europe. Together with me on the team are accomplished executives with vast experience in their fields. Our Board of Directors is chaired by Mr. Mark Germain, who was one of the founders of Alexion and Neurocrine, to name a few. Together with Mark, I will mention Mr. Sam Moed, who served as the Global Head of Corporate Strategy at Bristol-Myers Squibb; and Mr. Jay Green, who served as the CFO of GSK Vaccines. Our cap table includes 838,578 American depository shares traded on the NASDAQ, and these are the shares that are outstanding. In addition, we have warrants for 557,829 ADSs, which, if exercised, can bring additional $4.3 million in cash to the company. The EIB we’ll receive after the deal that I will explain shortly, 1,000 preferred shares which are convertible to 364,000 ADSs in aggregate, and each preferred share is convertible to 364 ADSs. Our 2024 strategic guideline principles are to increase shareholder values by the following points: one, fast track IL-17 development to toxicology studies; two, progress assets created through the research collaboration agreement with Max Planck and UMG to in-licensing; ramp up the CDMO business unit to target sales of $1.25 million; hedge or share R&D risks by partnering with other pharma companies; careful spending to sustain company’s [indiscernible] rate; and ensure sufficient capital to support R&D, either through and, of course, preferably with non-dilutive and if necessary, with dilutive funding; keep and develop the talent.
So let’s talk about our Q2 financial results and here is a table summarizing what we’ve reported in the recent few days. So R&D expenses as of June 30, 2024 amounted to $2.79 million in approximation versus June 30th of last year, $3.45 million. The decrease is primarily due to a reduction in salaries and reduced use of subcontractors. We took these measures in order to sustain our cash position. Marketing and G&A expenses were at $1 million for the first six months of 2024 compared to $2.3 million and the decrease is due to a reduction in salaries, share based compensation and professional services. Our financial expenses also decreased from $1.5 million in 2023 — in the six months of 2023 to $0.53 million in the first six months of 2024. And the reason that 2023 was high is because the value was driven by reclassification of warrants to equity, which improved our balance sheet and then the warrant deducement deal in December 2023 and also the revaluation of the loan, resulting in a lower book carrying value at the end of last year. Our net loss for the first six months of 2024 amounted to $4.48 million compared to $7.28 million in the previous year — in the first six months of 2023. And the decrease is primarily due to the reduction in operating expenses across all business units, R&D and CDMO.
Our cash available as of June 30th is $3.21 million versus $7.63 million at the end of June 30, 2023. We provided this first — in this quarter, the first time CDMO revenues. And we also received Israel Innovation Authority grant to support the CDMO ramp-up. Both helped us to reduce cash burn. And then we will talk shortly about the announcement we just made a couple of hours ago about an investment commitment — equity commitment that we received from Mr. Daniel Stone that will also allow for additional $2 million before the end of this year. Shareholder equity at the end of this quarter will be negative $7.28 million versus negative $4.57 million at June 30th mark. However, the EIB debt to equity deal, which is expected to close in the next couple of days, should increase the shareholder equity by approximately $19 million, which should bring approximately — on a pro forma basis, the June 30, 2024 to be approximately $12 million positive in shareholder equity. The EIB loan to equity. So that’s the main thing that we did from a financial — from an accounting restructuring point of view. We have a new outstanding principal amount to equal EUR250,000 instead of the principal amount and the accrued interest, which amounted already to almost $29 million or EUR26.6 million that the new principle of the EUR250,000 will mature on the 31st of December 2031. No interest will accrue on this new outstanding principle. The EIB also agreed to cancel the 3% royalties on total consolidated revenues of the company in the future, and the requirement to pay 10% of any capital raise until the maturity was also canceled.
The outstanding principal amount, as I mentioned, the 26.6 million, including interest, will be converted to 1,000 preferred shares. Each preferred share will carry a redemption value equal to $34,000 and each preferred share will be convertible to 364 ADSs. Point is, it’s either or. So if somebody converts, if the holder — shareholder converts to ADSs, the redemption value is canceled. Scinai will pay the preferred shareholder the redemption value of the preferred shares only when either: one, the Board of Directors of Scinai decides to pay the redemption value, it’s our own decision, and only when we are allowed as per Israeli law, or in case of liquidation of Scinai. The preferred shares will be entitled to preference in liquidation. The preference — the preferred shares will not have cumulative dividend rights, and they will not have voting rights. Scinai will require a vote of the majority of the preferred shares — holders in order to allow these four points: one, raise a new senior debt; accept the merger and acquisition; voluntary [de-list] from the NASDAQ; or issue additional preferred shares. The preferred shares will also contain a provision precluding the holder from converting to ADSs. If after such exercise, the holder would beneficially own in excess of 4.99% of Scinai’s outstanding shares capital in a 12 month period. So that’s a limiting factor that basically can limit and pace the conversion rate of these prepared shares into ADSs. In addition, these preferred shares cannot be converted to ADSs for the first 12 months after the closing. Closing is subject to customary closing procedures and is expected before August 23rd.
The next topic that I’d like to discuss with you is our NASDAQ compliance plan and — so on June 18th, Scinai presented its plan to regain compliance to the NASDAQ hearing panel. On July 2nd, we received the decision granting us extension to the deadline. On July 3rd, we prepared a white paper together with a large big four accounting company explaining the accounting principles for the treatment of the EIB loan to equity deal. On August 9th, the loan restructuring deal had been signed. And closing is pending, of course, as I said, the customary closing procedure by August 23rd. August 13th, we made a PR announcing the signing of the loan restructuring. August 13th, we also requested an extension to the deadline from the hearing panel to allow for the deal with EIB to close. On August 14th, the financial reports for Q2 were approved by the Board and filed with the SEC. And the financials were, of course, reviewed and included full footnotes detailing the accounting principles for the dealing with the loan restructuring deal with the EIB. And that’s an abnormal move from a foreign private issuer. We are not normally required to have our quarter results fully reviewed and with footnotes, but we did that in order to show to our investors and the SEC and the NASDAQ that indeed, the debt-to-equity deal indeed is going to impact our balance sheet in a way that will resolve the shareholder equity deficit. By or before August 23rd, the loan restructuring deal is going to close. Scinai will then issue a PR plus 6-K. We will announce to you and you will receive the announcement. And then we will provide the hearing panel with required dividends for meeting the equity compliance. And then we expect within a couple of days to hear back from the hearing panel with the back to compliance letter. And once we receive it, we, of course, disclose it on a PR with a 6-K.
So the exciting news of today is private equity commitment with Mr. Daniel Stone signed today. Main terms, Daniel Stone through RK Stone Miami LLC will provide Scinai with a commitment amount of $2 million until December 31, 2024, so until the end of this year. Scinai will pay a commitment fee of 5% of the committed amount, so about $100,000 in cash or shares, together with the first advance. Daniel will buy unregistered ADSs at a 5% discount to the market price. The market price will be determined by the lower of the 10 day VWAP of the 10 trading days prior or to the advance notice that we submit or the three day VWAP of the three days — trading days post the advance notice. Each advance can be up to $500,000 per month. Prefunded warrants will be issued for the incremental amount in case the advance will bring Daniel about 9.9%. All these shares are not going to be registered, and Daniel will hold them for at least six months post the signing. We also had all the directors and officers signing a lockup agreement so that everybody knows that this is a very strong position and long position by one of our largest shareholders, arguably the largest one now.
The other positive announcement I want to remind you of is the positive regulatory feedback from the Paul Erlich Institute. We went through the Paul Erlich Institute for an advice. And on June 4th, we met with the scientific advisory meeting with the Paul Erlich Institute, the scientific advice of which is considered acceptable guidance for IMPD filing with the European Medicines Agency and is also considered the European comparable to a pre-IND with the FDA in the United States. On July 23rd, we announced the receipt of positive regulatory feedback from the PEI for our drug development program towards Phase 1/2a clinical trial of our anti-IL-17 AF nanoAb in plaque psoriasis. We also designate this molecule now SCN-1. The minutes of the meeting clarified our preclinical toxicology and clinical program for plaque psoriasis with intralesional injections for the treatment of patients with mild to moderate plaque psoriasis. The PEI has requested to see data of efficacy in blocking IL-17F. And this data became available already as per the company’s announcement on July 15th, describing the positive in-vivo proof of concept results.
The PEI accepted the company’s position that toxicology studies can be conducted in pigs rather than in nonhuman primates, that’s a big cost saving and time saving for the company. The PEI also accepted the company’s position to compare our drug to placebo directly in patients with mild to moderate plaque psoriasis while skipping the need for testing in healthy volunteers, resulting in a Phase 1/2a clinical trial, which will assess both safety and efficacy in the same time. Moreover, the PEI agreed to compare our drug to placebo on the same human subject. This strategy could significantly reduce the number of patients required for the clinical trial. Currently, we plan on approximately 24 subjects, and to arrive to a proof of concept in human beings with such a small cohort will be a massive success for us. Last, the PEI commented that the manufacturing process looks well developed and that controls and specifications presented are acceptable. The Phase 1/2a is expected to include approximately 24 plaque psoriasis patients and is expected to commence in the second half of 2025 with readout in 2026.
On the R&D side, this is the in-vivo study that we published the results of. You can see here a table. What we need here is a very innovative and highly regarded animal model during which a SCID mice is engrafted with human skin on their backs. And then the psoriasis disease is induced — and basically by activation of — by injection of IL-2 and activated PBMCs from psoriatic patients. After the human skin transplantation and the psoriasis induction, we started treatment. The treatment groups are mentioned here below. You can see that we use the negative control, the irrelevant nanobody. We have a positive control, which provided with sucukinumab, which is a standard of care for moderate to severe patients but is also requested many times by mild psoriatic patients and for moderate psoriatic patients, mainly in patients where the lesions are located in areas that are hard to treat or are generating a considerable disease burden. The other positive control was betamethasone, which was provided topically twice a day for three weeks. And then three test items that we provided the same drug in the same concentration. But once every other day, once a week, like Cosentyx and then once only. And then we did a follow-up period of three weeks.
What we can see here from the result is that the expression of [markers] in the skin of xenograft after the termination of the experiment, you can see here on the left, the IL-17 expression, this is the red frame. You can see it on the control on the vehicle, observed in the negative control blocked by the nanoAb and the other therapies. You can see here that the other therapies provided a clear scheme, including ours. And the vehicle here, you can see basically the IL-17 expression. Same with IL-17F. These two isoforms of the IL-17 are the most important in psoriasis. Many of the drugs existing today are neutralizing only IL-17A, while the more modern ones also targets IL-17F. Uniqueness of our drug is that we target both in the same molecule and that we can provide it by intralesional local administration of a biologic. It’s going to be first time when a biologic can be applied by the patient directly to the lesion without the need to expose the patient either to systemic use of monoclonal antibodies, which are super expensive and have their systemic risk or to use steroids, which generate long term skin atrophy and a lot of side effects. Here, you can see an observation of the skin. The next slide, you can see we measure different parameters that were evaluated during the proof of concept. You can not expect it to remember them all by heart but you can see that we — of course, with the consultation with expert dermatologists, we looked at different markers that will tell us whether our drug impacted the different points in the cascade and the pathogenesis of the disease.
When we look at the results, you can see that our drug performs very nicely in comparison to the current two most popular drugs, which is betamethasone, which is the steroid creams and the ointments that are used for treatment of mild disease and then — or sucukinumab, which is used for moderate to severe. What’s important is that we are, as I said, bringing a new biologic to be injected locally by the patient, saving either the side effects of the betamethasone or the unneeded cost and exposure. And of course, mild patients will not be prescribed with sucukinumab because they are not in the label. When we look at the time line and we look at the blood sampling, that was something that we also measured, these ones are in the skin, yes. And here, you can see the blood levels. And in the blood, we can see that at day zero before treatment, all the groups expressed the same level of IL-17. And then after 25 days of treatment, we see a difference. Everybody is significantly different than the vehicle that stayed high. And after 35 days, everybody is still significantly different from the vehicle again, but we don’t see any statistical difference between our drug and the other of the drugs. Meaning our drug can be at least as good as the other options. But again, with the unique positioning of self local intralesional administration of a potent biologic instead of using either steroids or systemic, very expensive monoclonal antibodies.
Same for IL-17F. So again, it will be available on our Web site. So what’s the takeaways? First of all, the mode of action was verified. Our nanoAb blocked IL-17A/F and disrupted the whole psoriatic [indiscernible]. The local administration of nanoAb into the lesion leads to comparable effect versus comparator drugs. The therapeutic effect of the nanoAb lasts far beyond its half-life, and that’s an important point to notice. One of the challenges of working with a nanobody versus monoclonal antibody is a short half life. On one hand, the short half life provides a very good safety profile. Once the nanobody goes into blood, it will be eliminated within a couple of hours. So the exposure risk for the entire body is very minimal. We wanted to check whether injecting this drug directly to the skin will generate a beneficial clinical result in the skin beyond the half life, which is very short. And as you could see from the previous slides, the effect lasted for a few weeks after. Blood concentration of IL-17 correlated with the overall therapeutic effect, which is also important finding for us, because we will be able to gauge the performance of the drug by taking blood samples instead of the need to terminate animals in the in-vivo trials. And then no observed adverse effects, at least for now, it’s not an official toxicology study but we always look at different effects on the animals.
What are the next steps? So the next step for us is to test and increase dose together with five inductions, because if you look at the treating schedule for sucokinumab and any other monoclonal antibody used to treat psoriasis, these drugs are first induced for five — are using an induction of five weeks on which patients will receive one injection per week for five weeks. And then after that, they start to space for once a month. What we want to accomplish is to do the same induction period but then to start space and hopefully to arrive to once in three months use. So the advantage to the patient would be a very long period between treatment, of course, compared to steroids. It’s a massive relief for the patients. If you think about the patient that needs to use steroids, they need to apply twice a day, they need to use it in the brain before they put the makeup or they dress up with their clothes for work. They need to put it again in the evening before they go to bed or sit on the sofa. It’s a disturbance, the fill rate is a disaster. People don’t use it and the side effects are not nice.
You can see that in our corporate slide, you will see effect of steroids on the skin. Specifically, one has it on his — or her face, sex organs, on the scalp, the palms of the hands, on the bottom of the feet, this can be disastrous. So this injection of a biologic, nonpainful. It’s a very small injection, 3-millimeter needle, hardly anyone can feel it, and that should provide a relief for a few weeks. Our goal is to arrive to approximately three months, but let’s see, we still need to assess it. And so we will do this assessment. Our next in-vivo proof of concept will basically repeat the previous that we did with Technion, but we will now go in the termination period or, let’s say, evaluation period of 12 weeks post the finalization of the treatment. And we will go for once a week for five weeks as compared to the treatment schedule of all the monoclonal antibodies, so that we will have a very good assessment of whether the treatment can generate a long lasting effect on the skin way beyond what is currently expected from both monoclonal antibodies and also the steroids.
So to summarize our IL-17 program summary, there is a need for a better treatment for patients with mild to moderate psoriasis and for specific lesions that are hard to treat with the current therapies. Biological drugs are the fastest and most efficient yet. They are administered systemically and are expensive. Blocking both IL-17A/F isoforms is an effective mechanism to control psoriasis. Scinai’s nanoAbs administered locally intradermally already showed superior neutralization of IL-17 in cell culture and ex-vivo and human psoriatic [skins]. In our in-vivo study, the nanoAbs was compared to sucukinumab and anti-IL-17 [indiscernible] [nanoAb] and betamethasone reducing multiple inflammatory parameters, and now we will optimize the schedule of administration to extend the duration of the therapeutic effect. Let me give you some update about our CDMO business unit. Our CDMO unit is offering drug development services for early stage biotech projects. We own highly equipped labs for biologic drugs manufacturing process development, analytical method development and quality control. We also own 20,000 square feet cGMP facility for biological drugs manufacturing for clinical trials while meeting EMA and FDA standards. Since January 2024, our CDMO unit generated work orders valued at $600,000 from five clients, and additional contracts are in advanced negotiations. Our 2024 guidance is at $1.25 million.
In addition, we have been pursuing extensive targeted marketing activities, including online advertisements, direct outreach campaigns and participation in major pharmaceutical conferences, such as BIO-Europe, Spring in Barcelona in March this year, Biomed Israel Conference in Tel Aviv in May, which we marketed our CDMO services and met potential partners for R&D pipeline and potential investors. We will be attending the EADV conference for dermatology in Amsterdam at the end of September. And also BIO-Europe in November in Sweden. As our CDMO unit is new and we are in a rapid growth stage, acquiring new clients and building our reputation and brand awareness of our CDMO services, we expect revenues from the CDMO business to increase materially in the next coming years. There is also — this is also coupled with growing demand for boutique CDMO services from early stage biotech companies looking for fast project onset at competitive pricing without compromising on meeting the most stringent scientific and quality standards. Our CDMO potential build capacity, including the already installed equipment, is set up for approximately $24 million in top line revenues from services per year, which should result in approximately $11 million EBITDA. Of course, we are now in a ramp — in a buildup — in the ramp-up stage, but it will take us a few years to arrive to full capacity utilization, but we are working towards this goal. Our CDMO revenues offset our fixed costs for facility and personnel and allow us to control spend level on our internal R&D projects.
So last, significant potential for value creation. As I mentioned, we have a pipeline of nanoAb-based drugs. We have promising preclinical results. We are preparing for a first human clinical trial of our anti-IL-17A nanoAb. We have a very good collaboration with the Max Planck Society and UMG, Germany, where we developed the future pipeline project — products through our research contract agreement with collaboration with Max Planck and UMG. We have additional targets. Everything is on our Web site and I can show later if the questions asked. Targeting diseases with underserved needs and attractive commercial opportunities. We have a derisked strategy where we go after molecular targets that have been already validated to be effective in clinical trials or in commercial use by other monoclonal antibodies, but that are still [leaving] an unmet need for certain populations. And we are trying to capture this unmet need and this value by targeting these populations through various ways of administration, route of administration, the different advantages of the physicochemical characteristics of our molecules. Our CDMO business unit buffers the R&D risk and that’s a very important point. Thank you very much, and now I will move to questions, please.
Question-and-Answer Session
A – Liat Halpert
Thank you, Amir. One question that was asked, what do you see as the long term future and share price of Scinai? And will there be continued growth of this company?
Amir Reichman
So of course, we believe that Scinai is an undervalued company. I cannot say my personal projections, that would not be fair. But if you — but I invite people to look at comparable companies that — at a preclinical stage, where — which are projected to start clinical trials within a year. We have a deep pipeline of products, which is very derisked. The source of the products and the IPs from a highly prestige universities from the Max Planck Institute in Germany and from UMG, the PEI are highly complex and won many prizes. And the targets are derisked, as I mentioned before. We also have the CDMO business unit. So it’s abnormal for a small company like us to also own its own facility for CDMO services. And the main hurdle for value growth as of now, in our view, was the large liability that was on our balance sheet amounting for a book recording a carrying value of $19.6 million. The actual debt was already amounting to $29 million. And so if you look at the balance sheet, it really crushed our shareholder equity. Now with this new debt-to-equity agreement with our lender, we believe that this cleared a lot of the potential concerns of investors to come and chime in and build value for the company. The biobetter approach that we bring is — you can look at other companies like, for example, Apogee, that looked at already targets — molecules that were already created by other companies, but they created a biobetter approach by extending their half life and providing for fewer injections per year, and this company’s now traded on several billion dollars.
If you look at nanobody specifically, you can look at Moonlake Immunotherapeutics, it’s a Swiss company, also traded at approximately $3 billion value. And they have an nanobody for psoriasis to be injected systemically, which validates the thinking about nanobodies and also the neutralization of IL-17A/F. However, they are going after different diseases, Hidradenitis Suppurativa and psoriatic arthritis. They might go after psoriasis but again for moderate to severe, and their pipeline is basically this one module. And in our case, we have nine nanobodies for different diseases, for example, IL-4 receptor alpha, which we plan to use for atopic dermatitis. We have IL-13. We have TSLP, IL-4, Angiopoietin 2 and VEGF. So altogether, we can build different bispecifics. We can build different constructs. So the potential with the company is massive.
Liat Halpert
Your recent positive regulatory news for your lead antibody candidate is quite exciting. Can you elaborate on the clinical and commercial potential and time line of this program?
Amir Reichman
So as I mentioned, we will be commencing the longer proof of concept in animals just to mitigate any risk. It’s preferable for us to go now and test the exact scheduling to be tested in humans. So we want to do it first in animals. So we don’t waste a lot of investors’ money on trying something with a specific schedule of dosing in humans and then bring a new schedule and a new synopsis and then try on humans again. So that’s a very expensive approach. Instead of that, we want to do it again in animals and try and see whether we can extend the time span between injections from one month up to three months. After the conclusion of this in vivo study, which we are about to commence in September, just in a couple of weeks, this study will end in the first quarter of 2025. We will then do toxicity studies based on the very confirmed and better confident schedule of the treatment. And then right after, we will start the Phase 1/2a in the second half of 2025. This study will last until the first quarter of 2026. And if that’s successful, we will be going to the regulatory agencies to discuss already prior to that a potential combined Phase 2/3 or Phase 2b and then 3, but it will position the company in a much better stage — place in order to negotiate potential additional sublicensing or commercial rights with other companies.
The other thing I want to mention is that the IL-17 nanobody as a construct can be targeted to different indications and can be constructed to be used with different other antibodies on bispecifics, for example. So we do have the ability to continue and develop that molecule for multiple users in different formats, different route of administrations and with different diseases. So the potential of this molecule is quite large. In addition to that with available capital, we will exercise our option. We have an exclusive option for exclusive license under pre-agreed financial terms with the Max Planck Institute to bring on board our next nanobodies for the next drugs. And that will be an additional value creation for the company, expanding the potential of the company and diversifying risks for our investors.
Liat Halpert
Can you remind us of what total shareholders’ equity will be after the EIB restructuring?
Amir Reichman
The total shareholder equity after the EIB restructuring. Yes, let me show you the slide, it’s here. Yes. So the EIB will receive at the closing, 1,000 preferred shares. If the preferred shares are converted in full to ADSs, it will add 364,000 ADSs to the outstanding. So fully diluted including all the warrants if they are exercised, we will have 1.865 million shares. As of today, we have 838,000. And I want to remind, these 1,000 preferred shares are not convertible for the next year. And when convertible, they can be converted so that the holder can only hold — can only receive up to 4.99% of the share capital of the company in any given year. So the pace of conversion is going to be quite slow. And again, these warrants, if exercised, will, of course, inject additional capital to the company, further accelerating our ability to generate additional value and meet milestones and catalysts.
Liat Halpert
What are some of the key regulatory considerations and strategies Scinai is employing to navigate the approval process for its nanoAb candidate?
Amir Reichman
So first of all, we are working with one of the best regulatory affairs agencies and regulatory affairs advisers in Europe and also with knowledge and high experience in the United States. We are working always to develop the right package to present to the regulatory agencies the justification for either an accelerated path, as I described and demonstrated just now, going directly to Phase 1/2a with patients that are sick instead of going through the traditional Phase 1 with healthy volunteers, Phase 2 and then Phase 3. We argued that we have the right data package to support and write clinical arguments to support the approval of a Phase 1/2a. The other thing is, for example, what type of animal to use in toxicology study. So again, we came with a very robust package to the PEI, demonstrating that the toxicology study can provide the regulatory agency with the right and sufficient data for safety in order to approve our IMPD going into in human trials. Such an approach will result with the significant cost saving for the company and time saving, because the ability to acquire to buy today NHPs and initiate studies in NHPs with all the applications and requirements in the market today is significantly delaying such an approach. The market, the industry standard for antibodies is to use NHPs. Again, with a very thorough regulatory strategy and knowledge and experience, we were able to come with a significant — basically guidance that will help us to have a shorter time to market and at lower costs. And we expect to continue with this strategy going forward so that our time to market will be at a competitive pace. Nevertheless, with reducing any potential risk for failure in the Phase 3 before launch.
Liat Halpert
Last question. As a CEO, what is your long term vision for Scinai and how do you envision the company shaping the future of immunotherapy and disease management?
Amir Reichman
So I see the strategy of the company in several phases. In the first phase, the company is now sitting in the value creation process between the universities and research centers and the medium to large pharma companies. As of today, we do not have the capability and capacity to launch commercial products and manage their distributions and sales. Therefore, over the coming years, our focus will be to take patented technology that we have full license for, bring it through preclinical Phase 1, Phase 2. And during this time, be anywhere between the preclinical proof of concept to the in-human proof of concept, engage with larger pharma companies in partnering deals and sublicensing the commercial rights to them so that we can ensure reliable commercial launch and supply and sales. And of course, large partners that will help us with the financing of the Phase 3 clinical trials. This strategy will allow us to go back every time and restart developing new molecules and expanding the diversification of the risk, lowering the risk for our investors while generating cash inflows through upfronts, milestones and royalties. With time, once we see that we have enough cash, we will then consider to get engaged in commercial sales, do our own launch or do the sales in our own territories. That’s one thing. The other business unit is the CDMO business unit. We believe that this category of very early stage biotech is a very attractive category during the COVID pandemic, there was a massive consolidation in the CDMO space. And a lot of the small CDMOs disappeared from the area.
Now there was a trough in the financing of a lot of biotechs, so [many] biotechs became short with cash. Now they are able to raise capital, but the offering of the CDMOs that are out there is not really tailored to match the needs of such early stage startups. These early stage startups really need a boutique CDMO small enough entrepreneurs-for-entrepreneurs that can understand their needs, can basically tailor a project for their needs with the right pricing, with the right timing, with the right availability. Somebody goes now to a large CDMO and they tell them, okay, we have a slot for you in eight months. The small early stage biotech, they might not have 8 months of cash in hand. So that’s the value proposition here and we see a massive surge in demand for patients and start-up of the projects, and we are very happy about it. And so I believe that the CDMO business for early stage projects is a very important way for us to both generate cash to reduce risk for our shareholders but also, it’s kind of like a gym because we are practicing the top technologies, the best technologies. We have an insight of the different things that are happening in the biotech world, we are experiencing drug development of different types. And so in the end, instead of using — developing our own R&D programs via other external CDMOs, we do it in-house and leveraging our knowledge to further accelerate the time line of our internal R&D programs.
Liat Halpert
Thank you. Thank you, everyone.
Amir Reichman
Right. So we are before — I want to take the opportunity to say thank you for everybody that came here to listen to our investor webinar. We invite you to visit our Web site at www.scinai.com. Lots of slides and brochures and very insightful information there. You are more than welcome to contact us directly at [email protected] with any questions. And thank you very much, everybody, for your valuable time, and thank you very much, Liat, for guidance.
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