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TranscriptFY2026 Q22026-08-26FY2026 Q2 earnings call transcript
Earnings source - 43 paragraphs
FY2026 Q2 earnings call transcript
With that, let's jump in. As we discussed, first half results got published yesterday. I think there was a lot of positives coming out of that. Before we get into the individual numbers, can you put the first half of 2026 into perspective for investors, Amir, and what changed at Scinai? Where does the company stand today versus the beginning of the year?
Yeah. The day before yesterday. Time flies. I think the most important way to look at the first half of 2026 is that Scinai today is materially different company than the one that entered the year. At the beginning of 2026, we had our innovative immunology R&D pipeline and an emerging CDMO business in Jerusalem. During the first half, we significantly expanded the commercial side of the company through the acquisition of former Recipharm operations in Yavne, Israel. That transaction added much more than equipment and infrastructure. It added an experienced operating team, established quality systems, technical knowhow, customer relationships, and additional manufacturing capabilities. So today, Scinai has two complementary value-creating platforms, our immunology R&D activities, and the broader two-site CDMO business operating in Jerusalem and Yavne, Israel. The first half was therefore largely about transforming the operating platform.
The second half is increasingly about demonstrating what we can do with it, converting customer activity into revenue, increasing utilization of the infrastructure we now have, and advancing our R&D programs into capital discipline way.
Perfect. Thank you. Yeah, thanks for correcting me. Sorry. The week moves fast, just as this summer's been moving fast for us. So, two days ago was the earnings. But thanks for that initial update. I think from what I observed, at least from the port, there were several moving pieces in the first half financials as a result of this Recipharm transaction that you just alluded to. What are the real numbers that investors should be focusing on as they think about that report?
Thank you, Andrew. There are few numbers I think investors should focus on, but it is important to distinguish between the accounting effects of the Recipharm transaction and the underlying operating performance. Revenue for the first half was approximately $949,000, compared approximately $773,000 in the first half of 2025. At the same time, the expanded CDMO footprint brought a larger fixed, semi-fixed cost base into the company before utilization had fully ramped. As a result, we reported a gross loss of approximately $2.37 million and an operating loss of approximately $4.6 million. The most significant accounting item was the approximately $6.4 million bargain purchase gain associated with the Recipharm transaction. That is a non-cash, non-operating accounting gain based on the preliminary purchase price allocation, what is called PPA. Primarily because of that gain, we reported net income of approximately $1.50 million for the first half, $1.57 million, sorry.
I would not want investor to interpret the reported net income as an operating profitability. The underlying business still generated an operating loss during the period. From liquidity perspective, however, as of June 30, 2026, we had approximately $2.85 million of cash and restricted cash. The financial picture therefore reflects a company that has expanded its operating capabilities materially, while the revenues and utilization of that infrastructure are still in the process of scaling, and I believe you will see that in the coming quarter in the next half.
Great. Thank you. Yeah, that is important nuance there with the accounting with this transaction and where that leaves us and how the Scinai business is actually in a very good spot right now with how that all fleeces out. Great. Moving on here into more of the fundamental business, can you talk a little bit about what capabilities Scinai has today that it did not have entering 2026? And is management still integrating now at this stage from that transaction, or has it shifted to an execution focus?
Thank you. That is an excellent question. The transaction significantly broadened what Scinai can offer to customers. In Jerusalem, our capabilities are focused primarily on biologic development, analytical services, aseptic processing, and clinical cGMP manufacturing. Yavne site adds complementary capabilities in early chemistry development and small-scale cGMP manufacturing of active pharmaceutical ingredients, API, for clinical programs. But I think it is important to emphasize that we did not simply acquire equipment. We acquired an experienced pharmaceutical team, established quality systems, operating procedures, customer relations, and knowhow that would take considerable time and capital to build independently. At this point, management's focus is increasingly on execution, utilization, and commercialization rather than simply integration. The relationship with Recipharm is also strategically important.
The commercial collaboration is intended to facilitate cooperation and potential customer referrals between our early and clinical stage capabilities and Recipharm's broader manufacturing network as programs mature. Just to clarify, Recipharm AB was the international CDMO company that sold us Recipharm Israel facility and business. The objective is to make the combined platform productive, bring in more customer work, execute well, increase utilization, and build longer-term customer relationships.
Great. Fantastic. Yeah, no, and I think a key takeaway from what you just said is the way that you were able to structure this transaction is you can hit the ground running and start executing sooner because you're not building this from scratch, right? There was this fundamental business in place that you're essentially just integrating with your already outstanding business, which I think is an exciting aspect of this transaction.
Exactly.
Moving back more to the financial side of this. I saw one of the items in the first half report was one of the more notable updates is the approximately, I think it was $3.1 million of committed customer orders as of August 16, which obviously happened post the end of the quarter. Can you tell us a little bit about what that represents?
All right. Committed customer orders is a management KPI. As of August 16, we had approximately $3.1 million of what we define as committed customer orders. These are signed customer purchase orders for specified CDMO services under existing contractual agreements. Usually, they are non-cancelable, and usually, clients pay an upfront payment against it. Approximately $1.6 million of that relates to the Yavne, and approximately $1.5 million to Jerusalem. I want to be precise about what that number means. It is a measure of customer-authorized commercial activity. It should not be interpreted as $3.1 million of future revenue or as a traditional backlog figure, because portions may have already been invoiced or recognized as revenues. And the timing of the remaining revenue recognition depends on execution on our side of the underlying projects and satisfaction of the applicable accounting criteria.
However, as of August 10th, I can tell you that approximately $2.1 million had been already invoiced to customers.
While approximately $1 million of the 3.1 represents signed work orders that had not yet been invoiced.
What I find encouraging is that the activity is distributed almost equally between Jerusalem and Yavne. That indicates that we are seeing meaningful commercial activity across the broader CDMO platform, rather than only within the business we acquired.
Got you. Okay. That's helpful. Thank you. Speaking more on that kind of CDMO commercial traction and that expansion you allude to, what does the expanded U.S. clinical manufacturing engagement tell you about the platform as it stands today?
I think this is a very good example of the kind of customer progression we want to see. The relationship began with feasibility and cGMP readiness activities, subsequently expanded toward a broader CMC development and clinical manufacturing program intended to support the customer's planned U.S. regulatory submission with the FDA and subsequent clinical development. We have already commenced substantive activities and received approximately $650,000 in cash payments and advances after June 30. The expanded definitive agreement remains under negotiation, I do not want to imply a final contract value, scope, or development timeline that has not yet been agreed. But strategically, this is exactly the type of relationship we want to build, beginning with a defined technical need and expanding into a broader development and manufacturing engagement.
Fantastic. Yeah, no, it's great to see that clientele and that customer base expanding out progressively. That's fantastic. Another thing I wanted to go back to is that commercial execution and some of some targets you've previously announced. I believe it was an objective of approximately $5 million in CDMO revenue for 2026, which was the initial objective. Is that still the objective today? And what would a successful execution look like by year-end?
Yes. We continue to pursue approximately $5 million of CDMO revenue for 2026. Achievement of that objective, of course, will depend on the timing and execution of customer projects and, in addition, satisfaction of the applicable revenue recognition criteria and our ability to continue converting additional commercial opportunities. I would not want investors to derive that target mechanically from the $3.1 million of committed customer orders because these are different measures. For me, successful execution by year-end would mean several things. First, converting meaningful amount of customer work into recognized revenue. Second, continuing to expand the level of customer-authorized work across the sites. And then third, increasing utilization of the infrastructure and workforce that we already have in place. And fourth, generating repeat business.
Repeat business is particularly important in CDMO because winning the first project shows that a customer is willing to work with you, while winning the next project is a much stronger indication that you delivered. Success is not just increasing the commercial pipeline, it is turning customer commitments into executed work, revenue, and longer-term relationships. And to go back, yes, we are still supporting the $5 million in CDMO revenue for 2026.
Fantastic. Yeah, no, that is great too. Like you said, not only get new business, but keep building on that current business you have and expanding those relationships into those later stage projects, which I think is a great sign of good work delivered. Now I want to shift a little bit from the CDMO to more of some of these R&D priorities, right? Because as we talked about at the offset, Scinai is a platform that is not only developing this growing CDMO business, but there is this exciting early preclinical platform as well. Beyond the commercial business, what should investors watch for from the R&D pipeline during the remainder of 2026?
On the R&D side, our focus is increasingly on prioritization and capital discipline. We continue to believe that our NanoAb platform can support differentiated therapeutic formats, but we are being very deliberate about where we allocate capital. For each program, we are looking not only at the science, but also at intended product profile, development feasibility, differentiation, technical risk, and the financing required to reach the next meaningful value inflection point. We therefore intend to use non-dilutive funding, collaborations, and strategic partnerships whenever possible, rather than asking shareholders to finance every stage of development internally. PC111 remains an important program for us and is being advanced under our option agreement with PinCell. We believe it addresses serious dermatology conditions with significant unmet medical need, but we are also maintaining a disciplined approach to how and when we deploy capital toward the program.
Yeah, very smart. I think there is a lot of excitement with a few different assets within the pipeline, so I would definitely encourage folks to check those out. Great. I think we hit on a lot of the core takeaways from the report. So I would encourage people to continue submitting questions. As we are getting close to wrapping up here, I have one more question for Amir, but then we will jump into the audience Q&A. But before we wrap up here, I think a good place to leave on is, if we are having this conversation again at the beginning of 2027, so looking several months down the road, what would you like to have accomplished between now and then, right? What should investors be looking out for from an execution story?
Exactly tapping into the last word you just said, I would like investors to be able to look back at the second half of 2026 and see measurable execution. On the commercial side, I would like to see customer commitments translated into work and revenue, additional customers coming onto the platform, higher utilization of our capacity across Jerusalem and Yavne, and evidence of repeat business. On the R&D side, I would like us to have advanced our highest priority programs through clearly defined milestones while maintaining the capital discipline we have established. At the corporate level, I would like the market to have a much clearer understanding of what Scinai has become. We are building a company that combines innovative immunology R&D with real pharmaceutical development and manufacturing capabilities.
When we speak again in early 2027, I want to be talking less about what we intend to build and much more about what we have demonstrated, revenue generated, customers added, utilization increased, R&D milestones achieved, and capital deployed intelligently.
Fantastic. Thank you. Thank you. That was quite helpful. Perfect. Now I would like to take some time to jump into some audience questions. I see one or two coming in here and I will give everyone another kind of call it 15, 20 seconds to submit some additional questions. What I will just add at the end here is I think Scinai represents a really unique opportunity, right? Not only as this growing CDMO platform that is clearly getting more customer accounts, but then there is the excitement behind this R&D pipeline, which on the earlier side, but still very exciting with some of the assets that you have acquired and are focused on developing and in spaces that we are seeing continued interest and support just across the sector.
I think it is a really exciting time for Scinai as a platform at this stage, and excited to see what the rest of this year and kind of early 2027 looks like. With that said, I see a couple questions coming in here on both platforms. Let me just pull those up and I think we have time for a couple. This was the first one I saw, so we will start here. Okay, so this one has to do with kind of the SEPA that your team has in place, Amir. The question says, I saw that Scinai is updating the F-1 registration statement covering the $15 million SEPA. Should shareholders expect $15 million of dilution in the near term?
Absolutely not. The filing updates the registration statement that we already had underlying our existing SEPA to reflect our June 30th financial information. This is a post-effective amendment. It is very normal. It does not basically mean that we are going to raise $15 million tomorrow through this instrument. Also we had to reflect in this post-effective amendment also the August 21st ADS ratio change. It is not a new $15 million financing, and it does not mean that we have decided to draw the full amount.
However, the SEPA gives us the right, but not the obligation, to access capital under the facility. We, as management, control whether and when to use it, and the size of each draw, subject to terms of the agreement. I also want to be clear that any actual issuance of new equity is dilutive. That is clear. The advantage of the SEPA is flexibility.
Advances through the SEPA are priced at 97% of the applicable VWAP pricing formula and do not carry warrants. The commitment fee is separate from the pricing of individual advances and has already been paid. When deciding whether to use the facility, we can take into account the company's funding needs, prevailing share price, and the market liquidity, volume trade, et cetera, and size any draw in a responsible way. We therefore view the SEPA as one additional financing tool available to the company alongside cash generation from the CDMO business, customer advances, non-dilutive funding, and other financing alternatives.
Got you. Thank you. Yeah, I am glad you clarified that as it is a tool that can be used, that does not have to be used. Your last statement there actually transitions well into this next question that I saw come in, also on the liquidity funding angle. It says your cash and restricted cash was approximately $2.85 million, and the filings say the company requires additional capital. How would investors think about funding from here? Obviously, SEPA is one vehicle, but would love to hear what I think what this question is asking is, what other ways you think about funding at this stage?
Yeah. We are very focused on improving the company's liquidity through a combination of operational execution, sales, and disciplined financing. On the operating side, I would say the priority is to expand our customer base, increase the number and value of committed customer orders to generate more stability and ability to project how much we are going to generate, and execute those projects efficiently so that customer commitments convert into revenues in a reliable way and as quickly as possible, where customer agreements allow it in a way that helps cash flow and help us fund the underlying project activity and reduces the working capital burden on Scinai. At the same time, I would say we continue to control discretionary spending and prioritize capital allocation carefully, particularly within R&D.
On the financing side, we continue to pursue non-dilutive funding, grants, for example, governmental grants and NGOs, and maintain access to capital market tools such as the SEPA, which we intend to use selectively rather than as an automatic source of funding. Our approach is not based on one financing source. It is a combination of our growing CDMO cash generation, improving in working capital efficiency, disciplined spending, and non-dilutive funding, and of course, selective use of capital markets.
Fantastic. That's, I think, helpful and answers the question. The best companies in the market use a variety of different financing mechanisms, right, to get the cash they need. I think you're thinking about that the right way. I think we got time for one more question before we enter closing up here. I'd like to go back to this one, because this is something you touched upon earlier in the call, and I think it's important clarifying, verifying. It says, how much of the $3.1 million of committed customer orders is still future revenue, and are you still pursuing the approximately $5 million CDMO revenue objective for 2026? Which I think you stated at the end of the call that you are, but maybe you can talk a little bit more on that $3.1 million number and what that relates to.
No, absolutely. It is important to clarify, and it is an industry standard and also across industries to use management KPIs to clarify the situation, because not always accounting can capture exactly what's going on now and give the visibility to investors of the health of the business. The first point I would like to emphasize is that committed customer orders, as I said before, should not be interpreted as forecast of future revenue or future cash. The $3.1 million represents signed customer purchase orders for the specified CDMO services that we provide. As we disclosed, approximately $2.1 million has been already invoiced, so it means that's going to be paid rather soon or has been paid already. That was as of August 10.
We are already in the 25, so while approximately $1 million, as of August 10, represented signed work orders that had not been yet invoiced. That doesn't mean that the $2.1 million invoice has all been recognized as revenue, because as you know, according to accounting rules, sometimes you take an advance, it's not regarded as a revenue until you finish the deliverable, for example, a project and a report and things like that. But the more important thing is that it is really talking a lot about the cash we have and the ability to maintain our runway, and that's something for companies at our side, that's quite important for investors. Again, revenue recognition depends on the performance of applicable services and satisfaction of the relevant accounting criteria. But yes, we continue to pursue the $5 million of CDMO revenue for 2026.
That remains our objective, subject to, of course, timing and execution of customer projects, satisfaction of the applicable revenue recognition criteria, and our ability to continue converting additional commercial opportunities. The $3.1 million of committed customer orders and the $5 million revenue objective are related indicators of commercial progress, but they are not the same measure and should not be added or compared mechanically.
Fantastic. No, I think that provides great clarity, so appreciate that. I do see one or two other questions here, but in the sense of time here, I just want to make sure we're cognizant. We will follow up separately with those who submitted those offline and make sure you get answers to that, but why don't you jump to kind of wrapping up the closing statements here. No, I think before we hop, I think, Amir, what would be helpful is, what is the one takeaway you would like investors to leave with today after everything we discussed, right? Because we did talk about a lot here.
I am quite excited about where we are now, and I would want investors to leave with a clear understanding that Scinai is now in a completely different stage of its development. We have significantly expanded our commercial platform. We are seeing increasing customer activity across both Jerusalem and Yavne, and our focus now is on execution, converting the activity into revenues, improving utilization, and strengthening the financial resilience of the company. At the same time, we are continuing to advance our R&D programs with greater discipline around prioritization, funding, and capital allocation. We want to invest where we believe we can create the greatest value while using non-dilutive funding, partnerships, and external capital efficiently. For the remainder of 2026, the focus is very straightforward: execute commercially, strengthen the financial position of the company, and advance the R&D portfolio in a disciplined way.
I want to thank you and everybody who took the time to join us today and for your continued interest in Scinai.
Fantastic. Thank you, Amir. Thank you for your time and walking through everyone the core fundamental updates of the recent financial report and the excitement for the rest of 2026. We appreciate your time, and thank you to everyone who joined the call today, as Amir said, and the interest in the story. We look forward to continuing to update you as we progress through the rest of the year. Thanks again, and we will talk soon.
Thank you, Andrew. Thank you, everybody, for attending.
Investor releaseQuarter not tagged2026-08-24Scinai Reports First Half 2026 Corporate Highlights and Results with Spotlight on Growing CDMO Momentum
PR Newswire
Scinai Reports First Half 2026 Corporate Highlights and Results with Spotlight on Growing CDMO Momentum
Investor webinar scheduled for August 26, 2026 at 11:00 a.m. EDT JERUSALEM, Aug. 24, 2026 /PRNewswire/ – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai" or the "Company"), a biopharmaceutical company combining innovative therapeutic development with a revenue-generating contract development and manufacturing organization ("CDMO"), today provided a corporate update and reported financial results for the six months ended June 30, 2026. Corporate Highlights Committed Customer Orders1 reached approximately $3.1 million as of August 16, 2026, of which approximately $2.1 million had been invoiced. The Company is progressing an expanded clinical manufacturing and CMC program for a U.S.-based biopharmaceutical company building on an existing contractual relationship and prior work performed through the customer's affiliate. Approximately $650 thousand in cash payments and advances have been received in connection with the expanded U.S. program, and substantive activities are underway while the definitive agreement covering the broader scope and commercial terms remains under negotiation. The expanded program is intended to support an investigational drug product toward U.S. IND submission and Phase III clinical development. The Company continues to pursue approximately $5 million in CDMO revenues for 2026 First Half 2026 Financial Results Revenues increased to $949 thousand, compared with $773 thousand for the six months ended June 30, 2025. The increase was primarily attributable to the inclusion of revenues generated by the acquired Yavne operations from the acquisition date. Revenue recognized during the period reflects only the portion of customer engagements for which the applicable services had been performed and revenue recognition criteria satisfied through June 30, 2026, and does not reflect the full value of signed customer work orders extending beyond the reporting period. Cost of revenues increased to $3.3 million, compared to approximately $2.0 million for the six months ended June 30, 2025, primarily reflecting the expanded cost base of our CDMO business following the acquisition and consolidation of the Yavne operations, including additional personnel, facility, depreciation and other manufacturing-related costs. Gross loss was approximately $2.4 million, compared with approximately $1.3 million in the prior-year period, reflecting the expan…Read full documentShow less
Investor webinar scheduled for August 26, 2026 at 11:00 a.m. EDT JERUSALEM, Aug. 24, 2026 /PRNewswire/ – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai" or the "Company"), a biopharmaceutical company combining innovative therapeutic development with a revenue-generating contract development and manufacturing organization ("CDMO"), today provided a corporate update and reported financial results for the six months ended June 30, 2026. Corporate Highlights Committed Customer Orders1 reached approximately $3.1 million as of August 16, 2026, of which approximately $2.1 million had been invoiced. The Company is progressing an expanded clinical manufacturing and CMC program for a U.S.-based biopharmaceutical company building on an existing contractual relationship and prior work performed through the customer's affiliate. Approximately $650 thousand in cash payments and advances have been received in connection with the expanded U.S. program, and substantive activities are underway while the definitive agreement covering the broader scope and commercial terms remains under negotiation. The expanded program is intended to support an investigational drug product toward U.S. IND submission and Phase III clinical development. The Company continues to pursue approximately $5 million in CDMO revenues for 2026 First Half 2026 Financial Results Revenues increased to $949 thousand, compared with $773 thousand for the six months ended June 30, 2025. The increase was primarily attributable to the inclusion of revenues generated by the acquired Yavne operations from the acquisition date. Revenue recognized during the period reflects only the portion of customer engagements for which the applicable services had been performed and revenue recognition criteria satisfied through June 30, 2026, and does not reflect the full value of signed customer work orders extending beyond the reporting period. Cost of revenues increased to $3.3 million, compared to approximately $2.0 million for the six months ended June 30, 2025, primarily reflecting the expanded cost base of our CDMO business following the acquisition and consolidation of the Yavne operations, including additional personnel, facility, depreciation and other manufacturing-related costs. Gross loss was approximately $2.4 million, compared with approximately $1.3 million in the prior-year period, reflecting the expanded operating cost base of the Company's CDMO platform while facility utilization continues to increase. Research and development expenses decreased to approximately $0.8 million, compared to approximately $1.2 million for the six months ended June 30, 2025 primarily reflecting a lower level of research and development expenditures during the period and the continuing allocation of resources toward our CDMO activities, partially offset by expenditures associated with our current therapeutic development programs, including the PinCell arrangement and NanoAb activities. Marketing, general and administrative expenses increased to approximately $1.4 million, compared to approximately $1.3 million for the six months ended June 30, 2025 reflecting, among other things, the expanded corporate and administrative requirements associated with the acquisition and integration of the Yavne operations and operation of the enlarged group structure. Operating loss was approximately $4.6 million, compared with approximately $3.8 million for the first half of 2025. Net income was approximately $1.6 million, compared with a net loss of approximately $4.1 million in the prior-year period, primarily reflecting an approximately $6.4 million bargain purchase gain associated with the acquisition of Recipharm Israel. The bargain purchase gain does not represent operating revenue or operating cash flow. Net cash used in operating activities was approximately $3.9 million, compared with approximately $2.6 million in the first half of 2025. Cash, cash equivalents and restricted cash totaled approximately $2.9 million as of June 30, 2026, and shareholders' equity was approximately $11.7 million. At the closing of the acquisition, Recipharm Israel held approximately €2.0 million in cash, alongside funds for certain pre-closing expenses and liabilities. The acquired cash contributed to the Company's post-acquisition liquidity position. CEO Commentary Amir Reichman, Chief Executive Officer of Scinai, commented: "The first half of 2026 was focused on expanding and integrating our CDMO platform. As we move through the second half of the year, our focus is increasingly on commercial execution, increasing facility utilization and converting the capabilities we have built into revenue. We are particularly encouraged by the expansion of an existing U.S. customer engagement from an initial feasibility and cGMP-readiness project into a broader proposed clinical manufacturing and CMC program designed to support a planned U.S. IND submission and Phase III clinical development with potential future expansion into commercial manufacturing. We have already received approximately $650 thousand in cash payments and advances and commenced substantive activities while the definitive agreement covering the expanded scope and commercial terms is being negotiated. We believe this opportunity is significant not only because of its potential financial contribution, but also because successful execution would demonstrate our ability to support an advanced U.S. clinical development program through CMC development, manufacturing readiness and clinical cGMP manufacturing. Our priorities for the remainder of 2026 are clear: execute our existing customer programs, convert our commercial pipeline into revenue, increase utilization of our Jerusalem and Yavne facilities, progress this significant U.S. opportunity and continue advancing our therapeutic programs with disciplined capital allocation." R&D Update Scinai continues to pursue a capital-efficient development strategy focused on PC111 and its NanoAbs platform. For PC111, the Company is evaluating its funding and development path, including potential participation in a future Polish FENG funding round, and is in discussions with PinCell regarding a potential extension of the existing option arrangement. For the NanoAbs platform, Scinai continues to prioritize its systemic IL-17 bispecific antibody program and its research collaboration and license arrangements with the Max Planck Society and University Medical Center Göttingen. Investor Webinar Scinai will provide additional perspective on the expanded U.S. clinical manufacturing opportunity, its broader CDMO commercial pipeline, progress across its R&D programs, including PC111 and the NanoAbs platform, and its strategic priorities for the remainder of 2026 during an investor webinar on August 26, 2026 at 11:00 a.m. EDT. Investors and other interested parties are invited to register here: LINK The webinar will include a management presentation followed by a question-and-answer session. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company focused on the development of innovative immunology therapies and the operation of a contract development and manufacturing organization. The Company is advancing therapeutic programs based on technology licensed from the Max Planck Society and pursuant to its option arrangement with PinCell S.r.l. Scinai also owns Scinai Biopharma Services Ltd., a CDMO providing development and manufacturing services to biotechnology and pharmaceutical companies through facilities in Jerusalem and Yavne, Israel. For more information, please visit www.scinai.com. Company Contacts Business Development | +972 8 930 2529 | [email protected] Investor Relations, Allele Capital Partners | +1 978 857 5075 | [email protected] (1) Committed Customer Orders We define "committed customer orders" as the aggregate value of signed customer purchase orders for specified CDMO services under existing contractual arrangements, whether or not such amounts have been invoiced. Management uses committed customer orders as an indicator of committed commercial activity and anticipated CDMO utilization, and we believe this measure provides investors with useful information regarding the value of customer-authorized projects under signed purchase orders. Committed customer orders are presented for supplemental informational purposes only and are not intended as a substitute for GAAP financial measures. Although customer purchase orders are generally non-cancellable, committed customer orders should not be interpreted as an indication of future revenue or cash receipts. The timing and amount of revenue recognition and cash payments depend on various factors, including performance of the applicable services, achievement of contractual milestones and satisfaction of the relevant accounting criteria. Projects may also be delayed, modified or remain open for extended periods. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements include, among other things, statements regarding the growth of the Company's CDMO business; Committed Customer Orders; future and expansion of existing customer engagements and business-development opportunities; utilization of the Jerusalem and Yavne facilities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks that the Company will be unable to execute customer projects and convert commercial opportunities into recognized revenue and cash flow; that the contemplated expanded clinical manufacturing and CMC program for a U.S.-based biopharmaceutical company will not be an beneficial to the Company as anticipated, will not occur or will be delayed; that the Company will not successfully negotiate and execute definitive customer agreements; that the Company will not successfully perform development, scale-up and cGMP manufacturing activities; that the Company will not increase facility utilization, attract and retain customers and partners; that the Company will not achieve its revenue targets; that the Company will not successfully advance its PC111 and the NanoAbs platform; that the Company will not succeed in obtaining potential non-dilutive funding from its grant applications; that the Company will be unable to obtain sufficient financing or non-dilutive funding; and that the Company will be unable to regain and maintain compliance with Nasdaq's continued-listing requirements. Additional risks and uncertainties are described in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date of this press release. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements. SCINAI IMMUNOTHERAPEUTICS LTDCONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS As of June 30, 2026 Unaudited View original content to download multimedia:https://www.prnewswire.com/news-releases/scinai-reports-first-half-2026-corporate-highlights-and-results-with-spotlight-on-growing-cdmo-momentum-302858235.html
Investor releaseQuarter not tagged2026-06-10Scinai Reports First Quarter 2026 Financial Results and Provides Corporate Update Highlighting Expansion of CDMO Platform and Advancement of Strategic Growth Initiatives
PR Newswire
Scinai Reports First Quarter 2026 Financial Results and Provides Corporate Update Highlighting Expansion of CDMO Platform and Advancement of Strategic Growth Initiatives
JERUSALEM, June 10, 2026 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), ("Scinai" or the "Company"), a biopharmaceutical company combining innovative therapeutic development with a revenue-generating CDMO subsidiary, today reported financial results for the three months ended March 31, 2026 and provided a corporate update. Corporate Highlights Completed the acquisition of Recipharm Israel, expanding the Company's CDMO platform through the addition of a second manufacturing site in Yavne, Israel, and establishing a strategic commercial collaboration with global CDMO leader Recipharm AB. Advanced multiple non-dilutive funding initiatives supporting the Company's PC111 and NanoAb development programs. Prioritized development of a systemic IL-17 bispecific antibody as the lead validation program for the Company's NanoAb platform. Continued strategic collaboration activities with the Max Planck Society and University Medical Center Göttingen. Amir Reichman, Chief Executive Officer of Scinai, commented: "The first quarter of 2026 marked an important milestone in Scinai's evolution. Through the acquisition of Recipharm Israel and the subsequent consolidation of our CDMO activities under Scinai Biopharma Services, we have expanded our operational footprint, manufacturing capabilities and commercial reach. Scinai today consists of two complementary businesses: a focused immunology R&D organization advancing innovative therapeutic programs and Scinai Biopharma Services, our wholly owned CDMO subsidiary. We believe this structure provides multiple avenues for value creation, including CDMO growth, strategic partnerships, non-dilutive grant funding and advancement of innovative therapeutic programs. During the quarter, we strengthened our balance sheet through the Recipharm transaction, advanced multiple grant applications and refined our R&D strategy around programs that we believe offer the strongest scientific, commercial and partnering potential. As we move forward, our priorities remain clear: grow our CDMO business, secure non-dilutive funding, advance PC111 and our NanoAb platform, and continue building a capital-efficient biotechnology company capable of creating sustainable long-term shareholder value." Financial Results for the First Quarter of 2026 Revenues for the three months ended March 31, 2026 were $489 thousand, compared to $586 thousand…Read full documentShow less
JERUSALEM, June 10, 2026 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), ("Scinai" or the "Company"), a biopharmaceutical company combining innovative therapeutic development with a revenue-generating CDMO subsidiary, today reported financial results for the three months ended March 31, 2026 and provided a corporate update. Corporate Highlights Completed the acquisition of Recipharm Israel, expanding the Company's CDMO platform through the addition of a second manufacturing site in Yavne, Israel, and establishing a strategic commercial collaboration with global CDMO leader Recipharm AB. Advanced multiple non-dilutive funding initiatives supporting the Company's PC111 and NanoAb development programs. Prioritized development of a systemic IL-17 bispecific antibody as the lead validation program for the Company's NanoAb platform. Continued strategic collaboration activities with the Max Planck Society and University Medical Center Göttingen. Amir Reichman, Chief Executive Officer of Scinai, commented: "The first quarter of 2026 marked an important milestone in Scinai's evolution. Through the acquisition of Recipharm Israel and the subsequent consolidation of our CDMO activities under Scinai Biopharma Services, we have expanded our operational footprint, manufacturing capabilities and commercial reach. Scinai today consists of two complementary businesses: a focused immunology R&D organization advancing innovative therapeutic programs and Scinai Biopharma Services, our wholly owned CDMO subsidiary. We believe this structure provides multiple avenues for value creation, including CDMO growth, strategic partnerships, non-dilutive grant funding and advancement of innovative therapeutic programs. During the quarter, we strengthened our balance sheet through the Recipharm transaction, advanced multiple grant applications and refined our R&D strategy around programs that we believe offer the strongest scientific, commercial and partnering potential. As we move forward, our priorities remain clear: grow our CDMO business, secure non-dilutive funding, advance PC111 and our NanoAb platform, and continue building a capital-efficient biotechnology company capable of creating sustainable long-term shareholder value." Financial Results for the First Quarter of 2026 Revenues for the three months ended March 31, 2026 were $489 thousand, compared to $586 thousand for the three months ended March 31, 2025. Revenue for the quarter included approximately $200 thousand generated by the Yavne facility following completion of the Recipharm Israel acquisition. Cost of revenues increased to $1.6 million from $0.4 million in the comparable prior-year period. The increase primarily reflected growth of the Company's CDMO operations and implementation of a revised cost allocation methodology under which certain employee and facility costs previously classified as research and development expenses are now allocated to cost of revenues. Accordingly, cost of revenues and R&D expenses are not directly comparable between periods. Research and development expenses were $0.6 million, compared to $1.3 million in the prior-year period. The decrease primarily reflects the revised cost allocation methodology referred to above and does not represent a corresponding reduction in R&D activities. Marketing, general and administrative expenses were $0.7 million, compared to $0.5 million in the prior-year period primarily reflecting the expansion of the Company's operations following the Recipharm Israel acquisition. Operating loss was $2.5 million, compared to $1.6 million in the prior-year period. The increase primarily reflects increased expenses resulting from the expansion of the Company's CDMO activities, including the acquisition of the Yavne facility, as well as changes in cost allocation methodology that affect period-to-period comparability. Net income was $3.6 million, compared to a net loss of $1.6 million in the prior-year period, primarily reflecting a non-cash bargain purchase gain of $6.2 million associated with the acquisition of Recipharm Israel. Cash, cash equivalents and restricted cash totaled $3.1 million as of March 31, 2026, compared to $1.8 million as of December 31, 2025. Total assets increased to $17.6 million and shareholders' equity increased to $11.8 million. Operational Update Expansion of CDMO Platform During the quarter, Scinai completed the acquisition of Recipharm Israel and entered into a strategic commercial collaboration agreement with Recipharm AB. The Company subsequently consolidated its CDMO activities, assets and employees under Scinai Biopharma Services Ltd. Through the commercial collaboration, Scinai seeks to leverage Recipharm's global network and commercial reach while providing customers with development and manufacturing solutions spanning early-stage development through commercial-scale manufacturing. The acquisition added a second manufacturing and development site in Yavne, Israel, complementing the Company's existing biologics-focused facility in Jerusalem. The combined platform now offers customers broader capabilities spanning biologics, sterile injectable products and small-molecule API development and manufacturing services. Based on the preliminary purchase price allocation, the acquisition added approximately $6.2 million of net identifiable assets to the Company's balance sheet, including approximately $2.8 million of cash and $3.6 million of manufacturing infrastructure and equipment. The acquisition also expanded the Company's commercial opportunity pipeline by broadening the range of development and manufacturing services available to customers and adding an established portfolio of active projects and customer relationships. Management believes the combined Jerusalem and Yavne platform provides greater revenue diversification and a more resilient operating model, while enabling more efficient utilization of shared corporate resources and infrastructure across both sites. Non-Dilutive Funding Strategy Scinai continues to pursue a capital-efficient development strategy centered on non-dilutive funding opportunities. During the quarter and subsequent period, the Company advanced multiple grant applications supporting both its therapeutic pipeline and its CDMO expansion initiatives. The Company's PC111 program and systemic IL-17 bispecific NanoAb program successfully advanced through the initial stages of evaluation under separate Polish FENG grant applications. In addition, the Company's local intradermal IL-17 NanoAb program advanced to the final interview stage of the FENG review process, with a professional examiner evaluation meeting scheduled for June 16, 2026. Scinai has also entered the formal review process for an Israel Innovation Authority grant application supporting development of the systemic IL-17 bispecific NanoAb program and is preparing an additional Israel Innovation Authority application supporting expansion of its CDMO platform through installation of GMP lyophilization capabilities. Management expects several grant decisions during the second half of 2026. These initiatives reflect the Company's strategy of pursuing multiple non-dilutive funding opportunities across its R&D and CDMO businesses in order to support future growth while minimizing shareholder dilution. R&D Update PC111 Scinai continues to advance PC111, a fully human monoclonal antibody targeting soluble Fas Ligand for the treatment of severe dermatological conditions including pemphigus and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN). The Company submitted a revised FENG grant application supporting development of the program and extended its option agreement with PinCell through August 2026. NanoAb Platform Following scientific, commercial and regulatory evaluation of multiple development paths, Scinai has prioritized development of a systemic IL-17 bispecific antibody program as the primary validation program for its NanoAb platform. Management believes this program offers an attractive combination of commercial opportunity, differentiated scientific profile, partner interest and a more conventional development pathway than certain alternative NanoAb delivery strategies. The Company also continues its collaboration with the Max Planck Society and University Medical Center Göttingen and is engaged in discussions regarding expansion and amendment of existing license arrangements. Outlook Management remains focused on expanding CDMO revenues and customer relationships, integrating and optimizing the expanded CDMO platform, securing non-dilutive grant funding, advancing PC111 and the IL-17 bispecific NanoAb program, pursuing strategic partnering opportunities and maintaining disciplined capital allocation. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company focused on the development of innovative immunology therapies. The Company is advancing a pipeline of therapeutic candidates licensed from the Max Planck Society and from PinCell S.r.l. Scinai also owns Scinai Biopharma Services Ltd., a contract development and manufacturing organization (CDMO), providing development and manufacturing services to biotechnology and pharmaceutical companies through facilities in Jerusalem and Yavne, Israel. For more information, please visit: www.scinai.com Company Contacts Business Development | +972 8 930 2529 | [email protected] Relations – Allele Capital Partners | +1 978 857 5075 | [email protected] Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements include, among other things, statements regarding the Company's CDMO growth strategy; expansion of operational capabilities; integration of the Yavne facility into Scinai Biopharma Services' CDMO platform; execution of commercial collaboration activities with Recipharm AB; purchase price allocation resulting from the acquisition of Recipharm Israel; advancement of the Company's PC111 and NanoAb development programs; development of the systemic IL-17 bispecific antibody program; grant applications and potential non-dilutive funding opportunities; strategic collaborations with the Max Planck Society and University Medical Center Göttingen; future business development and partnering opportunities; and the Company's ability to create long-term shareholder value. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks related to the Company's ability to execute its operational and strategic plans; successfully integrate acquired operations; expand its CDMO activities and benefit from the commercial collaboration agreement with Recipharm AB; changes in the purchase price allocation resulting from the acquisition of Recipharm Israel; attract and retain customers, collaborators and partners; advance its product candidates through development; obtain regulatory approvals; ability secure sufficient financing or non-dilutive funding, including through grant applications; successfully execute commercial collaboration activities; realize anticipated benefits from strategic transactions and collaborations; and general market, industry, regulatory, geopolitical and economic conditions. More detailed information regarding these and other risks and uncertainties is included in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date of this press release. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. SCINAI IMMUNOTHERAPEUTICS LTD. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS March 31, 2026 Unaudited The preliminary allocation of the purchase price is summarized below (in thousands of U.S. dollars): View original content to download multimedia:https://www.prnewswire.com/news-releases/scinai-reports-first-quarter-2026-financial-results-and-provides-corporate-update-highlighting-expansion-of-cdmo-platform-and-advancement-of-strategic-growth-initiatives-302796684.html
Investor releaseQuarter not tagged2026-04-01Scinai Reports Full-Year 2025 Results, with CDMO Revenues Doubling and Strategic Expansion Through Recipharm Collaboration
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Scinai Reports Full-Year 2025 Results, with CDMO Revenues Doubling and Strategic Expansion Through Recipharm Collaboration
JERUSALEM, April 1, 2026 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI); ("Scinai" or the "Company"), a biopharmaceutical company operating a dual R&D and CDMO business model designed to combine therapeutic innovation with revenue-generating drug development and manufacturing services, today reported financial results for the year ended December 31, 2025. Corporate and Financial Highlights CDMO revenues doubled year-over-year to $1.3 million, reflecting continued commercial traction and execution of development and manufacturing programs Expanded CDMO platform post year-end through the acquisition of Recipharm Israel and entry into a strategic commercial collaboration with Recipharm, enhancing manufacturing capabilities and broadening service offerings Established a differentiated lifecycle CDMO model with global reach, enabling customer programs to transition from early-stage development through late-stage and commercial manufacturing Positioned PC111, a fully human monoclonal antibody targeting inflammatory pathways with potential applications in severe dermatological conditions, as the Company's flagship value driver. Resubmitted application for non-dilutive FENG grant funding covering PC111 and IL-17-based programs, advancing key pipeline assets through capital-efficient funding mechanisms FENG grant structure provides significant capital efficiency, with €12 million of potential grant funding matched by approximately €3 million of Company investment, enabling up to 5x leverage on R&D capital Net cash used in operating activities for the year ended December 31, 2025, was $6.0 million, representing a slight decrease year-over-year. Financial Results for Full-Year 2025 Revenues for the year ended December 31, 2025, were $1.3 million, compared to $0.7 million for the year ended December 31, 2024. The increase reflects continued expansion of Scinai's CDMO activities. R&D expenses for the year ended December 31, 2025, amounted to $2.4 million, compared to $5.5 million for the year ended December 31, 2024. The decrease was primarily due to lower allocation of employees and facility costs to the R&D business unit. Marketing, general and administrative expenses for the year ended December 31, 2025, were $2.5 million, compared to $2.5 million for the year ended December 31, 2024. Financial expenses, net, for the year ended December 31, 2025, were $…Read full documentShow less
JERUSALEM, April 1, 2026 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI); ("Scinai" or the "Company"), a biopharmaceutical company operating a dual R&D and CDMO business model designed to combine therapeutic innovation with revenue-generating drug development and manufacturing services, today reported financial results for the year ended December 31, 2025. Corporate and Financial Highlights CDMO revenues doubled year-over-year to $1.3 million, reflecting continued commercial traction and execution of development and manufacturing programs Expanded CDMO platform post year-end through the acquisition of Recipharm Israel and entry into a strategic commercial collaboration with Recipharm, enhancing manufacturing capabilities and broadening service offerings Established a differentiated lifecycle CDMO model with global reach, enabling customer programs to transition from early-stage development through late-stage and commercial manufacturing Positioned PC111, a fully human monoclonal antibody targeting inflammatory pathways with potential applications in severe dermatological conditions, as the Company's flagship value driver. Resubmitted application for non-dilutive FENG grant funding covering PC111 and IL-17-based programs, advancing key pipeline assets through capital-efficient funding mechanisms FENG grant structure provides significant capital efficiency, with €12 million of potential grant funding matched by approximately €3 million of Company investment, enabling up to 5x leverage on R&D capital Net cash used in operating activities for the year ended December 31, 2025, was $6.0 million, representing a slight decrease year-over-year. Financial Results for Full-Year 2025 Revenues for the year ended December 31, 2025, were $1.3 million, compared to $0.7 million for the year ended December 31, 2024. The increase reflects continued expansion of Scinai's CDMO activities. R&D expenses for the year ended December 31, 2025, amounted to $2.4 million, compared to $5.5 million for the year ended December 31, 2024. The decrease was primarily due to lower allocation of employees and facility costs to the R&D business unit. Marketing, general and administrative expenses for the year ended December 31, 2025, were $2.5 million, compared to $2.5 million for the year ended December 31, 2024. Financial expenses, net, for the year ended December 31, 2025, were $0.8 million, compared to financial income of $13.4 million for the year ended December 31, 2024. The change was primarily driven by the financial income from loan conversion recognized in 2024, which did not recur in 2025. Net loss for the year ended December 31, 2025, was $8.3 million, compared to net income of $4.8 million for the year ended December 31, 2024. The variance reflects the financial income from loan conversion recognized in 2024. As of December 31, 2025, cash, cash equivalents and restricted cash totalled $1.8 million, compared to $2.1 million as of December 31, 2024. Operational Update During 2025, Scinai expanded its CDMO activities, executing multiple development and manufacturing programs and continuing to build its customer base, primarily among biotech companies in Israel and the United States. On the R&D side, the Company re-prioritized its pipeline, positioning PC111 as its lead value driver while refining its NanoAbs development strategy. As part of this shift, the Company selected a systemic IL-17 bi-specific program as the primary path for platform validation, focusing on a more capital-efficient and partner-aligned development approach. Development activities under the NanoAbs platform continued in collaboration with the Max Planck Society. The Company also shifted its funding strategy toward non-dilutive sources, with a focus on securing grant funding to support key programs, including PC111 and IL-17-based assets. Post Year-End Strategic Development In February 2026, Scinai completed the acquisition of Recipharm Israel's manufacturing site in Yavne and entered into a strategic commercial collaboration agreement with Recipharm. This transaction expands the Company's capabilities beyond biologics into small-molecule development and manufacturing and strengthens its positioning as an integrated CDMO platform. Through this collaboration, Scinai is positioned to support customer programs from early-stage development through late-stage and commercial manufacturing via Recipharm's global network, while maintaining ongoing participation in the value chain. On the R&D side, the Company extended its option agreement with Pincell to August 31, 2026, maintaining strategic flexibility around the advancement of the PC111 program. The Company also resubmitted its FENG grant application for PC111 and submitted two additional FENG grant applications for its IL-17 NanoAb programs, supporting its strategy to advance multiple programs through non-dilutive funding. Management Commentary Amir Reichman, Chief Executive Officer of Scinai, commented: "2025 was a year of focused execution, during which we continued to grow our CDMO activities while refining our strategic priorities. We doubled our revenues year-over-year and improved operating efficiency, while positioning PC111 as our flagship value driver and advancing our capital-efficient development model through non-dilutive funding initiatives. The Recipharm transaction completed after year-end represents a significant step forward, expanding our capabilities, footprint and market reach, and enabling us to participate across a broader portion of the drug development lifecycle. Looking ahead, we remain focused on scaling our CDMO business, advancing PC111 and our NanoAbs platform, and leveraging non-dilutive funding to maximize the impact of our capital." A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission and posted on the Company's investor relations website at https://www.scinai.com/investorsrelations. The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at [email protected] About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units: (i) Scinai R&D, focused on the development of innovative therapeutics in inflammation and immunology, and (ii) its contract development and manufacturing organization (CDMO) business, operated through its subsidiary, Scinai Biopharma Services Ltd. Scinai's R&D activities are centered on two key pillars. The Company is advancing its NanoAbs platform, which is focused on the development of novel therapeutics based on VHH antibody fragments with unique properties suitable for advanced mono- and multi-specific antibody formats, in collaboration with the Max Planck Society and the University Medical Center Göttingen. In parallel, the Company is progressing its PC111 program through an option agreement to acquire Pincell S.r.l., a clinical-stage biotechnology company. PC111 is a fully human monoclonal antibody targeting pathways involved in inflammation and keratinocyte cell death, with potential applications in severe dermatological conditions. The Company also continues to evaluate opportunities to acquire or in-license additional assets in or near clinical development. The Company's CDMO business provides integrated development and manufacturing services to emerging biotech companies, supporting programs from early-stage development through clinical-stage production. Following the acquisition of Recipharm Israel in February 2026, Scinai is expanding its manufacturing capabilities and consolidating its CDMO activities under Scinai Biopharma Services Ltd., with the goal of supporting a broader range of modalities and customer programs. Scinai's strategy is to build a capital-efficient, integrated biotechnology platform by combining internal pipeline development, externally sourced assets, and revenue-generating CDMO operations. Company website: www.scinai.com Company Contacts Investor Relations - Allele Capital Partners | +1 978 857 5075 | [email protected] Business Development | +972 8 930 2529 | [email protected] Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements include, among other things, statements regarding the Company's strategy, including the growth of its CDMO business, the expected benefits of the Recipharm transaction and collaboration, the development and potential of its R&D programs, including PC111 and its NanoAbs platform, and the Company's efforts to obtain non-dilutive funding, including FENG grants. Words such as "expects," "intends," "plans," "believes," "may," "will," "anticipates," "estimates," and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the Company's ability to successfully integrate and realize the expected benefits of the Recipharm transaction, its ability to secure non-dilutive funding, including grant approvals, the progress and timing of its R&D programs, including PC111, its ability to generate revenues from its CDMO business, and general market conditions, including the Company's ability to meet the continued listing requirements of The Nasdaq Capital Market. More detailed information regarding these and other risks and uncertainties is included under the heading "Risk Factors" in the Company's Annual Report on Form 20-F and in the Company's subsequent filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date of this press release. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise. Logo: https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg View original content:https://www.prnewswire.com/news-releases/scinai-reports-full-year-2025-results-with-cdmo-revenues-doubling-and-strategic-expansion-through-recipharm-collaboration-302731295.html
Investor releaseQuarter not tagged2025-12-02Scinai Reports Nine-Month 2025 Results as CDMO Growth Continues and NanoAbs Pipeline Advances
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Scinai Reports Nine-Month 2025 Results as CDMO Growth Continues and NanoAbs Pipeline Advances
JERUSALEM, Dec. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company developing innovative inflammation and immunology (I&I) therapeutics and operating a growing boutique CDMO business unit, today reported its financial results and corporate highlights for the nine months ended September 30, 2025. First Nine Months 2025 Financial Summary Revenues for the nine months ended September 30, 2025 were $1,049 thousand, compared to $452 thousand for the nine months ended September 30, 2024. The increase reflects continued expansion of Scinai Bioservices, including contributions from the Company's U.S. subsidiary. R&D expenses for the nine months ended September 30, 2025 amounted to $1,799 thousand, compared to $4,195 thousand for the nine months ended September 30, 2024. The decrease was primarily due to lower allocation of employees and facility costs to the R&D business unit. Marketing, general and administrative expenses for the nine months ended September 30, 2025 were $1,929 thousand, compared to $1,767 thousand for the nine months ended September 30, 2024. The increase was mainly due to insurance reimbursement recorded in 2024. Financial Expenses, net, for the nine months ended September 30, 2025, were $607 thousand compared to financial income of $13,374 thousand for the nine months ended September 30, 2024. The change was primarily driven by the financial income from loan conversion recorded in 2024. Net loss for the nine months ended September 30, 2025 was $6,244 thousand compared to net profit of $7,026 thousand for the nine months ended September 30, 2024. The variance reflects the financial income from loan conversion recognized in 2024. As of September 30, 2025, cash, cash equivalents and short-term deposits totaled $3,005 thousand, compared to $1,964 thousand as of September 30, 2024. Business Update CDMO Business - Scinai Bioservices Scinai Bioservices continues to expand its role as a boutique CDMO serving early-stage biotech companies in Israel, the United States, and Europe. The Company's U.S. subsidiary contributed $502 thousand in revenues during the first nine months of 2025, demonstrating early traction in North America. Scinai recently received a non-dilutive grant of approximately NIS 809,000 net (approximately $246,000) from the Israel Innovation Authority to fund two…Read full documentShow less
JERUSALEM, Dec. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company developing innovative inflammation and immunology (I&I) therapeutics and operating a growing boutique CDMO business unit, today reported its financial results and corporate highlights for the nine months ended September 30, 2025. First Nine Months 2025 Financial Summary Revenues for the nine months ended September 30, 2025 were $1,049 thousand, compared to $452 thousand for the nine months ended September 30, 2024. The increase reflects continued expansion of Scinai Bioservices, including contributions from the Company's U.S. subsidiary. R&D expenses for the nine months ended September 30, 2025 amounted to $1,799 thousand, compared to $4,195 thousand for the nine months ended September 30, 2024. The decrease was primarily due to lower allocation of employees and facility costs to the R&D business unit. Marketing, general and administrative expenses for the nine months ended September 30, 2025 were $1,929 thousand, compared to $1,767 thousand for the nine months ended September 30, 2024. The increase was mainly due to insurance reimbursement recorded in 2024. Financial Expenses, net, for the nine months ended September 30, 2025, were $607 thousand compared to financial income of $13,374 thousand for the nine months ended September 30, 2024. The change was primarily driven by the financial income from loan conversion recorded in 2024. Net loss for the nine months ended September 30, 2025 was $6,244 thousand compared to net profit of $7,026 thousand for the nine months ended September 30, 2024. The variance reflects the financial income from loan conversion recognized in 2024. As of September 30, 2025, cash, cash equivalents and short-term deposits totaled $3,005 thousand, compared to $1,964 thousand as of September 30, 2024. Business Update CDMO Business - Scinai Bioservices Scinai Bioservices continues to expand its role as a boutique CDMO serving early-stage biotech companies in Israel, the United States, and Europe. The Company's U.S. subsidiary contributed $502 thousand in revenues during the first nine months of 2025, demonstrating early traction in North America. Scinai recently received a non-dilutive grant of approximately NIS 809,000 net (approximately $246,000) from the Israel Innovation Authority to fund two-thirds of a NIS 1.23 million (approximately $373,000) investment in an advanced sterile fill-and-finish system. The new system is designed to provide rapid batch turnaround and flexible switching between campaigns, substantially improving small-batch manufacturing capacity for early-stage biotech clients. Installation and qualification are expected in Q1 2026, with commercial operation planned in Q2 2026. The IIA noted in its award letter that the lack of local, flexible GMP manufacturing infrastructure is a major bottleneck for Israel's 300+ biopharma companies and recognized Scinai's growing role in addressing this national and global gap. R&D Business - NanoAbs and PC111 Programs NanoAbs Pipeline — Focused on High-Value IL-17 Programs and Strategic Partnering Scinai is advancing a focused NanoAb pipeline in inflammation and immunology, supported by two STEP grant applications of up to €15 million each, with funding decisions expected in Q1 2026. The Company is actively seeking partners for co-development or licensing across all programs. SCN-1 (Lead Program): Intradermal IL-17A/F NanoAb for Mild–Moderate Psoriasis Approaching Phase 1/2a, a decision on the Company's application for a €15 million grant under the EU STEP program is expected Q1 2026 First localized biologic designed specifically for mild–moderate psoriasis. Potent IL-17A/F neutralizing VHH delivered intradermally in a painless manner via mesogun, enabling targeted treatment with minimal systemic exposure. Establishes a new category between topicals and systemic biologics. Clear value for patients, physicians, payers, and commercial partners. Supported by translational data and progressing toward Phase 1/2a entry. Bispecific IL-17A/F + Second Target (VHH-Fc): Long-Acting Systemic Biologic For psoriasis, PsA, HS, and broader I&I, a decision on the Company's application for a €15 million grant under the EU STEP program is expected Q1 2026. This grant application is separate and in addition to the one related to SCN-1 mentioned above. Dual-target VHH-Fc architecture provides enhanced biologic activity and extended half-life. Applicable across multiple high-value I&I indications. Designed for systemic administration with differentiated mechanism and dosing profile. Third Program: Four New NanoAbs from Max Planck / UMG Collaboration Patent filings in 2025, Exclusive licensing option expected to be exercised by Q1 2026 Four novel NanoAbs generated under Scinai's research collaboration with MPG and UMG. Patent applications filed in 2025. Scinai plans to exercise its exclusive licensing option by Q1 2026. Expands the pipeline into additional high-need I&I pathways. PC111 - Strategic Assessment Following Grant Outcome On November 24, 2025, Scinai received formal notice from the Polish grant authorities that its €12 million FENG grant application supporting development of PC111 was not approved. As a result, Scinai and its development partner, Pincell Srl, are currently reviewing the program's forward path and evaluating several alternatives. These include, among other options, submitting a new non-dilutive grant application in early 2026 or potentially terminating Scinai's option to acquire Pincell if a viable financing path cannot be secured. Scinai currently holds an exclusive option to exercise the Share Purchase Agreement (SPA) for 100% of Pincell's fully diluted share capital through February 28, 2026, with no additional purchase price required at exercise. The exercise of this option is conditional upon Scinai demonstrating at least $3 million specifically earmarked for PC111's development. The Company will update the market once its joint assessment with Pincell is complete and a defined strategic path has been selected. Partnering Outlook Scinai is currently engaged in outreach for co-development, global or regional licensing, or broader platform partnerships across all pipeline programs. CEO Statement "2025 has been a year of significant progress across our CDMO and R&D business units," said Amir Reichman, CEO of Scinai. "Our CDMO operations continue to build momentum and strengthen their position as a trusted partner for emerging biotech companies. On the R&D side, while the recent grant outcome for PC111 was not what we had hoped for, the underlying science remains strong. Together with our partners at Pincell, we are now evaluating the best strategic path forward for the program, including potential non-dilutive funding routes or alternative options. At the same time, our NanoAbs pipeline continues to advance with promising differentiation and clear partnering opportunities. With growing operational capabilities and a disciplined approach to resource allocation, we remain committed to creating long-term value for patients and shareholders." About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units: Scinai Bioservices, a boutique CDMO providing analytical method development, process development, and clinical cGMP manufacturing services for biotech clients worldwide. Scinai R&D, focused on developing innovative I&I therapeutics based on NanoAbs (VHH antibody fragments) with unique physicochemical properties suitable for advanced mono- and multi-specific antibody formats Company website: www.scinai.com Company Contacts Investor Relations - Allele Capital Partners | +1 978 857 5075 | [email protected] Business Development | +972 8 930 2529 | [email protected] Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding grant applications under the EU STEP program and timing of commercial operations. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2025 and thereafter, failure to sign agreements with other potential clients of the CDMO business; failure to receive grants under the EU STEP program or a delay in receiving grant decisions; delay in commencement of commercial operation of advanced sterile fill-and-finish system; a delay in the commencement and results of pre-clinical and clinical studies, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other NanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 7, 2025, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Logo - https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg View original content:https://www.prnewswire.com/news-releases/scinai-reports-nine-month-2025-results-as-cdmo-growth-continues-and-nanoabs-pipeline-advances-302630483.html
Investor releaseQuarter not tagged2025-09-02Scinai Reports Six-Month 2025 Financial Results Highlighting Continued CDMO Revenue Growth and Strengthened Balance Sheet
PR Newswire
Scinai Reports Six-Month 2025 Financial Results Highlighting Continued CDMO Revenue Growth and Strengthened Balance Sheet
JERUSALEM, Sept. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its financial results for the six months ended June 30, 2025. Six-Month 2025 Financial Summary Revenues for the six months ended June 30, 2025, totaled $773 thousand, compared to $284 thousand for the six months ended June 30, 2024. The increase reflects the continued growth of the Company's CDMO business, which generated contract revenues. R&D expenses for the six months ended June 30, 2025, amounted to $1,237 thousand, compared to $2,788 thousand for the same period in 2024, primarily due to lower allocation of wages and facilities to R&D activities. Marketing, general and administrative expenses were $1,256 thousand in the six months ended June 30, 2025, compared to $1,003 thousand in the same period of 2024. The increase was primarily due to share-based payments and due to an insurance reimbursement recorded in 2024. Net loss was $4,134 thousand, compared to $4,481 thousand in the six months ended June 30, 2024, reflecting higher revenues and lower R&D expenses. Cash - as of June 30, 2025, cash and cash equivalents totaled $989 thousand. Subsequently, in July and August 2025, the Company successfully raised an additional $4.2 million through its Standby Equity Purchase Agreement with Yorkville Advisors, significantly strengthening its cash position. Business Update CDMO Scinai Bioservices, the Company's CDMO business unit, continues to grow steadily, with its U.S. subsidiary contributing $421 thousand in revenues in the first half of 2025. As of August 31, 2025, total CDMO service orders for 2025 reached $1.0 million, net of raw materials and disposables, with invoiced revenues of $850 thousand. R&D Scinai is advancing its anti-IL-17 NanoAb program with two product profiles in development: one focused on localized treatment of psoriasis patients with small but debilitating lesions, and another aimed at systemic treatment of moderate-to-severe plaque psoriasis through an innovative tri-specific antibody design. The Company plans to apply for up to €15 million in grant financing unde…Read full documentShow less
JERUSALEM, Sept. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its financial results for the six months ended June 30, 2025. Six-Month 2025 Financial Summary Revenues for the six months ended June 30, 2025, totaled $773 thousand, compared to $284 thousand for the six months ended June 30, 2024. The increase reflects the continued growth of the Company's CDMO business, which generated contract revenues. R&D expenses for the six months ended June 30, 2025, amounted to $1,237 thousand, compared to $2,788 thousand for the same period in 2024, primarily due to lower allocation of wages and facilities to R&D activities. Marketing, general and administrative expenses were $1,256 thousand in the six months ended June 30, 2025, compared to $1,003 thousand in the same period of 2024. The increase was primarily due to share-based payments and due to an insurance reimbursement recorded in 2024. Net loss was $4,134 thousand, compared to $4,481 thousand in the six months ended June 30, 2024, reflecting higher revenues and lower R&D expenses. Cash - as of June 30, 2025, cash and cash equivalents totaled $989 thousand. Subsequently, in July and August 2025, the Company successfully raised an additional $4.2 million through its Standby Equity Purchase Agreement with Yorkville Advisors, significantly strengthening its cash position. Business Update CDMO Scinai Bioservices, the Company's CDMO business unit, continues to grow steadily, with its U.S. subsidiary contributing $421 thousand in revenues in the first half of 2025. As of August 31, 2025, total CDMO service orders for 2025 reached $1.0 million, net of raw materials and disposables, with invoiced revenues of $850 thousand. R&D Scinai is advancing its anti-IL-17 NanoAb program with two product profiles in development: one focused on localized treatment of psoriasis patients with small but debilitating lesions, and another aimed at systemic treatment of moderate-to-severe plaque psoriasis through an innovative tri-specific antibody design. The Company plans to apply for up to €15 million in grant financing under the EU STEP program, with a decision expected in Q1 2026, to fund Phase 1/2a clinical trials. In 2025, Scinai filed patents for four additional NanoAbs from its collaboration with the Max Planck Society and University Medical Center Göttingen and is exercising its exclusive option to license them. By October 2025, the Company expects to apply for a European Funds for a Modern Economy (FENG) grant to support the development of a novel multi-specific antibody targeting TH2-related diseases such as asthma, atopic dermatitis, and COPD. In March 2025, Scinai signed an option agreement to acquire PinCell srl, an Italian biotech company developing PC111, a potential treatment for severe dermatological conditions. A related €12 million FENG grant application is under review, with a funding decision expected in Q3 2025. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of VHH antibody fragments (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects. Company website: www.scinai.com Company Contacts Investor Relations - Allele Capital Partners | +1 978 857 5075 | [email protected] Business Development | +972 8 930 2529 | [email protected] Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2025 and thereafter; failure to sign agreements with other potential clients of the CDMO business; the risk that the Company will not be awarded, or there will be delays in decisions with respect to, the potential grants from the FENG program, the EU Step program and/or the IIA; that the Company will not exercise its right to acquire PinCell; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other nanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of nanoAbs will not be met or that Scinai will not be successful in bringing the nanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for nanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 7, 2025, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Logo: https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg View original content:https://www.prnewswire.com/news-releases/scinai-reports-six-month-2025-financial-results-highlighting-continued-cdmo-revenue-growth-and-strengthened-balance-sheet-302543710.html SOURCE Scinai Immunotherapeutics Ltd.
Investor releaseQuarter not tagged2025-05-30Scinai Reports Q1 2025 Financial Results Highlighting Strong CDMO Revenue Momentum and Reduced Cash Burn
PR Newswire
Scinai Reports Q1 2025 Financial Results Highlighting Strong CDMO Revenue Momentum and Reduced Cash Burn
JERUSALEM, May 30th, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its financial results for the first three months ended March 31, 2025. Three (3) Months of 2025 Financial Summary Revenues for the three months ended March 31, 2025, totaled $586 thousand. The Company's CDMO unit began generating revenues in the second quarter ended June 30, 2024. As disclosed in the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on May 7, 2025, CDMO revenues for the full year 2024 were $658 thousand. The year-over-year increase in revenues for the first quarter of 2025 reflects a higher number of contracts executed during the period, driven by continued growth in the CDMO business. R&D expenses for the three months ended March 31, 2025, amounted to $1,296 thousand, compared to $1,568 thousand for the same period in 2024. The decrease was primarily due to lower wages and reduced direct R&D expenses. Marketing, general and administrative expenses for the three months ended March 31, 2025, amounted to $500 thousand compared to $484 thousand for the three months ended March 31, 2024. Financial income, net, for the three months ended March 31, 2025, amounted to $11 thousand, compared to financial expenses of $231 thousand for the same period in 2024. The improvement was primarily due to the conversion of the EIB loan into preferred shares of the Company stock in the third quarter of 2024. Net loss for the three months ended March 31, 2025, was $1,557 thousand, compared to a net loss of $2,159 thousand for the three months ended March 31, 2024. The decrease was primarily due to lower R&D expenses, reduced financial expenses, and the recognition of gross income. As of March 31, 2025, Scinai had cash and cash equivalents and short-term deposits of $1,018 thousand compared to $1,964 thousand as of March 31, 2024. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I)…Read full documentShow less
JERUSALEM, May 30th, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its financial results for the first three months ended March 31, 2025. Three (3) Months of 2025 Financial Summary Revenues for the three months ended March 31, 2025, totaled $586 thousand. The Company's CDMO unit began generating revenues in the second quarter ended June 30, 2024. As disclosed in the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on May 7, 2025, CDMO revenues for the full year 2024 were $658 thousand. The year-over-year increase in revenues for the first quarter of 2025 reflects a higher number of contracts executed during the period, driven by continued growth in the CDMO business. R&D expenses for the three months ended March 31, 2025, amounted to $1,296 thousand, compared to $1,568 thousand for the same period in 2024. The decrease was primarily due to lower wages and reduced direct R&D expenses. Marketing, general and administrative expenses for the three months ended March 31, 2025, amounted to $500 thousand compared to $484 thousand for the three months ended March 31, 2024. Financial income, net, for the three months ended March 31, 2025, amounted to $11 thousand, compared to financial expenses of $231 thousand for the same period in 2024. The improvement was primarily due to the conversion of the EIB loan into preferred shares of the Company stock in the third quarter of 2024. Net loss for the three months ended March 31, 2025, was $1,557 thousand, compared to a net loss of $2,159 thousand for the three months ended March 31, 2024. The decrease was primarily due to lower R&D expenses, reduced financial expenses, and the recognition of gross income. As of March 31, 2025, Scinai had cash and cash equivalents and short-term deposits of $1,018 thousand compared to $1,964 thousand as of March 31, 2024. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects. Company website: www.scinai.com. Company Contacts Investor Relations - Allele Capital Partners | +1 978 857 5075 | [email protected] Business Development | +972 8 930 2529 | [email protected] Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2025 and thereafter; failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other nanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of nanoAbs will not be met or that Scinai will not be successful in bringing the nanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for nanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 7, 2025, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Logo - https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg View original content:https://www.prnewswire.com/news-releases/scinai-reports-q1-2025-financial-results-highlighting-strong-cdmo-revenue-momentum-and-reduced-cash-burn-302469394.html SOURCE Scinai Immunotherapeutics Ltd.
Investor releaseQuarter not tagged2025-05-08Scinai Announces Annual Financial Results for 2024
PR Newswire
Scinai Announces Annual Financial Results for 2024
JERUSALEM, May 7, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its annual financial results for the full year 2024. Full year 2024 Financial Summary Revenues for 2024, amounted to $658 thousands, compared to no revenues for 2023. The increase was due to the CDMO starting to generate revenues for the first time in 2024. R&D expenses for 2024, amounted to $5.6 million compared to $5.2 million for 2023. The change was not material and primarily reflects minor fluctuations in R&D activities during the period. Marketing, general and administrative expenses for 2024, amounted to $2.6 million compared to $4.5 million for 2023. The decrease was primarily due to decrease in wages, share based compensation and professional services. Financial income, net in 2024, amounted to $13.5 million compared to $3.2 million for 2023. The increase was primarily due to financial income from loan conversion to equity. Net Gain for 2024, was $4.8 million compared to net loss of $6.5 million for 2023. The increase was primarily due to $14.8 million financial income from loan conversion to equity. As of December 31, 2024, Scinai had cash and cash equivalents and short-term deposits of $1.9 million compared to $4.9 million as of December 31, 2023. Our complete audited financial results are available in our Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission today. A copy of the Company's annual report on Form 20-F is available on the SEC's website - LINK and posted on the Company's investor relations website at https://www.scinai.com/investorsrelations. The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at [email protected]. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-riske…Read full documentShow less
JERUSALEM, May 7, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its annual financial results for the full year 2024. Full year 2024 Financial Summary Revenues for 2024, amounted to $658 thousands, compared to no revenues for 2023. The increase was due to the CDMO starting to generate revenues for the first time in 2024. R&D expenses for 2024, amounted to $5.6 million compared to $5.2 million for 2023. The change was not material and primarily reflects minor fluctuations in R&D activities during the period. Marketing, general and administrative expenses for 2024, amounted to $2.6 million compared to $4.5 million for 2023. The decrease was primarily due to decrease in wages, share based compensation and professional services. Financial income, net in 2024, amounted to $13.5 million compared to $3.2 million for 2023. The increase was primarily due to financial income from loan conversion to equity. Net Gain for 2024, was $4.8 million compared to net loss of $6.5 million for 2023. The increase was primarily due to $14.8 million financial income from loan conversion to equity. As of December 31, 2024, Scinai had cash and cash equivalents and short-term deposits of $1.9 million compared to $4.9 million as of December 31, 2023. Our complete audited financial results are available in our Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission today. A copy of the Company's annual report on Form 20-F is available on the SEC's website - LINK and posted on the Company's investor relations website at https://www.scinai.com/investorsrelations. The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at [email protected]. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects. Company website: www.scinai.com. Company Contacts Investor Relations - Allele Capital Partners | +1 978 857 5075 | [email protected] Business Development | +972 8 930 2529 | [email protected] Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2025 and thereafter; failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other nanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of nanoAbs will not be met or that Scinai will not be successful in bringing the nanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for nanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 7, 2025, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Logo - https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg View original content:https://www.prnewswire.com/news-releases/scinai-announces-annual-financial-results-for-2024-302449086.html SOURCE Scinai Immunotherapeutics Ltd.
TranscriptFY2024 Q22024-08-20FY2024 Q2 earnings call transcript
Earnings source - 14 paragraphs
FY2024 Q2 earnings call transcript
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.
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.
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?
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.
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?
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.
Can you remind us of what total shareholders' equity will be after the EIB restructuring?
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.
What are some of the key regulatory considerations and strategies Scinai is employing to navigate the approval process for its nanoAb candidate?
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.
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?
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.
Thank you. Thank you, everyone.
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.