NLS Pharmaceutics AG (NLSP): Business Model Canvas [Dec-2025 Updated]

You're analyzing a biotech that just executed a major pivot, and mapping the Business Model Canvas for NLS Pharmaceutics AG (NLSP), now NewcelX, reveals a high-stakes strategy: they are driving their lead narcolepsy drug, Quilience, through pivotal Phase 3 trials while integrating a whole new cell therapy pipeline post-merger. Honestly, this model is pre-revenue, relying on capital raises to fund operations and cover the USD 2.22 million net loss reported for the half year ended June 30, 2025, betting hard on repurposing known compounds to accelerate development timelines. Still, you need to see how their Key Resources, like Orphan Drug Designation, are positioned against the massive R&D Cost Structure; check out the full nine-block breakdown below to understand the near-term risks and the path to future revenue streams.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Key Partnerships

You're looking at the core alliances that underpin NLS Pharmaceutics AG's (now NewCelX Ltd.) strategy as of late 2025. These aren't just handshake agreements; they represent critical access to technology, capital, and clinical execution.

Merger Partner: Kadimastem Ltd.

The merger with Kadimastem Ltd. is the defining partnership, fundamentally reshaping the company's pipeline and structure. This transaction, expected to close on October 30, 2025, moves NLS Pharmaceutics into regenerative medicine alongside its CNS focus.

The resulting ownership split shows the scale of the integration:

The share exchange was set with a final ratio of approximately 0.62 NLS common shares per Kadimastem ordinary share, following a 1:10 reverse stock split of NLS shares. To facilitate this merger and prepare for Kadimastem's pipeline execution, NLS secured significant capital, including a $25 million committed equity facility agreement (ELOC). The initial equity financing rounds totaled $3 million gross proceeds, with the final tranche closing on June 27, 2025.

Technology Pipeline Expansion: Aexon Labs and the Doxa Platform

The collaboration with Aexon Labs for the dual orexin receptor agonist (DOXA) platform is key to expanding the CNS pipeline beyond existing candidates. NLS Pharmaceutics entered an option agreement for the DOXA platform back in 2023.

This partnership recently yielded the AEX-6xx series, which includes the lead compound AEX-635. The companies are preparing for investigational new drug (IND)-enabling studies and plan to initiate preclinical partnering discussions in the fourth quarter of 2025. The combined company believes that the $25 million ELOC, along with approximately $7 million raised in recent equity financing, will bolster its cash position to support operations for at least the next 12 months.

Research and Development: Academic Institutions

NLS Pharmaceutics maintains a network of academic collaborations to support its research and development efforts. These relationships are vital for early-stage scientific validation and talent acquisition in Switzerland and France.

• Partnership with Universität Zürich
• Partnership with ETH Zürich
• Partnership with Centre Hospitalier Universitaire Vaudois CHUV
• Partnership with Université de Lausanne
• Partnership with Assistance Publique Hôpitaux de Paris

Specific financial commitments related to these academic research agreements for the 2025 fiscal year are not publicly detailed in the latest filings.

Diabetes Program Support: BIRD Foundation

The Israel-U.S. Binational Industrial Research and Development (BIRD) Foundation provides crucial, milestone-based funding for the ITOL-102 Type 1 Diabetes cell therapy program, which was inherited via the Kadimastem merger.

The Foundation's confidence is quantified through recent disbursements:

• Additional milestone payment approved in July 2025: approximately NIS 564,400 (or $166,000 USD).
• Total support from the BIRD Foundation to date: nearly NIS 3 million (or $882,352 USD).

For context on the BIRD Foundation's overall impact, since its establishment in 1977, it has invested over $300 million in more than 1,000 joint projects, resulting in over $10 billion in direct and indirect sales. Omer Carmel, Director of Business Development at the BIRD Foundation, confirmed continued support for the ITOL-102 program under the NewCelX Ltd. framework.

Clinical Trial Management: Clinical Research Organizations (CROs)

Managing the upcoming clinical programs, including Kadimastem's Phase IIa trial for Amyotrophic Lateral Sclerosis (ALS) using AstroRx® and the Phase I study for IseltRx for type 1 diabetes, requires external expertise from CROs. These organizations handle the logistical and regulatory heavy lifting for Phase 3 trials, but specific contract values or the total spend allocated to CRO services for the 2025 fiscal year are not itemized in the publicly available financial reports.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Key Activities

You're looking at the core engine driving NLS Pharmaceutics AG's strategy as it heads into the final quarter of 2025, right after the expected merger close. This is where the real work-and the real cash burn-is happening. Honestly, the key activities are heavily weighted toward clinical execution and financial maneuvers to support that execution.

Conducting pivotal Phase 3 clinical trials for Quilience (Mazindol ER) in narcolepsy remains the central focus for the legacy NLS pipeline. The AMAZE Program, authorized by the U.S. Food and Drug Administration (FDA) in May 2023, involved two double-blind Phase 3 trials, NLS-1031 and NLS-1032, each enrolling N=50 adult patients with narcolepsy with cataplexy. The primary endpoint measurement was the weekly cataplexy episodes over 8 weeks of treatment. We were anticipating the release of interim analysis or preliminary data around Q1 2025, with final results expected in the second half of 2025. If those final results landed as anticipated, the path to potential FDA approval and commercial launch by late 2026 or early 2027 becomes clearer.

The R&D focus has definitely broadened following the merger with Kadimastem. While the legacy focus remains on CNS disorders, the combined entity, expected to trade as NewcelX Ltd. under the ticker NCEL starting October 31, 2025, is integrating cell therapy candidates.

• Advance Kadimastem's AstroRx® program into Phase IIa trials for ALS.
• Advance Kadimastem's IsletRx program into Phase I studies for diabetes.
• Present preclinical data on Mazindol ER for fentanyl dependence (Study KO-943) at the 2025 ASCP Annual Meeting (May 27 to May 30, 2025).
• Investigate novel dual orexin receptor agonists (AEX-41 and AEX-2) for narcolepsy.

Securing regulatory milestones is intrinsically linked to the clinical trial success. The company's strategy for both Quilience and Nolazol has been to potentially leverage the 505(b)(2) regulatory pathway. The FDA authorization to proceed with the Phase 3 program for Quilience was a major step, secured in May 2023. The entire timeline hinges on positive data from the second half of 2025 to support a submission targeting late 2026 or early 2027 approval.

For managing intellectual property (IP), the activity centers on maintaining a strong position for Mazindol ER while integrating the IP surrounding the new cell therapy candidates like AstroRx® and IsletRx. The company's rigorous scientific approach evaluates opportunities based on a strong intellectual property position.

Capital raising and investor relations are critical activities, especially given the merger closing on October 30, 2025. You can see the recent efforts to bolster the balance sheet:

Also, investor relations involved managing the transition to the new entity, including regaining compliance with Nasdaq Listing Requirements and scheduling key governance events like the AGM 2025 and EGM September 2025. The company is definitely focused on driving shareholder value through potential out-licensing or asset sale transactions as part of its overall strategy. Finance: draft 13-week cash view by Friday.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Key Resources

You're looking at the core assets NLS Pharmaceutics AG brought into the combination that formed NewCelX Ltd. as of late 2025. These are the tangible and intangible things that make the business run and create value, especially now that the merger with Kadimastem is finalized.

Proprietary Formulation Patents for Quilience and Nolazol (Mazindol ER/CR)

The intellectual property around the extended-release (ER) and controlled-release (CR) formulations of Mazindol is central. While the underlying molecule has history, the proprietary delivery systems are the key differentiators for NLS Pharmaceutics AG's pipeline assets.

• Quilience® (Mazindol ER) is being developed for narcolepsy and idiopathic hypersomnia (IH).
• Nolazol® (Mazindol Controlled-Release) completed a Phase 2 study in the U.S. for ADHD.
• An Israeli patent covering Mazindol for ADHD is expected to expire no earlier than 2037.

The Phase 3 program for Quilience, the AMAZE Program, encompasses two double-blind trials, NLS-1031 and NLS-1032, each with N=50 adult patients with narcolepsy. Final Phase 3 results were anticipated in the second half of 2025.

Orphan Drug Designation (ODD) for Quilience in the US and Europe

The ODD status provides significant commercial and regulatory advantages for Quilience, which is a proprietary extended-release formulation of Mazindol (Mazindol ER).

This designation typically grants market exclusivity, tax credits, and fee waivers, which are critical for a company targeting rare disorders.

Small, Highly Experienced Team Focused on CNS and Neurodegenerative Disorders

The team's expertise is concentrated in Central Nervous System (CNS) disorders, which was the core focus of NLS Pharmaceutics AG before the merger. Post-merger, this expertise is combined with Kadimastem's cell therapy focus, but the original CNS team remains a key resource.

The leadership structure of the combined entity, NewCelX Ltd., is defined by key personnel:

• Executive Chairman & Chief Executive Officer: Ronen Twito (from Kadimastem).
• Chief Scientific Officer and Director: Prof. Michel Revel (founder of Kadimastem).

Prof. Revel's background includes work on Rebif®, which saw peak annual sales of $2.4 billion and over 1.5 million patient-years of treatment.

Cash Reserves from Recent Financing to Fund R&D and Clinical Trials

Funding runway is a non-negotiable resource in biopharma. A financing transaction announced in late 2022 was expected to fund NLS Pharmaceutics AG's operations through 2025. The final ownership split post-merger was estimated to be adjusted based on NLS's cash balance following its most recent financing transaction. As of September 10, 2025, the market capitalization of NLS Pharmaceutics Ltd. was reported at $7.12M.

The combined company, NewCelX Ltd., is positioned to advance the combined pipeline, which includes the cell therapy programs following the merger closing, expected after the SEC declared the registration statement effective on September 9, 2025.

Cell Therapy Technology and Pipeline Acquired via the Kadimastem Merger

The merger created NewCelX Ltd., which unites NLS's small-molecule expertise with Kadimastem's cell therapy assets. This diversification is a major resource shift.

The key cell therapy assets integrated are:

• AstroRx®: Preparing to initiate a Phase 2a clinical trial in the U.S. for the treatment of ALS.
• IsletRx: A stem cell-derived islet cell therapy for insulin-dependent diabetes, which had a successful Pre-IND meeting with the FDA.

The transaction aimed for a post-closing fully diluted share split of approximately 84.4% for Kadimastem stakeholders and 15.6% for NLS stakeholders.

Finance: draft 13-week cash view by Friday.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Value Propositions

You're looking at the value NLS Pharmaceutics AG brought to the table before the October 30, 2025, merger that created NewcelX Ltd. The core value was centered on differentiated CNS treatments and a strategic expansion into cell therapy, which is reflected in the combined entity's structure where Kadimastem shareholders now hold 84.4% and NLS shareholders hold 15.6% of the new company's issued share capital.

Quilience: A non-amphetamine, Schedule IV treatment for narcolepsy with a favorable safety profile.

The value proposition for Quilience, the controlled-release formulation of mazindol (mazindol CR), rests on its mechanism and regulatory status for narcolepsy. It is positioned as a non-amphetamine option. You should note that Mazindol CR functions as a partial orexin 2 receptor agonist, which targets the underlying cause of the disorder, unlike some stimulants.

• Quilience has Orphan Drug Designations in both the U.S. and Europe for narcolepsy.
• The lead asset leverages repurposing of a known compound, aiming to accelerate development timelines.

Addressing underlying disease cause via partial orexin 2 receptor agonism.

This mechanism is key; Mazindol is a triple monoamine reuptake inhibitor and, critically, a partial orexin receptor 2 agonist. This mechanism is what sets it apart in the sleep disorder space. The company completed a Phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD, where it met all primary and secondary endpoints and was well-tolerated.

Expanded pipeline targeting high-unmet-need CNS disorders like ADHD and addiction.

The value extended beyond narcolepsy into other CNS areas, leveraging the same core compound. For instance, preclinical data on Mazindol ER regarding its dual efficacy in Fentanyl reward and withdrawal was presented at the 2025 ASCP Annual Meeting between May 27, 2025, and May 30, 2025.

To give you a sense of the legacy NLS Pharmaceutics AG financial footing leading into this transaction, consider the H1 2025 results. The net loss for the half year ended June 30, 2025, was USD 2.22 million, up from USD 2.04 million the prior year. The basic loss per share from continuing operations was USD 1.05 for H1 2025.

Novel cell therapies for neurodegenerative diseases and diabetes (post-merger).

The merger brought in significant new value through Kadimastem's pipeline, which is now part of the combined NewcelX entity. This is a major shift from NLS's prior focus. The combined company is advancing these cell-based therapies.

Here's a quick look at the combined portfolio's development status as of the merger close on October 30, 2025:

Repurposing known compounds to accelerate development timelines.

This strategy is a foundational element of the original NLS value proposition, aiming to reduce the time and risk associated with novel chemical entities. The lead asset, Mazindol CR, is a prime example of this approach. As of the last active trading day for NLSP on October 30, 2025, the stock price was $0.76 / share, with a reported Market Cap of $31.64 million and 4.15 million shares outstanding.

The operational cash flow for the last 12 months prior to the merger was negative at -$4.81 million, which is typical for a clinical-stage company focused on R&D. This cash burn was offset by the strategic value created through the merger, which brought in the cell therapy platform.

• The merger was structured so that Kadimastem shareholders received 0.706 NewcelX common shares for each Kadimastem ordinary share.
• The transaction involved a 1-for-10 reverse share split implemented by NewcelX in connection with the merger.
• Following the close, NewcelX had approximately 4,558,378 common shares outstanding.

The value proposition is now a dual one: de-risked CNS assets moving toward potential commercialization and a novel cell therapy platform targeting severe, high-unmet-need diseases like ALS and diabetes. That's a defintely broader value set than before.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Customer Relationships

You're looking at the relationship strategy for NLS Pharmaceutics AG, especially now, post-merger with Kadimastem, which closed around October 29, 2025. The focus here is building deep, credible ties with the scientific and financial communities to support their CNS pipeline.

High-touch engagement with Key Opinion Leaders (KOLs) and sleep specialists remains central to validating their science. This isn't just about shaking hands; it's about scientific exchange. For instance, NLS Pharmaceutics announced the submission of Three Research Abstracts to the 2025 ASCP Annual Meeting, which took place from May 27, 2025, to May 30, 2025. These presentations covered critical areas like Mazindol ER for fentanyl dependence and dual orexin receptor agonists for narcolepsy. Furthermore, the company hosted a Virtual Key Opinion Leader (KOL) Event to review top-line results from its Phase 2a clinical trial evaluating Quilience® (Mazindol ER) in narcolepsy. This high-touch approach is designed to get expert buy-in early.

For direct communication with patient advocacy groups for rare CNS disorders, the strategy centers on alignment with their core mission, though specific quantitative metrics on group engagement aren't always public. What is public is the network of high-level scientific collaboration, including partnerships with institutions like Universität Zürich and ETH Zürich. These relationships signal a commitment to rigorous, patient-focused research, which advocacy groups value highly.

Your investor relations and public disclosures section reflects the volatile journey of a clinical-stage company. For the half-year ended June 30, 2025, NLS Pharmaceutics reported a net loss of USD 2.22 million, up from USD 2.04 million the prior year, with a basic loss per share from continuing operations of USD 1.05. The market reacted to capital structure changes; around September 30, 2025, the company filed to sell 5 million common shares, which naturally sparked concerns over potential dilution. Following the merger completion, the fully diluted share split was estimated to result in Kadimastem shareholders holding approximately 85% and former NLS shareholders holding about 15%. The stock, NLSP, traded its last day on October 30, 2025, at 0.7620 USD before delisting.

The credibility-building through scientific presentations at major conferences is quantifiable through their submission volume. The Three Research Abstracts submitted to ASCP 2025 were key relationship touchpoints with the broader sleep specialist community. These presentations focused on data for Mazindol ER, AEX-41, and AEX-2. Honestly, for a company at this stage, these scientific milestones are the primary currency for building trust with prescribers and future partners.

Here's a quick look at some of the key figures shaping these customer relationships as of late 2025:

The company's engagement strategy is heavily weighted toward scientific validation, which is typical when you're trying to establish a novel mechanism of action, like with Mazindol ER. You defintely see the focus on peer-reviewed credibility over broad marketing spend at this juncture.

Finance: draft 13-week cash view by Friday.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Channels

You're looking at how NLS Pharmaceutics AG, now operating as NewCelX Ltd. post-merger closing on October 30, 2025, gets its value proposition to the market, which is heavily weighted toward clinical data generation and future commercial partnerships.

Clinical trial sites (US and global) for drug development and data generation

The channel for data generation relies on a network of clinical investigators and sites. As of late 2025, NLS Pharmaceutics AG (now NewCelX Ltd.) had 4 total clinical trials where it acted as the Lead Sponsor, with 1 trial in Phase 3 and 3 trials in Phase 2, involving a total enrollment across these trials of 251 participants in the past. The pipeline advancement channel is now focused on the combined entity's assets, including the AstroRx® program, which is slated for a Phase 2a multi-site clinical trial in the U.S.. The Phase 3 study for Quilience (NLS-2) in Narcolepsy Type 1 (NCT05914194) involved 48 participants and was completed on Jul 30, 2025.

The reliance on external academic and clinical partners for data generation is evident through past collaborations, including partnerships with Universität Zürich, ETH Zürich, Centre Hospitalier Universitaire Vaudois CHUV, Université de Lausanne, and Assistance Publique Hôpitaux de Paris.

Direct sales force (future, post-approval) targeting specialized prescribers

A dedicated direct sales force is a future channel, post-approval for candidates like Quilience (for narcolepsy) or Nolazol (for ADHD). Currently, the company's operational focus, as reflected in its H1 2025 net loss of USD 2.22 million and forecasted 2025 EBIT of -22MM, is on R&D and merger integration, not on commercial infrastructure build-out. The post-merger entity will also integrate Kadimastem's cell therapy pipeline, which includes AstroRx® for ALS and IsletRx for diabetes, which will require specialized sales channels targeting neurologists and endocrinologists, respectively, upon potential approval.

Licensing and commercialization agreements with larger pharmaceutical partners

This channel is critical for NLS Pharmaceutics AG, as evidenced by past and current structures. The company has a strategic licensing agreement with Aexon Labs for its DOXA portfolio. Historically, NLS Pharmaceutics entered into an agreement with Novartis Pharma AG. Financially, to support the merger and pipeline, the company secured a $25 million committed equity facility agreement in March 2025. The company reported 0MM in forecasted annual revenue for the period ending 2025-12-31, indicating pre-commercialization status.

Here are some key figures related to the company's financial and structural channels as of late 2025:

Scientific publications and medical education platforms

Dissemination of data through scientific channels is a primary activity for a clinical-stage company. NLS Pharmaceutics AG submitted three research abstracts to the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP), held from May 27 to May 30, 2025, in Scottsdale, Arizona.

The specific data presented via these publication channels included:

• Evaluating Mazindol ER for fentanyl dependence (Study KO-943).
• Preliminary results of AEX-41 and AEX-2 in a mouse model of narcolepsy.
• A comprehensive multitarget strategy for managing Diabetes-Associated Neurological and Sleep Disorders (DANS).

The presentation of preclinical data on Mazindol ER at the ASCP meeting on May 29, 2025, highlighted its effect at a 0.5 mg/kg dose in neutralizing fentanyl reward effects in mice.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Customer Segments

You're looking at the core groups NLS Pharmaceutics AG targets with its specialized CNS therapies, particularly for narcolepsy. Honestly, in this niche, the customer segments are tightly defined, blending patient needs with the prescribing physician base and the capital markets that fund the journey.

The primary patient base is defined by rare and complex Central Nervous System (CNS) disorders. NLS Pharmaceutics AG is focused on patients diagnosed with Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2). These are not broad markets; they are specific patient populations requiring targeted intervention for conditions like Excessive Daytime Sleepiness (EDS) and Cataplexy. The narcolepsy with cataplexy segment, for instance, dominated the market share in 2024, accounting for 37% of the narcolepsy therapeutics market by treatment type.

To give you a sense of the scale in key markets, DelveInsight estimated around 360,000 diagnosed prevalent cases of narcolepsy across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan in 2024. Specifically in the US, the 2024 estimate pointed to approximately 95,000 female and 90,000 male patients with narcolepsy. The overall global narcolepsy therapeutics market size was valued at USD 4.12 billion in 2025.

Here's a quick breakdown of how the patient segment is often segmented in the market analysis, which directly informs NLS Pharmaceutics AG's focus:

• Narcolepsy Type 1 (with Cataplexy) held 61.63% of the market share in 2024.
• Narcolepsy Type 2 (without Cataplexy) is projected for an 11.24% CAGR through 2030.
• The Narcolepsy Without Cataplexy segment is anticipated to grow at a notable CAGR of 9.7% during the projected period.

The second key segment involves the healthcare professionals who manage these patients. These are the gatekeepers for NLS Pharmaceutics AG's product, Mazindol ER (Quilience), which promotes wakefulness and reduces cataplexy. You are targeting:

• Neurologists specializing in sleep disorders.
• Sleep medicine specialists who use diagnostic tools like nocturnal polysomnography (PSG) and Multiple Sleep Latency Tests.
• Clinicians who are aware of the neurobiological root of the disorder, focusing on agents that target the orexin system or have partial OX2R agonist activity.

The third, and perhaps most volatile, segment is the financial community. As a clinical-stage biopharmaceutical company, NLS Pharmaceutics AG relies on capital to advance its pipeline, including the development of Quilience. This segment includes:

• Investors and institutional funds focused on the biotech sector and CNS therapeutics.
• Shareholders who track milestones like the proposed merger with Kadimastem Ltd..
• Analysts covering companies with products aiming to restore wakefulness regulation.

For the investor segment, here are some concrete financial markers as of late 2025. Note that stock performance can shift rapidly in this sector, so these figures are snapshots:

The company has actively engaged this investor segment through financing. In the first quarter of 2025, NLS Pharmaceutics AG closed two equity financing transactions, bringing in aggregate gross proceeds of $2.5 million. Furthermore, the company signed a $25 million equity facility commitment to support its clinical programs and the pending merger. BVF Partners is listed as an institutional investor. Finance: draft 13-week cash view by Friday.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Cost Structure

You're looking at the cost side of NLS Pharmaceutics AG's business model right before its transition into NewcelX Ltd. For a clinical-stage biotech, costs are heavily weighted toward development and compliance, especially when nearing major corporate events like a merger.

High R&D expenses are a constant in this industry, historically driven by the costs of advancing Quilience through its clinical program, particularly the Phase 3 trial costs. While the trailing twelve months (TTM) ending June 30, 2025, showed a lower reported Research & Development figure, this is a key area of expenditure that dictates future value.

General and administrative (G&A) costs cover the necessary overhead to keep the lights on and the company compliant with public market rules. This includes legal fees and the ongoing costs associated with maintaining NASDAQ compliance, which can be substantial for a smaller entity.

The cost structure is heavily influenced by the small team size. Employee compensation is a fixed cost tied to a highly specialized group. As reported in earlier filings, the team was small, which helps keep the personnel burn rate relatively low compared to larger pharma operations.

The financial results for the first half of 2025 reflect these ongoing operational costs. The net loss for the half year ended June 30, 2025, was USD 2.22 million. This compares to a net loss of USD 2.04 million for the same period a year prior, showing an increase in the loss rate for the first half of the year.

Finally, significant, non-recurring costs are associated with the corporate restructuring. The finalization of the reverse merger with Kadimastem, which resulted in the formation of NewcelX Ltd. and trading under the ticker 'NCEL' starting October 31, 2025, involved substantial legal and advisory fees. The financial statements for the period ending June 30, 2025, capture some of these transition expenses.

Here's a look at the key expense components from the financial data available for the period ending June 30, 2025 (TTM figures in millions USD):

You should also note the personnel structure, which is a critical component of the operating cost base:

• Reported team size: 7 employees.
• Employee count in 2021 was 6 full-time and 1 part-time.
• The company's core team is small and specialized.

Finance: draft 13-week cash view by Friday.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Revenue Streams

You're looking at the current financial reality for NLS Pharmaceutics AG as of late 2025. Honestly, the story here is all about runway funding because, as expected for a company at this stage, the top line from product sales is still a future event.

Currently pre-revenue; primary stream is equity financing and capital raises.

The immediate financial lifeblood for NLS Pharmaceutics AG comes from securing capital through the equity markets. This is how you fund the clinical development and regulatory path for Quilience. Since the last reported earnings for the half year ended June 30, 2025, showed a net loss of USD 2.22 million, these capital raises are critical to bridge the gap to commercialization. The company has been actively executing on financing agreements throughout 2025.

Here's a quick look at the recent capital activity that defines the current revenue stream:

• Secured an equity facility for gross proceeds of $25,000,000 announced in June 2025.
• Completed a $3 million equity financing round in mid-2025.
• The final closing of a tranche on June 27, 2025, brought in $1 million.
• Another transaction in June 2025 involved securing $1 million via preferred participation certificates.
• The company reported cash on hand of $3.07 million in its latest financial snapshot.

This activity is best summarized by mapping the key financing events that have occurred leading up to the end of 2025, which is your current revenue stream:

The operating cash flow for the last 12 months was negative at -$4.81 million, reinforcing that equity financing is the only current revenue source offsetting operational burn.

Future revenue from commercial sales of Quilience, post-FDA approval (expected late 2026/early 2027).

The true, sustainable revenue stream for NLS Pharmaceutics AG hinges entirely on the successful commercial launch of Quilience, their lead asset for narcolepsy and ADHD. The expectation right now is that this will begin generating sales sometime in late 2026 or early 2027, assuming the necessary FDA approvals clear on schedule. Until then, this stream remains theoretical, but it is the primary driver of the company's valuation.

Potential milestone payments from future licensing or partnership deals.

Beyond direct product sales, NLS Pharmaceutics AG has the potential to book non-recurring revenue through strategic agreements. These are typically milestone payments tied to achieving certain development or regulatory goals for their assets, or upfront payments upon licensing a compound to a larger pharmaceutical partner for specific territories or indications. While no specific dollar amounts are public for these potential payments as of late 2025, these are a standard component of a biotech revenue model.

Future revenue from Nolazol and the new cell therapy pipeline assets.

Following the merger completion with Kadimastem Ltd. in October 2025, the revenue outlook expands to include the combined pipeline. This means future revenue potential is also tied to the commercial success of assets like Nolazol, which targets different CNS indications, and the cell therapy assets now integrated into the portfolio. These assets represent diversification away from Quilience, adding secondary potential revenue streams once they advance through clinical stages and reach the market.