Issue #82

Inside the immunotherapy "operating system" and the biological GPS redefining cancer treatment for 2026.

The oncology revolution isn’t being won by the most aggressive chemotherapy or the broadest surgical strokes—it’s being decided quietly, at the cellular level, where the body’s own immune system is being reprogrammed to hunt and destroy cancer. As medicine moves away from "one-size-fits-all" treatments toward precision immunotherapy, two distinct approaches are defining the new standard of care:

the intelligent software of the immune system that identifies hidden tumors, and the biological hardware that powers a sustained, natural attack against them.

This is where the cancer conversation shifts from management to potential cures—and where the most scientifically advanced and commercially ready winners are emerging.

👉 One company is perfecting a "biological GPS" designed to train the immune system to recognize and eliminate leukemia cells that have previously evaded all other treatments.

👉 The other has successfully launched a "natural killer" cell orchestrator that is rapidly becoming the gold standard for bladder cancer treatment.

👉 Both are tackling high-unmet-need markets, backed by significant analyst support, and hitting critical clinical or commercial inflection points.

In this edition, we break down the targeted vaccine and the cell-activating powerhouse driving the next generation of oncology—and why these two stocks sit at the foundation of a future where cancer is a manageable, and perhaps even curable, condition.

SELLAS Life Sciences (NASDAQ: SLS)

SELLAS Life Sciences (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company specializing in the development of novel cancer immunotherapies. The company’s primary focus is on its lead product candidate, Galinpepimut-S (GPS), a Wilms Tumor 1 (WT1)-targeting peptide immunotherapy, and SLS009, a highly selective CDK9 inhibitor. Unlike traditional pharmaceutical giants, SELLAS focuses on the "last mile" of clinical development for therapies addressing high unmet needs in myeloid leukemias and other cancers.

Business Model and Revenue Streams 📦

SELLAS operates on a high-risk, high-reward clinical development model typical of the biotechnology sector. The company does not currently have any FDA-approved products on the market, meaning it does not generate recurring product revenue. Instead, its financial structure is defined by:

• Strategic Licensing and Partnerships: SELLAS acquires and develops promising intellectual property (like GPS from Memorial Sloan Kettering) and advances it through the regulatory gauntlet. Future revenue is expected to come from licensing fees, milestone payments, and eventual commercial sales or royalties upon regulatory approval.
• Capital-Efficient Clinical Expansion: The company leverages collaborations, such as its recent 2026 agreement with the European IMPACT-AML network, to expand its clinical footprint without bearing the full cost of independent site management. This "asset-light" approach allows them to run global trials while maintaining a lean operational structure.

The company is heavily influenced by macroeconomic and regulatory policies. In 2025 and early 2026, a more constructive interest rate environment has benefited long-duration assets like SELLAS, making it easier to raise capital. Furthermore, supportive FDA commentary regarding oncology and rare diseases has streamlined the path for innovation. However, the company remains sensitive to the broader "biotech funding reality," where investors demand high-quality clinical data over speculative growth.

Recent Performance and Corporate Developments 📈

SELLAS reported a notable improvement in its financial health during the third quarter of 2025 and bolstered its position further through early 2026.

Q3 2025 Financial Highlights: 💰

• Net Loss: The company reported a net loss of $6.8 million, or $0.06 per share, which beat analyst expectations of a $0.08 loss per share. This represents an improvement from the $7.1 million loss in the same period of 2024.
• Operating Expenses: R&D expenses fell to $4.2 million, down from $4.4 million YoY, reflecting disciplined clinical spending.
• Cash Position: As of late 2025, SELLAS significantly fortified its balance sheet. Following a $31 million warrant exercise in October 2025, the company ended the year with approximately $73 million in cash and equivalents, providing a substantial "runway" for its upcoming clinical milestones.

Strategic Initiatives and Mergers: 🤝

While there have been no major mergers, SELLAS has focused on strategic clinical expansion. In January 2026, the company entered a major agreement with IMPACT-AML to launch SLS009 into frontline Acute Myeloid Leukemia (AML) trials in Europe. This follows positive Phase 2 data presented at the ASH 2025 meeting, where SLS009 demonstrated promising efficacy in patients with challenging mutations.

Profitability and Fair Value 🎯

SELLAS is not yet profitable, a standard status for late-stage biotechs. Profitability is entirely dependent on the unblinding and successful results of its Phase 3 REGAL trial for GPS. As of late December 2025, the trial reached 72 of the 80 required "events" (deaths) needed to trigger final data analysis.

The company’s "fair value" is currently a subject of debate among analysts. Those bullish on the stock point to its intrinsic value being tied to the multi-billion dollar AML maintenance market. If GPS is approved, the current market capitalization could be viewed as significantly undervalued. However, conservative valuation models (like Alpha Spread’s base case) suggest the stock may be overvalued until the binary risk of the REGAL trial is cleared.

Analyst Estimates and Ratings 📊

• Consensus Rating: The consensus among covering analysts is a "Buy," though recent months have seen a mix of "Buy" and "Hold" (or "Sell" from quantitative-focused firms) as the Phase 3 data looms.
• Price Target: Wall Street remains optimistic, with an average 12-month price target of approximately $6.97 to $7.00. This suggests a potential upside of nearly 85–100% from its early 2026 trading range of roughly $3.50 to $3.80.

Investor-Focused Takeaway: Is SLS Right for Your Portfolio?

SELLAS offers a high-conviction play on the oncology sector, specifically in the AML space. The company has successfully navigated its recent "cash crunch" and is now entering its most critical year with a solid balance sheet.

What to Watch in the Near Term: 📈

• The 80th Event: Watch for the announcement that the REGAL trial has reached its 80th event. This will trigger the unblinding of data—the single biggest catalyst in the company’s history.
• SLS009 Enrollment: Monitor the Q1 and Q2 2026 enrollment for the SLS009 clinical program in the U.S. and Europe.
• Regulatory Feedback: Any guidance from the FDA or EMA regarding the "breakthrough" potential of their pipeline could lead to significant price volatility.

Recommendation:

SELLAS Life Sciences (SLS) is a speculative "Buy" for investors with a high risk tolerance. The stock is currently priced as a binary bet on clinical success; while the upside is substantial if the REGAL trial meets its endpoints, the lack of current revenue makes it sensitive to any clinical delays or data misses.

ImmunityBio (NASDAQ: IBRX)

Our second featured stock is ImmunityBio (NASDAQ: IBRX), a vertically integrated immunotherapy company that is rapidly transitioning from a R&D-heavy biotech to a high-growth commercial powerhouse.

ImmunityBio (NASDAQ: IBRX) is revolutionizing cancer treatment through its "Immunity 2.0" approach, which focuses on orchestrating the body's natural killer (NK) cells and T-cells to target tumors without the toxicity of traditional chemotherapy. Its flagship product, ANKTIVA, is the first FDA-approved immunotherapy for non-muscle-invasive bladder cancer (NMIBC) and is currently being studied across a dozen other indications.

Business Model and Revenue Streams 📦

ImmunityBio’s business model has shifted dramatically over the past year. While it remains a high-spend clinical innovator, it is now successfully monetizing its primary asset. The company's revenue streams are currently anchored by:

• Product Sales (ANKTIVA): This is the primary engine of growth. After its commercial launch, ANKTIVA has seen explosive adoption. Preliminary results for fiscal year 2025 show net product revenue of approximately $113 million, a staggering 700% increase year-over-year.
• Global Licensing and Strategic Alliances: ImmunityBio leverages a "global health security" strategy, partnering with entities like the Serum Institute of India and expanding into markets like Saudi Arabia, where it recently received accelerated approvals for both bladder and lung cancer treatments.

Macroeconomic Policy Impact:

The company is navigating a complex 2026 economic landscape. While higher interest rates in previous years pressured biotech valuations, the current environment has stabilized. However, ImmunityBio remains sensitive to healthcare policy and drug pricing regulations. Since ANKTIVA is a high-value biologic, any shifts in Medicare reimbursement policies or international pricing caps directly affect its bottom line. Conversely, the company has benefited from "Fast Track" and "Breakthrough Therapy" designations, which are part of a broader U.S. policy to accelerate oncology innovation.

Recent Performance and Corporate Developments 📈

The start of 2026 has been a period of rapid-fire positive catalysts for ImmunityBio, following a record-breaking 2025.

Q4 and FY 2025 Financial Highlights: 💰

• Revenue Surge: Preliminary Q4 2025 revenue hit $38.3 million, a 20% increase from Q3 and a 431% jump year-over-year. This steady quarter-over-quarter growth suggests that "market saturation" is still far off.
• Operational Execution: Unit sales volume for ANKTIVA grew by 750% in 2025 compared to 2024, demonstrating that the commercial team is effectively converting clinical interest into prescriptions.
• Cash Position: The company reported ending 2025 with approximately $242.8 million in cash and marketable securities, providing a sufficient buffer for its 2026 expansion plans.

Strategic Initiatives and Mergers: 🤝

ImmunityBio has avoided dilutive mergers, choosing instead to focus on Strategic Alliances. A major highlight in January 2026 was the inaugural U.S.-Saudi Biotech Alliance Summit, which solidified the company's presence in the Middle East. Furthermore, clinical progress in their QUILT-2.005 trial (for BCG-naive bladder cancer) has exceeded enrollment expectations, potentially opening up a much larger frontline market by late 2026.

Profitability and Fair Value 🎯

Despite the revenue explosion, ImmunityBio is not yet profitable. The company reported a net loss for 2025 as it continues to reinvest heavily in its vast clinical pipeline, which includes trials for lung cancer, glioblastoma, and indolent lymphomas.

In terms of Fair Value, the stock presents a classic "growth vs. value" tug-of-war:

• Undervaluation Thesis: Many Discounted Cash Flow (DCF) models suggest the stock is significantly undervalued—some estimates place its intrinsic value as high as $18.00 per share based on projected cash flows through 2030.
• Relative Valuation: With a Market Cap around $5.4 billion, the stock's price-to-sales ratio is high, but bulls argue this is justified by its 700% revenue growth rate and the multi-billion dollar potential of its lung cancer and lymphoma programs.

Analyst Estimates and Ratings 📊

• Consensus Rating: The current consensus is a "Strong Buy." Out of five major analysts covering the stock in the last 30 days, 100% have maintained "Buy" or "Strong Buy" ratings.
• Price Target: The average 12-month price target is approximately $11.80, suggesting an upside of roughly 100% from recent trading levels around $5.50–$6.00. Some aggressive targets stretch as high as $24.00 to $25.00 if European approvals and lung cancer data exceed expectations.

Investor-Focused Takeaway: Is IBRX Right for Your Portfolio?

ImmunityBio is no longer just a "science project"; it is a commercial-stage entity with a product that is clearly resonating with oncologists. It offers a rare combination of triple-digit revenue growth and a "de-risked" lead asset.

What to Watch in the Near Term: 📈

• European Expansion: Watch for the final decision from the European Commission regarding ANKTIVA’s marketing authorization, which could trigger a massive new revenue stream.
• Lung Cancer Data: Keep an eye on updates for the combination therapy of ANKTIVA and checkpoint inhibitors in Non-Small Cell Lung Cancer (NSCLC).
• Quarterly Growth Rates: Investors should monitor if the 20% sequential revenue growth can be maintained or if it begins to level off in mid-2026.

Recommendation:

ImmunityBio (IBRX) is a high-conviction growth play. While volatility is guaranteed given its lack of current net profit, the "sales ramp" of ANKTIVA provides a much higher floor for the stock than typical clinical-stage biotechs.

Final Take: The Biological Software and Cellular Hardware Powering Oncology

The immunotherapy revolution isn’t just about lab results and headlines—it’s about execution in the clinic and the pharmacy. That requires two things: precision software that teaches the immune system to target "invisible" cancer cells and advanced hardware that activates the body’s natural killer cells to sustain a relentless attack.

That’s where SELLAS Life Sciences (SLS) and ImmunityBio (IBRX) stand apart.

🧬 SELLAS Life Sciences (SLS) — The Precise "Software" for AML

• The Clinical Catalyst: Nearing the definitive 80th event in its Phase 3 REGAL trial; every month of delay increases the statistical probability of a survival breakthrough.
• Deeply Specialized: Focused on the "last mile" of difficult-to-treat myeloid leukemias where standard care offers few options.
• Strategic Runway: Fortified balance sheet with ~$73M in cash and a lean, asset-light clinical model.
• ➤ Best for: Investors looking for a high-conviction, binary-event play with massive upside potential upon successful Phase 3 unblinding.

🛡️ ImmunityBio (IBRX) — The High-Growth "Hardware" for Solid Tumors

• Commercial Powerhouse: Reported a staggering 700% revenue surge in 2025, driven by the explosive launch of ANKTIVA.
• Global Footprint: Secured landmark approvals in the U.S., U.K., and Saudi Arabia, with EU conditional approval broadening its reach.
• Platform Scalability: Moving beyond bladder cancer into frontline AML, lung cancer, and glioblastoma.
• ➤ Best for: Investors seeking leveraged exposure to the next generation of immunotherapy with a proven commercial ramp and institutional "Strong Buy" backing.

Investor Insight

🧩 Want a high-upside clinical innovator with a critical data catalyst? → SLS ⚙️ Want an aggressive growth story with triple-digit revenue expansion? → IBRX

Bottom Line:

Modern oncology doesn’t scale on hope—it scales on survival data and market adoption. SELLAS is holding the code for a potential new standard of care in leukemia, while ImmunityBio is building the commercial engine that makes chemo-free cancer treatment a reality.

As the 2026 biotech landscape shifts toward rewarding real clinical results, SLS and IBRX aren't just tickers to watch—they are foundational to the future of cancer care.

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Happy Trading
​— Team Premium Stock Alerts