– Dr. Chang led XOLAIR® from invention through FDA approval and commercialization, exceeding $5 billion in sales so far – Los Angeles, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Company”, “We” or “Us”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that Nancy T. Chang, former Tanox, Inc. CEO and proven biotechnology leader, has joined the Immix Biopharma Board of Directors concurrent with her investme ...

LOS ANGELES, CA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it has received a strategic investment from Goose Capital and former Tanox, Inc. CEO Dr. Nancy T. Chang, Goose founding member. At Tanox, Dr. Chang and her team invented and developed FDA-approved XOLAIR® (omalizumab) for severe asthma, TROGARZO® (ibalizu ...

Core Insights - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [3] - The company will present and host institutional investor meetings at the Stifel 2025 Healthcare Conference from November 11-13, 2025 [1][2] - The lead candidate, NXC-201, is a BCMA-targeted CAR-T cell therapy currently being evaluated in a U.S. multi-center study for relapsed/refractory AL Amyloidosis [3] Company Overview - Immix Biopharma, Inc. is listed on Nasdaq under the ticker IMMX [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [3] - Interim results for NXC-201 were presented at ASCO 2025, indicating ongoing clinical evaluation [3] Investor Engagement - The company will be available for one-on-one meetings during the Stifel conference, encouraging interested investors to contact their Stifel representative [2] - A replay of the presentation will be accessible on the Immix website under the Investors section [2]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Immix Biopharma, Inc. as of June 30, 2025, and for the three and six months ended June 30, 2025 and 2024, detail the company's financial position, operational results, changes in equity, and cash flows, reflecting increased net losses and a decrease in cash reserves, primarily driven by escalating research and development expenses for its clinical programs [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20%28Unaudited%29%20and%20December%2031%2C%202024) The balance sheet as of June 30, 2025, shows a significant decrease in cash and cash equivalents to **$11.6 million** from **$17.7 million** at year-end 2024, with total assets declining to **$15.6 million** from **$22.9 million**, while total liabilities increased to **$11.0 million**, and total stockholders' equity fell sharply to **$4.7 million** from **$13.3 million**, reflecting the company's net loss and cash burn Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $11,637,945 | $17,681,954 | | Total current assets | $12,325,460 | $20,197,834 | | Total assets | $15,635,104 | $22,947,872 | | Total current liabilities | $10,009,738 | $8,687,118 | | Total liabilities | $10,982,073 | $9,696,669 | | Total stockholders' equity | $4,653,031 | $13,251,203 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20ended%20June%2030%2C%202025%20and%202024%20%28Unaudited%29) The company reported a net loss of **$6.6 million** for the three months ended June 30, 2025, a **50% increase** from the **$4.4 million** loss in the same period of 2024, and for the six-month period, the net loss was **$11.2 million** in 2025 compared to **$9.7 million** in 2024, with widening losses primarily due to a substantial increase in research and development expenses Statement of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,972,458 | $2,224,139 | $5,947,532 | $5,472,808 | | General and administrative | $2,745,247 | $2,478,357 | $5,453,098 | $4,819,821 | | Loss from operations | ($6,717,705) | ($4,702,496) | ($11,400,630) | ($10,292,629) | | Net loss | ($6,622,563) | ($4,405,850) | ($11,165,091) | ($9,736,914) | | Loss per common share | ($0.22) | ($0.15) | ($0.37) | ($0.36) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased from **$13.3 million** at the end of 2024 to **$4.7 million** as of June 30, 2025, primarily driven by the net loss of **$11.2 million** for the six-month period, partially offset by capital raised from stock issuances under the At-The-Market (ATM) facility - For the six months ended June 30, 2025, the company's total stockholders' equity decreased by approximately **$8.6 million**, from **$13,251,203** to **$4,653,031**[19](index=19&type=chunk) - The decrease in equity was primarily due to a net loss of **$11,165,091**, which was partially offset by proceeds from stock issuances, including **$1,094,399** net from the ATM facility[16](index=16&type=chunk)[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was **$7.0 million**, with **$1.1 million** generated from financing activities, primarily through its ATM offering, resulting in a net decrease in cash and cash equivalents of **$6.0 million**, leaving an ending balance of **$11.6 million** Cash Flow Summary (Six Months Ended June 30) | Cash Flow Activity | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | ($6,994,921) | ($9,082,817) | | Net cash used in investing activities | ($195,343) | ($398,987) | | Net cash provided by financing activities | $1,110,116 | $15,948,567 | | Net change in cash and cash equivalents | ($6,044,009) | $6,465,307 | | Cash and cash equivalents – end of period | $11,637,945 | $23,975,098 | [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) The notes provide critical context to the financial statements, highlighting the company's clinical-stage nature, significant accounting policies, and major financial events, including details on financing activities, such as the ATM agreement and a CIRM grant, license agreements with ongoing payment obligations, and a 'going concern' warning due to recurring losses and insufficient capital to fund operations for the next twelve months - The company is a clinical-stage biopharmaceutical firm focused on developing cell therapies for AL Amyloidosis and other diseases[25](index=25&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern, as it does not have sufficient capital to sustain operations for at least the next twelve months from the filing date[39](index=39&type=chunk) - In June 2025, the company initiated an At The Market (ATM) offering agreement to sell up to **$50 million** of its common stock, and as of June 30, 2025, it had raised net proceeds of **$1.1 million** under this agreement[38](index=38&type=chunk) - The company was awarded an **$8 million** grant from CIRM in July 2024 and has received **$3.6 million** in reimbursements as of June 30, 2025, with the remaining **$4.4 million** contingent on achieving milestones[37](index=37&type=chunk)[87](index=87&type=chunk) - The company has significant financial commitments under a license agreement with HADASIT and BIRAD, including quarterly payments totaling approximately **$13.0 million** due through September 2026, plus potential royalties and milestone payments[83](index=83&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on its lead CAR-T candidate, NXC-201, for AL Amyloidosis, highlighting recent positive clinical data and regulatory designations like RMAT, with the analysis of financial results showing widening net losses due to increased R&D spending on clinical trials, and the liquidity section underscoring a 'going concern' issue, stating that current cash is insufficient for the next year and detailing plans to raise additional capital through its ATM facility and other means [Overview](index=26&type=section&id=Overview) Immix Biopharma is a clinical-stage company focused on developing its lead CAR-T cell therapy candidate, NXC-201, for AL Amyloidosis and other serious diseases, with NXC-201 having received FDA RMAT and ODD designations, and recent clinical data from ongoing trials presented at major conferences (ASH, ASCO) showing high overall and complete response rates in relapsed/refractory AL Amyloidosis patients - The company's lead candidate, NXC-201, is a CAR-T therapy for AL Amyloidosis that has received FDA Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation (ODD)[106](index=106&type=chunk)[107](index=107&type=chunk) - Clinical data presented at ASCO 2025 for 10 patients showed a **70% complete response (CR) rate**, with all patients normalizing pathological disease markers and no relapses recorded[123](index=123&type=chunk) - The company is conducting two clinical trials for NXC-201 in AL Amyloidosis: the U.S.-based Phase 1b/2 NEXICART-2 and the ex-U.S. Phase 1b/2a NEXICART-1[116](index=116&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Comparing the periods ended June 30, 2025, and 2024, the company's net loss increased for both the three-month and six-month periods, primarily driven by a significant rise in Research and Development expenses, which grew from **$2.2 million** to **$4.0 million** for the second quarter, due to costs associated with the ongoing CAR-T clinical trials, while General and Administrative expenses also saw a moderate increase Comparison of Operating Expenses (Three Months Ended June 30) | Expense Category | 2025 (USD) | 2024 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | General and administrative | $2,745,247 | $2,478,357 | +$266,890 | | Research and development | $3,972,458 | $2,224,139 | +$1,748,319 | - The increase in R&D expense was primarily driven by costs for the ongoing Phase 1b/2a CAR-T clinical trial, including patient treatment, site onboarding, and license fees[136](index=136&type=chunk) - Net loss for Q2 2025 was **$6.6 million**, compared to **$4.4 million** in Q2 2024, mainly due to the increase in R&D expenses[139](index=139&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had **$11.6 million** in cash and cash equivalents, but management states these funds are not sufficient to support planned operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern, with the company relying on its June 2025 ATM agreement, which allows for sales of up to **$50 million** in stock, and remaining CIRM grant funds to finance future operations, though additional capital will be necessary - The company had approximately **$11.6 million** in cash and cash equivalents as of June 30, 2025[152](index=152&type=chunk) - Management believes that current cash and cash equivalents will not be sufficient to fund planned operations over the next twelve months, and there is substantial doubt about the company's ability to continue as a going concern[152](index=152&type=chunk)[176](index=176&type=chunk) - The company is funding operations through its June 2025 ATM agreement (raised **$2.4 million** as of Aug 6, 2025), and an **$8 million** CIRM grant (**$4.4 million** remaining to be disbursed upon milestone achievement)[150](index=150&type=chunk)[151](index=151&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a "smaller reporting company" as defined by the Exchange Act and is therefore not required to provide the information for this item - As a 'smaller reporting company,' the company is not required to provide quantitative and qualitative disclosures about market risk[166](index=166&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were not effective due to a previously identified material weakness in internal control over financial reporting, stemming from the company's small size and lack of adequate segregation of duties, with a remediation plan ongoing - Management concluded that disclosure controls and procedures were not effective as of June 30, 2025[167](index=167&type=chunk) - The ineffectiveness is due to a material weakness in internal control over financial reporting related to the company's small size and limited personnel, which prevents adequate segregation of duties[168](index=168&type=chunk) - The company is working to remediate the material weakness by establishing additional points of segregation of duties and upgrading IT controls[170](index=170&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently aware of any pending legal proceedings that would have a material adverse effect on its business, financial condition, or operating results - The company is not currently a party to any material legal proceedings[174](index=174&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes to its risk factors from its 2024 Annual Report, with the exception of highlighting the risk related to its ability to continue as a 'going concern', which arises from recurring losses and the need to raise additional capital to fund future operations - The company's ability to continue as a going concern is identified as a key risk, as existing cash is not expected to fund operations into the third quarter of 2026, creating substantial doubt about its viability within one year[176](index=176&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the six months ended June 30, 2025, the company issued a total of **183,531 shares** of restricted common stock, valued at a combined **$0.3 million**, for investor relations services under various marketing agreements, with these issuances exempt from registration under the Securities Act - The company issued shares of restricted common stock for investor relations services in three separate transactions during the first six months of 2025[178](index=178&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) During the quarter ended June 30, 2025, none of the company's directors or officers adopted or terminated any Rule 10b5-1 trading plans for the purchase or sale of company securities - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the second quarter of 2025[183](index=183&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including the At The Market Offering Agreement, officer certifications (pursuant to Sarbanes-Oxley Act Sections 302 and 906), and Inline XBRL data files - Exhibits filed include the At The Market Offering Agreement with Citizens JMP Securities, LLC, and required certifications by the Principal Executive Officer and Principal Financial Officer[185](index=185&type=chunk)

Core Insights - Immix Biopharma is focused on advancing its lead candidate, NXC-201, a BCMA-targeted CAR-T cell therapy, for relapsed/refractory AL Amyloidosis, with plans for a Biologics License Application (BLA) submission [1][2][3] - The company is also exploring partnerships to license out its Other Serious Disease (OSD) programs, leveraging promising clinical results from NXC-201 [2][3] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases [3] - NXC-201 is currently being evaluated in a U.S. multi-center study (NEXICART-2) for relapsed/refractory AL Amyloidosis, with interim results presented at ASCO 2025 [3] - The therapy has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3]

Core Insights - Immix Biopharma, Inc. has announced a class-leading safety profile for its CAR-T therapy NXC-201, with no neurotoxicity observed in low-volume disease to date, which supports potential future indication expansion [1][3] - The company is focused on completing the NEXICART-2 study for Biologics License Application (BLA) submission, aiming for FDA approval [2][3] - The U.S. prevalence of relapsed/refractory AL Amyloidosis is projected to grow at 12% annually, reaching approximately 33,277 patients by 2024, with the amyloidosis market expected to increase from $3.6 billion in 2017 to $6 billion by 2025 [5] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company developing cell therapies specifically for AL Amyloidosis and other serious diseases [3] - The lead candidate, NXC-201, is a sterically-optimized BCMA-targeted CAR-T cell therapy designed to filter out non-specific activation [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [3] Industry Context - AL Amyloidosis is caused by abnormal plasma cells producing misfolded amyloid proteins, leading to organ damage and high mortality rates [4] - The market for amyloidosis treatments is expected to grow significantly, indicating a rising demand for effective therapies [5]

Core Insights - Immix Biopharma is advancing its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis, expanding to 18 sites in the U.S. [1][2] - The company is on track for the first Biologics License Application (BLA) for a cell therapy targeting an unaddressed orphan indication [1][2] - Interim results from the NEXICART-2 trial were presented at ASCO 2025, showcasing the progress of the therapy [1][2][3] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [3] - The lead candidate is NXC-201, a BCMA-targeted CAR-T cell therapy, currently evaluated in a multi-center study [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3] Market Context - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [5] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [5]

NXC-201 Platform and Clinical Trial - NXC-201 is a sterically-optimized CAR-T construct from the Immix N-GENIUS platform with a "digital filter" to reduce non-specific activation and enhance tolerability[6] - The company plans to submit a BLA for NXC-201[9] - The NEXICART-2 trial is a U S multi-center trial with registrational design for relapsed/refractory AL Amyloidosis with 40 patients enrolled[6,39] - Interim clinical data readout for the NEXICART-2 trial in relapsed/refractory AL Amyloidosis is expected in 2Q 2025[35] - Planned NEXICART-2 enrollment completion is expected in 4Q 2025 / 1Q 2026[35] AL Amyloidosis Market and NXC-201 Potential - The relapsed/refractory AL Amyloidosis target market has a U S patient prevalence of 34,600, representing a multi-billion dollar value[6] - There are currently no FDA-approved drugs for relapsed/refractory AL Amyloidosis[6,27] - Current standards of care induce a complete response in 0-10% of patients with relapsed/refractory AL Amyloidosis[19,21,27] - In the NEXICART-2 U S trial, 70% complete responses (CR) were observed in 7 out of 10 patients, with the remaining three being MRD-negative 10-6, predicting future CR[49] NXC-201 Safety and Tolerability - NXC-201 demonstrated no ICANS neurotoxicity in clinical trials[54] - NXC-201 has a median CRS duration of 1 day, which is 4-8x shorter than other CAR-T therapies[32]

Core Viewpoint - Immix Biopharma, Inc. (IMMX) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, indicating potential for stock price increase [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [2][4]. - Rising earnings estimates for Immix Biopharma suggest an improvement in the company's underlying business, likely leading to increased stock prices [5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Immix Biopharma's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating superior earnings estimate revisions and potential for market-beating returns [10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Immix Biopharma is expected to earn -$0.62 per share, reflecting an 18.4% year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Immix Biopharma has increased by 27.1%, indicating positive sentiment among analysts [8].

Core Points - Immix Biopharma, Inc. was selected to attend an FDA CEO forum led by FDA Commissioner Marty A. Makary on June 5, 2025, focusing on modernizing the regulatory framework for biotechnology and pharmaceutical industries [1][2] - The forum aimed to gather input from industry leaders to enhance patient access to safe and effective therapies, with Immix Biopharma expressing alignment with the FDA's vision for an efficient regulatory environment [2] - Immix Biopharma is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis, with its lead candidate being NXC-201, a BCMA-targeted CAR-T cell therapy currently in a multi-center study [3] Company Overview - Immix Biopharma, Inc. (Nasdaq: IMMX) is focused on developing cell therapies for serious diseases, particularly AL Amyloidosis [3] - The lead candidate, NXC-201, is being evaluated in the NEXICART-2 study (NCT06097832) for relapsed/refractory AL Amyloidosis, with interim results presented at ASCO 2025 [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3]