Immix Biopharma(US:IMMX)2023-03-27 20:15Part I Business Immix Biopharma develops Tissue-Specific Therapeutics and cell therapies for oncology and immune-dysregulated diseases, with lead candidates IMX-110 and NXC-201 in clinical trials Overview of Business Units ImmixBio focuses on Tissue-Specific Therapeutics for solid tumors, while Nexcella develops cell therapies for blood cancers, both with lead candidates in clinical trials - ImmixBio is focused on developing Tissue Specific Therapeutics for solid tumors and immune-dysregulated diseases, with its lead candidate IMX-110 having treated 19 patients with advanced solid tumors as of February 202331 - Nexcella, a majority-owned subsidiary, develops cell therapies for blood cancers. Its lead candidate, NXC-201, has shown a 90% overall response rate in 42 multiple myeloma patients and a 100% complete response rate in 5 AL amyloidosis patients32 IMMIXBIO – TISSUE SPECIFIC THERAPEUTICS ImmixBio develops Tissue-Specific Therapeutics via its SMARxT platform, with lead candidate IMX-110 in Phase 1b/2a trials for solid tumors showing promising STS data - ImmixBio's SMARxT Tissue-Specific Platform has produced three drug candidates: IMX-110 (oncology), IMX-111 (oncology), and IMX-120 (inflammation)34 - IMX-110, the lead asset, is in Phase 1b/2a clinical trials for solid tumors. It combines a poly-kinase inhibitor and an apoptosis inducer to disable resistance pathways and induce tumor cell death3337 IMX-110 Clinical Trial Data for Soft Tissue Sarcoma (STS) | Metric | Result | | :--- | :--- | | Median Progression-Free Survival (mPFS) | 4 months | | Radiological PFS | 6 months in 50% of patients | | Prior Lines of Therapy | 3 to 13 lines for 100% of patients | | Drug-Related Serious Adverse Events | Zero | | Tumor Shrinkage | Experienced by 75% of STS patients | - The FDA has granted IMX-110 Orphan Drug Designation (ODD) for soft tissue sarcoma and Rare Pediatric Disease Designation (RPDD) for rhabdomyosarcoma4142 NEXCELLA – CELL THERAPIES FOR HEMATOLOGIC MALIGNANCIES Nexcella develops NXC-201, a CAR-T therapy for multiple myeloma and AL amyloidosis, demonstrating high efficacy and a favorable safety profile for potential outpatient use NXC-201 Clinical Data Highlights (as of Oct 2022) | Indication | Metric | Result (Therapeutic Dose, n=29) | | :--- | :--- | :--- | | Multiple Myeloma | Overall Response Rate (ORR) | 90% | | | Complete Response (CR/sCR) | 59% | | | Neurotoxicity (ICANS) | 0% | | | Grade ≥3 CRS | 3% | | AL Amyloidosis | Metric | Result (All Doses, n=5 published) | | | Hematologic CR | 100% | | | Organ Response (Cardiac, Renal, Liver) | 100% | - NXC-201's favorable safety profile, characterized by manageable, low-grade Cytokine Release Syndrome (CRS) and no observed neurotoxicity (ICANS), supports its potential development as the first outpatient CAR-T cell therapy160179 - Nexcella plans to enroll approximately 100 patients in its MM study and 30-40 patients in its ALA study, with the goal of submitting its first NXC-201 BLA to the FDA in the first half of 2025202204 Manufacturing, Competition, and Intellectual Property The company relies on third-party manufacturing, faces intense competition, and protects its pipeline with patents expiring between 2033 and 2043 - The company does not own or operate manufacturing facilities and relies entirely on third-party contract manufacturing organizations (CMOs) for the production of its product candidates208 - Key competitors include Janssen/Johnson & Johnson, Bristol Myers Squibb, and Arcellx in multiple myeloma, and Prothena and Caelum Biosciences in AL amyloidosis211 - As of March 17, 2023, the company's patent portfolio includes 11 granted patents in the U.S. and Europe, 3 pending applications, and 2 pending international (PCT) applications. Platform patents are expected to expire between 2033 and 2036218 - Nexcella holds global exclusive rights to patents covering its N-GENIUS platform and NXC-201, with any resulting patents expected to expire in 2043222 Key Agreements and Corporate Structure Key agreements include Nexcella's $1.5 million upfront license for NXC-201 and internal agreements defining funding and services, with Immix Biopharma owning 98% of Nexcella - Nexcella entered into a Research and License Agreement with Hadasit and BIRAD, paying a $1.5 million upfront fee and committing to approximately $13.0 million in quarterly payments through September 2026, up to $20 million in sales milestones, and a 5% royalty on net sales for the NXC-201 technology227228 - Immix Biopharma has a Founders Agreement with Nexcella, under which it received preferred and common stock in Nexcella and provides funding via senior unsecured promissory notes. The agreement also entitles Immix to equity and cash fees based on Nexcella's financing and sales229234 - A Management Services Agreement is in place where Immix provides management and advisory services to Nexcella for an annual fee of $500,000, increasing to $1.0 million if Nexcella's net assets exceed $100 million235236 - As of January 12, 2023, Immix Biopharma owned 98% of its subsidiary, Nexcella239 Government Regulations The company's products are subject to extensive FDA and international regulations, involving multi-phase clinical trials and potential expedited review pathways, with ongoing post-approval compliance - The FDA approval process for new drugs generally involves pre-clinical studies, an effective IND application, multi-phase human clinical trials (Phase 1, 2, 3), and submission and approval of an NDA or BLA244247 - The company may seek expedited development and review programs, including Fast Track Designation, Breakthrough Therapy Designation, and Rare Pediatric Disease Designation, to potentially accelerate the approval process for its product candidates256257261 - In Australia, where the IMX-110 trial is being conducted, clinical trials must occur under either the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes, both supervised by a Human Research Ethics Committee (HREC)283284 - Sales of approved products will be subject to healthcare laws, including federal Anti-Kickback Statutes, the Stark Law, and HIPAA, with non-compliance potentially leading to significant civil and criminal penalties291293 Risk Factors The company faces significant financial, development, operational, intellectual property, and stock ownership risks, including substantial losses and reliance on third parties - Financial Risks: The company has a history of substantial losses ($8.2 million in 2022) and an accumulated deficit of $38.0 million. It will require significant additional financing, which may not be available on favorable terms and could cause dilution to existing stockholders298301304 - Development & Regulatory Risks: All product candidates are in early-stage development with uncertain outcomes. Clinical trials are expensive, time-consuming, and may be delayed or fail. Patient enrollment for rare diseases can be difficult, and unforeseen side effects could halt development or prevent approval308310318323 - Operational Risks: The company relies on third-party CMOs for all manufacturing, posing risks of supply disruption and compliance failures. The biotechnology industry is highly competitive, and the company's products may not achieve market acceptance. The COVID-19 pandemic could also adversely impact operations and clinical trials328330364373 - Intellectual Property Risks: The company's success depends on its ability to obtain and maintain patent protection, which is uncertain and costly. It may face litigation for infringing on the IP rights of others or need to defend its own patents, resulting in substantial costs383392390 - Stock Ownership Risks: The stock price may be volatile. The company may be unable to maintain its Nasdaq listing. A significant portion of common stock (approx. 64.73%) is controlled by directors, officers, and principal stockholders, allowing them to control stockholder votes412417419 Unresolved Staff Comments The company has no unresolved staff comments from the SEC - None438 Properties The company leases its executive office in Los Angeles on an as-needed basis, deeming current facilities adequate - The company leases its principal executive office in Los Angeles, CA on an as-needed basis and believes its facilities are currently adequate439 Legal Proceedings The company is not currently involved in any material legal proceedings or claims - The company is not currently a party to any material legal proceedings440 Mine Safety Disclosures This item is not applicable to the company - Not applicable441 Part II Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on Nasdaq, has not paid dividends, and completed a share repurchase program in Q4 2022 - The company's common stock began trading on The Nasdaq Capital Market under the symbol "IMMX" on December 16, 2021444 - The company has never paid cash dividends and does not intend to in the foreseeable future, retaining earnings for business development446 Issuer Purchases of Equity Securities (Q4 2022) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | Nov 2022 | 34,945 | $1.26 | | Total Q4 | 34,945 | $1.26 | - A $1,000,000 share repurchase program authorized on April 29, 2022, expired on December 31, 2022450 Management's Discussion and Analysis of Financial Condition and Results of Operations The company reported a net loss of $8.2 million in 2022, a significant reduction from 2021, with increased operating expenses and $13.4 million cash on hand Results of Operations Comparison (Years Ended Dec 31) | Line Item | 2022 | 2021 | | :--- | :--- | :--- | | General and administrative expenses | $4,023,170 | $1,225,487 | | Research and development | $4,195,778 | $126,527 | | Total operating expenses | $8,218,948 | $1,352,014 | | Change in fair value of derivative liability | $0 | $(22,759,829) | | Net loss | $(8,229,713) | $(24,383,879) | - The increase in R&D expenses in 2022 was primarily due to costs for the ongoing Phase 1b/2a clinical trial and a $1.5 million upfront license fee for the Nexcella agreement465 - The significant decrease in net loss from 2021 to 2022 is mainly attributable to a $22.8 million non-cash charge for the change in fair value of a derivative liability related to convertible notes, which was recognized in 2021 prior to the IPO and did not recur in 2022466 Cash Flow Summary (Years Ended Dec 31) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,408,303) | $(1,589,307) | | Net cash used in investing activities | $0 | $(802) | | Net cash provided by financing activities | $3,232,063 | $18,848,934 | - Management anticipates that its cash on hand of $13.4 million as of December 31, 2022, will be sufficient to fund planned operations for at least 12 months from the filing date of the report476 Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, Immix Biopharma is exempt from providing market risk disclosures - Not required as the company is a smaller reporting company497 Financial Statements and Supplementary Data Audited financial statements show total assets of $14.9 million, a net loss of $8.2 million in 2022, and an accumulated deficit of $38.0 million Consolidated Balance Sheet Data (as of Dec 31) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Cash | $13,436,714 | $17,644,478 | | Total Assets | $14,908,101 | $18,192,088 | | Total Liabilities | $1,748,296 | $202,039 | | Total Stockholders' Equity | $13,159,805 | $17,990,049 | | Accumulated Deficit | $(37,985,247) | $(29,755,534) | Consolidated Statement of Operations Data (Year Ended Dec 31) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Total operating expenses | $8,218,948 | $1,352,014 | | Net loss | $(8,229,713) | $(24,383,879) | | Loss per common share | $(0.59) | $(6.64) | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants - None627 Controls and Procedures Management identified a material weakness in internal controls as of December 31, 2022, due to limited personnel, but has implemented remediation efforts - Management concluded that disclosure controls and procedures were not effective as of December 31, 2022628 - A material weakness was identified due to the company's small size and limited personnel, leading to a lack of formal processes and procedures for detailed review of accounting transactions629 - Remediation efforts, including the addition of accounting consultants, have been implemented to address the material weakness631 Other Information The company reports no other information for this item - None634 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - Not applicable636 Part III Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance is incorporated by reference from the 2023 Proxy Statement - Information is incorporated by reference from the 2023 Proxy Statement639 Executive Compensation Information on executive compensation is incorporated by reference from the 2023 Proxy Statement - Information is incorporated by reference from the 2023 Proxy Statement640 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information on security ownership is incorporated by reference from the 2023 Proxy Statement - Information is incorporated by reference from the 2023 Proxy Statement641 Certain Relationships and Related Transactions, and Director Independence Information on related party transactions and director independence is incorporated by reference from the 2023 Proxy Statement - Information is incorporated by reference from the 2023 Proxy Statement642 Principal Accountant Fees and Services Information on principal accountant fees and services is incorporated by reference from the 2023 Proxy Statement - Information is incorporated by reference from the 2023 Proxy Statement643 Part IV Exhibits and Financial Statement Schedules This section lists the financial statements and exhibits filed as part of the Annual Report on Form 10-K - This section contains the index to the Consolidated Financial Statements (page F-1) and a list of all exhibits filed with the report646647 Form 10-K Summary The company reports no summary for this item - None651