Immix Biopharma Inc
For the period ended Jun 30, 2024. Filed Aug 12, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 12, 2024
IMMX$8.06+11.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0001493152-24-018458
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-12.
0001493152-24-031358
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 72 previous paragraphs and 89 current paragraphs.
53 unchanged; 16 reworded; 14 added; 3 removed; 0 previous and 6 current paragraphs rearranged.
Tables are not compared: 2 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
Absorption of Nexcella Subsidiary
Current report
On May 20, 2024, Nexcella, was merged (the “Merger”) with and into the Company, with the Company as the surviving corporation. The Merger was effected pursuant to Section 253 of the Delaware General Corporation Law (“DGCL”) when the Company filed a Certificate of Ownership and Merger (“Certificate of Merger”) with the Secretary of State of the State of Delaware. Immediately prior to the Merger, the Company owned greater than 95% of the outstanding common stock on a fully diluted basis of Nexcella, par value $0.0001 per share (the “Nexcella Shares”), and 100% of the outstanding shares of each other class of capital stock of Nexcella. Under the DGCL, the only approval required was that of the Company’s Board of Directors for the Merger to become effective. As a result of the Merger, Nexcella ceased to exist and all assets, operations and other property and rights of Nexcella have been succeeded to by the Company. Pursuant to the terms of the Certificate of Merger, as a result of the Merger, each of the outstanding Nexcella Shares (other than Nexcella Shares held by the Company) were converted, into common stock of the Company (“Company Merger Shares”). In connection with the Merger, the Company issued 989,876 shares of its common stock to the former stockholders of Nexcella (other than shares held by the Company) (including Company common stock issued to third-party cash investors in Nexcella) (the “Merger Shares”). In addition, the Company issued to the former participants in the Nexcella 2022 Equity Incentive Plan, 275,759 restricted stock awards to receive common stock in the Company and options to purchase up to 595,676 shares of Company common stock at an exercise price of $2.47 per share (the closing price on May 17, 2024), under the Company’s Amended and Restated 2021 Omnibus Equity Incentive Plan.
Current report
The license remains with the Company after the Nexcella Absorption.
Current report
General and administrative expenses were $2,478,357 for the three months ended June 30, 2024, compared to $1,511,467 for the three months ended June 30, 2023.
Current report
Research and development expense was $2,224,139 for the three months ended June 30, 2024, compared to $2,209,244 for the three months ended June 30, 2023.
Current report
Six Months Ended June 30, 2024 compared to the Six Months Ended June 30, 2023
Current report
General and Administrative Expense
Current report
General and administrative expenses were $4,819,821 for the six months ended June 30, 2024, compared to $2,713,201 for the six months ended June 30, 2023.
Current report
Research and Development Expense
Current report
Research and development expense was $5,472,808 for the six months ended June 30, 2024, compared to $3,528,264 for the six months ended June 30, 2023.
Current report
Interest Income
Current report
Provision for Income Taxes
Current report
Net Loss
Current report
On July 25, 2024, the Company was awarded an $8 million grant from the California Institute for Regenerative Medicine to support the clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis. The award is payable to the Company upon achievement of milestones that are primarily based on patient enrollment in the Company’s clinical trials. Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions of the grant, CIRM may suspend or permanently cease disbursements. Funds received under this grant may only be used for allowable project costs specifically identified with the CIRM-funded project. Such costs can include, but are not limited to, salary for personnel, itemized supplies, consultants, and itemized clinical study costs. Under the terms of the grant, both CIRM and the Company will co-fund the research project and the amount of the Company’s co-funding requirement is predetermined as a part of the award. The Company expects to begin receiving funds from the grant beginning in September of 2024.
Removed paragraphs (3)
Previous report
Figure 1: Select ImmixBio Possible Autoimmune Target Indications
Previous report
General and administrative expense was $2,341,464 for the three months ended March 31, 2024, compared to $1,201,734 for the three months ended March 31, 2023.
Previous report
Research and development expense was $3,248,669 for the three months ended March 31, 2024, compared to $1,319,020 for the three months ended March 31, 2023.
Reworded paragraphs (16)
Previous wording
The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 29,712 patients in 2023. AL amyloidosis has a one-year mortality rate of 47 percent, 76 percent of which is caused by cardiac amyloidosis, according to Alexion. The current market size for amyloidosis therapies is $3.6 billion, expected to reach $6 billion in 2027, according to Grand View Research.
Current wording
The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal 2021, estimated to reach 29,712 patients in 2023. Untreated patients with AL amyloidosis and cardiac involvement have a median survival of less than 1 year, according to Quock, et al. Journal of Comparative Effective Research, 2023. The current market size for amyloidosis therapies is estimated at $3.6 billion, expected to reach $6 billion in 2027, according to Grand View Research.
Previous wording
As of February 2024, we have treated 73 patients in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313), of which 63 were relapsed/refractory multiple myeloma patients, and 10 were relapsed/refractory AL Amyloidosis patients.
Current wording
As of June 2024, we have treated 76 patients in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313), of which 63 were relapsed/refractory multiple myeloma patients, and 13 were relapsed/refractory AL Amyloidosis patients.
Previous wording
In November 2023, the U.S. FDA cleared an IND application for NXC-201 to enroll U.S. patients into NXC-201 clinical trials.
Current wording
In November 2023, the FDA cleared an IND application for NXC-201 to enroll U.S. patients into NXC-201 clinical trials.
Previous wording
Our other programs include NXC-201 for autoimmune diseases, a $25 billion combined annual market size according to Grand View Research and Fortune Business Insights; NXC-201 for frail relapsed/refractory multiple myeloma, a $14 billion market size growing to $27 billion according to Wilcock, et al, Nature Reviews; IMX-110 for soft tissue sarcoma, a $3 billion market size according to Medgadget, and in combination with anti-PD-1 for colorectal cancer, a $27 billion market size according to IndustryARC.
Current wording
Our other programs include NXC-201 for autoimmune diseases, a $25 billion combined annual market size according to Grand View Research and Fortune Business Insights and other preclinical candidates.
Previous wording
In addition, Nexcella is required to pay sales milestone payments of up to $20 million for Net Sales exceeding $700 million and Nexcella has committed to funding NXC-201 clinical trials in Israel over four years for an estimated total cost of approximately $13 million, spread on a quarterly basis over that period, which Nexcella believes will generate clinical trial data owned by Nexcella. The term of the Agreement commenced on December 8, 2022 and, unless earlier terminated pursuant to the terms thereof, will continue in full force and effect until the later of the expiration of the last Valid Claim under a Licensed Patent or a Joint Patent (as defined in the Agreement) or Exclusivity Right covering a Licensed Product or the expiration of a continuous period of 15 years during which there shall not have been a First Commercial Sale of any Licensed Product in any country in the world. Licensors may terminate the Agreement immediately if Nexcella or its affiliates or sublicensees commences an action in which it challenges the validity, enforceability or scope of any of the Licensed Patents or Joint Patents. In addition, either party may terminate the Agreement if the other party materially breaches the Agreement and fails to cure such breach within 30 days. Additionally, Licensors may terminate the Agreement if Nexcella becomes insolvent or files for bankruptcy.
Current wording
In addition, Nexcella is required to pay sales milestone payments of up to $20 million for Net Sales exceeding $700 million and Nexcella has committed to funding NXC-201 clinical trials in Israel over four years for an estimated total cost of approximately $13 million, spread out on a quarterly basis over that period, which Nexcella believes will generate clinical trial data owned by Nexcella. The term of the Agreement commenced on December 8, 2022 and, unless earlier terminated pursuant to the terms thereof, will continue in full force and effect until the later of the expiration of the last Valid Claim under a Licensed Patent or a Joint Patent (as defined in the Agreement) or Exclusivity Right covering a Licensed Product or the expiration of a continuous period of 15 years during which there shall not have been a First Commercial Sale of any Licensed Product in any country in the world. Licensors may terminate the Agreement immediately if Nexcella or its affiliates or sublicensees commences an action in which it challenges the validity, enforceability or scope of any of the Licensed Patents or Joint Patents. In addition, either party may terminate the Agreement if the other party materially breaches the Agreement and fails to cure such breach within 30 days. Additionally, Licensors may terminate the Agreement if Nexcella becomes insolvent or files for bankruptcy.
Previous wording
On February 5, 2024, the Company entered into an Underwriting Agreement (the “Agreement”) with Titan Partners Group LLC, a division of American Capital Partners, LLC (the “Underwriter”), relating to an underwritten offering (the “Offering”) of 5,535,055 shares of common stock of the Company. The public offering price is $2.71 per share of Common Stock and the Underwriter has agreed to purchase the Common Stock pursuant to the Underwriting Agreement at a price of $2.5203 per share. On February 8, 2024, the Company closed the offering and received net proceeds of $13,565,760, after deducting underwriting discounts and commissions and estimated offering expenses. Pursuant to the Agreement, the Company granted the Underwriter a 30-day over-allotment option to purchase up to an additional 783,970 shares of Common Stock which was exercised in full on March 1, 2024 for net proceeds of $1,954,594, after deducting underwriting discounts and offering expenses.
Current wording
On February 5, 2024, the Company entered into an Underwriting Agreement (the “Agreement”) with Titan Partners Group LLC, a division of American Capital Partners, LLC (the “Underwriter”), relating to an underwritten offering (the “Offering”) of 5,535,055 shares of common stock of the Company. The public offering price was $2.71 per share of Common Stock and the Underwriter agreed to purchase the Common Stock pursuant to the Underwriting Agreement at a price of $2.5203 per share. On February 8, 2024, the Company closed the offering and received net proceeds of $13,565,760, after deducting underwriting discounts and commissions and estimated offering expenses. Pursuant to the Agreement, the Company granted the Underwriter a 30-day over-allotment option to purchase up to an additional 783,970 shares of Common Stock which was exercised in full on March 1, 2024 for net proceeds of $1,954,594, after deducting underwriting discounts and offering expenses.
Previous wording
Interest income was $267,908 for the three months ended March 31, 2024, compared to $27,892 for the three months ended March 31, 2023. Interest income in the current period was related to interest received on investments in a money market fund increased as a result of the Company maintaining higher balances in money market funds during the current period.
Current wording
Interest income was $306,915 for the three months ended June 30, 2024, compared to $128,848 for the three months ended June 30, 2023. Interest income in the current period was related to interest received on investments in a money market fund and increased from the prior period as a result of the Company maintaining higher balances in money market funds during the current period.
Previous wording
Provision for income taxes for the three months ended March 31, 2024 was $8,839 compared to $5,170 for the three months ended March 31, 2023, due to withholding taxes relating to our Australian subsidiary.
Current wording
Provision for income taxes for the three months ended June 30, 2024 was $10,269 compared to $6,349 for the three months ended June 30, 2023, due to withholding taxes relating to our Australian subsidiary.
Previous wording
Net loss for the three months ended March 31, 2024 was $5,331,064 compared to $2,498,032 for the three months ended March 31, 2023, which increase was due primarily to the increase in general and administrative expenses and research and development expenses.
Current wording
Net loss for the three months ended June 30, 2024 was $4,405,850, compared to $3,598,212 for the three months ended June 30, 2023, which increase was due primarily to the increase in general and administrative expenses and research and development expenses, as discussed in greater detail above.
Previous wording
The expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general consulting expenses, which were higher for the three months ended March 31, 2024, due to increased professional services of $343,658, increased investor relations services of $333,155, of which $317,785 was increase in non-cash from shares issued for services, and increased stock-based compensation of $295,561 from additional equity awards issued to the officers, directors and consultants.
Current wording
The expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general consulting expenses, which were higher for the six months ended June 30, 2024, due to increased professional services of $375,325, increased investor relations services of $655,847, both due to service scope expansion and price increases, of which $271,801 was an increase in non-cash from shares issued for services, increased compensation of $192,442 due to hiring additional employees and increased stock-based compensation of $531,737 from additional equity awards issued.
Previous wording
The increased research and development expenses during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, were related to our ongoing Phase 1b/2a clinical trial and our CAR-T clinical trial, including, but not limited to, contract research organization (“CRO”) and related costs for maintaining and treating patients in the clinical trial.
Current wording
The increased research and development expenses during the six months ended June 30, 2024, as compared to the three months ended June 30, 2023, were related to our ongoing Phase 1b/2a clinical trial and our CAR-T clinical trial, including, but not limited to, contract research organization (“CRO”) and related costs for maintaining and treating patients in the clinical trial.
Previous wording
As of March 31, 2024, we had $27.3 million of total working capital.
Current wording
As of June 30, 2024, we had $23.4 million of total working capital.
Previous wording
Net cash used in operating activities was $3,826,846 for the three months ended March 31, 2024 and $2,091,996 for the three months ended March 31, 2023. Net cash used for the three months ended March 31, 2024 was primarily related to our net loss of $5,331,064 offset by non-cash items of stock-based compensation expense of $943,264, depreciation expense of $3,010 and right of use asset amortization of $20,840. Operating activities also included an increase in accounts payable and accrued expenses of $1,924,742, an increase in the tax receivable of $911,540, and an increase in prepaid expenses of $476,990. Net cash used for the three months ended March 31, 2023, was primarily related to our net loss of $2,498,032 offset by non-cash items of stock-based compensation expense of $329,919 and depreciation expense of $505. Operating activities also included an increase in accounts payable of $190,806 an increase in the tax receivable of $72,188 and an increase in prepaid expenses of $43,006.
Current wording
Net cash used in operating activities was $9,082,817 for the six months ended June 30, 2024 and $5,607,342 for the six months ended June 30, 2023. Net cash used for the six months ended June 30, 2024 was primarily related to our net loss of $9,736,914, offset by non-cash items of stock-based compensation expense of $1,581,114, depreciation expense of $6,889 and right of use asset amortization of $41,256. Operating activities also included an increase in accounts payable and accrued expenses of $119,782, an increase in the tax receivable of $815,290, and an increase in prepaid expenses of $278,480. Net cash used for the six months ended June 30, 2023, was primarily related to our net loss of $6,096,244 offset by non-cash items of stock-based compensation expense of $777,575 and depreciation expense of $1,011. Operating activities also included an increase in accounts payable of $1,128,291, an increase in the tax receivable of $47,239 and an increase in prepaid expenses of $1,370,736.
Previous wording
Net cash used in investing activities was $301,913 for the three months ended March 31, 2024 compared to $0 for the three months ended March 31, 2023.
Current wording
Net cash used in investing activities was $398,987 for the six months ended June 30, 2024, consisting solely of purchase of property and equipment, compared to $0 for the six months ended June 30, 2023.
Previous wording
Net cash provided by financing activities was $15,948,567 for the three months ended March 31, 2024 and $118,916 for the three months ended March 31, 2023. Net cash provided by financing activities in 2024 was related to proceeds of $425,724 from the sale of common shares through an at-the-market offering and proceeds of $15,520,354 from the sale of common shares through a public offering. Net cash provided by financing activities in 2023 was related to was related to proceeds of $103,916 from the sale of common shares through an at-the-market offering and proceeds of $175,000 from the sale of common shares of our majority-owned subsidiary, Nexcella, offset by payments of deferred offering costs of $160,000.
Current wording
Net cash provided by financing activities was $15,948,567 for the six months ended June 30, 2024 and $4,810,576 for the six months ended June 30, 2023. Net cash provided by financing activities in 2024 was related to proceeds of $425,724 from the sale of common shares through an at-the-market offering and proceeds of $15,520,354 from the sale of common shares through a public offering. Net cash provided by financing activities in 2023 was related to proceeds of $4,811,393 from the sale of common shares through an at-the-market offering and proceeds of $175,000 from the sale of common shares of our majority-owned subsidiary, Nexcella, offset by payments of deferred offering costs of $175,817.
Previous wording
Our continuation as a going concern is dependent upon our ability to obtain necessary financing to continue operations and the attainment of profitable operations. As of March 31, 2024, we have incurred an accumulated deficit of $58,670,286 and have not yet generated any revenue from operations. Management anticipates that our cash on hand and funds that may be raised pursuant to the Sales Agreement will be sufficient to fund planned operations for at least 12 months from the filing date of this Quarterly Report on Form 10-Q.
Current wording
Our continuation as a going concern is dependent upon our ability to obtain necessary financing to continue operations and the attainment of profitable operations. As of June 30, 2024, we have incurred an accumulated deficit of $63,063,222 and have not yet generated any revenue from operations. Management anticipates that our cash on hand and funds that may be raised pursuant to the Sales Agreement will be sufficient to fund planned operations for at least 12 months from the filing date of this Quarterly Report on Form 10-Q.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
While our focus is NXC-201 in AL Amyloidosis and autoimmune disease, we continue to collect and organize IMX-110 data in monotherapy for soft tissue sarcoma, a $3 billion market size according to Medgadget, and in combination with anti-PD-1 for colorectal cancer, a $27 billion market size according to IndustryARC, to evaluate next steps.
Current report — wording carried from elsewhere
The expenses incurred in both periods were related to salaries, patent maintenance costs and general accounting and other general consulting expenses, which were higher for the three months ended June 30, 2024, due to increased professional services of $31,667, increased investor relations services of $322,692 both due to service scope expansion and price increases, increased compensation expense of $189,291 due to hiring of additional employees, and increased stock-based compensation of $236,176 from additional equity awards issued.
Current report — wording carried from elsewhere
The increased research and development expenses during the three months ended June 30, 2024, as compared to the three months ended June 30, 2023, were related to our ongoing Phase 1b/2a clinical trial and our CAR-T clinical trial, including, but not limited to, contract research organization (“CRO”) and related costs for maintaining and treating patients in the clinical trial, as well as costs related to opening U.S. clinical sites.
Current report — wording carried from elsewhere
Interest income was $574,823 for the six months ended June 30, 2024, compared to $156,740 for the six months ended June 30, 2023. Interest income in the current period was related to interest received on investments in a money market fund which increased as a result of the Company maintaining higher balances in money market funds during the current period.
Current report — wording carried from elsewhere
Provision for income taxes for the six months ended June 30, 2024 was $19,108 compared to $11,519 for the six months ended June 30, 2023, due to withholding taxes relating to our Australian subsidiary.
Current report — wording carried from elsewhere
Net loss for the six months ended June 30, 2024 was $9,736,914 compared to $6,096,244 for the six months ended June 30, 2023, which increase was due primarily to the increase in general and administrative expenses and research and development expenses, each as discussed in greater detail above.