Calidi Biotherapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
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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 13, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-14.
0001493152-24-019305
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001493152-24-031688
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 137 previous paragraphs and 181 current paragraphs.
88 unchanged; 36 reworded; 55 added; 10 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 7 previous and 8 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 (55)
Current report
Our subsidiary Nova Cell, Inc. (“Nova Cell”) was formed to be a technology service provider that develops innovative stem cell-based products using our cellular manufacturing process. Through Nova Cell we anticipate expanding potential uses from oncology to other fields that require regenerative medical applications, such as cosmetics, orthopedics, auto-immune diseases, and various other therapies.
Current report
Research and development expenses for the three months ended June 30, 2024 and 2023 were $2.2 million and $3.2 million, respectively. The decrease of $1.0 million was primarily attributable to a decreasein labclinical trial services and lab service fees of $1.0 million.
Current report
General and administrative expenses for the three months ended June 30, 2024 and 2023 were $3.6 million and $3.4 million, respectively. The decrease of $0.2 million was primarily due to decreases in salaries and benefits of $0.7 million, partially offset by increases in insurance costs of $0.4 million, dues and legal fees of $0.3 million, and marketing and advertising expenses of $0.2 million.
Current report
Results of Operations
Current report
Comparison of Six Months Ended June 30, 2024 and 2023
Current report
Research and Development Expenses
Current report
Research and development expenses for the six months ended June 30, 2024 and 2023 were $4.9 million and $5.8 million, respectively. The decrease of $0.9 million was primarily attributable to a decrease in lab clinical trial services and lab service fees of $1.1 million, partially offset by an increase in salaries and benefits of $0.2 million.
Current report
General and Administrative Expenses
Current report
Other Income (Expense), Net
Current report
On July 10, 2024, we filed a First Certificate of Amendment to Second Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for-10 reverse stock split of the shares of the Company’s common stock, par value $0.0001 per share, effective on July 15, 2024 (the “Reverse Stock Split”). As a result of the Reverse Stock Split, every ten shares of issued and outstanding Common Stock was automatically combined into one issued and outstanding share of Common Stock, without any change in the par value per share. No fractional shares were issued as a result of the Reverse Stock Split, and any fractional shares that would otherwise have resulted from the Reverse Stock Split were rounded up to the next whole number. The number of authorized shares of Common Stock under our Second Amended and Restated Certificate of Incorporation, as amended, remained unchanged.
Current report
All references to share and per share amounts for all periods presented in the unaudited condensed consolidated financial statements have been retrospectively restated to reflect this Reverse Stock Split.
Current report
On May 31, 2024, we entered into an inducement offer letter agreement (the “May Inducement Offer”) with nine (9) holders of the Calidi’s existing Series B unit purchase warrants (“Series B Warrants”) and Series C unit purchase warrants (“Series C Warrants” and together with the Series B Warrants, the “Existing Warrants”), which Existing Warrants were originally issued on April 18, 2024 and had an exercise price of $6.00 (see Note 8). Following the closing of the May Inducement Offer, such warrant holders immediately exercised some or all of their respective outstanding Existing Warrants to purchase up to an aggregate of 1,069,800 shares of Calidi’s common stock, Series B-1 Warrants to purchase up to 267,300 shares of common stock and Series C-1 Warrants to purchase up to 802,500 shares of Common Stock, at a reduced exercise price of $2.00. In consideration for the immediate exercise of some or all of the Existing Warrants for cash, we agreed to issue unregistered new Series D common stock purchase warrants (“Series D Warrants”) to purchase up to 1,069,800 shares of Common Stock (see Note 8). We received gross proceeds of $2.1 million in cash from the exercise of the Existing Warrants pursuant to the May Inducement Offer, prior to deducting placement agent fees and offering expenses.
Current report
On April 18, 2024, pursuant to the April Public Offering (see Note 1), the Company’s $1.0 million convertible note, inclusive of outstanding principal and accrued interest, was automatically converted into shares of Common Stock Unit shares, with terms identical to those sold in the April Public Offering. As of that date, the convertible note was no longer outstanding.
Current report
On April 18, 2024, in connection with the closing of the April Public Offering, Calidi issued Placement agent warrants to purchase up to 75,988 shares of common stock, which (i) have an exercise price equal to $6.60 per share; and (ii) are exercisable for 5 years after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Current report
On June 3, 2024, in connection with the closing of the May Inducement Offer, Calidi issued Placement agent warrants to purchase up to 53,490 shares of common stock, which (i) have an exercise price equal to $3.75 per share; and (ii) are exercisable for 5 years after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Current report
As of June 30, 2024, all placement agent warrants to purchase a total of 129,478 shares of common stock remain outstanding.
Current report
Series A Warrants
Current report
On April 18, 2024, in connection with the closing of the April Public Offering, Calidi issued Series A warrants to purchase 1,519,750 shares of common stock. Furthermore, on April 18, 2024, in connection with the mandatory conversion of a $1.0 million Convertible Note, Calidi issued additional Series A warrants to purchase 256,885 shares of common stock. The Series A Warrants have (i) an exercise price equal to $6.00 per share; and (ii) are exercisable for 5 years after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Current report
As of June 30, 2024, all Series A warrants to purchase 1,776,635 shares of common stock remain outstanding.
Current report
Pursuant to the Reverse Stock Split effected July 15, 2024, the exercise price of the Series A warrants was reset to $1.52 per share, effective July 22, 2024.
Current report
Series B Warrants
Current report
On April 18, 2024, in connection with the closing of the April Public Offering, Calidi issued Series B warrants to purchase 1,519,750 shares of common stock. Furthermore, on April 18, 2024, in connection with the mandatory conversion of a $1.0 million Convertible Note, Calidi issued additional Series B warrants to purchase 256,885 shares of common stock. The Series B Warrants have (i) an exercise price equal to $6.00 per share; and (ii) are exercisable for 1 year after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Current report
As of June 30, 2024, Series B warrants to purchase 267,300 shares of common stock were exercised at a reduced exercise price of $2.00 in connection with the May Inducement Offer. Pursuant to the issuance of common stock per the Series B warrant exercises, Calidi received gross proceeds of approximately $0.5 million.
Current report
As of June 30, 2024, Series B warrants to purchase 1,509,335 shares of common stock remain outstanding.
Current report
Pursuant to the Reverse Stock Split effected July 15, 2024, the exercise price of the Series B warrants was reset to $1.52 per share, effective July 22, 2024.
Current report
Series C Warrants
Current report
On April 18, 2024, in connection with the closing of the April Public Offering, Calidi issued Series C warrants to purchase 1,519,750 shares of common stock. Furthermore, on April 18, 2024, in connection with the mandatory conversion of a $1.0 million Convertible Note, Calidi issued additional Series C warrants to purchase 256,885 shares of common stock. The Series B Warrants have (i) an exercise price equal to $6.00 per share; and (ii) are exercisable for 4 months after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Current report
As of June 30, 2024, Series C warrants to purchase 802,500 shares of common stock were exercised at a reduced exercise price of $2.00 in connection with the May Inducement Offer. Pursuant to the issuance of common stock per the Series C warrant exercises, Calidi received gross proceeds of approximately $1.6 million.
Current report
As of June 30, 2024, Series C warrants to purchase 974,135 shares of common stock remain outstanding.
Current report
Pursuant to the Reverse Stock Split effected July 15, 2024, the exercise price of the Series C warrants was reset to $1.52 per share, effective July 22, 2024.
Current report
Series B-1 Warrants
Current report
On June 3, 2024, in connection with the closing of the May Inducement Offer, Calidi issued Series B-1 warrants to purchase 267,300 shares of common stock, which (i) have an exercise price equal to $2.00 per share; and (ii) are exercisable for 5 years after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Current report
As of June 30, 2024, all Series B-1 warrants to purchase 267,300 shares of common stock remain outstanding.
Current report
Pursuant to the Reverse Stock Split effected July 15, 2024, the exercise price of the Series B-1 warrants was reset to $1.52 per share, effective July 22, 2024.
Current report
Series C-1 Warrants
Current report
On June 3, 2024, in connection with the closing of the May Inducement Offer, Calidi issued Series C-1 warrants to purchase 802,500 shares of common stock, which (i) have an exercise price equal to $2.00 per share; and (ii) are exercisable for 5 years after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Current report
As of June 30, 2024, Series C-1 warrants to purchase 50,000 shares of common stock were exercised. Pursuant to the issuance of common stock per the Series C-1warrant exercises, the Company received gross proceeds of approximately $0.1 million.
Current report
As of June 30, 2024, Series C-1 warrants to purchase 752,500 shares of common stock remain outstanding.
Current report
Pursuant to the Reverse Stock Split effected July 15, 2024, the exercise price of the Series C-1 warrants was reset to $1.52 per share, effective July 22, 2024.
Current report
Series D Warrants
Showing the first 40 of 55 passages. Open the source sections for the rest.
Removed paragraphs (10)
Previous report
Research and development expenses for the three months ended March 31, 2024 and 2023 were $2.7 million and $2.6 million, respectively. The increase of $0.1 million was primarily attributable to an increase in consulting services and regulatory costs of $0.1 million, and an increase in salary and benefits due to higher headcount of $0.1 million, partially offset by a decrease in laboratory spending of $0.1 million.
Previous report
As of March 31, 2024, the total carrying value of the Convertible Note, including accrued interest and net of debt discount, was $1.0 million.
Previous report
As of March 31, 2024, the total carrying value of the Convertible Note, including accrued interest and net of debt discount, was $3.4 million.
Previous report
On April 12, 2024, the maturity date of $0.3 million of the 2023 Term Note was extended to January 1, 2025. Approximately $0.2 million of the amended 2023 Term Note will accrue interest at 18% per annum commencing on April 12, 2024, while the interest rate of the other $0.1 million of the amended 2023 Term Note will remain unchanged. All other terms and conditions remained substantially unchanged.
Previous report
Extension of Term Notes
Previous report
On April 12, 2024, the maturity date of $0.3 million of the 2023 Term Note was extended to January 1, 2025. Approximately $0.2 million of the amended 2023 Term Note will accrue interest at 18% per annum commencing on April 12, 2024, while the interest rate of the other $0.1 million of the amended 2023 Term Note will remain unchanged. All other terms and conditions remained substantially unchanged.
Previous report
Repayment of Convertible Promissory Note
Previous report
April Public Offering
Previous report
Reverse Stock Split
Previous report
Pursuant to the April Purchase Agreement, we agreed to hold an annual or special meeting of stockholders on or prior to the seventy-fifth (75th) calendar day following April 18, 2024 for the purpose of obtaining approval as may be required by the applicable rules and regulations of the NYSE American (or any successor entity) from the shareholders of Calidi to consummate a reverse stock split of Calidi’s Common Stock (“Stockholder Approval”), with the recommendation of the Calidi’s Board of Directors that such proposal is approved, and Calidi shall solicit proxies from its stockholders in connection therewith in the same manner as all other management proposals in such proxy statement and all management-appointed proxyholders shall vote their proxies in favor of such proposal. If Calidi does not obtain Stockholder Approval at the first meeting, Calidi will be required to call a meeting within every forty-five (45) day period thereafter to seek Stockholder Approval until the earlier of the date on which Shareholder Approval is obtained or the Pre-Funded Warrants or the Series A Common Warrants, Series B Common Warrants, Series B-1 Common Warrants, Series C Common Warrants and Series C-1 Common Warrants (collectively “Common Warrants”) are no longer outstanding. The Board has set the record date of April 26, 2024 for the special meeting to be held on June 6, 2024 (the “Special Meeting”). The Special Meeting will held for purposes of seeking stockholder approval for an amendment to our Second Amended and Restated Certificate of Incorporation, at the discretion of the Board of Directors of Calidi (the “Board”),to effect a reverse stock split with respect to Calidi’s issued and outstanding Voting Common Stock and Non-Voting Common Stock, at a ratio between 1-for-10 and 1-for-50 (the “Range”), with the ratio within such Range to be determined at the discretion of the Board (the “Reverse Stock Split Proposal”), and approval on other matters relating to potential issuances of securities of over 20% of the issued and outstanding shares of Voting Common Stock in compliance with NYSE American Rule 713(a), as more fully described in the preliminary proxy statement on Schedule 14A filed with the SEC on April 29, 2024.
Reworded paragraphs (36)
Previous wording
CLD-101 (NeuroNova™ Platform) for Newly Diagnosed High Grade Glioma (“HGG”) (also referred to as “NNV1” as to the indication). CLD-101 is our product candidate utilizing our NeuroNova™ Platform targeting HGG. Prior to our licensing agreement with Northwestern University, an open-label, investigator sponsored, Phase 1, dose- escalation clinical trial for NNV1 in patients with newly diagnosed high-grade gliomas was completed. This clinical trial demonstrated that single administration of CLD-101 was well tolerated in patients with newly diagnosed HGG. A Phase 1b clinical trial will commence for NNV1 in collaboration with Northwestern University during the third quarter of 2024. This trial will explore the final dosing regimen for NNV1, including the feasibility of repeated dosing in newly diagnosed HGG. Extensive biomarker analysis will be performed on tumor biopsies and blood samples to determine viral distribution, specific tumor targeting and induction of anti-tumor immunity.
Current wording
CLD-101 (NeuroNova™ Platform) for Newly Diagnosed High Grade Glioma (“HGG”) (also referred to as “NNV1” as to the indication). CLD-101 is our product candidate utilizing our NeuroNova™ Platform targeting HGG. Prior to our licensing agreement with Northwestern University, an open-label, investigator sponsored, Phase 1, dose- escalation clinical trial for NNV1 in patients with newly diagnosed high-grade gliomas was completed. This clinical trial demonstrated that single administration of CLD-101 was well tolerated in patients with newly diagnosed HGG. A Phase 1b clinical trial will commence for NNV1 in collaboration with Northwestern University during the first quarter of 2025. This trial will explore the final dosing regimen for NNV1, including the feasibility of repeated dosing in newly diagnosed HGG. Extensive biomarker analysis will be performed on tumor biopsies and blood samples to determine viral distribution, specific tumor targeting and induction of anti-tumor immunity.
Previous wording
CLD-201 (SuperNova™) for Advanced Solid Tumors (triple-negative breast cancer (“TNBC”), head & neck squamous cell carcinoma (HNSCC), and advanced soft tissue sarcoma (also referred to as “SNV1”). SNV1 is our first internally developed pre-clinical product candidate utilizing our SuperNova™ Delivery Platform. Based on our pre-clinical studies, we believe SNV1 has therapeutic potential for the treatment of multiple solid tumors such as head and neck cancer, triple-negative breast cancer and melanoma. We have held a pre-IND meeting with FDA to discuss the filing of our IND application for the clinical development of CLD-201. We anticipate commencing a Phase 1 clinical trial for SNV1 during the second half of 2024.
Current wording
CLD-201 (SuperNova™) for Advanced Solid Tumors (triple-negative breast cancer (“TNBC”), head & neck squamous cell carcinoma (HNSCC), and advanced soft tissue sarcoma (also referred to as “SNV1”). SNV1 is our first internally developed pre-clinical product candidate utilizing our SuperNova™ Delivery Platform. Based on our pre-clinical studies, we believe SNV1 has therapeutic potential for the treatment of multiple solid tumors such as head and neck cancer, triple-negative breast cancer and melanoma. We have held a pre-IND meeting with FDA to discuss the filing of our IND application for the clinical development of CLD-201. We anticipate commencing a Phase 1 clinical trial for SNV1 during the first half of 2025.
Previous wording
CLD-400 (RTNova) for Lung cancer and Metastatic Solid Tumors, Our pre-clinical program involving enveloped oncolytic viruses (discovery phase), builds upon our experience of using cells to protect, potentiate and deliver virotherapies. CLD-400 program is derived from research from prior pre-clinical CLD-202 program. RTNova consists of an engineered vaccinia virus enveloped by a cell membrane, that is potentially capable of targeting lung cancer and advanced metastatic disease due to its remarkable ability to survive in the bloodstream. Metastatic solid tumors involve cancer cells that break away from where they first formed (primary cancer) and travel through the blood or lymph system to form new tumors, known as metastatic tumors, in other parts of the body. In preclinical models, RTNova has shown early signs of its capability to target multiple distant and diverse tumors and transform their microenvironments leading to their elimination. In addition, the program has shown potential synergistic effects with other immunotherapies, including cell therapies, to attack and eliminate disseminated solid tumors.
Current wording
CLD-400 (RTNova) for Lung cancer and Metastatic Solid Tumors, our pre-clinical program involving enveloped oncolytic viruses (discovery phase), builds upon our experience of using cells to protect, potentiate and deliver virotherapies. CLD-400 program is derived from research from prior pre-clinical CLD-202 program. RTNova consists of an engineered vaccinia virus enveloped by a cell membrane, that is potentially capable of targeting lung cancer and advanced metastatic disease due to its increased ability to survive in the bloodstream. Metastatic solid tumors involve cancer cells that break away from where they first formed (primary cancer) and travel through the blood or lymph system to form new tumors, known as metastatic tumors, in other parts of the body. In preclinical studies, RTNova has shown early signs of its resistance to human humoral immunity and capability to target multiple distant and diverse tumors and transform their microenvironments leading to their elimination. In addition, the program has shown potential synergistic effects with other immunotherapies, including cell therapies, to attack and eliminate disseminated solid tumors.
Previous wording
Since inception, we have incurred significant operating losses. Our net loss was $7.2 million for the three months ended March 31, 2024. As of March 31, 2024, we had an accumulated deficit of $106.8 million. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.
Current wording
Since inception, we have incurred significant operating losses. Our net loss was $5.8 million and $13.0 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2024, we had an accumulated deficit of $112.6 million. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.
Previous wording
Changes in economic conditions, including rising interest rates, public health issues, including the recent COVID-19 pandemic, lower consumer confidence, volatile equity capital markets and ongoing supply chain disruptions and the impacts of geopolitical conflicts, may also affect our business.
Current wording
Changes in economic conditions, including rising interest rates, public health issues, including the COVID-19 pandemic and its aftereffects, lower consumer confidence, volatile equity capital markets and ongoing supply chain disruptions and the impacts of geopolitical conflicts, may also affect our business.
Previous wording
Based on our operating plan, we believe we do not have sufficient cash on hand to support current operations for at least one year from the date of issuance of our unaudited condensed consolidated financial statements as of, and for the three months ended March 31, 2024. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern. See Note 1 to our unaudited condensed consolidated financial statements. In addition, we will be required to raise additional capital through the issuance of our equity securities to support our operations which will have an ownership and economic dilutive effect to our current shareholders who purchased their shares of common stock at prices above our current trading price, and such capital raising may adversely affect the price of our common stock. Further, the sale of or the perception of a sale of a substantial number of our common stock by certain selling securityholders pursuant to another registration statement filed with the SEC will adversely affect the price of our common stock due to our limited trading volume and adversely affect the share price that we may obtain in future financings and may adversely affect our ability to conduct and complete future financings.
Current wording
Based on our operating plan, we believe we do not have sufficient cash on hand to support current operations for at least one year from the date of issuance of our unaudited condensed consolidated financial statements as of, and for the three and six months ended June 30, 2024. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern. See Note 1 to our unaudited condensed consolidated financial statements. In addition, we will be required to raise additional capital through the issuance of our equity securities to support our operations which will have an ownership and economic dilutive effect to our current shareholders who purchased their shares of common stock at prices above our current trading price, and such capital raising may adversely affect the price of our common stock. Further, the sale of or the perception of a sale of a substantial number of our common stock by certain selling securityholders pursuant to another registration statement filed with the SEC will adversely affect the price of our common stock due to our limited trading volume and adversely affect the share price that we may obtain in future financings and may adversely affect our ability to conduct and complete future financings.
Previous wording
As a result of the Business Combination, all outstanding stock of Calidi were cancelled in exchange for the right to receive newly issued shares of Common Stock (also referred to as “New Calidi Common Stock”), par value $0.0001 per share, and all outstanding options to purchase Calidi stock were assumed by Calidi. The total consideration received by Calidi Security Holders at the Closing of the transactions contemplated by the Merger Agreement is the newly issued shares of Common Stock and securities convertible or exchangeable for newly issued shares of Common Stock with an aggregate value equal $250.0 million, plus an adjustment of $23.8 million pursuant to the net debt adjustment provisions of the Merger Agreement by reason of the Series B Financing. As a result, the Calidi Security Holders received an aggregate of 27,375,600 shares of Common Stock as Merger Consideration.
Current wording
As a result of the Business Combination, all outstanding stock of Calidi were cancelled in exchange for the right to receive newly issued shares of Common Stock (also referred to as “New Calidi Common Stock”), par value $0.0001 per share, and all outstanding options to purchase Calidi stock were assumed by Calidi. The total consideration received by Calidi Security Holders at the Closing of the transactions contemplated by the Merger Agreement is the newly issued shares of Common Stock and securities convertible or exchangeable for newly issued shares of Common Stock with an aggregate value equal $250.0 million, plus an adjustment of $23.8 million pursuant to the net debt adjustment provisions of the Merger Agreement by reason of the Series B Financing. As a result, the Calidi Security Holders received an aggregate of 2,737,560 shares of Common Stock as Merger Consideration.
Previous wording
As additional consideration, each Calidi stockholder was entitled to earn, on a pro rata basis, up to 18,000,000 Escalation Shares. During the Escalation Period, Calidi Stockholders may be entitled to receive up to 18,000,000 Escalation Shares with incremental releases of 4,500,000 shares upon the achievement of each share price hurdle if the trading price of Common Stock is $12.00, $14.00, $16.00 and $18.00, respectively, for a period of any 20 days within any 30-consecutive-day trading period. The Escalation Shares have been placed in escrow and are outstanding from and after the Closing, subject to cancellation if the applicable price targets are not achieved. While in escrow, the shares will be non-voting.
Current wording
As additional consideration, each Calidi stockholder was entitled to earn, on a pro rata basis, up to 1,800,000 Escalation Shares. During the Escalation Period, Calidi Stockholders may be entitled to receive up to 1,800,000 Escalation Shares with incremental releases of 450,000 shares upon the achievement of each share price hurdle if the trading price of Common Stock is $120.00, $140.00, $160.00 and $180.00, respectively, for a period of any 20 days within any 30-consecutive-day trading period. The Escalation Shares have been placed in escrow and are outstanding from and after the Closing, subject to cancellation if the applicable price targets are not achieved. While in escrow, the shares will be non-voting.
Previous wording
Holders of FLAG Class A Common Stock who did not redeem their shares obtained their pro rata portion of an additional 85,849 Non-Redeeming Continuation Shares issued at Closing. At the Closing, Calidi Security Holders own approximately 76% of the outstanding shares of New Calidi Common Stock.
Current wording
Holders of FLAG Class A Common Stock who did not redeem their shares obtained their pro rata portion of an additional 8,585 Non-Redeeming Continuation Shares issued at Closing. At the Closing, Calidi Security Holders own approximately 76% of the outstanding shares of New Calidi Common Stock.
Previous wording
General and administrative expenses for the year ended three months ended March 31, 2024 and 2023 were $4.0 million and $2.8 million, respectively. The increase of $1.2 million was primarily due to increases in legal fees of $0.8 million, insurance costs of $0.4 million, director and consulting costs of $0.2 million, and dues and subscriptions of $0.1 million, partially offset by a decrease in salaries and benefits of $0.3 million.
Current wording
General and administrative expenses for the six months ended June 30, 2024 and 2023 were $7.6 million and $6.2 million, respectively. The increase of $1.4 million was primarily due to increases in legal fees of $1.0 million, insurance costs of $0.7 million, director and consulting costs of $0.3 million, marketing and advertising of $0.3 million, consulting fees of $0.1 million, and dues and subscriptions of $0.1 million, partially offset by a decrease in salaries and benefits of $1.0 million and travel expenses of $0.1 million.
Previous wording
Other income (expense), net for the three months ended March 31, 2024 and 2023 were $0.5 million and $1.0 million other expense, respectively. The decrease of $0.5 million primarily relates the decrease in grant income from the CIRM of $0.7 million, and the increase in interest expense and other expenses of $0.1 million, partially offset by the net change in fair value in Simple Agreement for Future Equity (SAFEs), Forward Purchase Agreement Derivative Asset, Private warrants, and Contingently Convertible and Convertible Notes Payable of $1.3 million.
Current wording
Other income (expense), net for the six months ended June 30, 2024 and 2023 were $0.5 million and $7.0 million other expense, respectively. The decrease of $6.5 million primarily relates the decrease in grant income from the CIRM of $1.4 million, partially offset by the net change in fair value in Simple Agreement for Future Equity (SAFEs), Forward Purchase Agreement Derivative Asset, Private warrants, and Contingently Convertible and Convertible Notes Payable of $5.2 million, and a decrease in other expenses related to Series B Convertible Preferred Stock financing costs of $2.7 million.
Previous wording
As of March 31, 2024, we had a cash balance of $1.2 million and restricted cash of $0.2 million. Our debt and liability obligations as of March 31, 2024 include $9.6 million in accounts payable and accrued expenses and other current liabilities, $2.5 million in related party term notes payable, $4.5 million in convertible notes payable, $0.7 million in warrant liabilities, $0.6 million in term notes payable, and $0.2 million in related party bridge loans payable.
Current wording
As of June 30, 2024, we had a cash balance of $0.8 million and restricted cash of $0.2 million. Our debt and liability obligations as of June 30, 2024 include $8.9 million in accounts payable and accrued expenses and other current liabilities, including related party amounts, $2.5 million in related party term notes payable, $1.9 million in convertible notes payable, $0.6 million in warrant liabilities, including related party amounts, $0.2 million in term notes payable, and $0.2 million in related party bridge loans payable.
Previous wording
On April 18, 2024, we closed on a public offering of our securities pursuant to that certain securities purchase agreement dated April 16, 2024 entered into by and among Calidi and certain purchasers. In connection with the public offering we sold an aggregate of 13,232,500 Common Stock Units and 1,965,000 PFW Units at an effective combined purchase price of $0.40 per Common Stock Unit or PFW Unit for aggregate gross proceeds of approximately $6.1 million before deducting placement agent fees and offering expenses payable by Calidi. The securities offered and sold in the public offering were registered pursuant to registration statement on Form S-1, as amended, filed with the SEC and declared effective on April 15, 2024.
Current wording
On April 18, 2024, we closed on a public offering of securities pursuant to that certain securities purchase agreement dated April 16, 2024 entered into by and among Calidi and certain purchasers (the “April Public Offering”). In connection with the April public offering, the Company sold an aggregate of 1,323,250 Common Stock Units and 196,500 Pre-Funded Warrant (“PFW”) Units at an effective combined purchase price of $4.00 per Common Stock Unit or PFW Unit for aggregate gross proceeds of approximately $6.1 million before deducting placement agent fees and offering expenses payable by the Company. The securities offered and sold in the public offering were registered pursuant to registration statement on Form S-1, as amended, filed with the SEC and declared effective on April 15, 2024.
Previous wording
On January 19, 2024, Calidi received approximately $0.2 million in aggregate proceeds from the issuance of certain bridge loans (the “2024 Bridge Loan”), which mature one year from the issuance date and bear simple interest of 12% per annum. As consideration for the 2024 Term Loans, Calidi agreed to issue an aggregate of 8,929 shares of restricted common stock to the Lender.
Current wording
On January 19, 2024, Calidi received approximately $0.2 million in aggregate proceeds from the issuance of certain bridge loans (the “2024 Bridge Loan”), which mature one year from the issuance date and bear simple interest of 12% per annum. As consideration for the 2024 Term Loans, Calidi agreed to issue an aggregate of 893 shares of restricted common stock to the Lender.
Previous wording
On April 19, 2024, we paid the $1.5 million convertible note in full upon the closing of a public offering by Calidi, in which the Holder participated in an amount equal to the principal amount of the convertible note. As of that date, the convertible note was no longer outstanding.
Current wording
On April 19, 2024, the $1.5 million convertible note was paid in full upon the closing of a public offering by Calidi, in which the Holder participated in an amount equal to the principal amount of the convertible note. As of that date, the convertible note was no longer outstanding.
Previous wording
In connection with the closing of the FLAG Merger on September 12, 2023, Calidi assumed 11,500,000 public warrants to purchase common stock with an exercise price of $11.50 per share. The Public Warrants became exercisable 30 days after the Closing. Each whole share of the warrant is exercisable for one share of Calidi ‘s common stock. Calidi may redeem the outstanding Public Warrants for $0.01 per warrant, if the reported last sale price of the common stock equals or exceeds $18.00 per share (as adjusted for stock dividends, sub-divisions, reorganizations, recapitalizations and the like) for any 20 trading days within a 30-trading day period commencing after the warrants become exercisable and ending on the third trading day before Calidi sends the notice of redemption to the warrant holders. Upon issuance of a redemption notice by Calidi, the warrant holders may, at any time after the redemption notice, exercise the Public Warrants on a cashless basis.
Current wording
In connection with the closing of the FLAG Merger on September 12, 2023, Calidi assumed 1,150,000 public warrants to purchase common stock with an exercise price of $115.00 per share. The Public Warrants became exercisable 30 days after the Closing. Each whole share of the warrant is exercisable for one share of Calidi ‘s common stock. Calidi may redeem the outstanding Public Warrants for $0.01 per warrant, if the reported last sale price of the common stock equals or exceeds $180.00 per share (as adjusted for stock dividends, sub-divisions, reorganizations, recapitalizations and the like) for any 20 trading days within a 30-trading day period commencing after the warrants become exercisable and ending on the third trading day before Calidi sends the notice of redemption to the warrant holders. Upon issuance of a redemption notice by Calidi, the warrant holders may, at any time after the redemption notice, exercise the Public Warrants on a cashless basis.
Previous wording
Calidi further assumed 1,912,514 private warrants to purchase common stock with an exercise price of $11.50 per share. The private warrants in general, will not be transferable, assignable or salable until 30 days after the Closing (excluding permitted transferees) and they will not be redeemable under certain redemption scenarios. Otherwise, the private warrants have terms and provisions that are identical to those of the public warrants, including the exercise price, exercisability and exercise period.
Current wording
Calidi further assumed 191,217 private warrants to purchase common stock with an exercise price of $115.00 per share. The private warrants in general, will not be transferable, assignable or salable until 30 days after the Closing (excluding permitted transferees) and they will not be redeemable under certain redemption scenarios. Otherwise, the private warrants have terms and provisions that are identical to those of the public warrants, including the exercise price, exercisability and exercise period.
Previous wording
On February 21, 2024, in connection with a settlement agreement, Calidi issued an additional 400,000 private warrants to purchase Restricted Shares which (i) has an exercise price equal to $1.32; and (ii) are exercisable for 5 years after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Current wording
On February 21, 2024, in connection with a settlement agreement, Calidi issued an additional 40,000 private warrants to purchase Restricted Shares which (i) has an exercise price equal to $13.20; and (ii) are exercisable for 5 years after the date of issuance of the warrants, subject to the terms set forth in such warrant.
Previous wording
As of March 31, 2024, all 11,500,000 Public Warrants, 1,912,514 Private Warrants, and 400,000 warrants to purchase Restricted Shares were outstanding, respectively.
Current wording
As of June 30, 2024, all 1,150,000 Public Warrants, 191,217 Private Warrants, and 40,000 warrants to purchase Restricted Shares were outstanding, respectively.
Previous wording
As of March 31, 2024 and December 31, 2023, the interest rate of the 2021 Term Notes was 24% and the total carrying value, including accrued interest was approximately $0.6 million.
Current wording
As of June 30, 2024 and December 31, 2023, the interest rate of the 2021 Term Notes was 24% and the total carrying value, including accrued interest was approximately $0.7 million and $0.6 million, respectively. The interest rate on the 2021 Term Notes was amended on August 12, 2024, to 14% per annum.
Previous wording
As of March 31, 2024 and December 31, 2023, the interest rate of the 2022 Term Notes was 24% per annum for a total principal of $0.2 million, and 16% and 15% per annum for a total principal of $0.2 million, respectively. As of March 31, 2024 and December 31, 2023, the total carrying value, including accrued interest, was $0.4 million.
Current wording
As of June 30, 2024 and December 31, 2023, the interest rate of the 2022 Term Notes was 24% per annum for a total principal of $0.2 million, and 16% and 15% per annum for a total principal of $0.2 million, respectively. As of June 30, 2024 and December 31, 2023, the total carrying value, including accrued interest, was $0.4 million. The interest rate of 24% per annum on the 2022 Term Notes for a total principal of $0.2 million was amended on August 12, 2024, to 14% per annum.
Previous wording
As of March 31, 2024 and December 31, 2023, the interest rate of the 2023 Term Notes was 24% per annum for a total principal of $1.1 million and 14% per annum for a total principal of $0.6 million. As of December March 31, 2024 and December 31, 2023, the total carrying value, including accrued interest and net of debt discount, was $2.0 million and $1.9 million, respectively.
Current wording
As of June 30, 2024 and December 31, 2023, the interest rate of the 2023 Term Notes was 24% per annum for a total principal of $1.1 million, 18% per annum for a total principal of $0.2 million, and 14% per annum for a total principal of $0.1 million. As of June 30, 2024 and December 31, 2023, the total carrying value, including accrued interest and net of debt discount, was $1.7 million and $1.9 million, respectively. The interest rate on the 2023 Term Notes with a total principal of $1.1 million was amended on August 12, 2024, to 14% per annum.
Previous wording
Other commitments and contingencies include (i) various operating and financing leases for equipment, office facilities, and other property containing future minimum lease payments totaling $4.9 million, (ii) certain manufacturing and other supplier agreements with vendors principally for manufacturing drug products for clinical trials and continuing the development of the CLD-101 and CLD-201 programs totaling $0.4 million, (iii) litigation costs of $0.2 million, and (iv) severance costs due on June 23, 2024 totaling $0.5 million. In accordance with the provisions of the Separation Agreement, the severance costs of $0.5 million will accrue interest at the rate of 8.0% per annum in the event that this amount is not paid when due, and the principal plus accrued interest shall be paid no later than two years after the effective date of the severance agreement.
Current wording
Other commitments and contingencies include (i) various operating and financing leases for equipment, office facilities, and other property containing future minimum lease payments totaling $4.5 million, (ii) certain manufacturing and other supplier agreements with vendors principally for manufacturing drug products for clinical trials and continuing the development of the CLD-101 and CLD-201 programs totaling $0.4 million, (iii) litigation costs of $0.2 million, and (iv) severance costs due on January 1, 2025 totaling $0.4 million. In accordance with the provisions of the Separation Agreement, the severance costs of $0.4 million will accrue interest at the rate of 8.0% per annum in the event that this amount is not paid when due, and the principal plus accrued interest shall be paid no later than two years after the effective date of the severance agreement.
Previous wording
On March 8, 2024, Calidi and one of the sellers mutually terminated and cancelled 340,000 shares per the Forward Purchase Agreement described above.
Current wording
On March 8, 2024, Calidi and one of the sellers mutually terminated and cancelled 34,000 shares per the Forward Purchase Agreement described above.
Previous wording
Cash Flow Summary for the three months ended March 31, 2024 and 2023
Current wording
Cash Flow Summary for the six months ended June 30, 2024 and 2023
Previous wording
The following table shows a summary of our cash flows for the three months ended March 31, 2024 and 2023 (in thousands):
Current wording
The following table shows a summary of our cash flows for the six months ended June 30, 2024 and 2023 (in thousands):
Previous wording
Net cash used in operating activities was $3.8 million for the three months ended March 31, 2024, primarily resulting from our net loss of $7.2 million. Our net loss was reduced by certain non-cash items that included $1.9 million from the change in our operating assets and liabilities, $0.9 million in stock-based compensation, $0.3 million in amortization of right of use assets, $0.2 million in change in fair value of debt, other liabilities and derivatives, and $0.1 million in depreciation expense.
Current wording
Net cash used in operating activities was $9.3 million for the six months ended June 30, 2024, primarily resulting from our net loss of $13.0 million. Our net loss was reduced by certain non-cash items that included $1.6 million in stock-based compensation, $1.1 million from the change in our operating assets and liabilities, $0.6 million in amortization of right of use assets, $0.2 million in depreciation expense, and $0.1 million in change in fair value of debt, other liabilities and derivatives.
Previous wording
Net cash used in operating activities was $3.1 million for the three months ended March 31, 2023, primarily resulting from our net loss of $6.5 million. Our net loss was reduced by certain non-cash items that included $1.5 million from the change in fair value of debt and other liabilities, $1.4 million in stock-based compensation, $0.2 million in amortization of debt discount and financing costs, $0.1 million in amortization of right of use assets, and $0.1 million in depreciation expense.
Current wording
Net cash used in operating activities was $8.3 million for the six months ended June 30, 2023, primarily resulting from our net loss of $19.0 million. Our net loss was reduced by certain non-cash items that included $5.4 million from the change in fair value of debt, including change in fair value of related party debt, $2.7 million in financing costs related to the Series B financing, $2.5 million in stock-based compensation, $0.9 million from the change in our operating assets and liabilities, and $0.8 million in amortization and depreciation expenses.
Previous wording
Net cash used in investing activities was $5,000 for the three months ended March 31, 2024, which primarily related to the purchase of certain machinery and equipment.
Current wording
Net cash used in investing activities was $5,000 for the six months ended June 30, 2024, which primarily related to the purchase of certain machinery and equipment.
Previous wording
Net cash used in investing activities was $0.1 million for the three months ended March 31, 2023, which primarily related to the purchase of machinery and equipment.
Current wording
Net cash used in investing activities was $0.4 million for the six months ended June 30, 2023, which primarily related to the purchase of machinery and equipment.
Previous wording
Net cash provided by financing activities was $3.0 million for the three months ended March 31, 2024, which primarily related to proceeds from issuance of convertible notes payable of $3.0 million, and related party proceeds from issuance of a bridge loan payable of $0.2 million, partially offset by payment of financing costs of $0.2 million.
Current wording
Net cash provided by financing activities was $8.2 million for the six months ended June 30, 2024, which primarily related to proceeds from the April Public Offering of $5.4 million, proceeds from issuance of convertible notes payable of $3.0 million, proceeds from the May Inducement Offer of $2.1 million, related party proceeds from issuance of a bridge loan payable of $0.2 million, and proceeds from the exercise of common stock warrants of $0.1 million, partially offset by repayment of convertible notes payable of $1.5 million, payment of financing costs of $0.8 million, and repayment of term notes payable of $0.3 million.
Previous wording
Net cash provided by financing activities was $3.8 million for the three months ended March 31, 2023, which primarily related to proceeds from issuance of term notes payable of $2.5 million, which included $1.6 million from related parties, proceeds from Simple Agreement for Future Equity (SAFEs) of $1.4 million, partially offset by repayment of financing lease obligations and payment of deferred financing costs of $0.1 million.
Current wording
Net cash provided by financing activities was $10.4 million for the six months ended June 30, 2023, which primarily related to proceeds from issuance of preferred stock related to the Series B financing, entirely from related parties, of $5.2 million, proceeds from issuance of term notes payable of $3.2 million, including from related parties, proceeds from Simple Agreement for Future Equity (SAFEs) of $2.8 million, proceeds from stock option exercises of $0.2 million, partially offset by repayment of loans payable obligations and payment of deferred financing costs of $1.0 million.
Previous wording
Based on our current operating plan, available cash and additional access to capital discussed above under the “Liquidity and Capital Resources” section, we believe we do not have sufficient cash on hand to support current operations for at least one year from the date of issuance of the unaudited condensed consolidated financial statements as of and for the three months ended March 31, 2024 appearing elsewhere in this Form 10-Q. Based on our existing cash and cash equivalents as of May 10, 2024, we believe we have insufficient cash to continue operations through June, 2024, unless we raise additional short-term capital. To finance our operations, we will need to raise substantial additional capital, which cannot be assured. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern for at least one year from the date that our aforementioned unaudited condensed consolidated financial statements were issued. See Note 1 to our unaudited condensed consolidated financial statements appearing elsewhere in this Form 10-Q for additional information on our assessment.
Current wording
Based on our current operating plan, available cash and additional access to capital discussed above under the “Liquidity and Capital Resources” section, we believe we do not have sufficient cash on hand to support current operations for at least one year from the date of issuance of the unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2024 appearing elsewhere in this Form 10-Q. Based on our existing cash and cash equivalents as of August 13, 2024, we believe we have insufficient cash to continue operations through June, 2024, unless we raise additional short-term capital. To finance our operations, we will need to raise substantial additional capital, which cannot be assured. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern for at least one year from the date that our aforementioned unaudited condensed consolidated financial statements were issued. See Note 1 to our unaudited condensed consolidated financial statements appearing elsewhere in this Form 10-Q for additional information on our assessment.
Previous wording
The discussion andanalysis of ourfinancial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The preparation of our condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. We review our estimates on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.
Current wording
The discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The preparation of our condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. We review our estimates on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.
Previous wording
Our significant accounting policies and estimates are described in Note 2 to the consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. The accounting estimates that are most critical to a full understanding and evaluation of our reported financial results are described in Management’s Discussion and Analysis of Financial Condition and Results of Operations in Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. There were no material changes to our critical accounting estimates during the three months ended March 31, 2024.
Current wording
Our significant accounting policies and estimates are described in Note 2 to the consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. The accounting estimates that are most critical to a full understanding and evaluation of our reported financial results are described in Management’s Discussion and Analysis of Financial Condition and Results of Operations in Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. There were no material changes to our critical accounting estimates during the three and six months ended June 30, 2024.
Previous wording
Inflation generally affects us by increasing our cost of labor. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the three months ended March 31, 2024 and 2023.
Current wording
Inflation generally affects us by increasing our cost of labor. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the three and six months ended June 30, 2024 and 2023.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Other income (expense), net for the three months ended June 30, 2024 and 2023 were $13,000 other income and $6.0 million other expense, respectively. The decrease of $6.0 million primarily relates the decrease in grant income from the CIRM of $0.6 million, partially offset by the net change in fair value in Simple Agreement for Future Equity (SAFEs), Forward Purchase Agreement Derivative Asset, Private warrants, and Contingently Convertible and Convertible Notes Payable of $3.9 million, and a decrease in other expenses related to Series B Convertible Preferred Stock financing costs of $2.7 million.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
On April 14, 2024, the $1.5 million convertible note agreement was amended to include a mandatory prepayment of the entire convertible note upon the closing of a public offering of Calidi’s securities registered with the Securities and Exchange Commission in which Holder participates in an amount equal to the principal amount of the convertible note. All other terms and conditions remained substantially unchanged. See Note 12 for further details over subsequent events.
Previous report — wording carried elsewhere
On April 19, 2024, the $1.5 million convertible note was paid in full upon the closing of a public offering by Calidi, in which the Holder participated in an amount equal to the principal amount of the convertible note. As of that date, the convertible note was no longer outstanding. See Note 12 for further details over subsequent events.
Previous report — wording carried elsewhere
On April 18, 2024, we closed on a public offering of our securities pursuant to that certain securities purchase agreement dated April 16, 2024 entered into by and among Calidi and certain purchasers. In connection with the public offering we sold an aggregate of 13,232,500 Common Stock Units and 1,965,000 PFW Units at an effective combined purchase price of $0.40 per Common Stock Unit or PFW Unit for aggregate gross proceeds of approximately $6.1 million before deducting placement agent fees and offering expenses payable by Calidi. The securities offered and sold in the public offering were registered pursuant to registration statement on Form S-1, as amended, filed with the SEC and declared effective on April 15, 2024.