On August 13, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Candel Therapeutics, AUG 13, 2024, View Source [SID1234645793]).

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"The second quarter of 2024 represented a pivotal period for Candel, characterized by robust clinical advancements and key regulatory successes, that further validate our innovative approach to cancer immunotherapy," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Our encouraging overall survival phase 2 data for CAN-2409 highlights the potential of our lead candidate to address a significant unmet need for non-small cell lung cancer patients, who are non-responsive to immune checkpoint inhibitor treatment, and for patients with borderline resectable pancreatic cancer. In addition, the FDA granting orphan drug designation for

CAN-3110 in recurrent high-grade glioma underscores the promise of this first-in-class, novel asset developed for difficult-to-treat cancers."

Dr. Tak continued, "Our inclusion in the Russell 3000 Index also marks a significant milestone in Candel’s growth and offers an opportunity to increase our recognition within the investment community. These achievements, coupled with a successful R&D event at ASCO (Free ASCO Whitepaper), have set a strong foundation as we approach several key readouts in the latter half of 2024."

Second Quarter 2024 & Recent Highlights

•Program Updates
oCAN-2409 – Pancreatic Cancer

▪In early April, announced positive updated survival data from the phase 2 randomized controlled clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, in borderline resectable pancreatic ductal adenocarcinoma (PDAC).

▪Data showed notable improvements in estimated median overall survival (mOS) of 28.8 months after experimental treatment with CAN-2409 versus 12.5 months in control group.

▪At 24 months, survival rate was 71.4% in CAN-2409 treated patients after chemoradiation and prior to surgery versus 16.7% in the control group. At 36 months, estimated survival was 47.6% in the CAN-2409 group after chemoradiation and prior to surgery versus 16.7% in the control group.

▪No new safety signals were observed, providing further support that multiple injections of CAN-2409 have been generally well-tolerated to date, with no dose-limiting toxicities and no cases of pancreatitis reported.

▪Analysis of resected tumors showed the formation of dense aggregates of immune cells, including CD8+, cytotoxic tumor infiltrating lymphocytes and dendritic cells, within the tumor microenvironment after CAN-2409 administration, confirming the activation of a robust antitumoral immune response.

▪Received orphan drug designation from the FDA for CAN-2409 for the treatment of pancreatic cancer.

oCAN-2409 – Non-Small Cell Lung Cancer

▪Presented topline overall survival data from the phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor (ICI) therapy in patients with stage III/IV NSCLC inadequately responding to ICI therapy at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.
▪Data showed mOS of 20.6 months in patients with progressive disease despite ICI treatment compared to published results of less than 12 months with SoC docetaxel-based chemotherapy in similar patient populations.1
▪CAN-2409 treatment resulted in activation of the systemic immune response after two administrations of CAN-2409, including increased numbers of circulating cytotoxic and memory T cells associated with subsequent prolonged survival.
▪As of the April 1, 2024 data cut-off date, CAN-2409 treatment in NSCLC continued to exhibit a favorable safety and tolerability profile.
oCAN-3110 – Recurrent High-Grade Glioma
▪Received orphan drug designation from the FDA for CAN-3110 for the treatment of rHGG.
▪Presented a Trial-in-Progress poster at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting on the ongoing phase 1b clinical trial exploring multiple doses of CAN-3110 in patients with rHGG.
oenLIGHTEN Discovery Platform
▪Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting unveiling the second candidate from the enLIGHTEN Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures (TLS), being developed as a novel therapeutic for solid tumors.
•Corporate Updates

oHosted successful NSCLC Research and Development panel during the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, featuring prominent scientific and medical thought leaders discussing the topline overall survival data from the phase 2 clinical trial of CAN-2409 in NSCLC.

oAnnounced inclusion in the Russell 3000 Index, effective July 1, 2024, as part of FTSE Russell’s annual reconstitution of its U.S. equity indexes.
Anticipated Milestones

•Updated phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024.
•Phase 2b topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024.
•Phase 3 topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024.
Financial Results for Second Quarter Ended June 30, 2024

Research and Development Expenses: Research and development expenses were $5.0 million for the second quarter of 2024 compared to $5.9 million for the second quarter of 2023. The decrease was primarily due to lower clinical development costs driven by a reduction in regulatory, manufacturing and clinical trial costs for CAN-2409 programs and lower payroll-related expenses following the corporate restructuring in the fourth quarter of 2023. These decreases were partially offset by increased stock-based compensation expense. Research and development expenses included non-cash stock compensation expense of $1.3 million for the second quarter of 2024 compared to $0.3 million for the second quarter of 2023.

General and Administrative Expenses: General and administrative expenses were $3.6 million for both the second quarter of 2024 and the second quarter of 2023. There was a small decrease, primarily due to lower insurance costs and recruiting costs. These decreases were partially offset by increased professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.6 million for the second quarter of 2024 compared to $0.4 million for the second quarter of 2023.

Net Loss: Net loss for the second quarter of 2024 was $22.2 million, compared to a net loss of $9.6 million for the second quarter of 2023, and included other expense, net of $13.7 million and $35,000, respectively, primarily due to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents, as of June 30, 2024, were $21.5 million, as compared to $35.4 million as of December 31, 2023. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2025.

On August 13, 2024 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported financial results for the second quarter ended June 30, 2024 (Press release, Nkarta, AUG 13, 2024, View Source [SID1234645816]).

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"Patients remain our focus, and early execution on our clinical trials across disease areas is a testament to that commitment," said Paul J. Hastings, CEO of Nkarta. "NKX019 has the potential to reach people living with a wide range of autoimmune diseases, and we will continue to evaluate ways to maximize our impact in this field. Our cellular engineering enables us to evaluate a reduced toxicity lymphodepletion regimen, to limit hospitalization and patient burden, and spare the complications of other agents."

Continued execution in clinical development of NKX019 for autoimmune diseases

Received clearance from FDA of second Investigational New Drug (IND) application for NKX019 in autoimmune disease, supporting the planned initiation of Ntrust-2, a clinical trial of NKX019 for the treatment of systemic sclerosis, myositis and vasculitis. Patients enrolled in Ntrust-2 will receive three doses of NKX019 on Days 0, 3, and 7 following lymphodepletion (LD) with single-agent cyclophosphamide (cy).
Initiation of an investigator-sponsored trial (IST) of NKX019 in systemic lupus erythematosus (SLE) with or without LN by researchers at Columbia University Irving Medical Center. Patients enrolled in the IST will receive three doses of NKX019 on Days 0, 7, and 14 following LD with single-agent cy.
Autoimmune milestones 2024-2025

Initiation of patient enrollment in Ntrust-2 clinical trial expected by year-end 2024.
Preliminary clinical data from Ntrust-1 and Ntrust-2 clinical trials planned for 2025.
Mid-year update for NKX019 in non-Hodgkin lymphoma (NHL)

Nkarta presented follow-up data from its Phase 1 clinical trial of NKX019 in relapsed/refractory NHL at the Pan Pacific Lymphoma Conference in July 2024, including follow-up on 4 patients who were retreated and re-entered complete response (CR), demonstrating the safety and encouraging effectiveness (4/4 CR) of retreatment.
Nkarta previously opened a cohort with a compressed (7-day) dosing schedule, where patients with large B-cell lymphoma (LBCL) who have progressed following CAR T therapy receive NKX019 on Days 0, 3, and 7 following LD with fludarabine (flu) and cy.
Nkarta has completed enrollment of patients into the 7-day dosing cohort in LBCL following CAR T and expects to announce data from this cohort in late-2024.
Future development of NKX019 in NHL will be contingent on favorable outcomes from the seven patients that have been treated in the new cohort.
Leadership Updates

In July 2024, Nadir Mahmood, Ph.D., joined Nkarta as President, and David R. Shook, M.D., was promoted to Chief Medical Officer, Head of Research & Development, with both executives reporting to Paul J. Hastings, Chief Executive Officer.
In June 2024, George Vratsanos, M.D., FACR, an accomplished biopharmaceutical executive with scientific and clinical expertise in immunology and autoimmunity, joined Nkarta’s Board of Directors.
Second Quarter 2024 and Recent Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $426.7 million as of June 30, 2024.
Research and development (R&D) expenses were $23.1 million for the second quarter of 2024. Non-cash stock-based compensation expense included in R&D expense was $2.2 million for the second quarter of 2024.
General and administrative (G&A) expenses were $7.6 million for the second quarter of 2024. Non-cash stock-based compensation expense included in G&A expense was $2.2 million for the second quarter of 2024.
Net loss was $25.0 million, or $0.34 per basic and diluted share, for the second quarter of 2024. This net loss includes non-cash charges of $6.7 million that consisted primarily of share-based compensation and depreciation expenses.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into late 2027.
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies.

About Ntrust Clinical Trials in Autoimmune Disease
Ntrust-1 and Ntrust-2 are multi-center, open label, dose escalation clinical trials that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable long-term remissions via a "reset" of the immune system through the elimination of pathogenic B cells. Per the trial protocols, patients receive three-dose cycles of NKX019 at 1 billion or 1.5 billion cells per dose following single-agent lymphodepletion with cyclophosphamide, an agent with an established safety profile across autoimmune diseases. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval.

In the Ntrust-1 study, patients with refractory lupus nephritis receive NKX019 on Days 0, 7 and 14. Patients in Ntrust-1 may also receive additional cycles to restore response.

Once initiated, Ntrust-2 will enroll patients with systemic sclerosis (scleroderma), idiopathic inflammatory myopathy (myositis), and ANCA-associated vasculitis into parallel cohorts, and NKX019 will be dosed on Days 0, 3, and 7, a regimen that may be advantageous across all Nkarta clinical trials. Each trial is designed to initially enroll up to 12 patients.

On August 13, 2024 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx Biosciences" or the "Company"), a biopharmaceutical company with two programs in ongoing clinical trials and a strong emerging pipeline, reported financial results for the second quarter of 2024 and provided an update on recent corporate highlights (Press release, Inhibrx, AUG 13, 2024, https://www.prnewswire.com/news-releases/inhibrx-biosciences-reports-second-quarter-2024-financial-results-and-recent-corporate-highlights-302221636.html [SID1234645832]).

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Separation from the Former Parent

In January 2024, Inhibrx, Inc. (the "Former Parent") announced its intent, as approved by its board of directors, to effect the spin-off of INBRX-101, an optimized, recombinant alpha-1 antitrypsin ("AAT"), augmentation therapy currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency.

On May 30, 2024, the Former Parent completed the transaction, pursuant to which (i) all assets and liabilities primarily related to INBRX-101 (the "101 Business"), were transferred to Aventis Inc. (the "Acquirer"), a wholly-owned subsidiary of Sanofi S.A. ("Sanofi"); and (ii) by way of a pre-closing reorganization (the "Separation"), the Company acquired the assets and liabilities and corporate infrastructure associated with its ongoing programs, INBRX-106 and ozekibart (INBRX-109), and its discovery pipeline, as well as the remaining close-out obligations related to its previously terminated program, INBRX-105.

Upon the closing, each Former Parent stockholder received: (i) $30.00 per share in cash, (ii) one contingent value right per share, representing the right to receive a contingent payment of $5.00 in cash upon the achievement of a regulatory milestone, and (iii) one SEC-registered, publicly listed, share of Inhibrx Biosciences for every four shares of the Former Parent’s common stock held. The Former Parent retained an equity interest in Inhibrx Biosciences of 8% upon the distribution of shares to the Former Parent stockholders (the "Distribution").

In connection with the Separation, the Acquirer paid transaction consideration totaling approximately $2.2 billion in aggregate value, including the $35.00 per share consideration and the assumption of the third-party debt obligations of the Former Parent. In addition, the Acquirer assumed all assets and liabilities under contracts primarily related to INBRX-101 upon close of the transaction. The Acquirer also reimbursed the Company or paid on behalf of the Company $68.0 million in transaction costs.

From and after the closing, Inhibrx Biosciences continues to operate as a stand-alone, publicly traded company focused on its two clinical programs, ozekibart (INBRX-109) and INBRX-106. Inhibrx Biosciences continues to trade as INBX on the Nasdaq Global Market. We do not expect the results of operations directly arising from and related to the Separation and Distribution to occur in future periods.
Financial Results

Cash and Cash Equivalents. As of June 30, 2024, Inhibrx Biosciences had cash and cash equivalents of $226.9 million, compared to $255.4 million as of May 30, 2024 following the Separation from the Former Parent. The Company’s cash outflows during this period relate primarily to the distribution of consideration totaling $17.7 million, which was paid out to the Former Parent’s optionholders and remitted by the Company within ten business days of the close of the transaction in accordance with the terms of the Separation and Distribution. Other cash outflows during the period relate to the Company’s ongoing operations.

R&D Expense. Research and development expenses were $67.6 million during the second quarter of 2024, compared to $34.1 million during the second quarter of 2023. The increase in research and development expenses was primarily due to the following factors:

stock option expense recognized upon the acceleration of outstanding stock options in connection with the Separation and Distribution;

an increase in CMC expenses due to the nature of the development and manufacturing activities performed at its CDMO and CRO partners supporting the Company’s clinical and preclinical therapeutic candidates, which reflect the stage-specific needs of its programs during each period, including early and late-stage drug substance clinical manufacturing, analytical development, quality control, testing and stability studies, drug product development, scale-up, robustness studies, and selected biologics license applications-enabling activities; and

offset in part by a decrease in clinical trial expenses following the termination of the Company’s INBRX-105 program and the removal of the INBRX-101 program following the Separation.

G&A Expense. General and administrative expenses were $93.4 million during the second quarter of 2024, compared to $7.3 million during the second quarter of 2023. The increase in general and administrative expenses was primarily due to the following factors:

an increase in legal, advisory, and consulting fees incurred in connection with the Separation and Distribution;

stock option expense recognized upon the acceleration of outstanding stock options in connection with the Separation and Distribution;

an increase in pre-commercialization expenses, which was primarily related to increases in consulting services to support the Company’s commercial operations business intelligence strategies and market research expenses related to ozekibart (INBRX-109) and INBRX-101 prior to the transaction;

an increase in professional service expenses related to legal services which support the Company in its general corporate and intellectual property matters, and legal proceedings.

Other Income (Expense). Other income was $2.0 billion during the second quarter of 2024, compared to other expense of $5.7 million during the second quarter of 2023. Other income during the second quarter of 2024 consists of gains recorded in connection with the completion of the Separation and Distribution, related to (i) the consideration paid by the Acquirer for all outstanding common stock, warrants, and stock options, (ii) the extinguishment of the Company’s outstanding debt which was assumed by the Acquirer, (iii) assets and liabilities related to the 101 Business, which were assumed by the Acquirer, and (iv) transaction costs paid for by the Acquirer.

Net Income (Loss). Net income was $1.9 billion during the second quarter of 2024, or earnings per share of $127.10, basic, and $125.48, diluted, compared to a net loss of $47.1 million during the second quarter of 2023, or $4.31 per share, basic and diluted.

On August 13, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Candel Therapeutics, AUG 13, 2024, View Source [SID1234645800]).

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"The second quarter of 2024 represented a pivotal period for Candel, characterized by robust clinical advancements and key regulatory successes, that further validate our innovative approach to cancer immunotherapy," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Our encouraging overall survival phase 2 data for CAN-2409 highlights the potential of our lead candidate to address a significant unmet need for non-small cell lung cancer patients, who are non-responsive to immune checkpoint inhibitor treatment, and for patients with borderline resectable pancreatic cancer. In addition, the FDA granting orphan drug designation for CAN-3110 in recurrent high-grade glioma underscores the promise of this first-in-class, novel asset developed for difficult-to-treat cancers."

Dr. Tak continued, "Our inclusion in the Russell 3000 Index also marks a significant milestone in Candel’s growth and offers an opportunity to increase our recognition within the investment community. These achievements, coupled with a successful R&D event at ASCO (Free ASCO Whitepaper), have set a strong foundation as we approach several key readouts in the latter half of 2024."

Second Quarter 2024 & Recent Highlights

•
Program Updates
o
CAN-2409 – Pancreatic Cancer

▪
In early April, announced positive updated survival data from the phase 2 randomized controlled clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, in borderline resectable pancreatic ductal adenocarcinoma (PDAC).

▪
Data showed notable improvements in estimated median overall survival (mOS) of 28.8 months after experimental treatment with CAN-2409 versus 12.5 months in control group.

▪
At 24 months, survival rate was 71.4% in CAN-2409 treated patients after chemoradiation and prior to surgery versus 16.7% in the control group. At 36 months, estimated survival was 47.6% in the CAN-2409 group after chemoradiation and prior to surgery versus 16.7% in the control group.

▪
No new safety signals were observed, providing further support that multiple injections of CAN-2409 have been generally well-tolerated to date, with no dose-limiting toxicities and no cases of pancreatitis reported.

▪
Analysis of resected tumors showed the formation of dense aggregates of immune cells, including CD8+, cytotoxic tumor infiltrating lymphocytes and dendritic cells, within the tumor microenvironment after CAN-2409 administration, confirming the activation of a robust antitumoral immune response.

▪
Received orphan drug designation from the FDA for CAN-2409 for the treatment of pancreatic cancer.

o
CAN-2409 – Non-Small Cell Lung Cancer ▪
Presented topline overall survival data from the phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor (ICI) therapy in patients with stage III/IV NSCLC inadequately responding to ICI therapy at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.
▪
Data showed mOS of 20.6 months in patients with progressive disease despite ICI treatment compared to published results of less than 12 months with SoC docetaxel-based chemotherapy in similar patient populations.1
▪
CAN-2409 treatment resulted in activation of the systemic immune response after two administrations of CAN-2409, including increased numbers of circulating cytotoxic and memory T cells associated with subsequent prolonged survival.
▪
As of the April 1, 2024 data cut-off date, CAN-2409 treatment in NSCLC continued to exhibit a favorable safety and tolerability profile.
o
CAN-3110 – Recurrent High-Grade Glioma
▪
Received orphan drug designation from the FDA for CAN-3110 for the treatment of rHGG.
▪
Presented a Trial-in-Progress poster at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting on the ongoing phase 1b clinical trial exploring multiple doses of CAN-3110 in patients with rHGG.
o
enLIGHTEN Discovery Platform
▪
Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting unveiling the second candidate from the enLIGHTEN Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures (TLS), being developed as a novel therapeutic for solid tumors.
•
Corporate Updates

o
Hosted successful NSCLC Research and Development panel during the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, featuring prominent scientific and medical thought leaders discussing the topline overall survival data from the phase 2 clinical trial of CAN-2409 in NSCLC.

o
Announced inclusion in the Russell 3000 Index, effective July 1, 2024, as part of FTSE Russell’s annual reconstitution of its U.S. equity indexes.

Anticipated Milestones

•
Updated phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024.
•
Phase 2b topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024.
•
Phase 3 topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024.
Financial Results for Second Quarter Ended June 30, 2024

Research and Development Expenses: Research and development expenses were $5.0 million for the second quarter of 2024 compared to $5.9 million for the second quarter of 2023. The decrease was primarily due to lower clinical development costs driven by a reduction in regulatory, manufacturing and clinical trial costs for CAN-2409 programs and lower payroll-related expenses following the corporate restructuring in the fourth quarter of 2023. These decreases were partially offset by increased stock-based compensation expense. Research and development expenses included non-cash stock compensation expense of $1.3 million for the second quarter of 2024 compared to $0.3 million for the second quarter of 2023.

General and Administrative Expenses: General and administrative expenses were $3.6 million for both the second quarter of 2024 and the second quarter of 2023. There was a small decrease, primarily due to lower insurance costs and recruiting costs. These decreases were partially offset by increased professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.6 million for the second quarter of 2024 compared to $0.4 million for the second quarter of 2023.

Net Loss: Net loss for the second quarter of 2024 was $22.2 million, compared to a net loss of $9.6 million for the second quarter of 2023, and included other expense, net of $13.7 million and $35,000, respectively, primarily due to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents, as of June 30, 2024, were $21.5 million, as compared to $35.4 million as of December 31, 2023. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2025.

On August 13, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported it has entered into definitive agreement for the purchase and sale of 2,000,000 shares of its American Depository Shares and Pre-Funded Warrants at an offering price of $1 per share in a registered direct offering and an additional 2,000,000 cash exercise only Series G warrants with an exercise price of £0.78 with a single investor (Press release, TC Biopharm, AUG 13, 2024, View Source [SID1234645833]).

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The gross proceeds to the Company from the offering are expected to be $2.0 million.

The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital. A final prospectus supplement containing additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the offering, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.