On May 14, 2024 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported first quarter financial results and provided a business update (Press release, Cyclacel, MAY 14, 2024, View Source [SID1234643215]).

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"We are excited to report that we have begun enrolling patients in the Phase 2, proof of concept (PoC) stage of our 065-101 study of fadraciclib, our oral CDK2/9 inhibitor, and are on track to deliver key readouts this year," said Spiro Rombotis, President and Chief Executive Officer. "Receipt of $8.0 million gross proceeds in a private placement together with existing resources support our ongoing clinical program. Pharmacokinetic, pharmacodynamic, safety and anticancer activity data from the Phase 1, dose escalation stage of 065-101 in patients with advanced solid tumors and lymphoma will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Data to date suggest that fadraciclib is differentiated from other next generation CDK inhibitors."

"Having determined the recommended Phase 2 dose for fadraciclib we are now enrolling patients in the Phase 2 PoC stage of 065-101" said Brian Schwartz, M.D., interim Chief Medical Officer. "We are initially concentrating on the biomarker cohort which is enrolling patients prospectively selected for CDKN2A/CDKN2B alterations to be followed by patients with T-cell lymphoma. There are no approved medicines for patients with CDKN2A/CDKN2B alterations. Including currently opened trial sites, we expect a total of up to seven sites will participate with the majority in the United States. We are encouraged about fadra’s prospects and look forward to presenting emerging data from the 065-101 study later in the year."

Key Upcoming Milestones for 2024

· Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting
· Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma

Financial Highlights

As of March 31, 2024, pro forma cash and cash equivalents totalled $9.9 million, including proceeds from this month’s private placement and $0.8 million received for the United Kingdom research & development tax credit. Cash and cash equivalents as of March 31, 2024, totalled $2.8 million, compared to $3.4 million as of December 31, 2023.

Net cash used in operating activities was $0.5 million for the three months ended March 31, 2024, which includes $2.9 million received in March in respect of the United Kingdom research & development tax credit, compared to $6.9 million for the same period of 2023. The Company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024.

Research and development (R&D) expenses were $2.8 million for the three months ended March 31, 2024, as compared to $5.7 million for the same period in 2023. R&D expenses relating to fadraciclib were $1.8 million for the three months ended March 31, 2024, as compared to $4.1 million for the same period in 2023 due to a decrease in clinical trial and other non-clinical expenditures. R&D expenses related to plogosertib were $1.0 million for the three months ended March 31, 2024, as compared to $1.4 million for the same period in 2023 due to a decrease in manufacturing and other non-clinical expenditures.

General and administrative expenses remained relatively flat at approximately $1.6 million for each of the three months ended March 31, 2024 and 2023.

Total other expenses, net, for the three months and year ended March 31, 2024, were $0.1 million, compared to $0.2 million for the same period of the previous year.

United Kingdom research & development tax credits for the three months March 31, 2024, were $1.4 million, which includes $0.8 million related to the 2023 claim which was received in May 2024, compared to $1.3 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months March 31, 2024, was $2.9 million (including stock-based compensation expense of $0.2 million), compared to $5.8 million (including stock-based compensation expense of $0.4 million) for the same period in 2023.

Conference call information:

Call: (888) 632-3384 / international call: (785) 424-1794

Archive: (800) 938-1584 / international archive: (402) 220-1542

Code for live and archived conference call is CYCCQ124. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 14, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported updated data from the ongoing TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) AML to be presented at the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences (Press release, Curis, MAY 14, 2024, View Source [SID1234643214]).

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This update includes data for 25 new patients in the FLT3 mutation (FLT3m) and U2AF1/SF3B1 Splicing Factor mutation (SFm) cohorts who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID.

Prior

Data

New
Data*

Total

FLT3m AML

3

9

12

SFm AML

3

17

20

adjustment for patients with dual mutation**

(1)

(1)

(2)

5

25

30

* data cut-off as of February 26, 2024
** 2 patients had both FLT3m and SFm (dual mutation)
1 patient in the initial group of 5 patients; 1 patient in the new group of 25 additional patients

FLT3m Cohort – 12 relapsed/refractory patients enrolled to date

12 R/R AML patients with FLT3m were treated with emavusertib. Prior therapies included venetoclax (8/12), hypomethylating agents or HMA (9/12), and FLT3 inhibitors (9/12). Preliminary data show 6 objective responses in 11 response-evaluable patients: 3 complete remission (CR), 1 CR with partial hematologic recovery (CRh) and 2 morphologic leukemia-free state (MLFS) with on-treatment duration range of 46-324 days. 4 patients are ongoing at the data-cutoff, including 1 CRh and 1 MLFS.

3 of 3 patients who were naïve to FLT3i treatment achieved objective response (2 CR, 1 MLFS)
3 of 8 patients who progressed on, or following, prior FLT3i treatment achieved objective response (1 CR, 1 CRh, 1 MLFS)
1 patient is not response-evaluable
All responders demonstrated complete normalization of blast counts in the bone marrow. One of these patients proceeded to allogenic stem cell transplantation. Responses were achieved rapidly in this population, with 5 of 6 responses occurring within one cycle of treatment.

SFm Cohort – 20 relapsed/refractory patients enrolled to date

20 R/R AML patients with SFm were treated with emavusertib. Prior therapies included venetoclax (18/20) and HMA (17/20). Preliminary data show 4 of 18 response-evaluable patients in this population have achieved objective response (CR/CRh/MLFS). 8 of 20 patients are ongoing at the data-cutoff, including 1 MLFS and 3 non-responding patients who have shown increased neutrophil counts.

All 4 responders (1 CR, 2 CRh, 1 MLFS) had received prior treatment with an HMA; 3 of whom had also received prior treatment with venetoclax
3 additional non-responding patients are ongoing and have shown increased neutrophil counts
2 patients are not response-evaluable
All responders demonstrated complete normalization of blast counts in the bone marrow. One of these patients proceeded to allogenic stem cell transplantation. "In addition to the responders, we see increased neutrophil counts in several additional ongoing patients. Since a leading cause of death in patients with AML is infection (related to low neutrophil counts), an increase in neutrophils represents a meaningful clinical improvement for these patients," said Dr. Robert Martell, MD, PhD, Chief Scientific Officer of Curis.

"We are encouraged by emavusertib’s continued demonstration of clear single-agent activity supporting its potential in both monotherapy and combination therapy in AML," said James Dentzer, President and CEO of Curis.

On May 14, 2024 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported business and financial results for the fiscal second quarter 2024 ended March 31, 2024 (Press release, Citius Pharmaceuticals, MAY 14, 2024, View Source [SID1234643213]).

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Second Quarter 2024 Business Highlights and Subsequent Developments

- LYMPHIR (denileukin diftitox) biologics license application (BLA) accepted by the U.S. Food and Drug Administration (FDA) with August 13, 2024, assigned as Prescription Drug User Fee Act (PDUFA) target action date;

- Data analysis underway for completed Mino-Lok Pivotal Phase 3 trial with topline results anticipated in calendar 2Q 2024;

- Continued engagement with FDA following end of Phase 2b meeting to determine next phase in the development of Halo-Lido for the treatment of hemorrhoids;

- Merger of our wholly owned subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form publicly listed Citius Oncology, Inc. is progressing and pending review by Securities and Exchange Commission (SEC) and TENK shareholder approval;

- Robert Smith elected to the Citius Board of Directors at the Annual Meeting of Stockholders; and,

- Completed $15 million registered direct offering in April 2024 extending the Company’s cash runway.

Financial Highlights

- Cash and cash equivalents of $12.6 million as of March 31, 2024;

- $15 million in gross proceeds from a registered direct offering on April 30, 2024, extends the Company’s cash runway through December 2024;

- R&D expenses were $3.6 million and $6.2 million for the three and six months ended March 31, 2024, respectively, compared to $4.7 million and $8.2 million for the three and six months ended March 31, 2023, respectively;

- G&A expenses were $4.3 million and $7.9 million for the three and six months ended March 31, 2024, respectively, compared to $4.8 million and $7.4 million for the three and six months ended March 31, 2023, respectively;

- Stock-based compensation expense was $3.1 million and $6.1 million for the three and six months ended March 31, 2024, respectively, compared to $1.2 million and $2.4 million for the three and six months ended March 31, 2023, respectively; and,

- Net loss was $8.5 million and $17.8 million, or ($0.05) and ($0.11) per share for the three and six months ended March 31, 2024, respectively, compared to a net loss of $10.5 million and $14.1 million, or ($0.07) and ($0.10) per share for the three and six months ended March 31, 2023, respectively.

"I am pleased to share that we made solid progress this quarter as we focused on execution and managing our finances. The data analysis of our late-stage asset, Mino-Lok, the only treatment of its kind in development to salvage infected catheters, remains on track. We look forward to reporting the topline results later this quarter. Once we review the results, we plan to engage with the FDA to determine the optimal next steps in the program and look forward to advancing this much-needed alternative to the current standard of care, which often involves painful and costly catheter removal and replacement," stated Leonard Mazur, Chairman and CEO of Citius.

"Importantly, the BLA submission for LYMPHIR, our novel IL-2 receptor targeted oncology therapy, was accepted by the FDA, and assigned a late summer 2024 PDUFA target action date. In anticipation of potential approval, we continue to align the organization for a successful launch," added Mazur.

"Despite a tough capital market environment for pre-revenue companies, we successfully completed a $15 million registered direct offering, expanding our cash runway and providing capital to support the execution of our strategic plan. We believe that the merger of our oncology subsidiary with TenX to form a publicly listed company will make our company more attractive to investors and increase the value of our assets. This transaction is progressing, and we expect it to be completed in the coming months as we finalize SEC review and await approval by TENK shareholders. As we continue to meet our goals, we believe additional opportunities to strengthen our capital structure will become available," concluded Mazur.

SECOND QUARTER 2024 FINANCIAL RESULTS:

Liquidity

As of March 31, 2024, the Company had $12.6 million in cash and cash equivalents.

As of March 31, 2024, the Company had 159,094,781 common shares outstanding.

Based on our cash and cash equivalents as of March 31, 2024, and after giving effect to a capital raising that closed on April 30, 2024, we expect to have sufficient funds to continue our operations through December 2024. We expect to raise additional capital in the future to support our operations beyond December 2024.

Research and Development (R&D) Expenses

R&D expenses were $3.6 million for the quarter ended March 31, 2024, compared to $4.7 million for the quarter ended March 31, 2023. For the six months ended March 31, 2024, R&D expenses were $6.2 million as compared to $8.2 million during the six months ended March 31, 2023, a decrease of $1.9 million. The decrease primarily reflects incremental costs related to the completion of the Mino-Lok Phase 3 trial and remediation activities for the LYMPHIR BLA resubmission, offset by lower costs in the current period due to the completion of the Halo-Lido Phase 2b trial.

We expect that research and development expenses will stabilize at current levels in fiscal 2024 as we focus on the commercialization of LYMPHIR, complete our Phase 3 trial for Mino-Lok, and analyze the data from our Phase 2b trial and begin planning our Phase 3 trial for Halo-Lido

General and Administrative (G&A) Expenses

G&A expenses were $4.3 million for the quarter ended March 31, 2024, compared to $4.8 million for the quarter ended March 31, 2023. The decrease was primarily due to lower costs for pre-launch and market research activities associated with LYMPHIR during the period.

For the six months ended March 31, 2024, G&A expenses were $7.9 million as compared to $7.4 million during the six months ended March 31, 2023. The primary reason for the increase was higher costs for pre-launch and market research activities associated with LYMPHIR.

General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the quarter ended March 31, 2024, stock-based compensation expense was $3.1 million as compared to $1.2 million for the quarter ended March 31, 2023. For the six months ended March 31, 2024, stock-based compensation expense was $6.1 million as compared to $2.4 million for the six months ended March 31, 2023. The increase is primarily due to the Citius Oncology stock plan.

Net loss

Net loss was $8.5 million, or ($0.05) per share for the quarter ended March 31, 2024, compared to a net loss of $10.5 million, or ($0.07) per share for the quarter ended March 31, 2023. The $2 million decrease in the net loss was due to decreases of $1.1 million in research and development expenses and $0.5 million in general and administrative expenses, and the increase in other income of $2.3 million, being partially offset by the increase in stock-based compensation expense of $1.9 million.

Net loss was $17.8 million, or ($0.11) per share for the six months ended March 31, 2024, compared to a net loss of $14.1 million, or ($0.10) per share for the six months ended March 31, 2023. The increase in the net loss was primarily due to the increase in stock-based compensation expense.

On May 14, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported financial results for the quarter ended March 31, 2024, and provided a corporate update (Press release, Cellectar Biosciences, MAY 14, 2024, View Source [SID1234643212]).

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"We plan to announce data from our CLOVER WaM pivotal study evaluating iopofosine I 131 in Waldenstrom’s macroglobulinemia in June and are on track to submit our NDA in the second half of 2024. We remain pleased with patient enrollment in the phase 1b pediatric high-grade glioma study and expect to announce data in the second half of 2024," said James Caruso, president, and CEO of Cellectar. "Either alone or in collaboration, we continue to assess the versatility of our delivery platform with a wide range of cancer targeting compounds including peptides, oligos and our alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225, which is planned to enter a phase 1 study in either triple negative breast or pancreatic cancer no later than first quarter 2025."

First Quarter and Recent Corporate Highlights

· Announced positive topline data achieving its primary endpoint in its CLOVER WaM pivotal study, evaluating iopofosine I 131, a potentially first-in-class, targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients with a median of four prior lines of therapy. The CLOVER WaM study met its primary endpoint with a major response rate of 61%. The overall response rate was 75.6%. The Company plans to announce data for all evaluable patients in June 2024.

· Reported a complete remission rate of 64% and overall response rate of 73% in highly refractory patients in an investigator-initiated Phase I study of iopofosine in combination with External Beam Radiotherapy in recurrent head and neck cancer. In addition to the high rate of complete remission, durability of clinical activity achieved a 67% overall survival and 42% progression free survival at one year.

· Reported the complete central nervous system clearance in a relapsed/refractory Waldenstrom’s macroglobulinemia patient, providing further validation for iopofosine I 131 to treat solid and hematologic tumors, including those located across the blood-brain barrier.

· Enrolled the first patient in the company’s Phase 1b clinical study of iopofosine I 131 in pediatric high-grade gliomas (pHGG). The study is supported by a $2 million Fast Track SBIR grant from the National Institute of Health’s National Cancer Institute (NCI), which was awarded based in part on the promising Phase 1a trial data.

· Announced promising preclinical data for its proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225 (225Ac-CLR 121225) an actinium-labeled phospholipid ether (PLE), in pancreatic cancer models. The development of this compound expands the company’s clinical pipeline of PLE cancer targeting compounds to include targeted alpha therapies (TATs).

· Announced strategic partnerships with leading community-based oncology networks Florida Cancer Specialists and American Oncology Network (AON) to advance the treatment of WM in the community setting.

First Quarter 2024 Financial Highlights

· Cash and Cash Equivalents: As of March 31, 2024, the company had cash and cash equivalents of $40.0 million, compared to $9.6 million as of December 31, 2023. Net cash used in operating activities during the three months ended March 31, 2024, was approximately $13 million. The company believes its cash balance as of March 31, 2024, is adequate to fund its basic budgeted operations into the fourth quarter of 2024.

· Research and Development Expense: R&D expense for the three months ended March 31, 2024, was approximately $7.4 million, compared to approximately $6.7 million for the three months ended March 31, 2023. The overall increase in R&D expense was primarily a result of increased manufacturing and related costs related to the development of supply chain and production sourcing enhancements, partially offset by a decrease in general research and development costs.

· General and Administrative Expense: G&A expense for the three months ended March 31, 2024, was $4.6 million, compared to $2.1 million for the same period in 2023. The increase in G&A costs was primarily driven by costs associated with the development of infrastructure necessary to support commercialization upon anticipated NDA approval, including the related marketing and personnel costs.

· Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2024, was ($21.6) million, or $(0.74) per share, compared to $(8.6) million, or ($0.76) per share in the three months ended March 31, 2023.

Conference Call & Webcast Details

Cellectar management will host a conference call for investors today, May 14, 2024, beginning at 8:30 am Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. The call will be available via webcast by clicking HERE or on the Events page of the company’s website after the conclusion of the call.

On May 14, 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 first quarter ended March 31, 2024, and provided a corporate update (Press release, Candel Therapeutics, MAY 14, 2024, View Source [SID1234643211]).

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"It was a catalyst-rich first quarter for Candel, marked by significant advances across both our clinical and preclinical programs," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Notably, as our clinical data mature with long-term follow up, we are beginning to observe highly differentiated results in long-term survival of patients treated with our viral immunotherapies. An example of these clinical results was recently shared in an update of the phase 2 randomized clinical trial of CAN-2409 in patients with borderline resectable pancreatic cancer, where a notable improvement in overall survival, in patients treated with CAN-2409 plus standard of care chemoradiation, was demonstrated compared to chemoradiation alone. The FDA granted CAN-2409 both Fast Track Designation and Orphan Drug Designation for treatment of patients with pancreatic ductal adenocarcinoma to improve median overall survival and treatment of pancreatic cancer, respectively, providing steady momentum to advance this promising investigational treatment for patients with significant unmet medical need."

Dr. Tak continued, "We are also excited to announce that topline overall survival data from our phase 2 clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer and an inadequate response to immune checkpoint inhibitors will be presented at the upcoming ASCO (Free ASCO Whitepaper) meeting in Chicago on Monday, June 3, 2024."

"In addition to our advances in the clinic, we have made great progress with our enLIGHTENTM Discovery Platform. In April 2024, we presented our second drug candidate from this platform, a first-in-class multimodal immunotherapy candidate for induction of tertiary lymphoid structures, in a late-breaking presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. We believe this preclinical candidate offers groundbreaking potential in the treatment of cancer," continued Dr. Tak. "We expect to release additional preclinical and clinical data in the coming year, consistent with our commitment to innovation and patient care."

First Quarter 2024 & Recent Highlights

•
Program Updates

o
CAN-2409 – Pancreatic Cancer

▪
In early April, announced positive updated survival data, from the ongoing randomized phase 2 clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for 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 versus 16.7% in the control group after chemoradiation. At 36 months, estimated survival was 47.6% in the CAN-2409 group 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.

•
Previous analysis of resected tumors showed dense aggregates of immune cells, including CD8+, cytotoxic tumor infiltrating lymphocytes and dendritic cells, in PDAC tissue after CAN-2409 administration, confirming activation of a robust antitumoral immune response.

▪
Received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CAN-2409 for the treatment of pancreatic cancer.

o
CAN-2409 – Non-small cell lung cancer (NSCLC)

▪
Announced a poster titled "Overall survival after treatment with CAN- 2409 plus valacyclovir in combination with continued ICI in patients with stage III/IV NSCLC with inadequate response to ICI" was accepted for the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and will be presented by Charu Aggarwal, MD, MPH, Associate Professor for Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania, on June 3, 2024 in Chicago, IL.

o
CAN-3110 – Recurrent High-Grade Glioma (rHGG)

▪
Received Fast Track Designation from the FDA for CAN-3110 for the treatment of patients with rHGG to improve OS.

▪
Announced during the 5th Glioblastoma Drug Development Summit in Boston that six patients have been treated with multiple injections (up to six injections) of CAN-3110 in cohort C of the ongoing phase 1b clinical trial, reporting a favorable safety and tolerability profile.

▪
Announced a Trial-in-Progress poster, titled "Longitudinal stereotactic injections of oncolytic immunoactivating rQNestin34.5v.2 (CAN-3110) with concomitant biopsies for "-omic" analyses in recurrent glioblastoma (GBM)" was accepted for the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and will be presented by David A. Reardon, MD, Professor of Medicine at Harvard Medical School and Clinical Director, Center for Neuro-Oncology at Dana Farber Cancer Institute, on June 1, 2024, in Chicago, IL.

o
enLIGHTEN Discovery Platform

▪
Presented preclinical data at the 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.

Anticipated Milestones

•
Phase 2 topline OS data for CAN-2409 in NSCLC to be presented at ASCO (Free ASCO Whitepaper) on June 3, 2024
•
Updated Phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024
•
Phase 2 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 First Quarter Ended March 31, 2024

Research and Development Expenses: Research and development expenses were $4.1 million for the first quarter of 2024 compared to $5.5 million for the first quarter of 2023. The decrease was primarily due to lower employee-related expenses following the corporate restructuring in the fourth quarter of 2023 and lower clinical development costs driven by a reduction in regulatory costs for CAN-2409 programs. Research and development expenses included non-cash stock compensation expense of $0.6 million for the first quarter of 2024 compared to $0.3 million for the first quarter of 2023.

General and Administrative Expenses: General and administrative expenses were $3.8 million for the first quarter of 2024 compared to $4.2 million for the first quarter of 2023. The decrease was primarily due to lower employee-related expenses following the corporate restructuring in the fourth quarter of 2023 and lower insurance costs. These decreases were partially offset by increased professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.5 million for the first quarter of 2024 compared to $0.4 million for the first quarter of 2023.

Net Loss: Net loss for the first quarter of 2024 was $8.2 million, compared to a net loss of $8.8 million for the first quarter of 2023, and included other expense, net of $0.3 million and other income, net $0.8 million, respectively. The change from other income, net in the first quarter of 2023 to other expense, net in the first quarter of 2024 was primarily due to the change in the fair value of the Company’s warrant liability and lower interest income.

Cash Position: Cash and cash equivalents, as of March 31, 2024, were $25.7 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 fourth quarter of 2024.