On August 14, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported second quarter 2024 financial results and provided a corporate update (Press release, Alpha Tau Medical, AUG 14, 2024, View Source [SID1234645902]).

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"While we continue to advance our ReSTART U.S. multicenter pivotal trial in recurrent cutaneous squamous cell carcinoma, the overwhelming interest from clinicians and the broader community in our ongoing internal organ trials has been fantastic," stated Alpha Tau CEO Uzi Sofer. "We are fortunate to see such strong clinician demand for participation in clinical trials, at a time when we expect meaningful data generation, in particular with continued progress in our clinical trials in pancreatic cancer outside the U.S. as well as regulatory progress on similar trials in the U.S. We also continue to prepare for potential future product launches by advancing our commercial planning activities and solidifying our supply chain, as we have secured approvals for our new manufacturing plant in Hudson, New Hampshire and commenced renovation of the facility for our needs. Alpha Tau expects to remain adequately capitalized to support all of these programs over the coming years," he concluded.

Recent Corporate Highlights:

● In June, Alpha Tau announced the publication of "Extended Follow-Up Outcomes from Pooled Prospective Studies Evaluating Efficacy of Interstitial Alpha Radionuclide Treatment for Skin and Head and Neck Cancers" in the journal Cancers. The pooled analysis included data from 4 international clinical trials spanning an array of hard-to-treat indications including skin, head & neck, and oral cavity. Initial response data demonstrated an overall response rate of almost 100% in treated lesions and a complete response rate of 89%. With follow-up as long as 51 months (median follow-up of 14 months), no moderate or severe long-term toxicities were noted, and 2-year local recurrence-free survival was estimated at 77%. For more information, please refer to View Source

● In May, the first patient with liver cancer metastases was treated in a feasibility and safety study of Alpha DaRT at McGill University Health Center in Montreal, Canada. The trial aims to recruit up to 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. For more information, please refer to View Source

Upcoming Milestones

● Planning treatment of the first patient in the Israeli recurrent lung cancer safety and feasibility trial in H2 2024. The trial is currently open for recruitment; for more information please see here: View Source

● Targeting first brain cancer treatment in H2 2024.

● Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma by around year-end 2024. For more information please see here: View Source

● Anticipating response from PMDA in Japan by year-end 2024 for pre-market approval for Alpha DaRT in patients with recurrent head and neck cancer.

● Targeting announcement of safety, feasibility and efficacy data from advanced inoperable pancreatic cancer studies in Montreal and in Jerusalem by the end of Q1 2025. For more information please see here: View Source and View Source

Financial results for quarter ended June 30, 2024

R&D expenses for the six months ended June 30, 2024 were $13.3 million, compared to $12.3 million for the same period in 2023, due to increased employee compensation and benefits, increased employee compensation and benefits, including share-based compensation, increased costs of raw materials, and increased travel expenses related to our U.S. multi-center pivotal trial, offset by lower third-party contractor expenses.

Marketing expenses for the six months ended June 30, 2024 were $1.1 million, compared to $0.9 million for the same period in 2023, due to increased employee compensation and benefits and increased marketing expenses.

G&A expenses for the six months ended June 30, 2024 were $3.0 million, compared to $3.6 million for the same period in 2023, primarily due to decreased professional fees (including D&O insurance and legal expenses), offset by increased travel expenses and increased employee compensation and benefits, including share-based compensation.

Financial income, net, for the six months ended June 30, 2024 was $2.1 million, compared to $0.02 million financial expense, net, for the same period in 2023, due to a decrease in revaluation of warrants, an increase in interest from bank deposits, and changes in foreign exchange rates, offset by interest on long-term loan.

For the six months ended June 30, 2024, the Company had a net loss of $15.4 million, or $0.22 per share, compared to a net loss of $16.9 million, or $0.24 per share, in the first half of 2023.

Balance Sheet Highlights

As of June 30, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $74.1 million, compared to $84.9 million at December 31, 2023. The Company expects that this cash balance will be sufficient to fund anticipated operations for at least two years.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On August 14, 2024 Aileron Therapeutics, Inc. ("Aileron" or the "Company") (NASDAQ: ALRN), a biopharmaceutical company advancing a pipeline of potential first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, reported financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, Aileron Therapeutics, AUG 14, 2024, View Source [SID1234645901]).

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"Throughout the first half of the year, we focused on strengthening our balance sheet and advancing the development of inhaled LTI-03 in IPF," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "We are extremely pleased with the positive data from Cohort 1 of the ongoing Phase 1b clinical trial announced in May, particularly the achievement of statistical significance in three out of eight biomarkers which is a testament to the potential of LTI-03 to inhibit fibrosis and improve lung function. Additionally, in May, we raised approximately $18.2 million in net proceeds in an underwritten registered direct offering, which provides us with the resources to further validate LTI-03 in the ongoing Phase 1b trial. We look forward to reporting topline results from the high-dose cohort in the third quarter of this year."

Second Quarter 2024 Highlights and Recent Updates

Corporate Updates

In May 2024, the Company completed an underwritten registered direct offering of 4,273,505 shares of its common stock and accompanying warrants to purchase an aggregate of 4,273,505 shares of its common stock. Net proceeds from the offering were approximately $18.2 million, after deducting underwriting discounts and commissions and other offering expenses. The Company has the potential to receive approximately $20.0 million in additional proceeds from the exercise of the warrants issued in the offering.
Pipeline

Announced positive Cohort 1 data from the ongoing Phase 1b clinical trial evaluating the safety and tolerability of inhaled LTI-03 in patients diagnosed with IPF.

Following inhaled administration of low dose LTI-03 (2.5 mg BID, or twice daily) in twelve patients, a positive trend was observed in seven out of eight biomarkers. The findings included:
Evidence of LTI-03 reducing expression of multiple profibrotic proteins produced in both basal-like cells and fibroblasts that contribute to the progression of IPF, with statistically significant decreases in three biomarkers, reinforcing the potential of LTI-03 to inhibit fibrosis, inflammation and associated changes in the lungs.
LTI-03 stimulated production of solRAGE, a factor indicative of type I epithelial cell health, a critically important aspect of IPF that has gone largely unaddressed.
LTI-03 was generally well-tolerated with no serious adverse events ("SAEs") reported.
The Phase 1b trial is ongoing, with topline results from the high-dose Cohort 2 expected in the third quarter of 2024.

On May 1, 2024, the Company hosted a pulmonary care expert call to discuss the Cohort 1 Phase 1b results of LTI-03, featuring pulmonary care expert Andreas Günther, M.D., Head of the Center for Interstitial and Rare Lung Diseases at the Justus Liebig University in Giessen, Germany. A replay of the event can be accessed at View Source

LTI-01 is in development for loculated pleural effusion ("LPE"), a serious consequence of pneumonia with significant unmet medical need.
Second Quarter 2024 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2024, were $21.9 million, compared to $12.0 million as of March 31, 2024. After including the net proceeds raised from the May 2024 offering and based on its current operating plan, the Company expects its existing cash and cash equivalents to be sufficient to fund the completion of the Phase 1b clinical trial and its operations into the second half of 2025.

Research and Development ("R&D") Expenses: R&D expenses for the quarter ended June 30, 2024, were $3.7 million, compared to $0.2 million for the quarter ended June 30, 2023. The increase of $3.5 million was primarily a result of the clinical programs acquired as part of the Company’s acquisition of Lung Therapeutics, Inc. in October 2023 (the "Lung Acquisition"). During the quarter ended June 30, 2024, Aileron incurred expenses of $1.1 million on clinical trials, $2.0 million on manufacturing, and $0.1 million on regulatory and development consulting as well as $0.5 million on employee and related expenses associated with clinical programs acquired in the Lung Acquisition.

General and Administrative ("G&A") Expenses: G&A expenses for the quarter ended June 30, 2024, were $5.3 million, compared to $1.9 million for the quarter ended June 30, 2023. The increase of $3.4 million was primarily due to increased professional fees of $1.0 million and increased employee and related expenses of $1.8 million as a result of increased business activity and headcount associated with the Lung Acquisition, and increased facilities and other expenses of $0.5 million during the quarter ended June 30, 2024 as compared to the quarter ended June 30, 2023.

Net Loss: Net loss for the quarter ended June 30, 2024, was $8.9 million, compared to $1.8 million for the quarter ended June 30, 2023. The basic and diluted net loss per share for the quarter ended June 30, 2024 was $0.45 compared to $0.39 for the quarter ended June 30, 2023.

On August 14, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported positive clinical study updates for its Acclaim-1 and Acclaim-3 clinical trials for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), respectively, and plans to re-focus its oncology clinical development program (Press release, Genprex, AUG 14, 2024, View Source [SID1234645896]).

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Patients in the Company’s lung cancer clinical trials are being treated with the Company’s lead drug candidate, Reqorsa (quaratusugene ozeplasmid) Gene Therapy. Two patients in the Acclaim-1 study have had prolonged Progression Free Survival (PFS) and importantly, the first treated patient in the Acclaim-3 study attained a Partial Remission (PR) from the start of maintenance therapy.

Ryan Confer, President and Chief Executive Officer of Genprex, commented on the update:

"We are excited by these early and promising patient responses to REQORSA treatment, particularly as these patients represent some of the most difficult to treat lung cancer patient populations. There is significant unmet medical need for patients afflicted with lung cancer, as nearly all patients’ disease progresses following treatment, even when treated with today’s most advanced targeted therapies and immunotherapies. This leaves patients with limited therapeutic options. We are thrilled our novel gene therapy treatment for lung cancer, REQORSA, is demonstrating early evidence of efficacy with a favorable safety profile. We look forward to continuing to evaluate REQORSA in our lung cancer clinical trials while we advance our efforts to bring new therapies to those battling cancer."

Acclaim-1

The Acclaim-1 clinical trial is evaluating the combination of REQORSA and AstraZeneca’s Tagrisso to treat patients with late-stage NSCLC who have activating EGFR mutations and disease progression after treatment with Tagrisso. The Acclaim-1 clinical trial has received an U.S. Food and Drug Administration (FDA) Fast Track Designation for late-stage NSCLC patients whose disease progressed after treatment with Tagrisso.

Two patients from the Phase 1 dose escalation portion of the study have had prolonged PFS and are still continuing to receive treatment on the study. One of them has received the treatment combination of REQORSA and Tagrisso for more than two years. This patient, who was previously treated with Tagrisso and chemotherapy and who continues to receive REQORSA and Tagrisso treatment, attained a PR after the second course of REQORSA and Tagrisso, and has maintained this response for more than two years. The second patient has had stable disease without disease progression for more than 15 months, and is also continuing to receive REQORSA and Tagrisso treatment.

Mark Berger, MD, Chief Medical Officer of Genprex, discussed the positive outcomes:

"We are very pleased with the positive early efficacy results for these patients. It is very compelling that one of the patients in our Acclaim-1 clinical trial has continued to see benefit from REQORSA treatment for more than two years and it’s been documented that the side effects of REQORSA have diminished, rather than increased, over time."

The Phase 2a expansion portion of the study was designed to have two cohorts with 33 patients each. One cohort was for patients who have previously received only Tagrisso treatment, and one cohort was for patients who had previously received both Tagrisso treatment and chemotherapy. Based on resource prioritization and to focus on the patients for whom REQORSA is most likely to show a benefit, the Company has decided to limit its enrollment efforts moving forward to patients who received only prior Tagrisso treatment and to cease enrollment of the second cohort (patients who received prior Tagrisso treatment and chemotherapy). The Phase 2a expansion portion of the trial with one cohort is now expected to enroll approximately 33 patients. The Phase 2b randomized portion of the study, in which patients progressing on prior Tagrisso treatment will be randomized 1:1 to either REQORSA and Tagrisso combination therapy or to platinum-based chemotherapy, will remain unchanged.

Genprex will conduct an interim analysis following the treatment of 19 patients in the Phase 2a expansion portion who had previously received only Tagrisso treatment. The Company expects to complete the enrollment of the first 19 patients in the Phase 2a expansion portion of the study and conduct an interim analysis in the first half of 2025.

Acclaim-3

The Acclaim-3 clinical trial is evaluating the combination of REQORSA and Genentech’s Tecentriq as a maintenance therapy to treat patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The FDA has granted Fast Track Designationfor the Acclaim-3 population of patients and has also granted Orphan Drug Designation for the treatment of SCLC.

In this study, patients receive maintenance therapy with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Following completion of the Phase 1 dose escalation portion of the study, which the Company expects to complete during the second half of 2024, Genprex then expects to start the Phase 2 expansion portion of the study in the second half of 2024.

The first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 clinical trial experienced an initial positive response after enrollment and dosing commenced in May. The patient had a PR, which is defined as at least a thirty percent (30%) decrease in tumor size, from the time the patient had a baseline CT scan after induction therapy and prior to the start of maintenance therapy, to the time of the CT scan performed after two cycles of maintenance therapy. As the maintenance therapy consists of REQORSA and Tecentriq, and the patient had already received four cycles of Tecentriq during induction therapy and thus responses to Tecentriq would likely have occurred earlier, which suggests that REQORSA may be providing clinical benefit. A recent CT scan, performed after four cycles of maintenance therapy (three months), confirms that the patient had a 30% decrease in tumor size in measurable lesions; however one lesion not previously measurable had grown in size, thus leading to a conclusion of disease progression at three months.

Dr. Berger commented on these compelling results:

"This patient’s response was not expected during maintenance therapy with Tecentriq alone, and we believe these results are promising and a positive early indication for the study. Once ES-SCLC patients begin maintenance therapy with Tecentriq, median PFS is very short; only 2.6 months, and further tumor regression rarely occurs. The ES-SCLC patient in the Acclaim-3 clinical trial treated with our combination therapy experienced PR, but asymptomatic disease progression was diagnosed by CT scan three months after the start of maintenance therapy. We find this positive result to be promising, particularly because this patient was treated with the lower of two doses planned for the Phase 1 portion of this clinical trial, and we are hopeful that the combination of REQORSA and Tecentriq will improve outcomes and help extend the lives of these very difficult to treat lung cancer patients."

Genprex’s novel cancer treatment platform re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. The key component of REQORSA is a plasmid that expresses TUSC2, a tumor suppressor gene protein which plays a vital role in cancer suppression and normal cell metabolism. Nearly 100% of SCLCs have reduced or no TUSC2 protein expression, and 41% completely lack TUSC2 protein expression, thus restoring TUSC2 expression in SCLC has a strong biologic rationale. Nonclinical studies in mice support the hypothesis that re-expressing the TUSC2 protein in combination with Tecentriq may lead to improved clinical efficacy in SCLC.

Oncology Program Update

Mr. Confer and the executive team have evaluated resource allocations to ensure streamlined, focused strategies to support expeditious regulatory submissions for REQORSA and will implement the following changes to the Company’s oncology clinical development plans in order to prioritize resources and focus on the most promising aspects of the Acclaim-1 and Acclaim-3 lung cancer clinical trials.

The Acclaim-2 clinical trial, a Phase 1/2 trial evaluating the combination of REQORSA and Merck & Co’s Keytruda in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda, will cease enrollment of new NSCLC patients. Current patients in the Phase 1 dose escalation portion of the study will continue to be treated until disease progression. The Company made this decision based on a number of factors, including enrollment challenges and delays due to competition for eligible patients with numerous other trials involving the same patient population.
As described above, the Company will limit its enrollment efforts for the Phase 2a expansion portion of the Acclaim-1 study moving forward to patients who received only prior Tagrisso treatment and cease enrollment of the second cohort (patients who received prior Tagrisso treatment and chemotherapy). The Phase 2a expansion portion of the trial with one cohort is now expected to enroll approximately 33 patients. The Company continues to evaluate ways to optimize its clinical and research programs and operational strategies, as part of its ongoing prioritization initiative.
Commenting on the decision, Mr. Confer stated:

"The decision to discontinue the Acclaim-2 clinical trial is driven in part by the fact that there are hundreds of Keytruda combination lung cancer clinical trials, which made it difficult to recruit patients and investigators due to the volume of competing trials. We thank the clinicians and patients who participated in this study and look forward to potentially reviewing this patient population again at a future time, as we fully stand behind REQORSA’s potential to treat late-stage NSCLC patients whose disease progressed after treatment with Keytruda."

Additionally, Genprex reports that the Company is collaborating with an academic research partner to discover, develop and utilize biomarkers to:

select the patient population most likely to respond to REQORSA;
predict and measure target engagement; and
enable decisions on progression of the Company’s drug candidates to the next phase of development.
The Company’s academic research partner is currently analyzing biomarkers that would indicate lack of response in lung cancer that could enrich the Company’s population of responders in its clinical trials and enhance patient screening and enrollment in order to increase the likelihood of potential success of the Acclaim studies.

On August 14, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported financial results for the second quarter ended June 30, 2024, and provided an overview of recent and upcoming business highlights (Press release, Plus Therapeutics, AUG 14, 2024, View Source [SID1234645895]).

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Q2 2024 RECENT HIGHLIGHTS AND MILESTONES

•
Presented positive ReSPECT-LM Phase 1 study data at the 2024 Society for NeuroOncology /American Society for Clinical Oncology (SNO/ASCO) CNS Metastases Conference. Rhenium (186Re) Obisbemeda was safe and well-tolerated in the first 4 dosing cohorts (n=16 patients). Current median overall survival is 12 months with 8 of 16 patients treated remaining alive. Additional detail can be found here
•
Reported topline FORESEE clinical trial results at SNO/ASCO. The trial demonstrated that CNSide, PLUS’ novel diagnostic platform met its primary clinical endpoint. The CNSide test was found to help clinical decision making in over 90% of provider decisions (n=50/55 clinical decisions) and helped to inform therapy selection in 24% of provider decisions (n=13/55 clinical decisions). Furthermore, the CNSide test improved tumor cell detection in LM patients compared to cytology (80% vs. 29%) in matched samples. Additional details can be found here
•
Reported that isotopic rhenium-186, the active radioisotope in Rhenium (186Re) Obisbemeda, substantially spared the spinal cord vs. other beta-emitting radionuclides at the 2024 Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting
•
Submitted a new clinical protocol to the U.S. Food and Drug Administration (FDA), under its active Investigational New Drug application (IND 153715) for a Phase 1 study to evaluate multiple administrations of Rhenium (186Re) Obisbemeda for the treatment of patients with LM
•
Received $3.3 million grant payment from Cancer Prevention & Research Institute of Texas (CPRIT) in June 2024 to support the clinical development of Rhenium (186Re) Obisbemeda for LM

"Plus’ lead investigational drug Rhenium (186Re) Obisbemeda continues to show safety and promising signs of efficacy after a single administration in patients with LM," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We are on track to complete the single administration ReSPECT-LM Phase 1 trial soon, expand to multiple doses, and move to Phase 2 funded by our existing CPRIT award."

UPCOMING EVENTS AND MILESTONES

•
Presentations planned for the following upcoming medical conferences:
o
Congress of Neurological Surgeons (CNS) Annual Conference (September 28-October 2, 2024)
▪
Treatment Of Recurrent Glioblastoma (rGBM) Via Convection Enhanced Delivery (CED) With Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 2 Trial Update

o
Society for Neuro-Oncology (SNO) Annual Conference (November 22-26, 2024)
▪
Rhenium (186Re) obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the phase 1 dose escalation study and phase 2 administered dose selection
▪
CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment helps in clinical management of breast cancer and Non-Small Cell Lung cancer patients having Leptomeningeal Disease
▪
The Oncogenetic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor
•
Complete ReSPECT-LM Phase 1 single administration trial and determine the recommended Phase 2 dose
•
Initiate ReSPECT-LM Phase 1 multiple administration trial
•
Obtain IND approval for a Phase 1/2 trial of Rhenium (186Re) Obisbemeda via convection enhanced delivery (CED) funded by the Department of Defense (DoD) office of the Congressionally Directed Medical Research Programs (CDMRP) for pediatric ependymoma and high-grade glioma

FIRST HALF 2024 FINANCIAL RESULTS

•
The Company’s cash and investments balance was $8.4 million at June 30, 2024 compared to $8.6 million at December 31, 2023
•
The Company recognized $3.0 million in grant revenue in the first half of 2024 compared to $2.4 million in the same period of 2023, which represents CPRIT’s share of the costs incurred for our Rhenium (186Re) Obisbemeda development for the treatment of patients with LM
•
Total operating loss for the first half of 2024 was $7.0 million compared to $6.2 million in the same period of 2023. The increase is primarily due to increased spend related to the ReSPECT-LM trial
•
Net loss for first half of 2024 was $6.2 million, or $(1.15) per basic share, compared to a net loss of $6.3 million, or $(2.60) per basic share, for the same period the prior year

SECOND QUARTER 2024 RESULTS CONFERENCE CALL

The Company will hold a conference call and live audio webcast at 5:00 pm Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.

On August 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 second quarter financial results and provided a business update (Press release, Cyclacel, AUG 14, 2024, View Source [SID1234645894]).

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"Following oral fadraciclib data presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the Phase 2 stage of our 065-101 study is enrolling well," said Spiro Rombotis, President and Chief Executive Officer. "We are on track to report in the fourth quarter of 2024 initial data from the precision medicine cohort of 065-101 with our CDK2/9 inhibitor as monotherapy in patients with advanced solid tumors and later on in patients with T-cell lymphoma."

"We are enrolling patients prospectively selected for CDKN2A/CDKN2B alterations in the Phase 2, proof of concept (PoC) stage of 065-101," said Brian Schwartz, M.D., interim Chief Medical Officer. "We are pleased with strong investigator interest and are nearing completion of recruitment in the precision medicine cohort. There are no approved medicines for patients with CDKN2A/CDKN2B alterations. A second cohort to evaluate fadraciclib in patients with T-cell lymphoma is open for enrollment. We are encouraged about fadraciclib’s prospects and look forward to presenting emerging data from the 065-101 study later in the year."

Financial Highlights

As of June 30, 2024, cash equivalents totalled $6.0 million, compared to $3.4 million as of December 31, 2023. Net cash used in operating activities was $3.6 million for the six months ended June 30, 2024 compared to $8.2 million for the same period of 2023. Net cash provided by financing activities was approximately $6.3 million, net of expenses, for the six months ended June 30, 2024 from the issuance of common stock and warrants. 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 $2.0 million for the three months ended June 30, 2024, as compared to $4.7 million for the same period in 2023. R&D expenses relating to fadraciclib were $1.5 million for the three months ended June 30, 2024, as compared to $3.0 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 $0.5 million for the three months ended June 30, 2024, as compared to $1.4 million for the same period in 2023 due to a decrease in manufacturing costs and other non-clinical expenditures.

General and administrative expenses remained flat at approximately $1.6 million for each of the three months ended June 30, 2024 and 2023.

Total other expenses, net, for the three months and year ended June 30, 2024 were $0.1 million for each of the three months ended June 30, 2024 and 2023.

United Kingdom research & development tax credits for the three months ended June 30, 2024 were $0.4 million, compared to $0.6 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 ended June 30, 2024, was $3.3 million (including stock-based compensation expense of $0.2 million), compared to $5.5 million (including stock-based compensation expense of $0.4 million) for the same period in 2023.

Conference call information:

Call: (800) 225-9448 / international call: (203) 518-9708

Archive: (800) 934-7884 / international archive: (402) 220-6987

Code for live and archived conference call is CYCCQ224. 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.