On August 14, 2024 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the second quarter ended June 30, 2024 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 14, 2024, View Source [SID1234645920]).

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"The first half of 2024 has showcased the strength of our pipeline through the continued execution of key milestones for both risvodetinib (risvo) and IkT-001Pro," said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "We completed enrollment of The 201 Trial evaluating risvo in untreated Parkinson’s disease, and anticipate the last patient exiting the study in September, 2024. We anticipate reporting topline data in November, 2024. Additionally, 001Pro has advanced as a potential treatment for Pulmonary Arterial Hypertension (PAH). We have filed our IND and we intend to ramp up the 702 trial following IND clearance. Finally, the manufacturing requirements for 001Pro necessary for potential approval is advancing with the on-going development of a scalable process."

Recent Developments and Upcoming Milestones:

Completed enrollment of the Phase 2 ‘201’ trial evaluating risvodetinib in untreated Parkinson’s disease: On June 17, 2024, Inhibikase announced that the final participant had been enrolled in The 201 Trial evaluating the safety and tolerability of risvodetinib as a treatment in untreated Parkinson’s patients. The trial has enrolled and randomized 126 patients total. The last patient will exit the trial in September, 2024. As of July 29, 2024, 84 participants have completed the 12-week dosing period. There have been 41 mild and 8 moderate adverse events observed that may be related to risvo treatment. Six people withdrew from the trial without completing 12 weeks of treatment. Forty-six people have agreed to participate in biomarker studies of the change in synuclein aggregate deposition in the skin and seven have agreed to biomarker studies of the status of synuclein aggregate in the spinal fluid.
Expanded Pipeline with advancement of IkT-001Pro as a therapy in Pulmonary Arterial Hypertension: Following receipt of final meeting minutes from Inhibikase’s pre-IND meeting with the FDA in May 2024, the Company submitted its IND to the FDA and plans to begin ramp-up of the Phase 2 702 trial to evaluate IkT-001Pro as a treatment for PAH, subject to receipt of the Study May Proceed letter from the FDA. In the final meeting minutes, the FDA stated that Inhibikase had built a bridge between imatinib’s use in blood and gastrointestinal cancers and PAH and that the Company’s Phase 2 design, to be known as the 702 trial, was reasonable. The Company has completed the requested pre-clinical hERG safety study showing that IkT-001Pro does not inhibit hERG and therefore is unlikely to induce QTcF prolongation in treated patients. Imatinib has previously been shown to induce QTcF prolongation in some patients.
The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that 001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication. If approved, IkT-001Pro could be a branded product with all the value drivers of a novel treatment for an indication with high unmet need valued at $7.66 billion in 2023 according to global sales data from Evaluate Pharma.
Scaled manufacturing of IkT-001Pro: Following the Company’s pre-NDA meeting with the U.S. FDA in January 2024, Inhibikase scaled its process development efforts for IkT-001Pro to support late-stage clinical development and NDA batch requirements. Ongoing activities include development of new dosage forms, a more efficient production process and a high throughput tableting process that will lead to dosage forms for 001Pro tablets that are differentiated from generic imatinib mesylate in alignment with FDA feedback.
Successfully raised $4.0 Million in a registered direct offering and concurrent private placement: In May 2024, Inhibikase raised $4 million in aggregate gross proceeds from its registered direct offering and concurrent private placement. The Company is using the net proceeds from the offering to progress risvodetinib towards its planned Phase 3 trials in 2025 and completed pre-clinical studies requested by the FDA that enabled the IND filing for 001Pro in PAH.
Second Quarter Financial Results

Net Loss: Net loss for the quarter ended June 30, 2024, was $5.0 million, or $0.66 per share, compared to a net loss of $5.8 million, or $0.94 per share in the quarter ended June 30, 2023. The net loss per share for the three and six months ended June 30, 2023, was adjusted to show an improvement from ($1.11) to ($0.94) and from ($2.09) to ($1.74), respectively.

R&D Expenses: Research and development expenses were $3.1 million for the quarter ended June 30, 2024 compared to $4.5 million in the quarter ended June 30, 2023. The $1.5 million decrease in research and development expenses was due to a decrease of $1.4 million in IkT-001Pro expenses due to the completion of the three-part dose finding/dose equivalence study in 2023 and a net decrease of $0.1 million in other research and development expenses.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2024 were $2.0 million compared to $1.8 million for the quarter ended June 30, 2023. The $0.2 million increase was primarily driven by a $0.4 million increase legal and consulting fees partially offset by a $0.1 million decrease in D&O insurance and a $0.1 million net decrease in all other normal selling, general and administrative expenses.

Cash Position: Cash, cash equivalents and marketable securities were $7.9 million as of June 30, 2024. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into December, 2024.

Conference Call Information
The conference call is scheduled to begin at 8:00am ET on August 15, 2024. Participants should dial 1-877-407-0789 (United States) or 1-201-689-8562 (International). A live webcast may be accessed using the link HERE or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On August 14, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immuno-oncology therapy, reported financial results for the three and six months ended June 30, 2024 (Press release, IMUNON, AUG 14, 2024, View Source [SID1234645904]). The Company also provided an update on its clinical development programs with IMNN-001, including positive topline results from the Phase 2 OVATION 2 Study in patients with advanced ovarian cancer and an update on IMNN-101, its seasonal COVID-19 booster candidate.

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"The second quarter and recent weeks were exciting and highly rewarding," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Positive topline results from our Phase 2 OVATION 2 Study with IMNN-001 in advanced ovarian cancer were the culmination of years of dedication by the IMUNON team and set our company’s strategic plan going forward. We reported overall survival among patients treated with IMNN-001 of more than 11 months compared with patients treated with standard-of-care, and believe these results provide hope to women suffering from a disease with such a poor prognosis. Our next steps include holding an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to clarify our path to a Phase 3 pivotal study."

Dr. Lindborg added, "The addition of approximately $9.3 million in net proceeds from a capital raise last month in a challenging market, along with the steps we have taken to conserve capital allows the Company to report many important catalysts, including the initiation of a planned Phase 3 study of IMNN-001."

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

Reported Positive Topline Results From OVATION 2 Study in Advanced Ovarian Cancer – On June 24, 2024, the Company announced database lock for the OVATION 2 Study. At that time, median overall survival (OS) and progression-free survival (PFS) had been reached, and all patients in the open-label study had achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy. On July 30, 2024, the Company announced positive topline results from the Phase 2 OVATION 2 Study. Highlights from patients treated with IMNN-001 plus standard-of-care in a first-line treatment setting include:

An 11.1 month increase in median OS compared with standard-of-care alone in the intent-to-treat (ITT) population.
A hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival.
Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival.
For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm.
The PFS results, the trial’s primary endpoint, support the OS results with:

A three-month improvement in PFS compared with standard-of-care alone.
A hazard ratio in the ITT population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm.
The Company plans to hold an End-of-Phase 2 meeting with the FDA to discuss the protocol for a Phase 3 study, which is anticipated to begin in the first quarter of 2025. The Company also plans to present full OVATION 2 Study results at an upcoming medical conference and to submit the results for publication in a peer-reviewed medical journal.

MRD Study Advancing: Phase 1/2 Study of IMNN-001 in Combination with Bevacizumab, titled "Targeting Ovarian Cancer Minimal Residual Disease (MRD) Using Immune and DNA Repair Directed Therapies" – In February 2023, the Company and Break Through Cancer, a public foundation dedicated to supporting translational research in the most difficult-to-treat cancers that partners with top cancer research centers, announced the commencement of patient enrollment in a collaboration to evaluate IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer in the frontline, neoadjuvant clinical setting. MD Anderson Cancer Center, Dana-Farber Cancer Institute, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and Memorial Sloan Kettering Cancer Center will be participating in the trial. In addition, The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology (MIT) will provide artificial intelligence services including biomarker and genomic analysis.

The study is expected to enroll 50 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir Jazaeri, M.D., Vice Chair for Clinical Research and Director of the Gynecologic Cancer Immunotherapy Program in the Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson. Patients are being randomized 1:1 in a two-arm trial. The trial’s primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL), with secondary endpoints including overall survival (OS) and progression-free survival (PFS). SLL data are expected within one year following the completion of enrollment and final data are expected approximately three years following the completion of enrollment.

As of June 30, 2024, seven patients were enrolled and had received treatment in the Phase 1 portion of this study at the University of Texas MD Anderson Cancer Center. Memorial Sloan Kettering Cancer Center was added as a clinical site for this study in the first quarter of 2024.

PlaCCine: Next Generation Prophylactic Vaccine Proof of Concept

First Participants Vaccinated in IMUNON’s IMNN-101 Phase 1 Clinical Trial – On April 18, 2024, the Company announced that it received clearance from the FDA to begin a Phase 1 clinical trial with a seasonal COVID-19 booster vaccine. The primary objectives of this proof-of-concept study of the PlaCCine DNA Vaccine technology platform are to evaluate safety, tolerability, neutralizing antibody response and the vaccine’s durability in healthy adults. Secondary objectives include evaluating the ability of the IMNN-101 vaccine to elicit binding antibodies and cellular responses and their associated durability. As currently planned, the Phase 1 study will enroll 24 subjects evaluating three escalating doses of IMNN-101. For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant. Assuming positive results, IMUNON will advance discussions with potential partners to continue development of the platform.

During the second quarter of 2024, the Company announced that DM Clinical Research in Philadelphia was the first clinical site activated and ready for patient recruitment for this Phase 1 study. DM Clinical Research is an integrated national network of clinical trial sites focused on delivering advanced, preventive medicine to underserved communities. Topline data are anticipated by year-end 2024.

Corporate Developments

Received Gross Proceeds of $10 Million in Registered Direct Financing – On July 30, 2024, the Company entered into a Securities Purchase Agreement with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell in a registered direct offering an aggregate of 5,000,000 shares of the Company’s common stock at an offering price of $2.00 per share for gross proceeds of $10.0 million. In a concurrent private placement (together with the registered direct offering) and also pursuant to the Securities Purchase Agreement, the Company agreed to issue to the Purchasers unregistered warrants to purchase shares of common stock. The warrants have an exercise price of $2.00 per share and will be exercisable immediately for a term of five and one-half years following the date of issuance. The closing of the registered direct offering occurred on August 1, 2024.

SECOND QUARTER FINANCIAL RESULTS

IMUNON reported a net loss for the second quarter of 2024 of $4.8 million, or $0.51 per share, compared with a net loss of $5.6 million, or $0.61 per share, for the second quarter of 2023. Operating expenses were $5.0 million for the second quarter of 2024, a decrease of $0.5 million or 8% from $5.5 million for the second quarter of 2023.

Research and development ("R&D") expenses were $2.8 million in the second quarter of 2024, compared with $3.1 million in the same period of 2023. Costs associated with the OVATION 2 Study were $0.4 million in the second quarter of 2024, compared with $0.3 million in the same period of 2023. Costs associated with the PlaCCine vaccine trial were $0.3 million in the second quarter of 2024. Other clinical and regulatory costs were $0.6 million in the second quarter of 2024, compared with $0.4 million in the same period of 2023.

R&D costs associated with the development of IMNN-001 to support the OVATION 2 Study were $0.2 million in the second quarter of 2024, compared with $0.4 million in the same period of 2023. The development costs of the PlaCCine DNA vaccine technology platform decreased to $0.7 million in the second quarter of 2024, compared with $1.3 million in the same period of 2023. CMC costs decreased to $0.5 million in the second quarter of 2024, compared with $0.7 million in the same period of 2023. The lower CMC costs were primarily due to the Company’s establishment of internal capability to produce plasmid DNA.

General and administrative expenses were $2.2 million in the second quarter of 2024, compared with $2.3 million in the same period of 2023. The decrease was primarily attributable to lower non-cash stock compensation expenses of $0.1 million and employee-related expenses of $0.1 million, offset by an increase in legal fees of $0.1 million.

Other non-operating income was $0.2 million in the second quarter of 2024, compared with other non-operating expenses of $0.1 million in the same period of 2023. The Company incurred a loss on extinguishment of debt expense of $0.3 million on its loan facility with Silicon Valley Bank in the second quarter of 2023 upon the repayment in full of this loan facility. Investment income from the Company’s short-term investments decreased by $0.1 million for the second quarter of 2024, compared with the same period in 2023.

The Company had $5.3 million in cash, investments and accrued interest receivable as of June 30, 2024. Combined with net proceeds of approximately $9.0 million from the registered direct offering announced in July 2024, the Company believes it has sufficient capital resources to fund its operations into the third quarter of 2025.

FIRST HALF FINANCIAL RESULTS

For the six months ended June 30, 2024, the Company reported a net loss was $9.7 million, or $1.03 per share, compared with a net loss of $11.2 million, or $1.28 per share, for the same six-month period of 2023.

Net cash used for operating activities was $10.4 million for the first six months of 2024, compared with $10.8 million for the same period in 2023. Cash used in financing activities for the first six months of 2023 resulted from the early repayments of the Company’s loan facility with Silicon Valley Bank of $6.4 million, partially offset by sales of equity under the Company’s At-the-Market Equity Facility of $2.7 million.

R&D expenses were $6.1 million in the first half of 2024, compared with $5.8 million in the same period of 2023. Costs associated with the OVATION 2 Study were $0.7 million in the first half of 2024, compared with $0.6 million in the same period of 2023. Costs associated with the PlaCCine vaccine trial were $0.9 million in the first half of 2024. Other clinical and regulatory costs were $1.1 million in the first half of 2024, compared with $0.7 million in the same period of 2023.

R&D costs associated with the development of IMNN-001 to support the OVATION 2 Study were $0.7 million in the first half of 2024, compared with $0.8 million in the same period in 2023. The development of the PlaCCine DNA vaccine technology platform decreased to $2.0 million in the first half of 2024 from $2.3 million in the same period of 2023. CMC costs decreased to $0.8 million in the first half of 2024 from $1.4 million in the same period of 2023.

General and administrative expenses were $3.9 million in the first half of 2024, compared with $5.4 million in the same period of 2023. The decrease was primarily attributable to lower non-cash stock compensation expenses of $0.4 million, legal expenses of $0.4 million, employee-related expenses of $0.3 million and insurance expenses of $0.1 million.

Other non-operating income was $0.3 million in the first half of 2024, compared with $8,505 in the same period of 2023. The Company incurred interest expense of $0.2 million on its loan facility with Silicon Valley Bank in the first half of 2023. The Company incurred debt extinguishment expense on its loan facility with Silicon Valley Bank in the first half of 2023 of $0.3 million, which was repaid in full in the second quarter of 2023. Investment income from the Company’s short-term investments decreased by $0.2 million for the first half of 2024 from the same period in 2023 due to lower investment balances.

Conference Call and Webcast

The Company is hosting a conference call at 11:00 a.m. Eastern time today to provide a business update, discuss second quarter 2024 financial results and answer questions. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Second Quarter 2024 Earnings Call. A live webcast of the call will be available here.

The call will be archived for replay until August 28, 2024. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 1829664. A webcast of the call will be available here for 90 days.

On August 14, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported its financial results for the fiscal quarter ended June 30, 2024 and provided an update on recent developments (Press release, IGM Biosciences, AUG 14, 2024, View Source [SID1234645903]).

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"We continue to make significant progress in the clinical development of our two lead product candidates," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We are pleased to have completed enrollment of 127 patients in our randomized study of 3mg/kg of aplitabart plus FOLFIRI and bevacizumab in second line colorectal cancer. We are also pleased to have successfully cleared the first two cohorts of our clinical trial of imvotamab in severe rheumatoid arthritis as well as the first cohort of our clinical trial of imvotamab in severe systemic lupus erythematosus."

Pipeline Updates

Aplitabart (death receptor 5 agonist)

Clinical development of aplitabart advances.
Enrollment completed in randomized colorectal cancer clinical trial. The Company announced that it has completed enrollment in its randomized clinical trial of 3 mg/kg of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. A total of 127 patients, exceeding the trial design target of 110 patients, were enrolled across multiple clinical trial sites in the United States, Asia and Europe. This randomized trial is designed to assess the benefit of 3 mg/kg of aplitabart when administered in combination with FOLFIRI and bevacizumab compared to the current standard of care treatment of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). The release of data from this randomized clinical trial will depend on the timing of PFS events in both the control and the experimental arms of this study. Based on its assumptions as to the timing of PFS events, the Company expects to be able to release top-line PFS results from this study by the end of the first quarter of 2025.
Imvotamab (CD20 x CD3 T cell engager)

Clinical development of imvotamab in autoimmune diseases advances.
First and second dose cohorts in rheumatoid arthritis successfully completed. The Company announced that it has cleared both the first and second dose cohorts of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis and is currently enrolling the third cohort. This study is designed to evaluate three cohorts of progressively higher dose regimens of imvotamab, with each cohort designed to recruit eight patients, six of whom receive imvotamab and two of whom receive placebo.
First dose cohort in systemic lupus erythematosus successfully completed. The Company announced that it has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE), with each dose cohort designed to recruit six patients, all of whom are to be treated with imvotamab. The Company is currently enrolling patients in a second dose cohort and plans to enroll a third dose cohort, with each cohort at progressively higher dose regimens of imvotamab.
Enrollment initiated in myositis. The Company has initiated recruitment of patients in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis).
IGM-2644 (CD38 x CD3 T cell engager)

Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company has made significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases. The Company currently expects to begin enrolling patients in a single arm, open-label clinical study testing IGM-2644 in generalized myasthenia gravis (gMG) by the end of 2024.
Second Quarter 2024 Financial Results

Cash and Investments: Cash and investments as of June 30, 2024 were $256.4 million, compared to $337.7 million as of December 31, 2023.
Collaboration Revenue: For the second quarter of 2024, collaboration revenues were $1.3 million compared to $0.4 million for the second quarter of 2023.
Research and Development (R&D) Expenses: For the second quarter of 2024, R&D expenses were $42.0 million, compared to $55.7 million for the second quarter of 2023.
General and Administrative (G&A) Expenses: For the second quarter of 2024, G&A expenses were $10.6 million, compared to $13.0 million for the second quarter of 2023.
Net Loss: For the second quarter of 2024, net loss was $47.9 million, or a loss of $0.79 per share, compared to a net loss of $64.4 million, or a loss of $1.43 per share, for the second quarter of 2023.
2024 Financial Guidance
The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2026.

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.