On August 12, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, presented data in a podium presentation updating the progress of its ReSPECT-LM clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM) (Press release, Plus Therapeutics, AUG 12, 2024, View Source;_hsenc=p2ANqtz-_7iHFh0KC8ADHT3IGm6h7byl9V4K0V69JyOE9qDTPXopUgBVfARSb1X2ufy9S8Czy3EIXS309imxXx6d5vPJC9WIkhuA&_hsmi=319707572&utm_content=319707572&utm_source=hs_email [SID1234645751]). The data were presented at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) CNS Metastases Conference August 8-10, 2024 in Denver, Colorado.

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The presentation, titled, "Phase 1 Dose Escalation of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for the Treatment of Leptomeningeal Metastases (LM): Ongoing Clinical Study Update for Initial Safety and Feasibility," provided a safety and efficacy update on the single dose trial for the first 4 cohorts (n = 16 patients). The trial is currently enrolling in Cohort 5. The study was presented by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio.

Key ReSPECT-LM highlights through Cohort 4:

16 patients were treated: 8 patients had a breast cancer primary diagnosis, 4 patients had a lung cancer primary diagnosis, and 4 patients had a mix of other primary cancers
There were no dose limiting toxicities through cohort 4 and the maximum tolerated dose or maximum feasible dose was not reached
We observed a linear increase in absorbed radiation dose to the spinal fluid and ventricles and cranial subarachnoid space over 4 cohorts
In cohort 4, the mean average absorbed radiation dose to the ventricles and cranial subarachnoid space was 156 Gy vs. 1 Gy to the spleen
The majority of adverse events (AEs) across all 4 cohorts were mild or moderate and unrelated or unlikely related to the study drug
There was a mean reduction of CSF circulating tumor cells (CTCs) of 53% at 28 days post treatment vs. baseline (CTCs only performed on only Cohorts 1-3 as testing was commercially unavailable during Cohort 4)
Median overall survival for Cohorts 1-4 was 12 months with 8 of 16 patients alive at the time of analysis
"The ReSPECT-LM Phase 1 dose escalation study continues to show feasibility, safety, and a response in circulating tumor cells in LM patients treated with Rhenium (186Re) Obisbemeda," said Dr. Andrew Brenner, M.D., Ph.D., "Furthermore, a median overall survival rate of 12 months is very encouraging and is consistent with the high doses of absorbed radiation delivered and the mean circulating tumor cell reduction we have observed."

The FDA has granted Fast Track designation to Rhenium (186Re) Obisbemeda for the treatment of LM. The FDA has also granted Orphan Drug designation to Rhenium (186Re) Obisbemeda for the treatment of LM in breast cancer patients.

The ReSPECT-LM clinical trial is funded in part, by a 3-year, $17.6 million grant by the Cancer Prevention & Research Institute of Texas. Additional information about the ReSPECT-LM trial can be found here.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (186Re) Obisbemeda

Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

On August 13, 2024 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported business updates for the company’s top strategic priorities and provided financial results for the second quarter of 2024 (Press release, Boundless Bio, AUG 12, 2024, View Source [SID1234645749]).

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"At Boundless, we’re on a bold mission to pioneer a new category of cancer treatment for patients with oncogene amplified cancer who are in dire need of new therapeutic options," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "In the second quarter of 2024, we continued to advance our first clinical-stage ecDTx, BBI-355, began dosing patients with our second ecDTx, BBI-825, and completed the analytical validation and received IRB approval of our novel ecDNA diagnostic, ECHO, for deployment as a clinical trial assay in our BBI-355 POTENTIATE trial. Though we have made progress toward our goals, the number of patients enrolled thus far in the combination cohorts of the BBI-355 POTENTIATE trial is lower than originally projected. While we implement measures to accelerate enrollment, we have chosen to scale back our early discovery efforts and streamline our operations to extend our runway and help ensure we have the necessary capital for our core ecDTx programs. Moving forward, we believe we are well-positioned to move our lead programs through initial clinical proof-of-concept data readouts and remain steadfast in advancing this innovative approach for patients with high unmet need."

Strategic Priorities for Core Programs

Boundless Bio has outlined its core portfolio priorities to support the achievement of potential near-term catalysts and long-term patient impact. Through 2025, the company’s core strategic priorities remain:

•
Executing the ongoing Phase 1/2 POTENTIATE (Precision Oncology Trial Evaluating Novel Therapeutic Interrupting Amplifications Tied to ecDNA) clinical trial of its lead ecDNA directed therapeutic candidate (ecDTx), BBI-355, a novel, oral CHK1 inhibitor, to generate initial proof-of-concept in solid tumor cancer patients with driver oncogene amplifications;
•
Executing the ongoing Phase 1/2 STARMAP (Study Targeting Acquired Resistance: MAPK Amplifications) clinical trial of its second ecDTx, BBI-825, a novel, oral RNR inhibitor, to generate initial proof-of-concept in colorectal cancer patients with BRAFV600E or KRASG12C mutations and resistance oncogene amplifications;
•
Advancing the company’s third ecDTx program, directed to a novel, previously undrugged kinesin target essential for ecDNA segregation, into IND-enabling studies; and
•
Deploying its proprietary ecDNA diagnostic in the clinic to identify ecDNA+ patients who are most likely to benefit from its ecDTx therapeutics.

In alignment with its strategic priorities, Boundless Bio has narrowed its discovery research work and, as a result, modestly reduced its workforce. The company believes the combination of these operational efficiencies and its cash, cash equivalents, and short-term investments of $179.3 million as of June 30, 2024, provides an operating runway into the fourth quarter of 2026.

BBI-355, a novel, oral, potent, selective CHK1 inhibitor targeting replication stress for cancer patients with driver oncogene amplifications

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The company presented preclinical and clinical pharmacodynamic data on BBI-355 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024.
•
Enrollment is progressing in the Phase 1/2 POTENTIATE clinical trial evaluating BBI-355 as a single agent and in combination with targeted therapies in patients with locally advanced or metastatic solid tumors with oncogene amplifications.
•
To date, no new safety signals have been observed, and there has been no evidence of combinatorial toxicity in the dose escalation cohorts evaluating BBI-355 in combination with either the EGFR inhibitor erlotinib or the FGFR inhibitor futibatinib.
•
The initial pace of enrollment in the combination cohorts has been slower than anticipated. The company has recently implemented multiple initiatives to help accelerate enrollment, including engaging with next-generation sequencing vendors to identify patients, adding new clinical sites in the US, and preparing for the initiation of ex-US sites.
•
Based on its current projections, the company now anticipates reporting initial clinical proof-of-concept data from POTENTIATE in the second half of 2025.

BBI-825, a novel, oral, potent, selective RNR inhibitor targeting ecDNA assembly and repair for cancer patients with resistance oncogene amplifications

•
In April 2024, the company announced the first patient had been dosed with BBI-825 in the Phase 1/2 STARMAP clinical trial.
•
Multiple dose levels have been completed in the single-agent, dose-escalation portion of the STARMAP clinical trial and, to date, BBI-825 has demonstrated oral bioavailability and has been generally well-tolerated. Initial clinical proof-of-concept data from the trial are expected in the second half of 2025.

ecDTx 3, a novel kinesin program involved in ecDNA segregation

•
The company’s third ecDTx program, directed to a previously undrugged kinesin target essential for ecDNA segregation whose inhibition is synthetic lethal to ecDNA-enabled cancer cells, is currently advancing through lead optimization.

ECHO, a proprietary diagnostic for detection of ecDNA amplified oncogenes

•
The company’s proprietary ecDNA diagnostic, referred to as ECHO (ecDNA Harboring Oncogenes), is designed to detect ecDNA in patient tumor specimens. ECHO was previously determined by the FDA to be a non-significant risk device for use as a clinical trial assay (CTA) in the BBI-355 POTENTIATE trial.
•
ECHO has now been analytically validated and institutional review board (IRB)-approved for use as a CTA in the BBI-355 POTENTIATE trial.

Second Quarter 2024 Financial Results

•
Cash Position: Cash, cash equivalents, and short-term investments totaled $179.3 million as of June 30, 2024.
•
R&D Expenses: Research and development (R&D) expenses were $14.7 million for the second quarter of 2024 compared to $11.1 million for the same period in 2023.
•
G&A Expenses: General and administrative (G&A) expenses were $4.7 million for the second quarter of 2024 compared to $2.9 million for the same period in 2023.
•
Net Loss: Net loss totaled $17.0 million for the second quarter of 2024 compared to $12.4 million for the same period in 2023.

About BBI-355

Boundless Bio’s lead ecDTx, BBI-355, is a novel, oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1) being studied in the ongoing, first-in-human, Phase 1/2 POTENTIATE clinical trial (NCT05827614) in cancer patients with oncogene amplifications. CHK1 is a master regulator of cells’ response to replication stress (RS). RS is elevated in cancer cells with oncogene amplification, including on ecDNA, and, because of this, represents a key vulnerability of those cells. BBI-355 was designed to exploit the elevated RS in ecDNA-enabled oncogene amplified cancer cells by disrupting proper CHK1 function in regulating RS and thereby facilitating catastrophic RS to preferentially kill cancer cells relative to healthy cells.

About BBI-825

Boundless Bio’s second ecDTx, BBI-825, is a novel, oral, selective small molecule inhibitor of ribonucleotide reductase (RNR) being studied in the ongoing, first-in-human, Phase 1/2 STARMAP clinical trial (NCT06299761) in colorectal cancer patients with BRAFV600E or KRASG12C mutations and resistance gene amplifications. In preclinical studies, BBI-825 demonstrated low double digit nanomolar RNR inhibition and tumor growth inhibition, including regressions, in both the prevention and treatment of amplification-mediated resistance in mitogen-activated protein kinase (MAPK) pathway-activated tumors. RNR is the rate-limiting enzyme responsible for cellular de novo synthesis of deoxynucleotide triphosphates (dNTPs), the building blocks of DNA, and is essential to the assembly and repair of ecDNA. BBI-825 was shown to dysregulate ecDNA-reliant cancer cell dNTP pools, deplete ecDNA, and was synthetic lethal in multiple oncogene amplified preclinical cancer models.

On August 12, 2024 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the three months ended June 30, 2024, and provided a business update (Press release, Azitra, AUG 12, 2024, View Source [SID1234645748]).

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Q2 2024 and Recent Business Highlights

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Completed a follow-on offering of $10 million in gross proceeds expected to provide cash runway into 2025. With the recent financing, the company anticipates announcing multiple clinical milestones

● Strengthened global intellectual property portfolio with newly granted and allowed patents

● Exhibited positive preclinical data from ATR-04 at the Society of Investigative Dermatology Annual Meeting

● Presented positive preclinical data of ATR-12 and clinical design in Netherton Syndrome at the ASGCT (Free ASGCT Whitepaper) Annual Meeting

● Opened a Phase 1b clinical trial for ATR-12 for recruitment

Francisco Salva, CEO of Azitra commented:

"Azitra is poised to achieve significant milestones in the second half of 2024 and beyond, propelling our pipeline forward. In Q3 2024, we expect to dose the first Netherton syndrome patient with ATR-12. Additionally, we anticipate filing and clearing an Investigational New Drug (IND) application for ATR-04, targeting epidermal growth factor receptor inhibitor (EGFRi) rash, a condition with high unmet need. This milestone will expand our clinical pipeline to two clinical-stage programs.

Approximately year-end 2024, we anticipate reporting initial safety data from the ATR-12 Phase 1b trial in Netherton syndrome patients and providing an update on our Bayer license agreement. We expect to initiate a first-in-human clinical trial with ATR-04 for EGFRi rash this fall.

Looking ahead to mid-2025, we eagerly anticipate reporting topline data from the ATR-12 Phase 1b trial, a defining moment as we aim to demonstrate biological proof of concept of our innovative approach in addressing this severe, rare skin disorder.

With a clear roadmap, strong financial position, and dedicated team, Azitra is well-positioned to execute these milestones, deliver transformative therapies to patients in need, and ultimately maximize shareholder value."

Pipeline and Upcoming Milestones

○ Q3 2024: First Netherton syndrome patient dosed with ATR-12

○ Q3 2024: New investigational new drug (IND) application filed and cleared with the FDA for a Phase 1/2 clinical study of ATR-04 in patients with dermal toxicity undergoing treatment with EGFR inhibitors ("EGFRi rash")

○ YE 2024: Initial safety data from first set of Netherton syndrome patients in the Phase 1b trial

○ YE 2024: First patient dosed with ATR-04 for EGFRi rash by year end 2024

○ YE 2024: Bayer collaboration continues with update on license agreement expected by year end

○ Mid 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients expected

Financial Results for the Three Months Ended June 30, 2024

● Service Revenue – Related Party: The Company generated $7,500 service revenue during the quarter ended June 30, 2024, compared to $172,000 for the comparable period in 2023.

● Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2024, were $1.1 million compared to $0.8 million for the comparable period in 2023.

● General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2024, were $1.5 million compared to $0.8 million for the comparable period in 2023.

● Net Loss was $2.6 million for the quarter ended June 30, 2024, compared to $5.1 million for the comparable period in 2023.

● Cash and cash equivalents: As of June 30, 2024, the Company had cash and cash equivalents of $0.8 million.

About ATR-12

ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately 20,000 patients globally. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients. Azitra has an open IND for a Phase 1b clinical trial that is actively recruiting adult Netherton syndrome patients (NCT06137157). Azitra has identified Netherton syndrome patients for enrollment in its 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints.

About ATR-04

ATR-04 is a live biotherapeutic product candidate including an isolated, naturally derived S. epidermidis strain that was engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFR inhibitor ("EGFRi") associated rash, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. There are approximately 150,000 patients suffering from EGFRi rash in the United States. Azitra plans to initiate a Phase 1/2 clinical study in patients undergoing EGFRi rash by year end 2024.

On August 12, 2024 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter ended June 30, 2024 (Press release, Y-mAbs Therapeutics, AUG 12, 2024, View Source [SID1234645741]).

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"We demonstrated commercial progress with DANYELZA in the second quarter of this year while continuing to advance our development pipeline," said Mike Rossi, President and Chief Executive Officer. "Our dedicated U.S. sales team with deep neuroblastoma expertise continues to penetrate new centers with DANYELZA, a leading anti-GD2 therapy, added to two more hospital formularies in the second quarter of 2024, while our ex-U.S. distribution partners have gained traction in our Eastern Asia and Latin America markets. Additionally, we remain focused on advancing our novel Self-Assembly DisAssembly ("SADA") Pretargeted Radioimmunotherapy ("PRIT) technology platform and continue to evaluate potential expansion of indications for naxitamab in our mission of delivering better and safer therapies to patients. Looking ahead, we are on track to complete Part A of our GD2-SADA Phase 1 clinical trial in the fourth quarter of this year with a data readout to follow and are on track to dose the first patient in our CD38-SADA Phase 1 in Non-Hodgkin’s Lymphoma trial in the second half of this year."

Second Quarter 2024 and Recent Corporate Highlights

● Appointed Peter Pfreundschuh as Chief Financial Officer and deepened radiopharmaceutical expertise with the appointment of Norman LaFrance, M.D. as Chief Development Officer.
● Y-mAbs’ distribution partner in Latin America, Adium, initiated the commercial launch of DANYELZA in Brazil and Mexico.
● Entered into a distribution agreement with TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC for the named patient program distribution of DANYELZA in Turkey.
● Received marketing authorization approval for DANYELZA in Hong Kong. Y-mAbs’ Asian distribution partner, SciClone Pharmaceuticals, is expected to initiate the commercial launch of DANYELZA in Hong Kong this year.
● Presented preclinical GD2-SADA data at the Society of Nuclear Medicine & Molecular Imaging 2024 annual Meeting on June 8-11, 2024, in Toronto, Canada.
● Highlighted new interim analysis of Phase 2 data for naxitamab in several poster presentations and preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting on May 31-June 4, 2024, in Chicago, IL.

Financial Results

Revenues

Total net product revenues were $22.8 million and $42.2 million for the quarter and six months ended June 30, 2024, which represented an increase of 10% and 3%, respectively, over $20.8 million and $41.0 million in the comparable periods of 2023.

DANYELZA total net product revenues of $22.8 million in the second quarter of 2024, represented a 10% increase compared to the second quarter of 2023, primarily driven by increased international revenues. Y-mAbs’ international DANYELZA net product revenues were $7.6 million for the three months ended June 30, 2024, an increase of 55% over $4.9 million in the comparable period in 2023. The increase of net product revenue in the quarter ended June 30, 2024, compared to the quarter ended June 30, 2023, was a result of increased volume from Western Europe, as well as the commercial launch for Brazil and Mexico in Latin America. U.S. DANYELZA net product revenues were $15.2 million and $15.9 million for the three months ended June 30, 2024 and 2023, respectively, representing a 4% decline driven by a volume decrease due to the launch of competing therapy in another class of agents and some ongoing clinical trial activities.

The Company’s total net product revenue was $42.2 million for the six months ended June 30, 2024, as compared to $41.0 million in the comparable period in 2023. The 3% increase was primarily driven by a $1.2 million increase in the U.S. DANYELZA net product revenue in the six months ended June 30, 2024, while international net product revenue was relatively flat.

As of June 30, 2024, Y-mAbs has delivered DANYELZA to 65 centers across the U.S. since initial launch, with two new accounts added in the U.S. in the second quarter of 2024. During the quarter ended June 30, 2024, approximately 67% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center ("MSK"), compared to 60% in the first quarter ended March 31, 2024.

The Company did not have license revenue for the quarters ended June 30, 2024 and 2023. The Company had license revenues of $0.5 million for the six months ended June 30, 2024, from our distribution partner, Adium, related to our acceptance of the price for DANYELZA in Brazil from the Brazilian Medicines Market Regulation Chamber. There was no license revenue recorded for the six months ended June 30, 2023.

Operating Costs and Expenses

Cost of Goods Sold

Cost of goods sold was $3.0 million and $4.6 million for the quarter ended June 30, 2024 and 2023, respectively. Cost of goods sold was $5.1 million and $6.7 million for the six months ended June 30, 2024 and 2023, respectively. The Company defines gross margin as net product revenues less cost of goods sold divided by net product revenues. Our gross margins increased in the three and six months ended June 30, 2024, compared to the comparable periods in 2023, due to a favorable gross profit mix from lower vial volumes from our international regions.

Research and Development

Research and development expenses were $12.3 million for the quarter ended June 30, 2024, and relatively flat compared to $12.1 million for the quarter ended June 30, 2023. For the six months ended June 30, 2024 and 2023, research and development expenses were relatively flat at $25.6 million and $25.5 million, respectively.

Selling, General, and Administration

Selling, general, and administrative expenses were $17.2 million for the three months ended June 30, 2024, which was a $5.9 million increase compared to $11.3 million for the three months ended June 30, 2023. The increase was primarily attributable to a net impact of $3.6 million related to the Company’s settlement of a shareholder class-action lawsuit, which is the net impact of the Company’s $19.7 million accrued legal settlement, less the corresponding insurance recovery of $16.1 million and an additional legal settlement of $0.2 million in the three months ended June 30, 2024.

For the six months ended June 30, 2024, selling, general, and administrative expenses were $28.7 million, an increase of $5.2 million for the six months ended June 30, 2023. The increase was primarily attributable to a net impact of $3.8 million related to the Company’s two legal settlements, as noted above.

Interest and Other Income

Interest and other income were $0.6 million for the three months ended June 30, 2024, as compared to $1.1 million for the three months ended June 30, 2023. The decrease of $0.5 million was primarily due to a $0.2 million gain from repayment of a secured promissory note in the three months ended June 30, 2023, and a $0.2 million increase in foreign currency transaction losses. The Company did not have the repayment of a secured promissory note in the three months ended June 30, 2024.

For the six months ended June 30, 2024 and 2023, the interest and other income was $1.1 million and $2.2 million, respectively. The decrease of $1.1 million was primarily due to a $0.8 million increase in foreign currency transaction losses related to the remeasurement of foreign currency denominated assets and liabilities.

Net Loss

Y-mAbs reported a net loss for the three months ended June 30, 2024, of $9.2 million, or ($0.21) per basic and diluted share, compared to net loss of $6.3 million, or ($0.14) per basic and diluted share, for the three months ended June 30, 2023. For the six months ended June 30, 2024, the Company reported a net loss of $15.9 million, or ($0.36) per basic and diluted share, as compared to net loss of $12.7 million, or ($0.29) per basic and diluted share, for the six months ended June 30, 2023. The increase in net loss for the three and six months ended June 30, 2024 was primarily driven by the net $3.8 million in charges related to the Company’s two legal settlements, as described above.

Cash and Cash Equivalents

As of June 30, 2024, Y-mAbs had approximately $77.8 million in cash and cash equivalents which, together with anticipated DANYELZA product revenues, is expected to support operations as currently planned into 2027. This estimate reflects the Company’s current business plan that is supported by assumptions that may prove to be inaccurate. Cash utilized in the first half year of 2024 was $0.8 million, which was favorable to internal company forecasts.

2024 Financial Guidance

Management updates its full year 2024 guidance:

● Anticipated Total Net Revenues now expected to be between $87 million and $95 million;
● Anticipated Operating Expenses expected to remain between $115 million and $120 million;
● Anticipated Total Annual Cash Burn expected to remain between $15 million and $20 million; and
● Cash and Cash Equivalents anticipated to continue to support operations as currently planned into 2027.
Webcast and Conference Call

Y-mAbs will host a conference call on Monday, August 12, 2024, at 8:00 a.m. ET. To participate in the call, please use the following dial-in information:

Investors (domestic):(877) 407-0792

Investors (international):(201) 689-8263

To access the live webcast, please use this link. Prior to the call and webcast, a slide presentation pertaining to the Company’s quarterly earnings will be made available on the Investor Relations section of the Y-mAbs website, www.ymabs.com, shortly before the call begins.

On August 12, 2024 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, TScan Therapeutics, AUG 12, 2024, View Source [SID1234645740]).

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"We continue to make meaningful progress across our pipeline and remain on track to provide a clinical update on the ALLOHATM Phase 1 heme trial at the end of the year. We continue to successfully manufacture our product candidates internally and have now engaged a CDMO with global capabilities as we start to prepare for commercial manufacturing. Receipt of RMAT designation from the FDA is an important milestone that highlights the transformative potential of TSC-100 and TSC-101, and we look forward to working closely with the FDA to support the development of these TCR-T therapy candidates," said Gavin MacBeath, Ph.D., Chief Executive Officer. "In our solid tumor program, we are currently enrolling patients across the first two dose levels. Our goal is to start treating patients with multiplex therapy by the end of the year, which should set us up to report meaningful response data in 2025."

Recent Corporate Highlights

•
The Company recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for its two lead TCR-T therapy candidates TSC-100 and TSC-101. The ALLOHA Phase 1 heme trial is designed to evaluate the ability of TSC-100 and TSC-101 to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning.

•
The Company signed a letter of intent with a global contract development and manufacturing organization (CDMO) to initiate manufacturing activities for pivotal trials and commercialization.

•
In June, the Company announced the appointment of Garry A. Nicholson to its Board of Directors. In addition, following the retirement of former Chairman Timothy Barberich, Stephen Biggar, M.D., Ph.D., assumed the role of Chair.

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Upon the U.S. market opening on July 1, 2024, the Company joined the broad-market Russell 3000 Index as a part of the annual reconstitution. The Russell U.S. Index reconstitution captures the 4,000 largest U.S. stocks as of April 30, 2024, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes.

Upcoming Anticipated Milestones

Heme Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101, are designed to treat residual disease and prevent relapse in patients with AML, ALL, or MDS undergoing allogeneic HCT (the ALLOHA trial, NCT05473910).

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Opening of expansion cohorts at the proposed recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints is planned for the third quarter of 2024.
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Reporting of one-year clinical and translational data on initial patients is anticipated by the end of 2024.
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Initiation of a registration trial, pending feedback from regulatory authorities, and reporting of two-year clinical and translational data are anticipated in 2025.

Solid Tumor Program: TScan continues to expand the ImmunoBank, a collection of therapeutic TCR-Ts that target different cancer-associated antigens presented on diverse HLA types. TScan’s strategy is to treat patients with multiple TCR-Ts to overcome tumor heterogeneity and prevent resistance that may arise from either target or HLA loss (screening protocol: NCT05812027; treatment protocol: NCT05973487).

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First patient dosed in early May, with enrollment proceeding across the TCR-T therapy candidates.
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Initial singleplex data expected by the end of 2024.
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Additional investigational new drug (IND) filings planned to continue to expand the ImmunoBank.
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Response data for multiplex therapy anticipated in 2025.

Second Quarter 2024 Financial Results

Revenue: Revenue for the second quarter of 2024 was $0.5 million, compared to $3.1 million for the second quarter of 2023. The decrease was primarily due to the timing of research activities pursuant to the Company’s collaboration agreement with Amgen which commenced in May 2023.

R&D Expenses: Research and development expenses for the second quarter of 2024 were $26.9 million, compared to $21.2 million for the second quarter of 2023. The increase of $5.7 million was primarily driven by an increase in clinical studies expense associated with the ongoing enrollment of our ALLOHA Phase 1 heme trial and start-up activities and initial enrollment in our Phase 1 solid tumor clinical trial, as well as an increase in personnel expenses due to additional headcount in support of our expanded research and development activities. Research and development expenses included non-cash stock compensation expense of $1.2 million and $0.6 million for the second quarter of 2024 and 2023, respectively.

G&A Expenses: General and administrative expenses for the second quarter of 2024 were $7.8 million, compared to $6.5 million for the second quarter of 2023. The increase of $1.2 million was primarily driven by an increase in personnel expenses due to increased headcount to support business activities. General and administrative expenses included non-cash stock compensation expense of $1.1 million and $0.6 million for the second quarter of 2024 and 2023, respectively.

Net Loss: Net loss was $31.7 million for the second quarter of 2024, compared to $24.0 million for the second quarter of 2023, and included net interest income of $2.5 million and $0.6 million, respectively.

Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2024, were $297.7 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will continue to fund its current operating plan into the fourth quarter of 2026.

Share Count: As of June 30, 2024, the Company had issued and outstanding shares of 52,932,746, which consists of 48,656,158 shares of voting common stock and 4,276,588 shares of non-voting common stock, and outstanding pre-funded warrants to purchase 65,587,945 shares of voting common stock at an exercise price of $0.0001 per share.