On August 12, 2024 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated small molecules for the safe and effective destruction of various cancers, bacteria and viruses reported the Company’s unaudited condensed consolidated interim financial statements for the six-month period ended June 30, 2024. ("Financial Statements") (Press release, Theralase, AUG 12, 2024, View Source [SID1234645739]).

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Theralase will be hosting a conference call on Wednesday August 21st, 2024 at 11:00 am ET, which will include a presentation of the financial and operational results for the six-month period ended June 30, 2024. Questions are welcome. To ensure Theralase has time to review and properly address them during the call, please send them in advance to [email protected].

Zoom Meeting Link: View Source

Conference Call in: 1-647-558-0588 (Canada) / 1-646-558-8656 (US) – not required for those attending by Zoom.

An archived version will be available on the website following the conference call.

Financial Summary:

For the six-month period ended June 30th:

1 Other represents foreign exchange, interest accretion on lease liabilities and / or interest income

Financial Highlights

For the six-month period ended June 30, 2024;

Total revenue decreased 35%, year over year.
Cost of sales was $186,324 (67% of revenue) resulting in a gross margin of $90,077 (33% of revenue). In comparison, the cost of sales for the same period in 2023 was $224,947 (53% of revenue) resulting in a gross margin of $201,140 (47% of revenue). The gross margin decrease, as a percentage of sales year over year, is attributed to an increase in material costs.
$145,915, from $147,304 for the same period in 2023, a 1% decrease.
The decrease is a result of reduced spending on general and administrative expenses (59%) and stock-based compensation (28%) (due to the cumulative effect of accounting for the vesting of stock options granted in the current and previous years).
for the Drug Division decreased to $1,368,333 from $1,594,676 for the same period in 2023, a 10% decrease. The decrease is primarily attributed to a decrease in costs for Study II patient enrollment and treatment.
The increase is attributed to development of a new software program for the TLC-2000 Cool Laser Therapy system.
Net loss was $2,400,461, which included $374,445 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss in 2023 of $2,564,187, a 6% year-over-year reduction, which included $474,558 of net non-cash expenses. The Drug Division represented $1,938,024 of this loss (81%). The decrease in net loss is primarily attributed to decreased spending on research and development expenses in Study II.
Operational Highlights:

Non-Brokered Private Placement:

On February 5, 2024, the Company closed a non-brokered private placement of units. On closing, the Company issued an aggregate of 6,666,670 units at a price of $CAN 0.18 per Unit for aggregate gross proceeds of approximately $CAN 1,200,000 of which 1,310,502 units were purchased by certain insiders of the Corporation, representing gross proceeds of $235,890. Each Unit consisted of one common share of the Company and one non-transferable warrant. Each Warrant entitles the holder to acquire an additional Common Share at a price of $CAN 0.25 for a period of 5 years following the date of issuance.

On April 24, 2024, the Company closed a non-brokered private placement of units. On closing, the Company issued an aggregate of 4,167,778 units at a price of $0.18 per Unit for aggregate gross proceeds of approximately $750,200. Each Unit consisted of one common share of the Company and one non-transferable common share purchase warrant. Each Warrant entitles the holder to acquire an additional Common Share at a price of $0.25 for a period of 5 years following the date of issuance.

On July 8, 2024, the Company closed a non-brokered private placement of units. On closing, the Company issued an aggregate of 3,522,729 units at a price of $0.22 per Unit for aggregate gross proceeds of approximately $775,000. Each Unit consisted of one common share of the Company and one non-transferable common share purchase warrant. Each Warrant entitles the holder to acquire an additional Common Share at a price of $0.30 for a period of 5 years following the date of issuance.

In 2024, the Company plans to secure funding through various equity and debt instruments to allow the Company the ability to become base shelf eligible. This will allow the Company sufficient funding to complete enrollment into Study II by year end, data lock in mid 2026 and position the Company for FDA and Health Canada approval by the end of 2026, subject to achieving FDA Priority Review."

Study II Update:

On February 8th, 2024, Dr. Michael Jewett joined the Company in the role of an independent consultant, to assist the Company in the accruement of patients into Study II. Under the terms of the consulting agreement, Dr. Jewett will be responsible for working with existing clinical study sites and helping to onboard new clinical study sites to assist Theralase to complete enrollment and provide the primary study treatment to 75 to 100 patients in Study II, preferably by December 31, 2024.

To date, Theralase has enrolled and treated 72 patients in Study II, who have been provided the primary Study II Procedure. The clinical study sites have screened an additional 3 patients, who they are planning to enroll and treat over the next 4 to 6 weeks, bringing the total to 75 treated patients.

Theralase plans to add up to 5 new CSSs in 2024, as well as increase enrollment at the existing 10 Clinical Study Sites ("CSSs") to complete Study II accruement by the end of 2024 / beginning of 2025.

90% (65/72) of treated patients have been evaluated at the 90 days assessment visit for treatment safety and efficacy according to the clinical study protocol.

For the primary endpoint of Study II (Complete Response ("CR") at any point in time) 63% (41/65) of treated patients achieved a CR.

For the secondary endpoint of Study II (duration of CR) 44% (18/41) of treated patients, who achieved a CR, maintained their CR response for at least 12 months.

For the tertiary endpoint of Study II (safety of Study Procedure) 100% (65/65) experienced no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.

Break Through Designation Update:

In 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase has access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure the timely collection of clinical data to support the approval process. The accelerated communication with the FDA potentially allows, the Study Procedure, to be the first intravesical, patient-specific, light-activated, Ruthenium-based small molecule for the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS, (with or without recurrent / resected papillary Ta/T1 tumours). FTD can also lead to Break Through Designation ("BTD"), Accelerated Approval ("AA") and/or Priority Review, if certain criteria are met, which the FDA previously defined to the Company for BTD as clinical data on approximately 20 to 25 patients enrolled and provided the primary Study Procedure, who demonstrate significant safety and efficacy clinical outcomes.

To this list, the FDA has added: Post Study II Monitoring of Response and Central Pathology Laboratory Review.

The Company is currently working with the CSSs, a biostatistics organization and a regulatory organization to update the pre-BTD submission with clinical data clarifications, identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in 3Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company plans to compile a BTD submission for review by the FDA in 3Q2024 in support of the grant of a BTD approval.

Theralase has commenced receiving clinical data from the CSSs with a significant number of patients, who achieved CR, continuing to experience a duration of their CR beyond 450 days, with some patients demonstrating CR for up to 3 years and counting, post the primary Study Procedure.

Study II Preliminary Clinical Data:

Performance to Primary, Secondary and Tertiary Objectives:

The interim clinical data above demonstrates that:

For the primary objective, 63% of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a Complete Response ("CR") (negative cystoscopy and negative urine cytology, among other definitions). Including patients, who demonstrated an Indeterminate Response ("IR") (negative cystoscopy and positive or suspicious urine cytology), the Total Response ("TR") increases to 71%. This represents almost 3 out of 4 Bacillus Calmette Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") patients treated with Theralase’s unique Study Procedure are demonstrating complete destruction of their CIS bladder cancer within their bladders.

For the secondary objective, 44% (almost 1 out of 2) patients, who demonstrated a CR at any point in time continued to demonstrate a CR at 15 months from date of first treatment with 46% of patients demonstrating a TR.

> 90% of patients who demonstrated a CR at 450 days continue to demonstrate this response beyond 450 days.

For the tertiary objective, no patients have been diagnosed with a Serious Adverse Event ("SAE") directly related to the Study Drug or Study Device 100% (65/65).

Note:

For patients to be included in the statistical clinical analysis they must be enrolled in Study II, provided the primary Study Procedure and evaluated by a Principal Investigator ("PI") at the 90 days assessment visit (cystoscopy and urine cytology)
One patient passed away prior to their 90 days assessment and is therefore not included in the efficacy statistical analysis, only in the safety statistical analysis; therefore, there are 65 patients that have been statistically analyzed for efficacy.
Evaluable Patients are defined as patients who have been evaluated by a PI and thus excludes a patient’s clinical data at specific assessment days, if that clinical data is pending.
7 patients have been enrolled and provided the primary Study Procedure but, have not been evaluated at their 90 day assessment; therefore, 65 patients are considered Evaluable Patients at 90 days, with 41 patients considered Evaluable Patients at 450 days.
The data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with clinical data still pending.
Patient Response Chart:

The Swimmer’s plot below is a graphical representation of the interim clinical results (n=41) for patients who achieved a CR at any point in time and their response over 1080 days, graphically demonstrating a patient’s response to a treatment over time. As can be seen in the plot, clinical data is still pending for patients, who have demonstrated an initial CR at 90 days and continue to demonstrate a duration of that response.

The Swimmer’s Plot illustrates:

63% (41/65) Evaluable Patients achieved CR at any point in time, with 44% (18/41) patients, who demonstrated CR, continuing to demonstrate CR at 450 days and thus achieving the primary and secondary objectives of Study II.
41% (17/41) Evaluable Patients demonstrate CR beyond 450 days.
Note: This is interim clinical data and clinical data is still being collected, but all indications demonstrate that the study has achieved its primary, secondary and tertiary objectives.

Kaplan-Meier Curve:

The Kaplan-Meier ("KM") Curve illustrates graphically, for patients who have achieved a CR, the duration of CR and probability of that CR continuing in the future.

Note: The information on the time-to-outcome event is not available for all patients in this analysis, as not all patients have been assessed at all available assessment visits. Only patients that achieved the primary objective (CR at any point in time) have been analyzed and data is plotted relative to the date at which their first CR was observed. The "X" denotes censored observations (subjects who achieved CR at their last assessment visit and are currently on-study or have been removed from study). Thus, the KM Curve estimates the risk of a patient failing to maintain a CR over time, according to currently available interim data.

In summary, the interim clinical data demonstrates that patients consenting to participate in Study II have a 63% chance of achieving CR.

If CR is obtained, then the patient has a 48.3%, 42.3% and 33.8% chance of remaining cancer free for 1, 2 and 3 years, respectively.

Serious Adverse Events

For 72 patients treated in Study II, there have been 14 Serious Adverse Events ("SAEs") reported:

3 – Grade 2 (resolved within 1, 1 and unknown days, respectively)
7 – Grade 3 (resolved within 1, 2, 3, 4, 4, 82 and unknown days, respectively)
3 – Grade 4 (resolved within 3, 6 and 8 days, respectively)
1 – Grade 5
Theralase believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device.

Note: A SAE is defined as any untoward medical occurrence that at any dose: Is serious or life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or results in death.

Dr. Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase stated, "The interim clinical data of Study II, to date, has proven to be world-class. Study II has demonstrated an ability to destroy urothelial cell carcinoma in a patient’s bladder for a Total Response ("TR") of 71% and a duration of that TR of 46%, at 450 days. The primary benefits of the Theralase technology versus competitive technologies are: a urologist-led treatment, a single out-patient procedure, high efficacy rates (patients achieve a CR in 63% of the cases with a 44% duration of that CR at 450 days), high probability of the ongoing duration of that complete response (34% ≥ 3 years, based on the Kaplan-Meier Curve analysis of the interim clinical data) and high safety profile (no SAEs directly associated with the Study Drug or Study Device); therefore, the Theralase technology presents a safe, effective alternative therapy for patients, who are at high risk of having their bladder removed."

Roger DuMoulin-White, B.E.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase stated, "Based on the interim clinical data accumulated to date, Study II has achieved its primary, secondary and tertiary endpoints and requires only a few additional patients enrolled and follow-up on all patients to complete the study. Theralase expects to complete patient follow-up by mid 2026 with review by Health Canada and the FDA on a marketing approval by end of 2026. The Theralase bladder cancer treatment has been proven clinically to be safe and effective in the treatment of BCG-Unresponsive NMIBC CIS, fulfilling an unmet need of the medical community."

About Study II:

Study II utilizes the therapeutic dose of the patented Study II Drug ("RuvidarTM" or "TLD-1433") (0.70 mg/cm2) activated by the proprietary Study II Device (TLC-3200 Medical Laser System or "TLC-3200"). Study II is focused on enrolling and treating approximately 75 to 100 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.

About RuvidarTM:

RuvidarTM is a peer reviewed, patented PDC currently under investigation in Study II.

On August 12, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the second quarter ended June 30, 2024, and recent corporate updates (Press release, Checkpoint Therapeutics, AUG 12, 2024, View Source [SID1234645724]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We’ve made significant recent progress as we seek approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (‘’cSCC’’) who are not candidates for curative surgery or curative radiation. We are pleased to have reached alignment with the U.S. Food and Drug Administration (‘‘FDA’’) on our strategy to potentially address the deficiencies identified in the complete response letter (‘‘CRL’’) received last December. Shortly thereafter, we resubmitted our Biologics License Application ("BLA"), which was accepted by the FDA for review as a complete response to the CRL. We look forward to working with the FDA in advance of the Prescription Drug User Fee Act (‘‘PDUFA’’) goal date of December 28, 2024, to potentially deliver this important therapeutic option to cutaneous squamous cell carcinoma patients and their families."

Recent Corporate Updates:

· Checkpoint submitted a BLA to the FDA in January 2023 seeking approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or curative radiation. In December 2023, the FDA issued a CRL for the cosibelimab BLA. The CRL only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization ("CMO") as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.

· In June 2024, Checkpoint reached alignment with the FDA on its BLA resubmission strategy for cosibelimab and resubmitted the BLA shortly thereafter.

· In July 2024, Checkpoint announced that the FDA accepted for review the resubmission of its BLA for cosibelimab as a complete response to the CRL issued in December 2023 and set a PDUFA goal date of December 28, 2024.

· Also in July 2024, Checkpoint announced a collaboration to explore the combined therapeutic potential of cosibelimab, its anti-PD-L1 antibody with dual mechanism of action, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.

· Also in July 2024, Checkpoint completed a registered direct offering priced At-the-Market under Nasdaq rules and a concurrent private placement of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $12.0 million.

Financial Results:

· Cash Position: As of June 30, 2024, Checkpoint’s cash and cash equivalents totaled $5.0 million, compared to $11.2 million at March 31, 2024 and $4.9 million at December 31, 2023, a decrease of $6.2 million for the quarter and an increase of $0.1 million, year-to-date. After the end of the second quarter, Checkpoint raised gross proceeds of approximately $12.0 million in a registered direct offering completed in July 2024.

· R&D Expenses: Research and development expenses for the second quarter of 2024 were $4.5 million, compared to $13.9 million for the second quarter of 2023, a decrease of $9.4 million. Research and development expenses for the second quarter of 2024 included $0.6 million of non-cash stock expenses, compared to $0.2 million for the second quarter of 2023.

· G&A Expenses: General and administrative expenses for the second quarter of 2024 were $2.2 million, compared to $2.3 million for the second quarter of 2023, a decrease of $0.1 million. General and administrative expenses for the second quarter of 2024 included $0.6 million of non-cash stock expenses, compared to $0.8 million for the second quarter of 2023.

· Net Loss: Net loss attributable to common stockholders for the second quarter of 2024 was $6.7 million, or $0.18 per share, compared to a net loss of $16.5 million, or $1.05 per share, in the second quarter of 2023. Net loss for the second quarter of 2024 included $1.2 million of non-cash stock expenses, compared to $1.0 million for the second quarter of 2023.

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.

•
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).

•
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.
•
Reporting of one-year clinical and translational data on initial patients is anticipated by the end of 2024.
•
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).

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

On August 12, 2024 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal third quarter 2024 ended June 30, 2024 (Press release, Citius Pharmaceuticals, AUG 12, 2024, View Source [SID1234645725]).

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Third Quarter 2024 Business Highlights and Subsequent Developments

- Announced FDA Approval of LYMPHIR (denileukin diftitox-cxdl), an immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL);

- Completed the merger of our wholly owned subsidiary with TenX Keane to form publicly listed Citius Oncology, Inc. on August 12, 2024; trading of Citius Oncology, Inc. (Nasdaq: CTOR) stock expected to begin on August 13, 2024;

- Achieved primary and secondary endpoints in Phase 3 Pivotal Trial of Mino-Lok, designed to salvage central venous catheters in patients with catheter-related bloodstream infections;

- Onboarded National Sales Director to recruit and lead the sales organization in preparation for the anticipated launch of LYMPHIR;

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

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

Financial Highlights

- Cash and cash equivalents of $17.9 million as of June 30, 2024;

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

- R&D expenses were $2.8 million and $9.0 million for the three and nine months ended June 30, 2024, respectively, compared to $3.8 million and $11.9 million for the three and nine months ended June 30, 2023, respectively; - G&A expenses were $4.8 million and $12.8 million for the three and nine months ended June 30, 2024, respectively, compared to $3.7 million and $11.1 million for the three and nine months ended June 30, 2023, respectively;

- Stock-based compensation expense was $3.1 million and $9.2 million for the three and nine months ended June 30, 2024, respectively, compared to $1.2 million and $3.5 million for the three and nine months ended June 30, 2023, respectively; and,

- Net loss was $10.6 million and $28.7 million, or ($0.06) and ($0.17) per share for the three and nine months ended June 30, 2024, respectively, compared to a net loss of $8.5 million and $22.6 million, or ($0.06) and ($0.15) per share for the three and nine months ended June 30, 2023, respectively.

"We continued to achieve multiple value-driving milestones during and since the end of the quarter. Last week, LYMPHIR was approved by the FDA for the treatment of a rare and incurable cancer. This the first FDA-approved product in our portfolio and paves the way for Citius Oncology to transition from a development stage company to a commercial biopharmaceutical organization," stated Leonard Mazur, CEO of Citius Pharma and Citius Oncology.

"The completion of our Phase 3 Pivotal Trial for Mino-Lok, followed by highly statistically significant topline results that met primary and secondary endpoints, further underscores our commitment to developing life-saving treatments. Operationally, we secured $15 million in additional funding to extend our runway, continued expanding our organizational resources to support the planned launch of LYMPHIR, and completed the spin-off of this asset into our majority-owned standalone, publicly traded oncology company. This should provide us with access to a broader investment community and enable both companies to begin to focus on their respective development and commercialization paths. In addition to the spin-off, Citius is evaluating opportunities to optimize the Company’s capital allocation, current cash runway, future cash needs, and potential non-dilutive sources of capital. We believe Citius is poised for a transformative second half of 2024," concluded Mazur.

THIRD QUARTER 2024 Financial Results:

Liquidity

As of June 30, 2024, the Company had $17.9 million in cash and cash equivalents.

As of June 30, 2024, the Company had 158,857,798 common shares outstanding.

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

Research and Development (R&D) Expenses

R&D expenses were $2.8 million for the quarter ended June 30, 2024, compared to $3.8 million for the quarter ended June 30, 2023. For the nine months ended June 30, 2024, R&D expenses were $9.0 million as compared to $11.9 million during the nine months ended June 30, 2023, a decrease of $2.9 million. The decrease primarily reflects incremental costs related to the completion of the Mino-Lok Phase 3 trial and remediation activities for the LYMPHIR BLA resubmission, offset by lower costs in the current period due to the completion of the Halo-Lido Phase 2b trial.

We expect that research and development expenses will stabilize at current levels in fiscal 2024 as we focus on the commercialization of LYMPHIR, prepare a submission to the FDA and schedule a Type B meeting for Mino-Lok, and analyze the data from our Phase 2b trial and begin planning our Phase 3 trial for Halo-Lido.

General and Administrative (G&A) Expenses

G&A expenses were $4.8 million for the quarter ended June 30, 2024, compared to $3.7 million for the quarter ended June 30, 2023. The increase was primarily due to lower costs for pre-launch and market research activities associated with LYMPHIR during the period.

For the nine months ended June 30, 2024, G&A expenses were $12.8 million as compared to $11.1 million during the nine months ended June 30, 2023. The primary reason for the increase was higher costs for pre-launch and market research activities associated with LYMPHIR.

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

Stock-based Compensation Expense

For the quarter ended June 30, 2024, stock-based compensation expense was $3.1 million as compared to $1.2 million for the quarter ended June 30, 2023. For the nine months ended June 30, 2024, stock-based compensation expense was $9.2 million as compared to $3.5 million for the nine months ended June 30, 2023. The increase is primarily due to the Citius Oncology stock plan.

Net loss

Net loss was $10.6 million, or ($0.06) per share for the quarter ended June 30, 2024, compared to a net loss of $8.5 million, or ($0.06) per share for the quarter ended June 30, 2023. The $2.1 million increase in the net loss was primarily due to increases of $1.0 million in general and administrative expenses and $1.9 million in stock-based compensation expense, partially offset by the $1.0 million decrease in research and development expenses.

Net loss was $28.3 million, or ($0.17) per share for the nine months ended June 30, 2024, compared to a net loss of $22.6 million, or ($0.15) per share for the nine months ended June 30, 2023. The increase in the net loss was primarily due to the increase in stock-based compensation expense.

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.