On May 10, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported that the Company will present updated data from the TakeAim Leukemia study Tuesday, May 14, 2024, at 4:00 p.m. ET (Press release, Curis, MAY 10, 2024, View Source [SID1234643079]). Management will host a conference call on the same day at 4:30 p.m. ET.

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To access the live conference call, please dial 800-836-8184 from the United States or 646-357-8785 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the conference call will be available on the Curis website shortly after completion of the call.

On May 10, 2024 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that management will be participating in fireside chats and investor meetings at both the JMP Securities Life Sciences Conference being held in New York on May 13 – 14, 2024 and the 2024 RBC Capital Markets Global Healthcare Conference being held in New York on May 14 – 15, 2024. Details for each fireside chat is as follows (Press release, CorMedix, MAY 10, 2024, View Source [SID1234643078]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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JMP Securities Life Sciences Conference
Date: Tuesday, May 14, 2024
Time: 9:30am EDT
Webcast: Click here

RBC Capital Markets Global Healthcare Conference
Date: Wednesday, May 15, 2024
Time: 1:35pm EDT
Webcast: Click here

A replay of each fireside chat will also be available in the "Events and Presentations" page on the investor relations portion of the Company’s website at: www.cormedix.com

On May 10, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2024, and recent corporate updates (Press release, Checkpoint Therapeutics, MAY 10, 2024, View Source [SID1234643077]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Over the past few months, we have worked closely with our third-party contract manufacturing organization ("CMO") for cosibelimab to resolve their inspection deficiencies noted in the complete response letter ("CRL") we received from the U.S. Food and Drug Administration ("FDA") last December. Recently, our CMO submitted to FDA their response to the inspection deficiencies, which we believe could allow for the resubmission of our biologics license application ("BLA"). We plan to meet with the FDA shortly, at which time we will seek to reach alignment for a potential mid-year BLA resubmission."

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 cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation, and the FDA accepted the BLA for filing in March 2023. 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 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. Checkpoint intends to seek to address the feedback in a potential BLA resubmission, which is currently targeted for mid-year.
In January 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 $14.0 million.
In March 2024, Checkpoint announced the appointment of life sciences executive, Amit Sharma, M.D., FACP, FASN, FNKF, currently Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease, as a non-executive director to Checkpoint’s Board of Directors.
Financial Results:

Cash Position: As of March 31, 2024, Checkpoint’s cash and cash equivalents totaled $11.2 million, compared to $4.9 million at December 31, 2023, an increase of $6.3 million.
R&D Expenses: Research and development expenses for the first quarter of 2024 were $8.5 million, compared to $15.8 million for the first quarter of 2023, a decrease of $7.3 million. Research and development expenses for the first quarter of 2024 included $0.5 million of non-cash stock expenses, compared to $0.4 million for the first quarter of 2023.
G&A Expenses: General and administrative expenses for the first quarter of 2024 were $2.5 million, compared to $2.3 million for the first quarter of 2023, an increase of $0.2 million. General and administrative expenses for the first quarter of 2024 included $0.6 million of non-cash stock expenses, compared to $0.7 million for the first quarter of 2023.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2024 was $10.9 million, or $0.33 per share, compared to a net loss of $10.5 million, or $0.89 per share, in the first quarter of 2023. Net loss for the first quarter of 2024 and 2023 both included $1.1 million of non-cash stock expenses.

On May 10, 2024 Bristol Myers Squibb (NYSE: BMY) reported the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, MAY 10, 2024, View Source;73L-Trial/default.aspx [SID1234643076]). CheckMate -73L evaluated Opdivo (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy (ipilimumab) versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC. The observed adverse events of Opdivo with CCRT followed by Opdivo plus Yervoy were generally consistent with the known profiles of each component in the regimen.

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"Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting," said Joseph Fiore, vice president, global program lead, thoracic cancers, Bristol Myers Squibb. "There remains a critical need to improve long-term outcomes for these patients and we believe these results will help inform future drug development efforts in this setting. We want to thank the patients, families and investigators for their contributions to this important research."

The company will complete a full evaluation of the data and work with investigators to share the results with the scientific community.

Opdivo and Opdivo-based combinations have shown positive outcomes and are approved treatment options for eligible patients with resectable or metastatic NSCLC.

About CheckMate -73L

CheckMate -73L is a Phase 3 randomized, open label trial evaluating Opdivo in combination with concurrent chemoradiotherapy (CCRT), followed by Opdivo plus Yervoy, or Opdivo (monotherapy), compared to CCRT alone followed by durvalumab, in patients with previously untreated, locally advanced stage III non-small cell lung cancer (NSCLC) that are not intended or eligible for curative surgery. A total of 925 patients were randomized to receive specified doses on specified days of either Opdivo in combination with CCRT followed by Opdivo plus Yervoy (Arm A), Opdivo in combination with CCRT followed by Opdivo monotherapy (Arm B), or CCRT followed by durvalumab (Arm C). The primary endpoint of the trial is progression-free survival (PFS) by RECIST 1.1 per blinded independent central review (BICR) for Arm A vs. Arm C. Secondary endpoints include overall survival (OS) across the study arms, PFS by RECIST 1.1 per BICR across the study arms, as well as objective response rate (ORR), time to response (TTR) and duration of response (DOR) per RECIST 1.1 per BICR, and additional safety and efficacy endpoints.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

On May 10, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported consolidated financial results for its second fiscal quarter ended March 31, 2024 (Press release, Applied DNA Sciences, MAY 10, 2024, View Source [SID1234643075]). The Company’s Form 10-Q can be viewed at View Source The Company will not host a financial webcast or call for this most recent quarterly reporting period. The Company will host an investor update call on June 12, 2024.

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Summary Second Quarter Fiscal 2024 Financial Results:

Total revenues were approximately $930 thousand for the three-month period March 31, 2024, compared to $4.4 million for the second quarter of fiscal 2023. The decrease in revenue of approximately $3.5 million was due to an expected decline in COVID-19 testing services revenue of $3.6 million, driven primarily by the conclusion of a testing contract with the City University of New York (CUNY) in June 2023. This decrease was offset by an increase in product revenue of $96 thousand.
Gross profit for the three-month period ended March 31, 2024, was $296 thousand, compared to $1.8 million for the same period in the prior fiscal year. The gross profit percentage was 32% and 41% for the three-month periods ended March 31, 2024, and 2023, respectively. The decline in gross profit percentage was primarily due to a decline in gross profit percentage for our MDx (Molecular Diagnostics) testing services segment, specifically related to an expected decrease in COVID-19 testing volumes year over year.
Operating expenses decreased to $3.9 million for the three-month period ended March 31, 2024, as compared to $4.5 million for the same period in the prior fiscal year. The decrease in operating expenses is the result of a decrease in selling, general and administrative expenses of approximately $523 thousand and a decrease in research and development expenses of $76 thousand. The decrease in SG&A expenses primarily relates to a decrease in payroll, as well as a decrease in stock-based compensation expense of approximately $88 thousand. These decreases were offset by increases of $217 thousand for the reversal of capitalized offering costs related to the ATM transaction that was terminated during the three-month period ended March 31, 2024, and an increase of approximately $162 thousand in professional fees.
Loss from operations was $3.6 million for the three-month period ended March 31, 2024, compared to $2.7 million for the same period in the prior fiscal year.
Excluding non-cash expenses, Adjusted EBITDA was a negative $3.3 million for the three-month period ended March 31, 2024, compared to a negative $2.1 million for the same period in the prior fiscal year.
Cash and cash equivalents stood at $3.1 million on March 31, 2024, compared with $7.2 million as of September 30, 2023.
Subsequent to the second fiscal quarter ended March 31, 2024, on April 25, 2024, the Company filed a Certificate of Amendment of its Certificate of Incorporation with the Secretary of State of the State of Delaware that effected a one-for-twenty (1:20) reverse stock split of its common stock, par value $.001 per share, effective April 25, 2024. All warrant, option, share, and per share information in this press release gives retroactive effect to a one-for-twenty reverse stock split that was affected on April 25, 2024.

On May 10, 2024, the Company announced that it received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market, informing the Company that it has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2).