Bristol Myers Squibb Provides Update on Phase 3 CheckMate -73L Trial

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.

APDN Announces Second Quarter Fiscal Year 2024 Financial Results

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).

Attovia Therapeutics Raises $105 Million Oversubscribed Series B Financing Led by Goldman Sachs Alternatives

On May 09, 2024 Attovia Therapeutics reported the closing of a $105 million oversubscribed Series B financing, bringing the total capital raised by the Company since its launch in June 2023 to $165 million (Press release, Attovia Therapeutics, MAY 9, 2024, View Source [SID1234647437]). Proceeds from the financing will be used to advance the Company’s lead programs ATTO-1310 and ATTO-002 through initial clinical data readouts, expand the Company’s immunology and inflammation pipeline, and to further develop the ATTOBODY platform.

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The Series B financing was led by Goldman Sachs Alternatives, with participation from new investors Cormorant Asset Management, Nextech Ventures, Redmile Group, EcoR1 Capital, Marshall Wace, and Logos Capital. Attovia’s existing investors Frazier Life Sciences, venBio, and Illumina Ventures, also participated in the round. Concurrent with the financing, Colin Walsh, Ph.D., Managing Director within Life Sciences Investing at Goldman Sachs Alternatives, was appointed to the Company’s Board of Directors.

"The strong investor interest and timing of this financing underscore the rapid progress we made with Attovia’s differentiated pipeline since the company inception, and the unique potential of our proprietary platform to develop attractive, next-generation immunology product candidates," said Tao Fu, chief executive officer of Attovia. "We are grateful for the support from such a strong group of investors, allowing us to advance our lead programs to the clinic in the near term, further expand our pipeline in novel bi-specifics, and catalyze potential business development opportunities."

Attovia is advancing a pipeline of spatially optimized biparatopic biologics generated from its ATTOBODY platform. The Company’s lead programs, ATTO-1310, a potential first-in-class, long half-life anti-IL31 ATTOBODY, and ATTO-002, a bispecific anti-IL31 x IL13 ATTOBODY, represent potential best-in-class therapeutics for a range of immune-mediated diseases. ATTO-1310 is currently in IND enabling studies and is on track to enter the clinic around year-end 2024 for the treatment of atopic dermatitis and other pruritic diseases. Attovia expects to nominate a development candidate for ATTO-002 in the second half of 2024 and advance the candidate to IND in 2025. The Company is also developing discovery stage programs that expand the ATTOBODY platform footprint to novel, difficult-to-drug targets, and offer additional multi-specific combinations.

"We believe Attovia is well positioned to be a leader in the development of best-in-class novel biologics for patients suffering from a range of diseases in immunology and inflammation," said Colin Walsh, Managing Director within Life Sciences Investing at Goldman Sachs Alternatives. "In a short amount of time, Attovia has leveraged its ATTOBODY platform to generate an impressive pipeline, and we are thrilled to support the further buildout of the company at this pivotal stage."

Consolidated Financial Results for the Fiscal Year Ended March 31, 2024

On May 9, 2024 Ono reported Consolidated Financial Results for the Fiscal Year Ended March 31, 2024 (Filing, 3 mnth, MAR 31, Ono, 2024, MAY 9, 2024, View Source [SID1234646124]).

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Takeda Quarterly Financial Report For the Quarter Ended March 31, 2024

On May 9, 2024 Takeda reported that Quarterly Financial Report For the Quarter Ended March 31, 2024 (Presentation, Takeda, MAY 9, 2024, View Source [SID1234644742]).

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