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).

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."

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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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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On May 9, 2024 The Jackson Laboratory (JAX), an independent, nonprofit biomedical research organization, and AbTherx, an innovator in biotechnology, reported a strategic partnership to develop and commercialize cutting-edge tools to expedite antibody discovery and derisk the development of vital new therapies (Press release, AbTherx, MAY 9, 2024, View Source [SID1234644017]). This collaboration will include co-development activities and leverages JAX’s extensive experience in model research and AbTherx’s Atlas Mouse platform to address critical challenges facing drug developers of all sizes.

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The Atlas Mouse technologies are engineered to leverage in vivo antibody selection and maturation processes for the creation of human antibodies and are specifically designed to overcome the limitations of historical antibody discovery technologies by offering enhanced speed, diversity, developability, and affinity. Such traits are essential for developing viable lead candidates more swiftly than traditional methods currently allow.

JAX will also become the exclusive distributor of select AtlasTM Mouse models, including AbTherx’s Full Human Diversity Mouse for monoclonal antibody development as well as the Binary Fixed Light Chain Mouse for bispecific and multispecific antibody development. JAX and AbTherx are additionally exploring opportunities to develop and distribute future models to expand on this existing suite of innovative tools.

"By combining JAX’s expertise in high-quality mouse models with the innovative capabilities of our Atlas Mouse platform, we are setting new industry standards," said Justin Mika, CEO of AbTherx. "This collaboration not only enhances our ability to create additional impactful technologies but also ensures that these advancements are within reach of researchers and developers globally, fostering a new era of medical innovation."

"Providing access to high-quality research tools is paramount at The Jackson Laboratory, and we are thrilled to extend our capabilities with innovative models that are pivotal for the creation of new therapeutics," said Mitchell Kennedy, Executive Vice President of The Jackson Laboratory and President of JAX Mice, Clinical & Research Services. "Our partnership with AbTherx is a natural synergy, combining our decades of expertise in mouse model development with their deep knowledge in antibody discovery. Together, we are not only enhancing the tools available to researchers but also accelerating the pace at which impactful treatments can reach patients worldwide."

An early access program is set to launch in the second half of the year, during which time drug developers are invited to test and evaluate these groundbreaking platforms. For more details or to participate in the early access program, please contact JAX at [email protected].