On May 7, 2024 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2024 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 7, 2024, View Source [SID1234642749]).

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"We are pleased to announce that following a review of the potential development pathways for ATI-2138, our investigational ITK/JAK3 compound with best-in-class potential, we have decided to progress ATI-2138 into a proof-of-concept Phase 2a trial in patients with moderate to severe atopic dermatitis," stated Dr. Neal Walker, co-founder and Interim Chief Executive Officer & President of Aclaris. "Across all of our programs, we remain focused on executing a capital efficient strategy to advance novel immuno-inflammatory therapies."

Research and Development Highlights:

ITK Inhibitor Programs
ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor
Aclaris plans to progress ATI-2138 into a Phase 2a trial in subjects with moderate to severe atopic dermatitis.
In September 2023, Aclaris reported positive results from its Phase 1 multiple ascending dose (MAD) trial of ATI-2138.
ITK Selective Compound
Aclaris is progressing to development candidate selection a second generation ITK selective inhibitor for autoimmune indications.
Lepzacitinib (ATI-1777), an investigational topical "soft" JAK 1/3 inhibitor
In January 2024, Aclaris reported positive top-line results from its Phase 2b trial in atopic dermatitis (AD).
Aclaris is currently seeking a global development and commercialization partner for this program (excluding Greater China). As previously announced, in 2022 Aclaris granted Pediatrix Therapeutics exclusive rights to develop and commercialize lepzacitinib in Greater China.
Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor
Aclaris plans to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib as a potential treatment for pancreatic cancer and metastatic breast cancer. Aclaris expects these trials to be primarily funded by grants awarded to Washington University.
Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $161.4 million compared to $181.9 million as of December 31, 2023. A majority of cash expenditures in the first quarter of 2024 were related to payments associated with exit activities, including the wind down of discontinued R&D programs and the previously announced reduction in force. Aclaris anticipates payments associated with these activities to be substantially completed by the second quarter of 2024. As a result, Aclaris expects significantly lower quarterly cash expenditures in future quarters, without giving effect to any potential business development activities resulting from its ongoing strategic review of its business.

Financial Results

First Quarter 2024

Net loss was $16.9 million for the first quarter of 2024 compared to $28.2 million for the first quarter of 2023.
Total revenue was $2.4 million for the first quarter of 2024 compared to $2.5 million for the first quarter of 2023. The decrease was primarily driven by lower contract research revenue during the three months ended March 31, 2024.
Research and development (R&D) expenses were $9.8 million for the quarter ended March 31, 2024 compared to $22.6 million for the prior year period.

The $12.8 million decrease was primarily the result of lower:
Zunsemetinib development expenses associated with clinical activities for a Phase 2a trial for hidradenitis suppurativa, a Phase 2b trial for rheumatoid arthritis, and drug candidate manufacturing costs.
Costs associated with lepzacitinib preclinical development activities and a Phase 2b clinical trial for AD.
ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial and other preclinical activities.
Compensation-related expenses due to a decrease in headcount and higher forfeiture credits.
General and administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2024 compared to $8.8 million for the prior year period. The decrease was primarily due to a reduction in compensation-related expenses due to lower headcount and higher forfeiture credits.
Licensing expenses were $1.0 million for the quarter ended March 31, 2024 compared to $1.1 million for the prior year period. The decrease was due to the achievement of a commercial milestone during the three months ended March 31, 2023, offset by an increase in royalties earned under the Lilly license agreement.
Revaluation of contingent consideration resulted in a $2.8 million loss for the quarter ended March 31, 2024 compared to a gain of $0.8 million for the prior year period.
Conference Call and Webcast

As previously disclosed on April 30, 2024, management will host a conference call and webcast, with an accompanying slide presentation, at 5:00 PM ET today to provide a corporate update. To access the live webcast of the call and the accompanying slide presentation, please visit the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On May 6, 2024 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, reported that China National Medical Products Administration (NMPA) has cleared Adcentrx’s Investigational New Drug (IND) application for ADRX-0706 which enables the company to include China-based clinical centers in the ongoing Phase 1a/1b study for the treatment of select advanced solid tumors (Press release, Adcentrx Therapeutics, MAY 7, 2024, View Source [SID1234642662]).

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ADRX-0706 is an ADC comprised of a novel fully human IgG1 antibody targeting human Nectin-4 linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies. Nectin-4 is a validated target for ADCs with high expression in multiple solid tumors and limited expression in normal tissues. It plays a crucial role in tumor progression and has been associated with poor prognosis and resistance to conventional therapies.

"NMPA’s clearance of the ADRX-0706 IND is an important milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We now have the ability to recruit patients in both the U.S. and China to generate valuable data in different patient populations, and the data will enable us to further explore ADRX-0706 in treating patients with high unmet needs across multiple tumor types."

The first-in-human Phase 1a/b clinical trial of ADRX-0706 is an open-label, multicenter dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumors. The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects an initial data readout in mid-2024.

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

On May 6, 2024 Assertio Holdings, Inc., a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, reported financial results for the first quarter ended March 31, 2024 (Press release, Assertio Holdings, MAY 6, 2024, View Source [SID1234644703]).

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"We are pleased to report a strong first quarter as our team continues to diligently execute our business plan and seeks to grow Assertio for the benefit of our stockholders," said Heather Mason, interim Chief Executive Officer. "Rolvedon generated its fifth consecutive quarter of demand growth since launch, driven by continued market penetration in the clinic setting. Additionally, we completed enrollment of Rolvedon’s same-day dosing trial, and expect the data readout by year-end, providing a potential opportunity for differentiation through medical society guidelines. We remain committed to our lean promotion platform and steadfast in our business development efforts as we work to secure additional new assets to fuel both sales growth and incremental cash flow generation."

"We are reiterating our guidance for 2024, calling for net product sales of $110 million to $125 million and adjusted EBITDA1 of $20 million to $30 million," concluded Mason.

On May 06, 2024 OverT Bio, a data-driven company working to unlock the curative potential of cell therapies in solid tumors, reported that it has raised $16 million in seed funding (Press release, OverT Bio, MAY 6, 2024, View Source [SID1234642713]). The round was co-led by ARTIS Ventures and Wing VC, with participation from Fusion Fund, OMX Ventures, Alexandria Venture Investments, Gaingels, Civilization Ventures, Hawktail, and Cancer Research Institute. The funding will go toward expanding discovery platforms focused on addressing the primary barriers for cell therapy, leading to durable and curative treatments for advanced solid tumors.

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OverT is the first to use patients’ immune response to cancer to find new receptors and targets that can be applied across the human population. The team searches the entire human genome to find new ways to make cell therapies more durable and capable of destroying cancers. The foundational science has been featured in leading scientific and medical journals, such as Nature and The New England Journal of Medicine.

"Cell therapies have shown, at least in blood cancers, that we can aim to completely cure patients that have even the most advanced diseases rather than just prolong their survival," said Dr. Mat Legut, co-founder and CEO of OverT. "With OverT’s ability to rapidly screen and engineer thousands of genes, we are building next-generation therapies to cure advanced cancers of the solid tissues."

OverT Bio combines cutting-edge cell engineering technologies with big data approaches to address major unmet medical needs in solid tumors. OverT has developed unique massively parallel genetic screening, single-cell multiomic, and synthetic biology platforms to build next-generation cell therapies. OverT’s core platform searches every gene in the genome to identify the best genetic modifications to endow immune cells with novel properties. The company has also built a similarly high-throughput approach to discover new receptors and targets that are both safe and efficacious.

"The OverT team is supercharging cell therapies and finding new cures for cancer," said Sara Choi, partner at Wing VC. "They’re a company that thinks differently and is guided by cutting-edge science – new ways to reprogram T cells, a new class of safe and broadly cancer-specific receptors often ignored by most immunologists. We look forward to supporting the team as they explore the edges of what’s possible in biotech."

"Everything OverT does is based on a patient-centric mission and focused on developing therapies that extend and enhance the lives of cancer patients," said Dr. Vasudev Bailey, partner at ARTIS Ventures. "OverT’s approaches to modifying cell behavior and for receptor discovery are highly differentiated from everything else out there. Instead of making incremental tweaks to existing therapies, OverT is making bold bets on how to create truly transformative cell therapies."

Leveraging decades of experience in cell therapy and immunology, OverT’s founding team has built a large intellectual property portfolio encompassing multiple discovery platforms and preclinical assets. Co-founder and CEO, Dr. Mat Legut, is an immunologist and entrepreneur with a track record of translating discoveries into clinical products, and co-founder, Dr. Neville Sanjana, is a faculty member at the New York Genome Center and NYU, and a pioneer in CRISPR and high-throughput functional genomics.

To learn more about OverT, please visit overt.bio.

On May 06, 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 that Boundless Bio Chief Financial Officer, Jami Rubin, will present at the Citizens JMP Life Sciences Conference 2024 (Press release, Boundless Bio, MAY 6, 2024, View Source [SID1234642712]).

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The podium presentation is scheduled for Monday, May 13, in New York, NY, at 1:00 p.m. ET. A live and archived webcast of the presentation will be accessible under "Events & Presentations" in the Investors section of Boundless Bio’s website.