Syndax Announces Participation in September Investor Conferences

On August 26, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that Michael A. Metzger, Chief Executive Officer, as well as members of the Syndax management team, will participate in the following upcoming investor conferences (Press release, Syndax, AUG 26, 2025, View Source [SID1234655486]):

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Citi’s 2025 BioPharma Back to School Conference with a fireside chat on Tuesday, September 2, 2025, at 4:45 p.m. ET.
H.C. Wainwright 27th Annual Global Investment Conference with a company presentation on Monday, September 8, 2025, at 9:00 a.m. ET.
A live webcast of these sessions will be available in the Investor section of the Company’s website at www.syndax.com, where a replay will also be available for a limited time.

Shattuck Labs Announces Closing of up to $103 Million Private Placement and Appointments to Board of Directors

On August 26, 2025 Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-mediated diseases, reported the closing of Shattuck’s recently announced private placement of up to approximately $103 million, led by OrbiMed (Press release, Shattuck Labs, AUG 26, 2025, View Source [SID1234655485]). Proceeds from the financing, assuming full exercise of common stock warrants, are expected to fund operations into 2029 and advance SL-325 through multiple clinical milestones, including placebo controlled, randomized, Phase 2 trials.

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In association with the closing of the financing, Shattuck also announced the appointment of two new members to its Board of Directors (the Board): Daniel Baker, M.D., industry expert, and Mona Ashiya, Ph.D., Member at OrbiMed. As part of this transition, Directors Tyler Brous, Carrie Brownstein, M.D., Michael Lee, and Kate Sasser, Ph.D., have stepped down from the Board.

"Our recent clearance for the SL-325 IND, closing of the private placement, and Board additions mark an important repositioning of Shattuck as an immunology and inflammation focused organization," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "We believe SL-325 is a potentially first-in-class DR3 blocking antibody with the potential for superior efficacy and reduced immunogenicity relative to TL1A-blocking antibodies. We are grateful to our outgoing Directors, Dr. Carrie Brownstein, Dr. Kate Sasser, Michael Lee, and Tyler Brous, for their longtime support of Shattuck and this transition. We are very pleased to welcome Dr. Dan Baker, M.D., who brings more than 20 years of industry leadership experience, having contributed to the development of Remicade, Simponi and Stelara while serving as the VP of Immunology and Disease Area Stronghold Leader at Johnson & Johnson/Janssen, and also Dr. Mona Ashiya, Ph.D., an accomplished biotechnology industry expert and Member at OrbiMed, to our Board of Directors."

"I look forward to leveraging my immunology and drug development background to help advance a novel DR3 blocking antibody as part of Shattuck’s Board of Directors and working with management to execute on its exciting development program in inflammatory bowel disease," said Dr. Baker. "With SL-325 entering a Phase 1 trial this quarter, I am excited about the multiple data read outs ahead and the opportunity to help guide the program towards proof-of-concept studies."

"I am pleased to be joining the Shattuck Board of Directors and share the Company’s strong commitment to improving outcomes for patients with immune-mediated diseases," said Dr. Ashiya, General Partner of OrbiMed.

Daniel Baker, M.D.

Dr. Baker has over 20 years of drug development experience in the pharmaceutical industry. He currently serves as the interim Chief Development Officer at Cue Biopharma. He has also served as Chief Executive Officer and Founder of KiRa Biotech Pty Ltd., a biotechnology company, and as Venture Partner at OneVentures Investments Australia, a venture capital firm, since 2019. From 2000 to 2019, he served as Vice President, Immunology R&D at Johnson & Johnson (Janssen/Centocor) where he oversaw clinical development of Remicade, Simponi and Stelara and

contributed to more than 15 regulatory approvals in the US, Europe and Japan. Following his retirement from Janssen in 2019, Dr. Baker served as CEO and founder of Kira Therapeutics and more recently as Executive Director on the board of Galapagos Therapeutics from April 2022 until October 2024. Dr. Baker received his Medical Degree from the University of Pennsylvania and completed his Medical Residency at Hershey Medical Center and Fellowship in Rheumatology and Immunology at the University of Pennsylvania, followed by a Research Fellowship in Rheumatology at Mass General Hospital.

Mona Ashiya, Ph.D.

Dr. Ashiya is currently a Member at OrbiMed Advisors LLC, an investment firm, where she has served in various roles of increasing responsibility since 2010. She currently serves on the boards of directors of Disc Medicine, Inc. (NASDAQ: IRON) and several private companies. Dr. Ashiya received her B.A. from the University of California, Berkeley and her Ph.D. in Cellular, Molecular and Developmental Biology from the University of Pittsburgh.

About SL-325

SL-325 is a potential first-in-class Death Receptor 3 (DR3) blocking antibody designed to achieve a complete and durable blockade of the clinically validated DR3/TL1A pathway. Shattuck’s preclinical studies demonstrate high affinity binding and superior activity over TL1A antibodies and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. Shattuck expects to commence a Phase 1 clinical trial in healthy volunteers in the third quarter of 2025.

Sana Biotechnology to Present at September 2025 Investor Conferences

On August 26, 2025 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentations at four investor conferences in September (Press release, Sana Biotechnology, AUG 26, 2025, View Source [SID1234655484]). The presentations will feature a business overview and update.

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Sana will present at Citi’s 2025 Biopharma Back-to-School Conference at 3:15 p.m. ET on Tuesday, September 2, 2025.
Sana will present at the 2025 Wells Fargo Healthcare Conference at 8:00 a.m. ET on Thursday, September 4, 2025.
Sana will present at the Morgan Stanley 23rd Annual Global Healthcare Conference at 11:30 a.m. ET on Monday, September 8, 2025.
Sana will present at the HC Wainwright 27th Annual Global Investment Conference at 9:30 a.m. ET on Tuesday, September 9, 2025.

The webcasts will be accessible on the Investor Relations page of Sana’s website at View Source A replay of each presentation will be available at the same location for 30 days following the conference.

Rigel to Participate in Upcoming September Investor Conferences

On August 26, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that Raul Rodriguez, the company’s president and chief executive officer, and Dean Schorno, the company’s chief financial officer, will participate in the following investor conferences in September (Press release, Rigel, AUG 26, 2025, View Source [SID1234655483]):

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Citi’s 2025 Biopharma Back to School Conference in Boston, MA
Rigel will participate in one-on-one meetings on Tuesday, September 2.

Cantor Global Healthcare Conference 2025 in New York, NY
Rigel will participate in one-on-one meetings and present a company overview on Wednesday, September 3, at 8:35 a.m. ET.

2025 Wells Fargo Healthcare Conference in Boston, MA
Rigel will participate in one-on-one meetings on Thursday, September 4.

H.C. Wainwright 27th Annual Global Investment Conference in New York, NY
Rigel will participate in one-on-one meetings and present a company overview on Tuesday, September 9, at 1:30 p.m. ET.
To access the live webcasts or archived recordings of the Cantor and H.C. Wainwright Conference presentations, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

EMA approves ODD for OXC-101 in AML

On August 26, 2025 Oxcia reported its drug candidate OXC-101 received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (Press release, Oxcia, AUG 26, 2025, View Source;utm_medium=rss&utm_campaign=ema-approves-odd-for-oxc-101-in-aml [SID1234655482]). Now, the European Medicines Agency (EMA) has also granted OXC-101 ODD approval for European markets.

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This approval significantly strengthens Oxcia’s position, both from a strategic, regulatory and commercial standpoint, according to Oxcia’s CEO Ulrika Warpman Berglund:

-These dual approvals give us up to 10 years of market exclusivity in the EU and 7 years in the US, accelerated regulatory processes and significant cost savings. EMA’s approval also provides support and scientific advice from EMA’s expert committee (COMP) for orphan drugs which is a large advantage.

EMA is also evaluating whether the drug candidate can offer significant benefit compared to existing treatments. Obtaining ODD from both the FDA and EMA, two of the world’s largest drug regulatory authorities, strengthens scientific credibility and differentiation from competitors. It facilitates the work of raising additional venture capital and signing licensing agreements with pharmaceutical companies.

Briefly about OXC-101 in AML

Oxcia’s lead drug candidate OXC-101 is a so-called "first-in-class" mitotic MTH1 inhibitor. It has a dual mechanism of action that allows it to target a weakness of cancer cells – their high levels of oxidative stress and their propensity to develop DNA damage. In short, OXC-101 induces further oxidative stress and prevents the cancer cells from repairing the DNA damage.

Preclinical studies have shown that OXC-101 significantly reduces tumor growth and prolongs survival in models of acute myeloid leukemia (AML). In addition, there is support for further development from clinical results from a phase I study in patients with advanced hematological cancers. In addition to OXC-101 having potential as a monotherapy with better efficacy than cytarabine (which is one of the standard treatments for AML) in AML disease models, OXC-101 may also further improve the efficacy of treatment with various standard combinations (various chemotherapies).

Oxcia is currently conducting an expansion study, a combined phase I/II study, in a selected group of patients with relapsed/recurrent AML. The treatment is given in combination with one of the standard treatments (idarubicin). Oxcia has obtained a Vinnova grant for the expansion phase of the study. The aim of the study is to confirm the promising preliminary effects previously observed, and to lay the foundation for a pivotal phase II study that could form the basis for a regulatory accelerated approval. In several of the patients in the MAATEO study, clinical benefits have been observed with a partial response and some stable disease up to 5 months, which is a long time for this aggressive disease in this phase. Some improvement in quality of life has also been reported.

In collaboration with Dr. Tom Erkers and Nona Struyf, Scilifelab/Karolinska Institute, so-called precision medicine studies are being carried out on bone marrow samples from patients in the MAATEO study. These studies aim to identify the patients with the best response. The method may be used to stratify patients in future studies.