On September 9, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder, will provide an overview of Puma at 3:30 p.m. ET on Monday, September 14, at the H.C. Wainwright 28th Annual Global Investment Conference. The conference will be held September 14-16, 2026 at the Lotte New York Palace Hotel in New York City.

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A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source The presentation will be archived on the website and available for 30 days.

(Press release, Puma Biotechnology, SEP 9, 2026, View Source [SID1234670700])

On September 9, 2026 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on overcoming cancer drug resistance, reported that John Yu, MD, CEO and Chairman, will present in person a corporate overview at the H.C. Wainwright 28th Annual Global Investment Conference. The conference is being held on September 14 – 16, 2026 at the Lotte New York Palace Hotel.

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Presentation Date: September 14, 2026

Time: 4:00 PM Eastern Time (Holmes 1)

Webcast Link: Available Here

A webcast of the presentation can be accessed on the investor relations section of the Kairos Pharma website. A replay of the webcast will be archived and available following the event for 90 days.

Dr. Yu will be available for one-on-one meetings throughout the conference. To request a meeting and to register for the conference, click below:

View Source

(Press release, Kairos Pharma, SEP 9, 2026, View Source [SID1234670699])

On September 9, 2026 Ridge Biotechnologies (Ridge Bio), a biotechnology company pioneering enzyme and conditionally-activated drug design to power the next wave of precision therapeutics, reported additional investment, bringing capital raised to approximately $38M. The upsized seed round was anchored by Dimension Capital, joining founding investor Sutter Hill Ventures (SHV), which incubated the company prior to its launch in the fall of last year, and Overlap Holdings, which participated in the initial oversubscribed seed fundraise. Ridge Bio will use the capital to support its new partnerships, scale its data-generation and machine learning platforms, broaden its bioconjugation enzyme and linker portfolio, and advance internal discovery programs toward the company’s longer-term goal of developing a new class of enzyme-based therapeutics.

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"We’ve moved quickly over the last year to demonstrate the potential of our technologies to improve therapeutic indices and ultimately benefit patients," said Weston Kightlinger, PhD, founder and CEO of Ridge Bio. "Our recent animal studies show that ADCs made with our NativeLink-AXC enzyme had several-fold lower toxicity than approved ADCs with improved efficacy, using the same antibody and payload amount. We’ve also demonstrated the generalizability of our platform to cutting-edge drug classes where precision assembly and release are even more important, including bispecific, peptide, degrader, and radio conjugates. This is why drug developers are bringing us targets they couldn’t safely reach, molecules they want to improve, and designs they couldn’t build in other ways. Our partners and our team are energized by these results, and this capital lets us meet that demand and double down on that momentum."

Ridge Bio uses proprietary machine learning models informed by high-throughput, cell-free experimentation to design precision enzymes and targeted drug delivery systems. The approach generates up to a million-fold more sequence-function data than conventional methods and allows for the design of bioconjugate drugs with improved or novel functionality. The company’s initial products are NativeLink enzymes, a line of designed enzymes that attach diverse payloads to proteins site-specifically and homogeneously without altering sequence, disulfide bonds, glycans, or upstream manufacturing; ProTrigger linkers, a platform for designing protease-cleavable linkers that release therapeutic payloads only in target tissues; and Catalytic Medicines, a new class of precision enzyme-based therapeutics.

Commercial Momentum and Investor Conviction

Ridge Bio has added several new partnerships over the past year, working with leading biotechs to apply NativeLink enzymes and ProTrigger linkers to their bioconjugate drug programs. The agreements span multiple modalities and reflect rising demand for technologies that improve therapeutic indices without forcing changes to established antibody manufacturing and providing access to targets that have been difficult to reach with conventional ADCs.

"We are excited to partner with Ridge Bio as they build a next-generation conjugate medicines platform grounded in computational design. By engineering built-to-spec enzymes and linker systems, Ridge aims to enable new targets and mechanisms of action while delivering superior stability, biodistribution, and tissue selectivity to widen the therapeutic window," said Nan Li, Co-Founder and Managing Partner at Dimension Capital.

"Ridge has achieved an extraordinary rate of technological innovation and commercial traction, and we’re excited to welcome the Dimension team and others as we continue to support and scale the company," said Keith Loebner, Managing Director at Sutter Hill Ventures.

Industry Recognition

Ridge Bio was honored with the 2026 SynBioBeta Rising Star Award, recognizing emerging leaders whose work is reshaping the field of synthetic biology. Founder and CEO Weston Kightlinger accepted the award on behalf of the Ridge Bio team.

Hans Wandall, MD, PhD, who nominated Ridge Bio for the award, said, "Precision targeting and machine learning are progressing at an extraordinary pace, but the approach that Ridge is taking is truly unique and the level of innovation is beyond what I am seeing across industry and academia."

"There are no do-overs, the magic only happens when you bring together the absolute best people you can find to steer cutting-edge capabilities from several fields towards a compelling market… Developing technologies to move the needle on safety and efficacy for patient benefit, that’s what really assembles and drives a team like this," said Kightlinger.

Leadership Team Expansion

Ridge Bio has appointed Romas Kudirka, PhD, as Vice President of ADCs. Dr. Kudirka brings more than 15 years of experience in antibody-drug conjugate development, most recently as Head of ADCs at Santa Ana Bio and Director of Chemistry and Bioconjugation at Bolt Biotherapeutics. His earlier work spans Catalent, Redwood Bioscience, and the Novartis Research Foundation. At Ridge Bio, he leads the translation of NativeLink enzymes and ProTrigger linker technologies into partner ADC programs.

Ridge Bio has also appointed Grant Blouse as a Scientific Advisor. Dr. Blouse brings more than 25 years of biopharmaceutical leadership spanning early discovery through clinical development across autoimmunity, hematology, and oncology. Grant has served as Chief Scientific Officer of TheraPaint, Chief Scientific Officer of Catalyst Biosciences, and Program Lead at Novo Nordisk. Dr. Blouse is a world-leading expert in enzyme-based therapeutics and advises Ridge Bio on strategy for the ProTrigger linkers and Catalytic Medicines products.

Grant joins Ridge Bio’s distinguished scientific advisory board that includes Carolyn Bertozzi, PhD (Stanford University, 2022 Nobel Laureate in Chemistry); Sangeeta Bhatia, MD, PhD (MIT/HHMI); Michael Jewett, PhD (Stanford University), the company’s academic co-founder and SAB chair; Gabe Kwong, PhD (Georgia Tech); Mandana Honu, PhD (Fathom Therapeutics and Sutter Hill Ventures, formerly Protillion Biosciences); Hans Wandall, MD, PhD (University of Copenhagen); and Vesna Mitchell, PhD (formerly Codexis).

(Press release, Ridge Bio, SEP 9, 2026, View Source [SID1234670698])

On September 9, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported two poster presentations at the 2026 Society of Hematologic Oncology (SOHO) Annual Meeting, which will be held September 9-12 in Houston, Texas.

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PharmaEssentia will present two-year results from the Phase 3 SURPASS-ET study (NCT04285086) and its ongoing extension in adults with high-risk essential thrombocythemia (ET) who were resistant to or intolerant of hydroxyurea. In the extension, it was observed that study participants who continued BESREMi (ropeginterferon alfa-2b-njft) maintained modified ELN response rates and platelet and white blood cell control through two years, with continued reduction in JAK2V617F variant allele burden and a safety profile consistent with prior reports. Patients followed in the extension study who transitioned from anagrelide to BESREMi after the 52-week core study showed improved hematologic control and reduced JAK2V617F allele burden relative to their prior anagrelide therapy. Long-term efficacy and safety analyses are ongoing. Two-year results were presented in part as an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress.

Additionally, PharmaEssentia will present real-world evidence from a retrospective cohort study of 55 patients with ET evaluating the use of BESREMi in community oncology settings. The analysis found that BESREMi was most commonly initiated after first-line therapy, while first-line use was also observed, predominantly in younger patients. Platelet counts and response rates trended toward optimal levels regardless of prior cytoreductive therapy history.

Poster Presentation Details

Title: Efficacy and Molecular Dynamics of Ropeginterferon Alfa-2b in High-risk Essential Thrombocythemia: Two-year Results from the Phase 3 SURPASS-ET Trial
Abstract Number: 944
Poster Number: MPN-944
Presenter: Dr. Lucia Masarova, University of Texas MD Anderson Cancer Center
Date: 9/9/26
Time: 6:25-7:55 PM

Title: Real-world Patient Characteristics, Treatment Patterns and Blood Counts of Patients with Essential Thrombocythemia Treated with Ropeginterferon Alfa-2b in the US Community Oncology Setting
Abstract Number: 1090
Poster Number: MPN-1090
Presenter: Dr. Solly Chedid, Singing River Cancer Center
Date: 9/9/26
Time: 6:25-7:55 PM

(Press release, PharmaEssentia, SEP 9, 2026, View Source [SID1234670697])

On September 9, 2026 TwoStep Therapeutics, a biotechnology company developing multi-specific targeted therapies for solid tumors, reported an oversubscribed $62.5 million Series A financing and clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for TS-104, the company’s lead multi-specific peptide-drug conjugate. The IND clearance enables TwoStep to initiate a first-in-human Phase 1 clinical trial of TS-104, with patient enrollment expected to begin later this year.

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The $62.5 million Series A was led by Insight Partners and Medical Excellence Capital, with M Ventures (the strategic, corporate venture capital arm of Merck KGaA, Darmstadt, Germany) and Pfizer Ventures joining as co-lead investors, alongside existing investors, NFX and 2048 Ventures. Additional investors also participated, including Stanford University, where the foundational science behind TwoStep was developed before the company launched in 2024. TwoStep was co-founded by Chief Executive Officer Caitlyn Miller, PhD, in collaboration with three faculty from Stanford University: Jennifer Cochran, Nobel laureate Carolyn Bertozzi, and Ronald Levy. The Series A financing brings TwoStep’s total capital raised to $71.2 million.

"This financing, together with FDA clearance of the IND, marks an important inflection point for TwoStep and positions us to advance TS-104, our lead peptide-drug conjugate, through Phase 1 clinical development in oncology. This trial will provide the first clinical evaluation of the multi-specific targeting approach at the heart of TwoStep and begin to assess its potential to broaden the reach of targeted therapies," said Caitlyn Miller, PhD, Co-Founder and Chief Executive Officer of TwoStep Therapeutics. "Beyond TS-104, the proceeds will enable us to advance our radioligand program and expand into next-gen peptide conjugates."

Most tumor-targeted therapies depend on high and relatively uniform expression of a single cell-surface target. In solid tumors, however, target expression can vary substantially across tumor types, between patients, and even among cells within the same tumor. This heterogeneity can restrict the addressable patient population, complicate patient selection, and allow target-low or target-negative tumor cells to escape treatment.

Rather than relying on a single target, TwoStep uses a polyspecific integrin-binding peptide (PIP) as the targeting component of its therapies. PIP is a small, synthetic peptide that targets five tumor-associated integrins expressed across a broad range of solid tumors. By engaging multiple targets rather than depending on high expression of a single antigen, PIP is designed to provide broader and more consistent tumor recognition across heterogeneous tumors. Its small size, rapid internalization, and flexible conjugation chemistry also provide attractive properties for targeted drug delivery, including the ability to pair the same targeting scaffold with different therapeutic payloads. TwoStep is leveraging this modular architecture to build a pipeline spanning peptide-drug conjugates and radioligand therapies. The company’s lead program, TS-104, couples PIP to the clinically validated cytotoxic payload MMAE.

"TwoStep is addressing one of the central challenges in solid-tumor drug development: identifying a targeting approach that can reach meaningful numbers of patients without relying on a single, uniformly expressed tumor target," said Matias Porras Paniagua, PhD, Vice President at Insight Partners. "By engaging multiple tumor-associated integrins through a small and rapidly internalizing targeting agent, TwoStep’s approach has the potential to broaden the reach of targeted therapies across tumor types and patient populations. As TS-104 enters clinical development, we look forward to seeing that potential realized in practice."

"MEC is proud to lead the Series A financing. TwoStep truly exemplifies the characteristics we seek in leading transformative biotechnology investments: highly differentiated science, rigorous execution, and a management team dedicated to translating innovation into meaningful clinical impact for patients. Reaching an FDA-cleared IND for TS-104 is a significant accomplishment. Moreover, the caliber of this investor syndicate reflects confidence in the company’s scientific foundation as well as its long-term potential," said John Prufeta, Founder and General Partner of Medical Excellence Capital, LLC. "We look forward to supporting Caitlyn and the outstanding TwoStep team to build a leading precision oncology company as they advance this potentially transformational program into the clinic."

In connection with the financing, TwoStep expanded its Board of Directors with the appointments of Matias Porras Paniagua, PhD (Insight Partners), John Prufeta (Medical Excellence Capital), Oliver Lyth, PhD (M Ventures), and Rana Al-Hallaq, PhD (Pfizer Ventures). The new directors join original Board members: Omri Amirav-Drory, PhD (NFX) and Caitlyn Miller, PhD (TwoStep).

(Press release, TwoStep Therapeutics, SEP 9, 2026, View Source [SID1234670696])