On June 30, 2026 Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover and develop precision medicines, reported the closing of an $85 million Series C financing led by existing investors. In connection with the financing, the company also announced the appointment of Anna Protopapas as Chief Executive Officer.

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The financing was led by Third Rock Ventures and Nextech Invest and included participation from Pfizer Ventures, Boxer Capital, GordonMD Global Investments LP, Invus, Casdin Capital, Eli Lilly and Company, Novartis, Agent Capital and Eventide Asset Management. Proceeds from the financing will be used to advance the Company’s prioritized programs, as well as for working capital and general corporate purposes.

Pipeline Prioritization

In connection with the financing, the Company has completed a strategic review of its pipeline and will concentrate resources on FX-111, a first-in-class, highly differentiated, potent and selective degrader targeting ARON, the transcriptionally active, hormone-bound androgen receptor for prostate cancer. By targeting ARON, FX-111 has the potential to overcome the key resistance mechanisms that limit conventional therapies directed at AROFF, particularly in high-risk AR-driven disease, with broad applicability across all stages of AR-driven disease. The Company received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) and expects to initiate clinical development in the third quarter of 2026. FlareTx is also advancing an ARON Regulated Induced Proximity Targeting Chimeras (RIPTAC) program through preclinical development. This program complements FX-111 and further expands the Company’s ability to address prostate cancer across the full disease continuum.

"At Nextech, we focus capital where we see the strongest scientific and clinical conviction," said Kanishka Pothula, Managing Partner at Nextech Invest. "We believe FlareTx’s ARON-targeting approach is highly differentiated and has the potential to address important limitations of current prostate cancer therapies. This financing reflects our continued conviction in the team, the platform, and the potential of FX-111 to become an important therapy for patients with AR-driven prostate cancer."

"Our continued support of FlareTx into this next phase of growth is a testament to the differentiated transcription factor platform that has advanced novel programs into the clinic with potentially transformational impact to patients," said Abbie Celniker PhD, FlareTx founder and Partner at Third Rock Ventures. "We are also very pleased to welcome Anna Protopapas as incoming CEO. Her proven track record of leadership in oncology, spanning global development through commercialization, makes her exceptionally well suited to lead the Company."

FX-909, a first-in-class, orally available PPARG inhibitor targeting the luminal lineage biology underlying urothelial cancer, is currently being evaluated in a Phase 1B dose expansion study. The Company intends to advance this program through an external partnership to fully realize its potential, including opportunities to explore combination regimens and earlier lines of therapy where luminal lineage biology plays a defining role.

"This is an exciting time for Flare Therapeutics and for patients with prostate cancer who desperately need new options. FX-111 offers a new approach to targeting the androgen receptor pathway that has the potential to transform prostate cancer treatment across all stages of disease, while avoiding mechanisms of resistance, representing a genuinely differentiated opportunity," said Anna Protopapas, incoming Chief Executive Officer. "I am thrilled to lead a team that has proven it can advance a platform focused on drugging transcription factors and look forward to demonstrating that potential as we initiate our Phase 1A clinical study for FX-111 in the coming weeks."

CEO Appointment

Anna Protopapas joined the board of Flare Therapeutics in February 2025 and became Chair in September 2025. Most recently, Ms. Protopapas served as President and Chief Executive Officer of Mersana Therapeutics from 2015 until September 2023, where she led advancement of the company’s ADC platforms and pipeline, transitioning the company to a publicly traded entity and raised significant capital through partnerships and equity financing. Prior to Mersana, Ms. Protopapas was President of Millennium, a wholly owned subsidiary of Takeda, where she led Takeda’s oncology business. Ms. Protopapas also served as Executive Vice President of Global Business Development at Takeda, where she led acquisitions and partnerships that helped catalyze Takeda’s growth and globalization. Earlier, Ms. Protopapas was an executive officer at Millennium and served in various senior leadership positions, playing an integral role in the company’s transformation from a genomics start-up to a fully integrated oncology leader and the subsequent acquisition of the company by Takeda. Ms. Protopapas has served as the Chair of the Board at Nuvalent since early 2022 (recently announced to be acquired by GSK for $10.6B) and previously served on the boards of ARIAD Pharmaceuticals (acquired by Takeda), Bioverativ (acquired by Sanofi) and Dicerna (acquired by Novo Nordisk) and Mersana Therapeutics (acquired by Day One). She received her B.S. in Science and Engineering from Princeton University, M.S. in Chemical Engineering Practice from the Massachusetts Institute of Technology and M.B.A. from Stanford Graduate School of Business.

(Press release, Flare Therapeutics, JUN 30, 2026, View Source [SID1234669028])

On June 30, 2026 Orion Pharma ("Orion") and Shilpa Biologicals Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited ("Shilpa"), reported to have entered into an agreement to commercialise intravenous (iv) nivolumab biosimilar in Europe. Nivolumab is an immune checkpoint inhibitor which is used to treat various cancers. Shilpa’s nivolumab biosimilar is currently under development by the company.

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Under the terms of the agreement, Orion will gain exclusive right to distribute, market and sell Shilpa’s iv nivolumab biosimilar in Europe. Shilpa will supply the product to Orion, and is entitled to receive from Orion certain development and regulatory milestone payments.

"We are pleased to add yet another product to our strategic partnership with Shilpa," said Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma. "This agreement is a step forward in our efforts to expand and strenghten our operations in hospital segment in Continental Europe, and an indication of the progress of the implementation of our division’s strategy which aims to create everybody an access to affordable quality medicines."

"Extending our partnership with Orion into immuno-oncology is a defining moment for Shilpa Biologicals," added Vishnukant Bhutada, Managing Director, Shilpa Medicare. "It reflects the trust our partners place in our quality, our science and our ability to deliver complex biologics at scale – and it moves us closer to our mission of making advanced medicines affordable and accessible worldwide."

(Press release, Orion, JUN 30, 2026, View Source [SID1234669027])

On June 30, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported that it has entered into definitive securities purchase agreements for a private placement expected to result in gross proceeds of approximately $50 million, before deducting placement agent fees and offering expenses, and an additional approximately $64 million of gross proceeds if the accompanying warrants are exercised in full for cash.

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The financing was led by BVF Partners L.P. with participation from GordonMD Global Investments, RTW Investments, and Coastlands Capital. The upfront proceeds are expected to extend the Company’s cash runway into the second quarter of 2027 and support the continued advancement of its lead clinical program, MICVO (micvotabart pelidotin), through key clinical milestones.

"We are pleased to have the support of a high-quality group of new and existing healthcare investors, whose participation reflects confidence in MICVO and our strategy to advance the program," said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. "This financing strengthens our balance sheet, provides the flexibility to extend patient follow-up in our expansion trial following completion of enrollment in the first quarter, and enables us to generate additional clinical evidence for MICVO. We look forward to an exciting second half of 2026 as we continue advancing MICVO for patients with head and neck cancer."

The Company has elected to incorporate additional patient follow-up and planned analyses into its next clinical update and now expects to report updated data from the ongoing Phase 1 monotherapy study in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) in Fall 2026. The update is expected to include patients treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, along with detailed analyses of the dose cap impact on safety, tolerability and efficacy.

The Company also expects to report updated data from the ongoing Phase 1/2 dose-escalation study evaluating MICVO in combination with pembrolizumab for first-line (1L) R/M HNSCC in the fourth quarter of 2026.

Under the terms of the financing, Pyxis Oncology has agreed to sell 19,600,153 shares of its common stock at a price of $2.551 per share and warrants to purchase an equal number of shares of common stock. The common stock warrants have an exercise price of $3.289 per share and are exercisable in accordance with their terms (including via cashless exercise). The private placement is expected to close on or about July 2, 2026, subject to the satisfaction of customary closing conditions.

Wells Fargo Securities acted as sole placement agent for the private placement.

The securities described above have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. Pyxis Oncology has agreed to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the shares of common stock issued in the private placement and the shares issuable upon exercise of the warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

(Press release, Pyxis Oncology, JUN 30, 2026, View Source [SID1234669026])

On June 30, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported that the U.S. Food and Drug Administration (FDA) has granted authorization for its Investigational Device Exemption (IDE) application for the use of Adaptive Biotechnologies’ clonoSEQ assay in the TENACITY-01 clinical trial (NCT07070219). The TENACITY-01 trial evaluates CTD402, Imviva’s investigational allogeneic anti-CD7 CAR-T cell therapy, for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) and patients with T-ALL/LBL in first or second complete remission with minimal (or measurable) residual disease (MRD-positive).

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Next-generation sequencing-based clonoSEQ provides highly sensitive, reliable detection of MRD—small amounts of cancer that remain after treatment but are often missed by standard methods and can lead to relapse. The relationship between MRD status and relapse risk is well-established, and a threshold of 0.01% (10-4) is widely used as a clinically actionable cutoff to define high-risk disease and guide treatment escalation in ALL (National Comprehensive Cancer Network). The use of clonoSEQ will serve a dual purpose in the TENACITY-01 trial—identifying patients with MRD levels of 0.1% or higher for enrollment eligibility and detecting and quantifying MRD in post-treatment bone marrow samples to support exploratory analyses.

IDE authorization signals that an assay is capable of being used in a highly regulated clinical development program where test results may be used for patient management. This IDE authorization enables the use of highly sensitive MRD assessment in the TENACITY-01 trial to identify eligible patients for enrollment and precisely evaluate treatment response.

Despite improvements in remission rates for newly diagnosed T-ALL/LBL, particularly in pediatric populations, high relapse rates remain a significant challenge. MRD status is one of the strongest independent predictors of relapse and survival in ALL, with studies showing 10-year event-free survival rates of approximately 77% versus 32% for MRD-negative versus MRD-positive pediatric patients (Berry et al., 2017).

"FDA authorization of our IDE is a significant step forward as we advance the TENACITY-01 clinical trial," said Jan Davidson-Moncada, MD, PhD, Imviva Biotech Chief Medical Officer. "Integrating clonoSEQ will allow us to more accurately monitor MRD and evaluate the durability of CTD402. These insights can accelerate clinical decision-making and ultimately support improved patient outcomes by enabling earlier intervention and more personalized treatment strategies."

"As the field moves increasingly toward MRD-guided treatment strategies, interventional clinical trials require MRD technologies that can deliver highly sensitive, standardized results across diverse clinical settings," said Mary Pat Lancelotta, Senior Vice President, MRD Biopharma at Adaptive Biotechnologies. "With its extensive clinical validation and broad use in hematologic malignancies, clonoSEQ is uniquely positioned to support these next-generation trial designs and help advance MRD-guided care for patients with T-ALL/LBL."

The ongoing global, single-arm, open-label TENACITY-01 trial is enrolling adolescents and adults (≥12 years) to evaluate the safety, efficacy, and cellular pharmacokinetics of CTD402. The current study will enroll up to 120 patients, divided between R/R and MRD-positive cohorts. All participants will receive a standard dose lymphodepletion (fludarabine/cyclophosphamide) and a flat dose of 400×10⁶ CTD402 CAR-T cells.

For more information, visit www.imvivabio.com.

About CTD402

CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva’s proprietary ANSWER inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an ‘off-the-shelf’ allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease.

A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).

(Press release, Imviva Biotech, JUN 30, 2026, View Source [SID1234669025])

On June 30, 2026 Liminatus Pharma, Inc. (Nasdaq: LIMN) ("Liminatus" or the "Company"), a biotechnology company developing innovative cancer therapies, reported that it has amended and restated the previously announced definitive merger agreement with InnocsAI LLC ("InnocsAI"), an oncology biotechnology company focused on next-generation cell therapy technologies.

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The transaction has been re-structured to allow closing prior to obtaining stockholder approval, with closing now expected to occur on July 2, 2026, subject to the satisfaction or waiver of customary closing conditions.

Under the amended terms of the merger agreement, the equity holders of InnocsAI will receive merger consideration consisting of a combination of Liminatus common stock and newly designated non-voting convertible preferred stock, at an issue price of $0.20 per common share, representing an aggregate implied transaction value of approximately $320 million, together with contingent value rights representing the right to receive 20% of future net proceeds from certain strategic transactions involving the acquired assets.

Upon closing of the merger:

The InnocsAI equity holders will receive shares of Liminatus common stock representing up to the maximum amount issuable without prior stockholder approval under applicable Nasdaq listing rules (or an estimated 19.99% of the Company’s outstanding common stock immediately prior to the closing); and
The balance of the merger consideration will consist of shares of newly designated non-voting convertible preferred stock.
The non-voting convertible preferred stock will not be convertible into common stock unless and until the Company has obtained stockholder approval for the issuance of the underlying common shares to the extent required under applicable Nasdaq listing rules.

The merger consideration is expected to be issued following the closing in accordance with the amended terms of the merger agreement and related transaction documents.

"This merger represents a transformational step in Liminatus’ strategy to build a diversified oncology biotechnology company," said Chris Kim, Chief Executive Officer of Liminatus Pharma. "InnocsAI’s innovative cell therapy platform complements our existing immuno-oncology programs and significantly broadens our development pipeline while providing multiple opportunities to create long-term shareholder value."

Strategic Benefits

The combined company is expected to benefit from:

An expanded oncology pipeline spanning cell therapy and immunotherapy.
Multiple preclinical product candidates.
Proprietary intellectual property supporting future oncology development.
Increased opportunities for strategic partnerships and licensing.
A diversified platform targeting both hematologic malignancies and solid tumors.
Following closing, Liminatus intends to pursue integration activities, file a registration statement on Form S-1 relating to the merger consideration, seek the required stockholder approvals, and continue advancing the combined oncology pipeline.

Additional information regarding the amended and restated merger agreement will be included in a Current Report on Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission (the "SEC").

(Press release, Liminatus Pharma, JUN 30, 2026, View Source [SID1234669024])