On May 15, 2025 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported the pricing of an offering of 834,237 shares of its common stock at an offering price of $6.61 per share and pre-funded warrants to purchase 1,587,108 shares of its common stock at an offering price of $6.6099 per pre-funded warrant share in an underwritten registered direct offering to a limited number of existing institutional investors, including entities affiliated with Adiumentum Capital Management, EcoR1 Capital, Panacea Venture and Redmile Group (Press release, Atara Biotherapeutics, MAY 15, 2025, View Source [SID1234653158]). The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable upon issuance. The offering is expected to close on or about May 16, 2025, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be $16 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Atara. Atara currently intends to use the net proceeds from the offering to fund its ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, and for working capital and general corporate purposes.

TD Cowen is acting as the sole bookrunner for the offering.

The securities described above are being offered by Atara pursuant to a shelf registration statement on Form S-3 (No. 333-275256), including a base prospectus, that was previously filed by Atara with the U.S. Securities and Exchange Commission (the "SEC") on November 1, 2023 and was declared effective on November 13, 2023. A prospectus supplement containing additional information relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained by contacting TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]

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

On May 15, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported corporate highlights and unaudited financial results for the first quarter of 2025 (Press release, Molecular Partners, MAY 15, 2025, View Source [SID1234653176]).

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"Molecular Partners is on track to reach key clinical milestones in 2025. In January, we expanded our strategic radiotherapy partnership with Orano Med and are continuing to advance the lead program, MP0712, towards a first-in-human trial. With the data package of MP0712 complete, we anticipate both the IND filing and initial clinical data on MP0712 in 2025. The early images and dosimetry data will be a strong surrogate for the expected efficacy and safety in Phase 1. Our multispecific T cell engager MP0533 is progressing in its Phase 1/2a trial in acute myeloid leukemia. Initial data from cohort 8, with an additional dosing point in the step-up dosing, indicate increased rates and depth of responses, while the fully amended dosing scheme is being tested in cohort 9. Our focus remains firmly on delivering results that further validate our science and create meaningful value for patients and stakeholders alike, based on a solid financial position with funding in place well into 2027," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Research & Development Highlights

MP0712, Radio-DARPin Pipeline and Global Partnership with Orano Med

In January 2025, Molecular Partners and Orano Med further expanded their agreement to co-develop up to ten 212Pb-labeled radiotherapy programs. Molecular Partners holds commercialization rights to MP0712, a Radio-DARPin therapy (RDT) candidate targeting delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC), and to the second program, targeting mesothelin (MSLN). In addition to its world class expertise and capabilities in the development of targeted alpha therapy (TAT) with 212Pb, Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization.

Molecular Partners presented preclinical data in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, showing high tumor uptake and a favorable toxicity profile for MP0712, with good efficacy and tumor reduction in mouse models matching clinically relevant DLL3 expression levels. With these data, the Investigational New Drug (IND)-enabling package is complete.

The IND application for MP0712 is planned for mid 2025 and dialogue with the U.S. Food and Drug Administration (FDA) is ongoing. Based upon discussion with the agency the Company has determined that a Phase 0 imaging study, which was previously planned, will not be necessary. MP0712 will proceed directly to a Phase 1 dose-escalation study utilizing 212Pb, which includes an imaging step using 203Pb. This study will initiate in the second half of 2025, pending IND submission and clearance.

In addition, Molecular Partners has received and accepted a request from Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa to provide MP0712 for imaging use under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). This approach enables the generation of first images applying MP0712 labelled with 203Pb in patients with SCLC. While the decision of where and how to share data from the image work under Section 21 remains at the discretion of NuMeRI, the Company anticipates providing an update on MP0712 in H2 2025.

The second RDT program co-developed with Orano Med targets MSLN, a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. The development of therapeutics against MSLN has been hampered by high shedding of MSLN, leading to high levels of soluble MSLN. Leveraging the unique properties of DARPins, Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN. First preclinical data from the MSLN program were presented at AACR (Free AACR Whitepaper) 2025, with in vivo results showing a favorable biodistribution with strong tumor accumulation of the Radio-DARPin in a MSLN-overexpressing model in mice. Molecular Partners will present more preclinical data on the MSLN program in an oral presentation at the 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in June.

MP0533 (Multispecific T Cell Engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (ClinicalTrials.gov: NCT05673057). Dose escalation in cohorts 1–7 showed an acceptable safety profile and initial activity, yet with unsustained responses (four responders reported and encouraging blast reductions across additional patients).

In the ongoing cohort 8, an additional dosing timepoint was introduced to allow steeper step-up and more frequent dosing to reach the MP0533 target dose faster. Data from this cohort indicate increased rates and depth of responses, with three out of eight evaluable patients demonstrating responses (data cutoff 16 December 2024). The Company will present additional data on Cohort 8 at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June 2025.

The study protocol has been amended to improve the exposure profile of MP0533 based on the learnings from the dose escalation cohorts, and has been approved by regulatory authorities in April 2025. It foresees further MP0533 dose densification and premedication to mitigate loss of exposure, with the objective to further increase the rate, depth and duration of responses observed in cohort 8. Enrollment has started and data on the amended dosing scheme are expected in 2025.

Switch-DARPin Platform (Next-generation Immune Cell Engagers)

By employing a multi-specific Switch-DARPin, Molecular Partners aims to increase the safety and potency of T cell engagers (TCEs). Preclinical proof-of-concept in a solid tumor model for a novel CD3 Switch-DARPin TCE was presented at AACR (Free AACR Whitepaper) 2025.The CD3 Switch-DARPin activates T cells specifically in the presence of cells co-expressing MSLN and epithelial cell adhesion molecule (EpCAM), increasing tumor specificity. The data presented provide further validation of Switch-DARPins and show that conditional T-cell activation with potent CD2 co-stimulation in solid tumors, but not in healthy tissues, is feasible.

Molecular Partners’ first Switch-DARPin program, MP0621, is designed to induce killing of hematopoietic stem cells (HSCs) as a next-generation conditioning regimen for HSC transplantation. The Company has presented pre-clinical proof-of-mechanism data on MP0621 in 2024. As its portfolio strategy prioritizes therapeutic candidates for oncology, MP0621 is being evaluated for partnering.

MP0317 (localized agonist)

Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 dose escalation trial of the localized CD40 agonist MP0317 in solid tumors at SITC (Free SITC Whitepaper) in November 2024. MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated trials of MP0317 in 2025, in combination with immune checkpoint inhibitors and additional standard of care for patients with solid tumors.

Corporate Governance Highlights

All motions proposed by the Board of Directors at the Annual General Meeting, held in April 2025, were approved by the shareholders of the Company.

Financial and Business Outlook
For the full year 2025, at constant exchange rates, the Company expects total operating expenses of CHF 55-65 million of which around CHF 7 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation.

The Company’s cash and cash equivalents and short-term time deposits were CHF 131 million as of March 31, 2025 and based on current operating assumptions, will be sufficient to fund its operating expenses and capital expenditure requirements well into 2027.

On May 15, 2025 Immunofoco, a company dedicated to advancing cell therapies for solid tumors, reported that its independently developed, innovative lentiviral vector-based In Vivo CAR-T Technology Platform made a remarkable appearance at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Immunofoco, MAY 15, 2025, View Source;immunofocos-in-vivo-car-t-technology-platform-debuts-with-groundbreaking-innovations-302456246.html [SID1234653194]). This platform has broken the patent barriers in this field, achieving significant in-vitro and in-vivo specificity and efficacy, and providing a new strategy for tumor immunotherapy.

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Novel Lentiviral Vector: Overcoming Patent Barriers with Superior Performance

Immunofoco’s team developed a novel lentiviral vector pseudotyped with the MxV glycoprotein (MxV-G), demonstrating performance in generating CAR-T cells in vivo. Compared with the traditional VSV-G pseudotyped lentiviral vector, MxV-G pseudotyped vector not only enhances viral titer and transduction efficiency but also enables generated CAR-T cells to more effectively target and kill tumor cells. This novel envelope has good clinical application potential in both traditional ex vivo CAR-T and in vivo CAR-T.

AI-Driven Optimization: Successful Construction of Precision-Engineered Tropism-Modified Mutants

To eliminate the natural tropism of MxV-G and enhance its specificity, the team used an AI-driven protein model to successfully design and construct a mutant MxV-G. The mutated MxV-G eliminates the infectivity to non-T cells while retaining its membrane-fusion-mediating activity. By introducing different T-cell targeting modules, its infectivity to T cells is restored, achieving precise targeting and improving the safety and efficacy of treatment.

Next-Generation T-Cell Targeting Molecules: Upgrading Specificity and Anti-Tumor Activity

To target T cells precisely, the team engineered multiple T-cell-targeting molecules (TCM). TCM3 demonstrated selective T-cell transduction with no off-target effects and outperformed αCD3/CD80/CD58 (MDF) and αCD3/CD80 in efficiency when paired with different membrane fusion protein variants. CAR-T cells generated by MxV-G-TCM3 showed high specificity across cell lines and reduced T-cell exhaustion markers, supporting sustained activity and improved tumor control. In mouse models, this combination exhibited significantly stronger in vivo anti-tumor efficacy compared to αCD3/CD80/CD58.

Dr. Hao Ruidong, Partner and Head of the R & D Center at Immunofoco, said, "CAR-T cell therapy has revolutionized cancer treatment, yet its complex manufacturing and high costs limit accessibility. Our novel in vivo CAR-T platform, powered by lentiviral technology, breaks foreign patent barriers in fusion proteins and T-cell targeting while showing strong in-vitro and in-vivo specificity and efficacy. With simpler manufacturing and lower costs, we aim to make this life-saving treatment accessible to more patients. Moving forward, we’ll advance its clinical potential to maximize impact."

On May 15, 2025 Eisai reported financial results and business update for the full year 2024 (Presentation, Eisai, MAY 15, 2025, View Source [SID1234653940]).

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On May 15, 2025 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the first quarter 2025 and business updates (Press release, Atara Biotherapeutics, MAY 15, 2025, View Source [SID1234653159]).

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"We are pleased that we have secured additional financing that is expected to extend our cash runway through the first quarter of 2026," said Cokey Nguyen Ph.D., President and Chief Executive Officer of Atara. "This enables Atara to continue to work to reduce costs and liabilities while maintaining the required support to achieve potential BLA approval."

Tabelecleucel (tab-cel or Ebvallo) for Post-Transplant Lymphoproliferative Disease (PTLD)

The FDA has lifted the clinical holds on EBVALLO studies. Atara plans to resume enrollment in the Phase 3 ALLELE clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) and the Phase 2 label-expansion multi-cohort clinical study.
The FDA has granted a date in the second quarter of 2025 for a Type A meeting to discuss the plan to address the issues raised by the FDA in the Complete Response Letter (CRL) issued in January 2025, and the path forward for resubmission of the EBVALLO BLA.
In March 2025, the Company completed the transfer of all worldwide manufacturing and supply responsibility, including all associated costs, to Pierre Fabre Laboratories, and the Company is in active discussions on accelerating the transfer of all remaining operational activities related to tab-cel to Pierre Fabre, except the BLA sponsorship, which the Company expects to be completed as early as June 2025.
Atara remains eligible for significant milestone payments from Pierre Fabre Laboratories upon FDA approval of the EBVALLO BLA and related commercial sales of EBVALLO, as well as significant royalties as a percentage of net sales. Pierre Fabre Laboratories holds worldwide Commercialization rights to EBVALLO.
CAR T Programs Discontinued

Atara has paused development of its CAR T programs (ATA3219 and ATA3431), with anticipated completion of wind-down activities in the second quarter of 2025.
Corporate Updates

Strategic Option Evaluation: As communicated in January and March, Atara engaged a well-known financial advisor to support the assessment of a range of strategic options, which may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. In April 2025, Atara paused its review of strategic options, pending the Type A meeting with the FDA which is scheduled in the second quarter of 2025, to discuss the plan to address the issues raised by the FDA in the CRL and the path forward for resubmission of the EBVALLO BLA.

Organizational Restructuring: In May 2025, Atara implemented a strategic restructuring to further reduce operating expenses and due to the wind down of the CAR T programs. This restructuring resulted in a company-wide workforce reduction of approximately 30%, retaining approximately 23 personnel essential to execute on its remaining transition responsibilities under the EBVALLO collaboration with Pierre Fabre Laboratories, including as the BLA holder until approval.

Financial Update: Atara has entered into an underwriting agreement for the issuance and sale of 834,237 shares of its common stock at a purchase price of $6.61 per share and the issuance and sale of pre-funded warrants to purchase up to 1,587,108 shares of its common stock at a purchase price of $6.6099 per share, representing fair market value based on closing, to entities affiliated with Adiumentum Capital Management, EcoR1 Capital, Panacea Venture and Redmile Group. The proceeds to Atara from the offering are expected to be $16 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Atara. Atara currently intends to use the net proceeds from the offering to fund its ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, and for working capital and general corporate purposes. The offering is expected to close on May 16, 2025, subject to the satisfaction of customary closing conditions.

First Quarter 2025 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2025 totaled $13.8 million, as compared to $42.5 million as of December 31, 2024.
Net cash used in operating activities was $28.1 million for the first quarter 2025, as compared to $29.6 million in the same period in 2024.
Total revenues were $98.1 million for the first quarter 2025, as compared to $27.4 million for the same period in 2024. Total revenues increased by $70.7 million year over year, primarily due to revenue recognized as a result of the completion of certain performance obligations under our Pierre Fabre agreement following the transfer of manufacturing responsibilities to Pierre Fabre as of March 31, 2025.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $6.0 million for the first quarter 2025, as compared to $9.8 million for the same period in 2024.
Research and development expenses were $27.4 million for the first quarter 2025, as compared to $45.5 million for the same period in 2024.
Research and development expenses include $8.3 million in restructuring charges comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act for the January and March 2025 reductions in force.
Research and development expenses also include $1.4 million of non-cash stock-based compensation expenses for the first quarter 2025, as compared to $4.7 million for the same period in 2024.
General and administrative expenses were $11.5 million for the first quarter 2025, as compared to $11.1 million for the same period in 2024.
General and administrative expenses include $1.5 million in restructuring charges comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act for the January and March 2025 reductions in force.
General and administrative expenses include $2.8 million of non-cash stock-based compensation expenses for the first quarter 2025, as compared to $3.7 million for the same period in 2024.
Atara reported net income of $38.0 million, or $3.53 basic earnings per share and $3.50 diluted earnings per share, for the first quarter 2025, as compared to a net loss of $31.8 million, or $5.65 basic and diluted loss per share, for the same period in 2024.
2025 Outlook and Cash Runway

Atara transitioned all tab-cel manufacturing costs and responsibilities to Pierre Fabre in the first quarter of 2025. Pierre Fabre continues to reimburse Atara for costs related to the remaining tab-cel operation activities.
In addition to reducing its headcount by approximately 85% since December 31, 2024, Atara continues to pursue additional initiatives aimed at enhancing operational efficiency.
Following the recognition of most of the one-time restructuring costs in the first quarter of 2025, we anticipate operating expenses to decrease continuously throughout the remainder of the year, with the largest reduction expected in the second quarter of 2025. In total, we expect full year 2025 operating expenses to decrease by approximately 65% from 2024.
Atara projects that cash, cash equivalents and short-term investments as of March 31, 2025, combined with the $16M gross proceeds from the May 2025 offering, in total will enable funding of planned operations into the first quarter of 2026.