On March 28, 2025 4SC AG (4SC, FSE Prime Standard: VSC) reported its financial results for the financial year ended 31 December 2024, presenting all material reporting period developments and providing an outlook for 2025 (Press release, 4SC, MAR 28, 2025, View Source [SID1234651591]). The full report is available at 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "4SC continues to be one hundred percent focused on the development of resminostat and as such has now responded to the EMA’s180 Day Assessment Report within the required deadline. 4SC is now awaiting further feedback from the Committee for Medicinal Products for Human Use, which is still expected around the end of April 2025. Depending on the decision of the CHMP we will then consider what could be the future direction of the Company."

Key highlights of 2024
4SC had a very busy year in 2024, with key achievements summarized below, and further detail provided in respective press releases.

In February 2024, at an Extraordinary General Meeting the Management and Supervisory Boards fulfilled their duty to inform the shareholders of a loss amounting to half of the share capital in accordance with the rules pursuant to Section 92 (1) German Stock Corporation Act (AktG).
Also in February 2024, 4SC AG submitted its Marketing Authorisation Application (MAA) for resminostat in advanced CTCL to the European Medicines Agency (EMA) and this was accepted – by the EMA – as sufficient for examination by the beginning of March 2024.
In March 2024, 4SC entered into a second loan agreement with Santo Holding (Deutschland) GmbH (Santo Holding) giving the Company access to a further €3.5 million in available funding.
In April 2024, the company announced that the renowned dermato-oncology expert and principal investigator of the RESMAIN study, Professor Dr. Rudolf Stadler (University Hospital Johannes Wesling, Minden, Germany) presented landmark data from the pivotal RESMAN study of resminostat (Kinselby) at the 5th World Congress of Cutaneous Lymphomas (5WCCL), in Pasadena, California, USA.
Also in April 2024, 4SC received a Pediatric Investigation Plan (PIP) product-specific waiver from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for resminostat (Kinselby).
In May 2024, 4SC entered into a partnership with Vuja De Sciences, Inc., New Jersey, USA (Vuja De) – a US based biotech company focused on evaluating domatinostat in combination with Rapamycin in cancers such as recurrent metastatic osteosarcoma and refractory sarcomas.
In July 2024, 4SC announced that it had been granted Orphan Drug Status for resminostat (Kinselby) in CTCL in Switzerland.
In September 2024, 4SC completed a capital increase from authorized capital by issuing a total of 792,080 of new no-par value bearer shares, each with a notional par value of €1.00. At a subscription price of €5.05 per offered share, 4SC secured gross proceeds of circa €4.0 As a result of the transaction, 4SC’s share capital increased from €10,114,009 to €10,906,089. The new shares were subscribed for by the Company’s main shareholder, Santo Holding. Statu­tory subscription rights were excluded pursuant to Section 186 Para. 3 sentence 4 of the German Stock Corporation Act (Aktiengesetz).
Business outlook for 2025
4SC is fully focused on the registration of resminostat (Kinselby) in the key geographies of the European Union, UK and Switzerland. Subject to a final decision from the EMA, the opportunity for value creation through the commercialization of resminostat (Kinselby) in the EU remains possible, but subject to very significant risk given EMA’s 180 Day Assessment Report issued in March 2025. 4SC AG has recently responded to the EMA’s Day-180 Assessment Report within the required deadline and expects to receive feedback from the Committee for Medicinal Products for Human Use (CHMP) around the end of April 2025. Depending on the decision of the CHMP the Management Board will then consider all options for the future direction of the Company.

In the meantime, it is likely that the Company will continue to report annual net losses in the short to medium term future.

4SC continued to hold discussions with potential partners in the pharmaceutical industry regarding resminostat (Kinselby) in 2024 and early 2025, but these are currently on hold until it is clear the MAA is approvable.

For Japan, 4SC has an ongoing Collaboration Agreement with Yakult Honsha for the commercialization of resminostat (Kinselby).

Cash balance development in full year 2024 and financial forecast
4SC’s cash balance/funds were at €8,311 thousand on 31 December 2024. The average monthly operating cash burn in 2024 was €626 thousand, which was between the forecast range of €600 thousand and €900 thousand for 2024. Taking into account the current financial planning and the intended operating activities, the Management Board estimates that currently available funds should be sufficient to finance 4SC for at least the next 12 months of operations and in particular, to receive a final decision from the EMA with respect to the company’s MAA for resminostat (Kinselby).

Whilst 4SC’s funds of €8,311 thousand (at the end of 2024) represent a solid cash position, management remains cautious as to 4SC’s ability to raise additional funds through further capital measurements and or to generate income from business partners.

For 2025, 4SC is expecting an average monthly use of cash from operations of between €400 thousand and €700 thousand. 4SC estimates that the net loss will decrease significantly in 2025 as compared to 2024, due mainly to the completion of the open label component of the RESMAIN study and the filling of responses to the EMA in relation to 4SC’s MAA in late 2024.

On March 28, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the full year 2024, and provided corporate updates (Press release, Sensei Biotherapeutics, MAR 28, 2025, View Source [SID1234651587]).

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"2024 was a pivotal year for Sensei, as we advanced solnerstotug through dose expansion and began to demonstrate its clinical potential in patients who have progressed on and are resistant to PD-(L)1 therapy" said John Celebi, President and CEO of Sensei Bio. "The responses we’ve observed in PD-(L)1 resistant tumors are highly encouraging and we believe support solnerstotug’s differentiated approach to targeting VISTA. In the context of available data across checkpoint inhibitor regimens, solnerstotug stands out for its encouraging response rates and favorable tolerability profile in PD-(L)1 resistant tumors, a setting with limited treatment options and no approved therapies targeting VISTA. We are now focused on completing dose expansion for patients on study and finalizing a robust Phase 2 strategy."

Highlights and Milestones

Solnerstotug (formerly SNS-101) is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Recent updates include:

Preliminary Activity in PD-(L)1 Resistant "Hot" Tumors
In March 2025, Sensei presented preliminary dose expansion data showing, as of the data cutoff of March 17, 2025:
Among 21 evaluable PD-(L)1 resistant "hot" tumor patients, the combination of solnerstotug + cemiplimab demonstrated a 14% ORR (overall response rate), which is almost 3x higher than historical PD-(L)1 rechallenge response rates (≤5%), and a 62% DCR (disease control rate), suggesting meaningful disease control in resistant tumors.
One durable complete response in a patient with Merkel Cell Carcinoma (MCC).
Two partial responses (PRs): one in a second MCC patient and one in a microsatellite instability-high (MSI-H) Colorectal Cancer (CRC) patient.
All patients with tumor shrinkage remain on treatment, suggesting potential for prolonged clinical benefit.
An additional 11 patients have not yet reached the first baseline scan, and an additional eight patients discontinued the study prior to any post-baseline scan.
All patients in this cohort had progressed on prior PD-(L)1.
Yesterday, Sensei hosted an investor webcast to discuss the dose expansion data, featuring Company leadership and Dr. Shiraj Sen, M.D., Medical Oncologist and Director of Clinical Research at NEXT-Oncology, Dallas, an investigator on the Phase 1/2 study. The replay of the webcast is available here.

Favorable Safety Profile:
Solnerstotug continues to be well tolerated, with no dose-limiting toxicities and the majority of AEs Grade 1 or 2 in severity to date. Out of 60 patients, there have been four (7%) cases of Grade 1 cytokine release syndrome (CRS), all mild and manageable. Two patients in the combination cohort experienced immune-mediated events.
Clinical Progress and Outlook:
Target enrollment (n=60) in the dose expansion cohort has been achieved.
Full expansion data expected by year-end 2025.
Scientific and Clinical Visibility:
Sensei presented new data and mechanistic insights across multiple forums in 2024:
SITC 2024: Spatial proteomic profiling of VISTA and PSGL-1 in diverse tumor types.
Nature Communications: Sensei published a peer-reviewed research paper in Nature Communications in April 2024 describing the mechanism of action of solnerstotug selectively targeting the active form of VISTA within the tumor microenvironment.
PEGS Europe, IO360, Keystone Symposia, and others: Continued showcasing of solnerstotug and the TMAb platform.
Corporate Updates

In Q4, Sensei implemented an organizational restructuring to streamline operations and focus resources on clinically advancing solnerstotug.
Appointed Josiah Craver as Senior Vice President of Finance and later as Principal Financial and Accounting Officer.
Named Ron Weitzman, M.D., F.A.C.P., as part-time Chief Medical Officer.
Year End 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $41.3 million as of December 31, 2024, as compared to $65.8 million as of December 31, 2023. Sensei expects its current cash balance to fund operations into the second quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were $18.6 million for the year ended December 31, 2024, compared to $18.3 million for the year ended December 31, 2023. The increase in R&D expenses was primarily attributable to higher expense associated with clinical trials and one-time employee termination benefits primarily offset by lower preclinical research expense and consulting fees.

General and Administrative (G&A) Expenses: G&A expenses were $13.0 million for the year ended December 31, 2024, compared to $18.8 million for the year ended December 31, 2023. The decrease in G&A expense was primarily attributable to lower costs for external professional services, lower personnel costs, and lower insurance costs.

Net Loss: Net loss was $30.2 million for the year ended December 31, 2024, compared to $34.1 million for the year ended December 31, 2023.

On March 28, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported upcoming poster presentations including one for CM24 in the treatment of pancreatic cancer, and two for NT219 in the treatment of colorectal and head and neck cancers, at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting (2025 AACR (Free AACR Whitepaper)), scheduled to take place from April 25th to April 30th in Chicago (Press release, Purple Biotech, MAR 28, 2025, View Source [SID1234651586]). Presentation details are below:

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Abstract Title: Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers

Session Title: Liquid Biopsy: Circulating Nucleic Acids 4 / Predictive Biomarkers 1

Session Date and Time: Wednesday, April 30, 9:00 a.m. – 12:00 p.m.

Abstract Title: APC-loss as a potential biomarker for NT219 treatment in colorectal cancer (CRC)

Session Title: Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes

Session Date and Time: Sunday, April 27, 2:00 – 5:00 p.m.

Abstract Title: NT219 overcomes immune evasion-resistant mechanisms in head and neck squamous cell carcinoma (HNSCC)

Session Title: Novel Drug Resistance Mechanisms

Session Date and Time: Monday, April 28, 2:00 – 5:00 p.m.

On March 28, 2025 Novartis reported that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy (Press release, Novartis, MAR 28, 2025, View Source [SID1234651584]).

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The expanded indication, which approximately triples the number of patients eligible to receive Pluvicto, is based on results of the Phase III PSMAfore trial. In the study, Pluvicto reduced the risk of radiographic progression or death by 59% (HR=0.41; 95% CI: 0.29, 0.56; p<0.0001) compared to a change in ARPI in patients with PSMA-positive mCRPC after treatment with ARPI therapy. At an updated exploratory analysis, Pluvicto more than doubled median radiographic progression-free survival (11.6 months vs. 5.6 months)*.

"The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI," said Michael Morris, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, and the Principal Investigator of the study in the US. "This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy."

In PSMAfore, the final overall survival (OS) analysis numerically favored Pluvicto, with a hazard ratio of 0.91 (95% CI: 0.72, 1.14), but was not statistically significant. The OS analysis was confounded by the high rate of patients who crossed over from the control arm to Pluvicto (60.3%). When adjusted for crossover, the OS hazard ratio was 0.59 (95% CI: 0.38, 0.91) with the inverse probability of censoring weighting (IPCW) method**.

Additional findings from the PSMAfore study showed Pluvicto demonstrated a consistent and favorable safety profile. The most frequently reported all-grade adverse events for Pluvicto were primarily Grade 1-2 and included dry mouth (61%), fatigue (53%), nausea (32%), and constipation (22%). Pluvicto did not impair the ability of patients to be treated with subsequent chemotherapy.

"The clinical development of PSMA-targeting radioligand therapy has provided important insights into the treatment of metastatic castration-resistant prostate cancer," said Oliver Sartor, MD, Chair of Genitourinary Cancer Disease Group and Director of Radiopharmaceutical Clinical Trials, Mayo Clinic. "The trial data demonstrated a clear clinical benefit in delaying disease progression in eligible patients, offering an additional therapeutic approach in this setting."

More than 35,000 men die from prostate cancer each year, and the incidence of the disease is rising.2 Half of patients with mCRPC will not live long enough to receive a second treatment.1 While hormone therapy and chemotherapy are essential treatments for mCRPC, they may not be appropriate for all patients.3 Many patients and their healthcare providers prefer to avoid or delay chemotherapy due to side effects, and treatment guidelines recommend avoiding the use of multiple ARPIs.4-7

"With worsening outcomes after each successive line of treatment, patients with this type of metastatic prostate cancer and their families have long faced limited options and uncertain outcomes," said Gina Carithers, CEO and President of the Prostate Cancer Foundation.8 "The now expanded approval of Pluvicto is an empowering development for the prostate cancer community. We now have more choices earlier in the treatment journey, enabling patients to advocate for their preferences and work with their oncologist or urologist to determine the treatment option that best suits their needs."

"Today’s approval for an expanded indication for Pluvicto brings more choice to nearly three times as many patients, enabling us to further establish radioligand therapies as a pillar in cancer care," said Victor Bultó, President US, Novartis. "As pioneers in the RLT space, Novartis is committed to providing education, resources, and practical solutions to healthcare providers to help ensure access for all patients navigating this challenging disease."

Novartis RLT Patient and Office Support
As the only organization with a dedicated commercial RLT portfolio, we have established a strong infrastructure to ensure patient access and now offer Pluvicto in multiple administration methods, including prefilled syringes. With unparalleled customer experience in the RLT space, Novartis can deliver Pluvicto to the nearly 600 US RLT treatment sites, typically within 5 days to ensure prompt treatment initiation.

Novartis has introduced innovative solutions—including the newly launched RLT Institute—to educate and simplify the integration of RLT into routine clinical practice. The Novartis RLT Institute is an educational platform focused on radiation safety for the setup of treatment sites, equipping site staff with the necessary knowledge to safely administer RLT.

Novartis Patient Support is available to help eligible patients get started on treatment, including help understanding insurance coverage and identifying potential financial assistance options. Patients or providers can speak to a live agent at 1-844-638-7222 or visit View Source

About Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
Pluvicto is an intravenous radioligand therapy (RLT) combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.

Based on two Phase III studies, Pluvicto is the only PSMA-targeted agent proven to significantly improve rPFS and demonstrate a safety profile with proven tolerability in both pre- and post-taxane settings for patients with ARPI-treated, PSMA-positive mCRPC. Pluvicto is the first and only targeted radioligand therapy for patients with PSMA-positive mCRPC before the need for chemotherapy.

Novartis is investigating Pluvicto in earlier stages of disease, including metastatic hormone-sensitive prostate cancer (PSMAddition, NCT04720157) and oligometastatic prostate cancer (PSMA-DC, NCT05939414).

*Results observed at third interim analysis of PSMAfore (NCT04689828) with a data cutoff of February 2024. Pluvicto met its primary endpoint of rPFS at the primary analysis based on centrally confirmed rPFS events with an October 2022 data cut off.
**IPCW is an established statistical method that includes a number of assumptions

On March 28, 2025, Nektar Therapeutics (the "Company") entered into an Equity Distribution Agreement (the "Agreement") with Piper Sandler & Co. ("Piper") and BTIG, LLC ("BTIG"), pursuant to which the Company may offer and sell, from time to time in its sole discretion, shares of its common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $75,000,000 (the "Shares"), through Piper and BTIG as its sales agents (Filing, Nektar Therapeutics, MAR 28, 2025, View Source [SID1234651582]). The Shares will be offered and sold pursuant to the Company’s Registration Statement on Form S-3 filed by the Company on March 28, 2025 (the "Registration Statement") and the sales agreement prospectus supplement that forms a part of such Registration Statement, following such time, if ever, as the Registration Statement is declared effective by the Securities and Exchange Commission. The issuance and sale, if any, of the Shares may be by any method permitted by law deemed to be an "at-the-market offering" as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made directly on the Nasdaq Capital Market, or on any other existing trading market for the Common Stock.

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The Company is not obligated to make any sales of Common Stock, and Piper and BTIG are not required to sell any specific number or dollar amount of shares of the Common Stock, under the Agreement. The Company and each of Piper and BTIG may suspend or terminate the offering of Shares upon notice to Piper and BTIG or the Company, as applicable, and subject to other conditions.

Subject to the Company’s request to sell Shares, Piper and BTIG will act as the Company’s sales agents and use commercially reasonable efforts to sell on the Company’s behalf, from time to time consistent with its normal trading and sales practices, such Shares based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Piper and BTIG a commission fee of 3.0% of the gross sales price of any Shares sold through Piper or BTIG, as applicable, under the Agreement, and also has provided Piper and BTIG with customary indemnification and contribution rights.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.