On March 27, 2026 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the fourth quarter and year ended December 31, 2025.

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"We have initiated a process to explore a range of alternatives available to the Company to maximize stockholder value," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "Such measures may include, among other options, a sale of the Company, a business combination or merger, a sale of assets, licensing or collaboration arrangements, or other strategic transactions. In addition to our clinical-stage candidates and our named earlier- stage candidates, our INDUKINE and INDUCER platforms provide exciting opportunities to apply our differentiated masking and protease linker technology in multiple additional modalities."

The Company has engaged Piper Sandler & Co. ("Piper Sandler") to serve as exclusive financial advisor to assist in the strategic evaluation process. The Company does not have a defined timeline for the exploration and evaluation of strategic alternatives and cannot confirm that the process will result in any strategic alternative being announced or consummated. The Company cannot provide any commitment regarding when or if this strategic evaluation process will result in any type of transaction, and there can be no assurance that such activities will result in any agreements or transactions that will enhance stockholder value. The Company does not intend to discuss or disclose further developments during this process unless and until its board of directors has approved a specific action or the Company has otherwise determined that further disclosure is appropriate.

Financial Results for the Fourth Quarter and Full Year 2025:

•Cash position: As of December 31, 2025, cash and cash equivalents were $57.1 million, compared to $65.7 million as of September 30, 2025. The Company believes its cash and cash equivalents as of December 31, 2025, will be sufficient to fund operational expenses and capital requirements into the fourth quarter of 2026.
•Research and development expenses: Research and development expenses were $6.9 million for the fourth quarter of 2025, compared to $15.7 million for the same period in 2024. Research and development expenses were $44.8 million for the full year 2025, compared to $56.4 million for the full year 2024.
•General and administrative expenses: General and administrative expenses were $2.5 million for the fourth quarter of 2025, compared to $4.6 million for the same period in 2024. General and administrative expenses were $15.8 million for the full year 2025, compared to $19.0 million for the full year 2024.
•Net loss: Net loss was $8.4 million for the fourth quarter of 2025, compared to $20.4 million for the same period in 2024. Net loss was $60.8 million for the full year 2025, compared to $70.5 million for the full year 2024.

(Press release, Werewolf Therapeutics, MAR 27, 2026, View Source [SID1234663982])

On March 27, 2026 PharmaMar (MSE: PHM), reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as first-line maintenance therapy for adult patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after standard induction therapy.

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The CHMP’s positive opinion is based on data from the Phase 3 IMforte trial, sponsored by Roche in collaboration with Jazz Pharmaceuticals in which the combination of lurbinectedin and atezolizumab was associated with a 46% reduction in the risk of disease progression or death, and a 27% reduction in the risk of death compared with atezolizumab monotherapy.

Dr. Luis Paz-Ares, Head of the Medical Oncology Service at the 12 de Octubre University Hospital in Madrid and principal investigator of the IMforte trial, highlights that: "This positive opinion represents a significant step forward in providing patients in Europe with access to an innovative therapy for a disease with a particularly poor prognosis. For the first time in this maintenance context, an improvement in overall survival and progression-free survival has been demonstrated, marking a milestone in the treatment of this disease. For healthcare professionals, this advancement provides a new treatment option to offer our patients."

Luis Mora, Managing Director of PharmaMar, commented: "The CHMP’s positive opinion represents a very important milestone in facilitating access for European patients to a new therapeutic option. It also represents important recognition of our Company’s commitment to research and development of innovative new compounds."

The European Commission will now decide on the marketing authorization in accordance with the established procedure. This combination is currently authorized for first-line maintenance treatment in 10 countries including the US, Switzerland, the United Arab Emirates, Oman, Uruguay, Peru, Paraguay, Ecuador, Israel and Taiwan.

Following a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the EMA, lurbinectedin has been approved as an Orphan Medicinal Product for small cell lung cancer. Orphan drug designation is a status granted by the EMA to drugs intended to treat rare or uncommon diseases that affect fewer than 5 people per 10,000 inhabitants in the European Union.

Small cell lung cancer accounts for about 15% of lung cancer cases and is characterized by its aggressive behavior, and an early tendency to spread[i],[ii]. Each year, around 62,000 new cases of SCLC[iii] are diagnosed in Europe,with most patients presenting advanced disease at the time of diagnosis.

(Press release, PharmaMar, MAR 27, 2026, View Source [SID1234663981])

On March 27, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that it will report combination dose optimization data from the Phase 1b trial of rinzimetostat (ORIC-944) in patients with metastatic castration resistant prostate cancer (mCRPC) in a conference call and webcast on Tuesday, March 31, 2026 at 4:30pm ET.

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To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

(Press release, ORIC Pharmaceuticals, MAR 27, 2026, https://investors.oricpharma.com/news-releases/news-release-details/oricr-pharmaceuticals-report-combination-dose-optimization-data [SID1234663980])

On March 27, 2026 Monopar Therapeutics Inc. ("Monopar," the "Company," "we") (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, reported the fourth quarter and full-year 2025 financial results and provided a summary of recent developments.

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"2025 was a productive year for Monopar, marked by multiple ALXN1840 data presentations, an important publication, a strengthened balance sheet and continued progress toward a planned New Drug Application submission for ALXN1840 in Wilson disease," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "We also recently strengthened our leadership team with the addition of Susan Rodriguez as Chief Commercial and Strategy Officer as we prepare for the potential launch of ALXN1840. We are grateful to the Wilson disease patients and their families whose experiences have informed our efforts to advance ALXN1840."

Recent Program Developments

ALXN1840 – NDA Submission Planned for Mid-2026 for Wilson Disease

Wilson disease is a rare genetic disorder characterized by impaired copper elimination, resulting in toxic accumulation in organs such as the liver and brain. ALXN1840 binds and mobilizes copper and has a novel mechanism of action as an albumin tripartite complex ("ATC") activator that differentiates it from currently available first-line therapies.

Based on recent interactions with the U.S. Food and Drug Administration ("FDA"), Monopar plans to submit a New Drug Application ("NDA") for ALXN1840 in mid-2026.

ALXN1840 updates:

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EASL 2025: Presented pooled long-term efficacy and safety data (n=255; median treatment duration 2.63 years), with additional safety data (n=266) supporting a favorable safety profile, as a late-breaking abstract

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ANA 2025: Presented data demonstrating long-term neurological benefit; the abstract was selected for oral and poster presentation and designated an "Abstract of Distinction"

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Journal of Hepatology / AASLD 2025: Reported statistically significant improvement in copper balance, with sustained improvement in daily copper balance driven by increased fecal copper excretion

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EL-PFDD: Attended externally led patient-focused drug development ("EL-PFDD") meeting with the FDA on January 29, 2026. During the meeting, patients and caregivers described the burden of Wilson disease, shared their experience with the currently available treatments, and highlighted the urgent need for additional treatment options

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Upcoming 2026 presentations: Abstracts accepted for presentation at EASL 2026 and the American Academy of Neurology ("AAN") 2026 Annual Meeting, including:

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Tiomolybdate choline stabilizes liver disease and improves neurological symptoms as well as quality of life in treatment-experienced Wilson disease patients (EASL 2026 oral presentation)

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Greater clinical benefit with tiomolybdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial (AAN 2026 late-breaking oral and poster presentation)

MNPR-101 Radiopharmaceutical Programs

MNPR-101-Zr (zirconium-89), MNPR-101-Lu (lutetium-177), and MNPR-101-Ac (actinium-225) target the urokinase plasminogen activator receptor ("uPAR"), which is expressed in multiple aggressive cancers, including triple-negative breast, colorectal, and pancreatic cancers.

MNPR-101 platform update:
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Ongoing Phase 1 clinical activity in Australia for MNPR-101-Zr and MNPR-101-Lu

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Investigational new drug ("IND") clearance received for MNPR-101-Lu to initiate a Phase 1 clinical trial in the US

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FDA-authorized physician-sponsored Expanded Access Program at Excel Diagnostics and Nuclear Oncology Center ("EDNOC") in Houston, Texas

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Preclinical development of MNPR-101-Ac

Financings

In 2025, Monopar strengthened its balance sheet through the following financing activities:

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Completed an underwritten public offering generating approximately $91.9 million, after a concurrent repurchase of common stock but before offering expenses

Results for the Fourth Quarter and Year Ended December 31, 2025, Compared to the Fourth Quarter and Year Ended December 31, 2024

Cash and Net Loss

Cash, cash equivalents and short-term investments as of December 31, 2025, were $140.4 million.

Monopar expects its current funds to support operations through at least December 31, 2027, including: (1) regulatory and potential commercial activities for ALXN1840; (2) continued development of MNPR-101 programs; and (3) internal research and development.

Net loss for the fourth quarter of 2025 was $5.2 million, or $0.61 per share, compared to $10.9 million, or $2.23 per share, for the fourth quarter of 2024.

Net loss for the year ended December 31, 2025, was $13.7 million, or $1.85 per share, compared to $15.6 million, or $4.11 per share, for the year ended December 31, 2024.

Research and Development ("R&D") Expenses

R&D expenses for the fourth quarter of 2025 were $3.9 million compared to $9.9 million for the fourth quarter of 2024. The decrease was primarily due to the absence of one-time expenses incurred in connection with the in-licensing of ALXN1840 in 2024, partially offset by higher R&D personnel expenses (driven by increased headcount and compensation), increased clinical material and manufacturing costs for the ALXN1840 program, and higher other R&D expenses.

R&D expenses for the year ended December 31, 2025, were $9.9 million compared to $13.0 million for the year ended December 31, 2024. The decrease was primarily due to the absence of one-time expenses incurred in connection with the in-licensing of ALXN1840 in 2024, as well as lower radiopharmaceutical clinical trial costs reflecting a shift in focus following the in-licensing, partially offset by higher R&D personnel expenses (driven by increased headcount and compensation), increased clinical material and manufacturing costs for the ALXN1840 program, and higher other R&D expenses.

General and Administrative ("G&A") Expenses

G&A expenses for the fourth quarter of 2025 were $2.2 million compared to $1.2 million for the fourth quarter of 2024. The increase was primarily due to higher Board of Directors (the "Board") and G&A personnel expenses (including stock-based compensation and bonuses), higher patent legal fees, and other increases in G&A expenses.

G&A expenses for the year ended December 31, 2025, were $6.8 million compared to $3.2 million for the year ended December 31, 2024. The increase was primarily due to higher Board and G&A personnel expenses (including stock-based compensation and bonuses), higher patent legal fees, and other increases in G&A expenses.

(Press release, Monopar Therapeutics, MAR 27, 2026, View Source [SID1234663979])

On March 27, 2026 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported 2025 year-end financial results and highlights, and provides a corporate update.

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Corporate Update

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone.
In March 2026, the Company reported the following:
•Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.
•Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B.
•A protocol amendment was submitted to Swissmedic, Switzerland’s regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026.
The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes.
In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. The Company has prioritized reinitiating patient enrollment and site activations during 2026 once sufficient funding is obtained.

IT-01 Study Manuscript Publication
In October 2025, the Company reported that eBioMedicine, a Lancet Discovery Science journal, published the Company’s phase 1/2 IT-01 clinical study manuscript, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," for the treatment of metastatic or refractory cancers. The manuscript included the following data results:

•In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved:
◦A disease control rate of 75% (48/64 patients) and median overall survival ("mOS") of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months
◦In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months
•In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient’s total tumor burden ("TTB") compared to those treated with less than 40% of their TTB, the:
◦Disease control rate was 83.3% (40/48) compared to 50% (8/16)
◦Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001
◦Improved survival was consistent across a range of low to high tumor burden and tumor sizes
•Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects
•Fifteen of 64 patients survived for more than 21 months
•INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment
•No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events
•Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors

Cash and Cash Runway
In 2025, the Company raised over $20 million in gross proceeds through two public offerings, one registered direct offering, and ATM issuances. These successful capital-raising efforts strengthened Intensity’s balance sheet with cash and cash equivalents of $11.9 million as of December 31, 2025, and extended its current operating runway into the second quarter of 2027.

Lewis H. Bender, Founder, President, and CEO, stated, "Our data published in the Lancet’s eBioMedicine journal for the treatment of metastatic disease, and the results reported on the safety and efficacy in the INVINCIBLE-4 study were promising and unique for a locally-delivered oncology drug. With the capital raised in 2025 and an unused $60 million ATM facility in place, we intend to resume patient enrollment in both studies as soon as possible. The American Cancer Society ("ACS") estimates that roughly 6,400 more deaths occurred in 2025 than in 2024, a trend that continues every year. Intensity remains committed to helping patients live longer, healthier lives with less toxicity. The ACS data supports the conclusion that today’s cancer treatments have many limitations, and that the unmet medical need for new ideas and better cancer therapies remains as strong as ever."

2025 Year End Financial Results

Research and development expenses were $6.8 million for the year ended December 31, 2025, compared to $10.5 million for the same period in 2024. Clinical trial expenses decreased $2.8 million primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and the Company plans to restart site activations and patient enrollment as soon as possible. Contract manufacturing costs declined by $0.6 million, as there were no new manufacturing batches of INT230-6 in 2025, along with $0.5 million of lower stock-based compensation. These decreases were partially offset by $0.3 million of bonus accruals for 2025 compared to zero bonus accruals for 2024.

General and administrative expenses were $5.2 million for the year ended December 31, 2025, compared to $6.1 million for the same period in 2024. Stock-based compensation decreased $0.6 million in 2025, and legal, audit, consulting, insurance and other general & administrative costs decreased due to cost efficiencies and less corporate development activity compared to the prior year period. These decreases were partially offset by $0.5 million of bonus accruals for 2025 compared to zero bonus accruals for 2024.

Overall, net loss was $11.6 million for the year ended December 31, 2025, compared to a net loss of $16.3 million for the year ended December 31, 2024.

As of December 31, 2025, cash and cash equivalents totaled $11.9 million.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, MAR 27, 2026, View Source [SID1234663978])