On March 6, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business updates.

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"2025 was a transformative year for Immuneering. We reported 64% overall survival at 12 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP, well above the benchmark for GnP standard of care. We designed atebimetinib with three mechanisms well-established to improve survival, and we believe these survival gains are driven by atebimetinib shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize combinability and performance status," said Ben Zeskind, Ph.D., Chief Executive Officer of Immuneering. "We also made rapid progress in preparation for our pivotal Phase 3 trial in first-line pancreatic cancer patients, MAPKeeper 301, having secured alignment with both the FDA and EMA on our trial design, and we are on track to dose the first patient mid-year. With cash runway expected into 2029, uniquely encouraging clinical data, and a solid pipeline, we are strongly positioned to deliver on our mission to help patients live longer and feel better."

Recent Corporate Highlights

Reported 64% Overall Survival at 12 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP: In January, the Company announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients (N=34), with 13.4 months median follow up. Immuneering reported 64% overall survival (OS) observed at 12 months as of the December 15, 2025 data cutoff date. Atebimetinib (320mg dosed once daily) + mGnP was observed to demonstrate a favorable tolerability profile, with only two categories of adverse events observed at or above the grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy), in comparison to toxicity profiles for other combinations in the front line pancreatic cancer setting, which demonstrate significantly more grade 3 and higher adverse events. No head-to-head clinical trial has been conducted evaluating atebimetinib and other candidates or products. Differences exist between trial designs, subject characteristics and other factors, and caution should be exercised when comparing data across studies.
Secured Alignment with FDA and EMA on pivotal Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients: In December, Immuneering announced that it expected to dose the first patient in its planned global pivotal Phase 3 registrational trial, MAPKeeper 301, in first-line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone. The Company remains on track with this guidance. Notably, the Company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the proposed Phase 3 trial.
Added to the Nasdaq Biotechnology Index (NBI): On December 22, 2025, Immuneering was added to the Nasdaq Biotechnology Index.

Anticipated Near-Term Milestones

Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including:

Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting.
1H 2026: Report updated survival data from over 50 first-line pancreatic cancer patients treated with atebimetinib + mGnP.
Mid-2026: Dose first patient in pivotal Phase 3 MAPKeeper clinical trial of atebimetinib + mGnP in first-line pancreatic cancer.
2H 2026: Dose first patient in trial of atebimetinib + Libtayo in RAS-mutant first-line non-small cell lung cancer.

Fourth Quarter and Full Year 2025 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2025 were $217.0 million, compared with $36.1 million as of December 31, 2024.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $9.3 million compared to $14.9 million for the fourth quarter of 2024. Full year 2025 R&D expenses were $42.0 million compared to $48.0 million for full year 2024. R&D expenses for the fourth quarter and full year 2025 decreased compared to the same respective periods in 2024, primarily driven by reduced spend related to the Company’s product candidate envometinib (IMM-6-415) and certain pre-clinical activities, in addition to decreased personnel related costs. This was partially offset by increased clinical and regulatory consulting resources utilized during the period to support atebimetinib’s ongoing development and regulatory readiness activities.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2025 were $4.5 million compared to $3.7 million for the fourth quarter of 2024. Full year 2025 G&A expenses were $17.3 million compared to $16.1 million for full year 2024. G&A expenses for the fourth quarter and full year 2025 increased compared to the same respective periods in 2024, primarily driven by increased employee-related costs and external professional fees, in addition to increased public filing costs associated with the Company’s various financing efforts.
Net Loss: Net loss attributable to common stockholders was $11.6 million, or $0.18 per share, for the quarter ended December 31, 2025, compared to $18.1 million, or $0.58 per share, for the quarter ended December 31, 2024. Net loss attributable to common stockholders for full year 2025 was $56.0 million, or $1.27 per share, compared to $61.0 million, or $2.04 per share, for full year 2024.

2026 Financial Guidance

Based on cash, cash equivalents and marketable securities as of December 31, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029.

About Atebimetinib

Atebimetinib is the first in a new category of oral drug candidates, Deep Cyclic Inhibitors (DCIs), designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Each of these mechanisms has been well established to improve survival in published studies. DCIs challenge the conventional model of sustained or continuous inhibition in oncology. Whereas most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily, DCIs are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably. Moreover, DCIs aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events. Atebimetinib targets MEK, a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers. Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit.

(Press release, Immuneering, MAR 6, 2026, View Source [SID1234663332])

On March 6, 2026 Lantheus Holdings, Inc. ("Lantheus") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has approved PYLARIFY TruVu (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent. PYLARIFY TruVu is indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

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"The FDA approval of PYLARIFY TruVu demonstrates Lantheus’ continued commitment to advancing innovation that directly expands patient access to high-quality diagnostic tools," said Mary Anne Heino, Executive Chairperson and CEO, Lantheus. "The availability of PYLARIFY TruVu addresses a key need identified by clinicians – greater access to our market-leading formulation."

PYLARIFY TruVu was submitted for FDA approval via the 505(b)(2) regulatory pathway, allowing for review based upon previously submitted data from two PYLARIFY pivotal studies: OSPREY and CONDOR. The new formulation has the same diagnostic properties and is expected to offer similar safety and effectiveness as PYLARIFY.

Additionally, PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution. These improvements are expected to increase batch sizes, enabling manufacturing sites with high‑energy cyclotrons to reach more patients and serve broader geographic markets. Overall, PYLARIFY TruVu has the potential to enhance supply flexibility and improve operating leverage for the network of PMFs that will manufacture and distribute the product.

"As we continue to innovate and expand our portfolio, ensuring a reliable and uninterrupted supply for our customers remains our top priority," said Dorothy Barr, Senior Vice President, Manufacturing and Technical Operations. "The PYLARIFY TruVu formulation is designed to enhance manufacturing efficiency, strengthen supply chain dependability and ultimately improve the healthcare system’s ability to deliver timely, accurate imaging for people with prostate cancer."

PYLARIFY TruVu is expected to be commercially available in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, allowing customers to transition from PYLARIFY to the new formulation with minimal disruption.

"As a community dedicated to improving the lives of people facing prostate cancer, we’ve seen firsthand how advanced PSMA PET diagnostic tools like PYLARIFY have truly been game changers, providing real-time, highly accurate information that can meaningfully shape treatment decisions," said Gina B. Carithers, President and CEO, Prostate Cancer Foundation. "With prostate cancer incidence expected to rise in the years ahead, it’s encouraging to see companies like Lantheus putting patients first and introducing innovations that help ensure timely, precise imaging while keeping pace with growing demand. Access to accurate diagnostics, especially when metastatic or recurrent disease is suspected, can profoundly impact both quality of life and long-term outcomes for people living with prostate cancer."

More than 760,000 people with prostate cancer have received PSMA PET scans with PYLARIFY since the FDA granted approval in May 2021 based on findings from the OSPREY and CONDOR studies.

PYLARIFY Pivotal Data Summary
The safety and efficacy of PYLARIFY and PYLARIFY TruVu were established based on the PYLARIFY pivotal trials, OSPREY and CONDOR. OSPREY was a phase 2/3 clinical trial of 385 patients. In Cohort A, 252 men with high-risk prostate cancer had evaluable histopathology for determining the diagnostic performance of PYLARIFY in identifying pelvic nodal metastases. OSPREY Cohort A assessed sensitivity, specificity, PPV, and NPV in pelvic lymph nodes and the prostate gland for PSMA-targeted PET with PYLARIFY. The median sensitivity, specificity, PPV and NPV were 38% (26, 51), 96% (94, 99), 77% (62, 92) and 83% (78, 88). Results showed that a PSMA-targeted PET scan with PYLARIFY significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV in men at risk for metastatic prostate cancer prior to initial therapy. Compared to standard imaging, PYLARIFY PET/CT delivered: Significantly higher specificity (97.9% vs 65.1%), nearly three times the PPV (86.7% vs 28.3%) and similar sensitivity to standard imaging (40.3% vs 42.6%).1

CONDOR was a robust, multicenter, phase 3 trial of 208 patients with suspected recurrent or metastatic prostate cancer with negative or equivocal results using standard imaging. The study design assessed correct localization rate (CLR), a metric of diagnostic performance measuring PPV at the patient level enhanced with anatomic lesion matching in patients with biochemically recurrent (BCR) prostate cancer.
CONDOR found that a PSMA-targeted PET scan with PYLARIFY in men with biochemical recurrent prostate cancer achieved the primary endpoint of correct localization rate (CLR): 85%-87% across all 3 readers (lower bound of 95% CI: 78%-80%).2

The safety of PYLARIFY was evaluated in 593 clinical patients who were exposed to a single dose of PYLARIFY and was generally well tolerated. The most common adverse reactions reported in ≤ 2% of patients were headache, dysgeusia and fatigue. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction.3

About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the U.S. An estimated 1 in 8 men will be diagnosed in their lifetime. The incidence rate for prostate cancer has been increasing since 2014 at a rate of 3% per year overall. For 2026, estimates suggest nearly 334,000 new cases and more than 36,000 deaths. Prostate cancer can be a serious disease and is the second-leading cause of cancer death in men (behind lung cancer), but most men diagnosed with prostate cancer do not die from it. In fact, more than 3.5 million men in the U.S. consider themselves prostate cancer survivors.4

PYLARIFY TruVu (piflufolastat F 18) Injection
PYLARIFY TruVu (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.1,2

PYLARIFY TruVu was developed to build on the success of PYLARIFY, the number one utilized PSMA PET imaging agent in the U.S. which has been used in over 760,000 scans across 48 states, Puerto Rico and Washington, D.C.5

INDICATION
PYLARIFY (piflufolastat F 18) and PYLARIFY TRUVU (piflufolastat F 18) Injection are indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY and PYLARIFY TRUVU imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY and PYLARIFY TRUVU for imaging biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY and PYLARIFY TRUVU for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY and PYLARIFY TRUVU uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly those with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
PYLARIFY and PYLARIFY TRUVU, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

DRUG INTERACTIONS
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY and PYLARIFY TRUVU in prostate cancer. The effect of these therapies on performance of PYLARIFY and PYLARIFY TRUVU PET has not been established.

To report suspected adverse reactions for PYLARIFY or PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see the full Prescribing Information for PYLARIFY and PYLARIFY TRUVU.

(Press release, Lantheus, MAR 6, 2026, View Source [SID1234663333])

On March 6, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported financial results for the full year ended December 31, 2025, and provided a corporate update.

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"2025 was an important and productive year for PMV Pharma as we reported positive Phase 2 interim data from the registrational PYNNACLE clinical trial and made significant progress in enrolling the study," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We look forward to submitting an NDA in the first quarter of 2027 for rezatapopt in platinum-resistant/refractory ovarian cancer."

PYNNACLE Phase 2 Monotherapy Update:

•
Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational, Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors.

•
PMV Pharma anticipates submitting a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027.

Full Year 2025 and Recent Corporate Highlights:

•
On March 2, 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to rezatapopt for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The FDA provides ODD status to drugs intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Benefits of the designation may include exemption from certain FDA fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved.

•
Phase 1 results from the ongoing Phase 1/2 PYNNACLE study were published in the New England Journal of Medicine, "Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors." The manuscript highlighted that rezatapopt demonstrated antitumor activity in heavily pretreated patients across multiple solid tumor types which provided proof-of-concept for p53 reactivation. Clinical activity and biomarker data were consistent with selective binding to the Y220C pocket and restoration of wild-type p53 tumor suppressor function.

•
Updated data from the ongoing PYNNACLE Phase 2 trial were presented as an oral presentation at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) based on a September 4, 2025 data cut-off.

o
34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6 months.

o
46% ORR observed among 48 evaluable patients in ovarian cancer cohort with a median duration of response of 8.0 months.

o
Treatment-related adverse events (TRAEs) were mostly Grade 1-2 with the most frequent TRAEs observed (>15%) being nausea, fatigue, blood creatinine increased, and alanine aminotransferase (ALT) increased.

•
Natural history study results were also presented at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) where TP53 Y220C–mutant advanced solid tumors were associated with poor outcomes reinforcing the significant unmet medical need addressed by rezatapopt.

•
New findings from the rezatapopt PYNNACLE Phase 2 trial in ovarian cancer were presented at the 2026 European Society of Gynecologic Oncology Congress, demonstrating robust and consistent ORRs across key ovarian cancer subgroups.

o
The ORR subgroup data included those with platinum-resistant, platinum-refractory disease, prior systemic therapies and folate receptor alpha status, that provide further evidence of the broad efficacy of rezatapopt within ovarian cancer patients.

o
After the September 4, 2025 data cut-off, among the 48 evaluable patients in the ovarian cancer cohort, a 50% ORR was observed with 23 confirmed responses and one unconfirmed partial response.
Fiscal Year 2025 Financial Results

•
As of December 31, 2025, PMV Pharma had $112.9 million in cash, cash equivalents, and marketable securities, compared to $183.3 million at December 31, 2024. Net cash used in operations was $73.6 million for the year ended December 31, 2025, compared to $51.3 million for the year ended December 31, 2024.

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Net loss for the year ended December 31, 2025, was $77.7 million compared to $58.7 million for the year ended December 31, 2024.

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Research and development (R&D) expenses were $69.9 million for the year ended December 31, 2025, compared to $58.5 million for the year ended December 31, 2024. The increase in R&D expenses was primarily related to clinical expenses for advancing rezatapopt, the Company’s lead product candidate.

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General and administrative (G&A) expenses were $16.3 million for the year ended December 31, 2025, compared to $26.9 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due to lower facility-related and personnel costs following the relocation of the Company’s lab and office space and staff reductions in the prior year.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors, conducted across approximately 70 sites.

For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, MAR 6, 2026, View Source [SID1234663334])

On March 6, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported that it has closed a $20 million non-convertible debt financing with Streeterville Capital.

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The transaction is structured as a note purchase agreement pursuant to which the Company issued two non-convertible promissory notes: (i) a promissory note in the original principal amount of $10,930,000 and (ii) a secured promissory note in the original principal amount of $10,000,000, together providing approximately $20 million in net proceeds to the Company.

The financing is expected to extend the Company’s cash runway into the summer of 2028. The Company intends to use the proceeds primarily to support key initiatives designed to accelerate the advance of stenoparib toward pivotal development, FDA approval and commercialization.

Additional information regarding the transaction is included in the Company’s Form 8-K filed with the Securities and Exchange Commission on March 6, 2026.

"This financing demonstrates the confidence which Streeterville has in Allarity and the capital received positions us to complete Phase 2 enrollment, prepare for our FDA meeting, advance our companion diagnostic strategy, and prepare for pivotal development of stenoparib in advanced ovarian cancer," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "The financing also supports broader strategic initiatives, including further advancement of our DRP companion diagnostic platform and potential exploratory development in additional WNT-driven tumor types. We view stenoparib as a novel, highly differentiated therapeutic candidate, and this non-convertible financing provides the resources necessary to propel its continued advancement, while reflecting confidence in the strength of our clinical progress and regulatory strategy."

Stenoparib has demonstrated durable clinical benefit in heavily pre-treated ovarian cancer patients, including previously reported extended overall survival. Notably, certain patients have remained on therapy for more than 30 months, highlighting the long-term therapeutic potential of stenoparib in this population. The open-label Phase 2 trial will generate the critical clinical data to inform future regulatory engagement and pivotal trial development.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, MAR 6, 2026, View Source [SID1234663337])

On March 6, 2026 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.1

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"The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. DARZALEX FASPRO, incorporating the ENHANZE technology, continues to set new standards in multiple myeloma treatment and outcomes," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme

The approval is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy. TECVAYLI in combination with DARZALEX FASPRO demonstrated statistically significant improvements in PFS and OS in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM. Results show an 83% reduction in the risk of disease progression or death compared to standard regimens (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001).2 The three-year PFS rate was 83%,2 underscoring a durable benefit.

For more information on this approval, please view Johnson & Johnson’s press release issued on March 5, 2026.

(Press release, Halozyme, MAR 6, 2026, View Source;FDA-Approves-TECVAYLI-in-Combination-with-DARZALEX-FASPRO-for-RelapsedRefractory-Multiple-Myeloma/default.aspx [SID1234663338])