GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors

On May 14, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE natural killer (NK) cell engager platform, reported that the first patient was dosed in a Phase 1 dose escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer (NK) cell engager for solid tumors expressing B7-H3.

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"Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE platform into the broader opportunity of treating patients with a variety of solid tumors. The ongoing Phase 1 progress with GTB-3650 in hematologic malignancies now gives us the confidence to advance the platform with GTB-5550 to target B7-H3, which is broadly expressed across many of the most common and difficult-to-treat solid tumor cancers. We look forward to providing updates on the trial’s progress throughout the second half of 2026.", said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.

The Phase 1 trial with GTB-5550 will be the first nanobody TriKE tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial will focus primarily on enrolling prostate cancer patients and evaluate up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 1b expansion component will enroll patients with up to 7 different tumor types (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity.

"Patients with metastatic castration-resistant prostate cancer have B7-H3 expressed in over 90% of tumors and PSA can serve as an early biomarker of therapeutic activity. We look forward to evaluating GTB-5550 across multiple solid tumor types as we continue dose escalation.", said Dr. Nicholas Zorko, MD, PhD, Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation, The University of Minnesota1.

GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. Subsequent cycles receive treatment three times weekly for 2 weeks followed by 2 weeks of no treatment. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). More details can be found on clinicaltrials.gov with the identifier: NCT07541573.

(Press release, GT Biopharma, MAY 14, 2026, View Source [SID1234665744])

Senti Biosciences Holdings Announces Positive FDA RMAT Meeting on Registrational Clinical and CMC Strategy for SENTI-202 in Relapsed/Refractory AML, Along with Important Efficacy and Durability Updates on the SENTI-202 Clinical Program

On May 14, 2026 Senti Biosciences Holdings, Inc. (Nasdaq: SNTI) ("Senti Bio" or the "Company"), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, reported the successful completion of a Type B Initial Comprehensive Multidisciplinary Regenerative Medicine Advanced Therapy (RMAT) meeting with the U.S. Food and Drug Administration (FDA) regarding SENTI-202, the Company’s first-in-class Logic Gated off-the-shelf CAR-NK cell therapy for relapsed/refractory acute myeloid leukemia (R/R AML) and updated Phase 1 clinical data.

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Following the RMAT meeting, the Company has finalized its pivotal clinical and chemistry, manufacturing and controls (CMC) strategy for SENTI-202. The Company plans to implement a single-arm, multi-center pivotal trial intended to support potential SENTI-202 registration in patients with R/R AML. This study is expected to evaluate SENTI-202 administered following lymphodepletion (LD) chemotherapy in a patient population consistent with the Phase 1 trial population.

In addition to the positive RMAT meeting, after conducting exploratory efficacy covariate analysis of the Phase 1 trial results, Senti has identified a specific Donor X attribute that correlates with efficacy of SENTI-202, with 50% (7/14) of the patients achieving a cCR when they received any SENTI-202 doses manufactured from Donor X-characteristic-derived NK cells in Cycle 1 versus 12.5% (1/8) achieving a cCR when they received SENTI-202 manufactured from non-Donor X NK cells (see Table below). As a result of this discovery, all future SENTI-202 manufacturing, including for pivotal study use, will use Donor X material​. The Donor X attribute is found in ~50% of adult donors, and published literature supports increased NK cell cytotoxicity in donors with this phenotype. The Donor X NK phenotype is independent of HLA or KIR matching, thus supporting SENTI-202’s allogeneic off-the-shelf usage. Retrospective analysis of preclinical MV4-11 NSG mouse model data confirmed increased activity and survival with Donor X product (see Figure below).

Senti Bio also announced that SENTI-202 continues to exhibit durable MRD-negative responses in the full 22 patient Phase 1 trial, which compares favorably with current FDA approved therapies for R/R AML. At RP2D, across all patients receiving a mix of Donor X and non-Donor X material, an ORR of 44% and cCR of 37.5% was observed with 100% of CRs being MRD negative. The complete remissions continue to be durable, with all the CR/CRh responders who were in remission as of the data-cut supporting the oral presentation at the 2025 ASH (Free ASH Whitepaper) annual meeting continuing to maintain remission with an additional 7 months of follow up, the longest duration being 21+ months.

"This positive FDA RMAT meeting marks a transformational moment for Senti Bio and significantly advances our path toward potential registration of SENTI-202," said Tim Lu, M.D., Ph.D., Chief Executive Officer and Co-Founder of Senti Bio. "This news, combined with the compelling clinical responses observed to date that led to refinements in our donor selection strategy, positions us to advance SENTI-202 toward a potential registrational study in relapsed/refractory AML. We believe this milestone further validates both our Gene Circuit platform and the differentiated therapeutic potential of Logic Gated cell therapies."

FDA previously granted RMAT designation to SENTI-202. This program is intended to facilitate the expedited development and review of regenerative medicine therapies addressing serious or life-threatening diseases.

"The FDA feedback provides important clarity around our registrational development strategy and further supports our conviction in the SENTI-202 program," said Kanya Rajangam, M.D., Ph.D., Chief Medical Officer of Senti Bio. "The excellent clinical activity observed thus far, including MRD-negative durable complete remissions alongside a favorable safety profile, gives us confidence as we transition toward later-stage development. We are focused on rapidly implementing the pivotal study while also exploring potential expansion opportunities in newly diagnosed AML and pediatric AML. Since the filing of our IND, Senti has focused on donor selection to minimize variability. We are in a strong position as we prepare for our clinical trials with the identification of a donor phenotype that correlates with increased activity and continues to support SENTI-202’s allogeneic manufacturing."

Relapsed/refractory AML remains an aggressive hematologic malignancy with limited therapeutic options and poor long-term survival outcomes. Senti Bio believes SENTI-202’s differentiated mechanism, off-the-shelf availability, and encouraging early clinical profile position the program as a potentially important next-generation treatment option for AML patients.

Table: Phase 1 SENTI-202-101 Trial R/R AML Patient Efficacy Data Based on Donor
Phenotype
All Patients​
(N=22)​ Any Donor X in Cycle 1​ No Donor X in Cycle 1​
ORR​ (Overall Response Rate) 8/14 (57%)​ 2/8 (25%)​
cCR​ 7/14 (50%)​ 1/8 (12.5%)​
Vehicle Non-engineered
NK (NK3) SENTI-202 (NK3) Non-engineered
NK (NK4) SENTI-202 (NK4)
Median Survival (d) 56.0 64.0 86.0 112.0 Not Reached
Figure: Retrospective analysis of preclinical MV4-11 NSG mouse model data confirms increased activity and survival with SENTI-202
made from Donor X product. Donor X characteristic was confirmed post-hoc.

About SENTI-202
SENTI-202 is a first-in-class Logic Gated off-the-shelf CAR-NK cell therapy designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, including AML and myelodysplastic syndrome (MDS), while sparing healthy bone marrow cells. SENTI-202 incorporates multiple engineered Gene Circuits, including OR GATE and NOT GATE logic systems and calibrated-release IL-15, to improve tumor specificity, persistence, and therapeutic activity.

SENTI-202 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration.

About the Phase 1 Study
The multinational, multicenter dose-finding study of SENTI-202 (NCT06325748) comprised an initial dose finding using a modified "3+3" study design to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of SENTI-202 when administered after lymphodepleting chemotherapy (Part 1) followed by disease-specific expansion cohorts at the RP2D (Part 2).

The primary objectives were to evaluate safety, determine the MTD and RP2D, and assess efficacy in expansion cohorts using ELN 2022 consensus criteria for AML, with key secondary objectives including measurable residual disease assessment, pharmacokinetics, and pharmacodynamics using CyTOF on serial bone marrow samples. For more information visit clinicaltrials.gov.

(Press release, Senti Biosciences, MAY 14, 2026, View Source [SID1234665743])

Senti Biosciences Holdings Reports First Quarter 2026 Financial Results and Highlights Advancement of SENTI-202 Program into Pivotal Phase

On May 14, 2026 Senti Biosciences Holdings, Inc. (Nasdaq: SNTI) (Senti Bio), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights.

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"We entered 2026 with a clear focus on advancing SENTI-202 and extending our operational runway while positioning the company for its next phase of clinical development," said Timothy Lu, M.D., Ph.D., Chief Executive Officer and Co-Founder of Senti Bio. "Since the start of the year, we have made meaningful progress across each of these priorities, including a positive regulatory engagement with the FDA on SENTI-202 – a Regenerative Medicine Advanced Therapy (RMAT) designated product – regarding the study design for the planned pivotal trial, execution of a strategic financing agreement that could provide up to $40 million in capital, and continued reductions in operating expenses and cash burn."

Dr. Lu added, "We believe the recent FDA interactions and feedback represent an important milestone for the program and further support the potential of SENTI-202 in relapsed/refractory hematologic malignancies. We remain focused on advancing SENTI-202 efficiently toward the next stage of pivotal development in R/R AML and exploring future combinations with standard of care chemotherapy in newly diagnosed AML patients. We also aim to use our differentiated gene circuit platform to create therapies for additional ex vivo and in vivo CAR therapies."

Recent Business Highlights

SENTI-202 Program Update

Senti Bio concluded a Type B Initial Comprehensive Multidisciplinary RMAT meeting with FDA. Based on the positive outcome of this meeting, Senti Bio has finalized its pivotal clinical and chemistry, manufacturing and controls (CMC) strategy for SENTI-202, which includes a single-arm, multi-center pivotal trial to support registration in R/R AML with SENTI-202 administered after LD chemotherapy. The Company believes the FDA interaction supports continued advancement of SENTI-202 and provides important clarity around a potential registrational development strategy.

In addition, Senti announced that it identified a specific Donor X attribute that correlates with efficacy of SENTI-202, with 50% (7/14) of the patients achieving a composite CR (cCR) when they received any SENTI-202 doses manufactured from Donor X-characteristic derived NK cells in Cycle 1. The Donor X attribute is found in ~50% of adult donors, is independent of HLA or KIR matching, and will be used in all future SENTI-202 manufacturing, thus supporting SENTI-202’s allogeneic off-the-shelf usage. Senti Bio also announced that SENTI-202 continues to achieve durable MRD-negative responses in the full 22 patient Phase 1 trial that compares favorably with current FDA approved therapies for R/R AML.

Additional details can be found on Senti Bio’s website.

Strategic Financing Agreement

In April 2026, Senti Bio entered into a securities purchase agreement with an affiliate of Celadon Partners SPV 24, pursuant to which Senti Biosciences, Inc., the Company’s wholly owned subsidiary, may issue up to $40 million aggregate principal amount of senior secured convertible notes in up to two tranches.

The financing includes:

An initial $10 million tranche, expected to close in May subject to specified closing conditions;
An additional tranche of up to $30 million, subject to investor election and additional conditions; and
Future potential contingent value rights tied to regulatory and commercial milestones for SENTI-202 that could provide up to an aggregate of $60 million in additional value to stockholders.
The Company expects to use proceeds from the financing to support general corporate purposes and advance clinical and manufacturing activities for SENTI-202.

Operational and Financial Restructuring Progress

During the first quarter, Senti Bio completed amendments to its Alameda lease and related GeneFab sublease arrangements, significantly reducing future lease obligations and streamlining operations.

These actions contributed to a $6.9 million gain from lease modification during the quarter and are expected to further reduce the Company’s ongoing operating expense profile.

First Quarter 2026 Financial Results

Cash Position: Cash and cash equivalents were $8.9 million as of March 31, 2026, compared to $16.4 million as of December 31, 2025.
Research and Development Expenses: Research and development expenses were $5.3 million for the first quarter of 2026, compared to $9.3 million for the same period in 2025. The decrease was primarily driven by lower external services and supplies costs.
General and Administrative Expenses: General and administrative expenses were $6.2 million for the first quarter of 2026, compared to $7.1 million for the same period in 2025. The decrease was primarily driven by lower external services and supplies costs.
Net Loss: Net loss was $4.2 million, or $0.14 per basic and diluted share, for the first quarter of 2026, compared to a net loss of $14.1 million, or $1.41 per basic and diluted share, for the first quarter of 2025. Net loss for the three months ended March 31, 2026 included non-cash stock-based compensation expense of $1.3 million, offset by a non-recurring $6.9 million gain on lease modification.
Cash Burn: Net cash used in operating activities was $7.5 million during the first quarter of 2026, compared to $14.1 million during the same period in 2025, reflecting continued operational discipline and restructuring actions.
About SENTI-202

SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome (MDS), while sparing healthy bone marrow cells. SENTI-202 has three main components. First, SENTI-202 contains an OR GATE, which is an activating CAR that recognizes and kills CD33 and FLT3 expressing cells. By targeting either or both of these antigens, SENTI-202 is designed to effectively kill both leukemic blasts (that largely express CD33) and leukemic stem cells (that predominantly express FLT3), which constitute a difficult-to-eradicate reservoir of AML disease. Second, SENTI-202 contains a NOT GATE, which is an inhibitory CAR that is designed to recognize EMCN selectively expressed on healthy hematopoietic stem and progenitor cells and protect those healthy cells from being killed even if they express CD33 and/or FLT3, thus potentially widening the therapeutic window. Third, SENTI-202 contains calibrated-release IL-15, which is designed to significantly increase cell persistence, expansion and activity of both the CAR-NK cells and host immune cells. The NK cells used to construct SENTI-202 are sourced from selected healthy adult donors, manufactured, cryopreserved and available off-the-shelf for use as needed. Senti Bio is currently enrolling adult patients with R/R CD33 and/or FLT3 expressing heme malignancies in a Phase 1 clinical trial for SENTI-202, which can be a potential first-in-class allogeneic treatment for AML/MDS patients.

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including AML.

(Press release, Senti Biosciences, MAY 14, 2026, View Source [SID1234665742])

Silexion Therapeutics Reports Positive Preliminary Immunotherapy Findings for SIL204 in KRAS-Driven Pancreatic Cancer

On May 14, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported positive preclinical findings from an ongoing translational immuno-oncology study evaluating its lead candidate, SIL204, in human KRAS-mutated pancreatic cancer cells. The study demonstrated a statistically significant increase in surface expression of major histocompatibility complex class I (MHC-I), also known as HLA-ABC, following treatment with SIL204 in human pancreatic cancer cells harboring the KRAS G12R mutation, as measured by flow cytometry.

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"These findings are particularly encouraging because they suggest SIL204 may influence biological pathways involved in the tumors evading the immune cells which are supposed to protect against the tumors, in addition to its previously demonstrated direct anti-tumor activity," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Checkpoint inhibitors have historically shown limited efficacy in pancreatic cancer in part because T cells often fail to adequately recognize these tumors. We believe the observed increase in MHC-I expression further supports an additional positive role of SIL204 in the area of immunotherapy which could facilitate positive outcomes in the treatment of pancreatic cancer."

MHC-I is essential for enabling cytotoxic T cells to recognize and attack tumor cells. Loss or suppression of MHC-I expression is widely recognized as a key mechanism by which tumors evade immune detection and resist immune-mediated destruction. Research has shown that oncogenic KRAS signaling contributes to immune evasion through suppression of antigen presentation and impairment of T-cell recognition pathways in pancreatic cancer and other KRAS-driven tumors.

Pancreatic cancer remains among the most immunologically resistant solid tumors and has historically demonstrated limited responsiveness to immune checkpoint inhibitor therapies such as anti-PD-1 agents, including pembrolizumab (Keytruda), outside of select biomarker-defined patient populations. By increasing MHC-I expression, SIL204 may help restore immune visibility of KRAS-mutated tumor cells, potentially supporting future therapeutic strategies designed to enhance responsiveness to PD-1/PD-L1 blockade.

Published research has increasingly highlighted the relationship between KRAS signaling, antigen presentation, and immune checkpoint resistance, with multiple recent studies suggesting that reversing KRAS-associated immune suppression may improve immune-mediated anti-tumor activity.

(Press release, Silexion Therapeutics, MAY 14, 2026, View Source [SID1234665741])

Medicus Pharma Reports First Quarter 2026 Financial Results and Provides Corporate Update

On May 14, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported financial results for the three months ended March 31, 2026, and provided a corporate update highlighting continued execution across its SkinJect and Teverelix development programs.

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During the first quarter of 2026, Medicus continued to advance its transition into a diversified clinical-stage biotechnology company with active development programs in dermatologic oncology and urology/oncology, while replenishing its balance sheet through multiple capital market initiatives.

The Company recently reported positive, decision grade, expanded dataset findings from its Phase 2 SKNJCT-003 study evaluating SkinJect Doxorubicin Microneedle Array (D-MNA) for the treatment of nodular basal cell carcinoma (BCC), including evidence of positive dose response and registrational grade clearance rates in the 200-µg treatment cohort.

In parallel, Medicus advanced Teverelix, its next-generation long-acting GnRH antagonist acquired through the acquisition of Antev Limited, with Food and Drug Administration (FDA) clearance to initiate a Phase 2b dose optimization study in advanced prostate cancer and submission of an optimized Phase 2 protocol in acute urinary retention recurrence prevention.

Management Commentary:

"During the first quarter of 2026, Medicus continued to execute on its transformation into a diversified clinical-stage biotechnology company, highlighted by expanded positive Phase 2 SkinJect data, advancement of Teverelix into additional clinical development pathways, and continued expansion of our regulatory and strategic initiatives," stated Dr. Raza Bokhari, Medicus’ Executive Chairman & CEO. "We believe the growing strength of our clinical datasets, combined with expanded financing flexibility and continued development of AI-enabled clinical capabilities, positions the Company to pursue multiple value-driving milestones in dermatologic oncology, prostate cancer, acute urinary retention, and rare disease indications throughout 2026 and beyond."

First Quarter 2026 and Recent Corporate Highlights

SkinJect Platform (Dermatology / Oncology / Rare Disease)

SkinJect, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome, collectively representing a ~$2 billion market opportunity.

In the first quarter 2026, the Company made the following noteworthy advances in the SkinJect program:

Reported positive topline and expanded dataset findings from the Phase 2 SKNJCT-003 clinical study evaluating D-MNA for nodular basal cell carcinoma.
Expanded analysis demonstrated positive dose-response trends and clinically meaningful clearance activity in the 200-µg treatment cohort.
Company believes the dataset supports continued FDA engagement regarding potential registrational development pathways.
Completed enrollment of 90 patients in the U.S.-based Phase 2 SKNJCT-003 study.
Continued expansion activities for the SKNJCT-004 UAE-based clinical study evaluating SkinJect in additional geographic markets.
Submitted an Orphan Drug Designation application to the FDA for SkinJect in Gorlin Syndrome patients.
Continued collaboration with the Gorlin Syndrome Alliance to support compassionate access and expanded access development initiatives.
Teverelix Platform (Prostate + Women’s Health)

Teverelix, a next generation GnRH antagonist, is a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, collectively representing an ~$6 billion market opportunity.

In the first quarter 2026, the Company made the following noteworthy advances in the Teverelix program:

FDA provided "study may proceed" clearance for the Company’s Phase 2b dose optimization study evaluating Teverelix in advanced prostate cancer.
Submitted optimized Phase 2 protocol to the FDA for prevention of recurrent acute urinary retention in men with benign prostatic hyperplasia.
Presented additional clinical data relating to Teverelix at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026.
Successfully amended the LifeArc licensing agreement, reducing the royalty rate payable on worldwide net sales from approximately 4% to 2%.
Other Strategic and Corporate Initiatives:

In the first quarter 2026, the Company continued to make progress in other relevant strategic and corporate initiatives, some of which are highlighted below:

Continued development of the Company’s AI-enabled clinical development collaboration with Reliant AI.
Expanded ATM financing capacity from up to approximately $15.3 million to up to $50 million subsequent to quarter end.
Continued evaluation of additional strategic acquisition and partnering opportunities aligned with the Company’s multi-strategy development platform.
Financial Highlights (Q1 2026):

During the first quarter of 2026, the Company continued to replenish its capital position through utilization of its at-the-market ("ATM") facility and Standby Equity Purchase Agreement ("SEPA"), securing approximately $10 million in aggregate gross financing proceeds during the quarter. Subsequent to quarter end, the Company also expanded its ATM facility from up to approximately $15.3 million to up to $50 million.

The Company operates as a clinical-stage enterprise and expects to incur operating losses for the foreseeable future. As disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, substantial doubt exists regarding the Company’s ability to continue as a going concern without additional financing. However, management believes the Company continues to have access to additional capital resources through public and private equity offerings, debt financings, strategic collaborations, licensing arrangements, and other financing initiatives. Financial results of the Company for the quarter ended March 31, 2026, include:

Cash and cash equivalents: $6.4 million as of March 31, 2026 (vs. $4.0 million as of March 31, 2025)
Operating expenses: $8.6 million (vs. $5.1 million in Q1 2025)
General & administrative: $5.9 million (vs. $3.1 million in Q1 2025)
Research & development: $2.7 million (vs. $2.0 million in Q1 2025)
Net loss: $9.0 million (vs. $5.1 million in Q1 2025)
Loss from operations: $8.6 million (vs. $5.1 million in Q1 2025)
Net loss per share: $0.31 (vs. $0.42 in Q1 2025)
The Company’s complete unaudited financial statements and results of operations for the quarter ended March 31, 2026 are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 14, 2026.

Expected Upcoming Catalysts in 2026

The Company expects 2026 to remain a catalyst-rich year with multiple anticipated milestones, including:

End-of-Phase 2 FDA meeting (SkinJect) to define registrational pathway
Potential registrational trial design alignment under 505(b)(2) framework
Advancement of Gorlin Syndrome Orphan Drug designation, Registrational grade IND and Pediatrics Rare Disease Voucher Program
Continued evaluation of HelixNano-enabled platform expansion opportunities
Expansion of Teverelix into women’s health (endometriosis) using genomics-enabled clinical strategy
Progression of agentic AI-driven clinical development platform with Reliant AI
Ongoing strategic partnering discussions across both core programs, Skinject and Teverelix
Potential expansion of strategic collaborations and licensing discussions
The Company believes its current financing infrastructure, including the expanded ATM facility and existing capital market access, provides flexibility to support ongoing operations and advancement of its clinical development programs.

(Press release, Skinject, MAY 14, 2026, View Source [SID1234665740])