On May 12, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the first quarter ended March 31, 2026.

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"We ended the first quarter of 2026 with strong momentum across our pipeline of highly differentiated I-O therapies leveraging our best-in-class masking technology," said René Russo, Pharm.D., president and chief executive officer of Xilio. "XTX501 has the potential to be a foundational backbone therapy for combination regimens across a broad range of solid tumors, and we are on track to advance this program into the clinic this year. In addition, our recent data for our CLDN18.2 program presented at AACR (Free AACR Whitepaper) further demonstrate the power of our masking technology to unlock the potential of T cell engagers. This progress, together with the recent achievement of another financial milestone under our AbbVie collaboration, highlights the productivity of our pipeline and underscores our ability to maximize the value of our clinically-validated masking technology."

Pipeline Progress and Business Updates

XTX501: bispecific PD-1 / masked IL-2

XTX501 is a novel bispecific PD-1 / masked IL-2 that has the potential to be a foundational "backbone" therapy for combination treatment with other agents. XTX501 is designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1 therapy) and tumor-selective pharmacodynamics consistent with its intended mechanism of action.

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Xilio is currently advancing XTX501 through investigational new drug (IND)-enabling studies and plans to submit an IND application in the middle of 2026.
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Xilio plans to initiate a Phase 1 trial for XTX501 in the second half of 2026 and report initial Phase 1 data in patients with metastatic non-small cell lung cancer in the second half of 2027, subject to clearance of the IND by the U.S. Food and Drug Administration.

Masked T Cell Engager Programs

Xilio is leveraging its proprietary, clinically-validated masking technology and modular T cell engager (TCE) architectures to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie Group Holdings Limited (AbbVie).

Xilio’s masked TCEs include a masked CD3 targeting domain and one or more tumor-associated antigen (TAA) binding domains (which may be masked) as part of the core molecule design. Depending on the desired properties that Xilio is seeking to achieve for a particular molecule, Xilio’s modular architecture enables the ability to incorporate a co-stimulatory domain designed to further enhance potency and durability of T cell response, include multiple TAA binding domains and/or also mask the TAA binding domain(s) and/or co-stimulatory signaling domain. Upon tumor-selective activation, Xilio’s TCE molecules are designed to release a potent, short half-life TCE in the tumor microenvironment.

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Xilio is advancing XTX601, a potential first-in-class masked TCE targeting CLDN18.2, a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal). In parallel, Xilio is leveraging its modular design architecture to evaluate designs that incorporate masking of the CLDN18.2 binding domain and/or the addition of a co-stimulatory domain. Xilio initiated IND-enabling activities for its CLDN18.2 program in the first quarter of 2026.
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In April 2026, Xilio presented new preclinical data for XTX601 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating protease-dependent, tumor-selective activation and potent anti-tumor activity in multiple preclinical models. In addition, XTX601 was well-tolerated in non-human primates with a favorable therapeutic index. For more information, read the press release here.
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Xilio is also advancing a potential first-in-class multi-specific, masked TCE program targeting PSMA and STEAP1 with built-in co-stimulatory signaling. PSMA and STEAP1 are expressed in most prostate cancer tumors, and targeting both TAAs with a single molecule has the potential to address tumor heterogeneity while minimizing the potential for resistance due to antigen escape. Xilio anticipates initiating IND-enabling activities for its PSMA+STEAP1 program in the second quarter of 2026.
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Xilio plans to submit IND applications for its CLDN18.2 and PSMA+STEAP1 programs in 2027.

Efarindodekin alfa: masked IL-12

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Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors and expects to deliver an option data package to Gilead Sciences, Inc. (Gilead) in the first half of 2027.

Recent Corporate Updates
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Xilio strengthened its board of directors with the appointment of Cheryl R. Blanchard, Ph.D., a renowned biopharmaceutical leader, in April 2026. Dr. Blanchard brings more than 30 years of leadership experience to Xilio, with deep scientific, operational and commercial leadership in life science companies.
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In the second quarter of 2026, Xilio achieved a $6.0 million development milestone related to the masked antibody-based immunotherapy program under the company’s collaboration, license and option agreement with AbbVie.

First Quarter 2026 Financial Results

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Cash Position: Cash and cash equivalents were $150.3 million as of March 31, 2026, compared to $137.5 million as of December 31, 2025. The increase was primarily driven by $37.3 million in net proceeds from a follow-on offering in February 2026.
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Collaboration and License Revenue: Collaboration and license revenue was $12.6 million for the quarter ended March 31, 2026, compared to $2.9 million for the quarter ended March 31, 2025. The increase was primarily driven by an increase in collaboration and license revenue recognized under the collaboration and license agreements with AbbVie and Gilead.
Exhibit 99.1

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Research & Development (R&D) Expenses: R&D expenses were $19.8 million for the quarter ended March 31, 2026, compared to $8.3 million for the quarter ended March 31, 2025. The increase was primarily driven by manufacturing activities related to IND-enabling studies and preclinical development activities for XTX501, increased costs related to masked TCE programs and indirect research and development, increased clinical development activities related to efarindodekin alfa and increased personnel-related costs.
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General & Administrative (G&A) Expenses: G&A expenses were $6.9 million for the quarter ended March 31, 2026, compared to $8.5 million for the quarter ended March 31, 2025. The decrease was primarily driven by a decrease in professional and consulting fees, including legal fees and other professional costs and a decrease in personnel-related costs.
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Net Loss: Net loss was $9.5 million for the quarter ended March 31, 2026, compared to a net loss of $13.3 million for the quarter ended March 31, 2025.

Cash Runway

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of March 31, 2026, together with the development milestone achieved under the AbbVie collaboration in the second quarter of 2026, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into early 2028.

This estimate excludes any potential additional milestone payments, option-related fees or other contingent payments under Xilio’s collaboration and license agreements with AbbVie and Gilead and excludes up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price.

Xilio has the potential to achieve up to $31.0 million in additional near-term milestones and option extension fees under the existing AbbVie collaboration through the first half of 2027.

(Press release, Xilio Therapeutics, MAY 12, 2026, View Source [SID1234665562])

On May 12, 2026 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers, reported financial results for the first quarter ended March 31, 2026.

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"Our first quarter performance reflects accelerating growth in market demand for YCANTH as the new standard of care for the treatment of molluscum contagiosum, a condition that impacts approximately 6 million people in the United States alone," said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. "As the only FDA-approved, HCP-administered therapy for molluscum, YCANTH is a product that is uniquely positioned to address the unmet need of patients with molluscum, largely children under the age of 14. Demand for YCANTH grew sharply during the first quarter, as we set new records for dispensed applicator units during the quarter and in the month of March. April dispensed applicator units increased further from the record total in March, and the Company has achieved the milestone of over 100,000 total dispensed applicator units since launch. We have also achieved another significant milestone in expanding to new markets as our partner, Torii Pharmaceutical, launched YCANTH in Japan for patients with molluscum following regulatory approval last year."

"We are beginning to realize the traction from the efforts we began to implement last year to stabilize and grow our business. Alongside the growth in demand for YCANTH, we believe Verrica’s future growth is enhanced by the potential of our late-stage clinical programs in basal cell carcinoma and common warts, which we believe could represent multi-billion dollar opportunities if these programs successfully complete their development and are approved," Dr. Rieger continued. "The exciting data from the Phase 2 study of our novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma is generating strong interest within the dermatology and oncology communities and among patients faced with treating basal cell carcinoma. Further, last December the first patient was dosed in the first trial (COVE-2) of the global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts, and we are happy to announce achievement of over 50% of the current targeted enrollment in the trial. We expect the second Phase 3 trial (COVE-3) in the common warts program, with sites in both the U.S. and Japan, will be initiated in mid-2026. If successful, the global Phase 3 program in common warts has the potential to greatly expand the market for YCANTH to an indication with an estimated 22 million patients in the United States. The efforts we are undertaking in commercializing YCANTH for molluscum lay the foundation for an efficient and rapid expansion into common warts, if approved, as there will be a significant overlap in the clinicians treating both indications who would have the ability to access the product for both patient populations through the same distribution channels."

Dr. Rieger concluded, "we are proud of our progress in establishing YCANTH as the new standard of care for molluscum and of our work to expand our products, indications and markets. Collectively, our commercially available asset and pipeline programs, if successful, could represent significant benefits for patients and value for our company and our shareholders."

Conference Call and Webcast Information

The Company will host a conference call on Tuesday, May 12, 2026, at 4:30 pm, to discuss its first quarter 2026 financial results and provide a business update. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-833-316-2483

International Dial-In Number: 1-785-838-9284

Conference ID: VERRICA

Participants can use Guest dial-in #s above and be answered by an operator.

Webcast:

View Source;tp_key=307852c58b

The call will be broadcast live over the Web and can also be accessed on Verrica Pharmaceuticals’ website: www.verrica.com.

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Business Highlights and Recent Developments

YCANTH (VP-102)

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During the first quarter of 2026, YCANTH dispensed applicator units totaled 15,302, representing a year-over-year increase of approximately 51.3% from the first quarter of 2025. On a sequential basis, YCANTH dispensed applicator units increased approximately 12.1% from the prior quarter. In the first quarter of 2026, while January was likely impacted by winter weather across the East Coast, dispensed applicator units per selling day rebounded sharply in February and March, setting a record monthly high since launch in March.

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On February 9, 2026, the Company announced the commercial launch of YCANTH in Japan by its partner, Torii Pharmaceutical Co. Ltd. ("Torii"), a wholly-owned subsidiary of Shionogi & Co., Ltd., for the treatment of molluscum.

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On January 7, 2026, the Company announced that the first patient was dosed in December 2025 in the first trial (COVE-2) of our global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts. If the Phase 3 program is successful, YCANTH could become the first therapy approved in either the United States or Japan for the treatment of common warts, a condition that impacts over 22 million people in the United States alone. The Company has retained full commercial rights for all potential YCANTH indications outside of Japan and believes that YCANTH for common warts could represent a substantial commercial and licensing opportunity.

VP-315

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On May 5, 2026, the Company announced that it will present data from its Phase 2 study of its novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma in a late-breaking abstract selected for oral presentation at the upcoming 2026 Society for Investigative Dermatology (SID) Annual Meeting, which will take place from May 13-16, 2026, in Chicago, Illinois. Data from the Company’s Phase 2 study will highlight an observed abscopal-like effect of VP-315 in non-treated basal cell carcinoma lesions.

CORPORATE

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On February 12, 2026, the Company announced the appointment of Chris Chapman as its Chief Commercial Officer. Mr. Chapman brings over 25 years of commercial experience in the pharmaceutical industry to Verrica, and most recently served as Chief Commercial Officer at Dermavant Sciences through its acquisition by Organon, where he played an instrumental role in launching VTAMA (tapinarof) cream, 1%, approved for adult plaque psoriasis in June 2022 and atopic dermatitis in December 2024.

First Quarter 2026 Financial Results

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Total revenue for the three months ended March 31, 2026, was $5.0 million.

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U.S. YCANTH product revenue, net was $4.3 million for the quarter ended March 31, 2026, compared to net product revenue of $3.4 million for the quarter ended March 31, 2025. The increase in product revenue, net was primarily related to an increase in deliveries of YCANTH to Verrica’s distribution partners commensurate with an increase in dispensed applicator unit volume.

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License and collaboration revenue was $0.7 million for the quarter ended March 31, 2026, consisting primarily of commercial supply for Torii’s YCANTH launch in Japan. License and collaboration revenue was not material for the three months ended March 31, 2025.

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Costs of product revenue were $0.5 million for the quarter ended March 31, 2026, compared to $0.4 million for the quarter ended March 31, 2025, consisting primarily of product costs related to the sale of YCANTH.

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Selling, general and administrative expenses were $10.0 million for the quarter ended March 31, 2026, compared to $8.8 million for the same period in 2025. Excluding the impact of stock-based compensation, the increase of $1.3 million was primarily due to increased commercial spend, related to the expansion of the sales force.

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Research and development expenses were $3.9 million for the quarter ended March 31, 2026, compared to $2.3 million for the same period in 2025. Excluding the impact of stock-based compensation, the increase was primarily attributable to costs associated with the Phase 3 program for common warts. The expense for the Phase 3 common warts program did not impact Verrica’s cash balance, as the first $40 million of payments for this program will be made by Torii under the Company’s collaboration and license agreement.

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Interest income was $0.2 million for the quarter ended March 31, 2026, compared to $0.3 million for the quarter ended March 31, 2025. The decrease in interest income was primarily due to lower cash balances.

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Interest expense was $0.2 million for the quarter ended March 31, 2026, compared to $2.2 million for the same period in 2025. The decrease of $2.0 million was related to the settlement and termination of the Company’s debt facility in November 2025.

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For the quarter ended March 31, 2026, net loss was $9.7 million, or $0.45 per share, compared to a net loss of $9.7 million, or $1.03 per share, for the same period in 2025.

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For the quarter ended March 31, 2026, non-GAAP net loss was $8.8 million, or $0.41 per share, compared to a non-GAAP net loss of $8.3 million, or $0.88 per share, for the same period in 2025.

(Press release, Verrica Pharmaceuticals, MAY 12, 2026, View Source [SID1234665561])

On May 12, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported the release of 12 Revuforj (revumenib) abstracts on the European Hematology Association (EHA) (Free EHA Whitepaper) website in advance of the EHA (Free EHA Whitepaper) 2026 Congress, taking place June 11-14, 2026, in Stockholm, Sweden.

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"The breadth of data accepted for presentation at EHA (Free EHA Whitepaper) underscores the strength of revumenib’s clinical profile, with activity observed across the acute leukemia treatment continuum in KMT2Ar, NPM1m, and NUP98r acute leukemias," said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. "Given the need for therapies that can reduce the risk of relapse after stem cell transplantation, we are excited for the presentation of new data from the post-transplant setting showing favorable outcomes with revumenib compared to historical data. We also look forward to sharing additional frontline and R/R combination data showing high rates of MRD negativity, transplant, and favorable tolerability, supporting physician decision making and our ongoing pivotal trials."

Dr. Botwood continued, "Collectively, these new data highlight our scientific leadership in menin inhibition and bolster our confidence that we are positioned to transform the treatment paradigm for 50% or more of patients with AML."

Key revumenib data accepted for presentation at EHA (Free EHA Whitepaper) 2026:

Findings from the ROAR study, a multicenter real-world study of revumenib in relapsed/refractory (R/R) acute leukemia.
Updated frontline data from the Phase 1 trial of revumenib in combination with intensive chemotherapy in NPM1 mutated (NPM1m), KMT2A-rearranged (KMT2Ar), or NUP98-rearranged (NUP98r) acute myeloid leukemia (AML).
Outcomes among adults and children with KMT2Ar, NPM1m, and NUP98r acute leukemia who received revumenib as maintenance following hematopoietic stem cell transplantation (HSCT).
Updated R/R data from the SAVE trial of revumenib in combination with venetoclax and decitabine/cedazuridine in NPM1m, KMT2Ar, and NUP98r acute leukemia.
Results in patients with R/R NUP98r acute leukemia treated with revumenib in AUGMENT-101 or via an expanded access program.
The accepted abstracts listed below are now available online on the EHA (Free EHA Whitepaper) conference website. Copies of the poster presentations will be made available in the ‘Publications & Meetings Presentations’ section of the Syndax website after the embargo lifts.

Full list of revumenib abstracts accepted for EHA (Free EHA Whitepaper) 2026 (all times in CEST):

Abstract Titles Presentation Details
Real-world evidence
Revumenib in the real world: interim findings from the ROAR study in relapsed/refractory acute leukemia Abstract Code: PF542
Poster Session 1
Friday, June 12, 6:45-7:45 pm
Frontline
Revumenib + intensive chemotherapy for newly diagnosed acute myeloid leukemia harboring genetic alterations in KMT2A, NPM1, or NUP98: updated phase 1 results from SNDX-5613-0708 Abstract Code: PF489
Poster Session 1
Friday, June 12, 6:45-7:45 pm
Post-HSCT maintenance
Revumenib as maintenance for AML following allogeneic stem cell transplantation Poster number: PS1629
Poster Session 2
Saturday, June 13, 6:45-7:45 pm
Encore of data accepted for oral presentation at ASCO (Free ASCO Whitepaper) 2026
Revumenib therapy post hematopoietic stem cell transplant for patients with relapsed/refractory KMT2Ar, NPM1m, and NUP98r acute myeloid leukemia: post hoc analysis of outcomes from AUGMENT-101 Abstract Code: PS1631
Poster Session 2
Saturday, June 13, 6:45-7:45 pm
Relapsed/refractory
Phase 1/2 study of the all-oral combination of revumenib (SNDX-5613) with decitabine/cedazuridine (ASTX727) and venetoclax (SAVE) in relapsed/refractory AML Abstract Code: PF495
Poster Session 1
Friday, June 12, 6:45-7:45 pm
Long-term follow-up of pediatric/young adult patients with relapsed/refractory KMT2Ar acute leukemia treated with revumenib in AUGMENT-101 Abstract Code: PF508
Poster Session 1
Friday, June 12, 6:45-7:45 pm
Efficacy of revumenib in acute myeloid leukemia harboring NPM1-mutated co-mutations: post hoc analysis of AUGMENT-101 Abstract Code: PF514
Poster Session 1
Friday, June 12, 6:45-7:45 pm
Pharmacokinetic assessment of revumenib in patients with relapsed/refractory acute leukemias harboring a KMT2A rearrangement or NPM1 mutation: Impact of food and concomitant medications Abstract Code: PF564
Poster Session 1
Friday, June 12, 6:45-7:45 pm
Encore of data accepted for poster presentation at ASCO (Free ASCO Whitepaper) 2026
Clinical activity of revumenib in patients with relapsed/refractory NUP98-rearranged acute leukemias Abstract Code: PS1607
Poster Session 2
Saturday, June 13, 6:45-7:45 pm
Trials in progress
A phase 3 study of revumenib in combination with intensive chemotherapy in patients with newly diagnosed NPM1-mutated acute myeloid leukemia (REVEAL-ND NPM1): Trial in progress Abstract Code: PB2821
Publication only
Revumenib + venetoclax/azacitidine in adults with newly diagnosed NPM1m or KMT2Ar acute leukemia ineligible for intensive chemotherapy (EVOLVE-2/HO177/AMLSG35-24/ACT-HOV-AML-002): Trial in progress Abstract Code: PB2796
Publication only
A phase 1/2 study of the menin inhibitor revumenib with the CELMod mezigdomide in relapsed/refractory KMT2A-rearanged, NPM1-mutant, and NUP98-rearranged acute leukemias Abstract Code: PS1658
Poster Session 2
Saturday, June 13, 6:45-7:45 pm

About Revuforj (revumenib)

Revuforj (revumenib) is an oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients one year and older. Revuforj is also indicated for the treatment of R/R acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options.

Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML.

Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.

Revuforj (revumenib)

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES

Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

QTc prolongation and Torsades de Pointes have occurred in patients receiving Revuforj. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate Revuforj in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension.

In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.

QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes.

Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation. QTc prolongation occurred in 21% of the 34 patients less than 17 years old, 35% of the 146 patients 17 years to less than 65 years old, and 46% of the 61 patients 65 years or older. One patient had a fatal outcome of cardiac arrest, and one patient had non-sustained Torsades de Pointes.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and throughout treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.

Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower-dose level after the QTcF interval returns to ≤480 msec
Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia
Embryo-Fetal Toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 9 (4%) patients who received Revuforj, including 4 with sudden death, 2 with differentiation syndrome, 2 with hemorrhage, and 1 with cardiac arrest.

Serious adverse reactions were reported in 184 (76%) patients. The most frequent serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).

The most common adverse reactions (≥20%) including laboratory abnormalities, were phosphate increased (51%), hemorrhage (48%), nausea (48%), infection without identified pathogen (46%), aspartate aminotransferase increased (44%), alanine aminotransferase increased (40%), creatinine increased (38%), musculoskeletal pain (37%), febrile neutropenia (37%), electrocardiogram QT prolonged (36%), potassium decreased (34%), parathyroid hormone intact increased (34%), alkaline phosphatase increased (33%), diarrhea (29%), bacterial infection (27%), triglycerides increased (27%), phosphate decreased (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).

DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

Strong CYP3A4 inhibitors: reduce Revuforj dose
Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj
QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec
SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.

Pregnancy and testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: no overall differences were observed in the effectiveness of Revuforj between patients who were 65 years and older, and younger patients. Compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.

To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including BOXED WARNINGS.

(Press release, Syndax, MAY 12, 2026, View Source [SID1234665560])

On May 12, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

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"The first quarter of 2026 marked an important period for SELLAS as we continued to execute across our clinical programs while preparing for the anticipated pivotal Phase 3 REGAL trial data readout," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are grateful for the ongoing commitment of the patients, caregivers, and investigators participating in the pivotal Phase 3 REGAL trial and we believe that the upcoming results, triggered by reaching the pre-specified 80th event, will be an important milestone for the Company."

"In parallel, we are generating increasingly compelling data with SLS009, including recent preclinical findings presented at AACR (Free AACR Whitepaper) demonstrating potent, mechanistically driven activity in AML through suppression of key survival pathways such as MCL-1 and induction of apoptosis, including in high-risk genetic subtypes like TP53 and ASXL1 mutations. Importantly, we have begun dosing patients in our Phase 2 study of SLS009 in newly diagnosed, first-line AML, targeting high-risk populations unlikely to benefit from standard therapies, including venetoclax. With REGAL approaching its critical readout and SLS009 advancing across clinical and translational fronts, we believe that SELLAS is entering an exciting time with multiple, high-value potential catalysts that could transform the AML treatment landscape."

Recent Corporate Highlights:

Phase 3 REGAL Trial of GPS: Ongoing Phase 3 REGAL trial evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy. Reaching the required pre-specified 80th event (death) will trigger the customary database lock, blinded data review procedures prior to statistical analysis, unblinding, and disclosure of topline results. As of May 11, 2026, 78 events have occurred and SELLAS will provide an update and announce when the 80th event has been reached.

Ongoing dosing of SLS009 in earlier-line AML: SELLAS has initiated an 80-patient Phase 2 trial in newly diagnosed AML patients, including those who become refractory early to AZA/VEN treatment identified through extensive transcriptomics, genomics, and proteomics models. The topline data are expected in Q4 2026. Additional information about the trial can be found at clinicaltrials.gov (NCT04588922).

Preclinical Data on SLS009 in AML Presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper): The data show that SLS009 induces apoptosis in AML cell lines, including those harboring high-risk ASXL1 and TP53 mutations. Pharmacodynamic changes were observed as early as 8 hours after treatment and became more pronounced over time, with reductions in MCL-1 and survivin levels that correlated with increased apoptosis. The poster, entitled "Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines," can be viewed here.

At-the-Market (ATM) Offering: SELLAS established an ATM equity offering under its S-3ASR shelf registration, providing the Company with the ability to raise up to $150 million in capital over time. The facility, to be utilized through TD Cowen, enables flexible and opportunistic access to the equity markets. The Company has not sold any shares of common stock through its ATM to date.

Financial Results for the First Quarter 2026:

Research and Development Expenses: Research and development expenses for the quarter ended March 31, 2026, were $5.1 million, compared to $3.2 million for the same period in 2025. The increase was primarily due to increases in manufacturing costs, clinical and regulatory consulting, and clinical trial expenses in preparation for a potential Biologics License Application for GPS following the final analysis of the REGAL study.

General and Administrative Expenses: General and administrative expenses for the first quarter of 2026 were $4.1 million, as compared to $2.9 million for the same period in 2025. The increase was primarily due to increases in professional fees, consulting and public company costs, and non-cash stock-based compensation.

Net Loss: The net loss was $8.4 million for the first quarter of 2026, or a basic and diluted loss per share of $0.05, as compared to a net loss of $5.8 million for the first quarter of 2025, or a basic and diluted loss per share of $0.07.
Cash Position: As of March 31, 2026, cash and cash equivalents totaled approximately $107.1 million. Subsequent to March 31, 2026, the Company received an additional $7.5 million in proceeds from the exercise of previously outstanding warrants.

(Press release, Sellas Life Sciences, MAY 12, 2026, View Source [SID1234665559])

On May 12, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported the presentation of preclinical data demonstrating that a surrogate SG293, an in vivo CAR T cell therapy, achieved cell-specific delivery, robust and dose-dependent CAR T cell generation, and deep B cell depletion in non-human primates (NHPs) without the use of lymphodepleting chemotherapy. SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. The data were reported in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting.

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"SG293 represents a differentiated in vivo CAR T cell approach designed to work without lymphodepletion to deliver potent therapeutic activity and exceptional specificity to minimize off-target effects," said Dhaval Patel, MD, PhD, Executive Vice President, Chief Scientific Officer. "Data presented at ASGCT (Free ASGCT Whitepaper) highlight the fusogen platform’s potential to enable development of therapies that offer off-the-shelf treatment options for patients with blood cancers, B cell-mediated autoimmune disorders, and multiple myeloma. The data support our strategy of advancing SG293 into the clinic for the treatment of non-Hodgkin lymphoma (NHL) later this year and SG227, a BCMA-targeted in vivo CAR T cell therapy, into the clinic for the treatment of multiple myeloma as early as mid-2027."

In an NHP model, a one-time intravenous administration of the surrogate SG293 led to potent CAR T cell generation, dose-dependent CAR T cell expansion, and complete peripheral B cell depletion. At 3 weeks, B cells were undetectable or minimally detectable in lymph nodes, and as B cells returned after depletion, the vast majority exhibited a naïve phenotype indicative of a "reset" of the B cell compartment. The targeted fusogen used in SG293 demonstrates a differentiated level of protection from off-target delivery risks in vitro when compared to other targeted fusogen technologies. The specific delivery and favorable on-target safety profile were confirmed in vivo in NHPs with surrogate SG293. Post-necropsy analysis of tissues showed no evidence of delivery to non-target cells, including hepatocytes, heart, or gonadal tissue. Post-infusion symptoms were mild and managed with acetaminophen, and CAR T-associated toxicities were manageable and consistent with autologous CAR T toxicities in this NHP model. Finally, the novel transgene design used in SG293 diminishes CAR protein incorporation onto the vector during manufacturing, which mitigates anti-CAR immunogenicity in NHPs and may enable improved durability of in vivo CAR T cells. These data demonstrate that SG293 represents a differentiated approach for enabling potent and precise in vivo CAR T cell therapy for oncology and autoimmune indications. Sana intends to explore SG293 initially in NHL and expects to generate first-in-human data as early as this year. If successful, the company intends to expand clinical development with SG293 into B cell-mediated autoimmune diseases and to initiate clinical development of SG227 for patients with multiple myeloma.

About SG293
SG293, which uses Sana’s proprietary fusogen-based in vivo delivery technology, is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver, heart, and gonadal tissue. Sana intends to explore SG293 in both B cell cancers and B cell-mediated autoimmune diseases.

About SG227
SG227, which uses Sana’s proprietary fusogen-based in vivo delivery technology, is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver, heart, and gonadal tissue. Sana intends to explore SG227 as a potential therapy for the treatment of multiple myeloma.

(Press release, Sana Biotechnology, MAY 12, 2026, View Source [SID1234665558])