On August 11, 2026 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported financial results for the second quarter ended June 30, 2026, and provided an update on recent corporate highlights.

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The Company is also updating its previous cash runway guidance. As of June 30, 2026, cash and cash equivalents were approximately $30 million, which are expected to fund operations into late-2027.

"The partnership with Sentynl Therapeutics which we announced earlier today marks a significant milestone for our alvelestat program and for the Company as a whole. We are now working together to refine the design of the global Phase 3 study for our potential first-in-class oral therapy for AATD-LD and look forward to a continued close collaboration during the short option period. Assuming exercise of the license option by Sentynl, we plan to initiate the Phase 3 trial in early 2027," said Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma. "Additionally, alongside our partner Ultragenyx, we have had initial regulatory interactions on setrusumab with the FDA and the MHRA and we expect to be in a position to provide an update on the potential path forward by the end of this year. We finished the quarter with approximately $30 million in cash. Thanks to our careful expense management, we now expect that this cash will provide runway into late-2027, exclusive of the potential $40 million in upfront and R&D payments that we are eligible to receive on exercise of the alvelestat option by Sentynl."

Second Quarter 2026 Highlights, Recent Developments, and Anticipated Milestones

Setrusumab (UX143)

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The Orbit and the Cosmic Phase 3 studies did not achieve statistical significance against the primary endpoints of reduction in annualized clinical fracture rate, however, both achieved high statistical significance against the key secondary endpoint of improvement in bone mineral density, as well as reductions in vertebral fractures and improvements in patient reported outcomes (PROs) associated with disease severity, pain / discomfort and daily activities, with these PRO improvements achieving statistical significance in the Orbit study. Setrusumab also achieved meaningful reductions in fractures in certain bones and in patients with higher fracture frequencies. Both studies demonstrated a safety profile consistent with that observed in previous trials.
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Mereo and its partner, Ultragenyx Pharmaceutical, Inc. ("Ultragenyx"), are engaged with regulatory agencies to determine a potential path forward for setrusumab in pediatric OI patients and, to-date, have held discussions with the regulators in the U.S. and the U.K. The FDA indicated openness to considering alternative approaches to fracture analysis, with additional conversations needed to further define what additional clinical data would be needed to support a potential BLA. In recent communications with the MHRA, they encouraged further dialogue on any future development proposal, and we plan to have further interactions following the FDA discussions.

Alvelestat (MPH-966)

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Mereo recently announced an option and license agreement with Sentynl Therapeutics, Inc. (Sentynl), a wholly owned subsidiary of Zydus Lifesciences Limited. Sentynl has the right to acquire a license for the U.S. commercial and global manufacturing rights to alvelestat for AATD-LD.
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Sentynl is a California-based, commercial-stage biopharmaceutical company with three currently approved products for rare diseases.
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Under the agreement, the companies will collaborate to refine the design of the planned global Phase 3 trial of alvelestat and to advance the manufacturing during the short option period.
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Mereo will receive a non-refundable option fee and, on option exercise, would also be eligible to receive $40 million in upfront and R&D payments, up to $435 million in regulatory and commercial milestone payments, as well as double-digit tiered royalties on U.S. net sales of alvelestat.

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Mereo will lead the global Phase 3 study and regulatory interactions until study completion and will retain rest-of-world commercial rights for alvelestat.
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On exercise of the option by Sentynl, the agreement provides funding for the global Phase 3 study, which could be initiated early in 2027.

Vantictumab (OMP18R5)

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āshibio, Inc. (āshibio), Mereo’s development and commercial partner for vantictumab, is continuing to advance toward initiation of a Phase 2 clinical trial in autosomal dominant osteopetrosis Type 2 (ADO2).
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āshibio is responsible for the global clinical development of vantictumab. Mereo has retained European commercial rights to the product, with āshibio holding commercial rights for the rest of the world.

Second Quarter 2026 Financial Results

Total research and development ("R&D") expenses decreased by $3.6 million, from $5.4 million in the second quarter of 2025 to $1.8 million in the second quarter of 2026. The decrease was primarily due to a reduction of $2.6 million in R&D expenses for setrusumab and $1.0 million for alvelestat. The decrease in program expenses for setrusumab was primarily driven by reduction of, and delays to, investment in manufacturing and ongoing activities, including medical affairs activities in Europe during the second quarter of 2026. The decrease in program expenses for alvelestat was primarily due to completion of activities undertaken in preparation for the potential Phase 3 study during 2025.

General and administrative ("G&A") expenses decreased by $0.3 million, from $5.5 million in the second quarter of 2025 to $5.2 million in the second quarter of 2026. The decrease was primarily due to reductions of approximately $2.2 million driven by delays to investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe and other realized cost savings. These decreases were partially offset by the recognition of a $1.9 million reduction in expenses in the second quarter of 2025 for amounts received from our depository to reimburse certain expenses incurred by us in respect of our ADR program, whereas the corresponding amount in the current year was recognized in the first quarter of 2026.

Net loss for the second quarter of 2026 was $7.0 million, compared to $14.6 million for the second quarter of 2025, primarily reflecting reductions in R&D and G&A expenses and a lower net foreign currency translation loss.

As of June 30, 2026, the Company had cash and cash equivalents of $30.1 million, compared to $41.0 million as of December 31, 2025. The Company expects, based on current operational plans, that its existing cash and cash equivalents balance will enable it to fund its currently committed clinical trials, operating expenses, and capital expenditure requirements into late 2027. This guidance does not include any future potential payments associated with business development activity around any of the Company’s programs.

Total ordinary shares issued as of June 30, 2026 were 798,093,044. Total ADS equivalents as of June 30, 2026 were 159,618,608, with each ADS representing five ordinary shares of the Company.

(Press release, Mereo BioPharma, AUG 11, 2026, View Source [SID1234669949])

On August 11, 2026 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported second quarter 2026 financial results and provides a business update.

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Management will host a conference call and live webcast at 8:00 a.m. Eastern time today to review financial results and provide an update. The archived webcast will be available for replay shortly after the close of the call.

Conference Call Details
Date: August 11, 2026
Time: 8:00 a.m. Eastern Time
Domestic Dial-In: (866) 652-5200
International Dial-In: (412) 317-6060
Webcast URL: View Source

Business Update

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared with standard-of-care ("SOC") in second- and third-line treatment of certain soft tissue sarcoma subtypes.
In April 2026, the Company initiated activities to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study using an FDA-reviewed amended protocol based on important learnings from patients previously enrolled in the study. The Company paused new site activations and patient enrollment in March 2025 due to funding constraints. At that time, the trial had enrolled 21 patients, and the Company continued to treat all patients, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its contract research organizations at significantly reduced ongoing costs. In addition, during this pause, the Company obtained important feedback and recommendations about the trial from key investigators and sarcoma thought leaders, and modifications to the protocol were made. The FDA has reviewed the amended protocol, which will be implemented for new patient enrollment. Submission of documentation necessary for restarting in the EU is in progress. Site activation and patient enrollment rates are expected to increase as sufficient funding is obtained.

INVINCIBLE-4 Study: Phase 2 open-label, randomized controlled, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before SOC in patients with early-stage, operable TNBC (Cohort A) and SOC alone (Cohort B).

In July 2026, the Company restarted patient treatment in the INVINCIBLE-4 Study and is currently targeting complete enrollment by the end of 2027. The Company paused new patient enrollment in September 2025 to revise the dosing regimen for patients receiving INT230-6 in Cohort A due to some patients experiencing localized skin irritation near the tumor site. In March 2026, a protocol amendment was approved by the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6 in Cohort A. In August 2026, the Company opened its first site in France for accrual following EU submission of the modified protocol.
Preliminary data from the first 14 patients (seven in each cohort) showed a 71% pathological complete response ("pCR") in patients receiving INT230-6 in Cohort A and a 42% pCR in patients receiving the SOC alone (Cohort B). There was also a 44% reduction in grade 3 adverse events in Cohort A compared with Cohort B and fewer immune-related adverse events when INT230-6 was added prior to the immunochemotherapy.

Capital Raises
In March 2026, the Company established a $60 million at-the-market ("ATM") facility. During the second quarter of 2026, the Company raised net proceeds of $1.6 million under the ATM. Subsequent to June 30, 2026, the Company has raised additional net proceeds of $1.3 million under the ATM.

"We are pleased that the capital raised in 2025 and to date in 2026 provides the resources to reinitiate the Phase 3 INVINCIBLE-3 Study. In addition, during the 2025 pause, we evaluated and modified the protocol based on feedback from key investigators and sarcoma thought leaders. The FDA-reviewed amended protocol will first be implemented in select U.S. sites," stated Lewis H. Bender, Founder, President and CEO of Intensity. "In the Phase 2 INVINCIBLE-4 Study, early data show potential for an improvement in the pCR rate with a reduction in the number of grade 3 adverse events including immune-related adverse events. These preliminary findings are encouraging, and we are excited that investigators have restarted treatment in patients in Switzerland. We look forward to enrolling new patients in this study in France now that sites are being activated. Lastly, we continue to pursue potential partnerships to advance our programs, and held meetings with potential strategic partners at the BIO International Conference in late June. While early, we are pleased with the interest expressed in our science and clinical trials, and we expect to continue discussions in the second half of 2026."

Second Quarter 2026 Financial Results

Research and development expenses were $1.8 million for the second quarter of 2026, compared with $1.5 million for the same period in 2025. The increase was primarily due to higher INVINCIBLE-3 Study costs as the Company initiated activities to resume enrollment in a limited number of U.S. sites in April. The Company paused new site activations and patient enrollments in March 2025 due to funding constraints. Research and development expenses also increased due to an estimated bonus accrual during the second quarter of 2026 compared with no bonus accrual during the second quarter of 2025, which was partially offset by lower stock-based compensation.

General and administrative expenses were $1.3 million for the second quarter of 2026, compared with $1.2 million for the same period in 2025. The increase was due to an estimated bonus accrual during the 2026 quarter compared with no bonus accrual during 2025 quarter, and higher Delaware franchise costs. These increases were partially offset by lower stock-based compensation as no stock-based compensation awards were granted during the first half of 2026.

Net loss was $3.0 million for the second quarter of 2026, compared with a net loss of $2.5 million for the second quarter of 2025.

As of June 30, 2026, cash and cash equivalents totaled $9.5 million. During the second quarter of 2026, the Company raised $1.7 million under the ATM, for net proceeds of $1.6 million.

About Triple Negative Breast Cancer in the Presurgical Setting
Women with aggressive forms of breast cancer, such as TNBC, are often counseled to undergo neoadjuvant (presurgical) systemic therapy to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11% to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors ("PR"), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50% to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related adverse events, including treatment-related adverse events that lead to death in 0.5% of patients.
About Sarcoma
Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body’s soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and abdomen. There are 197,000 patients in the US living with sarcoma and more than 100 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,400 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.
About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, AUG 11, 2026, View Source [SID1234669948])

On August 11, 2026 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing IKT-001, a novel once-daily oral anti-proliferative for Pulmonary Arterial Hypertension ("PAH"), reported financial results for the quarter ended June 30, 2026, and highlighted recent developments.

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"During our second quarter and in recent weeks we continued to advance our Phase 3 IMPROVE-PAH study with 26 country regulatory approvals together with the recent initiation of 43 clinical sites across a range of countries," said Mark Iwicki, Chief Executive Officer of Inhibikase. "Also, during the quarter, favorable results of pre-clinical and Phase 1 studies of IKT-001 were presented at the American Thoracic Society International Conference, with data demonstrating improvements in pulmonary vascular and hemodynamic markers of PAH and lower potential for GI toxicity compared to imatinib mesylate. Together with the recent grant of Orphan Drug Designation from the U.S. FDA and the $50 million proceeds from the sale of shares to RA Capital, Inhibikase is well-positioned to advance IKT-001 toward its potential as the first once-daily oral anti-proliferative offering significant potential benefits to the PAH patient population."

Recent Developments

In April 2026, Inhibikase received confirmation from the European Medicines Agency that the Company is permitted to initiate its Phase 3 study in PAH, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332). Globally, regulatory approvals for the Phase 3 study have been obtained in 26 countries with 3 additional country approvals pending and 4 additional country regulatory submissions planned.

The global IMPROVE-PAH trial is a two-part adaptive Phase 3 study. Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of change in Pulmonary Vascular Resistance ("PVR") at Week 24. Part B of IMPROVE-PAH seamlessly begins following the enrollment of the last patient in Part A and adopts an identical format to Part A except the primary endpoint of Part B is change in 6-minute walk distance ("6MWD") at Week 24 in approximately 346 patients.

In July 2026, the Company sold 25,000,000 shares of the Company’s common stock to RA Capital Management through its at-the-market ("ATM") facility for gross proceeds of $50 million. Subsequently, in July 2026, 18,030,000 of these shares of common stock were exchanged for pre-funded warrants to purchase shares of common stock.

In July 2026, the FDA’s Office of Orphan Products Development granted Orphan Drug Designation ("ODD") for IKT-001. ODD provides potential development incentives, including eligibility for tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon regulatory approval.

Presentations

In May 2026, pre-clinical and Phase 1 data for IKT-001 were presented at the American Thoracic Society ("ATS") International Conference in Orlando, Florida. These presentations included data demonstrating the following:

The potential for IKT-001 to have an improved gastro-intestinal ("GI") side-effect profile, including gastric emptying benefits and reduced impairment of intestinal motility compared to imatinib mesylate. IKT-001 remains intact in the stomach and the intestine and is not converted to imatinib until it reaches the blood, with in vitro pharmacology studies demonstrating an 18-fold decrease in c-Kit inhibition which has been implicated in the GI side-effects of imatinib.

Single doses of IKT-001 resulted in rapid and dose proportional exposure of circulating imatinib, which were well tolerated over a 300-800 mg range with no indication of dose-dependent GI toxicities.

Financial Results

Cash Position: As of June 30, 2026, cash, cash equivalents and marketable securities were $159.0 million. Subsequent to the close of the quarter the Company announced that it had sold 25,000,000 shares of the Company’s common stock to RA Capital Management through its ATM facility for gross proceeds of $50 million. The Company expects that the additional capital raised through this financing, together with existing cash reserves, will support operations through topline data readout in Part B of the ongoing global Phase 3 IMPROVE-PAH clinical study, assuming the full and timely exercise of the outstanding Series A and B Warrants.

As of June 30, 2026, there were 132.0 million shares of common stock and 42.5 million pre-funded warrants outstanding.

Net Loss: Net loss for the quarter ended June 30, 2026, was $19.6 million, or $0.11 per share, compared to a net loss of $9.9 million, or $0.11 per share in the quarter ended June 30, 2025. Net loss for the six months ended June 30, 2026, was $36.0 million, or $0.21 per share, compared to a net loss of $23.6 million, or $0.26 per share, for the six months ended June 30, 2025.

R&D Expenses: Research and development expenses were $13.4 million for the quarter ended June 30, 2026, compared to $5.3 million for the quarter ended June 30, 2025. Research and development expenses were $24.2 million for the six months ended June 30, 2026, compared to $15.8 million for the six months ended June 30, 2025.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2026 were $7.7 million, compared to $5.9 million for the quarter ended June 30, 2025. Selling, general and administrative expenses for the six months ended June 30, 2026 were $15.0 million, compared to $11.2 million for the six months ended June 30, 2025, which included $1.0 million of severance expenses for prior senior executives of the Company.

(Press release, Inhibikase Therapeutics, AUG 11, 2026, View Source [SID1234669947])

On August 11, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the quarter ended June 30, 2026, and provided a business update.

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"We continue to execute against our strategy of building a diversified targeted oncology company with multiple opportunities to bring needed therapies to patients," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "For varegacestat, the presentation of detailed Phase 3 RINGSIDE data at ASCO (Free ASCO Whitepaper) and subsequent FDA acceptance of our NDA with a PDUFA target action date of April 28, 2027 represent important steps toward a potential approval and launch. We are also continuing to advance our broader pipeline, with three additional clinical-stage programs now enrolling patients. We believe this momentum positions us well for a milestone-rich second half of 2026."

Pipeline Highlights

Varegacestat:

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In July 2026, the U.S. FDA accepted Immunome’s NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027.
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Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.
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Detailed efficacy and safety results from the Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors were presented in an oral abstract session at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
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RINGSIDE met its primary endpoint, with varegacestat demonstrating a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death vs. placebo (hazard ratio = 0.16, p<0.0001)
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Progression-free survival benefit was consistent across prespecified patient subgroups, including tumor location, baseline tumor size, patient age and prior systemic desmoid tumor therapy

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The trial met all key secondary endpoints, including a confirmed objective response rate of 56% vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review
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Varegacestat demonstrated statistically significant improvement in worst pain intensity at week 12, with a clinically significant difference observed as early as the first evaluation at week 4

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with objective responses observed in participants with B-cell lymphoma at multiple dose levels. Immunome expects to present initial lymphoma data for IM-1021 in 2026.

IM-1617: In June 2026, the first patient was dosed in the Phase 1, first-in-human trial evaluating IM-1617 in patients with advanced solid tumors. The study is designed to evaluate safety, tolerability, pharmacokinetics and preliminary anti-tumor activity and is expected to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer and breast cancer.

IM-3050: In July 2026, the first patient was dosed in the Phase 1, first-in-human trial evaluating IM-3050 in patients with FAP-expressing advanced solid tumors. The trial is designed to evaluate safety, tolerability, dosimetry, pharmacokinetics and preliminary anti-tumor activity of the investigational FAP-targeted radioligand therapy.

Preclinical ADC Pipeline: Immunome expects to submit Investigational New Drug applications (INDs) for IM-1340 and IM-1335 in mid- and late 2026, respectively. The programs are each directed at undisclosed solid tumor targets and incorporate HC74. Additional undisclosed ADCs are in discovery and lead optimization to support INDs in 2027 and beyond.

Second Quarter 2026 Financial Results

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As of June 30, 2026, cash, cash equivalents and marketable securities totaled $520.0 million. Immunome expects its current cash position to fund operations into 2028.
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Research and development expenses for the quarter ended June 30, 2026, were $59.9 million, including stock-based compensation expense of $4.2 million.
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General and administrative expenses for the quarter ended June 30, 2026, were $18.3 million, including stock-based compensation expense of $4.6 million.
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Immunome reported a net loss of $73.1 million for the quarter ended June 30, 2026.

(Press release, Immunome, AUG 11, 2026, View Source [SID1234669946])

On August 11, 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 second quarter ended June 30, 2026, and provided a corporate update.

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"The second quarter was an important period of execution for SELLAS as we continued to advance both of our lead clinical programs, GPS and SLS009," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "For GPS, we are approaching the pre-specified 80th event in the Phase 3 REGAL trial marking a critical step toward the final efficacy analysis and, if successful, a potential BLA submission to the FDA. At the same time, we are making meaningful progress with SLS009 in our ongoing Phase 2 frontline AML study, where dosing continues and enrollment is tracking ahead of industry standards, with topline data expected in the fourth quarter of 2026. In addition, we have obtained promising results from preclinical studies in pancreatic ductal adenocarcinoma (PDAC) and intend to support clinical development at a top-tier academic institution. Together, these programs reflect our commitment to developing differentiated therapies that may address significant unmet needs for patients with AML and support meaningful long-term value creation for SELLAS."

Recent Corporate Highlights:
Phase 3 REGAL Trial of GPS: Ongoing Phase 3 trial in AML patients who have achieved complete remission following second-line salvage therapy. The Company will announce when the required pre-specified 80th event occurs, which will trigger the customary database lock, blinded data review procedures before statistical analysis, unblinding, and disclosure of topline results.

Ongoing dosing of SLS009 in earlier-line AML: 28 patients have been enrolled, and enrollment and dosing continue in the ongoing 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. Topline data expected in Q4 2026. Additional information about the trial can be found at clinicaltrials.gov (NCT04588922).

Potential expansion of SLS009 into solid cancers: SLS009 has demonstrated the ability to act as a single agent in PDAC cells largely resistant to leading RAS inhibitors and synergize with the RAS inhibition mechanism of action. The data from these preclinical experiments are expected to be presented at an upcoming medical conference.

Financial Results for the Second Quarter 2026:

Research and Development Expenses: Research and development expenses for the quarter ended June 30, 2026, were $6.3 million, compared to $3.9 million for the same period in 2025. Research and development expenses in the first half of 2026 were $11.4 million compared to $7.1 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 (BLA) for GPS following the final analysis of the REGAL study.

General and Administrative Expenses: General and administrative expenses for the second quarter of 2026 were $4.4 million, as compared to $3.0 million for the same period in 2025. General and administrative expenses in the first half of 2026 were $8.5 million compared to $5.9 million for the same period in 2025. The increase was primarily due to increases in professional fees and non-cash stock-based compensation.

Net Loss: The net loss was $9.6 million for the second quarter of 2026, or a basic and diluted loss per share of $0.05, as compared to a net loss of $6.6 million for the second quarter of 2025, or a basic and diluted loss per share of $0.07. The net loss was $18.0 million for the first half of 2026, or a basic and diluted loss per share of $0.10, as compared to a net loss of $12.4 million for the second quarter of 2025, or a basic and diluted loss per share of $0.13.
Cash Position: As of June 30, 2026, cash and cash equivalents totaled approximately $138.3 million.

(Press release, Sellas Life Sciences, AUG 11, 2026, View Source [SID1234669945])