On July 30, 2026, Karyopharm Therapeutics Inc. (the "Company") reported topline results from its Phase 3 XPORT-EC-042 trial evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer. The trial did not meet its primary endpoint of progression free survival ("PFS"). In the trial, patients were randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The trial included two patient populations, for which the primary endpoint of PFS was designed to be tested sequentially: (1) a modified intent to treat population ("mITT") that included patients with either (a) TP53 wild-type tumors with proficient mismatch repair status ("pMMR") or (b) TP53 wild-type tumors with deficient mismatch repair status ("dMMR"), who are medically ineligible to receive checkpoint inhibitors; and (2) the trial’s original intent to treat ("ITT") population, which included all patients enrolled in the trial whose tumors are TP53 wild-type, regardless of MMR status.

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A trend favoring the selinexor arm was observed in the mITT population (n=236), with a median PFS of 12.75 months in the selinexor arm compared to 7.43 months in the placebo arm (hazard ratio=0.76 [95% CI: 0.51, 1.12]; one-sided p-value=0.0791).

The safety and tolerability profile of selinexor was consistent with its established safety profile, with no new safety signals observed. The Company intends to complete a full evaluation of the data from the XPORT-EC-042 trial and plans to present the data at a future medical meeting. The results of the XPORT-EC-042 trial do not affect ongoing trials of selinexor in other potential indications.

Myelofibrosis Update

On July 30, 2026, the Company announced that it plans to submit a supplemental New Drug Application ("sNDA") to the U.S. Food and Drug Administration ("FDA") in August 2026 seeking accelerated approval of selinexor in combination with ruxolitinib for the treatment of patients with myelofibrosis.

The planned submission follows productive engagements with the FDA, including written feedback that spleen volume reduction ≥ 35% ("SVR35") appears to qualify as a reasonably likely surrogate endpoint to predict overall survival and can be used to support an sNDA under the accelerated approval pathway. The Company plans to use overall survival data from long-term follow-up of the ongoing Phase 3 SENTRY trial to verify clinical benefit. Overall survival is a pre-specified secondary endpoint of SENTRY. The trial does not permit patient crossover; patients, investigators and the Karyopharm study team remain blinded to treatment assignment during ongoing follow-up.

The planned sNDA will be based on results from the randomized, double-blind, Phase 3 SENTRY trial that compared selinexor in combination with ruxolitinib against placebo in combination with ruxolitinib, including the statistically significant improvement in SVR35 at week 24, the rapid, deep and sustained nature of the spleen responses, a promising overall survival signal, reductions in variant allele frequency and the overall safety data package.

The Company intends to request Priority Review at the time of submission of the sNDA, which, if granted, would result in a Prescription Drug User Fee Act target action date approximately six months following the FDA’s receipt of the application.

The Company is actively engaged with the FDA on the final details of the sNDA submission. Contemporaneously with the Company’s announcement, the Company received additional correspondence from the FDA indicating that the FDA requires further discussion on the data to be used to support the sNDA and convert potential accelerated approval to traditional approval. The Company intends to address the FDA’s requests and provide the FDA with additional data and information prior to the submission of the sNDA in August 2026.

Corporate Update

The Company, with the assistance of its advisors, including its financial advisor Centerview Partners, is exploring potential financing transactions to extend its cash runway along with strategic alternatives in order to maximize both near and long-term value for all stakeholders. The Company’s ability to successfully consummate a financing transaction or execute on a strategic alternative is dependent on a number of factors. There is no assurance that these efforts will result in any type of transaction or, if they do, what the ultimate terms of any such transaction would be. The Company does not intend to discuss or disclose further developments unless and until its Board of Directors has approved a specific transaction or the Company otherwise determines that further disclosure is appropriate.

(Press release, Karyopharm, JUL 30, 2026, View Source [SID1234669574])

On July 30, 2026 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial-stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve patients’ lives, reported that it has entered into a securities purchase agreement for the purchase and sale of (i) an aggregate of 167,011 shares of the Company’s common stock and accompanying warrants at a combined purchase price of $5.66 per share to certain institutional investors ("Purchase Price") and a combined purchase price of $5.76 per share to certain of the Company’s directors and officers, and (ii) in lieu of shares of common stock to certain investors, pre-funded warrants to purchase up to 1,638,835 shares of the Company’s common stock and accompanying warrants at a combined purchase price of $5.6599, representing the Purchase Price less the $0.0001 exercise price of each pre-funded warrant. The financing is being led by certain institutional healthcare investors, with additional participation from certain of the Company’s directors and executive officers, including Chief Executive Officer Robert Goodman and Chief Financial Officer Dan Moorhead.

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"The financing announced today provides us with the capital and financial flexibility to execute the planned commercial launch of our second-generation LungFit PH, pending regulatory approval," stated Robert Goodman, Chief Executive Officer of Beyond Air.

Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with (i) a Series A common stock purchase warrant (the "Series A warrant") to purchase up to 1,805,846 shares of the Company’s common stock and (ii) a Series B common stock purchase warrant (the "Series B warrant") to purchase up to 1,805,846 shares of Company’s common stock. The Series A and Series B warrants will each have an exercise price of $5.51 per share. The Series A warrants will expire on the earlier of (i) the first anniversary of their issuance or (ii) the date that is 45 days following approval by the U.S. FDA of the Company’s pending premarket approval for the LungFit II, subject to the terms of the Series A warrants relating to the availability of an effective registration statement covering the resale of the shares issuable upon exercise thereof. The Series B warrants will expire five years following the date of issuance.

The private placement is expected to result in aggregate gross proceeds to the Company of up to $30.1 million, before deducting placement agent fees and other offering expenses payable by the Company, assuming all Series A warrants and all Series B warrants are exercised for cash, of which there can be no guarantee. The closing is expected to occur on or about July 31, 2026, subject to the satisfaction of customary closing conditions. The Company currently intends to use the net proceeds from the private placement for working capital and general corporate purposes.

Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock and shares of common stock underlying the pre-funded warrants, the Series A warrants and the Series B warrants, within 15 calendar days following the closing of the offering and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 75 days after the filing date in the event of a "full review" by the Securities and Exchange Commission.

Cantor is acting as lead placement agent in connection with the private placement. Citizens Capital Markets and Lake Street are acting as placement agents in connection with the private placement.

The securities described above are being offered and sold in a private placement and pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), and have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sales of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Beyond Air, JUL 30, 2026, View Source [SID1234669565])

On July 30, 2026 IMUNON, Inc. (Nasdaq: IMNN) ("IMUNON" or "the Company"), a clinical-stage biotechnology company developing its novel DNA-mediated immunotherapies, reported a progress update on its pivotal Phase 3 OVATION 3 trial of IMNN-001 in patients with newly diagnosed advanced ovarian cancer. Since initiating the trial, the Company has observed rapid site activation and an enrollment rate that is exceeding its forecast. The trial advanced from protocol submission to site activation in approximately 6 months and from protocol approval to first patient randomized in approximately 2 months, a third of the time of the external industry benchmark.

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The currently observed study-level enrollment rate of approximately 0.5 patients per site per month meaningfully exceeds the assumed rate of 0.3 patients per site per month used in the trial plan. That planning assumption was already set at a premium relative to the Company’s OVATION 2 experience and to historical industry ovarian cancer trials, which have generally enrolled at approximately 0.2 patients per site per month. The strong OVATION 3 enrollment is supported by highly promising clinical and biomarker data, most notably the overall survival (OS) evidence from the large, randomized Phase 2 OVATION 2 study and a high rate of conversion from pre-screening to randomization underscores strong interest in the trial by investigators and patients. More than 70% of sites are currently meeting or exceeding the assumed average enrollment rate of 0.3 patients per month. The Company now projects enrollment to be completed in the second quarter of 2029. Two pre-planned interim analyses are expected with the goal of early BLA filing for full regulatory approval if they achieve the pre-specified threshold.

"The early momentum we are seeing in OVATION 3 reflects the strength of our clinical data, the quality of our sites and the commitment of the investigators and patients participating in the trial," said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "We’ve seen enrollment build quarter after quarter, including through the early summer months when trials typically slow down, a trend we view as a strong signal of investigator and patient engagement. The consistent safety profile we’ve now observed across multiple studies further re-enforces our confidence in IMNN-001, uniquely designed to safely exploit the pluripotent capability of IL-12 to recruit the entirety of the patient’s own immune system to fight cancer, as we continue to advance our pivotal Phase 3 OVATION 3 trial."

IMNN-001 has continued to demonstrate a highly favorable safety and tolerability profile, with no observed episodes of cytokine release syndrome, systemic toxicities or serious immune-related adverse events that have historically foiled the use of IL-12 to effectively treat cancer patients. Safety profiles have been comparable between the two arms of the study (IMNN-001 plus neoadjuvant and adjuvant chemotherapy {N/ACT} versus N/ACT alone), consistent with observations from the Company’s ongoing Phase 2 Minimal Residual Disease (MRD) study. No safety issues have been raised in recent Independent Data Monitoring Committee (IDMC) reviews of either ongoing study.

About the Phase 3 OVATION 3 Trial

The pivotal Phase 3 OVATION 3 trial is evaluating intraperitoneal IMNN-001 at 100 mg/m² in combination with standard-of-care neoadjuvant and adjuvant chemotherapy versus chemotherapy alone in patients with newly diagnosed advanced epithelial ovarian cancer. The trial is enrolling an all-comers population that includes both homologous recombination-deficient and homologous recombination-proficient patients; eligible patients who respond to first-line platinum-based chemotherapy will proceed to PARP inhibitor maintenance according to applicable guidelines and prescribing information. The primary endpoint is overall survival, with secondary endpoints including chemotherapy response score, surgical response score at interval debulking surgery, time to second-line treatment or death, and objective response rate.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, JUL 30, 2026, View Source [SID1234669564])

On July 30, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the Phase II clinical study of its core product Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) for the treatment of first-line advanced biliary tract cancer (BTC) has completed enrollment of all 70 patients. In April 2026, the study successfully entered the expansion phase based on a favorable safety profile and robust efficacy that exceeded expectations, and rapidly completed full patient enrollment, fully demonstrating the efficient clinical advancement and continuously validated significant efficacy of Opamtistomig.

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Despite the recent adoption of PD-(L)1 immunotherapy combined with chemotherapy as a first-line standard of care for advanced BTC, clinical benefits remain limited. Current standard regimens, including pembrolizumab plus chemotherapy and durvalumab plus chemotherapy, have demonstrated objective response rates (ORR) below 30% and median overall survival (OS) of only approximately 12–13 months, leaving a substantial unmet medical need in this aggressive malignancy.

The potential of Opamtistomig as an IO 2.0 pan-tumor cornerstone therapy has been continuously validated across three dimensions: broad-spectrum anti-tumor activity, long-term survival benefit trends, and a safety profile comparable to PD-(L)1 monoclonal antibodies. Existing data show that, following extrapulmonary neuroendocrine carcinoma (EP-NEC) and small cell lung cancer (SCLC), Opamtistomig has once again demonstrated highly competitive efficacy in BTC, a typical immune-cold tumor, with the potential to elevate the efficacy of immunotherapy in BTC to new heights. Given that the predominant pathological type of BTC is adenocarcinoma, combined with the positive data previously observed in squamous cell carcinoma subtypes of major cancer types such as non-small cell lung cancer (NSCLC), Opamtistomig has shown clear efficacy in both adenocarcinoma and squamous cell carcinoma types, with its broad-spectrum anti-cancer potential being continuously validated.

The multicenter study is led by Academician Zhou Jian of Zhongshan Hospital, Fudan University and is being conducted across multiple hospitals in China. Results from safety run-in data showed that Opamtistomig in combination with chemotherapy demonstrated a favorable overall safety profile and good tolerability, with no new safety signals identified. Preliminary efficacy assessments showed an encouraging tumor shrinkage. Detailed clinical data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting to be held in Madrid, Spain from October 23 to 27, 2026.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The rapid progress of our Phase II BTC study reflects the strong confidence investigators and patients have placed in the encouraging efficacy signals generated by Opamtistomig to date. Immune-cold tumors remain among the greatest challenges in oncology and represent one of the most important frontiers for next generation immunotherapy. Across multiple immune-cold tumor types, Opamtistomig has consistently demonstrated promising clinical activity, further validating its potential as an IO 2.0 pan-tumor cornerstone therapy. We are committed to accelerating the clinical development of Opamtistomig in BTC and look forward to bringing a more effective and durable treatment option to patients with this devastating disease as early as possible."

About Biliary Tract Cancer
Biliary tract malignancies primarily include gallbladder cancer and intrahepatic/extrahepatic cholangiocarcinoma, with approximately 419,100 new cases globally in 2024. These malignancies are predominantly ‌adenocarcinomas‌ with high invasiveness, and most cases are diagnosed at advanced stages, leading to ‌poor prognosis‌ (5-year survival rate <5%)‌. Currently, global incidence of biliary tract malignancies is rising, with the highest prevalence observed in Asian countries.

Although ‌PD-1/L1 inhibitors combined with chemotherapy‌ have been approved as first-line treatment for advanced biliary tract malignancies, clinical benefits remain limited: ‌Modest improvement in median overall survival (OS)‌ (from ~11.5 to 12.8 months)‌ and ‌Low objective response rate (ORR)‌ (<30%)‌. These gaps highlight ‌unmet medical needs‌ for more effective therapies‌.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, JUL 30, 2026, View Source [SID1234669563])

On July 30, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported an update on the ongoing Phase 1 dose escalation ACESOT-1051 trial of its oral WEE1 inhibitor APR-1051.

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This latest corporate update builds on the positive progress in ACESOT-1051 to date in which APR-1051 demonstrated early signs of single-agent activity along with a favorable tolerability profile in patients with difficult-to-treat cancers.

Next Clinical Update and Accelerating Enrollment

Aprea expects to report the next clinical data update from ACESOT-1051 at a medical meeting in the fourth quarter of 2026. Enrollment is accelerating ahead of this anticipated clinical catalyst, with the number of active clinical sites expanding from three to ten. Aprea expects enrollment to reach 6 to 10 patients per month by Q4 of 2026, potentially increasing the pace of clinical data generation. The Company also plans to broaden the development by advancing APR-1051 into combination regimens, expanding the current study to include arms enrolling HPV-positive head and neck squamous cell carcinoma and colorectal cancer in combination with standard-of-care therapies.

"Expanding enrollment and adding combination regimens in HPV positive head and neck cancer and colorectal cancer will broaden the clinical dataset as we advance development of ACESOT-1051," said Gene Kennedy, M.D., Chief Medical Advisor of Aprea. "We look forward to sharing the next set of data from the trial at a medical meeting in the fourth quarter of this year,"

As previously announced, the Company is expanding enrollment to include at least 50 patients with uterine serous carcinoma or cyclin E-overexpressing, platinum-resistant ovarian cancer. Completion of dose escalation and backfill expansion is anticipated in the second quarter of 2027. This expansion is intended to further characterize the clinical activity of APR-1051 in biomarker-defined tumor populations with a mechanistic rationale for WEE1 inhibition.

Planned Combination Development

Aprea’s plans to evaluate APR-1051 in combination settings are supported by preclinical synergy observed in relevant disease models. In HPV-positive head and neck squamous cell carcinoma, the Company plans to combine APR-1051 with immune checkpoint therapy. In colorectal cancer, the Company plans to combine APR-1051 with standard-of-care chemotherapy.

The Company intends to advance dose levels that have already cleared safety review and shown single-agent activity into the planned combination regimens. This provides an appropriate starting point to establish the preliminary safety and preliminary efficacy of these regimens. In preclinical models, APR-1051 has demonstrated antitumor activity in combination with chemotherapy and with immuno-oncology agents, providing a rationale for the planned clinical combinations.

About ACESOT-1051 and Trial Design

ACESOT-1051 is a multi-center, open-label Phase 1 study evaluating oral, single-agent APR-1051 administered once daily in 28-day cycles. Part 1 is a dose escalation and dose backfill expansion of up to 100 patients, using accelerated titration at lower dose levels followed by a Bayesian optimal interval (BOIN) design. Part 2 is a dose selection optimization stage of up to 80 patients that will randomize patients 1:1 to two selected doses, to determine the recommended Phase 2 dose (RP2D).

Dose levels considered in the protocol range from 10 mg to 500 mg. Dose escalation is currently enrolling at the 300 mg cohort. Eligible patients are adults with advanced solid tumors harboring cancer-associated gene alterations, including uterine serous carcinoma regardless of biomarker status; cyclin E-overexpressing, platinum-resistant ovarian cancer (PROC); tumors harboring CCNE1, CCNE2, FBXW7, or PPP2R1A alterations; HPV-positive oropharyngeal, cervical, vaginal, or vulvar carcinoma; and KRAS- and TP53-mutated colorectal cancer.

The primary objectives are safety, dose-limiting toxicity, maximum tolerated or maximum administered dose, and RP2D. Secondary objectives include pharmacokinetics and antitumor activity assessed by RECIST/PCWG3.

The most recent update from the ACESOT-1051 trial was presented at the ASCO (Free ASCO Whitepaper) 2026 annual meeting; a copy of the poster can be found on the Aprea corporate website here.

For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

(Press release, Aprea, JUL 30, 2026, View Source [SID1234669562])