On September 30, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported the pricing of its previously announced registered public offering (the "Offering") of 36,047,919 shares of its common stock, or in lieu of common stock to certain investors, 1,883,121 pre-funded warrants to purchase shares of common stock, and accompanying common warrants to purchase 49,310,352 shares of common stock at an exercise price of $3.50. The combined public offering price for each share of common stock and accompanying common warrant is $2.90, and the combined public offering price for each pre-funded warrant and accompanying common warrant is $2.899 (equal to the combined public offering price per share of common stock and accompanying common warrant, minus $0.001), for expected gross proceeds to Pyxis Oncology of approximately $110 million, before deducting underwriting discounts, commissions and offering expenses. If all of the common warrants and pre-funded warrants are exercised in full, Pyxis Oncology would receive additional gross proceeds of approximately $172.6 million, before deducting applicable expenses.

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The common warrants will become exercisable only upon approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation to increase the number of authorized shares of common stock and the effectiveness of that amendment (the date of such effectiveness, the "Charter Amendment Effective Date"), and will expire upon the earlier of (i) the fifth anniversary of the Charter Amendment Effective Date and (ii) the 30th calendar day following the later (x) of the Charter Amendment Effective Date and (y) the Company’s public disclosure of overall survival data (the "OS Data Release Date") from its ongoing Phase 1 monotherapy study of micvotabart pelidotin (MICVO) in second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), expected in the first half of 2027. All of the securities in the Offering are to be sold by Pyxis Oncology.

Leerink Partners, Guggenheim Securities and Wells Fargo Securities are acting as joint bookrunning managers for the Offering.

The Offering is expected to close on or about October 1, 2026, subject to satisfaction of customary closing conditions.

Pyxis Oncology intends to use the net proceeds from the Offering to advance its lead clinical program, MICVO, through key clinical milestones, including Headliner, its planned Phase 3 trial in 2L+ R/M HNSCC, and for working capital and general corporate purposes.

The common stock, common warrants and pre-funded warrants are being offered pursuant to a registration statement on Form S-3 (File No. 333-291801), which was previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC"). The Offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the Offering will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus may be obtained from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-800-808-7525 ext. 6105, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 90 South 7th Street, 5th Floor, Minneapolis, Minnesota 55402, at (800) 645-3751 (option #5) or email a request to [email protected].

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

(Press release, Pyxis Oncology, SEP 30, 2026, View Source [SID1234671205])

On September 30, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported that the first patient worldwide has been successfully dosed in its Phase 2/3 clinical trial evaluating the Company’s lead candidate, SIL204, in patients with locally advanced pancreatic cancer (LAPC). The treatment was administered at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov") in Israel, marking a defining transition into active clinical execution for the Company’s global therapeutics program.

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The trial is a prospective, randomized, controlled, multinational, Phase 2/3, open-label study evaluating the efficacy and safety of SIL204 administered as an integrated therapeutic regimen in combination with standard-of-care chemotherapy, versus chemotherapy alone, in patients with LAPC. The study is structured with an initial safety run-in cohort of approximately 18 patients, followed by global expansion to enroll a randomized cohort of approximately 166 patients. The trial enrolls newly diagnosed, treatment-naïve adult patients with unresectable Stage 3 LAPC without distant metastases whose tumors harbor a confirmed KRAS mutation. SIL204 is administered as a first-line regimen alongside standard chemotherapy, with the choice of chemotherapy at the treating physician’s discretion.

In this trial, SIL204 is administered via an innovative dual-route delivery strategy designed to address the anatomical and biological barriers of pancreatic tumors. Treatment combines direct intratumoral administration via an endoscopic ultrasound (EUS)-guided procedure, targeting the primary pancreatic lesion to bypass dense tumor stroma, with subcutaneous abdominal injections designed to provide systemic exposure and address potential micro-metastases.

"Successfully dosing the first patient in our Phase 2/3 clinical trial of SIL204 is a defining operational and clinical milestone for Silexion, transitioning our lead RNAi program into active patient treatment," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Locally advanced pancreatic cancer is one of the most aggressive and lethal solid tumors, with patients facing a persistent lack of new therapeutic options. By combining direct local tumor penetration with systemic coverage, our integrated regimen is engineered to overcome the critical delivery barriers that have historically limited pancreatic cancer treatments. We are thrilled to initiate dosing at Tel Aviv Sourasky Medical Center and look forward to advancing additional clinical trial sites across Israel and Germany, as we work toward preliminary clinical readouts in the near term to evaluate SIL204’s potential to improve response rates and survival outcomes for patients with locally advanced pancreatic cancer."

Tel Aviv Sourasky Medical Center serves as the anchor clinical center for the trial in Israel following receipt of institutional ethics approval and authorization from the Israeli Ministry of Health. Additional Israeli oncology centers, alongside leading academic medical institutions in Germany approved under the European Union Clinical Trials Regulation (EU CTR) framework by the Federal Institute for Drugs and Medical Devices (BfArM), are progressing through site activation and are expected to join the Phase 2/3 program in the coming months.

(Press release, Silexion Therapeutics, SEP 30, 2026, View Source [SID1234671204])

On September 30, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, reported highly encouraging results from three core Investigational New Drug (IND)-enabling safety studies of ERNA-101, its lead synthetic, allogeneic induced mesenchymal stromal cell (iMSC) therapy engineered to express an IL-7/IL-15 fusion cytokine.

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Across repeat-dose GLP toxicology, tumorigenicity and biodistribution studies, ERNA-101 demonstrated a favorable nonclinical safety profile, with results addressing three critical questions as the Company prepares to advance the program toward first-in-human development:

Repeat-dose safety: No ERNA-101-related adverse findings were observed at any dose level tested in a 50-day GLP toxicology study in tumor-bearing mice with an intact immune system.
Tumorigenicity: No teratoma formation was observed in ERNA-101-treated animals through the six-month tumorigenicity in-life phase, addressing an important safety consideration for an iPSC-derived therapy.
Biodistribution: No significant ERNA-101 signal was detected in tumor-free animals or non-tumor tissues, supporting ERNA-101’s design to home to tumors without taking up residence elsewhere in the body.

Importantly, the results add a critical safety dimension to previously reported ERNA-101 efficacy data demonstrating complete tumor clearance and durable long-term survival in preclinical ovarian cancer models when combined with PD-1 blockade. Together, Ernexa believes the efficacy, safety and biodistribution findings provide an increasingly comprehensive nonclinical foundation for advancing ERNA-101 toward the clinic.

"We believe these results represent one of the most important milestones in Ernexa’s history because the ERNA-101 story is now coming together across efficacy, safety and tumor-targeted delivery," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "We have previously demonstrated compelling anti-tumor activity, including complete tumor clearance and durable survival in preclinical ovarian cancer models. Now, across three critical IND-enabling safety studies, we observed no ERNA-101-related adverse findings in our repeat-dose GLP study, no teratoma formation through the six-month tumorigenicity in-life phase and no significant ERNA-101 signal in tumor-free animals or non-tumor tissues."

"From a scientific perspective, these findings provide important support for the fundamental design of ERNA-101," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "Across repeat-dose toxicology, tumorigenicity and biodistribution, we are seeing encouraging results that strengthen the nonclinical foundation for advancing ERNA-101 toward the clinic."

Luther continued, "In straightforward terms, these results support what we designed ERNA-101 to do: find the tumor, deliver powerful immune-enhancing cytokines where they are intended to work and limit unnecessary exposure elsewhere in the body. With our core safety studies complete, GMP manufacturing underway and our FDA Pre-IND meeting behind us, we remain on track for our planned IND submission in the fourth quarter of 2026. Our focus now is execution and moving ERNA-101 toward the milestone that matters most: treating our first patient."

Repeat-Dose GLP Toxicology: No ERNA-101-Related Adverse Findings

In Ernexa’s pivotal 50-day GLP toxicology study, immunocompetent C57BL/6 mice with established ID8 ovarian tumors received ERNA-101 intraperitoneally once weekly for four doses at 0.33 × 10⁶, 1 × 10⁶ or 1 × 10⁷ cells per animal, compared with vehicle-treated controls.

The study was designed to evaluate ERNA-101 under conditions relevant to its planned clinical use, with tumor present, an intact immune system and repeat dosing.

Across all dose levels tested, there were:

No ERNA-101-related changes in clinical pathology;
No pathological evidence of treatment-related toxicity on microscopic evaluation by an independent board-certified veterinary pathologist; and
No treatment-related differences in the incidence or timing of unscheduled deaths, all of which were attributed to progression of the underlying tumor.

What the data mean: ERNA-101 is engineered to deliver an IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. Cytokines can powerfully activate the immune system, but systemic exposure can also cause significant toxicity. Ernexa designed ERNA-101 to use the natural tumor-homing properties of mesenchymal stromal cells to concentrate cytokine activity within tumors while limiting systemic exposure. The absence of ERNA-101-related toxicity in the repeat-dose study, together with the absence of acute cytokine release in the single-dose assessment, provides important support for that design strategy.

"A cytokine-armed cell therapy needs to be evaluated where its biology is active, in the presence of tumor and an intact immune system," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "That is what makes these results particularly encouraging. Across the repeat-dose study, we observed no ERNA-101-related adverse findings in clinical pathology or histopathology, and in the single-dose assessment, we observed no evidence of acute cytokine release. We believe the results support the fundamental concept behind ERNA-101: bring powerful immune activation to the tumor while limiting systemic exposure."

Tumorigenicity: No Teratoma Formation Observed Through Six-Month In-Life Phase

Because ERNA-101 is derived from induced pluripotent stem cells, or iPSCs, tumorigenicity is an important component of its nonclinical safety assessment. Specifically, the studies evaluate whether the final differentiated ERNA-101 cell product could form unwanted tumors known as teratomas.

Ernexa has completed a three-month tumorigenicity study and the in-life phase of a six-month tumorigenicity study in immunocompromised NSG mice. No gross evidence of teratoma formation was observed in ERNA-101-treated groups.

Histopathologic assessment confirmed the absence of tumor formation in the three-month study. Histopathologic evaluation of the six-month study is ongoing and is expected to be completed prior to IND submission.

What the data mean: For an iPSC-derived cell therapy, demonstrating that the final cell product does not form teratomas is a fundamental safety consideration. The absence of teratoma formation through the six-month in-life phase provides an encouraging answer to this important question as Ernexa prepares its IND package.

Biodistribution: No Significant ERNA-101 Signal in Tumor-Free Animals or Non-Tumor Tissues

Ernexa also completed a five-week biodistribution and persistence study designed to answer another straightforward but critical question: Where do ERNA-101 cells go after they are administered?

ERNA-101 was evaluated in both tumor-bearing and tumor-free animals. Using highly sensitive digital droplet PCR (ddPCR) specific for ERNA-101, the Company found no significant ERNA-101 signal in non-tumor-bearing animals or non-tumor-containing tissues.

The findings are consistent with the intrinsic tumor-homing properties of mesenchymal stromal cells and prior studies in which ERNA-101 cells were detected within tumors.

What the data mean: Ernexa designed ERNA-101 to home to tumors, deliver its immune-enhancing payload and avoid taking up residence elsewhere in the body. The biodistribution results provide important support for that targeted-delivery strategy.

"Biodistribution goes directly to the heart of the ERNA-101 thesis," Pierce said. "Put simply, we want the cells to go to the tumor, deliver their payload and not take up residence where they do not belong. Finding no significant ERNA-101 signal in tumor-free animals or non-tumor tissues is exactly the type of biodistribution profile we hoped to see and provides important support for the targeted delivery concept underlying our platform."

Efficacy + Safety + Tumor-Homing: Building a More Complete ERNA-101 Profile

The newly reported safety results build on previously reported ERNA-101 preclinical efficacy findings.

In ovarian cancer models, ERNA-101 remodeled the tumor microenvironment from immunosuppressive to immune-activated and increased infiltration of CD4+ and CD8+ T cells. When combined with PD-1 blockade, ERNA-101 achieved a high rate of complete tumor clearance and durable long-term survival, findings that were validated in independent studies.

In simple terms, the preclinical development program has now begun to address three fundamental questions:

Can ERNA-101 mediate tumor clearance?
Preclinical efficacy studies demonstrated compelling anti-tumor activity, including complete tumor clearance and durable survival in ovarian cancer models.

Can ERNA-101 potentially do so with an acceptable safety profile?
The core IND-enabling studies showed no ERNA-101-related adverse findings in repeat-dose GLP toxicology and no observed teratoma formation through the six-month tumorigenicity in-life phase.

Does ERNA-101 go where it is designed to go?
Biodistribution studies showed no significant ERNA-101 signal in tumor-free animals or non-tumor tissues.

"We believe the significance is in the totality of the data," Luther said. "Efficacy, safety and tumor-homing are not separate stories, they are interconnected parts of the same ERNA-101 thesis. The preclinical evidence generated to date is giving us encouraging answers across all three dimensions. That strengthens our conviction in the program as we prepare for the transition from preclinical development into the clinic."

Accompanying chart

Advancing Toward a Planned Q4 2026 IND

Completion of the core IND-enabling safety studies represents another major step in Ernexa’s planned transition toward becoming a clinical-stage oncology company.

The Company has completed its FDA Pre-IND meeting, completed its core IND-enabling safety studies and is advancing clinical-grade GMP manufacturing of ERNA-101.

Ernexa remains on track to submit an IND for ERNA-101 in Q4 2026 for a first-in-human clinical study in platinum-resistant ovarian cancer. Subject to IND clearance, the Company intends to initiate the study and dose the first patient, with initial clinical data currently expected in Q4 2027.

"There is a point in the development of every potentially important new therapy when the question begins to change," Luther concluded. "The question is no longer simply whether the science looks promising. It becomes whether you have built the foundation necessary to take that science into patients. With compelling preclinical efficacy, encouraging safety results, our core IND-enabling studies complete and manufacturing underway, we believe Ernexa is approaching that moment."

Mr. Luther continued, "Our objective now is clear: execute the IND submission, advance ERNA-101 into the clinic and begin determining whether the promise we have observed in preclinical models can translate into meaningful benefit for patients. For women facing platinum-resistant ovarian cancer, better treatment options are urgently needed. That need gives purpose to every milestone we achieve and urgency to everything that comes next."

(Press release, Ernexa Therapeutics, SEP 30, 2026, View Source [SID1234671203])

On September 30, 2026 Highlight Therapeutics, a clinical-stage biotechnology company developing immune activators to transform the treatment of skin tumors, reported positive results from the multicenter, single-arm Phase 2b SPOTLIGHT-204 clinical trial evaluating BO-112, a novel dsRNA-based intralesional treatment for patients with resectable primary low- and high-risk basal cell carcinoma (BCC). BO-112 is investigational and has not been approved by any regulatory authority. Results will be presented today in a late-breaking presentation at the 35th European Academy of Dermatology and Venereology (EADV) Congress in Vienna.

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The study met its primary endpoint of visual and pathological response at week 24 as well as key secondary endpoints, including safety and tolerability.

SPOTLIGHT-204 is believed to represent the largest cohort of high-risk head and neck (H&N) BCC patients treated to date with an intralesional therapy.

"Today marks an important milestone for Highlight Therapeutics as these results represent the first clinical validation of BO-112 in BCC and give us strong conviction to advance into late-stage development," said Mercedes Diz, Chief Executive Officer of Highlight Therapeutics. "We are excited to bring this potential non-surgical option a step closer to patients, particularly those with high-risk BCC in the head & neck, where the need is greatest. It is precisely in this hardest-to-treat population that SPOTLIGHT-204’s results stand out."

BCC is the most common human malignancy1, and its incidence continues to rise globally. Demand for treatments that preserve function and appearance keeps growing, but options remain limited. The most urgent need sits in high-risk BCC in cosmetically and functionally sensitive areas, particularly H&N and face, where appearance and function carry lasting emotional weight for patients2-3. For these patients, Mohs micrographic and conventional surgery achieve high cure rates but can result in significant scarring and functional compromise4, and surgery remains the only recommended option for the majority of patients5-6.

Josep Malvehy, MD, PhD, Professor of University of Barcelona and Director of Skin Cancer Program, Dermatology Department, Hospital Clínic of Barcelona, added, "I am very encouraged by the trial results. Effective non-surgical options remain an unmet clinical need for patients with high-risk BCC in the head & neck, who are also the hardest to manage surgically and carry the greatest concern about the impact of treatment. SPOTLIGHT-204 showed these patients achieved complete response in more than half of cases, and nearly two-thirds of those with facial lesions. These findings support BO-112’s potential as a well-tolerated, non-surgical option for this population."

SPOTLIGHT-204 Key Topline Phase 2b Results
The modified intention-to-treat population comprised 46 patients with 54 evaluable lesions assessed by a central review committee.

Primary endpoint met: 61% (n=28/46) of patients achieved the composite endpoint of visual and pathological response (Grade 3 or better) across all treated lesions, with high visual and histological concordance.
Meaningful response rates in both low and high-risk cohorts: 58% (n=21/36) of high-risk patients and 70% (n=7/10) of low-risk patients achieved visual and pathological response.
Strong activity in high-risk H&N: complete visual and complete pathological response (both Grade 1) achieved in 56% (18/32) of high-risk H&N patients and 62% (16/26) of the patients with lesions in the face.
Safety: BO-112 was well tolerated, with no serious adverse events (AEs), no Grade ≥3 treatment-related AEs, and no treatment discontinuations reported. The vast majority of treatment-related adverse events were mild, with 91% graded as Grade 1, and 88% resolving within three days.

EADV Late-breaking presentation details:

Abstract ID: LB-309
Abstract title: SPOTLIGHT-204: Primary Results of Intralesional BO-112 in Resectable Basal Cell Carcinoma
Presenter: Prof. M. Teresa Fernández-Figueras MD, PhD
Session title: D1T01.1 – Late Breaking News
Session date and time: Wednesday, 30 September, 15:00-15:15

About the SPOTLIGHT-204 Trial
SPOTLIGHT-204 (NCT06422936) is a Phase 2b, multicenter, single-arm clinical trial evaluating efficacy, safety and tolerability of intralesional BO-112 in patients with resectable primary low and high-risk BCC. The trial enrolled 50 patients, including 40 high-risk (36 presenting with head & neck lesions) and 10 low-risk who received three once-weekly intralesional BO-112 injections followed by complete surgical excision at week 24. The median age was 75 years (range 34–90) and 48% of patients were female. The primary endpoint is visual and pathological response at week 24, assessed by a central review committee. Key secondary endpoints include safety and tolerability as well as visual and pathological response assessed separately by investigator and central review.

About Basal Cell Carcinoma (BCC)
Basal cell carcinoma is the most common human malignancy1, and its incidence continues to rise globally. Mohs micrographic and conventional surgery achieve high cure rates but can leave significant scarring and functional compromise when lesions arise at cosmetically or functionally sensitive sites, particularly on the head and neck3. Effective non-surgical options that can be delivered at the point of care in dermatology practice therefore remain an unmet clinical need.

About BO-112
BO-112 is a double-stranded RNA nanoparticle formulated for intralesional administration. Its immunotherapeutic activity is mediated through activation of innate antiviral sensing pathways, induction of immunogenic tumor cell death, and subsequent development of tumor-specific adaptive immunity.

(Press release, Highlight Therapeutics, SEP 30, 2026, View Source [SID1234671202])

On September 30, 2026 Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IM-1340, a potential first-in-class antibody-drug conjugate (ADC) for the treatment of advanced solid tumors.

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IM-1340 is designed to target a transport receptor with a unique tumor expression profile spanning solid tumors, including neuroendocrine tumors, lung cancer, and colorectal cancer. It incorporates HC74, Immunome’s proprietary topoisomerase I (TOP1) inhibitor payload. Preclinical studies demonstrated encouraging anti-tumor activity across multiple tumor models, supporting the decision to advance this program into clinical development.

"IND clearance for IM-1340 marks another milestone in the advancement of Immunome’s ADC platform and demonstrates our ability to rapidly progress novel HC74-based programs into the clinic," said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We believe IM-1340 has the potential to treat multiple solid tumor types by combining a differentiated target with the favorable properties of our proprietary HC74 payload. We look forward to initiating clinical evaluation of IM-1340 and continuing to expand our ADC pipeline."

The Phase 1 study, which Immunome expects to initiate in the fourth quarter of 2026, is an open-label, multicenter dose-escalation and expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1340 in patients with advanced solid tumors.

About IM-1340

IM-1340 is a potential first-in-class ADC incorporating Immunome’s proprietary HC74 topoisomerase I inhibitor payload. The investigational therapy targets a transport receptor with expression across solid tumors, including neuroendocrine tumors, lung cancer, and colorectal cancer. In preclinical studies, IM-1340 demonstrated anti-tumor activity, including tumor regressions following a single dose in multiple in vivo models.

(Press release, Immunome, SEP 30, 2026, View Source [SID1234671201])