Month: September 2026

• Initiation of registrational Phase 3 study of VOQUEZNA® (vonoprazan) for as-needed (PRN) use in Non-Erosive Reflux Disease (NERD) builds on previously reported positive Phase 2 data
• Topline results expected in the first quarter of 2028
• pHalcon-NERD-302, if successful, is intended to support a potential VOQUEZNA label expansion to include as-needed treatment of heartburn episodes in patients with Non-Erosive GERD, a treatment regimen of interest to patients for which proton pump inhibitors (PPIs) are not currently approved in the U.S.

FLORHAM PARK, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases, today announced the initiation of patient screening in pHalcon-NERD-302, a registrational Phase 3 study evaluating an as-needed (PRN or on-demand) investigational dosing regimen of VOQUEZNA® (vonoprazan) tablets in adults with Non-Erosive Gastroesophageal Reflux Disease, or Non-Erosive GERD (NERD). Topline results are expected in the first quarter of 2028. If successful, the study is intended to support a potential regulatory submission seeking a label expansion for VOQUEZNA tablets for this treatment regimen.

“With pHalcon-NERD-302, we are studying what we believe could be an important new treatment approach for patients with Non-Erosive GERD. The study is designed to assess whether as-needed VOQUEZNA can provide rapid relief of heartburn when symptoms occur, with relief sustained over 24 hours. We have heard from many physicians and patients about the desire for an as-needed option. If successful, this study could support a potential label expansion for VOQUEZNA and an important opportunity to potentially broaden how VOQUEZNA may be used in the future to meet the needs of patients with Non-Erosive GERD,” said Steve Basta, President and Chief Executive Officer of Phathom Pharmaceuticals.

VOQUEZNA Phase 3 As-Needed Program
Building on previously reported positive Phase 2 results, pHalcon-NERD-302 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study investigating VOQUEZNA 10 mg as an as-needed treatment in adults with Non-Erosive GERD. The Phase 3 pHalcon-NERD-302 study is expected to enroll approximately 500 adults with Non-Erosive GERD who report heartburn at least four days per week. The study is planned to be conducted at approximately 80 sites in the U.S. Following a four-week, open-label run-in period with VOQUEZNA 10 mg once daily, patients without heartburn during the final seven days of the run-in period will be randomized 1:1 to receive VOQUEZNA 10 mg or placebo, as-needed, for 24 weeks of treatment. The primary endpoint, assessed at Week 12, is the percentage of heartburn episodes in which patients experience complete relief within two hours and sustained relief for 24 hours post-dosing.

“Non-Erosive GERD is characterized by episodic, often unpredictable heartburn. Proton-pump inhibitor acid-suppressing therapies generally rely on continuous daily use,” said Ronnie Fass, M.D., Division Director of Gastroenterology and Hepatology and Medical Director of the Digestive Health Center at MetroHealth Medical Center, Professor of Medicine at Case Western Reserve University School of Medicine, and an investigator for pHalcon-NERD-302. “An as-needed treatment approach would need to provide acid suppression that starts rapidly and is sustained long enough to control heartburn over 24 hours. The results from the earlier Phase 2 as-needed study of VOQUEZNA provide a strong rationale for evaluating its efficacy and safety in this Phase 3 trial.”

“One of the practical questions in managing Non-Erosive GERD is whether patients with intermittent symptoms need continuous daily therapy. This registrational study is designed to evaluate whether an as-needed treatment approach can provide effective heartburn relief when symptoms occur,” said Philip O. Katz, M.D., Professor of Medicine in the Division of Gastroenterology and Hepatology at Weill Cornell Medicine, gastroenterologist at NewYork-Presbyterian/Weill Cornell Medical Center, and an investigator for pHalcon-NERD-302. Dr. Katz serves as a consultant for Phathom Pharmaceuticals.

For more information about the pHalcon-NERD-302 study (NCT07752407), visit ClinicalTrials.gov.

About Non-Erosive Gastroesophageal Reflux Disease
Non-Erosive Gastroesophageal Reflux Disease (NERD) is the largest subcategory of gastroesophageal reflux disease (GERD) and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. More than 22 million U.S. patients are estimated to be treated annually with prescription medication for GERD, and approximately 15 million of these patients are believed to have NERD. Symptoms of NERD may impact overall quality of life and can include episodic heartburn, regurgitation, problems swallowing, and chest pain.

INDICATIONS AND USAGE

VOQUEZNA^® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated in adults:

• for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD.
• to maintain healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD.
• for the relief of heartburn associated with Non-Erosive GERD.
• in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection.
• in combination with amoxicillin for the treatment of H. pylori infection.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA, or in patients receiving rilpivirine-containing products.

For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with VOQUEZNA, refer to the Contraindications section of the corresponding prescribing information.

WARNINGS AND PRECAUTIONS

Presence of Gastric Malignancy: In adults, symptomatic response to therapy with VOQUEZNA does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in patients who have a suboptimal response or an early symptomatic relapse after completing treatment with VOQUEZNA. In older patients, also consider endoscopy.

Acute Tubulointerstitial Nephritis: Acute tubulointerstitial nephritis (TIN) has been reported with VOQUEZNA. If suspected, discontinue VOQUEZNA and evaluate patients with suspected acute TIN.

Clostridioides difficile-Associated Diarrhea: Published observational studies suggest that proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridioides difficile-associated diarrhea (CDAD), especially in hospitalized patients. VOQUEZNA may also increase the risk of CDAD. Consider CDAD in patients with diarrhea that does not improve. Use the shortest duration of VOQUEZNA appropriate to the condition being treated.

CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with VOQUEZNA, refer to Warnings and Precautions section of the corresponding prescribing information.

Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, especially in patients receiving high dose (multiple daily doses) and long-term therapy (a year or longer). Bone fracture, including osteoporosis-related fracture, has also been reported with vonoprazan. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines.

Severe Cutaneous Adverse Reactions (SCAR): Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with VOQUEZNA. Discontinue VOQUEZNA at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation.

Vitamin B12 (Cobalamin) Deficiency: Long-term use of acid-suppressing drugs can lead to malabsorption of Vitamin B12 caused by hypo- or achlorhydria. Vitamin B12 deficiency has been reported postmarketing with vonoprazan. If clinical symptoms consistent with vitamin B12 deficiency are observed in patients treated with VOQUEZNA, consider further workup.

Hypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported postmarketing with vonoprazan. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients.

Consider monitoring magnesium levels prior to initiation of VOQUEZNA and periodically in patients expected to be on prolonged treatment, in patients taking drugs that may have increased toxicity in the presence of hypomagnesemia or drugs that may cause hypomagnesemia. Treatment of hypomagnesemia may require magnesium replacement and discontinuation of VOQUEZNA.

Consider monitoring magnesium and calcium levels prior to initiation of VOQUEZNA and periodically while on treatment in patients with a preexisting risk of hypocalcemia. Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment, consider discontinuing VOQUEZNA.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily discontinue VOQUEZNA treatment at least 4 weeks before assessing CgA levels and consider repeating the test if initial CgA levels are high.

Fundic Gland Polyps: Use of VOQUEZNA is associated with a risk of fundic gland polyps that increases with long-term use, especially beyond one year. Fundic gland polyps have been reported with vonoprazan in clinical trials and during postmarketing use with PPIs. Most patients who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of VOQUEZNA appropriate to the condition being treated.

ADVERSE REACTIONS

Healing of Erosive GERD: The most common adverse reactions (≥2% of patients in the VOQUEZNA arm) include gastritis (3%), diarrhea (2%), abdominal distention (2%), abdominal pain (2%), and nausea (2%).

Maintenance of Healed Erosive GERD: The most common adverse reactions (≥3% of patients in the VOQUEZNA arm) include gastritis (6%), abdominal pain (4%), dyspepsia (4%), hypertension (3%), and urinary tract infection (3%).

Relief of Heartburn Associated with Non-Erosive GERD: The most common adverse reactions (≥2% of patients in the VOQUEZNA arm) include abdominal pain (2%), constipation (2%), diarrhea (2%), nausea (2%), and urinary tract infection (2%).

Treatment of H. Pylori Infection (VOQUEZNA and Amoxicillin): The most common adverse reactions (≥2% in any treatment arm) include diarrhea (5%), abdominal pain (3%), vulvovaginal candidiasis (2%), nasopharyngitis (2%), dysgeusia (1%), headache (1%), and hypertension (1%).

Treatment of H. Pylori Infection (VOQUEZNA, Amoxicillin and Clarithromycin): The most common adverse reactions (≥2% in any treatment arm) include dysgeusia (5%), diarrhea (4%), vulvovaginal candidiasis (3%), headache (3%), abdominal pain (2%), hypertension (2%), and nasopharyngitis (<1%).

For more information on adverse reactions and laboratory changes with amoxicillin or clarithromycin, refer to Adverse Reactions section of the corresponding prescribing information.

DRUG INTERACTIONS

VOQUEZNA has the potential for clinically important drug interactions, including interactions with drugs dependent on gastric pH for absorption, drugs that are substrates for certain CYP enzymes, and some diagnostic tests. Avoid concomitant use of VOQUEZNA with atazanavir or nelfinavir. See full Prescribing Information for more details about important drug interactions. Consult the labeling of concomitantly used drugs to obtain further information about interactions with vonoprazan.

For information about drug interactions, contraindications, and warnings and precautions of antibacterial agents (amoxicillin or clarithromycin) indicated in combination with VOQUEZNA, refer to their corresponding prescribing information.

USE IN SPECIFIC POPULATIONS

Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA during pregnancy. Healthcare providers are encouraged to register patients by calling 1-866-609-1612 or visiting https://voqueznapregnancyregistry.com/.

Lactation: There are no data on the effects of vonoprazan on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VOQUEZNA and any potential adverse effects on the breastfed child from VOQUEZNA or from the underlying maternal condition.

Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR < 30 mL/min). Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with severe renal impairment.

Hepatic Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with moderate to severe hepatic impairment (Child-Pugh Class B and C). Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with moderate to severe hepatic impairment.

You are encouraged to report suspected adverse reactions by contacting Phathom Pharmaceuticals at 1-888- 775-PHAT (7428) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here to see full Prescribing Information for VOQUEZNA.

About VOQUEZNA®
VOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Phathom in-licensed the rights to vonoprazan for the U.S., Europe and Canada from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America.

About Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB), for the U.S., Europe and Canada. Phathom currently markets vonoprazan in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, and as part of VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X.

Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including statements regarding: our plans, expectations, and goals for the development of VOQUEZNA for as-needed use in Non-Erosive GERD (NERD); potential timelines for the pHalcon-NERD-302 study (the “Study”), including timelines for site activation, screening, enrollment and reporting of topline results; the potential for the Study to be successful and to support the filing and approval of a label expansion for VOQUEZNA as an as-needed treatment in NERD; the potential role and need for an as-needed treatment option in the treatment of NERD; the potential of VOQUEZNA as such a treatment option, if the Study is successful and an expanded label is approved; our plans, expectations and strategies with respect to our business, goals, mission and vision; and our future performance, results and likelihood of success, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “guidance,” or “continue” or the negative of these terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including the risk that: we may encounter issues with the conduct of the Study that delay our timelines, including slower than expected site activation or enrollment, or issues with study conduct or data analysis; the Study may not replicate the results of our Phase 2 study; the Study may produce negative, mixed or otherwise inconclusive results; regulatory authorities may not agree that the results are sufficient to support a regulatory submission or approval of a label expansion for as-needed use in NERD; even if the results of the Study are positive, we may decide not to seek a label expansion; the success of the program may be impacted by potential safety or tolerability issues, competition from other therapies, treatment approaches, or ongoing clinical trials of other treatments; we may encounter manufacturing or other technical issues that negatively impact our conduct of the Study; future cash needs may cause us to change our plans; and any of the foregoing or other factors may negatively impact our ability to achieve our plans, goals, mission, vision and potential. For additional discussion of these and other risks, see the risk disclosure in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

MEDIA CONTACT
Nick Benedetto
1-877-742-8466
media@phathompharma.com

INVESTOR CONTACT
Eric Sciorilli
1-877-742-8466
ir@phathompharma.com

9/26 US-VPZ-26-0317

Patients reported high satisfaction and visible improvements in skin elasticity, youthfulness, and radiance

CLEARWATER, Fla., Sept. 29, 2026 (GLOBE NEWSWIRE) — Apyx Medical Corporation (NASDAQ:APYX) (“Apyx Medical” or the “Company”), the leader in surgical aesthetics marketed and sold as Renuvion^® and the AYON Body Contouring System^™ (AYON), today announced results from a prospective clinical study evaluating the effects of Renuvion helium plasma radiofrequency technology on biological markers of skin quality. The study was published in Plastic and Reconstructive Surgery—Global Open ¹.

The study provides new human tissue evidence indicating that Renuvion treatment may produce measurable changes beneath the surface of the skin that support improvements in skin quality observed by physicians and participants.

Key Findings from the Study at Day 180 (n=6) as compared to control tissue

• Increased elastin: Renuvion-treated tissue demonstrated a 30% increase in elastin fiber density and a 55% increase in elastin staining intensity, supporting improvements in a key component of skin elasticity and resilience.
• Reduced inflammation: Treated tissue demonstrated a 34% reduction in inflammation compared with untreated control tissue, supporting a healthier tissue environment following treatment.
• Regenerative skin remodeling: Human tissue analysis demonstrated a 27% increase in the incidence of elastin expression. Taken together, these histological findings were consistent with a pro-regenerative biologic response and favorable dermal remodeling. No significant fibrosis, abnormal vascularization or epithelial disruption was observed in treated tissue.
• Visible improvement: 100% of participants demonstrated improvement in both physician- and patient-assessed aesthetic improvement scores.
• High patient satisfaction: 100% of participants reported improvement, were satisfied with their treatment outcomes and indicated they would recommend the procedure to others.
• Improved skin quality: 100% of participants reported noticeable improvements in skin elasticity, radiance and youthfulness, providing patient-reported support for the biological changes observed in treated tissue.

“These findings provide important new evidence supporting the biological basis for the clinical benefits observed with Renuvion,” said Charlie Goodwin, President and Chief Executive Officer of Apyx Medical Corporation. “For years, surgeons have seen the clinical benefits of Renuvion in tissue contraction and have observed improvements in the quality of the overlying skin. This study provides direct human histological evidence supporting those observations, demonstrating meaningful changes in elastin and inflammation at the tissue level. We believe this research adds an important new dimension to the clinical understanding of Renuvion and its potential role in comprehensive aesthetic procedures. That is why we believe Renuvion should be part of every liposuction procedure, around the world. Liposuction addresses fat, but the quality of the tissue and skin left behind is also critical to the final result.

The prospective, single-arm, post-market study was conducted at two U.S. investigational sites and evaluated seven patients undergoing lower rhytidectomy, or facelift, surgery. Renuvion treatment was delivered to the subdermal tissue, while untreated areas served as internal controls. Six participants completed the Day 180 visit.

The study concluded that Renuvion treatment was well-tolerated and resulted in favorable dermal remodeling characterized by increased elastin and reduced inflammation without significant fibrosis. The authors noted that the findings represent direct, quantifiable human evidence that Renuvion can positively impact intrinsic biological markers associated with skin quality.

1. Kimbrell, M. L., & Holcomb, J. D. (2026). Histological Evaluation of Human Skin Biopsies Following Subdermal Helium Plasma Radiofrequency Treatment. Plastic and Reconstructive Surgery – Global Open, 14(9), e8116. Study link can be found here.

For more information about Renuvion and Apyx Medical’s growing body of clinical evidence, visit www.renuvion.com and www.apyxmedical.com.

Apyx Medical Contact:

Regis Cain, Senior Director Marketing
Regis.cain@apyxmedical.com

Investor Relations Contact:
Jeremy Feffer, Managing Director LifeSci Advisors
OP: 212-915-2568
jfeffer@lifesciadvisors.com

About AYON Body Contouring System™:

AYON is a groundbreaking, surgeon-designed body contouring system that combines precision, versatility, and innovation in an all-in-one platform. It seamlessly integrates advanced fat removal technologies, Renuvion’s tissue contraction and electrosurgical capabilities, empowering surgeons to deliver the most comprehensive body contouring treatments for patients. With advanced features like LIFT Technology for real-time adjustments and Renuvion for enhanced tissue contraction, AYON sets a new standard in surgical care, streamlining procedures and maximizing patient outcomes. Backed by Apyx Medical’s expertise and evidence-based design, AYON delivers consistent, reliable performance and an unmatched return on investment. As the first of its kind, AYON is revolutionizing body contouring and shaping the future of aesthetic surgery.

About Apyx Medical Corporation:

Apyx Medical Corporation is a surgical aesthetics company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Platform Technology products marketed and sold as Renuvion^® and the AYON Body Contouring System^TM in the cosmetic surgery market and J-Plasma^® in the hospital surgical market. Renuvion and J-Plasma offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results. The effectiveness of Renuvion and J-Plasma is supported by more than 90 clinical documents. The AYON Body Contouring System is an FDA-cleared, groundbreaking, surgeon-designed body contouring system that combines precision, versatility, and innovation in an all-in-one platform. It seamlessly integrates fat removal, closed loop contouring, electrosurgical capabilities and Renuvion for tissue contraction, empowering surgeons to deliver the most comprehensive body contouring treatments for patients. The Company also leverages its deep expertise and decades of experience in unique waveforms through OEM agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com. 

Cautionary Statement on Forward-Looking Statements:

Certain matters discussed in this release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.

All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but not limited to, statements regarding the Company’s anticipated public offering, including the completion of the public offering on the anticipated terms and the use of proceeds therefrom, projections of net revenue, margins, expenses, net earnings, net earnings per share, or other financial items; projections or assumptions concerning the possible receipt by the Company of any regulatory approvals from any government agency or instrumentality including but not limited to the U.S. Food and Drug Administration (the “FDA”), supply chain disruptions, component shortages, manufacturing disruptions or logistics challenges; or macroeconomic or geopolitical matters and the impact of those matters on the Company’s financial performance.

Forward-looking statements and information are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause the Company’s actual results to differ materially and that could impact the Company and the statements contained in this release include but are not limited to risks, uncertainties and assumptions relating to the regulatory environment in which the Company is subject to, including the Company’s ability to gain requisite approvals for its products from the FDA and other governmental and regulatory bodies, both domestically and internationally; sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; changes in general economic, business or demographic conditions or trends; changes in and effects of the geopolitical environment; liabilities and costs which the Company may incur from pending or threatened litigations, claims, disputes or investigations; and other risks that are described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and the Company’s other filings with the Securities and Exchange Commission. For forward-looking statements in this release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

– SPINOZA is studying obicetrapib in adults with biomarker evidence suggestive of preclinical Alzheimer’s disease who do not have noticeable memory or functional symptoms-

– The study will evaluate changes in blood-based biomarkers associated with Alzheimer’s disease, including p-tau 217, and additional cognitive and functional measures-

NAARDEN, the Netherlands and MIAMI, Sept. 29, 2026 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first participant in SPINOZA, a Phase 2b clinical trial evaluating obicetrapib in individuals with preclinical Alzheimer’s disease.

“The first participant dosed in SPINOZA marks an important milestone for NewAmsterdam as we expand the clinical evaluation of obicetrapib in Alzheimer’s disease,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “Alzheimer’s disease pathology typically begins years before clinical symptom onset, creating an opportunity for intervention. The commencement of this trial is an important step in our effort to understand whether obicetrapib may affect biological changes associated with the disease before noticeable symptoms develop. The findings from our BROADWAY Alzheimer’s disease biomarker analysis, together with the growing body of evidence linking lipid metabolism to Alzheimer’s disease pathology, provide a strong scientific rationale for further evaluating the effect of obicetrapib on biomarkers associated with disease progression and neurodegeneration.”

SPINOZA is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of obicetrapib in approximately 400 participants with preclinical Alzheimer’s disease. Eligible participants have biomarker evidence consistent with early Alzheimer’s disease pathology and carry ApoE4/E4, ApoE3/E4 or ApoE3/E3 genotypes. Participants will be randomized 1:1, stratified by genotype, to receive obicetrapib 10 mg or placebo for 52 weeks. Following completion of the double-blind treatment period, participants may enter a 26-week open-label extension study during which all participants will receive obicetrapib.

The SPINOZA trial design was informed by findings from the prespecified Alzheimer’s disease biomarker analysis in the Company’s Phase 3 BROADWAY trial, which demonstrated the strongest observed biomarker response in ApoE4/E4 participants and supportive signals across additional genotype-defined populations. These findings informed the genotype-stratified design of SPINOZA and the selection of enrollment criteria intended to further evaluate the effects of obicetrapib on biomarkers associated with Alzheimer’s disease pathology and neurodegeneration. SPINOZA further expands NewAmsterdam’s clinical development program for obicetrapib alongside its ongoing Phase 3 REMBRANDT, RUBENS and PREVAIL clinical trials.

People interested in learning more about the SPINOZA trial can visit spinoza.longboat.com. Additional eligibility criteria apply, and eligibility can only be determined by the study team following the required screening assessments.

About Obicetrapib

Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.

About the Phase 2b SPINOZA Trial

The SPINOZA trial is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study evaluating the effect of obicetrapib on plasma p-tau217 and other biomarkers associated with Alzheimer’s disease pathology and neurodegeneration in approximately 400 participants with preclinical Alzheimer’s disease.

Eligible participants are adults aged 55 to 85 years with preclinical Alzheimer’s disease (Stage 1 or Stage 2) as defined by FDA guidance for Early Alzheimer’s Disease drug development, a Mini-Mental State Examination (MMSE) score of at least 27, a global Clinical Dementia Rating (CDR) score of 0.5 or lower, and biomarker evidence of Alzheimer’s disease pathology. Enrollment is restricted to participants with ApoE4/E4, ApoE3/E4, or ApoE3/E3 genotypes. Participants will be randomized 1:1 to receive obicetrapib 10 mg or placebo, stratified by genotype.

The primary efficacy endpoint is change from baseline to Week 52 in plasma phosphorylated tau 217 (p-tau217), a biomarker associated with Alzheimer’s disease pathology. Secondary endpoints include changes in plasma Alzheimer’s disease biomarkers, including Aβ42/Aβ40, p-tau217/Aβ42, p-tau217/Aβ42/40 and BD-tau, as well as change from baseline to Week 52 in the Preclinical Alzheimer’s Cognitive Composite 5 (PACC5) score.

Following completion of the 52-week double-blind treatment period, eligible participants may choose to enter an open-label extension lasting at least 26 weeks, during which all participants will receive obicetrapib.

BROADWAY Alzheimer’s Analysis

In BROADWAY, a pre-specified analysis was designed to assess plasma biomarkers of Alzheimer’s disease in patients enrolled in the BROADWAY trial and evaluated the effects of longer duration of therapy (12 months) with a prespecified ApoE population, based on phenotypic analysis. The analysis included 1,535 patients, including 367 ApoE4 carriers (ApoE3/E4 or ApoE4/E4), whose ApoE status was able to be determined. Because this analysis was based on a subset of patients from BROADWAY (which was designed to evaluate LDL-C reductions in an ASCVD and/or HeFH population), the AD analysis was not controlled for baseline differences between the treatment and placebo populations, but statistical analyses were adjusted for baseline biomarker values and age. The absolute and percent change over 12 months in p-tau217, a key biomarker of AD pathology, was measured among patients with baseline and end of study datapoints above the lower limit of quantitation. Additional outcome measures included NFL, GFAP, p-tau181, and Aβ42/40 ratio absolute and percent change over 12 months. NewAmsterdam observed statistically significant lower absolute changes in p-tau217 compared to placebo over 12 months in both the full analysis set (p=0.025; n= 1,535) and in ApoE4 carriers (p=0.022; n=367) as well as favorable trends in the other AD biomarkers. Although a safety analysis was not performed in the AD analysis population, in BROADWAY obicetrapib was observed to be well-tolerated, with safety results comparable to placebo.

About NewAmsterdam

NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to building a new standard of care for people living with cardiometabolic and neurodegenerative diseases. The Company is advancing therapies designed to address a significant unmet need for safe, well-tolerated, and convenient treatment options that lower LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, alone and as a fixed-dose combination with ezetimibe, in patients at risk of cardiovascular disease with elevated LDL-C. Guided by its mission, the Company challenges convention with courage, translates deep biological insight into meaningful patient impact, and delivers with rigor, precision, and purpose.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and are subject to the “safe harbor” provisions created thereunder. All statements that are not historical facts are hereby identified as forwarding-looking statements for this purposes and include, among others, statements relating to: the therapeutic potential of the Company’s product candidate; the design, progression, timing and objectives of the Company’s clinical trials, including the SPINOZA trial; and other statements regarding the Company’s future operations, prospects, objectives, strategies and other future events. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon management’s current expectations and assumptions. Actual results or events could differ materially and adversely from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various risks, uncertainties and other factors, including, among others: uncertainties inherent in research and development, in the initiation and advancement of clinical trials and in the clinical development of obicetrapib in preclinical Alzheimer’s disease; whether results of early clinical trials and analyses will be indicative of the results of later clinical trials and analyses; risks to clinical trial site initiation, patient enrollment and follow-up; changes in domestic and foreign business, market, financial, political, and legal conditions; and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 18, 2026 and in its Quarterly Report on Form 10-Q filed with the SEC on August 5, 2026, as well as in other filings the Company may make with the SEC in the future, which are available at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date of this press release, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Company Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com

Media Contact
Real Chemistry on behalf of NewAmsterdam
Christian Edgington
P: 1-513-310-6410
cedgington@realchemistry.com  

Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com  

NEW YORK, Sept. 29, 2026 (GLOBE NEWSWIRE) — Apollo (NYSE: APO) plans to release financial results for the third quarter 2026 on Tuesday, November 3, 2026, before the opening of trading on the New York Stock Exchange. Management will review Apollo’s financial results at 8:30 am ET via public webcast available on Apollo’s Investor Relations website at ir.apollo.com. A replay will be available one hour after the event.

Apollo distributes its earnings releases via its website and email lists. Those interested in receiving firm updates by email can sign up for them here.

About Apollo

Apollo is a high-growth, global alternative asset manager. In our asset management business, we seek to provide our clients excess return at every point along the risk-reward spectrum from investment grade credit to private equity. For more than three decades, our investing expertise across our fully integrated platform has served the financial return needs of our clients and provided businesses with innovative capital solutions for growth. Through Athene, our retirement services business, we specialize in helping clients achieve financial security by providing a suite of retirement savings products and acting as a solutions provider to institutions. Our patient, creative, and knowledgeable approach to investing aligns our clients, businesses we invest in, our employees, and the communities we impact, to expand opportunity and achieve positive outcomes. As of June 30, 2026, Apollo had approximately $1.05 trillion of assets under management. To learn more, please visit www.apollo.com.

Contacts

Noah Gunn
Global Head of Investor Relations
Apollo Global Management, Inc.
(212) 822-0540
IR@apollo.com

Joanna Rose
Global Head of Corporate Communications
Apollo Global Management, Inc.
(212) 822-0491
Communications@apollo.com

Atlanta, Georgia, Sept. 29, 2026 (GLOBE NEWSWIRE) — Outdoor Holding Company (NASDAQ: POWW/POWWP) (“Outdoors Online,” “we,” “us.” “our” or the “Company”), the owner of GunBroker.com, the largest online marketplace for firearms, hunting and related products, announced that it will release financial results for its second quarter of its 2027 fiscal year premarket on November 16, 2026.

Management will host a conference call at 9:00 AM ET on November 16, 2026 to review financial results and provide an update on corporate developments. Following management’s formal remarks there will be a question-and-answer session.

The conference call will primarily be available through a live webcast at the following link: https://events.q4inc.com/attendee/891025686, which is also available through the Company’s website. The recording of the webcast will be posted on the Company’s website after the call is completed.

Those without internet access may dial in by calling (833) 461-5787 (domestic) or 1(585) 542-9983 (international). Please join at least 5-10 minutes prior to the scheduled start and follow the operator’s instructions. When requested, please use the meeting ID of 891 025 686.
About Outdoor Holding Company

With its corporate offices now headquartered in Atlanta, Georgia, Outdoor Holding Company is a publicly traded corporation that owns and operates subsidiaries serving outdoor enthusiasts, including GunBroker.

About GunBroker

GunBroker.com is the largest online marketplace dedicated to firearms, hunting, shooting and related products. Aside from merchandise bearing its logo, GunBroker currently sells none of the items listed on its website. Third-party sellers list items on the site and Federal and state laws govern the sale of firearms and other restricted items. Ownership policies and regulations are followed using licensed firearms dealers as transfer agents. Launched in 1999, the GunBroker.com site is an informative, secure and safe way to buy and sell firearms, ammunition, air guns, archery equipment, knives and swords, firearms accessories and hunting/shooting gear online. GunBroker promotes responsible ownership of firearms. For more information, please visit: www.gunbroker.com.

Forward-Looking Statements

This document contains certain “forward-looking statements”. All statements other than statements of historical fact are “forward-looking statements” for purposes of federal and state securities laws, including, but not limited to, any projections of earnings, revenue or other financial items; any statements of the plans, strategies, goals and objectives of management for future operations; any statements concerning proposed new products and services or developments thereof; any statements regarding future economic conditions or performance; any statements or belief; and any statements of assumptions underlying any of the foregoing.

Forward looking statements may include the words “may,” “could,” “estimate,” “intend,” “continue,” “believe,” “expect” or “anticipate” or other similar words, or the negative thereof. These forward-looking statements present our estimates and assumptions only as of the date of this report. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the dates on which they are made. We do not undertake to update forward-looking statements to reflect the impact of circumstances or events that arise after the dates they are made. You should, however, consult further disclosures and risk factors we include in Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports filed on Form 8-K.

Investor Contact:	Michael Bacal
	mbacal@darrowir.com
	917-886-9071

Source: Outdoor Holding Company

More than 200 ABM professionals help keep the 1.7-million-square-foot venue ready for Cardinals games, concerts, and major events

NEW YORK, Sept. 29, 2026 (GLOBE NEWSWIRE) — As the 2026 NFL season gets underway, ABM (NYSE: ABM), a leading provider of facility, engineering, and infrastructure solutions, is highlighting a longstanding partnership that helps keep State Farm Stadium clean, welcoming, and ready for game days and other major events. Since 2022, more than 200 ABM professionals have supported janitorial services across the 1.7-million-square-foot venue, helping prepare the stadium for Cardinals games, concerts, and other high-profile events throughout the year.

Behind every Cardinals game, concert, and major event is an experienced onsite janitorial team supporting the thousands of fans and guests who pass through State Farm Stadium’s turnstiles. Drawing on ABM’s deep sports and entertainment experience, these professionals help meet the demands of one of the region’s busiest venues.

“Great fan experiences start long before the gates open, and our team understands the tremendous amount of work and attention to detail required behind the scenes,” said Valerie Burd, President of Business & Industry, ABM. “They know the important role they play in delivering a first-class experience for every fan, player, employee, and visitor. We’re excited to build on that foundation through our partnership with the Cardinals.”

Opened in 2006, State Farm Stadium is home to the Arizona Cardinals and has become one of the nation’s most recognizable sports and entertainment destinations. The 63,400-seat venue has hosted three Super Bowls, the NCAA Men’s Final Four, the annual Fiesta Bowl, and major concerts and events. Its retractable roof and innovative natural-grass field tray allow the stadium to transform for events of dramatically different scale and format.

“The best venue experiences feel effortless to the fan, but making them feel that way takes incredible coordination and strategy,” said Brian Grant, Vice President, Sports & Entertainment, ABM. “Our onsite team understands the rhythm of this building: what has to happen before an event, what it takes to perform when tens of thousands of people arrive, and how quickly the venue needs to be ready for whatever comes next. They take real pride in helping State Farm Stadium shine.”

The relationship also extends beyond the stadium through ABM’s support of Cardinals Climb Hike for Special Needs, an Arizona Cardinals Foundation initiative benefiting organizations that serve individuals with intellectual and developmental disabilities. The initiative reflects a shared commitment to making a positive impact not only on the experiences taking place inside the stadium, but throughout the Arizona community.

The Cardinals partnership further strengthens ABM’s presence in the Phoenix sports and entertainment market, where ABM teams support venues across professional football, baseball, and basketball. Nationwide, ABM serves many of the country’s leading stadiums, arenas, and entertainment destinations, providing scalable facility solutions designed to help create clean, safe and enjoyable environments for fans, teams, and staff.

For more information about ABM’s Sports & Entertainment solutions, visit www.abm.com/industries/sports-entertainment.

About ABM
ABM (NYSE: ABM) is one of the world’s largest providers of integrated facility, engineering, and infrastructure solutions. Every day, our over 100,000 team members deliver essential services that make spaces cleaner, safer, and efficient, enhancing the overall occupant experience.

ABM serves a wide range of market sectors including commercial real estate, aviation, education, mission critical, and manufacturing and distribution. With over $8 billion in annual revenue and a blue-chip client base, ABM delivers innovative technologies and sustainable solutions that enhance facilities and empower clients to achieve their goals. Committed to creating smarter, more connected spaces, ABM is investing in the future to meet evolving challenges and build a healthier, thriving world. ABM: Driving possibility, together.

For more information, visit www.ABM.com.

MEDIA CONTACT:
Michael Valentino
ABM
media@abm.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fa69b5ed-c710-451a-bf7e-f7c70276dcd8

New survey of 1,001 U.S. adults reveals how rising education costs, shifting ROI expectations, and growing student debt anxiety are reshaping how Americans plan and pay for higher education

ISELIN, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) — Provident Bank, a leading New Jersey-based financial institution, announced today the results of its 2026 Higher Education Survey, which examines how American families are navigating the rising cost of higher education, evolving views on the value of a degree, and growing interest in alternative education paths. The findings reflect a financial reassessment now evident in how families plan, save, and make decisions related to college.

The financial pressure surrounding higher education remains a significant concern. The survey found that nearly 70% of respondents are concerned about the cost of higher education, and more than 70% say rising costs have already prompted changes in their families’ plans. As families weigh their options, the data reflects a more nuanced picture of how Americans think about the value of education today. Only 20.6% believe the financial return of a degree is clearly worth the cost, and 30.4% identify trade or technical school as the path offering the best financial return available.

“Higher education can be a powerful investment in a person’s future, but how families plan and pay for it can have financial implications for years to come. As a trusted financial partner, we have a responsibility to help customers make informed decisions, understand the options available to them, and provide tailored solutions that support both their educational aspirations and their long-term financial goals,” said Anthony Labozzetta, President & CEO, Provident Bank.

Key data highlights include:

• The Financial Return of a Degree Is No Longer a Given: Only 20.6% of respondents believe a higher education degree is clearly worth the cost today. 48.5% say it depends on the school, degree, and career path, and 19.4% say the cost outweighs the potential return outright. Skepticism also extends to graduate school: 43.9% of respondents say the financial return on a master’s degree is weaker than it was 10 years ago, either somewhat weaker (22.2%) or much weaker (21.7%), while only 13.8% say it is much stronger.
• Rising Costs Are Driving Behavioral Changes: 71.3% of respondents say rising education costs have changed their or their family’s plans either significantly (28.4%) or somewhat (42.9%). Less than 28% say costs have had no effect on their planning. Nearly 70% are extremely or very concerned about the cost of higher education today.
• Trade School Is Gaining Ground as a Financial Decision: 30.4% of respondents identify trade school or technical school as the education path offering the best financial return today, second only to four-year college (35.4%). Nearly two in three respondents (65%) say concerns about student debt have made trade schools, technical schools, or certificate programs more appealing, with more than 30% finding them much more appealing. 61.7% say they are more likely now than a few years ago to consider lower-cost education options such as in-state universities, community colleges, or trade schools.
• Savings and Debt Planning Are Lagging Behind Rising Costs: 19.4% of respondents are unsure how much student loan debt they or their child will need to take on. Among those who do expect debt, 9.9% expect $100,000 or more, and 11.8% expect between $50,000 and $74,999. Only 7.9% started saving before their child was born, and 13.5% have not started and do not plan to.
• Banks Have a Clear and Growing Opportunity to Support Families: 51.4% of respondents say it is extremely or very important that their bank offers dedicated products or guidance for saving toward education. However, only 24.4% say their current bank offers this kind of guidance, and they actually use it. 18.4% say their bank offers nothing at all in this area. As families face one of the most consequential financial decisions of their lives, the data points to a meaningful and largely untapped role for financial institutions.

“Planning for higher education is one of the most complex financial challenges a family faces, and our survey shows that most feel they’re doing it without adequate support. Provident’s Financial Wellness Center is designed to address that. From 529 guidance to education savings tools that help families understand their options before the bills arrive, we’re here to help families plan smarter, not just save harder,” said Renee Altomonte, Executive Vice President, Retail Banking Director, Provident Bank.

The survey was conducted by Pollfish, a market research provider, on behalf of Provident Bank. The findings are based on responses from 1,001 U.S. adults currently paying or saving for higher education — either their own or a dependent’s — across all four census regions, spanning a range of income levels, employment statuses, and age groups.

About Provident Bank

Founded in Jersey City in 1839, Provident Bank is the oldest community-focused financial institution based in New Jersey and is the wholly owned subsidiary of Provident Financial Services, Inc. (NYSE: PFS). With assets of $25.66 billion as of June 30, 2026, Provident Bank offers a wide range of customized financial solutions for businesses and consumers with an exceptional customer experience delivered through its convenient network of 135 branches across New Jersey and parts of New York and Pennsylvania, via mobile and online banking, and from its customer contact center. The bank also provides fiduciary and wealth management services through its wholly owned subsidiary, Beacon Trust Company, and insurance services through its wholly owned subsidiary, Provident Protection Plus, Inc. To learn more about Provident Bank, go to www.provident.bank or call our customer contact center at 800.448.7768.

Media Contact:

Keith Buscio, First Vice President, Director of Public Relations
Keith.Buscio@provident.bank

• U.S. FDA has granted Fast Track designation for TX2100 in HHT and cleared the Investigational New Drug (IND) application for the TX2100 Phase 1b clinical trial in HHT patients in the U.S.
• TX2100 Phase 1a clinical trial topline results demonstrated single ascending doses of TX2100 were generally safe and well-tolerated in healthy adult volunteers
• Company plans to initiate an open-label TX2100 Phase 1b clinical trial in patients with hematologic-support dependent HHT by year-end 2026, and initiate a Phase 2 clinical trial in parallel in patients with moderate-to-severe HHT in early 2027

WATERTOWN, Mass., Sept. 29, 2026 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic” or the “Company”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced favorable topline results from its Phase 1a clinical trial evaluating TX2100, an investigational VHH-Fc fusion antagonist antibody targeting the APJ (apelin) receptor, in healthy adult volunteers. The clinical trial was designed to support the advancement of clinical development for TX2100 as a potential treatment for Hereditary Hemorrhagic Telangiectasia (HHT), a rare, inherited vascular disorder with no currently approved therapies. The Company also announced that the U.S. Food and Drug Administration (FDA) granted TX2100 Fast Track Designation for HHT. In addition, the FDA recently cleared the Company’s Investigational New Drug (IND) application to conduct the upcoming TX2100 Phase 1b clinical trial in the U.S. in patients with HHT.

“We are very excited about our TX2100 clinical program as a potential first-in-class, selective anti-angiogenic therapy for HHT, a disease with no approved treatments,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic Therapeutic. “We are proceeding into clinical trials in HHT patients with a clear rationale: a differentiated mechanism, supportive preclinical data, and the favorable safety profile observed in the Phase 1a single ascending dose clinical trial. We look forward to evaluating TX2100 in patients living with HHT in our Phase 1b and Phase 2 trials, which are planned to advance in parallel in the months ahead.”

The TX2100 Phase 1a clinical trial met its primary objectives, including the following:

• Single ascending doses of TX2100, administered intravenously and subcutaneously, were generally safe and well-tolerated across all six planned dose cohorts.
• Treatment-emergent adverse events (TEAEs) were mild or moderate and transient. There were no deaths, serious adverse events (SAEs) or severe TEAEs at any dose. No clinically significant changes were observed in vital signs, laboratory assessments or electrocardiograms. Anti-drug antibody (ADA) results are pending.
• Pharmacokinetic (PK) results reflected target-mediated drug disposition (TMDD) at low concentrations, confirming TX2100’s high affinity binding to the APJ receptor and clearance through this mechanism, which is consistent with potent target engagement.
• Dose selection for the upcoming Phase 1b and Phase 2 clinical trials is being informed by two independent methods: exposures associated with high receptor occupancy inferred from the observed TMDD in the Phase 1a clinical trial, and target exposure levels shown to drive activity in nonclinical models of HHT. These two methods converged on a consistent target exposure range, supporting the approach to dose selection.
• The observed PK results support exploration of once weekly and every other week subcutaneous dosing regimens in future clinical trials.

Detailed results from the TX2100 Phase 1a clinical trial, including safety, tolerability, PK and ADA results will be presented at the CureHHT 16^th HHT International Scientific Conference, taking place October 12-16, 2026.

Marcella K. Ruddy, M.D., Chief Medical Officer of Tectonic Therapeutic commented, “Today’s topline safety results in healthy volunteers are consistent with TX2100’s preclinical results, including toxicology studies that demonstrated no dose limiting toxicities with wide safety margins. We selected our target exposures using two independent methods that pointed to the same range, which gives us confidence in our approach. Data from the ongoing Part B multiple-dose cohort of the Phase 1a trial will further confirm the dose-exposure relationship and dose selection for Phase 2.”

Tectonic plans to advance TX2100 into two clinical trials in HHT in the upcoming months: an open-label Phase 1b clinical trial in patients with hematologic-support dependent HHT, with endpoints exploring an improvement in need for iron and red blood cell support, as well as an improvement in hematologic parameters, and a placebo-controlled Phase 2 clinical trial in moderate-to-severe HHT patients, with endpoints expected to include epistaxis, hemoglobin, hematologic support, and other endpoints relevant to HHT. Phase 1b and Phase 2 trials are planned to run in parallel, with the Phase 1b anticipated to initiate by year-end 2026 and the Phase 2 trial anticipated to initiate in early 2027.

The clinical program for TX2100 has achieved recent regulatory milestones with the U.S. FDA. In August 2026, the FDA cleared the Company’s IND application for TX2100 for the treatment of HHT, enabling Tectonic to conduct the planned open label Phase 1b clinical trial in patients with HHT in the U.S. In September 2026, the FDA granted TX2100 Fast Track Designation for the treatment of HHT. Fast Track Designation is an FDA process designed to facilitate the development and expedite the review of investigational treatments intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

About the Phase 1a clinical trial with TX2100

The Phase 1a clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose (SAD), first-in-human trial conducted at CMAX Clinical Research in Adelaide, South Australia (ANZCTR registration: ACTRN12626000242325). The trial enrolled 48 healthy adult volunteers (men and women of non-childbearing potential, ages 18–55) across six sequential dose cohorts of eight participants each, randomized 3:1 to receive a single dose of TX2100 or matching placebo, administered via intravenous (IV) infusion or subcutaneous (SC) injection: Cohort A, 0.1 mg/kg IV; Cohort B, 0.3 mg/kg IV; Cohort C, 100 mg SC; Cohort D, 1 mg/kg IV; Cohort E, 300 mg SC; Cohort F, 600 mg SC. The primary objectives of the trial were to characterize the safety and tolerability of TX2100, assessed by the incidence of adverse events (AEs) and serious adverse events (SAEs), and clinically significant changes in safety laboratory parameters, 12-lead ECGs, and vital signs. The key secondary objective was to characterize the pharmacokinetic profile of TX2100; immunogenicity was also assessed.

Following the completion of Part A of the TX2100 Phase 1a clinical trial, Tectonic is conducting Part B of the trial which is a multiple dose cohort and has completed enrollment. Part B is evaluating six healthy volunteers in an open-label design who will be dosed with 600 mg SC on Day 1, followed by 200 mg SC dose on Day 8 and 200 mg SC dose on Day 15.

About TX2100, a VHH-Fc fusion antagonist antibody
TX2100, is a VHH-Fc fusion antagonist antibody that binds to the APJ receptor (also known as the apelin receptor; APLNR), a GPCR that mediates signaling by the pro-angiogenic peptide hormone apelin. APJ represents a differentiated approach for the potential treatment of HHT. APJ is a selective anti-angiogenic target that is primarily expressed in endothelial cells and is generally quiescent under normal physiological conditions, but is upregulated during pathologic angiogenesis, including in HHT preclinical models. TX2100 is designed as a selective APJ antagonist intended to inhibit disease-associated angiogenic signaling with the goal of providing a more favorable safety profile compared to less selective anti-angiogenic approaches. Anti-angiogenic agents have demonstrated activity in HHT preclinical models and in patients, and APJ antagonism has shown activity in multiple HHT preclinical models, supporting development of TX2100 for this indication.

About Hereditary Hemorrhagic Telangiectasia (HHT)
HHT is a rare, inherited vascular disorder affecting an estimated 75,000 people in the United States. HHT is the second most common inherited bleeding disorder and a disease for which there are currently no approved therapies. It is characterized by fragile, abnormal blood vessels that lead to recurrent bleeding, which can reduce quality of life, result in emergency room visits and hospitalizations, as well as chronic anemia requiring frequent iron infusions and/or blood transfusions. Many patients with HHT also develop arteriovenous malformations (AVMs) in vital organs such as the lungs, brain, and liver that, if left untreated, are at risk of rupturing and can result in serious and potentially life-threatening complications including lung or brain hemorrhage, stroke, heart failure, or death. Despite being a rare disease and the second most common inherited bleeding disorder, there are currently no approved therapies.

About Tectonic
Tectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit https://tectonictx.com/ and follow us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements.” These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the potential of TX2100, including its potential future benefit to patients, the Company’s plan with respect to TX2100, including the design, objectives, initiation, timing, progress and results of current and future clinical trials of TX2100, including the ongoing Phase 1a clinical trial for TX2100 and the planned Phase 1b and Phase 2 clinical trials for TX2100; the Company’s expectations regarding the presentation of full clinical data from the Phase 1a clinical trial; and the Company’s business strategies, plans and prospects. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions and ongoing global conflicts, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed for the quarter ended June 30, 2026 and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

CONTACT: Contacts:
Investors:
Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

Media:
Kathryn Morris
The Yates Network
kathryn@theyatesnetwork.com
(914) 204-6412

LOS ANGELES, Sept. 29, 2026 (GLOBE NEWSWIRE) — AXIL Brands, Inc. (“AXIL,” “we,” “us,” “our,” or the “Company”) (NYSE American: AXIL), an emerging global consumer products company for AXIL® hearing protection and enhancement products and Reviv3® hair and skin care products, today announced that the company expects to report its Fiscal First Quarter results for the period ending August 31, 2026 on Tuesday, October 6, after the close of the market.

Jeff Toghraie, CEO and Jeff Brown, CFO of Axil Brands will host a conference call (audio only) to discuss the results and provide a corporate update for investors at 5:00 PM ET, which will be accessible via telephone or over the internet. A question and answer (Q&A) session will be moderated at the conclusion of the prepared remarks.

Investors can access the live event by dialing in to 1-877-425-9470 or 1-201-389-0878 or by logging on for the webcast at https://viavid.webcasts.com/starthere.jsp?ei=1777813&tp_key=7330938b30

Investors wishing to ask questions are encouraged to send any questions in advance of the call (please submit by 12PM ET) to the following email address in advance:

Investors@goaxil.com

The call will be available via telephone replay through October 13, 2026. The telephone number for the replay is 1-844-512-2921 or 1-412-317-6671 and an access code, 13762995 will be required. A webcast (audiostream) will also be available for replay upon demand on the company’s corporate website, www.goaxil.com in the investor relations section.

About AXIL Brands, Inc.

AXIL Brands, Inc. is dedicated to developing and delivering innovative hearing enhancement and protection products that combine advanced technology with exceptional comfort and performance. The Company also operates in the hair and skin care market through its Reviv3 Procare brand. For more information, please visit goaxil.com.

Investor Relations:
investors@goaxil.com

Two new whitepapers argue that neither failure is about how smart the AI is, and that a bigger model fixes neither

SUNNYVALE, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) — As thousands of AI builders and business leaders gather at The AI Conference in San Francisco, eGain Corporation (NASDAQ: EGAN) published two whitepapers on the two problems most likely to stop a corporate AI project, and argues both trace back to the same overlooked cause: companies never organized the information their AI depends on.

The first paper, Ending Runaway Token Costs in Enterprise AI, addresses a complaint moving from software teams into customer service and back-office operations: AI bills that grow faster than expected and are nearly impossible to forecast. Companies pay for AI by the unit of work it does, and eGain’s argument is that most of that work is wasted. Asked a simple question, the system reads through a sprawl of company documents from scratch, every single time, because no one ever organized that material or mapped how it fits together. eGain likens it to sending a new hire into an unlabeled warehouse to find one box, then sending them back in for the next box, and the next. A second source of waste is using AI to handle work that is really just a rule. Calculating a late fee or checking whether someone qualifies for a refund does not require judgment, and asking an AI to reason it out fresh each time is an expensive way to do arithmetic. eGain’s answer is to organize company knowledge into a single trusted, mapped source so the AI goes straight to what it needs, and to route routine decisions to ordinary software. The company is confident enough in the savings that it prices many contracts on results rather than usage, absorbing the risk of the bill itself.

The second paper, The Trust Gap in AI Self-Service, explains why so many customer-facing AI projects look impressive in a demo and stall before going live. When a human service rep uses AI, the rep catches the mistakes. When the customer talks to the AI directly, no one does. That makes the industry’s favorite scorecard misleading. A system that is 95% accurate is not defined by the 95%. It is defined by what the other 5% looks like. An AI that says “I’m not certain, let me get you a person” has failed safely. An AI that states the wrong thing about a customer’s mortgage, confidently, with the bank’s name on it, has not. The paper is also pointed about a popular technical shortcut: letting the AI decide in the moment which company system to reach into and what to do there. eGain argues that approach is not dependable enough for live customer use, because there is no expert standing by to notice that the wrong account was charged.

“A runaway AI bill almost never means the model is too small. It means nobody told it where to look,” said Ashu Roy, CEO of eGain. “And once a customer is talking to the AI directly, there is no one left to catch a mistake before it lands. Getting the underlying information right is not a feature. It is the whole job.”

Availability: Both whitepapers are at eGain.com/resources. Journalists and analysts at The AI Conference can request advance copies and executive briefings at press@egain.com.

About eGain
eGain is a leading provider of AI-powered knowledge management and customer experience automation solutions and was named a Leader in the Gartner inaugural Magic Quadrant for Customer Service Knowledge Management Systems. With over 25 years of experience in knowledge management, eGain helps enterprises unify siloed content, automate trusted knowledge workflows, and deliver measurable AI-ROI through proven frameworks and methods. Global 2000 companies across industries rely on eGain to transform customer service, improve employee productivity, reduce costs, and accelerate AI adoption. Visit www.eGain.com for more info.

Gartner Disclaimer
Gartner, Magic Quadrant for Customer Service Knowledge Management Systems, Pri Rathnayake, Jennifer MacIntosh, Patrick Quinlan, Drew Kraus, 16 July 2026.

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