Author: Ravi Shankar

Potential Follow-On Orders Could Bring Total Orders to Approximately US$14.1 Million; Majority of the Initial Order Expected to Be Delivered by the End of 2028

Rehovot, Israel, Sept. 28, 2026 (GLOBE NEWSWIRE) — Maris-Tech Ltd. (Nasdaq: MTEK, MTEKW) (“Maris-Tech” or the “Company”), a global leader in edge computing, AI, and video intelligence solutions for defense applications, today announced that it has received an order valued at US$10 million for the development and supply of advanced video systems for multiple next-generation manned airborne platforms.

The order was received pursuant to a multi-year project being carried out by Magam Safety Ltd. (“Magam”) and Maris-Tech who will collaborate jointly in order to supply the advanced Video Systems for Next-Generation Airborne Defense Platforms.

Founded in 1934, Magam designs, manufactures and markets protective gear and rescue and survivability equipment for the aerospace, defense and health and life sciences sectors, and supplies products to the Israel Defense Forces. Its interdisciplinary team of textile, rubber and personal-protection experts, engineers and product designers deliver both off-the-shelf and tailored solutions, including fuel tanks, parachutes, life jackets, life rafts and anti-mine protectors.

The US$10 million order is part of a multi-year project that includes additional purchase options. If such options are exercised, Maris-Tech expects to receive additional orders that would bring the total value of orders received by Maris-Tech under the project to approximately US$14.1 million. The additional orders are subject to the exercise of such options.

Under the project, Maris-Tech will modify and upgrade some of its existing products and develop and supply advanced video systems for integration across multiple next-generation manned airborne platforms. The systems will be based on the Company’s field-proven Jupiter product line of video, AI edge-computing and streaming platforms, as well as the Company’s Opal high-end, ruggedized advanced video recording and NAS (Network Attached Storage) server software. The systems are designed to support the video requirements of the platforms in demanding airborne operating environments.

Maris-Tech expects to complete deliveries representing approximately US$7.1 million of the order value by the end of 2028.

Israel Bar, Chief Executive Officer of Maris-Tech, said: “This project reflects the continued application of our video capabilities in airborne environments. Working together with Magam we will support the development and supply of video systems across multiple next-generation platforms over the coming years.”

Amit Tesler, Chairman of Magam, said: “Magam has supplied the defense market for more than nine decades. Our cooperation with Maris-Tech on this project brings its video capabilities to the next-generation airborne platforms covered by the project, and we look forward to working together over the course of the project.”

About Maris-Tech Ltd.

Maris-Tech delivers AI-powered edge video solutions for mission-critical defense and security operations, enabling real-time situational awareness, intelligence gathering, and surveillance in bandwidth- and latency-constrained environments. Trusted by leading security organizations, Maris-Tech platforms are deployed across UAVs, UGVs, armored vehicles, and dismounted soldier systems, supporting missions that require ultra-low-latency video processing and onboard AI analytics. From intelligence collection in extreme conditions to AI-driven surveillance and terrain dominance, Maris-Tech masters the AI video pipeline at the edge through best-in-class SWaP-optimized, ruggedized computing solutions.

For more information, visit https://www.maris-tech.com/

Forward-Looking Statement Disclaimer

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe the Company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect”,” “may”, “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. For example, the Company is using forward-looking statements when it is discussing the anticipated scope, value, timing and delivery of the order, the potential for additional orders if additional purchase options are exercised, anticipated deliveries by the end of 2028, the Company’s cooperation with Magam, the development, modification, integration and supply of the Company’s products, and the expected capabilities, performance and benefits of the Company’s products and systems in demanding airborne operating environments. The Company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: the performance, amendment, suspension or termination of the applicable project; its ability to successfully market its products and services, including in the United States; the acceptance of its products and services by customers; its continued ability to pay operating costs and ability to meet demand for its products and services; the amount and nature of competition from other security and telecom products and services; the effects of changes in the cybersecurity and telecom markets; its ability to successfully develop new products and services; its success establishing and maintaining collaborative, strategic alliance agreements, licensing and supplier arrangements; the actions, decisions, performance and approvals of Magam, the end customer and other third parties, including the exercise of options and placement of additional orders; its ability to comply with applicable regulations; and the other risks and uncertainties described in the Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on May 15, 2026, and its other filings with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Relations:

Nir Bussy, CFO
Tel: +972-72-2424022
Nir@maris-tech.com

Closing expected mid-October 2026

DENVER, Sept. 28, 2026 (GLOBE NEWSWIRE) — Intermap Technologies, a global leader in geospatial intelligence powered by proprietary 3D data and AI-driven analytics, today announced that shareholders (“PCI Shareholders”) of PCI Geomatics Group Inc. (“PCI,” aka. “CATALYST”) have approved Intermap’s previously announced acquisition of the remaining PCI shares. The acquisition includes all of the issued and outstanding shares in the capital of PCI not already owned by Intermap and will be completed by way of an arrangement under the Canada Business Corporations Act (the “Arrangement”).

On September 25, 2026, PCI held a special shareholder meeting in person and virtually, via live webcast (the “Meeting”), with PCI Shareholders voting on a special resolution in connection with the proposed Arrangement (the “Arrangement Resolution”). The Arrangement Resolution was approved by: (i) 99.99% of the votes cast by PCI Shareholders present in person or by proxy at the Meeting, voting as a single class; 99.99% of the votes cast by holders of common shares in the capital of PCI present in person or by proxy at the Meeting, excluding votes cast by certain officers and/or directors of PCI; 100% of the votes cast by holders of Series B first preferred shares in the capital of PCI present in person or by proxy at the Meeting; and 100% of the votes cast by holders of special shares in the capital of PCI present in person or by proxy at the Meeting.

“We are pleased to have received the support of PCI Shareholders and to reach this important milestone,” said Patrick Blott, Chairman and CEO of Intermap. “We look forward to completing the transaction and bringing Intermap and PCI together as one company, combining our proprietary 3D data, geospatial intelligence and advanced imagery processing capabilities to create a stronger platform for growth.”

The Arrangement is subject to the approval of the Ontario Superior Court of Justice (Commercial List) (the “Court”). The anticipated hearing date for the application for the final order of the Court (the “Final Order”) is September 28, 2026. Subject to obtaining the Final Order, and the satisfaction or waiver of the conditions to implementing the Arrangement as set out in the arrangement agreement dated July 28, 2026 among Intermap, PCI and Grenadier Investments Limited, the Arrangement is expected to be completed mid-October, 2026.

Intermap Reader Advisory 
Certain information provided in this news release, including reference to the timing, completion and expected benefits of the Arrangement and the timing of receipt of the Final Order constitutes forward-looking statements. The words “anticipate”, “expect”, “propose”, “will”, “look forward” and similar expressions are intended to identify such forward-looking statements. Although Intermap believes that these statements are based on information and assumptions which are current, reasonable and complete, these statements are necessarily subject to a variety of known and unknown risks and uncertainties. Intermap’s forward-looking statements are subject to risks and uncertainties pertaining to, among other things, cash available to fund operations, availability of capital, revenue fluctuations, nature of government contracts, economic conditions, loss of key customers, retention and availability of executive talent, competing technologies, common share price volatility, loss of proprietary information, software functionality, internet and system infrastructure functionality, information technology security, breakdown of strategic alliances, and international and political considerations, as well as those risks and uncertainties discussed in Intermap’s Annual Information Form and other securities filings. In addition, completion of the Arrangement is subject to receipt of court approvals, together with the satisfaction or waiver of certain conditions precedent to the Arrangement which are outside of the control of Intermap. While the Company makes these forward-looking statements in good faith, should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary significantly from those expected. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements, including the Arrangement, will transpire or occur, or if any of them do so, what benefits that the Company will derive therefrom. All subsequent forward-looking statements, whether written or oral, attributable to Intermap or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. The forward-looking statements contained in this news release are made as at the date of this news release and the Company does not undertake any obligation to update publicly or to revise any of the forward-looking statements made herein, whether as a result of new information, future events or otherwise, except as may be required by applicable securities law.

About Intermap Technologies 
Intermap Technologies is a global leader in geospatial intelligence powered by proprietary 3D data and AI-driven analytics. The Company delivers actionable intelligence to government and commercial customers through a portfolio of applications, platforms and solutions that support risk management, infrastructure planning, operational readiness and mission-critical decision-making. Intermap’s proprietary 3D data foundation spans more than 300 million square kilometers across over 150 countries and powers intelligence solutions for government, insurance, aviation, telecommunications, transportation, renewable energy, agriculture, natural resources and space markets. Through advanced analytics, automated processing and enterprise-scale data delivery, Intermap helps organizations transform complex geospatial information into decision-ready intelligence. 

About CATALYST (PCI)
PCI (DBA CATALYST) is a world-leading developer of software and systems for remote sensing, imagery processing, and photogrammetry. With 45 years of experience in the geospatial industry, CATALYST is recognized globally for its excellence in providing software for accurately and rapidly processing satellite and aerial imagery, with more than 30,000 licenses in over 150 countries worldwide.

For more information, please visit www.intermap.com or contact:
Jennifer Bakken
Executive Vice President and CFO
CFO@intermap.com
+1 (303) 708-0955

Sean Peasgood
Investor Relations
Sean@SophicCapital.com
+1 (647) 260-9266

Closing expected mid-October 2026

DENVER, Sept. 28, 2026 (GLOBE NEWSWIRE) — Intermap Technologies, a global leader in geospatial intelligence powered by proprietary 3D data and AI-driven analytics, today announced that shareholders (“PCI Shareholders”) of PCI Geomatics Group Inc. (“PCI,” aka. “CATALYST”) have approved Intermap’s previously announced acquisition of the remaining PCI shares. The acquisition includes all of the issued and outstanding shares in the capital of PCI not already owned by Intermap and will be completed by way of an arrangement under the Canada Business Corporations Act (the “Arrangement”).

On September 25, 2026, PCI held a special shareholder meeting in person and virtually, via live webcast (the “Meeting”), with PCI Shareholders voting on a special resolution in connection with the proposed Arrangement (the “Arrangement Resolution”). The Arrangement Resolution was approved by: (i) 99.99% of the votes cast by PCI Shareholders present in person or by proxy at the Meeting, voting as a single class; 99.99% of the votes cast by holders of common shares in the capital of PCI present in person or by proxy at the Meeting, excluding votes cast by certain officers and/or directors of PCI; 100% of the votes cast by holders of Series B first preferred shares in the capital of PCI present in person or by proxy at the Meeting; and 100% of the votes cast by holders of special shares in the capital of PCI present in person or by proxy at the Meeting.

“We are pleased to have received the support of PCI Shareholders and to reach this important milestone,” said Patrick Blott, Chairman and CEO of Intermap. “We look forward to completing the transaction and bringing Intermap and PCI together as one company, combining our proprietary 3D data, geospatial intelligence and advanced imagery processing capabilities to create a stronger platform for growth.”

The Arrangement is subject to the approval of the Ontario Superior Court of Justice (Commercial List) (the “Court”). The anticipated hearing date for the application for the final order of the Court (the “Final Order”) is September 28, 2026. Subject to obtaining the Final Order, and the satisfaction or waiver of the conditions to implementing the Arrangement as set out in the arrangement agreement dated July 28, 2026 among Intermap, PCI and Grenadier Investments Limited, the Arrangement is expected to be completed mid-October, 2026.

Intermap Reader Advisory 
Certain information provided in this news release, including reference to the timing, completion and expected benefits of the Arrangement and the timing of receipt of the Final Order constitutes forward-looking statements. The words “anticipate”, “expect”, “propose”, “will”, “look forward” and similar expressions are intended to identify such forward-looking statements. Although Intermap believes that these statements are based on information and assumptions which are current, reasonable and complete, these statements are necessarily subject to a variety of known and unknown risks and uncertainties. Intermap’s forward-looking statements are subject to risks and uncertainties pertaining to, among other things, cash available to fund operations, availability of capital, revenue fluctuations, nature of government contracts, economic conditions, loss of key customers, retention and availability of executive talent, competing technologies, common share price volatility, loss of proprietary information, software functionality, internet and system infrastructure functionality, information technology security, breakdown of strategic alliances, and international and political considerations, as well as those risks and uncertainties discussed in Intermap’s Annual Information Form and other securities filings. In addition, completion of the Arrangement is subject to receipt of court approvals, together with the satisfaction or waiver of certain conditions precedent to the Arrangement which are outside of the control of Intermap. While the Company makes these forward-looking statements in good faith, should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary significantly from those expected. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements, including the Arrangement, will transpire or occur, or if any of them do so, what benefits that the Company will derive therefrom. All subsequent forward-looking statements, whether written or oral, attributable to Intermap or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. The forward-looking statements contained in this news release are made as at the date of this news release and the Company does not undertake any obligation to update publicly or to revise any of the forward-looking statements made herein, whether as a result of new information, future events or otherwise, except as may be required by applicable securities law.

About Intermap Technologies 
Intermap Technologies is a global leader in geospatial intelligence powered by proprietary 3D data and AI-driven analytics. The Company delivers actionable intelligence to government and commercial customers through a portfolio of applications, platforms and solutions that support risk management, infrastructure planning, operational readiness and mission-critical decision-making. Intermap’s proprietary 3D data foundation spans more than 300 million square kilometers across over 150 countries and powers intelligence solutions for government, insurance, aviation, telecommunications, transportation, renewable energy, agriculture, natural resources and space markets. Through advanced analytics, automated processing and enterprise-scale data delivery, Intermap helps organizations transform complex geospatial information into decision-ready intelligence. 

About CATALYST (PCI)
PCI (DBA CATALYST) is a world-leading developer of software and systems for remote sensing, imagery processing, and photogrammetry. With 45 years of experience in the geospatial industry, CATALYST is recognized globally for its excellence in providing software for accurately and rapidly processing satellite and aerial imagery, with more than 30,000 licenses in over 150 countries worldwide.

For more information, please visit www.intermap.com or contact:
Jennifer Bakken
Executive Vice President and CFO
CFO@intermap.com
+1 (303) 708-0955

Sean Peasgood
Investor Relations
Sean@SophicCapital.com
+1 (647) 260-9266

New 50 mg tablet formulation delivers an improved pharmacokinetic profile and enables greater exposure and patient convenience

FDA removal of the prior drug exposure limit provides greater dosing flexibility in
future clinical trials

CervoMed plans to advance a 100 mg twice-daily regimen expected to achieve higher plasma trough drug concentrations than those associated with clinical activity in prior trials

BOSTON, Sept. 28, 2026 (GLOBE NEWSWIRE) — CervoMed Inc. (“CervoMed” or the “Company”) (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced pharmacokinetic (PK), regulatory, and manufacturing advances that enable a higher-dose, twice-daily (BID) oral regimen of neflamapimod in future clinical trials.

The developments include a new neflamapimod 50 mg oral tablet formulation with a PK profile favorable for twice-daily dosing, the U.S. Food and Drug Administration’s (FDA) removal of the previous plasma drug exposure limit, and the implementation of a controlled manufacturing process designed to support reproducible, large-scale tablet production.

“The new 50 mg tablet addresses the formulation issue identified during the Phase 2b RewinD-LB study and we intend to move forward with it in future clinical development,” said John J. Alam, M.D., Chief Executive Officer of CervoMed. “Combined with the FDA’s removal of the prior exposure limit, the new pharmacokinetic profile enables us to advance a 100 mg twice-daily regimen that we expect will achieve substantially higher trough drug concentrations than those associated with clinical activity in previous trials, while reducing dosing frequency from three times to twice daily. These developments substantially reduce both clinical execution and manufacturing risk as we move the neflamapimod program forward.”

Supporting Data and Details

Formulation and manufacturing: New 50 mg tablet
The new 50 mg tablet contains the most stable crystalline form of neflamapimod, addressing the manufacturing variability seen with the 40 mg capsule used in the Phase 2b RewinD-LB study. This updated formulation is designed to provide a consistent drug product for future trials and, if approved, commercial supply. The new controlled manufacturing process enables reproducible, large-scale production of the tablet, thus reducing chemistry, manufacturing and controls (CMC) risk.

The new tablet was evaluated in a Phase 1 food-effect and drug-exposure study that met its primary objectives. After single-dose administration, the 50 mg tablet and the prior 40 mg capsule (previously referred to as “DP Batch B”) produced similar overall plasma drug exposure. However, the new tablet demonstrated a PK profile better suited to BID administration, with approximately 20% lower peak plasma concentration (C_max) and approximately 20% higher plasma concentration 12 hours post dose (C_trough, with BID dosing).

Regulatory: FDA removal of drug exposure limit
A 39-week dog toxicology study completed in the first half of 2026 established a no-observed-adverse-effect level (NOAEL) based on plasma drug levels, that was three-fold higher than in prior dog toxicology studies, and more than 30-fold higher than the pharmacologically and clinically active exposure range observed in previously completed clinical trials of neflamapimod in central nervous system disorders. After reviewing these data, the FDA removed the plasma drug exposure limit that had constrained neflamapimod dosing, providing CervoMed greater dosing flexibility in future clinical trials.

Dose selection: 100 mg twice daily
Based on the observed PK profile and pharmacokinetic pharmacodynamic (PK-PD) relationships across the neflamapimod clinical trials, CervoMed plans to advance a 100 mg BID regimen in future clinical trials. PK modeling indicates that the higher daily dose is expected to increase trough plasma drug concentrations by approximately 33% relative to the 40 mg three times a day (TID) regimen used in the Phase 2a clinical trial and the extension phase of the Phase 2b clinical trial in dementia with Lewy bodies (DLB).

The clinical safety and tolerability of the planned higher dose regimen are further supported by clinical data with neflamapimod administered at 80 mg BID (two 40 mg capsules), presented at the Alzheimer’s Association International Conference (AAIC) in July 2026. Compared with 80 mg BID, the planned 100 mg BID tablet regimen is expected to provide similar overall plasma drug exposure, with a higher C_trough and lower C_max.

These PK characteristics are particularly relevant to neflamapimod because previously reported PK-PD analyses indicate that clinical activity is associated with C_trough, while safety and tolerability are more closely related to C_max. The planned regimen is therefore designed to increase pharmacologically relevant trough concentrations without a commensurate increase in peak drug exposure.

About CervoMed
CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology. In November 2025, CervoMed announced alignment with the FDA on a potential registration path for neflamapimod in DLB, and the Company is currently focused on identifying a strategic partner to advance neflamapimod into a Phase 3 trial in DLB. CervoMed also recently completed enrollment in its ongoing Phase 2a clinical trial evaluating neflamapimod in nfvPPA, a subtype of frontotemporal disorders, from which interim biomarker data is anticipated in the early fourth quarter of 2026, and expects the first patient to be dosed with neflamapimod in the EXPERTS-ALS Phase 2a clinical trial in the fourth quarter of 2026.

Forward-Looking Statements
This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the Company’s need to acquire sufficient funding, including funding (through a strategic partnership or otherwise) for any Phase 3 trial in patients with DLB; the Company’s plan to focus on strategic partnering to advance neflamapimod into Phase 3 for DLB and the timing of entering into any such partnership, if at all; the therapeutic potential of neflamapimod in DLB, nfvPPA, ALS, or any other indication, including the degree of sustainability of any therapeutic effects, its potential impact on the rate of disease progression and/or clinical worsening, the optimal dosing regimen to achieve therapeutic effects, or any other treatment effects observed in any clinical trial on any clinical, biomarker, or other outcome measure, the expected pharmacokinetic profile, drug exposure, or other characteristics of the new 50 mg tablet formulation or the planned 100 mg twice-daily dosing regimen, including initial biomarker data from the Company’s Phase 2a trial in nfvPPA; the anticipated timing and achievement of clinical and development milestones, including the Company’s initiation of any Phase 3 trial in patients with DLB or the impact, if any, of the Innovation Passport Designation on any future regulatory milestone or the timing thereof; the anticipated data readouts from the Company’s Phase 2a trial in nfvPPA and the anticipated dosing of the first patient with neflamapimod in the EXPERTS-ALS trial; and any other expected or implied benefits, results, or expectations, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients with DLB or in any other indication. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources, the availability of additional funds on acceptable terms or at all, and the Company’s ability to continue as a going concern; the results of the Company’s clinical trials; the Company’s ability to successfully enter into a partnership to advance neflamapimod into Phase 3 for DLB in a timely manner, on acceptable terms, or at all; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA or other regulators; the Company’s ability to maintain the intellectual property protection afforded by the Company’s patent portfolio; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) on March 13, 2026, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law.

Contacts

Media:
Lisa Guiterman
Biongage Communications
lisa.guiterman@gmail.com
202-330-3431

Investor Relations:
Argot Partners
cervomed@argotpartners.com
212-600-1902

New 50 mg tablet formulation delivers an improved pharmacokinetic profile and enables greater exposure and patient convenience

FDA removal of the prior drug exposure limit provides greater dosing flexibility in
future clinical trials

CervoMed plans to advance a 100 mg twice-daily regimen expected to achieve higher plasma trough drug concentrations than those associated with clinical activity in prior trials

BOSTON, Sept. 28, 2026 (GLOBE NEWSWIRE) — CervoMed Inc. (“CervoMed” or the “Company”) (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced pharmacokinetic (PK), regulatory, and manufacturing advances that enable a higher-dose, twice-daily (BID) oral regimen of neflamapimod in future clinical trials.

The developments include a new neflamapimod 50 mg oral tablet formulation with a PK profile favorable for twice-daily dosing, the U.S. Food and Drug Administration’s (FDA) removal of the previous plasma drug exposure limit, and the implementation of a controlled manufacturing process designed to support reproducible, large-scale tablet production.

“The new 50 mg tablet addresses the formulation issue identified during the Phase 2b RewinD-LB study and we intend to move forward with it in future clinical development,” said John J. Alam, M.D., Chief Executive Officer of CervoMed. “Combined with the FDA’s removal of the prior exposure limit, the new pharmacokinetic profile enables us to advance a 100 mg twice-daily regimen that we expect will achieve substantially higher trough drug concentrations than those associated with clinical activity in previous trials, while reducing dosing frequency from three times to twice daily. These developments substantially reduce both clinical execution and manufacturing risk as we move the neflamapimod program forward.”

Supporting Data and Details

Formulation and manufacturing: New 50 mg tablet
The new 50 mg tablet contains the most stable crystalline form of neflamapimod, addressing the manufacturing variability seen with the 40 mg capsule used in the Phase 2b RewinD-LB study. This updated formulation is designed to provide a consistent drug product for future trials and, if approved, commercial supply. The new controlled manufacturing process enables reproducible, large-scale production of the tablet, thus reducing chemistry, manufacturing and controls (CMC) risk.

The new tablet was evaluated in a Phase 1 food-effect and drug-exposure study that met its primary objectives. After single-dose administration, the 50 mg tablet and the prior 40 mg capsule (previously referred to as “DP Batch B”) produced similar overall plasma drug exposure. However, the new tablet demonstrated a PK profile better suited to BID administration, with approximately 20% lower peak plasma concentration (C_max) and approximately 20% higher plasma concentration 12 hours post dose (C_trough, with BID dosing).

Regulatory: FDA removal of drug exposure limit
A 39-week dog toxicology study completed in the first half of 2026 established a no-observed-adverse-effect level (NOAEL) based on plasma drug levels, that was three-fold higher than in prior dog toxicology studies, and more than 30-fold higher than the pharmacologically and clinically active exposure range observed in previously completed clinical trials of neflamapimod in central nervous system disorders. After reviewing these data, the FDA removed the plasma drug exposure limit that had constrained neflamapimod dosing, providing CervoMed greater dosing flexibility in future clinical trials.

Dose selection: 100 mg twice daily
Based on the observed PK profile and pharmacokinetic pharmacodynamic (PK-PD) relationships across the neflamapimod clinical trials, CervoMed plans to advance a 100 mg BID regimen in future clinical trials. PK modeling indicates that the higher daily dose is expected to increase trough plasma drug concentrations by approximately 33% relative to the 40 mg three times a day (TID) regimen used in the Phase 2a clinical trial and the extension phase of the Phase 2b clinical trial in dementia with Lewy bodies (DLB).

The clinical safety and tolerability of the planned higher dose regimen are further supported by clinical data with neflamapimod administered at 80 mg BID (two 40 mg capsules), presented at the Alzheimer’s Association International Conference (AAIC) in July 2026. Compared with 80 mg BID, the planned 100 mg BID tablet regimen is expected to provide similar overall plasma drug exposure, with a higher C_trough and lower C_max.

These PK characteristics are particularly relevant to neflamapimod because previously reported PK-PD analyses indicate that clinical activity is associated with C_trough, while safety and tolerability are more closely related to C_max. The planned regimen is therefore designed to increase pharmacologically relevant trough concentrations without a commensurate increase in peak drug exposure.

About CervoMed
CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology. In November 2025, CervoMed announced alignment with the FDA on a potential registration path for neflamapimod in DLB, and the Company is currently focused on identifying a strategic partner to advance neflamapimod into a Phase 3 trial in DLB. CervoMed also recently completed enrollment in its ongoing Phase 2a clinical trial evaluating neflamapimod in nfvPPA, a subtype of frontotemporal disorders, from which interim biomarker data is anticipated in the early fourth quarter of 2026, and expects the first patient to be dosed with neflamapimod in the EXPERTS-ALS Phase 2a clinical trial in the fourth quarter of 2026.

Forward-Looking Statements
This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the Company’s need to acquire sufficient funding, including funding (through a strategic partnership or otherwise) for any Phase 3 trial in patients with DLB; the Company’s plan to focus on strategic partnering to advance neflamapimod into Phase 3 for DLB and the timing of entering into any such partnership, if at all; the therapeutic potential of neflamapimod in DLB, nfvPPA, ALS, or any other indication, including the degree of sustainability of any therapeutic effects, its potential impact on the rate of disease progression and/or clinical worsening, the optimal dosing regimen to achieve therapeutic effects, or any other treatment effects observed in any clinical trial on any clinical, biomarker, or other outcome measure, the expected pharmacokinetic profile, drug exposure, or other characteristics of the new 50 mg tablet formulation or the planned 100 mg twice-daily dosing regimen, including initial biomarker data from the Company’s Phase 2a trial in nfvPPA; the anticipated timing and achievement of clinical and development milestones, including the Company’s initiation of any Phase 3 trial in patients with DLB or the impact, if any, of the Innovation Passport Designation on any future regulatory milestone or the timing thereof; the anticipated data readouts from the Company’s Phase 2a trial in nfvPPA and the anticipated dosing of the first patient with neflamapimod in the EXPERTS-ALS trial; and any other expected or implied benefits, results, or expectations, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients with DLB or in any other indication. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources, the availability of additional funds on acceptable terms or at all, and the Company’s ability to continue as a going concern; the results of the Company’s clinical trials; the Company’s ability to successfully enter into a partnership to advance neflamapimod into Phase 3 for DLB in a timely manner, on acceptable terms, or at all; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA or other regulators; the Company’s ability to maintain the intellectual property protection afforded by the Company’s patent portfolio; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) on March 13, 2026, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law.

Contacts

Media:
Lisa Guiterman
Biongage Communications
lisa.guiterman@gmail.com
202-330-3431

Investor Relations:
Argot Partners
cervomed@argotpartners.com
212-600-1902

Independent Audit of Acquired Business Satisfies SEC Reporting Requirements Following Acquisition Closing; Purchase Price Allocation Reflects $4.18 Million All-Cash Transaction with No Goodwill and No Assumed Debt

Norwalk, CT, Sept. 28, 2026 (GLOBE NEWSWIRE) — Quantum Cyber N.V. (Nasdaq: QUCY) (“Quantum Cyber” or the “Company”), a Nasdaq-listed autonomous defense technology company assembling an AI-powered System-of-Systems platform for drone warfare, counter-UAS, and border security applications, today announced that it has filed with the U.S. Securities and Exchange Commission an Amendment No. 1 on Form 8-K/A (the “Amendment”) to its Current Report on Form 8-K originally filed on July 16, 2026 in connection with the completion of the acquisition of the Bridgeport, Connecticut manufacturing facility by the Company’s wholly-owned subsidiary, Quantum Drones Corporation, and the associated operating business of Arcade Technology LLC and Arcade Realty LLC (together, “Arcade”).

The Amendment furnishes the historical financial statements of the acquired business and the pro forma financial information required by Items 9.01(a) and (b) of Form 8-K, which were permissibly omitted from the original Current Report at the time of closing.

Independent Audit of the Acquired Business
Included as Exhibit 99.1 to the Amendment are the audited combined financial statements of Arcade Technology LLC and Arcade Realty LLC as of and for the years ended December 31, 2025 and December 31, 2024, accompanied by an unqualified independent auditors’ report issued by Haskell & White LLP. The audit was conducted in accordance with U.S. GAAP. The auditors’ report contains no going-concern qualification.

Also, filed as Exhibit 99.2, are the unaudited interim combined financial statements of the acquired business as of June 30, 2026 and December 31, 2025, and for the six month periods ended June 30, 2026 and 2025, which have been reviewed, but not audited, by Haskell & White LLP in accordance with the applicable auditing standards for reviews of interim financial information.

The Company believes the filing of these financial statements provides independent, third-party validation of the underlying operating substance of the business acquired. As disclosed in the audited financial statements, the acquired business has operated as Arcade Metal Stamping since 1948, is ISO 9001:2015–certified, and serves a diversified customer base across end markets that include, among others, government and defense, automotive, electrical and electronics, medical, telecommunications, and transportation equipment, from an approximately 53,000-square-foot facility at 38 Union Avenue, Bridgeport, Connecticut.

Unaudited Pro Forma Financial Information
Filed as Exhibit 99.3 is the unaudited pro forma condensed combined financial information giving effect to the acquisition, prepared in accordance with Article 11 of Regulation S-X. As disclosed in the pro forma financial information:

• The aggregate purchase price for the business and the real property was $4,180,000, consisting of $900,000 for the business assets, $980,000 for inventory, and $2,300,000 for the real property, in each case before customary closing prorations.
• The transaction was funded entirely from cash on hand. No debt was incurred in connection with the acquisition, and no liabilities of the acquired business were assumed by the Company.
• The preliminary purchase price allocation reflects $455,000 to land, $1,845,000 to building, $366,000 to machinery, $980,000 to inventory, and $534,000 to identifiable intangible assets, with no residual goodwill.
• The Small Business Administration Economic Injury Disaster Loan (EIDL) of Arcade, which was not assumed by the Company, was repaid in full by Arcade on July 16, 2026 using proceeds of the sale, and no encumbrance on the acquired personal property remains outstanding.

Retention of Seller Principals
As previously disclosed and reaffirmed in the audited financial statements, at closing, Quantum Drones Corporation entered into three-year employment agreements, each with non-compete covenants, with Steven Pepe, the former Chief Executive Officer and Member of Arcade, and William Rhone, the former Chief Financial Officer and Member of Arcade. The retention of the acquired business’s founding operators is intended to preserve customer relationships, tooling know-how, and manufacturing continuity as the facility is integrated into the Company’s domestic autonomous defense manufacturing platform.

Management Commentary
“When we announced this acquisition, we told shareholders we were buying a real, cash-generating American manufacturing business — not a shell, not a concept, not a pilot line — and that we were doing it clean, with cash, with no assumed debt, and with the operators staying on,” said David Lazar, Chief Executive Officer of Quantum Cyber. “Today’s filing puts audited numbers behind that description. We believe the audit report, the pro forma information, and the purchase price allocation together speak to the substance of what we acquired and to the discipline of how we acquired it.”

Availability of the Filing
The Form 8-K/A, including the audited historical financial statements filed as Exhibit 99.1, the unaudited interim historical financial statements filed as Exhibit 99.2, and the unaudited pro forma condensed combined financial information filed as Exhibit 99.3, is available on the SEC’s website at www.sec.gov and on the Investors section of the Company’s website at www.quantum-cyber.ai.

About Quantum Drones Corporation
Quantum Drones Corporation is a wholly owned Nevada-incorporated subsidiary of Quantum Cyber N.V. established to serve as the operational vehicle for the Company’s domestic defense technology programs and U.S. government procurement activities.

About Quantum Cyber N.V.
Quantum Cyber N.V. (Nasdaq: QUCY) is assembling an AI-powered, quantum-accelerated System-of-Systems autonomous defense platform that integrates drone warfare, counter-UAS, autonomous naval mine countermeasures, EMP shielding, anti-drone ammunition, command-and-control, and quantum antenna applications under a single Nasdaq-listed company. The Company acquires, licenses, and develops combat-proven autonomous technologies, deploying them as a coordinated, multi-domain portfolio across air, land, and sea. For more information, visit www.quantum-cyber.ai.

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “intend,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements relate to, among other things, the preliminary nature of the purchase price allocation and the potential for adjustments to that allocation; the Company’s ability to integrate and operate the acquired Bridgeport facility and business; the retention of acquired personnel, customers, and supplier relationships; the Company’s strategic transition to a vertically integrated autonomous defense manufacturer; and the Company’s ability to pursue U.S. government contracts and homeland security programs. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties, including that the purchase price allocation reflected in the pro forma financial information is preliminary and subject to change as additional information is obtained and analyses are finalized. Actual results may differ materially. Additional information concerning these and other factors may be found in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed on March 31, 2026, its Quarterly Report on Form 10-Q filed on May 15, 2026, its Quarterly Report on Form 10-Q filed on August 14, 2026, and its subsequent filings with the SEC. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by the Company in this press release is based only on information currently available and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as required by law.

Investor Relations Contact
Arx Investor Relations
North American Equities Desk
qucy@arxhq.com

Independent Audit of Acquired Business Satisfies SEC Reporting Requirements Following Acquisition Closing; Purchase Price Allocation Reflects $4.18 Million All-Cash Transaction with No Goodwill and No Assumed Debt

Norwalk, CT, Sept. 28, 2026 (GLOBE NEWSWIRE) — Quantum Cyber N.V. (Nasdaq: QUCY) (“Quantum Cyber” or the “Company”), a Nasdaq-listed autonomous defense technology company assembling an AI-powered System-of-Systems platform for drone warfare, counter-UAS, and border security applications, today announced that it has filed with the U.S. Securities and Exchange Commission an Amendment No. 1 on Form 8-K/A (the “Amendment”) to its Current Report on Form 8-K originally filed on July 16, 2026 in connection with the completion of the acquisition of the Bridgeport, Connecticut manufacturing facility by the Company’s wholly-owned subsidiary, Quantum Drones Corporation, and the associated operating business of Arcade Technology LLC and Arcade Realty LLC (together, “Arcade”).

The Amendment furnishes the historical financial statements of the acquired business and the pro forma financial information required by Items 9.01(a) and (b) of Form 8-K, which were permissibly omitted from the original Current Report at the time of closing.

Independent Audit of the Acquired Business
Included as Exhibit 99.1 to the Amendment are the audited combined financial statements of Arcade Technology LLC and Arcade Realty LLC as of and for the years ended December 31, 2025 and December 31, 2024, accompanied by an unqualified independent auditors’ report issued by Haskell & White LLP. The audit was conducted in accordance with U.S. GAAP. The auditors’ report contains no going-concern qualification.

Also, filed as Exhibit 99.2, are the unaudited interim combined financial statements of the acquired business as of June 30, 2026 and December 31, 2025, and for the six month periods ended June 30, 2026 and 2025, which have been reviewed, but not audited, by Haskell & White LLP in accordance with the applicable auditing standards for reviews of interim financial information.

The Company believes the filing of these financial statements provides independent, third-party validation of the underlying operating substance of the business acquired. As disclosed in the audited financial statements, the acquired business has operated as Arcade Metal Stamping since 1948, is ISO 9001:2015–certified, and serves a diversified customer base across end markets that include, among others, government and defense, automotive, electrical and electronics, medical, telecommunications, and transportation equipment, from an approximately 53,000-square-foot facility at 38 Union Avenue, Bridgeport, Connecticut.

Unaudited Pro Forma Financial Information
Filed as Exhibit 99.3 is the unaudited pro forma condensed combined financial information giving effect to the acquisition, prepared in accordance with Article 11 of Regulation S-X. As disclosed in the pro forma financial information:

• The aggregate purchase price for the business and the real property was $4,180,000, consisting of $900,000 for the business assets, $980,000 for inventory, and $2,300,000 for the real property, in each case before customary closing prorations.
• The transaction was funded entirely from cash on hand. No debt was incurred in connection with the acquisition, and no liabilities of the acquired business were assumed by the Company.
• The preliminary purchase price allocation reflects $455,000 to land, $1,845,000 to building, $366,000 to machinery, $980,000 to inventory, and $534,000 to identifiable intangible assets, with no residual goodwill.
• The Small Business Administration Economic Injury Disaster Loan (EIDL) of Arcade, which was not assumed by the Company, was repaid in full by Arcade on July 16, 2026 using proceeds of the sale, and no encumbrance on the acquired personal property remains outstanding.

Retention of Seller Principals
As previously disclosed and reaffirmed in the audited financial statements, at closing, Quantum Drones Corporation entered into three-year employment agreements, each with non-compete covenants, with Steven Pepe, the former Chief Executive Officer and Member of Arcade, and William Rhone, the former Chief Financial Officer and Member of Arcade. The retention of the acquired business’s founding operators is intended to preserve customer relationships, tooling know-how, and manufacturing continuity as the facility is integrated into the Company’s domestic autonomous defense manufacturing platform.

Management Commentary
“When we announced this acquisition, we told shareholders we were buying a real, cash-generating American manufacturing business — not a shell, not a concept, not a pilot line — and that we were doing it clean, with cash, with no assumed debt, and with the operators staying on,” said David Lazar, Chief Executive Officer of Quantum Cyber. “Today’s filing puts audited numbers behind that description. We believe the audit report, the pro forma information, and the purchase price allocation together speak to the substance of what we acquired and to the discipline of how we acquired it.”

Availability of the Filing
The Form 8-K/A, including the audited historical financial statements filed as Exhibit 99.1, the unaudited interim historical financial statements filed as Exhibit 99.2, and the unaudited pro forma condensed combined financial information filed as Exhibit 99.3, is available on the SEC’s website at www.sec.gov and on the Investors section of the Company’s website at www.quantum-cyber.ai.

About Quantum Drones Corporation
Quantum Drones Corporation is a wholly owned Nevada-incorporated subsidiary of Quantum Cyber N.V. established to serve as the operational vehicle for the Company’s domestic defense technology programs and U.S. government procurement activities.

About Quantum Cyber N.V.
Quantum Cyber N.V. (Nasdaq: QUCY) is assembling an AI-powered, quantum-accelerated System-of-Systems autonomous defense platform that integrates drone warfare, counter-UAS, autonomous naval mine countermeasures, EMP shielding, anti-drone ammunition, command-and-control, and quantum antenna applications under a single Nasdaq-listed company. The Company acquires, licenses, and develops combat-proven autonomous technologies, deploying them as a coordinated, multi-domain portfolio across air, land, and sea. For more information, visit www.quantum-cyber.ai.

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “intend,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements relate to, among other things, the preliminary nature of the purchase price allocation and the potential for adjustments to that allocation; the Company’s ability to integrate and operate the acquired Bridgeport facility and business; the retention of acquired personnel, customers, and supplier relationships; the Company’s strategic transition to a vertically integrated autonomous defense manufacturer; and the Company’s ability to pursue U.S. government contracts and homeland security programs. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties, including that the purchase price allocation reflected in the pro forma financial information is preliminary and subject to change as additional information is obtained and analyses are finalized. Actual results may differ materially. Additional information concerning these and other factors may be found in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed on March 31, 2026, its Quarterly Report on Form 10-Q filed on May 15, 2026, its Quarterly Report on Form 10-Q filed on August 14, 2026, and its subsequent filings with the SEC. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by the Company in this press release is based only on information currently available and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as required by law.

Investor Relations Contact
Arx Investor Relations
North American Equities Desk
qucy@arxhq.com

NDA submission completed following positive Phase 3 SELVA results; potential U.S. commercial launch in the first half of 2027, if approved

QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric and adult patients living with microcystic lymphatic malformations in the U.S.

WAYNE, Pa., Sept. 28, 2026 (GLOBE NEWSWIRE) — Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular anomalies for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that the Company has received a third year of grant funding from the FDA Office of Orphan Products Development. The funding supports the Phase 3 SELVA trial and ongoing open-label extension study of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations. The award follows FDA review of Palvella’s annual performance progress report, which included results from the Phase 3 SELVA trial.

“We are grateful for the FDA’s continued support of the QTORIN™ rapamycin program, including funding through the Orphan Products Grants Program, Breakthrough Therapy, Fast Track, and Orphan Drug designations, and the opportunity to submit our NDA on a rolling basis,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “Following positive Phase 3 SELVA results and completion of our NDA submission, we are advancing commercial readiness for a potential U.S. launch in the first half of 2027, if approved. We believe QTORIN™ rapamycin has the potential to become the first FDA-approved therapy for microcystic LMs and establish a new standard of care for pediatric and adult patients living with this serious, lifelong disease.”

In February 2026, Palvella announced positive topline results from the Phase 3 SELVA trial, which met its primary endpoint, pre-specified key secondary endpoint, and all four secondary efficacy endpoints, with all six efficacy endpoints achieving statistical significance (all p<0.001). In August 2026, Palvella completed the submission of its New Drug Application (NDA) for QTORIN™ rapamycin for the treatment of microcystic LMs.

Palvella’s Phase 3 SELVA trial was one of only seven new clinical trials selected for funding from 51 applications received by the FDA Orphan Products Grants Program in fiscal year 2024 and the only Phase 3 trial awarded a grant that year. Grant applications are independently reviewed and scored for scientific and technical merit by rare disease and regulatory experts and may involve consultation with the relevant FDA review division. Since its inception, the program has funded clinical trials that have facilitated the approval of more than 85 medical products for rare diseases.

About Palvella Therapeutics

Founded and led by rare disease biotech veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients living with serious, rare skin diseases and vascular anomalies for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases and vascular anomalies, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella’s second product candidate, QTORIN™ pitavastatin, is currently being developed for the treatment of disseminated superficial actinic porokeratosis. For more information, please visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter).

QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from clinical trials, Palvella’s clinical development plans and related anticipated development milestones and anticipated timing of regulatory submissions, Palvella’s plans with respect to the timing of, and anticipated FDA review process for, the NDA for QTORIN™ rapamycin, Palvella’s plans to pursue Breakthrough Therapy Designation, Palvella’s plans to meet with regulatory authorities, Palvella’s expectations regarding the benefits of orphan drug designation and potential benefit of orphan drug exclusivity for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, Palvella’s cash, financial resources and expected runway, Palvella’s expectations regarding its programs, including QTORIN™ rapamycin and QTORIN™ pitavastatin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to make regulatory submissions on anticipated timelines; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORIN™ rapamycin and QTORIN™ pitavastatin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; Palvella’s limited experience in commercial manufacturing; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

Contact Information

Investors

Wesley H. Kaupinen
Founder and CEO
Palvella Therapeutics
wes.kaupinen@palvellatx.com

Media

Marcy Nanus
Vice President of Investor Relations and Corporate Affairs
Palvella Therapeutics
marcy.nanus@palvellatx.com

NDA submission completed following positive Phase 3 SELVA results; potential U.S. commercial launch in the first half of 2027, if approved

QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric and adult patients living with microcystic lymphatic malformations in the U.S.

WAYNE, Pa., Sept. 28, 2026 (GLOBE NEWSWIRE) — Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular anomalies for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that the Company has received a third year of grant funding from the FDA Office of Orphan Products Development. The funding supports the Phase 3 SELVA trial and ongoing open-label extension study of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations. The award follows FDA review of Palvella’s annual performance progress report, which included results from the Phase 3 SELVA trial.

“We are grateful for the FDA’s continued support of the QTORIN™ rapamycin program, including funding through the Orphan Products Grants Program, Breakthrough Therapy, Fast Track, and Orphan Drug designations, and the opportunity to submit our NDA on a rolling basis,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “Following positive Phase 3 SELVA results and completion of our NDA submission, we are advancing commercial readiness for a potential U.S. launch in the first half of 2027, if approved. We believe QTORIN™ rapamycin has the potential to become the first FDA-approved therapy for microcystic LMs and establish a new standard of care for pediatric and adult patients living with this serious, lifelong disease.”

In February 2026, Palvella announced positive topline results from the Phase 3 SELVA trial, which met its primary endpoint, pre-specified key secondary endpoint, and all four secondary efficacy endpoints, with all six efficacy endpoints achieving statistical significance (all p<0.001). In August 2026, Palvella completed the submission of its New Drug Application (NDA) for QTORIN™ rapamycin for the treatment of microcystic LMs.

Palvella’s Phase 3 SELVA trial was one of only seven new clinical trials selected for funding from 51 applications received by the FDA Orphan Products Grants Program in fiscal year 2024 and the only Phase 3 trial awarded a grant that year. Grant applications are independently reviewed and scored for scientific and technical merit by rare disease and regulatory experts and may involve consultation with the relevant FDA review division. Since its inception, the program has funded clinical trials that have facilitated the approval of more than 85 medical products for rare diseases.

About Palvella Therapeutics

Founded and led by rare disease biotech veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients living with serious, rare skin diseases and vascular anomalies for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases and vascular anomalies, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella’s second product candidate, QTORIN™ pitavastatin, is currently being developed for the treatment of disseminated superficial actinic porokeratosis. For more information, please visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter).

QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from clinical trials, Palvella’s clinical development plans and related anticipated development milestones and anticipated timing of regulatory submissions, Palvella’s plans with respect to the timing of, and anticipated FDA review process for, the NDA for QTORIN™ rapamycin, Palvella’s plans to pursue Breakthrough Therapy Designation, Palvella’s plans to meet with regulatory authorities, Palvella’s expectations regarding the benefits of orphan drug designation and potential benefit of orphan drug exclusivity for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, Palvella’s cash, financial resources and expected runway, Palvella’s expectations regarding its programs, including QTORIN™ rapamycin and QTORIN™ pitavastatin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to make regulatory submissions on anticipated timelines; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORIN™ rapamycin and QTORIN™ pitavastatin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; Palvella’s limited experience in commercial manufacturing; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

Contact Information

Investors

Wesley H. Kaupinen
Founder and CEO
Palvella Therapeutics
wes.kaupinen@palvellatx.com

Media

Marcy Nanus
Vice President of Investor Relations and Corporate Affairs
Palvella Therapeutics
marcy.nanus@palvellatx.com

Certified Fraud and Forensic Investigations Expert Brings Deep Experience in FCPA Matters, Anti-Corruption Compliance and Financial Crime Risk Management Across the Americas

WASHINGTON, Sept. 28, 2026 (GLOBE NEWSWIRE) — FTI Consulting, Inc. (NYSE: FCN) today announced the appointment of José Claudio Treviño as a Senior Managing Director and Leader of the firm’s Mexico Risk & Investigations practice, strengthening its financial crime, forensic investigations, ethics and compliance, and anti-corruption expertise across Mexico and Latin America.

Mr. Treviño will work with FTI Consulting teams across the United States, Mexico, Latin America and the firm’s global network to help multinational organizations address complex fraud, corruption, Foreign Corrupt Practices Act (“FCPA”), regulatory compliance and cross-border financial crime risks.

Mr. Treviño brings more than 23 years of experience helping organizations prevent, detect and respond to financial crime and related misconduct. His work spans anti-bribery and corruption compliance, internal and external fraud matters, FCPA and UK Bribery Act issues, third-party risk management, pre- and post-acquisition due diligence, and the application of forensic technology to complex reviews and compliance programs.

Throughout his career, Mr. Treviño has led complex, multijurisdictional investigations and compliance reviews across the Americas and beyond. He has advised senior management, boards of directors, audit committees and internal and external legal counsel on allegations of fraud and corruption, regulatory compliance matters and the design and implementation of anti-fraud and anti-corruption programs.

“Companies operating across the Americas are navigating an increasingly complex environment in which regulatory expectations, cross-border enforcement and financial crime risks frequently intersect,” said Nicole Wells, Americas Leader of the Risk & Investigations practice at FTI Consulting. “José brings a rare combination of deep investigations and compliance experience with a bicultural understanding of the U.S. and Latin American markets. His experience advising organizations through sensitive, high-stakes matters will further strengthen our ability to help clients prevent and respond to financial crime risks across the region.”

Prior to joining FTI Consulting, Mr. Treviño was a Partner in Deloitte’s Spanish Latin America’s Forensic & Financial Crime practice. Earlier in his career, he held senior forensic consulting leadership positions at KPMG Mexico and served as the head of Anti-Bribery & Corruption – Financial Crimes Compliance for HSBC in Mexico. His advisory work has spanned a broad range of industries, including automotive, manufacturing, oil and gas, financial services, pharmaceuticals, medical devices and telecommunications.

Mr. Treviño is a Certified Fraud Examiner (“CFE”) and Certified Forensic Interviewer (“CFI”). He serves on the boards of the Instituto Mexicano de Mejores Prácticas Corporativas (“IMMPC”) and the Asociación Mexicana de Integridad y Compliance (“AMEXICOM”).

Commenting on his appointment, Mr. Treviño said, “Organizations today are confronting financial crime risks that increasingly transcend borders, regulations and traditional organizational silos. What attracted me to FTI Consulting is the opportunity to bring together exceptional investigations, compliance, data, technology and industry expertise to help clients address those challenges. I am excited to join a global platform with an entrepreneurial culture and to work alongside colleagues across the United States, Mexico and Latin America to continue building a differentiated financial crime and investigations offering across the Americas.”

About FTI Consulting
FTI Consulting, Inc. is a leading global expert firm for organizations facing crisis and transformation, with more than 8,100 employees located in 32 countries and territories as of June 30, 2026. In certain jurisdictions, FTI Consulting’s services are provided through distinct legal entities that are separately capitalized and independently managed. The Company generated $3.8 billion in revenues during fiscal year 2025. More information can be found at www.fticonsulting.com.

FTI Consulting, Inc.
555 12^th Street NW
Washington, DC 20004
+1.202.312.9100

Investor Contact:
Mollie Hawkes
+1.617.747.1791
mollie.hawkes@fticonsulting.com

Media Contact:
Nick Emmons
+1.617.510.1676
nick.emmons@fticonsulting.com