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Alpha Cognition Announces the Commercial Launch of ZUNVEYL (Benzgalantamine) for the Treatment of Mild to Moderate Alzheimer’s Disease

ZUNVEYL is the first oral FDA-approved treatment for Alzheimer’s disease in the past decade

32 person sales team hired to cover the $2 billion Long-Term-Care market

All launch activities delivered on-time and on-budget, positioning ZUNVEYL for success

VANCOUVER, British Columbia & DALLAS–(BUSINESS WIRE)–
Alpha Cognition Inc. (Nasdaq: ACOG), a biopharmaceutical company dedicated to advancing treatments for neurodegenerative diseases, today announced the official commercial launch of ZUNVEYL, a new treatment for mild to moderate Alzheimer’s disease. This milestone marks a major step forward in the company’s mission to provide innovative and accessible solutions for patients and caregivers — and to deliver new hope to the millions impacted by Alzheimer’s.

With a highly experienced commercial team in place, including industry leaders with proven success in the long-term care market, Alpha Cognition is poised to make a powerful impact. The company’s nationwide salesforce is fully deployed and actively engaging with healthcare providers to ensure that ZUNVEYL reaches the patients who need it most. The commercial strategy is specifically designed to address the unique challenges of the long-term care market, the largest segment for Alzheimer’s disease, and a $2 billion market opportunity.

“The launch of ZUNVEYL is a game-changer in our fight against Alzheimer’s disease,” said Lauren D’Angelo, Chief Operating Officer and Chief Commercial Officer of Alpha Cognition. “Our team has worked relentlessly to bring this treatment to market — from building out an industry-leading infrastructure to hiring a top notch sales team — all in record time. I’m incredibly proud of the dedication and expertise of our team, and we are excited to partner with healthcare professionals to ensure that patients receive the care they deserve.”

Alpha Cognition’s commercial team includes top talent with deep expertise in Alzheimer’s disease and long-term care. The sales team has, on average, 16 years of industry sales experience and 10 years of experience selling in the long-term care market. This veteran team is focused on driving rapid adoption of ZUNVEYL and ensuring that patients have access to ZUNVEYL from day one.

ZUNVEYL is designed to provide a differentiated treatment option for patients with mild to moderate Alzheimer’s disease, offering an alternative for those who may have limited options. With the commercial launch now underway, Alpha Cognition is engaging with healthcare providers, payers, and caregivers to support patient access and education. Patients can now access ZUNVEYL in three doses (5 mg, 10 mg, and 15 mg) through a prescription that can be filled at pharmacies nationwide.

To learn more about ZUNVEYL, visit ZUNVEYL.com.

About ZUNVEYL

ZUNVEYL (benzgalantamine) is a twice-daily treatment designed to address the cognitive symptoms of mild-to-moderate Alzheimer’s disease. By enhancing cholinergic function in the brain, ZUNVEYL supports memory, learning, and overall cognitive function, offering a meaningful improvement for patients and their caregivers.

About Alpha Cognition Inc.

Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options.

For more information, please visit www.alphacognition.com.

INDICATION AND USAGE

ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred.

WARNINGS AND PRECAUTIONS

Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered.

Anesthesia: See Drug Interactions Section

Cardiovascular Conditions: Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction.

Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope.

Gastrointestinal Conditions: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.

Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient’s weight during therapy with ZUNVEYL.

Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction.

Neurological Conditions: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer’s disease. Patients with Alzheimer’s disease should be monitored closely for seizures while taking ZUNVEYL.

Pulmonary Conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions.

ADVERSE REACTIONS

The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.

DRUG INTERACTIONS

Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications.

Use with Cholinomimetics and Other Cholinesterase Inhibitors: A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data may cause fetal harm.

Hepatic Impairment: In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended.

Renal Impairment: In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended.

These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information.

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the, the long-term benefits of ZUNVEYL, the Company’s timing and planned activities and business strategy to launch ZUNVEYL, the potential timing for the availability of ZUNVEYL, the potential future developments of ZUNVEYL, the market size and demand for ZUNVEYL and the Company’s potential growth opportunities, capital requirements,. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks related to our focus on the long-term care market, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1/A registration statement as filed with the SEC on January 10, 2025 and available at www.sec.gov. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

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Investor Contact:

Alpha Cognition Inc.

Email: [email protected]

KEYWORDS: Texas United States North America Canada

INDUSTRY KEYWORDS: Mental Health Health FDA Neurology General Health Pharmaceutical Biotechnology

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Corpay Cross-Border Grows in Europe with Launch of Luxembourg Office

Expansion aims to enhance service offering for institutional clients and bolster European growth through an increased market presence

TORONTO–(BUSINESS WIRE)–
Corpay, Inc.*, (NYSE: CPAY), a global leader in corporate payments, is proud to announce its entry into Luxembourg with the establishment of a new office for its Cross-Border business. As part of Corpay’s ongoing expansion in Europe, this significant move aligns with the company’s strategy to enhance its presence in key financial markets worldwide and supports its growth ambitions in the institutional investor and private funds space.

“The new Luxembourg office underscores our commitment to supporting the sophisticated needs of this global client base and enables us to provide a localized solution set for our institutional clients that establish their international investment structures in Luxembourg,” says Andrew Shortreid, SVP, Global Institutional Sales, Corpay Cross-Border Solutions. “Luxembourg’s status as a major financial hub in the EMEA region, with nearly 50% of its workforce engaged in financial services or related activities, makes it an ideal location for us. This new branch will enable us to better serve our cross-border clients in the investment industry globally.”

The Luxembourg financial centre is the largest in the Eurozone and the third largest in Europe, after London and Zurich. Recognized as the leading jurisdiction in Europe for cross-border international fund setups, Luxembourg is also the second-largest market for fund assets under management, following the US. As a global investment base, local funds commonly transact across a diverse range of currencies, including yen, Hong Kong dollars, pounds and euros.

The robust development of Luxembourg’s financial industry presents substantial opportunities for service providers facilitating the operations of various financial entities, such as fund managers raising capital from European investors through Luxembourgish entities and utilizing local administrative agents and legal professionals.

In light of this, Corpay is introducing a range of institutional solutions strategically targeted for this market including global multi-currency accounts, global payments, and other services focused on transaction support. This approach addresses the complexities of establishing financial relationships within Luxembourg’s conservative market and provides clients with an alternative to banks.

“Luxembourg represents a pivotal market for Corpay with its advanced financial sector, and we are thrilled to establish our presence here,” said Mark Frey, Group President, Corpay Cross-Border Solutions. “This expansion is a testament to our commitment to global growth and our dedication to meeting the needs of our clients in key financial markets. We look forward to leveraging our robust architecture and regulatory compliance to help our clients navigate Luxembourg’s stringent banking industry.”

“We are excited to welcome Roman Sokolowski as the branch manager for our new Luxembourg office. Roman brings a wealth of experience in the local market and a proven track record in the financial industry. His extensive network and proactive approach will be invaluable as we expand our presence and enhance client-centric solutions in this key jurisdiction,” added Andrew Shortreid.

About Corpay

Corpay, Inc. (NYSE: CPAY) is a global S&P500 corporate payments company that helps businesses and consumers pay expenses in a simple, controlled manner. Corpay’s suite of modern payment solutions help its customers better manage vehicle-related expenses (such as fueling and parking), travel expenses (e.g. hotel bookings) and payables (e.g. paying vendors). This results in our customers saving time and ultimately spending less. Corpay Cross-Border refers to a group of legal entities owned and operated by Corpay, Inc.

Corpay – Payments made easy. To learn more visit www.corpay.com.

^*“Corpay” in this document primarily refers to the Cross-Border Division of Corpay, Inc. https://www.corpay.com/cross-border; a full listing of the companies that are part of Corpay Cross-Border is available here: https://www.corpay.com/compliance.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250318567799/en/

Media Contact:

Keera Hart

Vice President

(905) 580-1257

[email protected]

Corpay Contact:

Brad Loder

VP, Cross-Border Marketing

(647) 627-6635

[email protected]

KEYWORDS: Europe Luxembourg North America Canada

INDUSTRY KEYWORDS: Payments Finance Banking Data Management Professional Services Technology Fintech Business

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Additional Proceeds Are invited into a Second Closing from Existing Strategic Investors

Corning Upgrades High-Confidence Springboard Plan to Now Add More Than $4 Billion in Annualized Sales, and to Achieve Operating Margin of 20%, by End of 2026 ⁽¹⁾

Company raises 2023-2027 sales CAGR from 25% to 30% in Optical Communications’ Enterprise business, driven by continued strong adoption of new Gen AI products for inside data centers

Company launches a new Solar Market-Access Platform that is expected to increase sales, profit, and cash flow beginning in the third quarter

Management raises first-quarter guidance; now expects sales to exceed $3.6 billion and EPS to come in at the high end of the range of $0.48 to $0.52

^{(1) In 2024, Corning shared details on its original high-confidence Springboard plan to add more than $3 billion in annualized sales, and to achieve operating margin of 20%, by the end of 2026. The starting point for Springboard is the annualized sales run rate of Q4 2023.}

CORNING, N.Y.–(BUSINESS WIRE)–Corning Incorporated (NYSE: GLW) today announced an upgrade to its Springboard plan, along with details on the key milestones achieved across the company, at an investor event in New York City.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250317478788/en/

Wendell P. Weeks, chairman and chief executive officer, said, “Today, we upgraded our high-confidence Springboard plan to now add more than $4 billion in annualized sales, and to achieve operating margin of 20%, by the end of 2026. We expect our upgraded sales to come with higher EPS and stronger cash flow and ROIC than we originally anticipated at the start of Springboard.”

Weeks continued, “Overall, we’re making great progress on Springboard across the company. Our strategies are working, and our customers are loving our innovations. As a result, in addition to upgrading our Springboard plan, we are raising our first-quarter guidance. We are also excited to launch a new Solar Market-Access Platform, which we expect to be a $2.5 billion business by 2028, with a positive impact on sales, profit, and cash flow later this year.”

Ed Schlesinger, executive vice president and chief financial officer, said, “When we introduced Springboard one year ago, we laid out a compelling financial plan to deliver robust sales, profit, and cash flow. Since the start of Springboard, we have grown core sales 18% and core EPS 46%, while expanding core operating margin to 18.5%. We also expanded core ROIC 390 basis points. Additionally, we grew adjusted free cash flow by 42% for full-year 2024.”

Schlesinger continued, “Today, we’re providing a significant upgrade to what was already a quite attractive investment thesis. We’ve upgraded our high-confidence Springboard plan by $1 billion. We now expect to add more than $4 billion in annualized sales, and to achieve a 20% operating margin, by the end of 2026.”

Highlights from Springboard Investor Event

• Company upgrades Springboard plan
  • Management upgrades its high-confidence Springboard plan to now add more than $4 billion in annualized sales, and to achieve operating margin of 20%, by the end of 2026. The company expects the upgraded sales to come with higher EPS and stronger cash flow and ROIC than originally anticipated at the start of Springboard.
  • Management also upgrades its internal Springboard plan to now add $6 billion in annualized sales by the end of 2026. The internal plan reflects the actual business plans of each Market-Access Platform without corporate-level risk adjustment.

• Management raises first-quarter guidance
  • Management now expects full-company sales to exceed $3.6 billion and EPS to come in at the high end of the range of $0.48 to $0.52.

• Gen AI products driving faster growth in Optical Communications
  • Management raises expected Enterprise 2023-2027 sales CAGR from 25% to 30%, driven by the continued strong adoption of new Gen AI products for inside data centers.
  • Corning introduced a new Gen AI fiber and cable system last year to interconnect AI data centers, enabling from two-to-four times the amount of fiber into an existing conduit. The company’s Carrier business has now fully commercialized these products, with production tripling every month in Q1, as three industry-leading customers adopt the technology.

• Company announces launch of new Solar Market-Access Platform
  • The company is contributing to U.S. energy independence by helping build a domestic solar supply chain.
  • Management expects the new Solar Market-Access Platform to grow from a ~$1 billion revenue stream in 2024 to a $2.5 billion revenue stream by 2028.
  • Corning is commercializing new made-in-America wafer products this year, with committed customer agreements, and management expects these products to have a positive impact on sales, profits, and cash flow starting in the second half of 2025.

• Display Technologies on track to maintain stable U.S. dollar net income
  • Display Technologies successfully implemented price increases in the second half of 2024 to deliver consistent profitability in a weaker yen environment.
  • Management remains confident that Display is on track to deliver net income of $900 million to $950 million this year and to deliver net income margin of 25%.

Presentation of Information in this News Release

In this news release, when describing the outlook for future periods, “sales”, “EPS”, “ROIC” and “operating margin,” refer to the company’s core net sales, core EPS, core ROIC, and core operating margin, which are non-GAAP measures. Non-GAAP financial measures are not in accordance with, or an alternative to, GAAP. Corning’s non-GAAP financial measures exclude the impact of items that are driven by general economic conditions and events that do not reflect the underlying fundamentals and trends in the company’s operations. The company believes presenting non-GAAP financial measures assists in analyzing financial performance without the impact of items that may obscure trends in the company’s underlying performance. Definitions of these non-GAAP financial measures and reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures for completed financial reporting periods can be found on the company’s website by going to the Investor Relations page and clicking “Quarterly Results” under the “Financials and Filings” tab.

With respect to the outlook for future periods, it is not possible to provide reconciliations for these non-GAAP measures because management does not forecast the movement of foreign currencies against the U.S. dollar, or other items that do not reflect ongoing operations, nor does it forecast items that have not yet occurred or are out of management’s control. As a result, management is unable to provide outlook information on a GAAP basis. Non-GAAP measures used in outlook for future periods reflect estimates, and GAAP financial measures ultimately achieved may vary materially.

Caution Concerning Forward-Looking Statements

The statements contained in this release and related comments by management that are not historical facts or information and contain words such as “will,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “see,” “would,” “target,” “estimate,” “forecast” or similar expressions are forward-looking statements. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include estimates and assumptions related to economic, competitive and legislative developments. Such statements relate to future events that by their nature address matters that are, to different degrees, uncertain. These forward-looking statements relate to, among other things, the company’s Springboard plan, the company’s future operating performance, the company’s share of new and existing markets, the company’s revenue and earnings growth rates, the company’s ability to innovate and commercialize new products, the company’s expected capital expenditure and the company’s implementation of cost-reduction initiatives and measures to improve pricing, including the optimization of the company’s manufacturing capacity.

Although the company believes that these forward-looking statements are based upon reasonable assumptions regarding, among other things, current estimates and forecasts, general economic conditions, its knowledge of its business and key performance indicators that impact the company, there can be no assurance that these forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The company undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.

Some of the risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements include, but are not limited to: global economic trends, competition and geopolitical risks, or an escalation of sanctions, tariffs or other trade tensions between the U.S. and other countries, and related impacts on our businesses’ global supply chains and strategies; changes in macroeconomic and market conditions and market volatility, including developments and volatility arising from health crisis events, inflation, interest rates, the value of securities and other financial assets, precious metals, oil, natural gas, raw materials and other commodity prices and exchange rates (particularly between the U.S. dollar and the Japanese yen, New Taiwan dollar, euro, Chinese yuan, South Korean won and Mexican peso), decreases or sudden increases of consumer demand, and the impact of such changes and volatility on our financial position and businesses; the availability of or adverse changes relating to government grants, tax credits or other government incentives; the duration and severity of health crisis events, such as an epidemic or pandemic, and its impact across our businesses on demand, personnel, operations, our global supply chains and stock price; possible disruption in commercial activities or our supply chain due to terrorist activity, cyber-attack, armed conflict, political or financial instability, natural disasters, international trade disputes or major health concerns; loss of intellectual property due to theft, cyber-attack, or disruption to our information technology infrastructure; ability to enforce patents and protect intellectual property and trade secrets; disruption to Corning’s, our suppliers’ and manufacturers’ supply chain, equipment, facilities, IT systems or operations; product demand and industry capacity; competitive products and pricing; availability and costs of critical components, materials, equipment, natural resources and utilities; new product development and commercialization; order activity and demand from major customers; the amount and timing of our cash flows and earnings and other conditions, which may affect our ability to pay our quarterly dividend at the planned level or to repurchase shares at planned levels; the amount and timing of any future dividends; the effects of acquisitions, dispositions and other similar transactions; the effect of regulatory and legal developments; ability to pace capital spending to anticipated levels of customer demand; our ability to increase margins through implementation of operational changes, pricing actions and cost reduction measures; rate of technology change; adverse litigation; product and component performance issues; retention of key personnel; customer ability to maintain profitable operations and obtain financing to fund ongoing operations and manufacturing expansions and pay receivables when due; loss of significant customers; changes in tax laws, regulations and international tax standards; the impacts of audits by taxing authorities; the potential impact of legislation, government regulations, and other government action and investigations; and other risks detailed in Corning’s SEC filings.

For a complete listing of risks and other factors, please reference the risk factors and forward-looking statements described in our annual reports on Form 10-K and quarterly reports on Form 10-Q.

Web Disclosure

In accordance with guidance provided by the SEC regarding the use of company websites and social media channels to disclose material information, Corning Incorporated (“Corning”) wishes to notify investors, media, and other interested parties that it uses its website (https://www.corning.com/worldwide/en/about-us/news-events.html) to publish important information about the company, including information that may be deemed material to investors, or supplemental to information contained in this or other press releases. The list of websites and social media channels that the company uses may be updated on Corning’s media and website from time to time. Corning encourages investors, media, and other interested parties to review the information Corning may publish through its website and social media channels as described above, in addition to the company’s SEC filings, press releases, conference calls, and webcasts.

About Corning Incorporated

Corning (www.corning.com) is one of the world’s leading innovators in materials science, with a 170-year track record of life-changing inventions. Corning applies its unparalleled expertise in glass science, ceramic science, and optical physics along with its deep manufacturing and engineering capabilities to develop category-defining products that transform industries and enhance people’s lives. Corning succeeds through sustained investment in RD&E, a unique combination of material and process innovation, and deep, trust-based relationships with customers who are global leaders in their industries. Corning’s capabilities are versatile and synergistic, which allows the company to evolve to meet changing market needs, while also helping its customers capture new opportunities in dynamic industries. Today, Corning’s markets include optical communications, mobile consumer electronics, display, automotive, solar, semiconductors, and life sciences.

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Media Relations Contact:

Gabrielle Bailey

(607) 684-4557

[email protected]

Investor Relations Contact:

Ann H.S. Nicholson

(607) 974-6716

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Mobile/Wireless Technology Semiconductor Other Technology Telecommunications Software Networks Hardware Consumer Electronics Artificial Intelligence

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Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2024 Financial Results

HOUSTON–(BUSINESS WIRE)–
Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2024.

Corporate Highlights FY2024 to Date

• Announced significant improvements of inflammatory blood markers from an investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer’s disease (AD)
• Announced that five of eight patients have been enrolled in the investigator-initiated academic study of LD IL-2 + CTLA4-Ig combination in patients with Frontotemporal Dementia (FTD)
• Announced positive results from an investigator initiated double-blind study of low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer’s Disease (AD) at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid. The study was titled, “A Phase II Clinical Trial of Interleukin-2 (IL-2) in Patients with Mild to Moderate Alzheimer’s Disease”
• Aligned with FDA on the non-clinical data needed to support the planned randomized, double-blind, placebo-controlled, Phase 2b trial of COYA-302 in patients with Amyotrophic Lateral Sclerosis (ALS)
• Announced expansion of pipeline- COYA 303; COYA 301 in combination with GLP-1 Receptor Agonist for treatment of inflammatory diseases and filing of new intellectual property portfolio for the combination

Financial Highlights FY 2024

• Raised $10.0M in a private placement of 1.38M shares of common stock. The majority of investors in the offering were existing institutional shareholders of company
• Received $5.0 million strategic investment by the Alzheimer’s Drug Discovery Foundation (ADDF) to help support the development of COYA 302 for the treatment of Frontotemporal Dementia (FTD)
• Received $3.85 million from the previously announced First Amendment and License Agreement with Dr. Reddy’s Laboratories, Inc., which is earmarked for funding the first Phase 2 clinical trial of COYA 302 in ALS in the United States. The original agreement was entered into on December 5, 2023.

Upcoming Expected Catalysts for 2025

• Q2 2025: Submission of additional nonclinical data to support the start of the COYA-302 Phase 2 trial in patients with ALS
• Upon IND acceptance and first patient dosing of COYA-302 in ALS, eligible to receive milestone payments of $8.4 million from strategic partner, Dr. Reddy’s Laboratories (DRL)
• Q2 2025: Publication of COYA-303 combination mechanistic data
• Q2 2025: Publication of data documenting role of inflammation in Parkinson’s Disease
• Q2 2025: ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS
• 2H 2025: Additional single cell proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer’s disease (AD)
• 2H 2025: Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD
• 2H 2025: Filing of IND for the COYA-302 Phase 2 trial in patients with FTD*
  
  (*Clinical trial initiated upon FDA IND approval)

Coya CEO Arun Swaminathan, Ph.D. commented, “We remain encouraged by the progress we made in 2024 and are well positioned for continued success in 2025. We continue to expand our pipeline while making significant progress on our ongoing programs in neurodegenerative diseases with high unmet need, and we are on track to initiate the randomized, double-blind controlled Phase 2b trial in patients with ALS upon IND acceptance.

“Our drug candidates all target neuroinflammation, which we see as a key driving factor towards disease progression in the neurological conditions we are addressing. Moreover, our approach to potential combination therapies for treatment of these neurodegenerative diseases differentiates us from other companies and offers, what we believe, a more potent treatment paradigm that could potentially lead to new options for patients and create meaningful shareholder value.

“The strong scientific and clinical rationale, our strong cash position and potential for new business development opportunities all together strengthens our optimism about our ability to execute on our corporate, clinical and regulatory goals and continue to build value. I look forward to sharing additional corporate, clinical, and regulatory progress as appropriate,” concluded Swaminathan.

Coya CMO, Dr. Fred Grossman said, “As we have indicated in the past, we expect 2025 to hold important milestones for the Company, including initiating the phase 2b trial of COYA 302, which is the combination of LD-IL2 and CTLA 4 IG, in ALS patients. We are on track for submission of all required nonclinical data to the FDA to support the initiation of the Phase 2 trial in patients with ALS. Additionally, we will be submitting an IND for a phase 2b study of COYA 302 in FTD patients. Clinical data from an investigator initiated clinical trial of combination of LD IL-2 and CTLA 4 IG will be reported and will support the planned phase 2b trial of COYA 302 n FTD.”

Financial Results

As of December 31, 2024, Coya had cash and cash equivalents of $38.3 million.

Research and development (R&D) expenses were $11.9 million for the year ended December 31, 2024, compared to $5.5 million for the year ended December 31, 2023. The change was primarily due to a $5.0 million increase in our preclinical expenses, a $1.1 million increase in internal research and development expenses, and a $0.3 million increase in costs attributable to our sponsored research agreement with Houston Methodist Hospital.

General and administrative expenses were $8.9 million for the year ended December 31, 2024, and $7.8 million for the year ended December 31, 2023, a change of approximately $1.1 million. The increase was primarily due to a $1.2 million increase in payroll and employee related benefits, a $0.3 million increase in franchise taxes and license fees and $0.2 million increase in our investor and public relations costs, partially offset by a $0.2 million decrease in insurance fees and a $0.4 million decrease in professional service fees.

Net loss was $14.9 million for the year ended December 31, 2024, compared to net loss of $8.0 million for the year ended December 31, 2023.

About Coya Therapeutics, Inc.

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system.

Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

COYA 302 – the Company’s lead biologic investigational product or “Pipeline in a Product” – is a proprietary combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone.

For more information about Coya, please visit www.coyatherapeutics.com.

Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or will occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

BALANCE SHEETS
(Audited)
	December 31,
	2024				2023
Assets
Current assets:
Cash and cash equivalents	$	38,339,762			$	32,626,768
Collaboration receivables		–				7,500,000
Prepaids and other current assets		5,968,666				1,069,557
Total current assets		44,308,428				41,196,325
Fixed assets, net		38,588				65,949
Total assets	$	44,347,016			$	41,262,274
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,588,128			$	1,155,656
Accrued expenses		1,388,060				2,973,215
Deferred collaboration revenue		848,286				923,109
Total current liabilities		3,824,474				5,051,980
Deferred collaboration revenue		945,447				574,685
Total liabilities		4,769,921				5,626,665
Stockholders’ equity:
Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none issued and outstanding as of December 31, 2024 and 2023		–				–
Common stock, $0.0001 par value; 200,000,000 shares authorized; 16,707,441 and 14,405,325 shares issued and outstanding as of December 31, 2024 and 2023, respectively		1,671				1,441
Additional paid-in capital		80,312,594				61,501,801
Subscription receivable		–				(11,250	)
Accumulated deficit		(40,737,170	)			(25,856,383	)
Total stockholders’ equity		39,577,095				35,635,609
Total liabilities and stockholders’ equity	$	44,347,016			$	41,262,274

STATEMENTS OF OPERATIONS
(Audited)
	Years Ended December 31,
	2024				2023
Collaboration revenue	$	3,554,061			$	6,002,206
Operating expenses:
Research and development		11,865,654				5,501,527
In-process research and development		25,000				543,186
General and administrative		8,885,757				7,833,481
Depreciation		27,361				27,361
Total operating expenses		20,803,772				13,905,555
Loss from operations		(17,249,711	)			(7,903,349	)
Other income:
Other income, net		1,648,637				639,365
Pre-tax loss		(15,601,074	)			(7,263,984	)
Income tax benefit (expense)		720,287				(723,852	)
Net loss	$	(14,880,787	)		$	(7,987,836	)
Share information:
Net loss per share of common stock, basic and diluted	$	(0.98	)		$	(0.79	)
Weighted-average shares of common stock outstanding, basic and diluted		15,238,919				10,163,850

STATEMENTS OF CASH FLOWS
(Audited)
	Years Ended December 31,
	2024				2023
Cash flows from operating activities:
Net loss	$	(14,880,787	)		$	(7,987,836	)
Adjustment to reconcile net loss to net cash used in operating activities:
Depreciation		27,361				27,361
Stock-based compensation, including the issuance of restricted stock		2,663,539				872,248
Acquired in-process research and development		25,000				543,186
Changes in operating assets and liabilities:
Collaboration receivable		7,500,000				(7,500,000	)
Prepaids and other current assets		(4,899,109	)			181,707
Accounts payable		477,450				298,816
Accrued expenses		(1,498,215	)			877,913
Deferred collaboration revenue		295,939				1,497,794
Net cash used in operating activities		(10,288,822	)			(11,188,811	)
Cash flows from investing activities:
Purchase of in-process research and development assets		(25,000	)			(543,186	)
Net cash used in investing activities		(25,000	)			(543,186	)
Cash flows from financing activities:
Proceeds from sale of common stock from 2023 Private Placement, net of offering costs		–				24,084,805
Proceeds from issuance of common stock upon IPO, net of offering costs		–				14,250,311
Payment of financing costs related to the 2023 Private Placement		(131,918	)			–
Proceeds from subscription receivable		11,250				–
Proceeds from the exercise of stock options		1,975				89,947
Proceeds from the exercise of warrants		2,141,128				–
Proceeds from sale of common stock, net of offering costs		14,004,381				–
Net cash provided by financing activities		16,026,816				38,425,063
Net increase in cash and cash equivalents		5,712,994				26,693,066
Cash and cash equivalents as of beginning of the year		32,626,768				5,933,702
Cash and cash equivalents as of end of the year	$	38,339,762			$	32,626,768
Supplemental disclosures of non-cash financing activities:
Conversion of convertible preferred stock upon IPO	$	–			$	8,793,637
Conversion of convertible promissory notes upon IPO	$	–			$	12,965,480
Subscription receivable related to warrant exercise	$	–			$	11,250
Financing costs related to the 2023 Private Placement in accrued expenses and accounts payable	$	–			$	131,918

 

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Posted on March 18, 2025 8:36 am

PROS Appoints Growth Veteran Katie May to Board of Directors

PROS Appoints Growth Veteran Katie May to Board of Directors

Scaling expert and proven tech business leader brings eCommerce, digital transformation and high-growth SaaS expertise to Board

HOUSTON–(BUSINESS WIRE)–PROS Holdings, Inc. (NYSE: PRO), a leading provider of AI-powered SaaS pricing and selling solutions, today announced the appointment of Katie May to its Board of Directors, effective immediately. May, an established entrepreneur and board veteran, joins PROS as an independent director, bringing deep expertise in eCommerce, digital transformation and high-growth SaaS strategies.

May is an experienced leader with more than 20 years in C-suite roles, including 14 years as an operating CEO. She has successfully scaled multiple high-growth companies to successful exits, including one IPO and two strategic acquisitions. Her expertise spans SaaS, software, marketplaces, SMB, eCommerce, shipping and digital transformation. She also brings extensive board leadership experience across public and private companies, having served on nine boards, including Pitney Bowes, Rokt Inc and Stamps.com.

“With experience across high-growth technology companies and marketplaces, Katie brings extensive knowledge of what it takes to scale a business,” said PROS Non-Executive Chairman of the Board Bill Russell. “We look forward to adding Katie’s perspective to the Board.”

“We are delighted to welcome Katie to the PROS Board,” said PROS President and CEO Andres Reiner. “Her knowledge and expertise in SaaS, digital commerce and scaling businesses make her an invaluable addition as we accelerate our mission to help companies outperform in an increasingly dynamic market.”

“PROS is sitting at the intersection of AI, pricing, and commerce—a space primed for disruption,” said May. “I’m thrilled to join the PROS Board at such a pivotal time and help accelerate the company’s journey in shaping the future of intelligent commerce and driving long-term success and value for our shareholders.”

Russell Reynolds advised the company in the Board search process.

About PROS

PROS Holdings, Inc. (NYSE: PRO) helps the world’s leading companies outperform across the top and bottom line. Leveraging leadership in revenue and pricing science, the PROS Platform combines predictive AI, real-time analytics, and powerful automation to dynamically match offer to buyer and price to product, accelerating revenue growth and maximizing profit. With solutions spanning pricing, revenue management, offer marketing, and CPQ, PROS helps businesses optimize transactions across every channel. Learn more at pros.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about our outlook; expectations; ability to achieve future growth and profitability goals; management’s confidence and optimism; and positioning. The forward-looking statements contained in this press release are based upon our historical performance and our current plans, estimates and expectations and are not a representation that such plans, estimates or expectations will be achieved. Factors that could cause actual results to differ materially from those described herein include, among others, risks related to: (a) cyberattacks, data breaches and breaches of security measures within our products, systems and infrastructure or products, systems and infrastructure of third parties upon whom we rely, (b) the macroeconomic environment and geopolitical uncertainty and events, (c) increasing business from customers, maintaining subscription renewal rates and capturing customer IT spend, (d) managing our growth and profit objectives effectively, (e) disruptions from our third party data center, software, data, and other unrelated service providers, (f) implementing our solutions, (g) cloud operations, (h) intellectual property and third-party software, (i) acquiring and integrating businesses and/or technologies, (j) catastrophic events, (k) operating globally, including economic and commercial disruptions, (l) potential downturns in sales and lengthy sales cycles, (m) software innovation, (n) competition, (o) market acceptance of our software innovations, (p) maintaining our corporate culture, (q) personnel risks including loss of any key employees and competition for talent, (r) expanding and training our direct and indirect sales force, (s) evolving data privacy, cyber security, data localization and AI laws, (t) our debt repayment obligations, (u) the timing of revenue recognition and cash flow from operations, and (v) returning to profitability. Additional information relating to the risks and uncertainties affecting our business is contained in our filings with the SEC. These forward-looking statements represent our expectations as of the date hereof. Subsequent events may cause these expectations to change, and PROS disclaims any obligations to update or alter these forward-looking statements in the future, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250318437311/en/

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Forge Appoints Financial Services Veteran Brian McDonald to Its Board of Directors

SAN FRANCISCO–(BUSINESS WIRE)–
Forge Global Holdings, Inc. (“Forge,” or the “Company”) (NYSE: FRGE), a leading private market platform, announced today the appointment of Brian McDonald to its Board of Directors, as well as to its Audit Committee and Risk Committee.

Mr. McDonald brings to Forge decades of leadership experience in financial services, wealth management, and digital business. Most recently, he served as Managing Director, Head of Direct and Institutional Businesses at Morgan Stanley, where he helped build and lead Morgan Stanley at Work, one of the world’s largest workplace financial platforms. Before that, he spent over 20 years at Charles Schwab, leading workplace and retail service functions, ultimately serving as Senior Vice President. His leadership has been instrumental in developing innovative financial solutions and advancing strategic initiatives within the industry.

“Brian’s deep understanding of financial technology, equity compensation, and digital business strategy makes him a valuable addition to our Board of Directors,” said Kelly Rodriques, CEO of Forge. “His rich experience at global financial institutions will be an asset to Forge as we continue to pursue profitable, technology-enabled growth and international expansion.”

In addition to his executive leadership roles, Mr. McDonald has been an advisor to companies focused on AI-driven investment platforms and digital transformation in wealth management. He is also an investor in the financial services and financial technology sectors, currently serving on the boards of two companies as an Executive in Residence at TIFIN, an AI platform for asset, wealth, and insurance services. Mr. McDonald holds a B.A. in Economics from Indiana University and an M.B.A. from Ball State Graduate School of Business.

“I am honored to join the board of Forge Global at such a pivotal time for the private market ecosystem,” said Mr. McDonald. “Forge has brought greater transparency, access, and efficiency to the private market. I look forward to working with the leadership team and my fellow board members to support the company’s continued growth and innovation.”

About Forge

Forge is a leading provider of marketplace infrastructure, data services and technology solutions for private market participants. Forge Securities LLC is a registered broker-dealer and a Member of FINRA that operates an alternative trading system.

Forward-Looking Statements

This press release contains “forward-looking statements,” which generally are accompanied by words such as “believe,” “may,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “target,” “goal,” “expect,” “should,” “would,” “plan,” “predict,” “project,” “forecast,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict, indicate, or relate to future events or trends or Forge’s future financial or operating performance, or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Forge’s beliefs regarding future opportunities for Forge to expand its business. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, while considered reasonable by Forge and its management, are subject to risks and uncertainties that may cause actual results to differ materially from current expectations. You should carefully consider the risks and uncertainties described in Forge’s documents filed, or to be filed, with the SEC, including in its Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. There may be additional risks that Forge presently does not know of or that it currently believes are immaterial that could also cause actual results to differ materially from those contained in the forward-looking statements. In addition, forward-looking statements reflect Forge’s expectations, plans, or forecasts of future events and views as of the date of this press release. Forge anticipates that subsequent events and developments will cause its assessments to change. However, while Forge may elect to update these forward-looking statements at some point in the future, Forge specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Forge’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

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