Here are a few analogies to describe Talphera:

• Like a focused Eagle Pharmaceuticals, developing specialized injectable drugs for acute and critical hospital care.
• Imagine a niche Baxter International, but exclusively developing new, specialized drugs and convenient pre-filled delivery systems for hospital critical care.

• Niyad: An investigational anticoagulant for the extracorporeal circuit.
• LTX-608: An anti-inflammatory and antiviral therapy with potential for treating conditions like COVID-19, DIC, ARDS, and acute pancreatitis.
• Fedsyra: A pre-filled ephedrine syringe.
• PFS-02: A pre-filled phenylephrine syringe.

Talphera, Inc. (TLPH), as a specialty pharmaceutical company, sells its products primarily to other companies within the healthcare supply chain, rather than directly to individuals. Its major customers are typically large pharmaceutical distributors who then supply the products to hospitals, clinics, and other medically supervised settings where Talphera's therapies are administered.

While Talphera does not publicly disclose specific names of its major customers, it is standard practice in the pharmaceutical industry for companies like Talphera to distribute their products through major drug wholesalers. The most prominent pharmaceutical distributors in the United States, who would likely serve as major customers, include:

• McKesson Corporation (NYSE: MCK)
• AmerisourceBergen Corporation (NYSE: ABC)
• Cardinal Health, Inc. (NYSE: CAH)

Vincent J. Angotti, Chief Executive Officer

Mr. Angotti has served as the Chief Executive Officer of Talphera, Inc. (formerly AcelRx Pharmaceuticals, Inc.) since March 2017. He has over two decades of experience leading executive and commercial teams in public and private life sciences companies. Prior to joining Talphera, he was the Chief Executive Officer of XenoPort, Inc., a biopharmaceutical company. During his tenure at XenoPort, he was involved in the re-acquisition of Horizant from GSK and implemented a successful re-branding and re-launch strategy, which led to XenoPort's acquisition by Arbor Pharmaceuticals, LLC in 2016 for $0.5 billion. Earlier, Mr. Angotti held senior sales and marketing positions at Reliant Pharmaceuticals, Inc. from 2001 to 2008, where he was integrally involved in the company's M&A discussions that culminated in Reliant's acquisition by GSK in 2007 for $1.7 billion. He began his career at Novartis Pharmaceuticals Corp. in sales and operations.

Raffi Asadorian, Chief Financial Officer

Mr. Asadorian serves as the Chief Financial Officer of Talphera, a position he assumed in July 2017. He plays a key role in the financial operations and strategy of the company. Recent SEC filings indicate his active involvement in the company's stock, including purchasing shares.

Pamela P. Palmer, MD, PhD, Chief Medical Officer and Co-Founder

Dr. Palmer co-founded AcelRx Pharmaceuticals (now Talphera) in July 2005 and has served as a director and Chief Medical Officer since then. Her career has been dedicated to pain research and treatment, including serving as an anesthesiologist at the University of California, San Francisco (UCSF). Dr. Palmer also co-founded Omeros Corporation, a biopharmaceutical company focused on developing therapeutics for pain management and clinical outcomes, in 1994. She previously held the role of medical director of the UCSF Pain Management Center from 1999 to 2005 and was a faculty member at UCSF conducting NIH-funded research on pain transmission from 1996 to 1999.

Badri Dasu, Chief Engineering Officer

Mr. Dasu is the Chief Engineering Officer at Talphera. He contributes his expertise to the engineering aspects of the company's product development.

The key risks to Talphera, Inc. (TLPH) primarily revolve around its ability to successfully develop and commercialize its lead product candidate, Niyad, its ongoing financial viability due to significant cash burn, and the immediate threat of delisting from the Nasdaq exchange.

1. Clinical Development and Regulatory Approval Risk: Talphera's business success is heavily dependent on the successful completion of clinical trials and the subsequent regulatory approval of its lead product candidate, Niyad. Niyad, a lyophilized formulation of nafamostat, is currently undergoing a registrational study (NEPHRO-CRRT) as an anticoagulant for the extracorporeal circuit and is being studied under an investigational device exemption. The company expects to file a premarket approval application with the FDA this year, with top-line data from the clinical study anticipated by the end of 2025. Any delays in clinical trials, failure to demonstrate efficacy or safety, or an inability to obtain regulatory approval from the FDA would significantly hinder the company's ability to generate revenue and commercialize its primary asset.
2. Financial Viability and Liquidity Risk: Talphera faces significant financial challenges, characterized by minimal revenue and persistent cash burn. The company reported a full-year 2024 net loss of $18.4 million and an extremely limited revenue stream of only $651,000 for the same period. This ongoing cash burn means the company is heavily reliant on external capital to fund its operations and clinical studies, leading to a risk of long-term dilution for shareholders without the commencement of commercial sales and profitability. The ability to maintain sufficient capital resources to conduct its clinical studies is a frequently cited risk.
3. Nasdaq Delisting Risk: Talphera has received formal notices of non-compliance from the Nasdaq Stock Market. Specifically, the company has not maintained the minimum required closing bid price of $1.00 per share for 30 consecutive business days. Additionally, Talphera's stockholders' equity has fallen short of Nasdaq's minimum $10 million threshold. Failure to regain compliance with these listing standards could result in the delisting of Talphera's common stock, which would significantly reduce its liquidity, potentially depress share value, and complicate its ability to raise future capital. The company has until September 7, 2026, to regain compliance for the bid price requirement, potentially considering a reverse stock split if necessary.

Talphera, Inc. (TLPH) focuses on the development and commercialization of therapies for use in medically supervised settings. The addressable market sizes for its main products are as follows:

Niyad (nafamostat for extracorporeal circuit anticoagulation)

• The global market for nafamostat mesylate, of which Niyad is a formulation, was valued at approximately $308.6 million in 2021 and is projected to reach $438.8 million by the end of 2025. This market is expected to grow to $887.3 million by 2033, demonstrating a Compound Annual Growth Rate (CAGR) of 9.2% from 2025 to 2033.
• Geographically, in 2025, North America accounts for 22.31% of the global nafamostat mesylate market revenue, Europe holds 29.69%, and the Asia Pacific region comprises 34.89%.

LTX-608 (nafamostat formulation for COVID-19, DIC, ARDS, acute pancreatitis)

• While a specific addressable market size in USD for LTX-608 across all its indications (COVID-19, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis) was not identified, Talphera estimates the annual number of DIC patients to be over 250,000.

Fedsyra (pre-filled ephedrine syringe) and PFS-02 (pre-filled phenylephrine syringe)

• Talphera believes its two pre-filled syringe product candidates (Fedsyra and PFS-02 combined) could achieve peak sales potential of over $100 million.
• For context, the broader global prefilled syringes market was estimated at approximately USD 9.59 billion in 2025 and is projected to reach USD 26.41 billion by 2034, with a CAGR of 12.1% during the forecast period. North America held the largest share of the global prefilled syringes market in 2025.
• The global phenylephrine hydrochloride market, which encompasses PFS-02, was valued at USD 777.6 million in 2022 and is anticipated to grow to USD 1.6 billion by 2032, exhibiting a CAGR of 7.7% during that period. The overall phenylephrine drugs market size was $28.03 billion in 2025 and is expected to reach $44.82 billion by 2030 globally.

Talphera, Inc. (TLPH) anticipates several key drivers for its future revenue growth over the next two to three years, primarily centered on the progression and potential commercialization of its pipeline products.

One significant driver is the potential **FDA approval and subsequent commercialization of Niyad**. Niyad, a lyophilized formulation of nafamostat, is Talphera's lead product candidate and is currently undergoing the NEPHRO CRRT registrational study as an anticoagulant for the extracorporeal circuit. The company expects to complete the NEPHRO study in the first half of 2026, targeting a Premarket Approval (PMA) submission in early 2026, with potential FDA approval in late 2026. Niyad has received FDA Breakthrough Device Designation, and there is strong physician demand for an alternative to current anticoagulant options. The FDA's approval to reduce the study size from 166 to 70 patients is also expected to accelerate study completion.

Another expected driver is the **advancement and potential market entry of LTX-608**. LTX-608, another nafamostat formulation, is under development for various indications, including COVID-19, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis. It is currently in Phase III clinical development for COVID-19. Given that nafamostat is already approved in Japan and South Korea for acute pancreatitis and DIC, successful clinical development and regulatory approval for LTX-608 in its target indications could significantly contribute to future revenue.

Finally, the **launch and market adoption of Talphera's pre-filled syringe products, Fedsyra and PFS-02**, represent a growth opportunity. These products, Fedsyra (ephedrine) and PFS-02 (phenylephrine), are being developed as ready-to-use pre-filled syringes for managing hypotension in medically supervised settings. These products aim to offer a safer, more economical, and time-saving method for delivering intraoperative medications compared to traditional vials or ampules, addressing a clear need in clinical settings.

Share Issuance

• In July 2023, AcelRx Pharmaceuticals (now Talphera) completed a private placement of common stock and pre-funded warrants, generating approximately $10 million in gross proceeds, with potential for an additional $16.3 million upon full exercise of common warrants.
• In September 2025, Talphera closed the first tranche of a private placement, raising $17 million, as part of a larger financing with total potential proceeds of up to $29 million.
• In April 2025, Talphera completed the first tranche of a three-tranche financing, raising $4.9 million, with the potential for total proceeds of up to $14.8 million.

Inbound Investments

• In September 2025, CorMedix Inc. made a strategic investment in Talphera, leading a private placement of up to $29 million. This included a $5 million strategic minority investment within the initial $17 million tranche.
• The September 2025 financing was also supported by existing stockholders Nantahala Capital, Rosalind Advisors, and Rock Springs Capital, alongside several new institutional investors.

Outbound Investments

• In January 2022, AcelRx Pharmaceuticals (now Talphera) completed the acquisition of Lowell Therapeutics, Inc., a privately held company.

Capital Expenditures

• AcelRx Pharmaceuticals anticipated approximately $2 million in capital expenditures for 2022, primarily focused on the final validation of an automated packaging line at its contract manufacturer.
• Capital expenditures for the last 12 months prior to March 2026 were reported as $100,000.