Form 8-K

8-K — TALPHERA, INC.

Accession: 0001437749-26-016724

Filed: 2026-05-13

Period: 2026-05-13

CIK: 0001427925

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — acrx20260511_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ex_960711.htm)

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0001427925

2026-05-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 13, 2026

TALPHERA, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-35068

41-2193603

(State of incorporation)

(Commission File No.)

(IRS Employer Identification No.)

1850 Gateway Drive, Suite 175

San Mateo, CA 94404

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (650) 216-3500

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value

TLPH

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02

Results of Operations and Financial Condition

On May 13, 2026, Talphera, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2026 and providing a corporate update (the “Release”). A copy of the Release is furnished herewith as Exhibit 99.1.

The information contained in this Item 2.02 and in Exhibit 99.1 shall be deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in Exhibit 99.1 shall not be incorporated by reference into any filing under the Securities Act or the Exchange Act made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01

Financial Statements and Exhibits

Exhibit No.

Description

99.1

Press Release dated May 13, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

TALPHERA, INC.

Date: May 13, 2026

By:

/s/ Raffi Asadorian

Raffi Asadorian

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ex_960711.htm · Sequence: 2

ex_960711.htm

Exhibit 99.1

Talphera Announces First Quarter 2026 Financial Results and Provides Corporate Update

NEPHRO CRRT clinical study expected to be completed this year

Cash and investments of $21.1 million at March 31, 2026

Conference call and webcast to be held on Wednesday, May 13, 2026 at 4:30 pm ET

SAN MATEO, Calif., May 13, 2026 – Talphera, Inc. (Nasdaq: TLPH), (“Talphera”), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced first quarter 2026 financial results and provided a corporate update.

“In early March, we announced the attainment of 50% enrollment in the NEPHRO CRRT study evaluating nafamostat. With continued steady enrollment, we have well exceeded this level, and continue to expect study completion later this year,” stated Vince Angotti, CEO of Talphera. “Our clinical study sites and principal investigators remain focused on enrollment and delivering a high quality study as they are eager for a potential alternative anticoagulant for Continuous Renal Replacement Therapy (CRRT). The investor and analyst event held in March also highlighted the need for an alternative, given the disadvantages of the currently used products, heparin and citrate. If approved, we continue to believe nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT,” continued Angotti.

First Quarter 2026 and Recent Highlights

●

In March 2026, announced reaching the 35-patient enrollment milestone, representing 50% enrollment in the NEPHRO CRRT study. Enrollment has continued to increase since this announcement, with study completion expected in 2026.

●

In March 2026, held an investor and analyst event with two key opinion leaders (KOLs) focused on anticoagulants used during CRRT and the potential for nafamostat to address an unmet need.

●

In March 2026, two posters were presented at the 31st Annual International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026), entitled: “A Randomized, Placebo-Controlled Multi-Center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy Who Cannot Tolerate Heparin or Are at a Higher Risk of Bleeding” and, “In Vivo Assessment of Nafamostat, A Novel Regional Anticoagulant in a Porcine Model AKI and CKRT”.

●

In March 2026, closed $4.1 million third tranche of the March 2025 private placement financing upon achieving the 35-patient enrollment milestone and other conditions.

First Quarter 2026 Financial Information

●

The cash and investments balance was $21.1 million as of March 31, 2026.

●

Combined R&D and SG&A expenses for the first quarter of 2026 totaled $3.9 million compared to $2.9 million for the first quarter of 2025. Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for the first quarter of 2026, compared to $2.7 million for the first quarter of 2025. The increase in combined R&D and SG&A expenses in the first quarter of 2026 was primarily due to higher Niyad® development expenses, reflecting increased enrollment, and an increase in certain G&A expenses.

●

Net loss attributable to common shareholders for the first quarter of 2026 was $2.6 million, or $0.04 per basic and diluted share, compared to a net loss of $2.6 million, or $0.10 per basic and diluted share, for the first quarter of 2025.

Conference Call and Webcast

Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time today to discuss the results and provide an update on the Company’s business.

Investors who wish to participate in the conference call may do so by dialing 1-800-836-8184 for North American callers, or 1-646-357-8785 (toll applies) for international callers outside of Canada. The conference ID is 24180. The webcast can be accessed here or by visiting the Investors section of the Company's website at www.talphera.com and clicking on the webcast link posted within Investors/News & Events/Upcoming Events section. The webcast will include a slide presentation and a replay will be available on the Talphera website for 90 days following the event.

About Talphera, Inc.

Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA).

This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com.

About Niyad and Nafamostat

Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera’s registrational study of Niyad is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets.

About the NEPHRO CRRT Study

The NEPHRO CRRT Study is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.

Forward-looking statements

This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as “believe,” “expect,” “anticipate,” “may,” “if,” “intends,” “plans,” “potential,” ”projected,” “will,” or the negative of these words or other comparable terminology, and include: Talphera’s expectation the NEPHRO CRRT clinical study will be completed later this year, and Talphera’s belief that nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT. Talphera’s discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera’s developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera’s ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption “Risk Factors” and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the “Investors” tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

Investor Contacts:

Talphera

Raffi Asadorian, CFO

650-216-3500

investors@talphera.com

LifeSci Advisors

Kevin Gardner

617-283-2856

kgardner@lifesciadvisors.com

###

Selected Financial Data

(in thousands, except per share data)

(unaudited)

Three Months Ended

March 31

Statement of Operations Data

2026

2025

Revenue

Operating costs and expenses:

Research and development (1)

1,650

1,169

Selling, general and administrative (1)

2,298

1,774

Total operating costs and expenses

3,948

2,943

Loss from operations

(3,948

)

(2,916

)

Other expense, net:

Interest income and other income, net

169

Gain on change in fair value of warrant liability

1,223

181

Total other expense, net

1,392

250

Net loss from continuing operations

(2,556

)

(2,666

)

Net income from discontinued operations

Net loss

(2,556

)

(2,593

)

Net loss per share attributable to stockholders:

Basic and diluted, continuing operations

(0.04

)

(0.10

)

Basic and diluted, discontinued operations

0.00

Basic and diluted loss per share

(0.04

)

(0.10

)

Shares used in computing net loss per share of common stock, basic and diluted

69,822

26,268

(1) Includes the following non-cash stock-based compensation expense:

Research and development

Selling, general and administrative

150

119

Total

214

196

Selected Balance Sheet Data

(in thousands)

March 31, 2026

December 31, 2025(1)

(Unaudited)

Cash, cash equivalents and investments

21,108

20,381

Total assets

30,155

29,719

Total liabilities

11,677

12,684

Total stockholders' equity

18,478

17,035

(1) Derived from the audited financial statements as of that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

Reconciliation of Non-GAAP Financial Measures

(Operating Expenses less stock-based compensation expense)

Three Months Ended

March 31

(in thousands)

(unaudited)

2026

2025

Operating expenses (GAAP):

Research and development

1,650

1,169

Selling, general and administrative

2,298

1,774

Total operating expenses

3,948

2,943

Less stock-based compensation expense

214

196

Operating expenses (non-GAAP)

3,734

2,747

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May 13, 2026

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