acrx20260630

acrx20260630_10q.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

For the quarterly period ended June 30, 2026

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

For the transition period from to

Commission File Number: 001-35068

TALPHERA, INC.

(Exact name of registrant as specified in its charter)


Delaware	41-2193603
(State or other jurisdiction of incorporation or organization)	(IRS Employer Identification No.)

1850 Gateway Drive, Suite 175

San Mateo, CA 94404

(650) 216-3500

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2) Yes ☐ No ☒

As of August 5, 2026, the number of outstanding shares of the registrant’s common stock was 51,905,796.

TALPHERA, INC.

QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED JUNE 30, 2026

TABLE OF CONTENTS


			Page
PART I. FINANCIAL INFORMATION			5

	Item 1.	Financial Statements	5

		Condensed Consolidated Balance Sheets as of June 30, 2026 and December 31, 2025 (unaudited)	5

		Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2026 and 2025 (unaudited)	6

		Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2026 and 2025 (unaudited)	7

		Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 and 2025 (unaudited)	8

		Notes to Condensed Consolidated Financial Statements (unaudited)	9

	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18

	Item 3.	Quantitative and Qualitative Disclosures About Market Risk	23

	Item 4.	Controls and Procedures	23

PART II. OTHER INFORMATION			24

	Item 1.	Legal Proceedings	24

	Item 1A.	Risk Factors	24

	Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	48

	Item 3.	Defaults Upon Senior Securities	48

	Item 4.	Mine Safety Disclosures	48

	Item 5.	Other Information	48

	Item 6.	Exhibits	49

Unless the context indicates otherwise, the terms “Talphera,” “we,” “us” and “our” refer to Talphera, Inc., and its consolidated subsidiary. “Niyad” and “Fedsyra” are trademarks, and “Zalviso” are registered trademarks, all owned by Talphera, Inc. This Quarterly Report also contains trademarks and trade names that are the property of their respective owners.

Forward-Looking Statements

This Quarterly Report on Form 10-Q, or Form 10-Q, contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by that section. The forward-looking statements in this Form 10-Q are contained principally under “Part I. Financial Information - Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Part II. Other Information - Item 1A. Risk Factors”. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Many important factors affect our ability to achieve our objectives, including:

•

our ability to obtain additional required financing and to continue as a going concern;

•

our ability to manage our operating costs and reduce our cash burn;

•

the accuracy of our estimates regarding the sufficiency of our cash resources, future revenues, expenses, and capital requirements;

•

the historical performance and high volatility in the market price of our common stock;

•

macroeconomic uncertainties, including tariffs, inflationary pressures, domestic and global supply chain disruptions, labor shortages, significant volatility in global markets, and recession risks;

•

our ability to conduct ourselves, or through a contract research organization, clinical trials in a timely and effective manner to advance the development of our product candidates, including our lead nafamostat developmental product candidate, Niyad®;

•

our ability to successfully file for and obtain regulatory approval for, and then successfully launch and commercialize our developmental product candidates;

•

the size and growth potential of the potential markets for our developmental product candidates in the United States and in other jurisdictions, and our ability to serve those markets;

•

our estimates of the existence of, and commercial potential for, markets for our developmental product candidates, if approved;

•

our ability to develop sales and marketing capabilities in a timely fashion, whether alone through recruiting qualified employees, by engaging a contract sales organization, or with potential future collaborators;

•

successfully establishing and maintaining commercial manufacturing and supply chain relationships with domestic and global third-party service providers, including single sources of supply for Niyad active pharmaceutical ingredients and finished goods located outside the U.S.;

•

our ability to manage effectively, and the impact of any costs associated with, potential governmental investigations, inquiries, regulatory actions or lawsuits that may be, or have been, brought against us;

•

our ability to obtain adequate government or third-party payer reimbursement for our developmental product candidates, if approved;

•

our ability to gain access to formularies and establish and then maintain effective relationships with pharmaceutical benefit managers and/or group purchasing organizations for our developmental product candidates, if approved;

•

our ability to attract additional collaborators with development, regulatory and commercialization expertise;

•

our ability to identify and secure potential strategic partners to develop, secure regulatory approval for and then commercialize our developmental product candidates;

•

our ability to successfully retain our key commercial, scientific, engineering, medical or management personnel and hire new personnel as needed;

•

existing and future legislation and other regulatory developments in the United States and foreign countries;

•

the performance of our third-party suppliers and manufacturers, including any supply chain impacts or work limitations;

•

the success of competing therapies that are or become available; and

•

our ability to obtain and maintain intellectual property protection for our approved products and product candidates.

In addition, you should refer to “Part II. Other Information - Item 1A. Risk Factors” in this Form 10-Q for a discussion of these and other important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Also, forward-looking statements represent our estimates and assumptions only as of the date of this Form 10-Q. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Talphera, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share and per share data)

	June 30, 2026			December 31, 2025⁽¹⁾
Assets
Current Assets:
Cash and cash equivalents	$	742		$	5,894
Short-term investments		16,334			14,487
Prepaid expenses and other current assets		911			519
Total current assets		17,987			20,900
In-process research and development asset		8,819			8,819
Total assets	$	26,806		$	29,719

Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable	$	387		$	544
Accrued and other liabilities		3,151			2,615
Liabilities of discontinued operations		650			650
Total current liabilities		4,188			3,809
Warrant liability		1,713			2,376
Liability related to the sale of future payments		6,499			6,499
Total liabilities		12,400			12,684

Commitments and Contingencies (Note 5)
Stockholders’ Equity:
Common stock, $0.001 par value—200,000,000 shares authorized as of June 30, 2026 and December 31, 2025; 51,905,796 and 49,328,097 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively		52			49
Additional paid-in capital		492,742			488,506
Accumulated deficit		(478,388	)		(471,520	)
Total stockholders’ equity		14,406			17,035
Total Liabilities and Stockholders’ Equity	$	26,806		$	29,719

(1)	The condensed consolidated balance sheet as of December 31, 2025 has been 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.

See notes to unaudited condensed consolidated financial statements.

Talphera, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

	Three Months Ended June 30,						Six Months Ended June 30,
	2026			2025			2026			2025
Revenue	$	—		$	—		$	—		$	27
Operating costs and expenses:
Research and development		1,690			1,500			3,340			2,669
Selling, general and administrative		2,234			2,193			4,532			3,967
Total operating costs and expenses		3,924			3,693			7,872			6,636
Loss from operations		(3,924	)		(3,693	)		(7,872	)		(6,609	)
Other (expense) income, net:
Interest income and other income, net		172			83			341			152
(Loss) gain on change in fair value of warrant liability		(560	)		121			663			302
Total other (expense) income, net		(388	)		204			1,004			454
Net loss from continuing operations		(4,312	)		(3,489	)		(6,868	)		(6,155	)
Net income from discontinued operations – See Note 3		—			—			—			73
Net loss	$	(4,312	)	$	(3,489	)	$	(6,868	)	$	(6,082	)
Net loss per share attributable to stockholders:
Basic and diluted, continuing operations	$	(0.06	)	$	(0.10	)	$	(0.09	)	$	(0.20	)
Basic and diluted, discontinued operations	$	0.00		$	0.00		$	0.00		$	0.00
``Basic and diluted loss per share	$	(0.06	)	$	(0.10	)	$	(0.09	)	$	(0.20	)
Shares used in computing net loss per share of common stock, basic and diluted – See Note 9		75,526,900			34,530,377			72,690,007			30,422,117

See notes to unaudited condensed consolidated financial statements.

Talphera, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share data)

	Common Stock				Additional Paid-in Capital			Accumulated Deficit			Total Stockholders’ Equity
	Shares		Amount
Balance as of January 1, 2026		49,328,097	$	49	$	488,506		$	(471,520	)	$	17,035
Stock-based compensation		—		—		214			—			214
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes		35,004		—		(16	)		—			(16	)
Net proceeds from issuance of common stock and pre-funded warrants in connection with private placement offerings		639,931		1		3,779			—			3,780
Issuance of common stock upon ESPP purchase		46,792		—		21			—			21
Net loss		—		—		—			(2,556	)		(2,556	)
Balance as of March 31, 2026		50,049,824	$	50	$	492,504		$	(474,076	)	$	18,478
Stock-based compensation		—		—		243			—			243
Issuance of common stock upon vesting of restricted stock units		30,494		—		(16	)		—			(16	)
Net proceeds from issuance of common stock and pre-funded warrants in connection with private placement offerings		—		—		13			—			13
Issuance of common stock upon cashless exercise of pre-funded warrants		1,825,478		2		(2	)		—			—
Net loss		—		—		—			(4,312	)		(4,312	)
Balance as of June 30, 2026		51,905,796	$	52	$	492,742		$	(478,388	)	$	14,406

	Common Stock				Additional Paid-in Capital			Accumulated Deficit			Total Stockholders’ Equity
	Shares		Amount
Balance as of January 1, 2025		17,029,469	$	17	$	465,214		$	(457,230	)	$	8,001
Stock-based compensation		—		—		196			—			196
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes		42,523		—		(18	)		—			(18	)
Issuance of common stock upon ESPP purchase		26,353		—		13			—			13
Net loss		—		—		—			(2,593	)		(2,593	)
Balance as of March 31, 2025		17,098,345		17		465,405			(459,823	)		5,599
Stock-based compensation		—		—		166			—			166
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes		19,192		—		(3	)		—			(3	)
Net proceeds from issuance of common stock and pre-funded warrants in connection with equity financing		3,405,118		3		4,351			—			4,354
Net loss		—		—		—			(3,489	)		(3,489	)
Balance as of June 30, 2025		20,522,655	$	20	$	469,919		$	(463,312	)	$	6,627

See notes to unaudited condensed consolidated financial statements.

Talphera, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

	Six Months Ended June 30,
	2026			2025
Cash flows from operating activities:
Net loss	$	(6,868	)	$	(6,082	)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash revenue related to the sale of future payments		—			(27	)
Net amortization of discount on short-term investments		(237	)		—
Stock-based compensation		457			362
Gain on change in fair value of warrant liability		(663	)		(302	)
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(392	)		(352	)
Accounts payable		(156	)		165
Accrued liabilities		535			(182	)
Net cash used in operating activities		(7,324	)		(6,418	)
Cash flows from investing activities:
Purchase of investments		(17,239	)