acrx20240331

acrx20240331_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 March 31, 2024

☐	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 Global 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 May 7, 2024, the number of outstanding shares of the registrant’s common stock was 16,992,977.

TALPHERA, INC.

QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2024

TABLE OF CONTENTS

		Page
PART I. FINANCIAL INFORMATION		5

Item 1.	Financial Statements	5

	Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023 (unaudited)	5

	Condensed Consolidated Statements of Operations for the three months ended March 31, 2024 and 2023 (unaudited)	6

	Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2024 and 2023 (unaudited)	7

	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023 (unaudited)	8

	Notes to Condensed Consolidated Financial Statements (unaudited)	9

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	29

Item 4.	Controls and Procedures	29

PART II. OTHER INFORMATION		29

Item 1.	Legal Proceedings	29

Item 1A.	Risk Factors	30

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	55

Item 3.	Defaults Upon Senior Securities	55

Item 4.	Mine Safety Disclosures	55

Item 5.	Other Information	55

Item 6.	Exhibits	56

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;

•

our ability to maintain listing of our securities trading on the Nasdaq exchange;

•

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

•

macroeconomic uncertainties, including 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 success of our corporate partner, Vertical Pharmaceuticals LLC, a wholly owned subsidiary of Alora Pharmaceuticals, LLC, or Alora, in integrating and commercializing the DSUVIA asset in the United States, including their effectiveness in marketing, sales, and distribution of the DSUVIA product, itself or with potential collaborators;

•

the extent of future sales of DSUVIA by Alora to the Department of Defense, or DoD;

•

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)

	March 31, 2024			December 31, 2023⁽¹⁾
Assets
Current Assets:
Cash and cash equivalents	$	12,122		$	5,721
Short-term investments		6,462			3,660
Prepaid expenses and other current assets		1,369			2,195
Total current assets		19,953			11,576
In-process research and development asset		8,819			8,819
Total assets	$	28,772		$	20,395
Liabilities and Stockholders' Equity
Current Liabilities:
Accounts payable	$	1,274		$	1,336
Accrued and other liabilities		1,340			2,445
Liabilities of discontinued operations, current portion		730			731
Total current liabilities		3,344			4,512
Warrant liability		2,780			1,778
Liability related to the sale of future payments		6,314			—
Total liabilities		12,438			6,290
Commitments and Contingencies
Stockholders’ Equity:
Common stock, $0.001 par value—200,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 16,992,726 and 16,952,219 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively		17			17
Additional paid-in capital		464,497			458,314
Accumulated deficit		(448,180	)		(444,226	)
Total stockholders’ equity		16,334			14,105
Total Liabilities and Stockholders’ Equity	$	28,772		$	20,395

(1)	The condensed consolidated balance sheet as of December 31, 2023 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, 2023.

See notes to condensed consolidated financial statements.

Talphera, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

	Three Months Ended March 31,
	2024			2023

Operating costs and expenses:
Research and development	$	1,433		$	1,047
Selling, general and administrative		2,804			4,281
Total operating costs and expenses		4,237			5,328
Loss from operations		(4,237	)		(5,328	)
Other income (expense), net:
Interest expense		—			(119	)
Interest income and other income, net		220			200
Gain on sale of future payments		1,246			—
Change in fair value of warrant liability		(1,002	)		5,311
Non-cash interest expense on liability related to sale of future payments		(181	)		—
Total other income (expense), net		283			5,392
Net (loss) income from continuing operations		(3,954	)		64
Net loss from discontinued operations– See Note 3		—			(8,216	)
Net loss	$	(3,954	)	$	(8,152	)
Net (loss) income per share attributable to stockholders:
Basic and diluted, continuing operations	$	(0.16	)	$	0.00
Basic and diluted, discontinued operations	$	0.00		$	(0.75	)
Basic and diluted loss per share	$	(0.16	)	$	(0.75	)
Shares used in computing net loss per share of common stock, basic and diluted – See Note 10		24,721,964			10,893,954

See notes to 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, 2024		16,952,519	$	17	$	458,314		$	(444,226	)	$	14,105
Stock-based compensation		—		—		302			—			302
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes		23,952		—		(17	)		—			(17	)
Net proceeds from issuance of pre-funded warrants in connection with equity financing		—		—		5,884			—			5,884
Issuance of common stock upon ESPP purchase		16,255		—		14			—			14
Net loss		—		—		—			(3,954	)		(3,954	)
Balance as of March 31, 2024		16,992,726	$	17	$	464,497		$	(448,180	)	$	16,334

	Common Stock				Additional Paid-in Capital			Accumulated Deficit			Total Stockholders’ Equity
	Shares		Amount
Balance as of January 1, 2023		8,243,680	$	8	$	447,635		$	(425,829	)	$	21,814
Stock-based compensation		—		—		569			—			569
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes		21,700		—		(22	)		—			(22	)
Exercise of prefunded warrants		2,632,898		2		—			—			2
Issuance of common stock upon ESPP purchase		26,016		1		30			—			31
Net loss		—		—		—			(8,152	)		(8,152	)
Balance as of March 31, 2023		10,924,294	$	11	$	448,212		$	(433,981	)	$	14,242

See notes to condensed consolidated financial statements.

Talphera, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

	Three Months Ended March 31,
	2024			2023
Cash flows from operating activities:
Net loss	$	(3,954	)	$	(8,152	)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash interest expense on liability related to sale of future payments		181			—
Depreciation and amortization		—			262
Non-cash interest expense related to debt financing		—			38
Stock-based compensation		302			569
Revaluation of warrant liability		1,002			(5,311	)
Impairment of net assets held for sale		—			7,007
Impairment of fixed assets		—			1,065
Gain on termination of lease liabilities		—			(1,098	)
Gain on extinguishment of debt liability