Neuphoria Provides Fiscal Year-End 2025 Financial Results and Business Updates

Rhea-AI Summary

Neuphoria Therapeutics (NASDAQ:NEUP), a clinical-stage biotech company, has announced its fiscal year 2025 financial results and provided significant clinical updates. The company has achieved the Last Patient Last Visit (LPLV) milestone in its AFFIRM-1 Phase 3 trial of BNC-210 for social anxiety disorder (SAD), with topline data expected in early Q4 2025.

Financial highlights include a cash position of $14.2 million as of June 30, 2025, extending runway through Q2 2027. The company reported reduced R&D expenses of $9.0 million (down from $9.4M) and G&A expenses of $7.8 million (down from $8.5M). Net loss significantly improved to $0.4 million ($0.23 per share) compared to $15.5 million ($18.62 per share) in the previous year.

Positive

• Significant reduction in net loss to $0.4M from $15.5M year-over-year
• Cash runway extended through Q2 2027
• Achievement of LPLV milestone in Phase 3 AFFIRM-1 trial
• Reduced operating expenses in both R&D and G&A categories

Negative

• Relatively low cash position of $14.2M for a clinical-stage biotech company
• Delayed initiation of SYMPHONY Phase 2b/3 trial to first half of 2026

Insights

Biotech Investment Analyst

Neuphoria's lower net loss, extended cash runway, and imminent Phase 3 results position it favorably despite still being pre-revenue.

Neuphoria's financial performance shows marked improvement with net losses shrinking dramatically from $15.5 million to just $0.4 million year-over-year, though we aren't provided with an explanation for this substantial improvement. The company has effectively managed its burn rate, with R&D expenses decreasing by $0.4 million and G&A expenses down by $0.7 million through operational efficiencies in headcount and insurance costs.

The company's $14.2 million cash position with runway extended through Q2 2027 (approximately 21 months) is strategically significant as it provides sufficient capital to navigate through the critical upcoming milestones - particularly the topline readout of their BNC-210 Phase 3 SAD trial expected in early Q4 2025. This timing alignment of cash runway with clinical milestones is crucial for clinical-stage biotechs.

The imminent Phase 3 data readout represents a potential major inflection point, with BNC-210 positioned as a first-in-class, acute, "as needed" treatment for social anxiety disorder. The management's reference to "clinically meaningful effects across multiple stress and anxiety indications" suggests confidence in the upcoming results. Additionally, their partnership with Merck on MK-1167 for Alzheimer's provides pipeline diversification and validation from a major pharmaceutical player.

From a development timeline perspective, Neuphoria appears to be maintaining progress with its PTSD program, with the SYMPHONY Phase 2b/3 trial initiation planned for H1 2026, demonstrating pipeline advancement beyond their lead program.

Last patient last visit (LPLV) milestone in AFFIRM-1 Phase 3 trial of BNC-210 in social anxiety disorder (SAD) achieved; topline readout anticipated in early Q4 2025

Cash runway extended through fiscal Q2 2027

BURLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today reported its financial results for its fiscal year ended June 30, 2025, and provided recent business updates.

“It is an exciting time for Neuphoria as we rapidly approach topline data from our AFFIRM-1 Phase 3 study of BNC-210 in social anxiety disorder, which is anticipated early in the fourth quarter of this year,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Neuphoria. “BNC-210 is supported by a robust body of clinical data, demonstrating clinically meaningful effects across multiple stress and anxiety indications. These data, along with its differentiated safety profile, give us confidence in BNC-210 as a potentially transformative treatment for patients struggling with SAD.”

Clinical Program Highlights

• The LPLV milestone has been achieved in the AFFIRM-1 Phase 3 trial evaluating BNC-210 as a first-in-class, acute, “as needed” treatment for SAD. Topline data are anticipated in early fourth quarter 2025.
• Start-up activities continue for the SYMPHONY Phase 2b/3 trial in PTSD. Neuphoria plans to initiate the clinical study in the first half of 2026.
• MK-1167, one of two positive allosteric modulator (PAM) candidates being advanced in a strategic partnership with Merck & Co, Inc., is currently being evaluated in a Merck-led Phase 2 trial in Alzheimer’s disease.
  

June 30^th Fiscal Year-End 2025 Financial Results and Key Highlights

Cash Position: Cash and cash equivalents were $14.2 million as of June 30, 2025. The Company expects its current cash position to be sufficient to fund operations through the second fiscal quarter of 2027.

R&D Expenses: Research and development expenses were $9.0 million for the year ended June 30, 2025, compared to $9.4 million for the year ended June 30, 2024. The decrease of $0.4 million was primarily due to the timing of clinical and consulting related spend.

G&A Expenses: General and administrative expenses were $7.8 million for the year ended June 30, 2025, compared to $8.5 million for the year ended June 30, 2024. The decrease of $0.7 million was primarily due to decreases in headcount and insurance costs.

Net Loss: Net loss was $0.4 million, or $0.23 per basic and diluted share, for the year ended June 30, 2025, compared to a net loss of $15.5 million, or $18.62 per basic and diluted share, for the year ended June 30, 2024.

About BNC-210

BNC-210 is an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor under development for the treatment of SAD and post-traumatic stress disorder (PTSD). BNC-210 has been given FDA Fast Track designation for acute treatment of SAD and other anxiety related disorders, and for treatment of PTSD and other trauma and stressor related disorders. BNC-210 has demonstrated rapid-onset, broad and meaningful anti-anxiety effects in completed clinical trials in SAD, generalized anxiety disorder (GAD) and panic attacks without evidence of sedation, impairments in cognition or addiction potential.

About Neuphoria Therapeutics Inc.

Neuphoria (Nasdaq: NEUP) is a clinical-stage biotechnology company dedicated to developing therapies that address the complex needs of individuals affected by neuropsychiatric disorders. Neuphoria is advancing its lead drug candidate, BNC-210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute, “as needed” treatment of social anxiety disorder (SAD) and for chronic treatment of post-traumatic stress disorder (PTSD). BNC-210 is a first-of-its-kind, well-tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction. In addition, Neuphoria has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Neuphoria's pipeline also includes the α7 nicotinic acetylcholine receptor next generation and the Kv3.1/3.2 preclinical programs, both in the lead optimization development stage.

Forward-Looking Statements

Neuphoria cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs, plans, burn rate and expectations. Certain forward-looking statements, including (without limitation) about (1) Neuphoria’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement and/or completion, as well as any successful or other outcome of various clinical trials, and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, and the Company's ability to realize the commercial potential of its products, as well as its regulatory strategy related to its clinical trials and, if successful, the regulatory pathway to any next stage in development or commercialization, (3) Neuphoria’s financial resources, and capital allocation and corporate development strategy, and (4) assumptions underlying any such statements. The inclusion of forward-looking statements should not be regarded as a representation by Neuphoria that any of its plans will be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. Certain forward-looking statements involve contracts, licenses and arrangements involving third parties and their respective clinical trial and research and development projects that are out of our control, including our agreements with Merck and Carina. They may terminate or delay any or all such projects in their discretion pursuant to the terms of our agreements with them, which could result in the Company not realizing any further milestone payments or further progress on the respective product pathways. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q, Current Reports on Form 8-K, each filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Neuphoria undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Neuphoria’s filings with the SEC, copies of which are available from the SEC’s website (www.sec.gov) and on Neuphoria’s website (www.neuphoriatx.com) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Neuphoria expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

FOR FURTHER INFORMATION PLEASE CONTACT:

General Spyridon (Spyros) Papapetropoulos info@neuphoriatx.com

IR & PR Argot Partners neuphoria@argotpartners.com

Consolidated Balance Sheet (unaudited)
	June 30,				June 30,
		2025				2024
Assets
Current assets:
Cash and cash equivalents	$	14,210,745			$	12,608,109
Accounts receivable, non-trade		11,948				126,884
Restricted cash		77,945				—
Prepaid expenses		740,193				458,765
Total current assets		15,040,831				13,193,758
Property and equipment, net		2,771				1,994
Intangible assets, net		4,804,791				5,467,522
Operating lease right-of-use assets		102,612				216,975
Restricted cash		—				78,826
Goodwill		8,638,609				8,690,018
Total assets	$	28,589,614			$	27,649,093
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable	$	1,154,369			$	2,243,662
Accrued expenses and other current liabilities		2,950,077				1,463,421
Operating lease liability		116,314				121,990
Total current liabilities		4,220,760				3,829,073
Operating lease liability, net of current portion		—				117,628
Contingent consideration		1,169,675				587,762
Deferred tax liability		495,113				963,540
Accompanying warrant liability		3,701,492				4,657,832
Other non-current liabilities		—				2,886
Total liabilities		9,587,040				10,158,721
Commitments and contingencies
Shareholders’ equity:
Common stock, $0.00001 par value, 1,978,460 and 1,103,954 shares issued and outstanding at June 30, 2025 and 2024, respectively		19				11
Additional paid-in capital, net of subscription receivable		200,194,324				198,481,027
Accumulated other comprehensive loss, net of tax		(2,845,066	)			(3,013,595	)
Accumulated deficit		(178,346,703	)			(177,977,071	)
Total shareholders’ equity		19,002,574				17,490,372
Total liabilities and shareholders’ equity	$	28,589,614			$	27,649,093

Consolidated Statement of Operations (unaudited)
	Year Ended June 30,
		2025				2024
License revenue	$	15,649,448			$	-
Operating expenses:
Research and development		9,005,097				9,417,785
General and administrative		7,773,442				8,474,591
Total operating expenses		16,778,539				17,892,376
Loss from operations		(1,129,091	)			(17,892,376	)
Other income (loss):
Interest income, net		166,498				220,097
Loss on foreign currency transactions		(414,996	)			(209,842	)
Research and development incentive award		299,905				95,215
Gain on fair value adjustments		239,686				2,207,420
Total other income		291,093				2,312,890
Loss before income tax benefit		(837,998	)			(15,579,486	)
Income tax benefit		468,366				87,320
Net loss		(369,632	)			(15,492,166	)
Other comprehensive income:
Unrealized gain on foreign currency translation		168,529				45,188
Total other comprehensive income		168,529				45,188
Total comprehensive loss	$	(201,103	)		$	(15,446,978	)
Net loss per share - basic and diluted	$	(0.23	)		$	(18.62	)
Weighted-average common shares outstanding - basic and diluted		1,622,924				832,225

Consolidated Statement of Cash Flows (unaudited)
	Year Ended June 30,
		2025				2024
Cash flows from operating activities:
Net loss	$	(369,632	)		$	(15,492,166	)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation		163,772				814,808
Depreciation and amortization expense		662,890				662,991
Non-cash rent expense		114,363				113,503
Change in fair value of accompanying warrant liability		(956,340	)			(338,983	)
Change in fair value of contingent consideration		716,654				(1,868,437	)
Effect of foreign currency remeasurement		242,348				(27,350	)
Changes in assets and liabilities:
Accounts receivable, non-trade		114,936				299,203
Prepaid expenses		(453,058	)			338,713
Accounts payable		(917,663	)			804,371
Accrued expenses and other current liabilities		1,486,656				277,854
Operating lease liabilities		(123,304	)			(114,147	)
Deferred tax liability		(468,427	)			(139,173	)
Contingent consideration		(133,080	)			-
Other non-current liabilities		(2,886	)			(11,964	)
Net cash provided by (used in) operating activities		77,229				(14,680,777	)
Cash flows from financing activities:
Proceeds from the sale of equity, net of subscriptions receivable of $0.1 million and issuance costs of $0.1 million		1,528,276				-
Proceeds from the sale of equity, net of issuance costs of $1.3 million		-				10,111,979
Proceeds from the sale of accompanying warrant		-				4,996,815
Net cash provided by financing activities		1,528,276				15,108,794
Effect of exchange rate on changes on cash, cash equivalents, and restricted cash		(3,750	)			76,974
Net increase in cash, cash equivalents, and restricted cash		1,601,755				504,991
Cash, cash equivalents, and restricted cash, beginning of period		12,686,935				12,181,944
Cash, cash equivalents, and restricted cash, end of period	$	14,288,690			$	12,686,935

FAQ

What are the key financial results for Neuphoria (NEUP) in fiscal year 2025?

Neuphoria reported cash and equivalents of $14.2M, R&D expenses of $9.0M (down from $9.4M), G&A expenses of $7.8M (down from $8.5M), and a significantly reduced net loss of $0.4M ($0.23 per share) compared to $15.5M in FY2024.

When will Neuphoria (NEUP) release topline data for the AFFIRM-1 Phase 3 trial?

Neuphoria expects to release topline data from the AFFIRM-1 Phase 3 trial in early Q4 2025, following the achievement of the Last Patient Last Visit milestone.

What is BNC-210 being developed for by Neuphoria (NEUP)?

BNC-210 is being developed as a first-in-class, acute, 'as needed' treatment for social anxiety disorder (SAD), with clinical data showing meaningful effects across multiple stress and anxiety indications.

How long will Neuphoria's (NEUP) current cash position last?

Neuphoria's current cash position of $14.2M is expected to be sufficient to fund operations through the second fiscal quarter of 2027.

What is the status of Neuphoria's (NEUP) partnership with Merck?

Neuphoria's partnership with Merck includes MK-1167, one of two PAM candidates, which is currently being evaluated in a Merck-led Phase 2 trial for Alzheimer's disease.