Tag: GlobeNewswire

RESTON, Va., Nov. 02, 2026 (GLOBE NEWSWIRE) — Lightbridge Corporation (“Lightbridge” or the “Company”) (Nasdaq: LTBR), a nuclear fuel technology company developing Lightbridge Fuel™ to produce more power from existing and new reactors, today reported financial results for the third quarter and nine months ended September 30, 2026, and provided an update on its fuel development activities.

Third Quarter 2026 and Recent Business Highlights

• Lightbridge was selected for the DOE Nuclear Energy Launch Pad INL program. In August 2026, Lightbridge was selected to participate in the program, which is administered by DOE’s National Reactor Innovation Center (NRIC) at Idaho National Laboratory (INL). Selection provides an accelerated pathway toward DOE authorization for the Company to design, build, and operate the Lightbridge Fuel™ Pilot Factory (Pilot Factory), which the Company also refers to as SHED, at INL to manufacture lead test assemblies (LTAs) of Lightbridge Fuel™ for demonstration in U.S. commercial power reactors. The Company is negotiating the applicable agreements and project scope with NRIC and INL. Authorization to construct and operate the Pilot Factory remains subject to additional DOE/INL agreements, reviews, and authorizations.
• Secured loop irradiation testing of clad fuel rodlets in the Advanced Test Reactor (ATR). In August 2026, the Company entered into Project Task Statement (PTS) No. 2 under its Cooperative Research and Development Agreement (CRADA) with Battelle Energy Alliance, LLC (BEA), the DOE operating contractor for INL. The work covers experimental design, materials, assembly, irradiation, shipment, and disposition of enriched uranium-zirconium fuel rodlets with cladding, in both cylindrical and multi-lobe geometries, irradiated in the ATR loop facility under controlled conditions representative of a commercial reactor.
• Post-irradiation examination of the first fuel samples is currently underway. The first batch of Lightbridge Fuel™ material coupon samples, discharged from the ATR on schedule in May 2026, is currently undergoing post-irradiation examination at INL.
• Expanded patent protection in Japan. In September 2026, the Japan Patent Office issued a notice of allowance for the Company’s multi-zone fuel element patent application, with allowed claims covering the fuel element design, a fuel assembly containing it, and an additive manufacturing method for producing it. Japan operates 32 reactors, 15 of which have returned to service, and its national energy plan targets nuclear at approximately 20% of electricity generation by fiscal 2040.

Management Commentary

“Selection for the Launch Pad INL program can help to accelerate our commercialization plan,” said Seth Grae, Chairman and Chief Executive Officer of Lightbridge. “Rather than waiting for a commercial fuel factory to be licensed before we could manufacture lead test assemblies, we now have a pathway toward DOE authorization for a dedicated Pilot Factory at INL, and we are negotiating the agreements and project scope with NRIC and INL. In parallel, the loop irradiation agreement we signed in August will enable irradiation testing of the clad Lightbridge Fuel rodlets in the ATR under the conditions similar to those in commercial pressurized water reactors. We believe the loop irradiation will allow us to go from the ATR directly to lead test assemblies in commercial nuclear power plants, rather than first deploying segments of fuel rods and lead test rods in commercial reactors.”

“Our path to acceleration comes at a pivotal moment for the nuclear sector, as major technology companies and utilities increasingly turn to nuclear energy to meet surging baseload power demand from AI, data centers, and industrial electrification. This requires getting substantially more power and higher capacity factors out of the existing nuclear fleet, alongside new builds. Utilities consistently tell us they want three things from an advanced fuel: longer operating cycles between refuelings, power uprates of 10% to 20% from the same plant footprint and operating license, and inherent safety margins that reduce capital and operating costs. Lightbridge Fuel is engineered specifically to meet those requirements.”

Financial Highlights

Working capital was approximately $234.2 million at September 30, 2026, compared to approximately $201.7 million at December 31, 2025.

Cash Flows Summary

Cash and cash equivalents totaled $236.7 million at September 30, 2026, compared to $201.9 million at December 31, 2025, an increase of $34.8 million. Cash equivalents consisted primarily of U.S. Treasury instruments with maturities of 30 to 90 days.

• Net cash used in operating activities was $13.2 million for the nine months ended September 30, 2026, compared to $8.1 million for the nine months ended September 30, 2025, reflecting higher research and development (R&D) and general and administrative (G&A) spending, partially offset by higher interest income.
• Net cash provided by financing activities was $48.1 million for the nine months ended September 30, 2026, compared to $121.4 million for the same period in 2025. The Company sold approximately 4.3 million shares of common stock under its at-the-market (ATM) program during the nine months ended September 30, 2026, for net proceeds of $48.9 million, including 579,685 shares for net proceeds of $4.5 million in the third quarter. As of September 30, 2026, approximately $91.4 million of common stock remained available for sale under the Company’s $150 million ATM program.

Third Quarter 2026 Operations Summary

• G&A expenses were $5.0 million for the three months ended September 30, 2026, compared to $3.2 million for the three months ended September 30, 2025. The $1.8 million increase reflects a $0.9 million increase in employee compensation and stock-based compensation for employees, contractors, and directors, driven by new hires, higher bonuses, and new stock-based awards; a $0.7 million increase in professional and consulting services; and a $0.2 million increase in other administrative expenses, including information technology, insurance, patent, and travel costs.
• R&D expenses were $5.3 million for the three months ended September 30, 2026, compared to $2.0 million for the three months ended September 30, 2025. The $3.3 million increase reflects a $1.9 million increase in employee compensation and stock-based compensation from new hires, higher bonuses, and new stock-based awards; a $1.0 million increase in information technology expenses, primarily computer software and operating costs for the Company’s high-performance computer; and a $0.4 million increase in INL project costs as the Company entered into additional agreement modifications and new PTSs.
• Total non-cash stock-based compensation expense was $2.4 million for the three months ended September 30, 2026, compared to $1.6 million for the three months ended September 30, 2025. Stock-based compensation included in G&A was $1.6 million, compared to $1.1 million in the prior-year quarter. Stock-based compensation included in R&D was $0.8 million, compared to $0.5 million in the prior-year quarter.
• Other income was $2.0 million for the three months ended September 30, 2026, compared to $1.1 million for the three months ended September 30, 2025, consisting of interest income earned on higher cash balances invested primarily in U.S. Treasury bills.
• Net loss was $8.3 million, or $(0.23) per basic and diluted share, for the three months ended September 30, 2026, compared to a net loss of $4.1 million, or $(0.16) per basic and diluted share, for the three months ended September 30, 2025.

Nine Months Ended September 30, 2026 Operations Summary

G&A expenses were $13.0 million for the nine months ended September 30, 2026, compared to $9.2 million for the nine months ended September 30, 2025. The $3.8 million increase reflects a $2.4 million increase in employee compensation and stock-based compensation, a $1.0 million increase in professional and consulting services, and a $0.4 million increase in other administrative expenses.

• R&D expenses were $12.6 million for the nine months ended September 30, 2026, compared to $5.3 million for the nine months ended September 30, 2025. The $7.3 million increase reflects a $4.3 million increase in employee compensation and stock-based compensation; a $1.7 million increase in information technology expenses, including software, operating costs for the Company’s high-performance computer, and code development; a $0.6 million increase in INL project costs; a $0.4 million increase in project development costs, primarily critical heat flux testing and safety analysis; and a $0.3 million increase in other outside R&D expenses.
• Total non-cash stock-based compensation expense was $6.3 million for the nine months ended September 30, 2026, compared to $3.6 million for the nine months ended September 30, 2025. Stock-based compensation included in G&A was $4.4 million, compared to $2.7 million in the prior period. Stock-based compensation included in R&D was $1.9 million, compared to $0.9 million in the prior period. The 2026 total stock-based compensation expense included a $0.7 million reversal recorded in the second quarter of previously recognized stock-based compensation for a performance milestone no longer deemed probable of achievement, of which $0.5 million was included in G&A and $0.2 million was included in R&D.
• Other income was $5.2 million for the nine months ended September 30, 2026, compared to $2.1 million for the nine months ended September 30, 2025.
• Net loss was $20.4 million, or $(0.62) per basic and diluted share, for the nine months ended September 30, 2026, compared to a net loss of $12.4 million, or $(0.55) per basic and diluted share, for the nine months ended September 30, 2025.

CONFERENCE CALL & AUDIO WEBCAST

Lightbridge will hold a conference call and audio webcast today, Monday, November 2, 2026, at 4:00 p.m. Eastern Time to discuss its third quarter fiscal 2026 financial results and provide an update on its fuel development activities. Seth Grae, Chairman and Chief Executive Officer, will lead the call, and other members of the executive team will be available to answer questions.

To access the call by phone, please dial 1-800-715-9871 (International dialers can dial 1-646-307-1963) with Conference ID 8688160. To avoid delays, we encourage participants to dial in to the conference call 15 minutes before the scheduled start time and have the Conference ID handy.

An audio webcast can be accessed at the following link (webcast). The Company encourages participants to take advantage of the webcast option.

A webcast replay will also be available for a limited time at the following link (webcast replay).

About Lightbridge Corporation 
Lightbridge Corporation (Nasdaq: LTBR) is focused on developing advanced nuclear fuel technology essential to delivering abundant clean energy and providing energy security to the world. The Company is developing Lightbridge Fuel™, a proprietary next-generation nuclear fuel technology for existing light water reactors and pressurized heavy water reactors, significantly enhancing reactor safety, economics, and proliferation resistance. The Company is also developing Lightbridge Fuel for new small modular reactors to deliver the same benefits, plus load-following.

Lightbridge has entered into two long-term framework agreements with Battelle Energy Alliance, LLC, the United States Department of Energy’s operating contractor for Idaho National Laboratory, the United States’ lead nuclear energy research and development laboratory. DOE’s Gateway for Accelerated Innovation in Nuclear program has twice awarded Lightbridge to support the development of Lightbridge Fuel over the past several years. An extensive worldwide patent portfolio backs Lightbridge’s innovative fuel technology. Lightbridge is included in the Russell 2000®, Russell 3000®, and Solactive Global Uranium and Nuclear Components Total Return Indexes. For more information, please visit www.ltbridge.com.

To receive Lightbridge Corporation updates via e-mail, subscribe at https://www.ltbridge.com/investors/news-events/email-alerts  

Lightbridge is on YouTube. Subscribe to access past demonstrations, interviews, and other video content at https://www.youtube.com/@lightbridgecorporation

Lightbridge is on X (formerly Twitter). Sign up to follow @LightbridgeCorp at http://twitter.com/lightbridgecorp. 

Forward Looking Statements 

With the exception of historical matters, the matters discussed herein are forward-looking statements. These statements are based on current expectations on the date of this news release and involve a number of risks and uncertainties that may cause actual results to differ significantly from such estimates. The risks include, but are not limited to: Lightbridge’s ability to commercialize its nuclear fuel technology; the degree of market adoption of Lightbridge’s product and service offerings; Lightbridge’s ability to fund general corporate overhead and outside research and development costs; market competition; our ability to attract and retain qualified employees; dependence on strategic partners; demand for fuel for nuclear reactors; Lightbridge’s ability to manage its business effectively in a rapidly evolving market; the availability of nuclear test reactors and the risks associated with unexpected changes in Lightbridge’s fuel development timeline; the increased costs associated with metallization of Lightbridge’s nuclear fuel; public perception of nuclear energy generally; changes in the political environment; risks associated with war in Europe and the Middle East; changes in the laws, rules and regulations governing Lightbridge’s business; development and utilization of, and challenges to, Lightbridge’s intellectual property; risks associated with potential shareholder activism; potential and contingent liabilities; as well as other factors described in Lightbridge’s filings with the Securities and Exchange Commission (the “SEC”). Lightbridge does not assume any obligation to update or revise any such forward-looking statements, whether as the result of new developments or otherwise, except as required by law. Readers are cautioned not to put undue reliance on forward-looking statements.

A further description of risks and uncertainties can be found in Lightbridge’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its other filings with the SEC, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Statements,” all of which are available at http://www.sec.gov/ and www.ltbridge.com.  

Investor Relations Contact: 
Matthew Abenante, IRC 
Senior Director of Investor Relations & Capital Markets  
Tel: +1 (347) 947-2093  
ir@ltbridge.com

*** tables follow ***

LIGHTBRIDGE CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

	September 30,				December 31,
	2026				2025
ASSETS
Current Assets
Cash and cash equivalents	$	236,735,081			$	201,862,421
Prepaid expenses and other current assets		1,274,477				712,983
Total Current Assets		238,009,558				202,575,404
Other Assets
Prepaid project costs and other long-term assets		2,755,892				1,140,000
Trademarks		127,187				119,391
Total Assets	$	240,892,637			$	203,834,795
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable and accrued liabilities	$	3,830,512			$	847,451
Total Current Liabilities		3,830,512				847,451
Stockholders’ Equity
Preferred stock, $0.001 par value, 10,000,000 authorized shares, no shares issued and outstanding at September 30, 2026 and December 31, 2025		—				—
Common stock, $0.001 par value, 100,000,000 authorized shares, 38,761,010 shares and 33,407,495 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively		38,761				33,407
Additional paid-in capital		441,219,021				386,719,120
Accumulated deficit		(204,195,657	)			(183,765,183	)
Total Stockholders’ Equity		237,062,125				202,987,344
Total Liabilities and Stockholders’ Equity	$	240,892,637			$	203,834,795

LIGHTBRIDGE CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

	Three Months Ended								Nine Months Ended
	September 30,								September 30,
	2026				2025				2026				2025
Revenue	$	—			$	—			$	—			$	—
Operating Expenses
General and administrative		5,039,852				3,164,343				13,084,565				9,146,989
Research and development		5,300,753				2,039,857				12,556,332				5,345,635
Total Operating Expenses		10,340,605				5,204,200				25,640,897				14,492,624
Operating Loss		(10,340,605	)			(5,204,200	)			(25,640,897	)			(14,492,624	)
Other Income
Interest income		2,009,488				1,104,955				5,210,423				2,101,933
Total Other Income		2,009,488				1,104,955				5,210,423				2,101,933
Net Loss Before Income Taxes		(8,331,117	)			(4,099,245	)			(20,430,474	)			(12,390,691	)
Income taxes		—				—				—				—
Net Loss	$	(8,331,117	)		$	(4,099,245	)		$	(20,430,474	)		$	(12,390,691	)
Net Loss Per Common Share
Basic and diluted	$	(0.23	)		$	(0.16	)		$	(0.62	)		$	(0.55	)
Weighted Average Number of Common Shares Outstanding
Basic and diluted		35,470,698				25,624,598				33,152,970				22,498,638

LIGHTBRIDGE CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

	Nine Months Ended September 30,
	2026					2025
Operating Activities
Net Loss	$	(20,430,474	)		$	(12,390,691	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		6,323,764				3,746,642
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(486,494	)			(808,317	)
Prepaid project costs and other long-term assets		(1,615,892	)			201,657
Accounts payable and accrued liabilities		2,977,061				1,135,512
Net Cash Used in Operating Activities		(13,232,035	)			(8,115,197	)
Investing Activities
Trademarks		(7,796	)			(6,117	)
Net Cash Used in Investing Activities		(7,796	)			(6,117	)
Financing Activities
Proceeds from sale of common stock in public offerings		50,655,941				124,659,368
Issuance costs related to sale of common stock in public offerings		(1,774,741	)			(4,207,920	)
Net proceeds from the exercise of stock options		10,807				1,243,794
Payments for taxes related to net share settlement of equity awards		(779,516	)			(234,621	)
Net Cash Provided by Financing Activities		48,112,491				121,460,621
Net Increase in Cash and Cash Equivalents		34,872,660				113,339,307
Cash and Cash Equivalents, Beginning of Period		201,862,421				39,990,827
Cash and Cash Equivalents, End of Period	$	236,735,081			$	153,330,134

Total 3Q 2026 net product revenue of $259.7 million, representing 52% year-over-year growth

AUVELITY^® 3Q 2026 net product sales of $207.6 million, representing 53% year-over-year growth

SUNOSI^® 3Q 2026 net product revenue of $48.2 million, representing 47% year-over-year growth

SYMBRAVO^® 3Q 2026 net product sales of $3.9 million, representing 88% year-over-year growth

SUMMIT Phase 3 trial of AXS-05 for smoking cessation initiated

Company to host conference call today at 8:00 AM Eastern Time

NEW YORK, Nov. 02, 2026 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the third quarter of 2026 and provided a general business update.

“Axsome delivered 52% year-over-year total revenue growth in the third quarter, surpassing a one-billion-dollar annual run rate. We expect sustained momentum driven by strong underlying demand for Auvelity in major depressive disorder, and continued acceleration of new patient initiations in Alzheimer’s disease agitation,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “Our industry-leading neuroscience pipeline continued to advance, leading to multiple anticipated regulatory and clinical trial milestones in the coming quarters. Our commercial and research and development performance positions us to continue to deliver innovation targeting significant unmet needs in brain health, with the potential to improve the lives of millions of patients.”

Third Quarter 2026 Financial Highlights

• Total net product revenue was $259.7 million for the third quarter of 2026, representing 52% year-over-year growth. Total net product revenue for the comparable period in 2025 was $171.0 million.
• AUVELITY net product sales were $207.6 million for the third quarter of 2026, representing 53% year-over-year growth. AUVELITY net product sales for the comparable period in 2025 were $136.1 million.
• SUNOSI net product revenue was $48.2 million for the third quarter of 2026, representing 47% year-over-year growth, which consisted of $38.5 million in net product sales, $1.2 million in royalty revenue associated with SUNOSI sales in out-licensed territories, and $8.5 million in milestone revenue. SUNOSI net product revenue for the comparable period in 2025 was $32.8 million, which consisted of $31.6 million in net product sales and $1.2 million in royalty revenue.
• SYMBRAVO net product sales were $3.9 million for the third quarter of 2026, representing 88% year-over-year growth. SYMBRAVO net product sales for the comparable period in 2025 were $2.1 million.
• Total cost of revenue was $17.8 million for the third quarter of 2026. Total cost of revenue for the comparable period in 2025 was $11.9 million.
• Research and development (R&D) expenses were $50.6 million for the third quarter of 2026, compared to $40.2 million for the comparable period in 2025. The increase primarily reflects costs for the ongoing clinical programs for solriamfetol, AXS-14, and AXS-05.
• Selling, general, and administrative (SG&A) expenses were $203.1 million for the third quarter of 2026, compared to $150.2 million for the comparable period in 2025. The increase primarily reflects commercialization activities for AUVELITY and SYMBRAVO.
• Net loss for the third quarter of 2026 was $12.9 million, or $(0.25) per share, compared to a net loss of $47.2 million, or $(0.94) per share, for the comparable period in 2025. The net loss in the third quarter of 2026 includes $26.4 million in stock-based compensation expense.
• Cash and cash equivalents totaled $313.9 million at September 30, 2026, compared to $322.9 million at December 31, 2025.
• Shares of common stock outstanding were 52,576,839 at September 30, 2026.

Financial Guidance

• Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.

Commercial Highlights

AUVELITY

AUVELITY is a first‑in‑class oral N-methyl-D-aspartate (NMDA) receptor antagonist and sigma‑1 receptor agonist approved in the U.S. for the treatment of major depressive disorder in adults, and for the treatment of agitation associated with dementia due to Alzheimer’s disease.

• Approximately 302,000 total prescriptions were written for AUVELITY in the third quarter of 2026, representing year-over-year and quarter-over-quarter increases of 40% and 14%, respectively. New-to-brand prescriptions, representing new AUVELITY patient starts, increased by 44% year-over-year and 21% quarter-over-quarter.
• Third quarter AUVELITY new-to-brand and total prescriptions among patients aged 65 years and older increased by 211% and 101%, respectively, compared to the third quarter of 2025. Third quarter AUVELITY new-to-brand and total prescriptions among patients aged 65 years and older increased by 99% and 43%, respectively, compared to the second quarter of 2026.
• Payer coverage for AUVELITY across all channels is currently at approximately 89% of all lives covered. The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are approximately 82% and 100%, respectively.

SUNOSI

SUNOSI is the first and only dopamine and norepinephrine reuptake inhibitor (DNRI) approved for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy.

• Approximately 64,400 prescriptions were written for SUNOSI in the U.S. in the third quarter of 2026, a 15% increase compared to the same period in 2025, and a 6% increase compared to the second quarter of 2026.
• Payer coverage for SUNOSI across all channels is at approximately 82% of all lives covered, including approximately 97% of commercial lives and 59% of government lives.

SYMBRAVO

SYMBRAVO is an oral, rapidly absorbed, multi-mechanistic, COX-2 preferential inhibitor and 5-HT_1B/1D agonist approved in the U.S. for the acute treatment of migraine with or without aura in adults.

• Approximately 25,000 prescriptions were written for SYMBRAVO in the third quarter of 2026, a 382% increase compared to the same period in 2025, and a 7% increase compared to the second quarter of 2026.
• Payer coverage for SYMBRAVO across all channels is at approximately 57% of all lives covered, including approximately 56% of commercial lives and 57% of government lives.

Development Pipeline

Axsome is advancing an industry-leading neuroscience pipeline of multiple, innovative product candidates addressing a broad range of serious psychiatric and neurological conditions. Recent and anticipated progress for key pipeline programs is summarized below.

AXS-05

AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for smoking cessation.

• Smoking Cessation: In August 2026, Axsome initiated the SUMMIT study, a Phase 3, randomized, double-blind, active- and placebo-controlled, multicenter trial to assess the efficacy and safety of AXS-05 for the treatment of smoking cessation. The Company anticipates topline results from the SUMMIT Phase 3 trial in the second half of 2027.

Solriamfetol

Solriamfetol is Axsome’s DNRI, TAAR1 agonist, and 5-HT_1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with EDS symptoms, binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).

• Attention Deficit Hyperactivity Disorder: Axsome is conducting the FOCUS-2 and FOCUS-3 Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating the efficacy and safety of solriamfetol as a treatment for children and adolescents in ADHD, respectively. The Company anticipates topline results from both studies in the second half of 2027.
• Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in BED. Target enrollment in the trial has been reached, and the Company anticipates topline results in the first quarter of 2027.
• Shift Work Disorder: Axsome is conducting the SUSTAIN study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in SWD in adults. The Company anticipates topline results from SUSTAIN in the second half of 2027.
• Major Depressive Disorder: Axsome is conducting the CLARITY study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial evaluating the efficacy and safety of solriamfetol for the treatment of MDD with EDS symptoms. The Company anticipates completion of enrollment in CLARITY in the first half of 2027.

AXS-12

AXS-12 (reboxetine) is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy.

• Narcolepsy: Axsome’s NDA for AXS-12 for the treatment of cataplexy in narcolepsy is currently under review by the FDA. The PDUFA target action date is May 1, 2027.

AXS-14

AXS-14 (esreboxetine) is Axsome’s novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine is the SS-enantiomer of reboxetine.

• Fibromyalgia: Axsome is conducting the FORWARD study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial evaluating the efficacy and safety of AXS-14 for the management of fibromyalgia. The Company anticipates completion of enrollment in the FORWARD Phase 3 trial in the third quarter of 2027.

AXS-17

AXS-17 is Axsome’s novel oral GABA_A receptor α2,3 subtype-selective positive allosteric modulator (PAM) being developed for the treatment of epilepsy.

• Epilepsy: Axsome plans to initiate clinical trials of AXS-17 in epilepsy in the first half of 2027.

AXS-20

AXS-20 (balipodect) is Axsome’s novel oral, potent, and selective phosphodiesterase 10A (PDE10A) inhibitor being developed for the treatment of schizophrenia.

• Schizophrenia: Axsome plans to initiate a pivotal Phase 3 trial of AXS-20 in schizophrenia in the first half of 2027.

Anticipated Milestones

• Clinical Trial Initiations:
  • Phase 1B trial of AXS-17 in epilepsy (1H 2027)
  • Phase 3 trial of AXS-20 in schizophrenia (1H 2027)
• Clinical Trial Topline Results:
  • Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (1Q 2027)
  • Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2H 2027)
  • Phase 3 FOCUS-2 trial of solriamfetol in children with ADHD (2H 2027)
  • Phase 3 FOCUS-3 trial of solriamfetol in adolescents with ADHD (2H 2027)
  • Phase 3 SUMMIT trial of AXS-05 in smoking cessation (2H 2027)
• Regulatory and Commercial:
  • AXS-12 for cataplexy in narcolepsy, PDUFA target action (May 1, 2027)

Conference Call Information

Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its third quarter 2026 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the conference call will be available for approximately 30 days following the live event.

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements.” The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI^®, AUVELITY^®, and SYMBRAVO^® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Axsome Therapeutics, Inc. Selected Consolidated Financial Data Axsome Therapeutics, Inc. Consolidated Balance Sheets (In thousands, except share and per share amounts)
		September 30, 2026				December 31, 2025
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents		$	313,859			$	322,933
Accounts receivable, net			343,114				224,464
Inventories, net			42,579				27,938
Prepaid and other current assets			25,084				13,651
Total current assets			724,636				588,986
Equipment, net			943				562
Right-of-use asset – operating lease			18,284				20,858
Goodwill			12,042				12,042
Intangible asset, net			35,751				40,519
Non-current inventory and other assets			35,117				26,838
Total assets		$	826,773			$	689,805
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	96,075			$	65,537
Accrued expenses and other current liabilities			331,756				232,853
Operating lease liability, current portion			663				434
Contingent consideration, current			11,225				10,012
Short-term borrowings			70,000				70,000
Total current liabilities			509,719				378,836
Contingent consideration, non-current			63,610				77,540
Loan payable, long-term			118,069				117,746
Operating lease liability, long-term			20,748				23,182
Finance lease liability, long-term			9,193				4,206
Total liabilities			721,339				601,510
Stockholders’ equity:
Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding)			—				—
Common stock, $0.0001 par value per share (150,000,000 shares authorized, 52,576,839 and 50,882,766 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively)			5				5
Additional paid-in capital			1,540,123				1,394,251
Accumulated deficit			(1,434,694	)			(1,305,961	)
Total stockholders’ equity			105,434				88,295
Total liabilities and stockholders’ equity		$	826,773			$	689,805

Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts)
		Three months ended September 30,								Nine months ended September 30,
		2026				2025				2026				2025
Revenues:
Product sales, net		$	249,951			$	169,784			$	655,706			$	439,101
Royalty revenue and milestone revenue			9,740				1,208				13,563				3,396
Total revenues			259,691				170,992				669,269				442,497
Operating expenses:
Cost of revenue (excluding amortization and depreciation)			17,804				11,912				46,093				35,149
Research and development			50,617				40,162				149,521				134,488
Selling, general and administrative			203,111				150,235				596,244				401,302
Loss (Gain) in fair value of contingent consideration			(2,380	)			13,185				(3,286	)			6,595
Intangible asset amortization			1,607				1,607				4,768				4,768
Total operating expenses			270,759				217,101				793,340				582,302
Loss from operations			(11,068	)			(46,109	)			(124,071	)			(139,805	)
Interest expense, net			(1,721	)			(1,120	)			(4,446	)			(5,385	)
Loss on debt extinguishment			—				—				—				(10,385	)
Loss before income taxes			(12,789	)			(47,229	)			(128,517	)			(155,575	)
Income tax benefit (expense)			(88	)			—				(216	)			960
Net loss		$	(12,877	)		$	(47,229	)		$	(128,733	)		$	(154,615	)
Net loss per common share, basic and diluted		$	(0.25	)		$	(0.94	)		$	(2.48	)		$	(3.13	)
Weighted average common shares outstanding, basic and diluted			52,445,193				50,021,851				51,818,984				49,449,220

Investors:

Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
adong@axsome.com

Media:

Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
dopland@axsome.com

MINNEAPOLIS, Nov. 02, 2026 (GLOBE NEWSWIRE) — Vireo Growth Inc. (CSE: VREO) (OTCQX: VREOF) (“Vireo” or the “Company”), today announced that the Company will host a conference call on Tuesday, November 10, 2026, at 8:00 a.m. ET to discuss its business strategy and financial results for the third quarter ended September 30, 2026. The Company’s results will be reported in a press release prior to the call.

Vireo Growth management will host the conference call, followed by a question-and-answer period. Interested parties can join the conference call by dialing in as directed below. Please dial-in 10 minutes prior to the call.

Date: Tuesday, November 10, 2026
Time: 8:00 a.m. Eastern Time
Toll-free dial-in number: +1 833 461 5787
International dial-in numbers 
Meeting ID: 406388419

A live audio webcast of this event will also be available in the Events & Presentations section of the Company’s Investor Relations website and via the following link: https://events.q4inc.com/attendee/406388419

About Vireo Growth Inc.

Vireo Growth Inc. (CSE: VREO; OTCQX: VREOF) is a leading vertically integrated cannabis company building a broad platform across cannabis and adjacent agricultural markets. The Company operates cultivation, manufacturing, retail dispensaries, home delivery, distribution, and agricultural supply businesses across the United States, creating exposure to both cannabis and complementary adjacent markets. With operations in 10 states and more than 170 dispensaries nationwide, Vireo combines disciplined capital allocation, strategic acquisitions, and local market execution to scale its platform and drive long-term shareholder value. The Company is focused on expanding market share and strengthening its portfolio of consumer brands and services, while supporting the customers, employees, shareholders, and communities it serves. For more information about Vireo, visit www.vireogrowth.com.

Contact Information:

Lynn Ricci
Director Investor Relations & Corporate Communications
investor@vireogrowth.com 
(781) 956-7052

Company to Host Conference Call at 8:30am ET

REHOVOT, Israel and HOBOKEN, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) — Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that it will release financial results for the third quarter and nine months ended September 30, 2026, prior to the open of the U.S. financial markets on Monday, November 9, 2026.

Kamada’s management will host an investment community conference call on Monday, November 9, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the call by dialing 1-877-407-0792 (from within the U.S.), 1-809-406-247 (from Israel), or 1-201-689-8263 (International) using conference I.D. 13763380. The call will be webcast live on the internet at:
https://viavid.webcasts.com/starthere.jsp?ei=1779441&tp_key=96a5dea210.

About Kamada

Kamada Ltd. (the “Company”) is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares. The Company’s strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth of its commercial portfolio, including continued investment in the commercialization and life cycle management of its proprietary products, consisting of six FDA-approved specialty plasma-derived products: KEDRAB®, GLASSIA®, CYTOGAM®, VARIZIG®, WINRHO SDF® and HEPAGAM B®, as well as KAMRAB®, and two equine-based anti-snake venom products. Second, distribution of third parties’ pharmaceutical products in Israel & the MENA region through in-licensing partnerships, including the launch of several biosimilar products in Israel. Third, the Company is ramping up its plasma collection operations to support revenue growth through the sale of normal source plasma to other plasma-derived manufacturers and to support its increasing demand for hyper-immune plasma. The Company currently owns three FDA-approved operating plasma collection centers in the United States, in Beaumont, Houston, and San Antonio, Texas. Fourth, the Company aims to secure new mergers and acquisitions, business development, in-licensing and/or collaboration opportunities, which are anticipated to enhance the Company’s marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term profitable growth. The Company is leveraging its manufacturing, research and development expertise to advance the development and commercialization of additional product candidates targeting areas of significant unmet medical need.

CONTACTS:

Chaime Orlev
Chief Financial Officer
IR@kamada.com

Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
britchie@LifeSciAdvisors.com

RONKONKOMA, N.Y., Nov. 02, 2026 (GLOBE NEWSWIRE) — SUNation Energy, Inc. (Nasdaq: SUNE) (“SUNation” or the “Company”), a leading provider of residential and commercial solar energy systems, battery storage solutions and comprehensive energy services, today announced that it has confidentially submitted a draft registration statement on Form S-4 (the “Registration Statement”) to the U.S. Securities and Exchange Commission (“SEC”) in connection with its previously announced proposed merger with Suniva, Inc. (“Suniva”).

The confidential submission of the Registration Statement marks an important milestone toward the completion of the previously announced proposed business combination between SUNation and Suniva that, upon consummation, would result in Suniva becoming a wholly owned subsidiary of SUNation, with the combined company expected to be known as Suniva Inc. and be listed on Nasdaq under the ticker symbol “SUNV”. The Registration Statement is expected to include a proxy statement/prospectus containing information about SUNation, Suniva and the proposed transaction.

Completion of the proposed merger remains subject to satisfaction or waiver of the conditions set forth in the merger agreement, including required stockholder approvals, the Registration Statement being declared effective by the SEC, Nasdaq approval of the listing of the shares to be issued in the merger, and other customary closing conditions.

ABOUT SUNATION ENERGY, INC.

SUNation Energy Inc. (Nasdaq: SUNE) is a leading provider of sustainable solar energy and backup power solutions to residential, commercial, and municipal customers. The Company designs, installs, and services solar energy systems and related technologies, helping customers reduce energy costs, increase energy independence, and transition to cleaner energy solutions.

For more information, visit: ir.sunation.com

CONTACTS

Scott Maskin, Chief Executive Officer
SUNation Energy, Inc.
smaskin@sunation.com

James Brennan, Chief Financial Officer
SUNation Energy, Inc.
jbrennan@sunation.com

Investor Relations
Alliance Advisors IR
IR@sunation.com

FORWARD-LOOKING STATEMENTS

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that are not historical facts and may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “estimate,” “plan,” “project,” “target,” “design,” “will,” “would” and similar expressions. These statements include, but are not limited to, statements regarding the proposed merger of SUNation and Suniva and its anticipated benefits; the expected timing and completion of the transaction; the combined company’s strategy, Nasdaq listing and future operations; expectations regarding the merger’s effect on margins, market access, access to capital markets and strategic opportunities; the expected relative ownership of SUNation and Suniva stockholders in the post-merger combined company, which is subject to potential adjustment based on SUNation’s net cash at closing; the combined company’s expected post-closing leadership; Suniva’s planned 4.5 gigawatt manufacturing expansion in Laurens County, South Carolina, including its estimated cost, building size, contracted water and power, expected timing and total annual cell capacity; the availability and sufficiency of debt and equity financing; long-term offtake agreements and the share of production capacity they cover; Suniva’s plan to become the largest domestic supplier of solar cells; production yields at the Norcross facility; Suniva’s PERC technology and its scalability and efficiency potential; and third-party forecasts regarding U.S. solar and data-center demand.

These forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks include, among others: the risk that the proposed merger may not be completed on the anticipated timeline or at all; the failure to obtain required stockholder approvals, SEC effectiveness of the Form S-4 registration statement, or Nasdaq listing approval; the risk of potentially extended SEC review of the Form S-4; the parties’ ability to satisfy the conditions to closing; risks relating to constructing, equipping, permitting and ramping up the Laurens facility on time and on budget; the ability to convert offtake agreements into realized revenue; competition, tariffs, trade actions and changes in tax incentives, including the Section 45X advanced manufacturing production credit; technology, supply-chain and execution risks; the accuracy of third-party market data and forecasts; the operating history of Suniva; potential net losses incurred as a result of the current expansion stage nature of Suniva, as well as net losses carried forward from SUNation’s long standing business operations; the ability to raise additional capital; the ability of Suniva to execute on its business plans and for the combined companies to integrate SUNation’s solar installation systems into Suniva’s solar cell manufacturing operations; the effects of the One Big Beautiful Act of 2025 on the residential solar industry, which has had a material negative impact on residential solar installations since the January 2026 effectiveness thereof; Suniva’s limited experience in operating a public company; the substantial competition Suniva faces in developing and selling its solar cell development products; the ability to attract, hire, and retain skilled executive officers and employees; the ability of SUNation or Suniva to protect their respective intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; uncertainties as to the timing of the consummation of the proposed transactions and the ability of each of the parties to consummate the proposed transactions; risks related to SUNation’s continued listing on Nasdaq until the closing of the proposed transactions; risks related to SUNation’s and Suniva’s ability to correctly estimate their respective operating expenses and expenses associated with the proposed transactions, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company’s cash resources; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Merger Agreement; competitive responses to the proposed transactions; unexpected costs, charges or expenses resulting from the proposed transactions; the outcome of any legal proceedings that may be instituted against SUNation, Suniva or any of their respective directors or officers related to the Merger or the proposed transactions contemplated thereby; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transactions; the effect of the announcement or pendency of the transactions on SUNation’s or Suniva’s business relationships, operating results and business generally; the compliance and qualification for initial listing on Nasdaq related to the expected trading of the combined company’s stock on Nasdaq and the combined company’s ability to remain listed following the proposed transactions; the risk that as a result of adjustments to the Exchange Ratio (as set forth in the Merger Agreement, SUNation’s stockholders and Suniva’s stockholders could own more or less of the combined company than is currently anticipated; risks related to the market price of SUNation common stock relative to the Exchange Ratio; legislative, regulatory, political and economic developments and general market conditions, including those surrounding the viability of residential solar businesses following the loss of federal tax credits beginning in January 2026; and the other risks described in SUNation’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and to be described in the Form S-4 and related proxy statement/prospectus.

Forward-looking statements speak only as of the date of this communication. Except as required by law, neither SUNation nor Suniva undertakes any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Readers are cautioned not to place undue reliance on these forward-looking statements.

NO OFFER OR SOLICITATION

This communication is for informational purposes only and does not constitute (i) a solicitation of a proxy, consent or approval with respect to any securities or in respect of the proposed transactions or (ii) an offer to sell or buy, or the solicitation of an offer to sell or buy, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act.

NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THE SECURITIES OR DETERMINED IF THIS PRESS RELEASE IS TRUTHFUL OR COMPLETE.

ADDITIONAL INFORMATION AND WHERE TO FIND IT

This press release is not a substitute for the registration statement or for any other document that SUNation may publicly file with the U.S. Securities and Exchange Commission (“SEC”) in connection with the proposed transactions. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS, CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME PUBLICLY AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders may obtain free copies of these documents, when available, at the SEC’s website at www.sec.gov. In addition, investors and stockholders should note that SUNation communicates with investors and the public using its website (www.sunation.com) and the investor relations website, (https://ir.sunation.com/), where anyone will be able to obtain free copies of the proxy statement/prospectus and other documents filed by SUNation with the SEC and stockholders are urged to read the proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transactions.

PARTICIPANTS IN THE SOLICITATION

SUNation, Suniva and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from SUNation’s shareholders in respect of the proposed transaction. Information regarding SUNation’s directors and executive officers is set forth in SUNation’s most recent Annual Report on Form 10-K, including any information incorporated by reference, as filed with the SEC on March 23, 2026, as well as any supplemental or amended information set forth in the Company’s periodic reports, current reports and other submissions we have subsequently filed and will file with the SEC. Additional information regarding the participants in the solicitation and a description of their direct and indirect interests will be included in the proxy statement/prospectus when it becomes publicly available.

• Dr. Megha Prasad and fellow physicians at NewYork-Presbyterian and Columbia complete first clinical cases with Conavi’s next-generation FDA-cleared hybrid IVUS–OCT imaging system
• Company introduces OCTIV™, powered by Novasight™, as the system’s commercial name
• OCTIV combines IVUS and OCT in one catheter, with enhancements focused on image quality, deliverability and ease of use
• First commercial placement and completed clinical cases advance Conavi’s U.S. rollout ahead of TCT 2026

TORONTO, Nov. 02, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today announced the completion of the first U.S. placement and clinical cases with OCTIV™, powered by Novasight™, its FDA-cleared hybrid intravascular imaging system, at NewYork-Presbyterian/Columbia University Irving Medical Center. Interventional cardiologist Dr. Megha Prasad performed the first cases, marking a milestone in Conavi’s U.S. commercial rollout.

“The first placement and clinical cases with OCTIV move our next-generation system from FDA clearance into clinical use in the United States,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “OCTIV brings the complementary information from IVUS and OCT into one catheter, with design enhancements focused on image quality, deliverability and ease of use.”

OCTIV combines intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) in a single imaging catheter, providing simultaneous, co-registered views of coronary arteries to support assessment of coronary artery disease and guide percutaneous coronary intervention (“PCI”). The placement and first cases mark a milestone in Conavi’s targeted U.S. commercial rollout following FDA 510(k) clearance.

“Having IVUS and OCT available in a single catheter gives us complementary information about the vessel during a coronary intervention,” said Dr. Megha Prasad, an interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center and associate professor of medicine at Columbia University Vagelos College of Physicians and Surgeons. “In our first week with the OCTIV hybrid IVUS-OCT system, the device helped us identify a range of issues, from in-stent restenosis to dissections and plaque ruptures, findings that helped inform our treatment plans. In ostial and multivessel cases, we were able to switch between hybrid and IVUS-only runs, which gave us the full picture while conserving contrast. Paired with physiology, it also helped us assess vessels in patients with microvascular disease.”

Hybrid Imaging and Key Differentiating Features
OCTIV brings together the following capabilities to support image-guided coronary interventions:

• Hybrid IVUS–OCT imaging: Simultaneous, co-registered images from a single catheter and pullback combine the imaging depth of IVUS with the high-resolution detail of OCT, allowing physicians to assess complementary features of the same vessel segment.
• Image quality: The platform includes enhancements designed to improve image quality, supporting visualization of vessel structures and detailed assessment of lesions and stent deployment.
• Catheter deliverability: An updated catheter design is intended to improve deliverability through coronary anatomy and facilitate access to the areas physicians need to assess.
• Ease of use: The patient interface module (“PIM”), which connects the catheter to the system, is positioned outside the sterile field. This configuration and a streamlined catheter connection workflow are designed to simplify setup and use in the catheterization laboratory.
• Contrast mitigation: Access to IVUS imaging without a contrast flush allows physicians to use IVUS for selected imaging steps and OCT where additional high-resolution detail is needed, supporting a tailored approach to contrast use.

NewYork-Presbyterian/Columbia University Irving Medical Center is the first U.S. site in the targeted rollout of OCTIV. Conavi is focused on supporting clinical use at the hospital and advancing placement of the system at additional U.S. institutions. The first clinical cases were completed ahead of Conavi’s participation in Transcatheter Cardiovascular Therapeutics (“TCT”) 2026. The Company’s conference participation includes a podium presentation by Dr. Prasad featuring hybrid IVUS–OCT imaging, preclinical research and physician education sessions.

The Company also introduced OCTIV as the commercial name for its next-generation system. The name brings together references to OCT and IVUS and is inspired by the musical term “octave”, reflecting two complementary imaging modalities working in harmony. OCTIV is powered by Conavi’s Novasight technology.

About Conavi Medical
Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented hybrid imaging system is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging beams to enable simultaneous hybrid imaging of coronary arteries. The hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration. For more information, visit http://www.conavi.com/.

(Note: Dr. Prasad discloses consulting payments from Conavi)

Forward-Looking Statements
This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the anticipated clinical benefits and performance of OCTIV, continued clinical use, placements at additional U.S. institutions, participation in TCT 2026, the commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging and the ability of Conavi’s hybrid imaging system to meet market needs. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the annual information form of the Company dated February 26, 2026 (available on the Company’s profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

Contact
Mark Quick, Chief Financial Officer | 416-483-0100
Christina Cameron, Investor Relations | 416-483-0100 ext. 121 | IR@conavi.com
Susan Thomas, Media | 619-540-9195

Commercial launch follows successful pilot, with customers reporting improved clinical decision-making and greater confidence in care decisions

SUNNYVALE, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) — Ceribell, Inc. (Nasdaq: CBLL) (“Ceribell” or the “Company”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced the commercial launch of its delirium monitoring solution on its point-of-care brain monitoring platform. Ceribell combines seizure detection and delirium monitoring in a single system using one headband, leveraging proprietary AI-powered algorithms to continuously analyze brain activity and deliver objective neurological trends at the bedside. It is the first and only FDA-cleared device used to aid in delirium screening and monitoring, following the Company’s December 2025 FDA 510(k) clearance.¹

Delirium, a clinical state characterized by an acute change in attention and awareness, is a common and serious neurological condition affecting ~30% of all ICU patients,² including up to 80% of those who are mechanically ventilated.³ It is associated with a 10% higher six-month mortality risk for every day it is experienced, longer hospital stays,⁴ and a 60% higher risk of post-ICU dementia.⁵ Despite its prevalence and severity, delirium, particularly the hypoactive subtype, often goes unrecognized because current assessment methods rely on intermittent, subjective bedside evaluations.

Hypoactive delirium and nonconvulsive seizures can present similarly in critically ill patients, and the Ceribell platform provides EEG-based monitoring for both. In critical care environments, the delirium monitoring solution continuously analyzes EEG segments to detect patterns associated with delirium and delivers these AI-enabled monitoring capabilities on the same hardware as Ceribell’s well-established seizure detection solution. Working alongside bedside clinical evaluations, the delirium monitoring solution alerts clinicians to support timely delirium screening and continuous patient monitoring. The commercial launch follows a successful pilot across multiple hospitals that had previously used the Ceribell platform for seizure detection.

“This device gives us the opportunity to test different interventions in individual patients to see what works to reduce their delirium burden. Unlike traditional approaches that rely on one-size-fits-all medical guidelines, we can now tailor treatment strategies directly to each patient. Delirium is often hard to recognize at the bedside. Continuous, objective EEG-based information gives clinicians another tool to screen for and monitor delirium in individual patients,” said Dr. Juliana Barr, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University.

The Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) of up to $2,171 per eligible Medicare patient case utilizing Ceribell’s AI-enabled delirium monitoring solution, effective October 1, 2026, subject to CMS eligibility criteria and payment rules.⁶ The NTAP is designed by CMS to support hospital adoption of innovative technologies, helping eligible hospitals offset the cost of new technology for qualifying inpatient cases, up to the payment cap and subject to CMS criteria and payment rules.

“Delirium is difficult to recognize in a busy ICU, and objective bedside monitoring gives clinicians valuable additional information,” said Jane Chao, Ph.D., co-founder and CEO of Ceribell. “Our pilot demonstrated that real-time data helps frontline teams intervene earlier and validate their treatment choices. Expanding access to this technology is a critical step toward our vision of establishing a new neurological vital sign.”

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding the commercial launch of AI-enabled delirium monitoring capabilities on the Ceribell System, expected customer adoption and usage, and the availability of reimbursement, are forward-looking statements. Forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope,” and other words of similar meaning. These statements are based on management’s current expectations and assumptions as of the date of this press release and involve risks and uncertainties that could cause actual results to differ materially from those described. Such risks and uncertainties, including but not limited to those related to regulatory approvals, clinical use and adoption, clinical outcomes, market acceptance, competition, and other factors, are described under the “Risk Factors” sections of the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other reports filed with the U.S. Securities and Exchange Commission (“SEC”). These filings are available on the SEC’s website at https://www.sec.gov and on Ceribell’s website at https://investors.ceribell.com. Ceribell undertakes no obligation to update any forward-looking statements as a result of new information, future events, or otherwise, except as required by applicable law.

About Ceribell, Inc.

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. Ceribell has developed the Ceribell System, a novel point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute-care setting. By combining proprietary, highly portable, and rapidly deployable hardware with sophisticated artificial intelligence (“AI”)-powered algorithms, the Ceribell System enables rapid diagnosis and continuous monitoring of patients with neurological conditions. The Ceribell System is FDA-cleared for use in detecting seizures and aiding in delirium screening and monitoring in intensive care units and emergency rooms across the U.S. Ceribell is headquartered in Sunnyvale, California. For more information, please visit https://www.ceribell.com or follow the Company on LinkedIn.

Investor Contact

Brian Johnston
Gilmartin Group
Investors@ceribell.com

Media Contact

Laura Hartlieb
Press@ceribell.com

---

References

1. FDA 510(k) Clearance Letter K251936
2. Krewulak, K.D., et al. (2018). Crit Care Med. 46(12):2029-2035
3. Ely, E.W., et al. (2004). JAMA. 291(14):1753-62
4. Taha A., et al. (2023). Medicine (Baltimore), 102(2), e32652
5. Wang, S., et al. (2024). Alzheimer’s Dement, 20(1), 278–287
6. FY2027 CMS Hospital IPPS Rule

Project Advancing Towards Updated PEA

VANCOUVER, British Columbia, Nov. 02, 2026 (GLOBE NEWSWIRE) — American Lithium Corp. (“American Lithium” or the “Company”) (TSX-V:LI | OTCQX:AMLIF | Frankfurt:5LA1) is pleased to announce an updated Mineral Resource Estimate (“MRE”) for the Macusani Uranium Project (“Macusani” or the “Project”), located in southeastern Peru. The updated resource estimate, with a larger share of the resource now classified as Measured and Indicated, positions Macusani as the largest known, undeveloped uranium project in South America.

The updated Macusani Project MRE is as follows:

• Measured: 10.482 million tonnes (“Mt”) at 179 parts per million (“ppm”) U₃O₈ totaling 4.13 million pounds (“Mlbs”) U₃O₈
• Indicated: 111.426 Mt at 216 ppm U₃O₈ totaling 53.03 Mlbs U₃O₈
• Inferred: 114.873 Mt at 258 ppm U₃O₈ totaling 65.32 Mlbs U₃O₈

Macusani benefits from near surface uranium mineralization, favourable historical metallurgical results, including rapid leach times and low acid consumption, and established regional infrastructure. Combined with community support and exploration upside, these characteristics support the Project’s potential to become a competitive, low-cost uranium producer.

“The updated Macusani Mineral Resource Estimate represents another important step forward for the Project and reinforces our confidence in its long-term potential,” stated Alex Tsakumis, CEO. “With more than 40 undrilled uranium surface occurrences across the project area, we see significant opportunity for Macusani to grow, particularly with the dedicated focus it deserves. It remains the Company’s intention to transition Macusani into a stand-alone uranium-focused company. With the world entering what many believe to be a nuclear renaissance, we look forward to participating in this exciting period as we continue to advance Macusani,” he added.

With the updated MRE complete, work on an updated Preliminary Economic Assessment (“PEA”) is well underway, incorporating current uranium pricing and development costs. The Company also plans to advance expansion and infill drilling, metallurgical piloting and ultimately a Pre Feasibility Study (“PFS”). These next steps will further evaluate Macusani’s economic potential and establish a clearer pathway toward future development.

The updated MRE has been established using conservative parameters for demonstrating reasonable prospects for eventual economic extraction (“RPEEE”). Current Peruvian mining costs, updated processing cost estimates combined with a long-term uranium selling price of US$100/lb U₃O₈ result in an open pit-constrained cut-off of approximately 47 ppm Uranium (“U”) and an underground mining block constrained cut-off of approximately 111 ppm U. The historical MRE used a global 75 ppm U cut-off, costs established in 2015 along with a US$50/lb U₃O₈ selling price assumption.

The revised resource estimate also reflects changes to Mineral Resource reporting practices introduced in 2020, several years after the previous MRE was completed in 2015. These changes include the application of stricter pit and stope constrained resource reporting, with differences between the historical and updated resource estimates reflecting updated reporting requirements and economic constraints rather than changes to the underlying geological model.

The updated MRE was completed by the Deloitte Consulting (Pty) Ltd (“Deloitte”) Qualified Person (“QP”) based in Johannesburg, South Africa, in accordance with the latest National Instrument NI 43-101 Standards of Disclosure for Mineral Projects (NI 43-101) and U.S. Securities and Exchange Commission (“SEC”) property disclosure regulations (S-K 1300) requirements.

Macusani Project Mineral Resource Details

The previous Macusani MRE, prepared by The Mineral Corporation (“TMC”), was last included in the NI 43-101 Preliminary Economic Assessment (“PEA”) report dated March 2015.

Deloitte updated the MRE effective July 01, 2026. The QP had previously contributed to the development of the MRE while employed by TMC and has conducted multiple site visits to the Macusani uranium deposits, most recently in March 2025.

The MRE used a total of 1,152 diamond drillholes completed across the Project, comprising 114,576 metres (“m”) of drilling. Sampling intervals varied to preserve the integrity of higher-grade mineralized zones. All assay data were vertically composited into 1.5 m bench composites, which formed the basis of the estimation process.

Geological interpretation and block modelling were undertaken using Datamine® software. Mineral Resources were estimated using Multiple Indicator Kriging (“MIK”) for two mineralized domains (Zones A and B), which are oriented sub-parallel to the basal mineralization surface. Dynamic anisotropy was applied to permit the rotation of search ellipsoids and variogram models on a cell-by-cell basis, thereby reflecting the gently dipping geometry of uranium mineralization.

The block models were constructed using parent cell dimensions of 50 m × 50 m × 3 m in well-informed areas and 100 m × 100 m × 3 m in less informed areas, accommodating both potential open-pit and underground mining scenarios. The selected estimation approach appropriately reflects the highly skewed uranium grade distribution and the interpreted geometry of the mineralized horizons. Tonnage estimates were derived using measured bulk density data. Mineral Resource classification was based on a combination of geostatistical parameters, including kriging efficiency, geological confidence, drillhole spacing, and quality assurance and quality control (“QAQC”) considerations.

As part of the update, the QP reviewed and validated the existing models through statistical analyses, visual validation, and swath plot assessments. The QP also reassessed the classification criteria to incorporate drillhole spacing, geological continuity, estimation confidence, and practical mining considerations. The updated MRE was subsequently constrained within conceptual open-pit shells and, where applicable, evaluated for underground extraction potential. RPEEE was demonstrated using assumptions relating to long-term uranium price (US$100/lb), mining and processing costs, metallurgical recovery, pit slope parameters, and appropriate cut-off grades (~47 ppm U for open pit and ~111 ppm U for underground).

Macusani Drillholes by Complex

Complex	Drill holes	Metres
Corachapi	204	11,933
Colibri	157	12,522
Kihitian	295	50,427
Isivilla	142	11,928
Corani	174	14,820
Sayaña	180	12,946
Total	1,152	114,576

Macusani updated Mineral Resource Estimate (Deloitte – effective July 01, 2026) – summary table

Complex	Deposit	Mining Method	Mineral Resource Category	Metric Units				Imperial Units
				Tonne (Mt)	U Grade (ppm)	U3O8 Grade (ppm)	U3O8 Content (000’kg)	Ton (Mt)	U3O8 Grade (lb/ton)	U3O8 Content (Mlb)
Corachapi	Corachapi	OP	Measured	10.482	151	179	1,871	11.555	0.36	4.13
	Corachapi	OP	Indicated	5.329	132	156	830	5.875	0.31	1.83
Colibri	Colibri II & III	OP	Indicated	32.238	184	217	6,985	35.536	0.43	15.40
Kihitian	Chilcuno Chico	OP	Indicated	27.366	180	212	5,804	30.166	0.42	12.79
	Chilcuno Chico	UG	Indicated	5.133	218	257	1,318	5.658	0.51	2.91
	Quebrada Blanca	OP	Indicated	3.529	279	329	1,163	3.890	0.66	2.56
	Quebrada Blanca	UG	Indicated	0.582	189	222	129	0.642	0.44	0.29
	Tantamaco	OP	Indicated	21.943	166	196	4,296	24.188	0.39	9.47
	Tantamaco	UG	Indicated	6.022	162	191	1,152	6.638	0.38	2.54
Isivilla	Isivilla	OP	Indicated	4.989	300	353	1,763	5.499	0.71	3.89
Corani	Nueva Corani	OP	Indicated	4.295	122	143	616	4.734	0.29	1.36
Total Measured and Indicated				121.908	180	213	25,927	134.381	0.43	57.16
Corachapi	Corachapi	OP	Inferred	4.258	159	188	799	4.694	0.38	1.76
Colibri	Colibri II & III	OP	Inferred	11.430	146	172	1,965	12.599	0.34	4.33
	Tupurumani	OP	Inferred	13.464	110	130	1,745	14.841	0.26	3.85
Kihitian	Chilcuno Chico	OP	Inferred	24.221	283	334	8,085	26.699	0.67	17.82
	Chilcuno Chico	UG	Inferred	11.846	298	351	4,160	13.058	0.70	9.17
	Quebreda Blanca	OP	Inferred	11.961	261	308	3,686	13.184	0.62	8.13
	Quebreda Blanca	UG	Inferred	3.391	256	302	1,022	3.738	0.60	2.25
	Tantamaco	OP	Inferred	11.137	185	218	2,425	12.276	0.44	5.35
	Tantamaco	UG	Inferred	2.823	198	234	660	3.111	0.47	1.45
	Tuturumani	OP	Inferred	1.558	132	156	243	1.717	0.31	0.54
	Tuturumani	OP	Inferred	0.654	154	181	119	0.721	0.36	0.26
Isivilla	Isivilla	OP	Inferred	5.740	320	378	2,168	6.327	0.76	4.78
	Puncopata	OP	Inferred	6.280	200	236	1,483	6.923	0.47	3.27
	Calvario I	OP	Inferred	2.024	232	274	554	2.231	0.55	1.22
Corani	Nueva Corani	OP	Inferred	4.087	107	126	515	4.505	0.25	1.14
Total Inferred				114.873	219	258	29,629	126.626	0.52	65.32

<sup>Notes:         
1. The Mineral Resources are reported on a 100% attributable basis.
2. All open pit (“OP”) Mineral Resources are reported using a ~47 ppm U pit shell and cut-off grade.
3. All underground (“UG”) Mineral Resources are reported using a ~111ppm U cut-off grade.
4. Tonne is metric tonne and ton is short ton. These are calculated based on a density of 1.98t/m3 for all complexes except Colibri that is based on a density of 1.99t/m3
5. Mineral Resources are not Mineral Reserves and do not have demonstrated economic viability. There is no certainty that any Mineral Resource will be converted into Mineral Reserve.
6. Rounding as required by reporting guidelines may result in apparent summation differences between tonnes, grade and content.
7. U grade to U308 grade conversion factor 1.1793
8. There are currently no known risks that could materially affect potential development.
9. The Mineral Resource estimate has been prepared by Stewart Nupen, B.Sc. (Hons), FGSSA, Pr Sci Nat of Deloitte in accordance with Canadian Institute of Mining, Metallurgy and Petroleum (“CIM”) “Estimation of Mineral Resource and Mineral Reserves Best Practices” guidelines and are reported in accordance with the Canadian Securities Administrators NI 43-101. The effective date of the Mineral Resource Estimate is July 01, 2026.</sup>

The Qualified Person

Stewart Nupen, B.Sc. (Hons), FGSSA, Pr Sci Nat (No 400174/07) of Deloitte, a QP as defined by NI 43-101, has prepared or supervised the preparation of, or has reviewed and approved, the scientific and technical data pertaining to the MRE contained in this release and will be preparing the NI-43-101 Technical Report for filing on SEDAR+ within 45 days. Ted O’Connor, P.Geo., Executive Vice President of American Lithium, and a Qualified Person as defined by National Instrument 43-101, has reviewed and approved the scientific and technical information contained in this news release.

About Deloitte
Deloitte, through its technical mining advisory (“DTMA”) team, offers leading advisory services in techno-economic and techno-strategic aspects tailored for the mining and metals sector. The DTMA team is recognized for its robust technical expertise in assessing acquisition and divesture opportunities, estimating Mineral Resources, and preparing corporate project disclosure documentation.

About American Lithium
American Lithium is developing two of the world’s largest, advanced-stage lithium projects, along with the largest undeveloped uranium project in Latin America. They include the TLC claystone lithium project in Nevada and the Falchani hard-rock lithium project in southern Peru, which also hosts a globally significant cesium resource, as well as the Macusani uranium project located in the same region. All three projects have completed robust preliminary economic assessments, exhibit significant expansion potential and enjoy strong community support.

For more information, please contact the Company at info@americanlithiumcorp.com or visit our website at www.americanlithiumcorp.com.

Follow us on Facebook, Twitter and LinkedIn.

On behalf of the Board of Directors of American Lithium Corp.

“Alex Tsakumis”

Chief Executive Officer

Tel: 604 428 6128

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

Cautionary Statement Regarding Forward Looking Information
This news release contains certain forward-looking information and forward-looking statements (collectively “forward-looking statements”) within the meaning of applicable securities legislation. All statements, other than statements of historical fact, are forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements regarding the business plans, expectations and objectives of American Lithium. Forward-looking statements are frequently identified by such words as “may”, “will”, “plan”, “expect”, “anticipate”, “estimate”, “intend”, “indicate”, “scheduled”, “target”, “goal”, “potential”, “subject”, “efforts”, “option” and similar words, or the negative connotations thereof, referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management and are not, and cannot be, a guarantee of future results or events. Although American Lithium believes that the current opinions and expectations reflected in such forward-looking statements are reasonable based on information available at the time, undue reliance should not be placed on forward-looking statements since American Lithium can provide no assurance that such opinions and expectations will prove to be correct. All forward-looking statements are inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including risks, uncertainties and assumptions related to: American Lithium’s ability to achieve its stated goals; the ability to access mineral properties for indeterminate amounts of time; the health of the employees or consultants; social or political instability in Peru; American Lithium’s ability to maintain the continuity of its business operating requirements; availability or failures of various local administration and critical infrastructure; reduced demand for the American Lithium’s potential products; availability of materials; availability of insurance and the associated costs; the ongoing ability to work cooperatively with stakeholders, including but not limited to local communities and all levels of government; the potential for delays in exploration or development activities; the interpretation of drill results, the geology, grade and continuity of mineral deposits; the possibility that any future exploration, development or mining results will not be consistent with our expectations; permits being obtained as planned; mining and development, including risks related to accidents, equipment breakdowns, labour disputes (including work stoppages, strikes and loss of personnel) or other unanticipated difficulties with or interruptions in exploration and development; commodity price and foreign exchange rate fluctuations; ; the cyclical nature of the industry in which American Lithium operates; failure to obtain adequate financing on a timely basis and on acceptable terms or delays in obtaining governmental approvals; environmental regulation and liability; political and regulatory risks associated with mining and exploration; the uncertain global economic environment and the effects upon the global market generally, any of which could have a material adverse impact on American Lithium’s business, the trading price of American Lithium’s shares and could negatively affect American Lithium’s ability to raise capital and may also result in additional and unknown risks or liabilities to American Lithium. Other risks and uncertainties related to prospects, properties and business strategy of American Lithium are identified in the “Risk Factors” section of American Lithium’s Management’s Discussion and Analysis filed on July 29, 2026 and in recent securities filings available at www.sedarplus.ca. Actual events or results may differ materially from those projected in the forward-looking statements. American Lithium undertakes no obligation to update forward-looking statements except as required by applicable securities laws. Investors should not place undue reliance on forward-looking statements.

$127.3 million in 3Q VYJUVEK global revenue and $1.1 billion since launch

VYJUVEK pricing negotiations in Germany and Italy completed

KB113 clinical data demonstrate regression in more than 80% of assessed basal cell carcinoma lesions in patients with Gorlin syndrome

Strong balance sheet, ending the quarter with $1.2 billion in cash and investments

Board authorizes share repurchase program of up to $400 million

PITTSBURGH, Nov. 02, 2026 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (the “Company” or “Krystal”) (NASDAQ: KRYS) today reported financial results for the third quarter ended September 30, 2026 and provided a business update.

“Continued growth in VYJUVEK revenue is supporting profitability and funding the advancement of our pipeline,” said Krish S. Krishnan, Chairman and Chief Executive Officer of Krystal Biotech. “Our financial strength allows us to invest fully in these programs and our global commercial expansion while returning capital to shareholders. The $400 million share repurchase program, under which we expect to repurchase shares opportunistically over the next two years, reflects our confidence in Krystal’s long-term growth prospects and our commitment to disciplined capital allocation.”

VYJUVEK® (beremagene geperpavec-svdt, or B-VEC)
for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

The Company recorded $127.3 million in global VYJUVEK net product revenue for the third quarter of 2026, an increase of 30% compared to the prior year third quarter. Gross margin for the quarter was 94%.

Patient demand in the United States continues to grow with over 760 reimbursement approvals secured for VYJUVEK nationwide. Steady expansion of the U.S. prescriber base is supporting continued adoption across the country.

The Company is also expanding its reach across its initial launch markets of Germany, France, and Japan, converting high physician interest and engagement into patient starts and broadening the prescriber base to bring VYJUVEK treatment closer to patients.

Pricing negotiations are now complete in both Germany and Italy, and the Company expects to launch VYJUVEK in Italy in early 2027. Pricing negotiations are ongoing in multiple European countries and the United Kingdom, with decisions expected in Spain later this year, and in France no earlier than 2027. The Company has also submitted a marketing authorization application for VYJUVEK in Australia and expects to submit an application for marketing authorization in Switzerland before year end.

Dermatology

KB111 for the treatment of Hailey-Hailey disease (HHD)

Enrollment is complete and dosing is ongoing in HALITE-1, the Company’s open-label, single-arm study evaluating the safety of KB111, administered once weekly for 12 weeks, in patients with HHD. HHD is a genetic disease characterized by painful rash and blistering in skin folds. In addition to pain, patients with HHD reporting debilitating symptoms of itch, burning, infections, and body odor, as well as severe, negative impacts on quality of life and psychological distress. The prevalence of HHD is not well characterized and is most commonly estimated at roughly 1 per 50,000, although underreporting is possible.

A total of five patients have been enrolled in HALITE-1. The Company expects to report interim study results before the end of the year. Details of the study can be found at www.clinicaltrials.gov under NCT identifier: NCT07717346.

The Company has also completed development of its HHD-specific severity scale for the clinical evaluation of KB111. The Company expects to meet with the FDA in the first quarter of 2027, following completion of scale validation, to discuss study results, the scale, and study designs to enable a registrational study start in 2027.

KB113 for the treatment of Gorlin syndrome (GS)

In October, the Company announced a positive clinical update supporting initial proof of concept for KB113 in the treatment of basal cell carcinoma (BCC) in patients with GS. GS is a genetic disease characterized by a greatly increased risk of developing BCCs. Patients with Gorlin syndrome can develop BCCs as early as infancy and may have hundreds of BCCs over their lifetimes requiring frequent and potentially disfiguring surgical procedures. Prevalence data for GS is limited but available data suggest the number of patients with GS in the United States could exceed 10,000.

In the Company’s three patient pilot, multicenter, single-arm, open-label study, more than 80% of assessed BCC lesions showed investigator-assessed clinical regression. Regression was observed in both injected and non-injected lesions, consistent with an abscopal effect. Histologic assessment also confirmed complete clearance of an injected BCC lesion in each patient. KB113 was well tolerated, with all reported adverse events mild or moderate in severity, transient, and resolving during the study.

Building on these positive initial results, the Company has initiated discussions with the FDA regarding the advanced clinical development of KB113 for the treatment of BCCs in patients with GS. The Company will provide an update on its clinical development plans following alignment with the FDA.

Ophthalmology

KB803 for the treatment and prevention of corneal abrasions in DEB patients

The Company has enrolled three additional patients in its registrational IOLITE study, including one child aged one year. The additional enrollment replaces two patients who withdrew for reasons unrelated to safety and provides supporting evidence for the potential treatment of corneal abrasions in DEB patients from birth. The Company now expects the last patient visit in February 2027 with top-line results reported shortly thereafter. The primary efficacy endpoint is the change in the average number of days per month with corneal abrasion symptoms while receiving KB803 versus placebo. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT07016750.

KB801 for the treatment of neurotrophic keratitis (NK)

Enrollment is ongoing in EMERALD-1, the Company’s registrational, 1:1 randomized, double-masked, multicenter, placebo-controlled study evaluating KB801 for the treatment of NK. The Company has activated 22 sites across the United States and is close to activating sites in France, Spain and the United Kingdom. Patient enrollment has progressed slower than initially anticipated, reflecting the study’s narrowly defined eligibility criteria and the challenges of enrolling patients in a placebo-controlled trial in an indication with an available approved therapy. The Company now expects to complete enrollment of approximately 60 patients in EMERALD-1 and report top-line results in 2027. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT06999733.

Respiratory

KB407 for the treatment of cystic fibrosis (CF)

Three patients are currently being dosed in the Company’s ongoing open-label, single-arm study evaluating the safety of repeat-dose KB407 administration over 24 weeks in patients with CF who are ineligible for, do not tolerate, or do not benefit from modulator therapy. The Company expects to enroll and dose three additional patients before year end, with interim study results now anticipated in the first half of 2027. Earlier this year, the Company announced positive interim clinical findings demonstrating successful delivery and expression of wild-type CFTR protein in the lungs of patients treated with KB407. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT05504837.

In the third quarter, the Company was selected for the FDA’s Complex Innovative Trial Design (CID) Meeting Program, advancing ongoing discussions regarding the Company’s innovative registrational study design. The CID Meeting Program is intended to facilitate and advance the use of complex and novel clinical trial designs and provides the opportunity for increased interaction with the FDA. The Company will share the design and associated statistical analysis of the registrational study following alignment with the FDA and is presently on track to initiate the registrational study in 2027.

KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease

The Company continues to enroll in repeat-dose Cohort 2B of SERPENTINE-1, the Company’s open-label dose escalation study evaluating KB408 in adult patients with AATD with a Pi*ZZ or a Pi*ZNull genotype. Cohort 2B is designed to evaluate the safety and tolerability of repeat KB408 dosing at the same dose level that was previously shown to safely deliver SERPINA1 to the lungs of AATD patients after a single dose. Details of the study can be found at www.clinicaltrials.gov under NCT identifier: NCT06049082. The Company expects to report interim study results in 2027.

Oncology

Inhaled KB707 for the treatment of non-small cell lung cancer (NSCLC)

KYANITE-1 is an ongoing Phase 1/2 open-label, multi-center, dose escalation and expansion study evaluating inhaled KB707, as monotherapy or in combination with standard of care therapies, in patients with locally advanced or metastatic solid tumors involving the lungs.

Interim clinical results from the KYANITE-1 dose expansion cohort evaluating inhaled KB707 in combination with pembrolizumab were presented at the American Society for Clinical Oncology 2026 Annual Meeting in May and demonstrated antitumor activity in patients with advanced NSCLC, with an objective response rate (ORR) of 31% and a disease control rate (DCR) of 75%. Multiple patients from this cohort remain on treatment and in follow-up with sustained disease control.

The Company is currently enrolling patients with advanced NSCLC in a global KYANITE-1 dose expansion cohort evaluating inhaled KB707 in combination with chemotherapy. An initial dose-optimization phase evaluated the safety and tolerability of the combination regimen in the first 10 patients and informed the selection of the chemotherapy dose for subsequent enrollment. Sites have also been activated in France and Spain. The Company expects to enroll approximately 70 patients to be dosed at the selected combination regimen by mid-2027.

Details of the KYANITE-1 study can be found at www.clinicaltrials.gov under NCT identifier: NCT06228326.

Aesthetics

KB304 for the treatment of wrinkles of the décolleté

Jeune Aesthetics, Inc., a wholly owned subsidiary of the Company, expects to initiate a Phase 2 study of its lead program KB304 in 2027.

Share Repurchase Program

The Company also announced today that its Board of Directors has authorized a share repurchase program under which Krystal may repurchase up to $400 million of its outstanding common stock. Repurchases may be made from time to time through open-market purchases, privately negotiated transactions, or by other means permitted under applicable securities laws, including through purchases compliant with Rule 10b-18 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and trading plans adopted under Rule 10b5-1 under the Exchange Act. The timing and amount of any repurchases will depend on a number of factors, including the market price of Krystal’s common stock, market and business conditions, the Company’s liquidity and capital requirements, clinical development and commercialization plans, alternative uses of capital, and legal and regulatory requirements. The program has no expiration date, does not obligate Krystal to repurchase any amount of common stock, and the program may be modified, suspended or discontinued at any time at the Company’s discretion.

Financial Results for the Quarter Ended September 30, 2026:

• Cash, cash equivalents and investments totaled $1.2 billion as of September 30, 2026
• Product revenue, net totaled $127.3 million and $97.8 million for the three months ended September 30, 2026 and September 30, 2025, respectively.
• Cost of goods sold totaled $7.6 million and $4.3 million for the three months ended September 30, 2026 and September 30, 2025, respectively.
• Research and development expenses for the three months ended September 30, 2026 were $14.9 million, inclusive of $2.6 million of stock-based compensation, compared to $14.6 million, inclusive of stock-based compensation of $2.6 million, for the three months ended September 30, 2025.
• Selling, general, and administrative expenses for the three months ended September 30, 2026 were $33.7 million, inclusive of stock-based compensation of $11.3 million, compared to $37.6 million, inclusive of stock-based compensation of $10.6 million, for the three months ended September 30, 2025.
• Net income for the three months ended September 30, 2026 was $63.1 million, or $2.13 per common share (basic) and $2.05 per common share (diluted). Net income for the three months ended September 30, 2025 was $79.4 million, or $2.74 per common share (basic) and $2.66 per common share (diluted).
• For additional information on the Company’s financial results for the three months ended September 30, 2026, please refer to the Form 10-Q filed with the SEC.

Financial Results for the Nine Months Ended September 30, 2026:

• Product revenue, net totaled $362.9 million and $282.0 million for the nine months ended September 30, 2026 and September 30, 2025, respectively.
• Cost of goods sold totaled $20.3 million and $16.5 million for the nine months ended September 30, 2026 and September 30, 2025, respectively.
• Research and development expenses for the nine months ended September 30, 2026 were $44.7 million, inclusive of $7.3 million of stock-based compensation, compared to $43.3 million, inclusive of stock-based compensation of $7.7 million, for the nine months ended September 30, 2025.
• Selling, general, and administrative expenses for the nine months ended September 30, 2026 were $114.6 million, inclusive of stock-based compensation of $34.4 million, compared to $105.3 million, inclusive of stock-based compensation of $33.1 million, for the nine months ended September 30, 2025.
• Net income for the nine months ended September 30, 2026 was $173.8 million, or $5.90 per common share (basic) and $5.66 per common share (diluted). Net income for the nine months ended September 30, 2025 was $153.4 million, or $5.31 per common share (basic) and $5.14 per common share (diluted).
• For additional information on the Company’s financial results for the nine months ended September 30, 2026, please refer to the Form 10-Q filed with the SEC.

Financial Guidance

($ in millions)		FY 2026 Guidance
Non-GAAP Research and Development (“R&D”) and Selling, General and Administrative (“SG&A”) expense(1)		$155.0 – $165.0

(1) Refer to Non-GAAP Financial Measures section below for additional information. Non-GAAP combined R&D and SG&A expense guidance does not include stock-based compensation as we are currently unable to confidently estimate Full Year 2026 stock-based compensation expense. As such, we have not provided a reconciliation from forecasted non-GAAP to forecasted GAAP combined R&D and SG&A Expense in the above. This could materially affect the calculation of forward-looking GAAP combined R&D and SG&A Expense as it is inherently uncertain.

Conference Call

The Company will host a conference call and webcast on November 2, 2026, at 8:30 am ET.

Investors and the general public can access the live webcast at: https://www.webcaster5.com/Webcast/Page/3018/54689.

For those unable to listen to the live conference call, a replay will be available for 30 days on the Investors section of the Company’s website at www.krystalbio.com.

About VYJUVEK

VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. VYJUVEK is approved in the United States, Europe, and Japan.

U.S. INDICATION

VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

IMPORTANT SAFETY INFORMATION

Adverse Reactions

The most common adverse drug reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Contraindications

None.

Warnings and Precautions

VYJUVEK gel may be applied by a healthcare provider, a caregiver, or the patient.

After treatment, patients and caregivers should be careful not to touch treated wounds and dressings until the next dressing change.

Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.

Patients should avoid touching or scratching wound sites or wound dressings.

In the event of an accidental exposure flush with clean water for at least 15 minutes.

For more information, see full U.S. Prescribing Information.

About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. Visit www.krystalbio.com to learn more or follow us on LinkedIn and X.

About Jeune Aesthetics, Inc.

Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc., is a biotechnology company leveraging a clinically validated gene delivery platform to develop products to fundamentally address – and reverse – the biology of aging and/or damaged skin. For more information, please visit http://www.jeuneinc.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are forward-looking statements, including statements regarding: the commercial launch and expansion of VYJUVEK in Europe, Japan, and additional markets (including the timing of launch in Italy, the timing of pricing and reimbursement decisions in Spain and France, and the timing of marketing authorization filings in other jurisdictions); the Company’s development plans for its product candidates; the timing of enrollment, data readouts, and regulatory interactions with respect to the Company’s clinical trials of its product candidates (including registrational study plans for KB111 and KB407, the timing of interim results for KB111, KB407 and KB408 and top-line results for KB803 and KB801, the Company’s plans for the further clinical development of KB113, and the Company’s plans to provide updates on the clinical development of KB113 and the KB407 registrational study following alignment with the FDA); the Company’s share repurchase program, including the timing, manner and amount of any repurchases; the Company’s 2026 financial guidance; and other statements about expectations, plans, and prospects. These statements are often identified by words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the Company’s ability to enroll patients in its clinical trials on anticipated timelines; whether results of early clinical trials, including results observed in a small number of patients, will be indicative of the results of later-stage studies; the outcome of the Company’s discussions with the FDA regarding the design of planned clinical trials; the availability, pricing, and commercial potential of VYJUVEK and the Company’s product candidates; the amount and timing of any share repurchases, whether the share repurchase program will enhance long-term stockholder value, and the effect of repurchases on the Company’s cash position and its ability to fund its operations and development programs; and other important factors set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change, and although the Company may elect to update these statements, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Non-GAAP Financial Measures

This press release includes forward-looking combined R&D and SG&A expense guidance that is not required by, or presented in accordance with, U.S. GAAP and should not be considered as an alternative to R&D and SG&A expense or any other performance measure derived in accordance with GAAP. The Company defines non-GAAP combined R&D and SG&A expense as GAAP combined R&D and SG&A expense excluding stock-based compensation. The Company cautions investors that amounts presented in accordance with its definition of non-GAAP combined R&D and SG&A expense may not be comparable to similar measures disclosed by competitors because not all companies calculate this non-GAAP financial measure in the same manner. The Company presents this non-GAAP financial measure because it considers this measure to be an important supplemental measure and believes it is frequently used by securities analysts, investors, and other interested parties in the evaluation of companies in the Company’s industry. Management believes that investors’ understanding of the Company’s performance is enhanced by including this forward-looking non-GAAP financial measure as a reasonable basis for comparing the Company’s ongoing results of operations. Management uses this non-GAAP financial measure for planning purposes, including the preparation of the Company’s internal annual operating budget and financial projections; to evaluate the performance and effectiveness of the Company’s operational strategies; and to evaluate the Company’s capacity to expand its business. This non-GAAP financial measure has limitations as an analytical tool, and should not be considered in isolation, or as an alternative to, or a substitute for R&D and SG&A expense or other financial statement data presented in accordance with GAAP in the Company’s consolidated financial statements. The Company has not provided a quantitative reconciliation of forecasted non-GAAP combined R&D and SG&A expense to forecasted GAAP combined R&D and SG&A expense because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence. This item, which could materially affect the computation of forward-looking GAAP combined R&D and SG&A expense, is inherently uncertain and depends on various factors, some of which are outside of the Company’s control.

CONTACT

Investors and Media:                                                                                        
Stéphane Paquette, PhD
Krystal Biotech
spaquette@krystalbio.com     

Condensed Consolidated Balance Sheet Data:

	September 30, 2026			December 31, 2025
(in thousands)	(unaudited)
Balance sheet data:
Cash and cash equivalents	$	462,841		$	496,304
Short-term investments		449,010			331,487
Long-term investments		282,301			128,066
Total assets		1,586,056			1,333,794
Total liabilities		150,472			114,234
Total stockholders’ equity	$	1,435,584		$	1,219,560

Condensed Consolidated Statements of Operations:

	Three Months Ended September 30,
		2026			2025			Change
(in thousands, except per share data)	(unaudited)
Revenue
Product revenue, net	$	127,341			$	97,800		$	29,541
Operating Expenses
Cost of goods sold		7,556				4,263			3,293
Research and development		14,891				14,585			306
Selling, general, and administrative		33,749				37,578			(3,829	)
Total operating expenses		56,196				56,426			(230	)
Income from operations		71,145				41,374			29,771
Other income
Interest and other income, net		9,000				6,593			2,407
Income before income taxes		80,145				47,967			32,178
Income tax (expense) benefit		(17,077	)			31,398			(48,475	)
Net income	$	63,068			$	79,365		$	(16,297	)
Net income per common share:
Basic	$	2.13			$	2.74
Diluted	$	2.05			$	2.66
Weighted-average common shares outstanding:
Basic		29,610				28,953
Diluted		30,838				29,833

	Nine Months Ended September 30,
		2026			2025			Change
(in thousands, except per share data)	(unaudited)
Revenue
Product revenue, net	$	362,920			$	282,025		$	80,895
Operating Expenses
Cost of goods sold		20,316				16,457			3,859
Research and development		44,739				43,251			1,488
Selling, general, and administrative		114,612				105,292			9,320
Total operating expenses		179,667				165,000			14,667
Income from operations		183,253				117,025			66,228
Other income
Interest and other income, net		24,413				21,315			3,098
Income before income taxes		207,666				138,340			69,326
Income tax (expense) benefit		(33,898	)			15,091			(48,989	)
Net income	$	173,768			$	153,431		$	20,337
Net income per common share:
Basic	$	5.90			$	5.31
Diluted	$	5.66			$	5.14
Weighted-average common shares outstanding:
Basic		29,477				28,893
Diluted		30,680				29,829

• The proposed business combination values Nuclea Energy at an enterprise value of $350 million, subject to adjustments at closing
• The transaction is expected to close in the first half of 2027
• Nuclea is developing advanced nuclear technologies to support growing demand for reliable, carbon-free electricity, driven in part by the expansion of data centers and other energy-intensive industries

NEWPORT BEACH, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) —

Nuclea Energy Inc. (“Nuclea”), a company developing advanced nuclear technologies, and NorthStrive Acquisition Corp I (Nasdaq: NSAI, NSAIU, NSAIW, NSAIR) (“NSAC I”), a special purpose acquisition company, today announced that they have entered into a definitive business combination agreement (the “Business Combination Agreement”) pursuant to which, if the proposed transaction is consummated, Nuclea would become a publicly traded company. On closing of the proposed transaction (the “Proposed Transaction”), NSAC I is expected to be renamed Nuclea-X Inc. (the “Combined Company”) and to list on The Nasdaq Stock Market LLC (“Nasdaq”). The Proposed Transaction implies an enterprise value for Nuclea of $350 million, subject to adjustments at closing.

Headquartered in Mississauga, Ontario, Nuclea Energy Inc. is a company developing advanced nuclear technology dedicated to delivering clean, reliable energy. The company’s flagship innovation is the Morpheus Micro Modular Reactor (MMR), a transportable, factory-built, lead-cooled, graphite-moderated system scalable from 3.5 MWe to 50 MWe. Through its pending acquisition of Moltex, Nuclea aims to pioneer a closed nuclear fuel cycle business. By integrating the proprietary WATSS spent nuclear fuel recycling process with a diverse reactor portfolio including the Stable Salt Reactor-Wasteburner (SSR-W) Small Modular Reactor (SMR) and the Morpheus, Nuclea aims to commercialize sustainable waste recycling and next-generation zero-emission global power.

The closing of the Proposed Transaction is subject to the satisfaction or waiver of certain closing conditions, including customary closing conditions such as approval by the shareholders of NSAC I and Nuclea, the registration statement on Form S-4 being declared effective by the U.S. Securities and Exchange Commission (the “SEC”) and approval of the Combined Company’s listing on Nasdaq, as well as additional conditions, including completion of the Moltex Acquisition (including clearance under the U.K. National Security and Investment Act 2021 and receipt of required export control licenses and other governmental authorizations), dissent rights not having been exercised with respect to more than 5% of Nuclea’s shares and the satisfaction of a minimum cash condition.

Josef Freundorfer, Chief Executive Officer of Nuclea, commented: “This transaction is a pivotal milestone for Nuclea. We believe the public company platform and capital from this combination with NSAC I will help us accelerate the development of our Morpheus reactor and pioneer a closed nuclear fuel cycle through our pending acquisition of Moltex. We believe we are uniquely positioned to deliver the sustainable, zero-emission power that data centers and other energy-intensive industries increasingly demand.”

Michel Tamer, Chief Executive Officer of NSAC I, commented: “We set out to identify a business serving high-growth markets across industrials and critical supply chains, with the potential to create lasting shareholder value,” said Michel Tamer, CEO of NorthStrive Acquisition Corp I and Head of M&A at NorthStrive Companies. “We believe Nuclea’s advanced nuclear technology and pending acquisition in nuclear fuel recycling deliver on that vision and reflect NorthStrive’s investment approach.”

Transaction Overview

Pursuant to the Business Combination Agreement, NSAC I will deregister as a Cayman Islands exempted company and continue to Canada under the Canada Business Corporations Act. Nuclea will then amalgamate with a wholly owned subsidiary of NSAC I under the Business Corporations Act (British Columbia), and the amalgamated company will become a wholly owned subsidiary of the Combined Company.

Nuclea’s shareholders will receive Class A shares of the Combined Company valued at $10.00 per share. The number of shares is based on a valuation of Nuclea of $350 million, reduced by Nuclea’s indebtedness and other agreed debt-like items at closing and by Nuclea transaction expenses above $1.5 million, and increased by Nuclea’s cash at closing (excluding bridge financing proceeds) and by NSAC I transaction expenses above $1.5 million, less 500,000 Class A shares issuable to an advisor to Nuclea. Outstanding Nuclea options will roll over into options of the Combined Company.

Nuclea’s shareholders will also receive an aggregate of 5,000,000 Class A Earnout Shares, 5,000,000 Class B Earnout Shares and 5,000,000 Class C Earnout Shares of the Combined Company with no voting or economic rights, that will convert into publicly-traded Class A Shares of the Combined Company if, within four years of closing, the Combined Company: (i) achieves criticality in a molten salt reactor or criticality of recycled nuclear fuel (Class A Earnout Shares); (ii) receives acceptance of a license or permit to construct from a nuclear regulator for a demonstration nuclear facility (Class B Earnout Shares); and (iii) receives approvals for at least $100 million of grants, government funding (including government loans) or other non-dilutive project financing (Class C Earnout Shares).

The Boards of Directors of Nuclea and NSAC I have unanimously approved the Proposed Transaction. Nuclea shareholders holding at least 66 2/3% of Nuclea’s shares, including Sagar Sanghera and Vinayak Ashok Gunda, have entered into voting agreements in support of the Proposed Transaction, and NorthStrive Sponsor I LLC, NSAC I’s sponsor, and Sinamor LLC have entered into a support agreement with NSAC I and Nuclea. Sinamor LLC has also entered into a securities purchase agreement with NSAC I and the sponsor to acquire Class B ordinary shares of NSAC I. Following closing, the Combined Company is expected to be led by Nuclea’s current management team, including Josef Freundorfer as Chief Executive Officer and Sagar Sanghera as Executive Chairman.

The Proposed Transaction is expected to close in the first half of 2027, subject to the satisfaction or waiver of the closing conditions described above.

Additional information about the Proposed Transaction, including a copy of the Business Combination Agreement, will be provided in a Current Report on Form 8-K to be filed by NSAC I with the SEC and available at www.sec.gov.

Advisors

D. Boral Capital LLC (“D. Boral”) is acting as Financial and Capital Markets advisors to NorthStrive Acquisition Corp I. Sichenzia Ross Ference Carmel LLP is acting as U.S. legal advisor and Carey Olsen is acting as Cayman Islands legal advisor to NSAC I. Cozen O’Connor LLP is acting as Canadian legal advisor to NSAC I. Houlihan Capital, LLC provided a fairness opinion to the Board of Directors of NSAC I dated October 29, 2026. Mintz LLP is acting as legal advisor to Nuclea. Panthers Capital Management LLC is acting as advisor to Nuclea. NorthStrive Companies Inc., is acting as business and M&A advisors to NSAC I., GB Capital Ltd., is acting as financial advisors to NSAC I.

About Nuclea Energy Inc.

Headquartered in Mississauga, Ontario, Nuclea Energy Inc. is an advanced nuclear technology company dedicated to delivering clean, reliable energy. The company’s flagship innovation is the Morpheus Micro Modular Reactor (MMR), a transportable, factory-built, lead-cooled, graphite-moderated system scalable from 3.5 MWe to 50 MWe. Through its pending acquisition of Moltex, Nuclea aims to pioneer a closed nuclear fuel cycle business. By integrating the proprietary WATSS spent nuclear fuel recycling process with a diverse reactor portfolio including the Stable Salt Reactor-Wasteburner (SSR-W) Small Modular Reactor (SMR) and the Morpheus, Nuclea aims to commercialize sustainable waste recycling and next-generation zero-emission global power. For more information, visit www.nuclea.energy.

About NorthStrive Acquisition Corp I (Nasdaq: NSAI)

NorthStrive Acquisition Corp I is a blank check company incorporated as a Cayman Islands exempted company for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. NSAC I completed its initial public offering of $100 million on August 19, 2026, and is sponsored by NorthStrive Sponsor I LLC, a wholly owned subsidiary of PMGC Holdings Inc. (Nasdaq: ELAB).

Additional Information and Where to Find It

For additional information on the Proposed Transaction, see NSAC I’s Current Report on Form 8-K, which will be filed concurrently with this press release. In connection with the Proposed Transaction, NSAC I intends to file relevant materials with the SEC, including a registration statement on Form S-4, which will include a proxy statement/prospectus of NSAC I, and will file other documents regarding the Proposed Transaction with the SEC. NSAC I’s shareholders and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus and the amendments thereto and the definitive proxy statement and documents incorporated by reference therein filed in connection with the Proposed Transaction, as these materials will contain important information about Nuclea, NSAC I and the Proposed Transaction. Promptly after the Form S-4 is declared effective by the SEC, NSAC I will provide the definitive proxy statement/prospectus and a proxy card to each shareholder entitled to vote at the meeting relating to the approval of the business combination and other proposals set forth in the proxy statement/prospectus. Before making any voting or investment decision, investors and shareholders of NSAC I are urged to carefully read the entire registration statement and proxy statement/prospectus, when they become available, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, because they will contain important information about the Proposed Transaction. The documents filed by NSAC I with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, once available, copies of the registration statement, the proxy statement/prospectus and the other documents filed by NSAC I with the SEC may be obtained free of charge through the website maintained by the SEC at www.sec.gov. In addition, once available, copies of the registration statement, the proxy statement/prospectus and the other documents filed by NSAC I with the SEC may be obtained free of charge from NSAC I by directing a written request to NSAC I at 520 Newport Center Drive, Suite 470, Newport Beach, CA 92660, Attention: Michel Tamer, Chief Executive Officer, or by telephone at (888) 445-4886.

No Offer or Solicitation

This communication does not constitute, and should not be construed to be, a proxy statement or the solicitation of a proxy, a solicitation of any vote or approval, consent or authorization with respect to any securities or in respect of the Proposed Transaction described herein and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

Participants in the Solicitation

NSAC I and its directors and executive officers may be deemed participants in the solicitation of proxies from its shareholders with respect to the Proposed Transaction. A list of the names of those directors and executive officers and a description of their interests in NSAC I will be included in the proxy statement/prospectus for the Proposed Transaction when available at www.sec.gov. Information about NSAC I’s directors and executive officers and their ownership of NSAC I shares is set forth in NSAC I’s final prospectus dated August 17, 2026, filed with the SEC in connection with its initial public offering (File No. 333-297611). Other information regarding the interests of the participants in the proxy solicitation will be included in the proxy statement/prospectus pertaining to the Proposed Transaction when it becomes available. These documents can be obtained free of charge from the source indicated above.

Nuclea and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of NSAC I in connection with the Proposed Transaction. A list of the names of such directors and executive officers and information regarding their interests in the Proposed Transaction will be included in the proxy statement/prospectus for the Proposed Transaction.

Cautionary Statement Regarding Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as “will,” “would,” “are expected to,” “is anticipated,” “estimated,” “believe,” “could,” “intend,” “may,” “might,” “plan,” “projection,” “pro forma,” “should,” “outlook” or words of similar meaning. These forward-looking statements include, but are not limited to, statements regarding Nuclea’s industry and market sizes, future opportunities for Nuclea and NSAC I, Nuclea’s technology development and regulatory plans, the completion of the Moltex Acquisition, the bridge financing, the continuance of NSAC I to Canada, and the Proposed Transaction between NSAC I and Nuclea, including the expected transaction and ownership structure and the likelihood, timing and ability of the parties to successfully consummate the Proposed Transaction. Such forward-looking statements are based upon the current beliefs and expectations of NSAC I’s and Nuclea’s management and are inherently subject to significant business, economic, regulatory and competitive uncertainties and contingencies, many of which are difficult to predict and generally beyond NSAC I’s or Nuclea’s control. Actual results and the timing of events may differ materially from the results anticipated in these forward-looking statements. There can be no assurance that the Proposed Transaction will be consummated on the anticipated timeline or at all, or that, if consummated, the Combined Company’s securities will be approved for listing or remain listed on Nasdaq. Factors that could cause actual results to differ include, but are not limited to: (i) the risk that the Proposed Transaction may not be completed in a timely manner or at all, including by NSAC I’s deadline of August 19, 2027 to complete a business combination; (ii) the failure to satisfy the conditions to closing, including approval by the shareholders of NSAC I and Nuclea, the effectiveness of the registration statement on Form S-4, satisfaction of the minimum cash condition and approval of the Combined Company’s listing on Nasdaq; (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the Business Combination Agreement; (iv) the amount of redemption requests made by NSAC I’s public shareholders; (v) the risk that the Moltex Acquisition, including any required U.K. regulatory clearances, is not completed on the anticipated terms, by November 30, 2026 or at all; (vi) the ability to obtain audited and other financial statements of Nuclea and the Moltex business required for the registration statement on Form S-4, including whether the SEC grants relief from the requirement to include financial statements of Moltex or the acquired Moltex assets; (vii) risks related to the continuance of NSAC I to Canada and the amalgamation; (viii) the ability of Nuclea to obtain the nuclear regulatory licenses, permits and approvals required to develop, construct and operate its facilities and technologies, and the timing of any such approvals; (ix) the risk that Nuclea’s technologies, including the WATSS process and its reactor designs, may not be successfully developed, demonstrated, licensed or commercialized, and that Nuclea may never achieve criticality or the earnout milestones; (x) Nuclea’s ability to raise additional capital, including grants, government funding and other non-dilutive financing, on acceptable terms or at all; (xi) the outcome of any legal proceedings that may be instituted against the parties following the announcement of the Proposed Transaction; (xii) the ability of the Combined Company to meet Nasdaq’s initial and continued listing standards; (xiii) the costs related to the Proposed Transaction; (xiv) changes in applicable laws, regulations and government policy relating to nuclear energy; and (xv) other risks and uncertainties to be included in the registration statement on Form S-4, including under the heading “Risk Factors,” and in NSAC I’s other filings with the SEC. All subsequent written and oral forward-looking statements concerning Nuclea and NSAC I or the Combined Company, the transactions described herein, or other matters and attributable to Nuclea and NSAC I or the Combined Company, or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as required by law, NSAC I and Nuclea do not undertake any obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

CONTACT: Contacts
Nuclea Energy Inc.
Josef Freundorfer, Chief Executive Officer
ir@nuclea.energy

NorthStrive Acquisition Corp I
Michel Tamer, Chief Executive Officer

Dealflow@northstrivespac1.com