Month: October 2026

Third-quarter royalty revenue up 51% year-over-year to $70.3 million

Raises Full-Year 2026 Adjusted Diluted EPS Guidance to $9.50 to $9.75, from $9.00 to $9.50¹; Reaffirms Revenue Guidance

Conference call begins at 8:30 a.m. Eastern Time today

JUPITER, Fla., Oct. 29, 2026 (GLOBE NEWSWIRE) — Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today reported financial results for the three and nine months ended September 30, 2026, and provided an operating forecast and business update. Ligand management will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the results and answer questions.

“Ligand delivered another strong quarter, with royalty revenue growing 51% year-over-year, driven by contribution from the XOMA portfolio and continued commercial momentum across our key royalty assets, including Filspari,” said Todd Davis, CEO of Ligand. “We also continued to put capital to work in differentiated assets, acquiring a royalty interest in Santen’s Ryjunea and entering into a structured financing agreement with AvenCell Therapeutics to advance its next-generation CAR-T pipeline. With a strong balance sheet and a portfolio of over 200 assets, we are well positioned to continue executing our royalty aggregation strategy, and we look forward to sharing an updated five-year outlook at our investor day on December 8th.”

Financial Results

Third Quarter 2026 Financial Results

Third-quarter 2026 results reflect continued strength in the royalty business, with royalty revenue increasing 51% year-over-year to $70.3 million, compared with $46.6 million for the prior-year period. Royalties accounted for 89% of total revenues and income in the quarter, with growth driven by the newly acquired XOMA assets and continued momentum across Ligand’s key commercial portfolio, including Travere Therapeutics’ Filspari and Merck’s Ohtuvayre.

Total revenues and income for the third quarter of 2026 were $78.7 million, compared with $115.5 million for the prior-year period, representing a decrease of 32%. The prior-year period included $53.1 million of Pelthos divestiture-related income (see Pelthos note below). Excluding that income, total revenues and income increased 26%. Captisol^® sales were $7.9 million, compared with $10.7 million, reflecting the timing of customer orders. Contract revenue and income were $0.5 million, compared with $58.2 million, with the decrease primarily due to the prior-year Pelthos divestiture-related income.

Cost of Captisol was $2.7 million for the third quarter of 2026, compared with $3.8 million for the prior-year period, with the decrease primarily attributable to lower Captisol sales. Amortization of intangibles was $10.2 million, compared with $8.1 million for the prior-year period, with the increase attributable to the intangibles acquired from the XOMA acquisition. Research and development expense was $2.8 million, compared with $21.0 million for the prior-year period, with the decrease primarily attributable to a $17.8 million charge recognized in the prior-year period related to the research and development funding arrangement associated with the AVIM Therapy royalty rights acquired in the Orchestra BioMed transaction. General and administrative expense was $72.6 million, compared with $28.4 million for the prior-year period. The increase primarily reflects transaction and integration costs and share-based compensation associated with the XOMA acquisition, as well as higher employee-related costs from the expansion of Ligand’s portfolio management and origination platform to scale its royalty portfolio. Fair value adjustments to contingent liabilities resulted in a $6.3 million loss in the third quarter of 2026, compared with a $0.5 million gain in the prior-year period. The change was primarily driven by fair value adjustments related to contingent liabilities assumed in the XOMA acquisition.

Net non-operating expense was $28.3 million for the third quarter of 2026, compared with net non-operating income of $85.8 million for the prior-year period. The change was primarily attributable to non-cash mark-to-market losses on equity-method investments and other investments, as well as net loss from short-term investments during the third quarter of 2026, compared with gains in the prior-year period.

GAAP net loss was $28.5 million, or $1.43 per share, for the third quarter of 2026, compared with GAAP net income of $117.3 million, or $5.68 per diluted share, for the prior-year period. Results for the third-quarter of 2026 included $39.5 million of pre-tax losses, consisting of a $35.7 million loss from changes in the fair value of equity-method and other investments and a $3.8 million net loss on short-term investments.

Adjusted net income was $57.5 million, or $2.67 per diluted share, compared with $63.8 million, or $3.09 per diluted share, for the prior-year period, representing decreases of 10% and 14%, respectively. The decreases were primarily attributable to the $24.5 million of Pelthos out-license income recognized in the prior-year period (see Pelthos note below) and higher general and administrative expense excluding share-based compensation and transaction and integration costs, partially offset by the 51% increase in royalty revenue. Adjusted net income is a non-GAAP financial measure. See the table below for a reconciliation of GAAP net (loss) income to adjusted net income.

Pelthos note: Prior-year results included $53.1 million of income related to Pelthos. Of that, $24.5 million was attributable to the Zelsuvmi out-license and was included in core revenues, and the $28.6 million gain on the sale was excluded. Growth rates that exclude this income compare the periods on a like-for-like basis.

Year-to-Date Financial Results

Royalty revenue for the nine months ended September 30, 2026 increased 46% to $161.3 million, compared with $110.5 million for the prior-year period, and accounted for 83% of total revenues and income. Royalty growth was primarily driven by the newly acquired XOMA assets and continued momentum across Ligand’s key commercial portfolio, including Travere Therapeutics’ Filspari and Merck’s Ohtuvayre. Total revenues and income were $194.2 million, compared with $208.4 million, representing a decrease of 7%. The prior-year period included $53.1 million of Pelthos divestiture-related income (see Pelthos note above). Excluding that income, total revenues and income increased 25%. Captisol sales were $24.6 million, compared with $32.4 million, reflecting the timing of customer orders. Contract revenue and income were $8.3 million, compared with $65.5 million, with the decrease primarily due to the prior-year Pelthos divestiture-related income.

Cost of Captisol for the nine months ended September 30, 2026 was $9.1 million, compared with $11.6 million for the prior-year period, with the decrease primarily attributable to lower Captisol sales. Amortization of intangibles was $26.4 million, compared with $24.6 million for the prior-year period, with the increase attributable to the intangibles acquired from the XOMA acquisition. Research and development expense was $19.6 million, compared with $77.7 million for the prior-year period, reflecting several prior-year charges: $44.3 million for the research and development funding arrangement associated with the D-Fi royalty rights acquired in the Castle Creek transaction, $17.8 million for the arrangement associated with the AVIM Therapy royalty rights acquired in the Orchestra BioMed transaction, and $6.4 million related to Ligand’s former Pelthos business. This was partially offset by $12.3 million of research and development funding arrangement expense recognized in the current-year period related to Orchestra BioMed. General and administrative expense was $122.6 million, compared with $67.4 million for the prior-year period. The increase primarily reflects transaction and integration costs and share-based compensation associated with the XOMA acquisition, as well as higher employee-related costs, including increased headcount, from the expansion of Ligand’s portfolio management and origination platform to scale its larger royalty portfolio.

Net non-operating expense was $14.7 million for the nine months ended September 30, 2026, compared with net non-operating income of $76.5 million for the prior-year period. The change was primarily attributable to non-cash mark-to-market losses on equity-method investments and other investments during the nine months ended September 30, 2026, compared with non-cash gains recognized in the prior-year period, partially offset by higher gains on short-term investments and higher net interest income.

GAAP net income was $6.7 million, or $0.31 per diluted share, for the nine months ended September 30, 2026, compared with $79.7 million, or $3.95 per diluted share, for the prior-year period. Results for the nine months ended September 30, 2026 included a $49.2 million pre-tax, non-cash loss from change in fair value of equity-method investments and other investments.

Adjusted net income was $142.9 million, or $6.67 per diluted share, compared with $122.4 million, or $6.07 per diluted share, for the prior-year period, representing year-over-year increases of 17% and 10%, respectively. The increase was primarily attributable to the 46% increase in royalty revenue, higher net interest income and realized gains on short-term investments, partially offset by higher general and administrative expense. Adjusted net income is a non-GAAP financial measure. See the table below for a reconciliation of GAAP net (loss) income to adjusted net income.

Adjusted Financial Measures

Ligand reports adjusted net income and adjusted earnings per diluted share in addition to, and not as a substitute for, financial measures calculated in accordance with GAAP, and does not consider such measures superior to GAAP results. The Company also reports “core” versions of these measures, which exclude any gains on the sale of the Pelthos business.

Adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to evaluate management performance and determine certain elements of management compensation. GAAP results include items such as share‑based compensation expense, amortization of acquisition‑related and intangible assets, changes in contingent liabilities, mark‑to‑market adjustments on investments in public companies, transaction‑related costs and related tax effects, which are excluded from adjusted results and are detailed in the reconciliations included at the end of this press release.

This press release includes adjusted total revenues and income, which excludes all $53.1 million of Pelthos-related income recognized in the prior-year period, including the portion attributed to out-license fees. Ligand believes the adjusted total revenues and income is a more meaningful indicator of its business performance than the GAAP total revenues and income.

Liquidity and Capital Resources

As of September 30, 2026, Ligand had cash, cash equivalents, and short-term investments of $447.4 million, compared with $733.5 million at December 31, 2025. The decrease was primarily driven by cash used for the XOMA acquisition, partially offset by the proceeds from the Company’s issuance of its convertible senior notes due 2031. As of September 30, 2026, including its equity investments and availability under its credit facility, Ligand has approximately $750 million of deployable capital available to pursue additional royalty acquisitions and strategic investments.

2026 Financial Guidance

Ligand is raising its 2026 full year adjusted earnings per diluted share guidance and reaffirming its 2026 revenue guidance. Ligand now expects the following:

• Royalty revenue of $225 million to $250 million (unchanged)
• Captisol sales of $35 million to $40 million (unchanged)
• Contract revenue of $10 million to $20 million (unchanged)
• Total revenue of $270 million to $310 million (unchanged)
• Adjusted earnings per diluted share² of approximately $9.50 to $9.75, raised from approximately $9.00 to $9.50

Third Quarter Corporate Highlights

On July 14, 2026, Ligand completed the acquisition of XOMA Royalty, a biotechnology royalty aggregator. The acquisition strengthens Ligand’s royalty portfolio by adding seven commercial products, including Roche’s VABYSMO® (faricimab-svoa), Servier and Ipsen’s OJEMDA™ (tovorafenib), and Zevra Therapeutics’ MIPLYFFA® (arimoclomol). Additionally, the acquisition adds 14 late-stage development programs, featuring Takeda’s mezagitamab and certain assets from Takeda’s externalized asset portfolio, including osavampator, volixibat, and OHB-607, along with more than 100 additional assets in various stages of development to Ligand’s portfolio. As a result, Ligand’s portfolio has more than doubled in size, now comprising over 200 commercial, clinical, and preclinical stage royalty assets.

On September 22, 2026, Ligand announced the acquisition of a milestone and royalty interest in Santen Pharmaceutical’s Ryjunea from Sydnexis for a $23 million upfront payment. Under the terms of the agreement, Ligand acquired a 100% interest in certain payments and related rights under Sydnexis’s existing license agreement with Santen. The acquired payment rights include a tiered low-double-digit to high-teens royalty on Ryjunea net sales in Europe, the Middle East and Africa, as well as certain milestone payments.

On September 24, 2026, Ligand announced it entered into a financing agreement with AvenCell Therapeutics, Inc., a clinical-stage cell therapy company developing controllable, allogeneic CAR-T therapies for patients with cancer, for up to $47 million. The investment is expected to help advance AvenCell’s pipeline, including AVC-201 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and AVC-203 for the treatment of B-cell malignancies. Under the terms of the agreement, Ligand has committed up to $41 million in exchange for a mid single-digit to low double-digit royalty on worldwide annual net sales of all current and future AvenCell pipeline assets, with the applicable rate determined based on the total amount ultimately funded. The capital will be funded in four tranches, with the first tranche payable at closing, and the remaining three tranches payable upon achievement of certain predetermined clinical milestones and other specified financing conditions. Ligand has also committed up to $6 million in AvenCell’s concomitant Series C financing.

Key Portfolio Developments

Qtorin rapamycin	On August 4, 2026, Palvella announced that it plans to initiate a Phase 3 trial of Qtorin rapamycin for the treatment of cutaneous venous malformations in the fourth quarter of 2026. Palvella is planning a resubmission to the FDA for Breakthrough Therapy Designation incorporating TOIVA patient interview transcripts and new 24-week data. On October 28, 2026, Palvella announced the FDA accepted for filing and granted Priority Review of the New Drug Application (“NDA”) for Qtorin rapamycin for the treatment of microcystic lymphatic malformations (“microcystic LMs”). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027. Palvella is preparing for a potential U.S. commercial launch in the first half of 2027, subject to FDA approval.
AVIM Therapy/VIRTUE SAB	On August 10, 2026, Orchestra BioMed highlighted several recent business updates: The FDA granted AVIM Therapy a second FDA Breakthrough Device Designation (“BDD”) specific to patients with uncontrolled hypertension despite anti-hypertensive medication who are indicated for a pacemaker. The Virtue Sirolimus AngioInfusion (“Virtue SAB”) pivotal trial is advancing with further site activations and patient enrollments. On October 1, 2026, Orchestra BioMed announced it surpassed full enrollment in the BACKBEAT global pivotal trial of AVIM Therapy with 330 patients randomized, exceeding its previously announced target of 316 randomized patients.
Zelsuvmi	On August 13, 2026, Pelthos announced several recent business updates: 11,925 Zelsuvmi units were dispensed by 4,571 unique prescribers during the second quarter of 2026, representing a 48% quarter-over-quarter increase. More than 25,000 patients have now been prescribed Zelsuvmi since it was commercially launched in July 2025. Pelthos expects to launch Xepi in the first quarter of 2027.
Lasofoxifene	On August 14, 2026, LeonaBio announced it is on track to complete enrollment of approximately 600 patients in the Phase 3 Elaine-3 clinical trial evaluating lasofoxifene in ER-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer in the fourth quarter of 2026 with topline data expected in the second half of 2027.
Ojemda	On September 16, 2026, Ipsen announced the Japanese Ministry of Health, Labour and Welfare (“MHLW”) approved Ojemda for low-grade glioma harboring a BRAF mutation or fusion gene.
Volixibat	On August 5, 2026, Mirum Pharmaceuticals announced volixibat was granted Breakthrough Therapy Designation for cholestatic pruritus due to primary sclerosing cholangitis (PSC). Additionally, a pre-NDA meeting was held for volixibat in cholestatic pruritus due to PSC and additional discussions are planned before potential NDA submission. On August 5, 2026, Mirum Pharmaceuticals announced enrollment was completed in the VANTAGE Phase 2b study of volixibat in cholestatic pruritus due to primary biliary cholangitis (PBC) with topline results expected in the first quarter of 2027.
Ersodetug	On September 9, 2026, Rezolute provided an update on the FDA’s review of data from its Phase 3 sunRIZE study of ersodetug for hypoglycemia due to congenital hyperinsulinism (“HI”). The study’s open-label extension is ongoing, with high participation and several indicators of improved glycemic control, including a notable reduction in the use of background standard-of-care therapies. On October 5, 2026, Rezolute announced that following a preliminary review of detailed data from the Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital HI, the FDA recommended a pre-BLA meeting with Rezolute as a precursor to submitting a BLA. On October 14, 2026, Rezolute announced completion of enrollment in the Phase 3 study of ersodetug in tumor HI and topline data is expected mid-December 2026.
Soticlestat	On August 13, 2026, Ovid announced a newly formed portfolio company with funds advised by Perceptive Advisors acquired global rights to soticlestat. Ovid secured equity in the company and the potential to receive regulatory and sales milestone payments and royalties upon success. Ligand is entitled to royalties and a share of milestones received by Ovid.
IV ganaxolone	On October 26, 2026, Immedica announced that it will advance the development of intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE) and plans to initiate a new phase 3 clinical study in 2027. Ligand is entitled to royalties, milestones and revenue from Captisol material sales.

Conference Call and Webcast

Ligand management will host a conference call today beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss its results and answer questions. To participate via telephone, please dial (833) 461-5787 using the conference ID 708822080. International participants outside of Canada may use the toll number +1(585) 542-9983. To participate via live or replay webcast, a link is available at www.ligand.com.

About Ligand Pharmaceuticals

Ligand is a leading royalty aggregator, partnering with biopharmaceutical companies to finance and advance late-stage clinical development programs. Ligand owns and manages one of the largest and most diversified portfolios of biopharmaceutical royalties in the industry, with economic interests in more than 200 development and commercial-stage assets. Ligand funds high-value programs in exchange for long-term economic interests, aligning capital with clinical and commercial success. Ligand’s royalty portfolio is designed to deliver consistent and predictable revenue streams across a broad range of therapeutic assets. Ligand also licenses its proprietary technologies, Captisol® and NITRICIL™, to support drug development and formulation across its global partner network. For more information, visit www.ligand.com or follow Ligand on X and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, regarding Ligand’s current expectations. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only as of the date hereof. These forward-looking statements include, without limitation, Ligand’s ability to expand its portfolio with life sciences royalty opportunities; the timing of clinical and regulatory events of Ligand’s partners and other commercialization and marketing efforts; the timing of the initiation or completion of preclinical studies and clinical trials by Ligand and its partners; the timing of product launches by Ligand or its partners; and guidance regarding projected 2026 financial results. Actual events or results may differ from Ligand’s expectations due to risks and uncertainties inherent in Ligand’s business, including, without limitation: Ligand relies on collaborative partners for milestone payments, royalties, materials revenue, contract payments and other revenue projections and may not receive expected revenue; royalty revenue and income for partners that had not reported product sales as of the date of this press release are based on estimates that may differ from actual results and if such results differ they will be adjusted in future periods; Ligand may not receive expected revenue from Captisol material sales; Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline or receive regulatory approval and there may not be a market for the product(s) even if successfully developed and approved; Ligand may not achieve its financial guidance for 2026; Ligand faces competition in acquiring royalties and locating suitable royalties to acquire; Ligand may not be able to create future revenues and cash flows through the acquisition of royalties or by developing innovative therapeutics; products under development by Ligand or its partners may not receive regulatory approval; the total addressable market for our partners’ products may be smaller than estimated; Ligand faces competition with respect to its technology platforms which may demonstrate greater market acceptance or superiority; Ligand is currently dependent on a single source supplier for Captisol and failures by such supplier may result in delays or inability to meet the Captisol demands of its partners; Ligand’s partners may change their development focus and may not execute on their sales and marketing plans for marketed products for which Ligand has an economic interest; Ligand’s collaboration partners may become insolvent; Ligand’s and its partners’ products may not be proved to be safe and efficacious and may not perform as expected and uncertainty regarding the commercial performance of such products; Ligand or its partners may not be able to protect their intellectual property and patents covering certain products and technologies may be challenged or invalidated; cyber-attacks or other failures in telecommunications or information technology systems could result in information theft, data corruption and significant disruption to Ligand’s business operations; Ligand’s partners may terminate any of their agreements or the development or commercialization of any of its products; Ligand and its partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, challenges, costs and charges associated with integrating acquisitions with Ligand’s existing businesses; Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs; restrictions under Ligand’s credit agreement may limit its flexibility in operating its business and a default under the agreement could result in a foreclosure of the collateral securing such obligations; Ligand may not realize the anticipated benefits from investments in financing instruments such as convertible notes, including the 2031 Notes; Ligand may not successfully integrate the XOMA portfolio or realize the anticipated benefits of the XOMA acquisition; and changes in general economic conditions, including as a result of war, conflict, epidemic diseases, the imposition and/or announcement of tariffs and ongoing or future litigation could expose Ligand to significant liabilities and have a material adverse effect on the Company. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand’s stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand’s public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release, including the possibility of additional license fees and milestone revenues we may receive. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Other Disclaimers and Trademarks

The information in this press release regarding certain third-party products and programs, including Lasofoxifene, a LeonaBio product, AVIM Therapy and Virtue SAB, Orchestra products, Filspari, a Travere Therapeutics product, Ohtuvayre and Capvaxive, Merck products, Qtorin rapamycin, a Palvella Therapeutics product candidate, Vabysmo, a Roche product, Ojemda, a Servier and Ipsen product, Miplyffa, a Zevra Therapeutics product, mezagitamab, osavampator and OHB-607, Takeda product candidates, volixibat, a Mirum Pharmaceuticals product candidate, Ryjunea, a Santen product, AVC-201 and AVC-203, AvenCell Therapeutics product candidates, ersodetug, a Rezolute product candidate, soticlestat, an Ovid Therapeutics product candidate, and Zelsuvmi, a Pelthos Therapeutics product, comes from information publicly released by the owners of such products and programs. Ligand is not responsible for, and has no role in, the development of such products or programs.

Ligand owns or has rights to trademarks and copyrights that it uses in connection with the operation of its business including its corporate name, logos and websites. Other trademarks and copyrights appearing in this press release are the property of their respective owners. The trademarks Ligand owns include Ligand, Captisol, NITRICIL and Zelsuvmi. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the®,© and™ symbols, but Ligand will assert, to the fullest extent under applicable law, its rights to its trademarks and copyrights.

References to “Ligand,” the “Company,” “we,” “our” and similar expressions include Ligand Pharmaceuticals Incorporated and our wholly-owned subsidiaries.

Contacts:

Investors:                                 

Melanie Herman
investors@ligand.com
(858) 550-7761

Media:

Kellie Walsh
media@ligand.com
(914) 315-6072

[Tables Follow]

LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
	Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Revenues and income:
Revenue from intangible royalty assets	$	47,427			$	40,161			$	117,720			$	91,832
Income from financial royalty assets		22,857				6,425				43,554				18,640
Royalties		70,284				46,586				161,274				110,472
Captisol		7,946				10,672				24,578				32,419
Income from Pelthos transaction – Zelsuvmi out-license		—				24,503				—				24,503
Income from Pelthos transaction – gain on the sale of the Pelthos business		—				28,569				—				28,569
Other		516				5,131				8,309				12,458
Contract revenue and income		516				58,203				8,309				65,530
Total revenues and income		78,746				115,461				194,161				208,421
Operating costs and expenses:
Cost of Captisol		2,650				3,801				9,137				11,557
Amortization of intangibles		10,205				8,097				26,399				24,612
Research and development		2,766				21,019				19,582				77,671
General and administrative		72,616				28,446				122,575				67,422
Fair value adjustments to contingent liabilities		6,267				(456	)			5,775				1,475
Fair value adjustments to partner program derivatives		—				(833	)			—				—
Total operating costs and expenses		94,504				60,074				183,468				182,737
Operating (loss) income		(15,758	)			55,387				10,693				25,684
Non-operating income and expenses:
(Loss) gain from short-term investments		(3,817	)			7,798				11,806				(3,630	)
(Loss) gain from change in fair value of equity-method investments and other investments		(35,727	)			75,887				(49,229	)			75,887
Interest income, net		2,594				2,964				13,052				4,336
Other non-operating expense, net		8,614				(899	)			9,629				(97	)
Total non-operating (expenses) income, net		(28,336	)			85,750				(14,742	)			76,496
(Loss) income before income taxes		(44,094	)			141,137				(4,049	)			102,180
Income tax benefit (expense)		15,609				(23,864	)			10,727				(22,511	)
Net (loss) income	$	(28,485	)		$	117,273			$	6,678			$	79,669
Basic net (loss) income per share	$	(1.43	)		$	5.99			$	0.33			$	4.11
Shares used in basic per share calculation		19,962				19,578				19,970				19,367
Diluted net (loss) income per share	$	(1.43	)		$	5.68			$	0.31			$	3.95
Shares used in diluted per share calculation		19,962				20,629				21,822				20,170

LIGAND PHARMACEUTICALS INCORPORATED
SELECTED BALANCE SHEET DATA
(unaudited, in thousands)
	September 30, 2026				December 31, 2025
Cash, cash equivalents and short-term investments	$	447,395			$	733,521
Accounts receivable, net		83,221				59,601
Total current and non-current financial royalty assets, net		800,114				219,669
Goodwill and intangible assets, net		509,899				326,979
Equity method investments		48,445				46,500
Other investments		94,479				121,451
Deferred income taxes, net		104,117				8,345
Total assets		2,237,462				1,560,637
Accounts payable and accrued liabilities		39,760				34,691
Total current and non-current contingent liabilities		38,867				3,221
Convertible senior notes, net		1,128,217				446,192
Total liabilities		1,275,699				543,425
Total stockholders’ equity	$	961,763			$	1,017,212

LIGAND PHARMACEUTICALS INCORPORATED
ADJUSTED FINANCIAL MEASURES
(Unaudited, in thousands, except per share amounts)

	Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Net (loss) income	$	(28,485	)		$	117,273			$	6,678			$	79,669
Adjustments:
Share-based compensation expense(1)		29,026				14,746				53,275				32,579
Non-cash interest expense(2)		1,393				447				2,209				2,263
Amortization of intangible assets		10,205				8,097				26,399				24,612
Amortization of financial royalty assets(3)		4,411				4,327				6,857				11,069
Change in contingent liabilities(4)		6,267				(456	)			5,775				1,475
Pelthos operating loss		—				—				—				13,212
Loss (gain) from short-term investments		3,817				(7,798	)			(11,806	)			3,630
Realized gain (loss) from short-term investments		2,904				(2	)			13,635				(22	)
Transaction and integration costs(5)		23,900				4,815				28,911				4,815
Provision for current expected credit losses on financial royalty assets		6,641				26				6,440				(724	)
R&D funding expenses		—				18,659				12,328				64,686
(Gain) loss from derivative assets		(8,544	)			(111	)			(9,076	)			134
Loss (gain) from change in fair value of equity-method investments and other investments(6)		35,727				(75,887	)			49,229				(75,887	)
Income from Pelthos transaction – gain on the sale of the Pelthos business(7)		—				(28,569	)			—				(28,569	)
Other		(307	)			166				(277	)			(1,612	)
Income tax effect of adjusted reconciling items above		(28,178	)			9,359				(39,832	)			(6,862	)
Excess tax benefit from share-based compensation(8)		(1,325	)			(1,260	)			(7,890	)			(2,073	)
Adjusted net income	$	57,452			$	63,832			$	142,855			$	122,395
Total revenues and income	$	78,746			$	115,461			$	194,161			$	208,421
Less: Income from Pelthos transaction – gain on the sale of the Pelthos business(7)		—				(28,569	)			—				(28,569	)
Core revenues and income	$	78,746			$	86,892			$	194,161			$	179,852
Diluted per-share amounts attributable to common stockholders:
Diluted net (loss) income per share	$	(1.43	)		$	5.68			$	0.31			$	3.95
Adjustments:
Share-based compensation expense(1)		1.35				0.71				2.49				1.62
Non-cash interest expense(2)		0.06				0.02				0.10				0.11
Amortization of intangible assets		0.47				0.39				1.23				1.22
Amortization of financial royalty assets(3)		0.20				0.21				0.32				0.55
Change in contingent liabilities(4)		0.29				(0.02	)			0.27				0.07
Pelthos operating loss		—				—				—				0.66
Loss (gain) from short-term investments		0.18				(0.38	)			(0.55	)			0.18
Realized gain (loss) from short-term investments		0.13				—				0.64				—
Transaction and integration costs(5)		1.11				0.23				1.35				0.24
Provision for current expected credit losses on financial royalty assets		0.31				—				0.30				(0.04	)
R&D funding expenses		—				0.90				0.58				3.21
(Gain) loss from derivative assets		(0.40	)			(0.01	)			(0.42	)			0.01
Loss (gain) from change in fair value of equity-method investments and other investments(6)		1.66				(3.68	)			2.30				(3.76	)
Income from Pelthos transaction – gain on the sale of the Pelthos business(7)		—				(1.38	)			—				(1.42	)
Other		(0.01	)			0.02				(0.01	)			(0.08	)
Income tax effect of adjusted reconciling items above		(1.30	)			0.46				(1.88	)			(0.35	)
Excess tax benefit from share-based compensation(8)		(0.06	)			(0.06	)			(0.37	)			(0.10	)
Adjustment for shares excluded due to anti-dilution effect on GAAP net loss		0.11				—				0.01				—
Adjusted earnings per diluted share	$	2.67			$	3.09			$	6.67			$	6.07
GAAP – weighted average number of common shares – diluted		19,962				20,629				21,822				20,170
Diluted effect of the convertible senior notes		—				—				(420	)			—
Shares excluded due to anti-dilutive effect on GAAP net loss		1,593				—				—				—
Adjusted weighted average number of common shares – diluted		21,555				20,629				21,402				20,170

(1) Amounts include a $10.8 million of share-based compensation expense recognized during the three and nine months ended September 30, 2026, related to the cash settlement of XOMA equity awards, which represents the portion attributable to the post-combination service period.

(2) Amounts represent (a) non-cash interest expense in connection with the royalty and milestone payments purchase agreement assumed as part of the Novan acquisition in September 2023; (b) non-cash debt related costs that are calculated in accordance with the authoritative accounting guidance for our convertible debt instruments that may be settled in cash and revolving credit facility; and (c) non-cash interest income from notes receivable.

(3) Amounts represent a portion of the contract payments and royalty receipts that are applied to reduce the carrying balance of our financial royalty assets.

(4) Amounts represent fair value adjustments to contingent liabilities assumed in the XOMA acquisition and those related to the CyDex and Metabasis transactions.

(5) Amounts represent (a) costs of $14.2 million and $19.1 million for the three and nine months ended September 30, 2026, respectively, related to the acquisition of XOMA, consisting primarily of advisory, legal and accounting fees; (b) severance costs and other integration related costs associated with the XOMA acquisition; and (c) costs related to other business development transactions.

(6) Amounts represent gains or losses from changes in the fair value of the Pelthos equity-method investment and Pelthos Series A Preferred Shares.

(7) During the third quarter of 2025, the Company recognized $53.1 million of income related to the divestiture of its Pelthos subsidiary, consisting of $24.5 million associated with the out-license of Zelsuvmi and a $28.6 million gain on the sale of the business. The full $53.1 million was recognized in contract revenue and income. For purposes of adjusted net income, management included the $24.5 million attributable to the out-license of Zelsuvmi and excluded the $28.6 million gain on the sale of the business. Management believes this presentation enhances transparency and comparability by reflecting the license-related component within ongoing operating results while excluding the gain associated with the sale of the business.

(8) Excess tax benefit from share-based compensation is recorded as a discrete item within the provision for income taxes on the consolidated statements of operations as a result of the adoption of an accounting pronouncement (ASU 2016-09) on January 1, 2017. Prior to the adoption, the amount was recognized in additional paid-in capital on the consolidated statement of stockholders’ equity.

---

¹ A reconciliation of forward-looking non-GAAP adjusted earnings per diluted share to the most directly comparable GAAP measure is not available without unreasonable effort, as certain items cannot be reasonably predicted because of their high variability, complexity and low visibility. Specifically, non-cash adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items, directly impact the calculation of our core adjusted earnings per diluted share.
² A reconciliation of forward-looking non-GAAP adjusted earnings per diluted share to the most directly comparable GAAP measure is not available without unreasonable effort, as certain items cannot be reasonably predicted because of their high variability, complexity and low visibility. Specifically, non-cash adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items, directly impact the calculation of our core adjusted earnings per diluted share.

SAN JOSE, Calif., Oct. 29, 2026 (GLOBE NEWSWIRE) — Legence Corp. (Nasdaq: LGN) (“Legence” or the “Company”) today announced that it will release results for the third quarter ended September 30, 2026 on Thursday, November 12, 2026, prior to the market open.  

In conjunction with the release, the Company will host an earnings conference call and webcast to review the results and its operations on Thursday, November 12, 2026, at 10:00 am EST. The call will be broadcast live in listen-only mode.   The webcast link to the call and the slide presentation to accompany the earnings release can be accessed on the Company’s website at https://investors.wearelegence.com/. Shortly after completion of the call, a replay of the webcast will be available on the Company’s website using the same link. The replay will be available through December 12, 2026.

About Legence
Legence is a leading provider of engineering, consulting, installation, and maintenance services for mission-critical systems in buildings. The company specializes in designing, fabricating, and installing complex HVAC, process piping, and other mechanical, electrical and plumbing (MEP) systems—enhancing energy efficiency, reliability, and sustainability in new and existing facilities. Legence also delivers long-term performance through strategic upgrades and holistic solutions. Serving some of the world’s most technically demanding sectors, Legence counts over 60% of the Nasdaq-100 Index among its clients.

Contact
Media: media@wearelegence.com
Investor Relations: ir@wearelegence.com

DEL Technology Integrating C4T’s Cereblon Library Can Rapidly Advance Projects Into Hit-To-Lead Stage

WATERTOWN, Mass., Oct. 29, 2026 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science, today highlighted its novel DNA-encoded library (DEL) that leverages C4T’s large library of cereblon-binding ligands and screening capabilities in a presentation at the 9^th Annual Targeted Protein Degradation Summit in Boston titled “Target-First Discovery of Molecular Glue Degraders Using DNA-Encoded Libraries.”

“Our new DEL capability captures both our strong track record of investing in cereblon and driving innovation across targeted protein degradation science to create a differentiated engine for generating new drug discovery opportunities,” said Scott Boyle, chief business officer of C4 Therapeutics. “To date, this new technology has shown it can deliver attractive hits against high-value targets within four months and further enhances the speed and precision of our discovery efforts. We are eager to push the boundaries of this library and our rapid screening process with diverse and undruggable targets both for our own internal pipeline and alongside future partners.”

Integrated within C4T’s TORPEDO^® platform, the addition of DEL creates a powerful hit-finding engine that enables the rapid development of targeted protein degraders. C4T has integrated the company’s cereblon-binding ligand libraries into its DEL capability, which has helped develop a diverse library unique to C4T. The target-first approach integrated into C4T’s DEL technology further enables rapid evaluation, validation, characterization and development of molecular glue degraders.

C4T has validated this DEL capability by identifying both known and novel molecular glue degrader hits for VAV1, which C4T does not plan to advance without a partner. Led by its target-first approach, C4T has also screened a range of high-value targets where degradation turns undruggable to druggable or provides a therapeutic benefit relative to inhibitors; this has identified hits for additional undisclosed targets. C4T remains focused on advancing cemsidomide through clinical development and its discovery strategy centered around undisclosed targets that drive inflammation, neuroinflammation and neurodegenerative diseases.

C4T will highlight this new capability and more information on the VAV1 target in a presentation at the 9^th Annual Targeted Protein Degradation Summit on October 29, 2026. The presentation is available on C4T’s website, under Scientific Presentations and Publications.

About the TORPEDO^® Platform
The proprietary TORPEDO^® platform drives C4 Therapeutics’ (C4T) efforts to create a new generation of small molecule medicines centered around heterobivalent degraders (BiDAC^™ degraders), molecular glue degraders (MonoDAC^® degraders) and degrader-antibody conjugates (DACs). A DNA-encoded library (DEL) that leverages C4T’s cereblon binder library alongside machine learning and artificial intelligence serves as a rapid hit-finding engine. Once a hit is identified, the TORPEDO platform utilizes diverse chemical libraries, degrader design assisted by structural biology, ternary complex models and proteomics, allowing C4T’s scientists to rapidly design degraders with properties that enhance catalytic degradation turnover and drug performance that directly impact disease.

About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO^® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com.

Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to discover or develop potential therapies for patients; the capabilities and potential benefits of our DEL and its ability to accelerate drug discovery; the capabilities of the TORPEDO^® platform; the advancement, timing, progress and potential benefits of our discovery and clinical programs, including cemsidomide; the potential for future collaborations, partnerships, milestone or royalty payments; and our ability to fund its future operations. Any forward-looking statements in this press release are based on management’s current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks inherent in drug discovery and development; the risk that screening results or identified hits may not be reproducible, validated or successfully translated into product candidates; the risk that the results of preclinical studies and/or clinical trials will not be predictive of results from future studies or trials; the timing and outcome of regulatory submissions or interactions; and the risk that any one or more of our programs or product candidates will cost more to develop or may not be successfully developed and commercialized. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in C4 Therapeutics’ most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4 Therapeutics undertakes no duty to update this information unless required by law.

Contacts:
Investors: 
Courtney Solberg
Associate Director, Investor Relations
CSolberg@c4therapeutics.com

Media: 
Loraine Spreen 
Senior Director, Corporate Communications & Patient Advocacy 
LSpreen@c4therapeutics.com

NORWOOD, Mass., Oct. 29, 2026 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQB: MRMD), a leading multi-state cannabis operator focused on improving lives every day, today announced that the Company’s Stockholders approved a proposed reverse stock split of the Company’s common stock (the “Reverse Stock Split”) at a Special Meeting of Stockholders (the “Special Meeting”) held October 28, 2026.

“I want to thank our Shareholders for their overwhelming support in approving the Reverse Stock Split proposal and authorizing our Board to determine whether and when to implement it,” said Jon Levine, Chief Executive Officer of MariMed.

There can be no assurance that the Board will determine to implement the Reverse Stock Split, that MariMed will be eligible for listing on a U.S. national securities exchange, that the Reverse Stock Split will enable the Company to satisfy all applicable listing requirements, or that the Reverse Stock Split will result in a sustained increase in the trading price or liquidity of the Company’s common stock.

Reverse Stock Split Details

The Company’s stockholders approved the following:

• The Board is authorized to determine whether and when to implement the Reverse Stock Split at a ratio of between one for fifty and one for one-hundred, in its discretion. The Board would determine the final ratio based on market conditions and other relevant considerations, including, potentially, the requirements associated with a potential listing of the Company’s common stock on a U.S. national securities exchange.
• The Board retains the discretion not to implement the Reverse Stock Split if it determines that doing so would not be in the best interests of the Company and its stockholders.
   
• No fractional shares would be issued in connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to receive a fractional share as a result of the Reverse Stock Split will instead receive a cash payment in lieu thereof.

If the Reverse Stock Split is implemented:

• The number of shares of MariMed common stock outstanding would be reduced by the applicable split ratio. The Reverse Stock Split would not, by itself, change a stockholder’s proportional ownership or voting power in the Company, except for any adjustments resulting from the treatment of fractional shares.

About MariMed
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

Important Caution Regarding Forward-Looking Statements
The information in this release contains “forward-looking” statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, which are subject to several risks and uncertainties. All statements other than statements of historical facts contained in this release, including without limitation statements regarding the potential implementation of the Reverse Split, the proposed listing of the Company’s common stock on a national exchange and the affect and impact of the Reverse Split, are forward-looking statements. Without limiting the foregoing, the words “anticipates,” “believes,” “estimates,” “expects,” “expectations,” “intends,” “may,” “plans,” and other similar language, whether in the negative or affirmative, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based on the Company’s current beliefs and assumptions regarding our business, timing of regulatory approvals, the ability to obtain new licenses, business prospects and strategic growth plan, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. The Company’s actual results may differ materially from those contemplated in these forward-looking statements due to various risks, uncertainties, and other important factors, including, among others, reductions in customer spending, its ability to recruit and retain key personnel, and disruptions from the integration efforts of acquired companies.

These factors are not intended to be an all-encompassing list of risks and uncertainties that may affect the Company’s business and results of operations. These statements are not a guarantee of future performance and involve risk and uncertainties that are difficult to predict, including, among other factors, changes in demand for the Company’s services and products, changes in the law and its enforcement, and changes in the economic environment. Additional information regarding these and other factors can be found in the Company’s reports filed with the U.S. Securities and Exchange Commission. In providing these forward-looking statements, the Company expressly disclaims any obligation to update these statements publicly or otherwise, whether as a result of new information, future events or otherwise, except as required by law.

All trademarks and service marks are the property of their respective owners.

Neither the CSE nor its Regulation Services accepts responsibility for the adequacy or accuracy of this release.

For More Information Contact:

Howard Schacter, Chief Communications Officer
Email: hschacter@marimedinc.com
Phone: (781) 277-0007

NEWPORT NEWS, Va., Oct. 29, 2026 (GLOBE NEWSWIRE) — HII (NYSE: HII) today reported results for the third quarter of fiscal 2026.

Highlights

• Record third quarter revenues of $3.5 billion
• Third quarter net earnings were $217 million or $5.48 diluted earnings per share
• New contract awards in the third quarter totaled $32.4 billion
• Company raises the FY26 shipbuilding revenue guidance range to between $10.5 and $10.7 billion¹
• Company reaffirms FY26 shipbuilding operating margin² guidance range of 6.0 to 6.5 percent¹
• Company reaffirms previously issued FY26 free cash flow² outlook¹

Third Quarter Results
Third quarter 2026 revenues of $3.5 billion were up 10.8% from the third quarter of 2025, driven by growth at Newport News Shipbuilding and Ingalls Shipbuilding.

Operating income in the third quarter of 2026 was $246 million and operating margin was 7.0%, compared to $161 million and 5.0%, respectively, in the third quarter of 2025.

Segment operating income² in the third quarter of 2026 was $262 million and segment operating margin² was 7.4%, compared to $179 million and 5.6%, respectively, in the third quarter of 2025.

Net earnings in the third quarter of 2026 were $217 million, compared to $145 million in the third quarter of 2025. Diluted earnings per share in the quarter was $5.48, compared to $3.68 in the third quarter of 2025.

Net cash provided by operating activities in the quarter was $520 million and free cash flow² was $429 million, compared to net cash provided by operating activities of $118 million and free cash flow² of $16 million in the third quarter of 2025.

New contract awards in the third quarter of 2026 were $32.4 billion. Year-to-date contract awards totaled $43.1 billion.

Commenting on the Company’s third quarter 2026 results, Chris Kastner, HII’s president and CEO said, “Our third quarter results reflect solid performance across all three segments, and the significant awards we received during the quarter have now secured approximately 90 percent of our expected shipbuilding revenue through 2030. With that visibility, our focus is squarely on shipbuilding execution. At Mission Technologies, we won landmark maritime autonomy awards for the Medium Unmanned Surface Vessel (MUSV) and the Lionfish Small Unmanned Undersea Vehicle (SUUV), demonstrating our continued leadership in unmanned systems and maritime autonomy.”

¹The financial outlook, expectations, and other forward-looking statements provided by the company for 2026 and beyond reflect the company’s judgment based on information available at the time of this release. Please see the “Cautionary Statement Regarding Forward-Looking Statements and Projections” section in this release and the “Forward-Looking Statements and Projections” section in our Quarterly Report on Form 10-Q for factors that may impact the company’s ability to meet expectations.

²Non-GAAP measures. See Exhibit B for definitions and reconciliations.

Results of Operations

		Three Months Ended														Nine Months Ended
		September 30														September 30
($ in millions, except per share amounts)			2026				2025			$ Change			% Change				2026				2025			$ Change			% Change
Sales and service revenues		$	3,537			$	3,192			$	345		10.8	%		$	10,054			$	9,008			$	1,046		11.6	%
Operating income			246				161				85		52.8	%			611				485				126		26.0	%
Operating margin %			7.0	%			5.0	%					191 bps				6.1	%			5.4	%					69 bps
Segment operating income1			262				179				83		46.4	%			658				522				136		26.1	%
Segment operating margin %1			7.4	%			5.6	%					180 bps				6.5	%			5.8	%					75 bps
Net earnings			217				145				72		49.7	%			574				446				128		28.7	%
Diluted earnings per share		$	5.48			$	3.68			$	1.80		48.9	%		$	14.53			$	11.35			$	3.18		28.0	%
1Non-GAAP measures that exclude non-segment factors affecting operating income. See Exhibit B for definitions and reconciliations.

Segment Operating Results

Ingalls Shipbuilding

		Three Months Ended															Nine Months Ended
		September 30															September 30
($ in millions)			2026				2025			$ Change				% Change				2026				2025			$ Change			% Change
Revenues		$	876			$	828			$	48			5.8	%		$	2,446			$	2,189			$	257		11.7	%
Segment operating income			59				65				(6	)		(9.2) %				166				165				1		0.6	%
Segment operating margin %			6.7	%			7.9	%						(112) bps				6.8	%			7.5	%					(75) bps

Ingalls Shipbuilding revenues for the third quarter of 2026 were $876 million, an increase of $48 million, or 5.8%, from the same period in 2025, primarily driven by higher volumes in amphibious assault ships.

Ingalls Shipbuilding segment operating income for the third quarter of 2026 was $59 million, a decrease of $6 million from the same period in 2025. Segment operating margin in the third quarter of 2026 was 6.7%, compared to 7.9% in the same period last year. The decrease in operating income was primarily driven by lower performance in surface combatants.

Key Ingalls Shipbuilding milestones for the quarter:

• Christened guided missile destroyer George M. Neal (DDG 131)
• Expanded distributed shipbuilding to amphibious ships and erected first grand block built by distributed shipbuilding partners on guided missile destroyer Thad Cochran (DDG 135)
• Signed performance-based production agreements with Path Robotics and GrayMatter Robotics designed to accelerate the development and deployment of advanced automation across U.S. Navy shipbuilding programs
• Launched intelligent mechanized automated welding pilot with HD Hyundai Heavy Industries

Newport News Shipbuilding

		Three Months Ended														Nine Months Ended
		September 30														September 30
($ in millions)			2026				2025			$ Change			% Change				2026				2025			$ Change			% Change
Revenues		$	1,910			$	1,617			$	293		18.1	%		$	5,424			$	4,616			$	808		17.5	%
Segment operating income			132				80				52		65.0	%			331				247				84		34.0	%
Segment operating margin %			6.9	%			4.9	%					196 bps				6.1	%			5.4	%					75 bps

Newport News Shipbuilding revenues for the third quarter of 2026 were $1.9 billion, an increase of $293 million, or 18.1%, from the same period in 2025. The increase was primarily driven by higher volumes in submarines and aircraft carriers.

Newport News Shipbuilding segment operating income for the third quarter of 2026 was $132 million, an increase of $52 million from the same period in 2025. Segment operating margin in the third quarter of 2026 was 6.9% compared to 4.9% in the same period last year. The increase in operating income was primarily driven by contract adjustments and incentives in the Virginia-class submarine program and higher submarine and aircraft carrier volumes.

Key Newport News Shipbuilding milestones for the quarter:

• Awarded contracts for the construction of Block VI Virginia-class and Build II Columbia-class submarines
• Achieved preliminary acceptance of John F. Kennedy (CVN 79)
• Awarded long-lead time materials contract for the construction of planned aircraft carrier CVN 82

Mission Technologies

		Three Months Ended														Nine Months Ended
		September 30														September 30
($ in millions)			2026				2025			$ Change			% Change				2026				2025			$ Change				% Change
Revenues		$	792			$	787			$	5		0.6	%		$	2,300			$	2,313			$	(13	)		(0.6) %
Segment operating income			71				34				37		108.8	%			161				110				51			46.4	%
Segment operating margin %			9.0	%			4.3	%					464 bps				7.0	%			4.8	%						224 bps

Mission Technologies revenues for the third quarter of 2026 were $792 million, an increase of $5 million, or 0.6%, from the same period in 2025. The increase was primarily due to higher volumes in Unmanned Systems, partially offset by lower volumes in Global Security.

Mission Technologies segment operating income for the third quarter of 2026 was $71 million, an increase of $37 million from the same period in 2025. Segment operating margin in the third quarter of 2026 was 9.0%, compared to 4.3% in the same period last year. The increase in operating income was primarily due to a successful milestone achievement and higher volumes in Unmanned Systems and higher equity income from nuclear and environmental joint ventures.

Mission Technologies results included approximately $18 million of amortization of purchased intangible assets in the third quarter of 2026, compared to approximately $22 million in the same period last year.

Mission Technologies EBITDA margin¹ in the third quarter of 2026 was 11.9%, compared to 7.8% in the third quarter of 2025.

Key Mission Technologies milestones for the quarter:

• Achieved third quarter 2026 book-to-bill of 2.4x
• Awarded contract for 10 ROMULUS USVs, accelerating deployment of proven autonomous capability
• Awarded option year contract for U.S. Navy Lionfish Small Unmanned Undersea Vehicle (SUUV) production
• Awarded $2.2 billion contract to advance U.S. surveillance and intelligence capabilities for the Western Hemisphere
• Expanded unmanned production facility by 25% to meet growing global maritime demand

¹Non-GAAP measures. See Exhibit B for definitions and reconciliations.

HII Financial Outlook¹

• FY26 shipbuilding revenue between $10.5 and $10.7 billion; expect shipbuilding operating margin² between 6.0% and 6.5%
• FY26 Mission Technologies revenue between $3.0 and $3.2 billion
• FY26 Mission Technologies segment operating margin of approximately 6%; and Mission Technologies EBITDA margin² of approximately 9%
• FY26 free cash flow² between $500 and $600 million
• Cumulative FY26 & FY27 free cash flow² target of between $1.2 billion and $1.3 billion

		Prior FY26 Outlook	Current FY26 Outlook1
Shipbuilding Revenue		$10.2B – $10.4B	$10.5B – $10.7B
Shipbuilding Operating Margin2		6.0% – 6.5%	6.0% – 6.5%
Mission Technologies Revenue		$3.0B – $3.2B	$3.0B – $3.2B
Mission Technologies Segment Operating Margin		~5%	~6%
Mission Technologies EBITDA Margin2		8.4% – 8.6%	~9%
Operating FAS/CAS Adjustment		($44M)	($40M)
Non-current State Income Tax Expense3		~($20M)	($27M)
Interest Expense		($105M)	($100M)
Non-operating Retirement Benefit		$213M	$213M
Effective Tax Rate		~17%	~17%
Depreciation & Amortization		~$330M	~$330M
Capital Expenditures		4% – 5% of Sales	~$500M
Free Cash Flow2		$500M – $600M	$500M – $600M

¹The financial outlook, expectations, and other forward-looking statements provided by the company for 2026 and beyond reflect the company’s judgment based on the information available at the time of this release. Please see the “Cautionary Statement Regarding Forward-Looking Statements and Projections” section in this release and the “Forward-Looking Statements and Projections” section in our Quarterly Report on Form 10-Q for factors that may impact the company’s ability to meet expectations.

²Non-GAAP measures. See Exhibit B for definitions. In reliance upon Item 10(e)(1)(i)(B) of Regulation S-K, reconciliations of forward–looking GAAP and non–GAAP measures are not provided because of the unreasonable effort associated with providing such reconciliations due to the variability in the occurrence and the amounts of certain components of GAAP and non-GAAP measures. For the same reasons, we are unable to address the significance of the unavailable information, which could be material to future results.

³Outlook is based on current tax law. Variability exists based on how and when individual states conform to recent federal tax law changes.

About HII

HII is America’s Seapower Company. The nation’s largest shipbuilder, HII builds the manned and unmanned maritime systems and all-domain mission technologies that project U.S. and allied power around the world. With a more than 140-year history of advancing U.S. national security, HII is headquartered in Virginia and employs 46,000 people across three divisions. For more information, visit www.HII.com.

Conference Call Information

HII will webcast its earnings conference call at 9 a.m. Eastern time today. A live audio broadcast of the conference call and supplemental presentation will be available on the investor relations page of the company’s website: www.HII.com. A replay of the call will be available on the website for a limited time.

Cautionary Statement Regarding Forward-Looking Statements and Projections

Statements in this earnings release and in our other filings with the SEC, as well as other statements we may make from time to time, other than statements of historical fact, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by words such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “guidance,” “outlook,” “predicts,” “potential,” “continue,” and similar words or phrases or the negative of these words or phrases. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Although we believe the expectations reflected in the forward-looking statements are reasonable when made, we cannot guarantee future results, levels of activity, performance, or achievements. There are a number of important factors that could cause our actual results to differ materially from the results anticipated by our forward-looking statements, which include, but are not limited to:

• our dependence on the U.S. Government for substantially all of our business;
• significant delays or reductions in appropriations for our programs and/or changes in customer priorities and requirements (including government budgetary constraints, government shutdowns, shifts in defense spending, and changes in customer short-range and long-range plans);
• our ability to estimate our future contract costs, including cost increases due to inflation, labor challenges, changes in trade policy, or other factors and our efforts to recover or offset such costs and/or changes in estimated contract costs, and perform our contracts effectively;
• changes in business practices, procurement processes and government regulations, including changes through executive orders, contract terms, or other policies or practices applicable to our industry, and our ability to comply with such requirements;
• adverse economic conditions in the United States and globally;
• our level of indebtedness and ability to service our indebtedness;
• our ability to deliver our products and services at an affordable life cycle cost and compete within our markets;
• our ability to attract, retain, and train a qualified workforce;
• subcontractor and supplier performance and the availability and pricing of raw materials and components;
• our ability to execute our strategic plan, including with respect to share repurchases, dividends, capital expenditures, and strategic acquisitions;
• investigations, claims, disputes, enforcement actions, litigation (including criminal, civil, and administrative), and/or other legal proceedings, and improper conduct of employees, agents, subcontractors, suppliers, business partners, or joint ventures in which we participate, including the impact on our reputation or ability to do business;
• changes in key estimates and assumptions regarding our pension and retiree health care costs;
• security threats, including cyber security threats, and related disruptions;
• natural and environmental disasters and political instability;
• health epidemics, pandemics and similar outbreaks; and
• other risk factors discussed herein and in our other filings with the SEC.

There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business, and we undertake no obligation to update or revise any forward-looking statements. You should not place undue reliance on any forward-looking statements that we may make.

This release also contains non-GAAP financial measures and includes a GAAP reconciliation of these financial measures. Non-GAAP financial measures should not be construed as being more important than comparable GAAP measures.

Exhibit A: Financial Statements

HUNTINGTON INGALLS INDUSTRIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (UNAUDITED)

		Three Months Ended September 30								Nine Months Ended September 30
(in millions, except per share amounts)			2026				2025				2026				2025
Sales and service revenues
Product sales		$	2,437			$	2,072			$	6,712			$	5,742
Service revenues			1,100				1,120				3,342				3,266
Sales and service revenues			3,537				3,192				10,054				9,008
Cost of sales and service revenues
Cost of product sales			2,100				1,815				5,826				4,962
Cost of service revenues			957				983				2,909				2,863
Income from operating investments, net			26				12				52				33
Other income and gains (losses), net			(3	)			—				(3	)			1
General and administrative expenses			257				245				757				732
Operating income			246				161				611				485
Other income (expense)
Interest expense			(26	)			(23	)			(75	)			(79	)
Non-operating retirement benefit			53				48				159				143
Other, net			2				18				22				30
Earnings before income taxes			275				204				717				579
Federal and foreign income tax expense			58				59				143				133
Net earnings		$	217			$	145			$	574			$	446
Basic earnings per share		$	5.49			$	3.69			$	14.57			$	11.35
Weighted-average common shares outstanding			39.5				39.3				39.4				39.3
Diluted earnings per share		$	5.48			$	3.68			$	14.53			$	11.35
Weighted-average diluted shares outstanding			39.6				39.4				39.5				39.3
Dividends declared per share		$	1.38			$	1.35			$	4.14			$	4.05
Net earnings from above		$	217			$	145			$	574			$	446
Other comprehensive income
Change in unamortized benefit plan costs			2				1				6				3
Tax expense for items of other comprehensive income			(1	)			(1	)			(2	)			(1	)
Other comprehensive income, net of tax			1				—				4				2
Comprehensive income		$	218			$	145			$	578			$	448

HUNTINGTON INGALLS INDUSTRIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (UNAUDITED)

($ in millions)		September 30, 2026				December 31, 2025
Assets
Current Assets
Cash and cash equivalents		$	387			$	774
Accounts receivable, net of allowance for expected credit losses of $3 million as of 2026 and $2 million as of 2025			361				339
Contract assets			2,125				1,758
Inventoried costs			240				219
Income taxes receivable			250				284
Prepaid expenses and other current assets			100				77
Total current assets			3,463				3,451
Property, plant, and equipment, net of accumulated depreciation of $2,892 million as of 2026 and $2,754 million as of 2025			3,849				3,726
Operating lease assets			275				267
Goodwill			2,650				2,650
Other intangible assets, net of accumulated amortization of $1,285 million as of 2026 and $1,222 million as of 2025			631				694
Pension plan assets			1,668				1,544
Miscellaneous other assets			444				417
Total assets		$	12,980			$	12,749
Liabilities and Stockholders’ Equity
Current Liabilities
Trade accounts payable		$	709			$	556
Accrued employees’ compensation			403				443
Current portion of postretirement plan liabilities			119				119
Current portion of workers’ compensation liabilities			214				217
Contract liabilities			780				1,220
Other current liabilities			513				490
Total current liabilities			2,738				3,045
Long-term debt			2,704				2,700
Pension plan liabilities			155				155
Other postretirement plan liabilities			187				200
Workers’ compensation liabilities			437				442
Long-term operating lease liabilities			225				223
Deferred tax liabilities			694				572
Other long-term liabilities			348				339
Total liabilities			7,488				7,676
Commitments and Contingencies
Stockholders’ Equity
Common stock, $0.01 par value; 150,000,000 shares authorized; 53,990,247 shares issued and 39,405,538 shares outstanding as of 2026, and 53,826,236 shares issued and 39,241,527 shares outstanding as of 2025			1				1
Additional paid-in capital			2,096				2,087
Retained earnings			5,893				5,487
Treasury stock			(2,449	)			(2,449	)
Accumulated other comprehensive loss			(49	)			(53	)
Total stockholders’ equity			5,492				5,073
Total liabilities and stockholders’ equity		$	12,980			$	12,749

HUNTINGTON INGALLS INDUSTRIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

		Nine Months Ended September 30
($ in millions)			2026				2025
Operating Activities:
Net earnings		$	574			$	446
Adjustments to reconcile net cash provided by operating activities:
Depreciation			167				164
Amortization of purchased intangibles			63				78
Stock-based compensation			47				43
Deferred income taxes			120				121
Gain on investments in marketable securities			(18	)			(28	)
Other non-cash transactions, net			17				15
Change in
Accounts receivable			(22	)			(162	)
Contract assets			(367	)			(186	)
Inventoried costs			(21	)			(13	)
Prepaid expenses and other assets			(2	)			(23	)
Accounts payable and accruals			(327	)			207
Retiree benefits			(132	)			(116	)
Net cash provided by operating activities			99				546
Investing Activities:
Capital expenditures
Capital expenditure additions			(288	)			(268	)
Grant proceeds for capital expenditures			7				6
Proceeds from sale of investments			—				5
Acquisitions of businesses			—				(132	)
Other investing activities, net			1				2
Net cash used in investing activities			(280	)			(387	)
Financing Activities:
Repayment of long-term debt			—				(500	)
Proceeds from line of credit borrowings			17				—
Repayment of line of credit borrowings			(17	)			—
Dividends paid			(163	)			(159	)
Employee taxes on certain share-based payment arrangements			(43	)			(14	)
Other financing activities, net			—				(5	)
Net cash used in financing activities			(206	)			(678	)
Change in cash and cash equivalents			(387	)			(519	)
Cash and cash equivalents, beginning of period			774				831
Cash and cash equivalents, end of period		$	387			$	312
Supplemental Cash Flow Disclosure
Cash paid for income taxes (net of refunds)		$	19			$	71
Cash paid for interest		$	96			$	86
Non-Cash Investing and Financing Activities
Capital expenditures accrued in accounts payable		$	14			$	7

Exhibit B: Non-GAAP Measures Definitions & Reconciliations

This earnings release contains non-GAAP (accounting principles generally accepted in the United States of America) financial measures as defined by SEC Regulation G and indicated by a footnote in the text of this release. Definitions for the non-GAAP measures, and related reconciliations, are provided below. Because not all companies use identical definitions or calculations, our presentation of these measures may not be comparable to similarly titled measures of other companies.

Segment Operating Income and Segment Operating Margin. We internally manage our operations by reference to segment operating income and segment operating margin and use these measures to evaluate our core operating performance. We believe that segment operating income and segment operating margin reflect additional ways of viewing aspects of our operations that, when viewed with our GAAP results, provide a more complete understanding of factors and trends affecting our business. These measures should be considered in addition to, and not as alternatives for, operating income and operating margin or any other performance measure presented in accordance with GAAP.

Segment operating income is defined as operating income for the relevant segment(s) before the Operating FAS/CAS Adjustment and non-current state income taxes.

Segment operating margin is defined as segment operating income as a percentage of sales and service revenues.

Shipbuilding operating margin, Mission Technologies EBITDA and Mission Technologies EBITDA margin. We use shipbuilding operating margin, Mission Technologies EBITDA and Mission Technologies EBITDA margin to evaluate our core operating performance. We believe these measures reflect additional ways of viewing aspects of our operations that, when viewed with our GAAP results, provide a more complete understanding of factors and trends affecting our business. These measures should be considered in addition to, and not as alternatives for, operating income and operating margin or any other performance measure presented in accordance with GAAP.

Shipbuilding operating margin is defined as the combined segment operating income of our Newport News Shipbuilding segment and Ingalls Shipbuilding segment as a percentage of shipbuilding revenue. Shipbuilding revenue is the sum of revenues of our Newport News Shipbuilding segment and Ingalls Shipbuilding segment.

Mission Technologies EBITDA is defined as Mission Technologies segment operating income before interest expense, income taxes, depreciation, and amortization.

Mission Technologies EBITDA margin is defined as Mission Technologies EBITDA as a percentage of Mission Technologies revenues.

Free cash flow. We use free cash flow as a key operating metric in assessing the performance of our business and as a key performance measure in evaluating management performance and determining incentive compensation. We believe free cash flow is an important liquidity measure that may be useful to investors and other users of our financial statements because it provides insight into our current and period-to-period performance and our ability to generate cash from continuing operations. Free cash flow has limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, net income as a measure of our performance or net cash provided by operating activities as a measure of our liquidity.

Free cash flow is defined as net cash provided by (used in) operating activities less capital expenditures net of related grant proceeds.

In reliance upon Item 10(e)(1)(i)(B) of Regulation S-K, reconciliations of forward-looking GAAP and non-GAAP measures are not provided because of the unreasonable effort associated with providing such reconciliations due to the variability in the occurrence and the amounts of certain components of GAAP and non-GAAP measures. For the same reasons, we are unable to address the significance of the unavailable information, which could be material to future results.

Reconciliations of Segment Operating Income and Segment Operating Margin

		Three Months Ended								Nine Months Ended
		September 30								September 30
($ in millions)			2026				2025				2026				2025
Ingalls revenues		$	876			$	828			$	2,446			$	2,189
Newport News revenues			1,910				1,617				5,424				4,616
Mission Technologies revenues			792				787				2,300				2,313
Intersegment eliminations			(41	)			(40	)			(116	)			(110	)
Sales and Service Revenues			3,537				3,192				10,054				9,008
Operating Income			246				161				611				485
Operating FAS/CAS Adjustment			12				9				29				25
Non-current state income taxes			4				9				18				12
Segment Operating Income			262				179				658				522
As a percentage of sales and service revenues			7.4	%			5.6	%			6.5	%			5.8	%
Ingalls segment operating income			59				65				166				165
As a percentage of Ingalls revenues			6.7	%			7.9	%			6.8	%			7.5	%
Newport News segment operating income			132				80				331				247
As a percentage of Newport News revenues			6.9	%			4.9	%			6.1	%			5.4	%
Mission Technologies segment operating income			71				34				161				110
As a percentage of Mission Technologies revenues			9.0	%			4.3	%			7.0	%			4.8	%

Reconciliation of Free Cash Flow

		Three Months Ended								Nine Months Ended
		September 30								September 30
($ in millions)			2026				2025				2026				2025
Net cash provided by operating activities		$	520			$	118			$	99			$	546
Less capital expenditures:
Capital expenditure additions			(95	)			(105	)			(288	)			(268	)
Grant proceeds for capital expenditures			4				3				7				6
Free cash flow		$	429			$	16			$	(182	)		$	284

Reconciliation of Mission Technologies EBITDA and EBITDA Margin

		Three Months Ended								Nine Months Ended
		September 30								September 30
($ in millions)			2026				2025				2026				2025
Mission Technologies sales and service revenues		$	792			$	787			$	2,300			$	2,313
Mission Technologies segment operating income		$	71			$	34			$	161			$	110
Mission Technologies depreciation expense			3				3				9				9
Mission Technologies amortization expense			18				22				53				67
Mission Technologies state tax expense			2				2				6				6
Mission Technologies EBITDA		$	94			$	61			$	229			$	192
Mission Technologies EBITDA margin			11.9	%			7.8	%			10.0	%			8.3	%

Contacts:
Brooke Hart (Media)
brooke.hart@hii.com
202-264-7108

Christie Thomas (Investors)
christie.thomas@hii.com
757-380-2104

—New data highlight BioCryst’s commitment to advancing a portfolio of therapies for people living with HAE—

RESEARCH TRIANGLE PARK, N.C., Oct. 29, 2026 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that four abstracts from its hereditary angioedema (HAE) portfolio have been accepted for presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting taking place in Phoenix, Arizona, November 12-16.

BioCryst will present new clinical data and real-world outcomes for ORLADEYO^® (berotralstat), the first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older, and one abstract featuring long-term clinical trial outcomes for navenibart, a long-acting injectable monoclonal antibody plasma kallikrein inhibitor being investigated for prophylaxis to prevent attacks of HAE.

BioCryst will present the following four posters​ at the Phoenix Convention Center:

• Hospitalization and Emergency Department Reductions After Initiating Berotralstat, Lanadelumab, or Subcutaneous Plasma-Derived C1-Inhibitor for Hereditary Angioedema; Poster #R077; Monitor 17; Friday, November 13, 4:20-4:35 p.m. MT
• Reductions in Healthcare Utilization Among Individuals with HAE Who Switched to Berotralstat from Another Prophylaxis; Poster #R096; Monitor 15; Saturday, November 14, 11:30-11:45 a.m. MT
• Growth-Related Berotralstat Dose Adjustment in Children with Hereditary Angioedema: 48-Week Dosing Experience from APeX-P; Poster #R097; Monitor 15; Saturday, November 14, 11:45 a.m.-12:00 p.m. MT
• Long-Term Safety, Efficacy, and Quality of Life with Navenibart in Hereditary Angioedema: ALPHA-SOLAR Interim Results; Poster #R110; Monitor 13; Sunday, November 15, 12:00-12:15 p.m. MT

In addition to the presentation times noted above, posters will be accessible to registered attendees during the ACAAI 2026 Annual Scientific Meeting.

Visit www.ORLADEYO.com for more information. 

About ORLADEYO^® (berotralstat)
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older. One dose of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

About navenibart
Navenibart is an investigational YTE-modified monoclonal antibody inhibitor of plasma kallikrein, an established and safe mechanism, currently being evaluated in clinical trials for long-term prevention of HAE attacks with potential best-in-class dosing every 3 or 6 months.

U.S. Indication and Important Safety Information

INDICATION
ORLADEYO® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older.

Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or doses of ORLADEYO higher than the prescribed once-daily dose are not recommended due to the potential for QTc interval prolongation.

IMPORTANT SAFETY INFORMATION
An increase in QTc interval was observed in adults at dosages higher than 150 mg once daily and was concentration dependent.

The most common adverse reactions (≥10%) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

In adult and pediatric patients aged 12 years and older with moderate or severe hepatic impairment (Child-Pugh B or C), the recommended dosage of ORLADEYO capsules is 110 mg once daily with food. In pediatric patients aged 2 to <12 years with moderate or severe hepatic impairment (Child-Pugh B or C), avoid use of ORLADEYO.

Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. P-gp inducers may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. Avoid concomitant use of P-gp inducers with ORLADEYO.

ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. Concomitant use of ORLADEYO with CYP2D6 or CYP3A4 substrates can increase exposure of the CYP2D6 or CYP3A4 substrates and may increase the risk of adverse reactions associated with the substrates. If ORLADEYO is concomitantly used with CYP2D6 or CYP3A4 substrates where minimal increases in the concentration of the substrates may lead to serious adverse reactions, closely monitor or modify the dosage of the CYP2D6 or CYP3A4 substrate.

The safety and effectiveness of ORLADEYO in pediatric patients <2 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.

To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

About BioCryst Pharmaceuticals
BioCryst is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (“HAE”) and other rare diseases, driven by its deep commitment to improving the lives of people living with these conditions. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor and is advancing a pipeline of potential first-in-class or best-in-class therapeutics for rare diseases. For more information, please visit www.biocryst.com or follow us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding BioCryst’s expectations relating to its HAE portfolio and the development, potential dosing profile, competitive positioning, and expectations for navenibart. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: BioCryst’s ability to successfully implement or maintain its commercialization plans for ORLADEYO; BioCryst’s ability to successfully progress its development plans for navenibart; the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results; ongoing and future clinical development of product candidates, including navenibart, may take longer than expected and may not have positive results; BioCryst may not advance human clinical trials with product candidates, including navenibart, as expected; the FDA or other applicable regulatory agencies may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may not review regulatory filings on our expected timeline, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates, may ultimately determine that there are deficiencies in the development program or execution thereof, may require additional information or studies, may disagree with our safety and efficacy conclusions, or may impose certain restrictions, warnings, or other requirements; product candidates, if approved, may not achieve market acceptance; and BioCryst’s ability to successfully commercialize its products and product candidates. This list is not exclusive. To see a more comprehensive set of risks, please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst’s forward-looking statements.

BCRXW

Contact:

Investors:
investorrelations@biocryst.com 

Media:
media@biocryst.com 

Integrated gas detection for airport GSE, expanded S24 configurations, and SkyVOX battery location with charging alerts strengthen Flux Power’s product portfolio and innovation pipeline through fiscal 2027

VISTA, Calif., Oct. 29, 2026 (GLOBE NEWSWIRE) — Flux Power Holdings, Inc. (NASDAQ: FLUX) (Flux Power), a developer of advanced lithium-ion energy storage solutions and fleet intelligence technology, today announced three product innovations spanning battery safety, expanded material handing applications and connected fleet intelligence. Together, the launches reflect Flux Power’s execution of its strategy to expand the applications it serves, extend its fleet intelligence capabilities and create additional opportunities for growth across material handling and airport ground support equipment (GSE) markets through fiscal 2027 and beyond.

Developed in collaboration with customers and OEM partners, the innovations build upon Flux Power’s integrated portfolio of lithium-ion batteries, battery management systems and SkyEMS® fleet intelligence, creating more opportunities to serve customers across their operations.

Flux Power Adds Integrated Gas Detection to Airport GSE Batteries

Next-generation monitoring goes beyond industry requirements, adding another layer of protection to Flux Power’s proven battery safety architecture.

Flux Power is adding integrated gas detection to its airport GSE battery lines, the next evolution of the multi-layered safety design already built into every Flux Power battery. Going beyond what industry standards require, the sensor continuously monitors conditions inside the battery and communicates directly with Flux Power’s battery management system (BMS). If a potential thermal event is detected, the BMS can alert a CAN-integrated vehicle and automatically shut down power. On batteries equipped with SkyVOX telematics, events are also reported to SkyEMS for real-time visibility, giving operators and ground crews added confidence on busy ramps.

The solution was developed with a major airline and demonstrated at Flux Power’s Vista, California headquarters recently.

“Safety on the ramp is non-negotiable for our airline customers,” said Mark Barmettler, VP of Engineering at Flux Power. “Flux Power’s integrated gas detection gives operators an added layer of protection and real-time visibility, which we believe makes lithium an even easier decision for GSE fleets.”

Initial shipments are expected in the first quarter of calendar 2027, beginning with an airline end user customer. Flux Power is also planning to offer a retrofit program for batteries already in service.

New S24 Configurations Expand Fleet Opportunities

Flux Power continues to expand its flagship S-Series category with two new S24 configurations, giving OEM partners and national account customers one lithium-ion platform across more of their forklift applications:

• Compact-Compartment Configuration: A new truck adapter and charger configuration developed with a national account customer for a leading forklift OEM truck with a compact battery compartment.
• The Heavy Duty S24 for Walkie Stackers: A maximum capacity configuration engineered for walkie stacker trucks, currently undergoing testing and qualification with a major OEM partner.

The new configurations extend the S-Series beyond its core applications to additional truck models and equipment categories. For OEM partners, a broader S-Series means a qualified Flux Power lithium-ion option across more of their truck lineups, making it easier to specify Flux Power and support their dealer networks with a consistent solution.

For current and new customers, it means standardizing more of their fleet on a single battery platform, backed by SkyEMS fleet intelligence, and one service partner across their sites. Flux Power believes the new S24 configurations will increase its potential share of each customer’s fleet and build a broader foundation for potential future commercial growth.

SkyVOX Brings Battery Location and Charging Alerts to Fleets

SkyVOX extends Flux Power’s fleet intelligence capabilities with battery location and intelligent charging alerts. Fleet managers can quickly locate connected batteries and identify which units need charging, helping to reduce time spent searching for equipment and preventing batteries from reaching a low state of charge mid-shift.

The newest addition to the SkyVOX family introduces external cellular and GPS antennas mounted outside the battery enclosure, so signals aren’t blocked when the SkyVOX telemetry device sits deep inside a steel truck compartment. The result is consistent location tracking and reliable event reporting to SkyEMS, even in installations where internal-antenna telematics often lose connection.

Building on the recently launched SkyEMS® 3.0, SkyVOX further connects battery intelligence with day-to-day fleet operations. Industry research has found that locating and dispatching ground support equipment can take 14 minutes per flight, underscoring the opportunity for real-time battery visibility to help crews deploy equipment faster, improve fleet utilization and keep airport operations moving efficiently.

Shipments are expected to begin in the fourth quarter of calendar 2026.

“These innovations advance Flux Power’s growth strategy across three key areas: battery safety, fleet intelligence and expanded equipment applications,” said Krishna Vanka, Chief Executive Officer of Flux Power. “By solving more customer challenges and extending our technology across more of their operations, we believe we’re creating new opportunities to grow our addressable market, deepen customer relationships and strengthen Flux Power’s competitive position. These launches are part of a broader pipeline of innovation we’re planning to advance through fiscal 2027.”

For more information, visit www.fluxpower.com.

About Flux Power

Flux Power (NASDAQ: FLUX) designs, manufactures, and sells advanced lithium-ion energy storage solutions for electrification of a range of industrial and commercial sectors including material handling and airport ground support equipment (GSE). Flux Power’s lithium-ion battery packs, including the proprietary battery management system (BMS) and telemetry, provide customers with a better performing, lower cost of ownership, and more environmentally friendly alternative, in many instances, to traditional lead acid and propane-based solutions. Lithium-ion battery packs reduce CO2 emissions and help improve sustainability and ESG metrics for fleets. For more information, please visit www.fluxpower.com.

Forward-Looking Statements
This release contains projections and other “forward-looking statements” relating to Flux Power’s business, that are often identified using “believes,” “expects” or similar expressions. Forward-looking statements include, but are not limited to, statements regarding Flux Power’s product roadmap, planned product introductions and planned pipeline of innovation through fiscal 2027, the expected shipment timing of its gas-sensing GSE batteries and SkyVOX telematics units, the planned rollout with its airline partner, any potential retrofitting of existing customer batteries, the outcome of OEM testing and qualification, the new S24 configurations increasing Flux Power’s potential share of each customer’s fleet, future product announcements, expected customer adoption of new products, and quotes from management. Forward-looking statements involve several estimates, assumptions, risks, and other uncertainties that may cause actual results to be materially different from those anticipated, believed, estimated, expected, etc. Accordingly, forward-looking statements are not guarantees of future results. Some of the important factors that could cause Flux Power’s actual results to differ materially from those projected in any such forward-looking statements include, but are not limited to: Flux Power’s ability to amend the terms of its agreement with Gibraltar Business Capital, LLC and Flux Power’s continued access to its credit facility thereunder; Flux Power’s ability to secure sufficient funding to support its current and proposed operations; Flux Power’s ability to continue as a going concern; Flux Power’s ability to meet projected revenue targets and generate sufficient cash from operations; Flux Power’s ability to regain compliance with and continue to meet the continued listing standards of the Nasdaq Stock Market; the impact of tariffs on Flux Power’s ability to cost-effectively source battery packs and materials used in its products; Flux Power’s ability to obtain raw materials and other supplies for its products at existing or competitive prices and on a timely basis; Flux Power’s anticipated growth strategies and its ability to manage the expansion of its business operations effectively; Flux Power’s ability to maintain or increase its market share in the competitive markets in which it does business; Flux Power’s ability to grow its revenue, increase its gross profit margin and become a profitable business; Flux Power’s ability to fulfill its backlog of open sales orders due to delays in the receipt of key component parts and other potential manufacturing disruptions; Flux Power’s ability to keep up with rapidly changing technologies and evolving industry standards, including its ability to achieve technological advances; Flux Power’s dependence on the growth in demand for its products; Flux Power’s ability to compete with both peers and larger companies with far greater resources than it; Flux Power’s ability to reduce production costs of its product line through new designs, manufacturing and supply arrangements; Flux Power’s ability to shift to new suppliers and incorporate new components into its products in a manner that is not disruptive to its business; Flux Power’s ability to obtain and maintain UL Listings and OEM approvals for its energy storage solutions; Flux Power’s ability to diversify its product offerings and capture new market opportunities; Flux Power’s ability to source its needs for skilled labor, machinery, parts, and raw materials economically; Flux Power’s ability to retain and/or successfully recruit key members of its senior management team; Flux Power’s ability to diversify its customer base to reduce its current dependence on a few major customers; and the expense, timing and outcome of legal proceedings relating to Flux Power’s accounting practices, financial disclosures and employment policies and practices, investigations and information requests that may be initiated or that may be asserted. Actual results could differ from those projected due to numerous factors and uncertainties. Although Flux Power believes that the expectations, opinions, projections, and comments reflected in these forward-looking statements are reasonable, it can give no assurance that such statements will prove to be correct, and that Flux Power’s actual results of ‎operations, financial condition and performance will not differ materially from the ‎results of operations, financial condition and performance reflected or implied by these forward-‎looking statements. Undue reliance should not be placed on the forward-looking statements and investors should refer to the risk factors outlined in Flux Power’s Form 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov/edgar. These forward-looking statements are made as of the date of this release, and Flux Power assumes no obligation to update these statements or the reasons why actual results could differ from those projected, except as required by applicable law.

Flux, Flux Power, and associated logos are trademarks of Flux Power Holdings, Inc. All other third-party brands, products, trademarks, or registered marks are the property of and used to identify the products or services of their respective owners.

Follow us at:
Blog: Flux Power Blog
News Flux Power News
Twitter: @Flux__Power
LinkedIn: Flux Power

Contacts

Media:
media@fluxpower.com
info@fluxpower.com

External Investor Relations:
Leanne Sievers
Shelton Group
flux-ir@sheltongroup.com

VANCOUVER, British Columbia, Oct. 29, 2026 (GLOBE NEWSWIRE) — Lux Metals Corp. (TSXV: LXM) (the “Company” or “Lux”) is pleased to report the copper results for the Zone 32 interval in hole LG26-241, the first hole of its 2026 diamond drill program at the La Grande Gold Project (the “Project”), located in the Eeyou Istchee James Bay region of Québec.

Highlights

• Complete results for the Zone 32 interval (see news release dated October 14, 2026) include 17.57 g/t Au and 0.71% Cu over 19.50 m from 220.5 m downhole (see Figures 1 and 2),
  • including 39.08 g/t Au and 1.45% Cu over 8 m.
  • One sample returned 165 g/t Au and 3.58% Cu over 1m (G240715, 232 to 233m).
  • One sample returned 45.40 g/t Au and 5.79% Cu over 1m (G240717, 233 to 234m).
• The 2026 drill program which comprised 3 holes totalling 1,416 m, has now been completed. Assays for the remaining holes and for the remainder of hole LG26-241 are pending and expected end of November 2026.
• The Company has launched a drone-borne magnetic survey over the Zone 32 area of the Project to map the structures controlling the gold-copper mineralization and refine targets for future drilling.

“With the copper results in hand, LG26-241 shows significant copper alongside the high-grade gold across the Zone 32 interval, confirming the gold-copper character of the system,” said Kim Quyên Nguyên, President and Chief Executive Officer of Lux Metals Corp. “The drill program is now complete, and the magnetic survey will help us trace the structures that control the mineralization as we plan our next steps.“

Figure 1: Drilling Localization Plan with Hole LG26-241

Figure 2: Cross Section of Drilling Location with Hole LG26-241

Table 1: Gold and Copper Assay Results¹ for Hole LG26-241

Hole Number	From (m)	To (m)	Length (m) 2	Au (g/t)	Cu (%)	Au (g/t)3
LG26-241	220.5	240	19.50	17.57	0.71	11.67
Including	229	237	8	39.08	1.45	24.70

¹ Gold values for the Zone 32 interval were previously reported on October 14, 2026. Copper values are reported here for the first time.
² Lengths are reported as core lengths; true width is estimated at 75% of the intercept.
³ Capped gold value at 50 g/t.

Table 2: Drill Hole Collar Information

Hole Number	Easting	Northing	Elevation (m)	Azimuth	Dip	Length (m)
LG26-241	396583	5932335	231	165	50	297

*Coordinate in UTM NAD83, Z18

Hole LG26-241: Copper Results for the Zone 32 Interval

On October 14, 2026, the Company reported gold assays for the Zone 32 interval in hole LG26-241 (17.57 g/t Au over 19.50 m, including 39.08 g/t Au over 8 m). At that time, multi-element (ICP) results, including copper, were pending. These results have now been received (Table 1). Assays for the remainder of hole LG26-241, outside this Zone 32 interval, are pending and will be reported once received and validated.

• Zone 32 (220.5 m to 240.0 m): 0.71% Cu over 19.50 m, including 1.45% Cu over 8 m. One sample returned 165 g/t Au and 3.58% Cu over 1m and another returned 45.40 g/t Au and 5.79% Cu over 1m. Copper is hosted by chalcopyrite, which occurs with pyrite and visible gold in the same sericite-altered shear zones and quartz veins, notably between 232.41 m and 233.62 m, indicating that gold and copper were introduced by the same mineralizing event.

2026 Drill Program Completed

The 2026 diamond drill program at La Grande was completed on October 20, 2026, with 3 holes totalling 1,416 m. In addition to LG26-241, the program tested the eastern extension of Zone 32 and the deep zone identified in historical hole LGS12-224. All core has been logged and sampled, and samples have been delivered to AGAT Laboratories in Val-d’Or. Assay results are expected end of November 2026 and will be released once received and validated.

Magnetic Survey Underway

The Company has started a high-resolution drone-borne magnetic survey over the Zone 32 area of the Project. The survey conducted will cover approximately 160 line-km at 35 m line spacing and is expected to be completed before November 2026.

Zone 32 lies along the contact between the La Grande-Sud tonalite and Yasinski Group volcanic rocks, where gold is concentrated in sheared, sericite-altered and sulphide-bearing tonalite. The survey is designed to map this contact and the associated shear structures at high resolution, identify along-strike and perpendicular structures, and, combined with the 2026 drilling results, help prioritize targets for the next drill program.

Quality Assurance and Quality Control

Drilling was conducted using a diamond drill rig with NQ sized core. Samples were logged and sampled on site, where core was sawn in half and bagged. Quarter core were also sawn for field duplicate. Each bag was secured using a zip-tie, and bagged into a rice bag that was sealed until opening at the laboratory. Samples were transported by road to AGAT Laboratories facility in Val-d’Or, Quebec for standard preparation (code 200075+200087), which include drying at 105°C, crushing 75% passing 2mm, riffle split 250g and pulverize 85% passing 75 microns. A 15g sub-sample is taken and shipped by air to AGAT Laboratory in Calgary for the four acid digestion 48 metals analysis with ICP-OES/MS finish. Most of the pulp is sent to AGAT Laboratory in Thunder Bay for gold fire assay of 50g with AAS finish. Samples returning greater than 10 g/t Au were re-analyzed by fire assay (50 g) with a gravimetric finish. Samples returning greater than 10,000 ppm Cu were re-analyzed for overlimit copper by four acid digestion with ICP OES/MS.

A Quality Assurance / Quality Control (QA/QC) protocol following industry best practice was incorporated to the sampling procedure. Measures include insertion at regular spacing of quartz blank (4%), certified reference materials (4%) and quarter core duplicate (4%). Additional blank material was added after each occurrence of visible gold, and additional high grade gold CRM were added in the mineralized zone. Validation of values for gold and copper from the blank and certified reference material from the release result returned acceptable results from industry standard.

Qualified Person

The scientific and technical information contained in this news release has been reviewed and approved by Jonathan Marleau, P.Geo., Senior Geologist at Dahrouge Geological Consulting Ltd., an independent consultant of the Company, who is a “qualified person” (within the meaning of National Instrument 43-101 – Standards of Disclosure for Mineral Projects) and independent of the Company for purposes of Section 1.5 of National Instrument 43-101 – Standards of Disclosure for Mineral Projects.

About Lux Metals Corp.

Lux Metals Corp. (TSXV: LXM) is a Canadian mineral exploration company focused on advancing its flagship La Grande Gold Project in Québec’s James Bay region. The Project hosts the high-grade Zone 32 gold system, supported by extensive historic drilling, direct access via the four-season Trans-Taïga Road, and district-scale exploration potential. For more information, visit www.lux-metals.com.

On Behalf of the Board of Lux Metals Corp.

Kim Quyên Nguyên

President and Chief Executive Officer

For more information, please contact 579-314-0129 or info@lux-metals.com.

Cautionary Note regarding Forward-Looking Statements

This news release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking statements relate to future events or future performance and reflect the expectations or beliefs of management of the Company regarding future events. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as “intends”, “expects”, “anticipates”, “plans” or “targeting”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “should”, “would”, “will”, “potentially” or “likely” occur. Forward-looking statements in this news release include, but are not limited to, statements regarding the timing of receipt of remaining assay results from the 2026 drill program; the completion, scope and objectives of the drone-borne magnetic survey; the interpretation of the gold-copper mineralization encountered in hole LG26-241; the identification of additional exploration targets; future drilling activities; and the potential expansion of mineralization at Zone 32 and elsewhere on the Project. This information and these statements, referred to herein as “forward-looking statements”, are not historical facts and are made as of the date of this news release. These forward-looking statements involve numerous risks and uncertainties, including risks related to exploration results; geological interpretation; the continuity and extent of mineralization; the receipt, timing and interpretation of assay results; the results of the magnetic survey; weather and field conditions; the availability of contractors, equipment and personnel; permitting and access; and other risks inherent in mineral exploration, and actual results might differ materially from results suggested in any forward-looking statements. In making the forward-looking statements in this news release, the Company has applied several material assumptions, including that assay results will be received within anticipated timelines; that the magnetic survey will be completed as planned; that exploration activities will proceed as currently contemplated; that contractors, equipment and personnel will remain available; that required permits and access will be obtained and maintained; and that the results of ongoing exploration will support the Company’s geological interpretation and exploration objectives. There can be no assurance that any forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader should not place any undue reliance on forward-looking information or statements. The Company undertakes no obligation to update forward-looking information or statements, other than as required by applicable law.

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 release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/047eb89d-b359-46cb-b978-f68ebc021eac

https://www.globenewswire.com/NewsRoom/AttachmentNg/9a88bb51-efa0-4bad-b96f-571531393c98

 

• Company estimates approximately one million U.S. patients each month discontinue GLP-1 medications and face the risk of weight regain
• One-third of surveyed GLP-1 users expressed a preference for an endoscopic procedure over continued GLP-1 medication
• A one-time procedure and freedom from daily or weekly medication were the most frequently selected positive attributes, supporting commercial planning for Revita

BURLINGTON, Mass., Oct. 29, 2026 (GLOBE NEWSWIRE) — Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced findings from company-sponsored market research highlighting strong patient interest in a one-time procedural approach to weight maintenance following GLP-1 therapy. The findings reinforce the potentially substantial commercial opportunity for investigational Revita and help inform the Company’s ongoing commercial planning.

Fractyl estimates that approximately one million patients each month in the United States face the challenge of weight regain following GLP-1 discontinuation. 65% of those taking a GLP-1 for weight loss (without type 2 diabetes) stop within one year, and only about 1 in 12 people prescribed a GLP-1 for obesity are still on it after three years [1,2]. For patients who stop treatment, the immediate question is how to preserve the weight loss they achieved. Revita is being developed to address this post-GLP-1 weight maintenance need.

The Company’s market research provides meaningful evidence of interest in a procedural treatment option. Among nearly 300 current or recent GLP-1 users surveyed, 33% preferred stopping GLP-1 therapy and receiving a hypothetical procedure. These findings suggest a sizable number of patients are actively interested in alternatives to chronic medications for maintaining weight loss.

“Many patients discontinue GLP-1 therapy due to cost, insurance coverage, side effects, or concerns about long-term medication use. However, growing evidence shows that most patients experience weight gain after discontinuation,” said Dr. Pichamol Jirapinyo, MD, MPH, DABOM, FASGE, FACG, AGAF, Assistant Professor of Medicine at Harvard Medical School and Director of the Bariatric Endoscopy Fellowship at Brigham and Women’s Hospital. “In clinical practice, we are seeing increasing numbers of patients seeking minimally invasive treatment options that could help them discontinue GLP-1 therapy while maintaining their weight loss. There is a substantial unmet need for safe, effective, and durable weight management solutions. A scalable, single-session outpatient procedure that could help patients maintain or achieve additional weight loss after GLP-1 discontinuation would represent a meaningful advancement in obesity care.”

“In addition to the large number of patients already discontinuing GLP-1s who are at immediate risk of weight regain, our research shows that 1 out of 3 patients who are still currently on a GLP-1 would choose a one-time procedural therapy over ongoing medication,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “This research reinforces our belief that there is meaningful patient interest in a procedural approach to weight maintenance. Together with the encouraging six-month results from REMAIN-1, these findings strengthen our confidence in Revita’s potential to address this need and are helping inform our preparations for future commercialization.”

Addressing a Maintenance Decision Patients Already Face

In the market research, respondents who had discontinued GLP-1 therapy identified the following as their top three reasons for stopping: 1) cost or coverage, 2) concerns about long-term use or safety, and 3) achievement of a weight-loss plateau. 84% selected a one-time procedure as their most valued feature, making it the most frequently selected attribute. Freedom from daily or weekly medication ranked second, selected by 64%. These findings provide further insight into patient priorities and help inform the Company’s planning for potential patient access.

Building on Physician Interest in a One-Time Procedural Alternative

These patient preference results build on Fractyl’s belief that metabolic interventionalists are highly enthusiastic about offering Revita to their patients as an alternative to lifelong GLP-1 therapy. There are approximately 1,000 bariatric and metabolic centers of excellence in the United States, with each center managing an estimated 2,000 patients on GLP-1 therapy today. The patients at these centers represent potential initial candidates for Revita, if authorized. The Company’s planning addresses physician education, treatment-center readiness and potential reimbursement pathways. Additionally, the newly issued Category III CPT code 1122T takes effect on January 1, 2027.

Advancing the Clinical Evidence for Revita

Revita is being evaluated for weight maintenance in adults with obesity following GLP-1 discontinuation. In the REMAIN-1 Pivotal Cohort, participants treated with Revita retained approximately 80% of their GLP-1-induced weight loss on average at six months, meeting the prespecified six-month co-primary endpoint vs sham (p=0.0023).

Revita was generally well tolerated, with no device- or procedure-related serious adverse events reported through the September 24, 2026, interim data cutoff. Fractyl expects to report 12-month topline results from the REMAIN-1 Pivotal Cohort, including the second co-primary endpoint, in the first quarter of 2027.

About Revita

The Revita® DMR System is Fractyl’s lead product candidate, designed to remodel the duodenal lining via a single, minimally invasive endoscopic procedure intended to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease. By targeting duodenal dysfunction, Revita is designed to address an underlying driver of obesity and enable durable weight maintenance following GLP-1 discontinuation. Revita has received FDA Breakthrough Device Designation for weight maintenance in people with obesity who discontinue GLP-1 therapies. Revita is for investigational use only in the United States and is CE marked in the European Union and United Kingdom.

About Fractyl Health

Fractyl is a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes. The Company’s lead product candidate, Revita, is an endoscopic procedural therapy in pivotal development for post-GLP-1 weight maintenance. Fractyl’s goal is to change the course of metabolic disease, advancing treatment from chronic management toward prevention and reversal of disease. Fractyl is headquartered in Burlington, Massachusetts.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact are forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words.

Forward-looking statements in this press release include, without limitation, statements regarding: the potential benefits of the Company’s sharpened strategic focus and reprioritization, including the proposed workforce reduction and its anticipated impact on the Company’s expenditures and financial runway; the promise and potential impact of the Company’s clinical trial data and product candidates, including Revita’s potential for maintaining weight loss after GLP-1 based therapy discontinuation and its potential to be the first procedural therapy for post-GLP-1 weight maintenance; the design, initiation, timing and results of clinical studies or readouts, including readouts from the REMAIN-1 Pivotal Cohort, including 12-month data; the potential launch or commercialization of any of the Company’s product candidates or products; the Company’s regulatory strategy, including the timing of any potential De Novo marketing application submission and the potential use and benefits of the De Novo pathway (FDA pre-submission feedback is advisory and non-binding, or as to the timing of any such authorization); the potential treatment population or benefits for any of the Company’s product candidates or products; the Company’s strategic and product development objectives and goals; the Company’s expected quarterly cash burn and cash runway; the Company’s exploration of strategic alternatives for Rejuva and the potential benefits thereof; and the timing of any of the foregoing.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the risks that are discussed more fully in its filings with the Securities and Exchange Commission (the SEC), including the “Risk Factors” section of its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 24, 2026, and other documents it subsequently files with or furnishes to the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 10, 2026.

These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.

1. Rodriguez PJ, et al. JAMA Netw Open. 2025;8(1):e2457349. jamanetwork.com
2. Prime Therapeutics, three-year GLP-1 persistence analysis, June 25, 2025 (commercial claims, n=5,780, 60-day gap). primetherapeutics.com

Contact
Brian Luque, Head of Investor Relations and Corporate Development
IR@fractyl.com, 951.206.1200

24.6% Objective Response Rate (ORR) in 69 Patients with Non-Squamous mNSCLC, Consistent with Previously Reported Results

IOV-LUN-202 Cohorts 1 and 2 Are Completing Enrollment and Support a Planned Supplemental Biologics License Application (sBLA) for Lifileucel in Non-Squamous mNSCLC in 2027

KRAS Wild-Type Subgroup Achieved 43.3% ORR Versus 11.4% in KRAS-Mutant Disease and Novel Biomarker-Enriched Subgroup Achieved 59.1% ORR

POSITILITY, a First-In-Class Biomarker-Enriched Study with Registrational Intent, to Begin Enrollment in November 2026

PHILADELPHIA, Oct. 29, 2026 (GLOBE NEWSWIRE) — Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company developing and delivering tumor infiltrating lymphocyte (TIL) therapies for cancer, today announced updated results from Cohorts 1 and 2 of its Phase 2 IOV-LUN-202 trial and a first-in-class biomarker-enriched precision TIL strategy for lifileucel in previously treated non-squamous mNSCLC.

IOV-LUN-202 Cohorts 1 and 2 are completing enrollment and support the planned sBLA for lifileucel in non-squamous mNSCLC in 2027.

As of the October 14, 2026 data cutoff, 17 of 69 patients responded, representing an ORR of 24.6%, consistent with the 25.6% ORR previously reported in 39 patients.

A retrospective analysis identified a biomarker-enriched subgroup defined by Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type status, human epidermal growth factor receptor 2 (HER2) wild-type status, and current or former smoking. This subgroup represented less than one-third of the broader study population (22 of 69 patients) but accounted for more than three-quarters of the observed responses (13 of 17), with an ORR of 59.1% (13 of 22 patients).

The KRAS findings and further biomarker enrichment provide the clinical foundation for Iovance’s precision TIL strategy. Iovance will prospectively evaluate this novel approach with POSITILITY, a first-in-class, prospective, biomarker-enriched cohort within the Phase 2 IOV-LUN-202 trial, designed with registrational intent.

Updated Results in the Broader Non-Squamous mNSCLC Population

Updated results from Cohorts 1 and 2 include 30 additional patients, bringing the total to 69 patients with non-squamous mNSCLC whose disease had progressed on or after platinum-based chemotherapy and immune checkpoint inhibitor therapy. Patients were enrolled without prospective selection using the novel biomarker-enrichment criteria.

The 17 reported responses included 15 confirmed responses and two unconfirmed partial responses (uPRs) awaiting confirmation. Radiologic assessments by an independent review committee are ongoing.

Response durability and the safety profile remained consistent with previous reports. The study incorporates an updated, reduced-dose lymphodepletion regimen that has improved the overall safety profile.

The broader IOV-LUN-202 Cohorts 1 and 2 are completing enrollment, with approximately 80 non-squamous NSCLC patients expected in the final dataset, and an sBLA for lifileucel in non-squamous mNSCLC is planned for 2027. Discussions with the U.S. Food and Drug Administration (FDA) are ongoing, and Iovance expects to provide further updates on the broader-population program in 2027.

KRAS Wild-Type Status Anchors the Precision TIL Strategy

To understand differences in response, Iovance evaluated clinical outcomes alongside tumor genomic and translational data. The analysis focused on tumor antigen presentation—the process by which tumor cells display targets for recognition by polyclonal TIL—and immune activity within the tumor microenvironment. Published preclinical studies in lung cancer models have linked oncogenic KRAS signaling to impaired antigen presentation and immune suppression, providing a biological rationale for investigating the association between KRAS status and response to lifileucel.¹

KRAS status emerged as the lead biomarker for Iovance’s novel enrichment strategy. In the broader population of 69 patients with non-squamous mNSCLC, the ORR was 43.3% (13 of 30 patients) in the KRAS wild-type subgroup, compared with 11.4% (4 of 35 patients) in the KRAS-mutant subgroup. Both complete responses occurred in patients with KRAS wild-type tumors. These findings provided the rationale for further enrichment within the KRAS wild-type subgroup.

Building on this signal, Iovance incorporated HER2 wild-type status and current or former smoking status into its enrichment strategy. These criteria draw on standard tumor genomic testing and routinely collected smoking history. Preclinical research suggests that aberrant HER2 signaling can suppress antitumor immunity, while smoking-associated mutations generate additional tumor targets for recognition by polyclonal TIL.

All 13 responses in the KRAS wild-type subgroup occurred among the 22 patients meeting the combined enrichment criteria, yielding an ORR of 59.1%, including both complete responses. These patients represented 31.9% of the broader study population but accounted for 76.5% of the observed responses. Together, the clinical findings and biological rationale support prospective evaluation of this combined enrichment strategy for lifileucel. The results for these populations are summarized in the following table.

Population	n	ORR*
Broader non-squamous NSCLC population	69	24.6% (17/69)
KRAS wild-type	30	43.3% (13/30)
KRAS-mutant	35	11.4% (4/35)
KRAS wild-type + HER2 wild-type	25	52.0% (13/25)
KRAS wild-type + HER2 wild-type + ever smoker	22	59.1% (13/22)

*ORRs include two uPRs, pending confirmation: one in the KRAS wild-type group and one in the KRAS-mutant group. Four KRAS-unassessed patients are excluded.

“These findings are reshaping how we develop TIL therapy for mNSCLC,” said Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance. “The expanded dataset reinforces the activity of lifileucel in previously treated disease, while the concentration of responses in KRAS wild-type tumors points to a more precision approach to patient selection. In the enriched subgroup, nearly six in ten patients responded, including two complete responses. We believe these insights could expand lifileucel’s potential as a one-time treatment for mNSCLC, with a best-in-class profile compared to other therapies in development.”

Iovance has launched POSITILITY as a first-in-class, prospective, biomarker-enriched cohort within the ongoing IOV-LUN-202 program, with enrollment to begin in November 2026 at the first of over 70 existing IOV-LUN-202 sites. Iovance intends for the study to support a potential registrational pathway, subject to FDA feedback.

“Tumor-reactive T cells need recognizable targets and a tumor microenvironment that supports a sustained antitumor response,” said Wayne Rothbaum, co-Chair of the Scientific Committee of Iovance’s Board of Directors. “The response pattern in IOV-LUN-202 provided a clinical rationale for testing how tumor biology can guide TIL therapy. Starting with KRAS status, and refining selection through HER2 status and smoking history, we identified a highly responsive mNSCLC subgroup where TIL biology converges with an immuno-reactive tumor microenvironment. We now aim to translate these novel findings into a precision development plan utilizing KRAS-based stratification, designed to identify patients most likely to benefit from lifileucel therapy.”

Supporting Frontline Data and Development Plans

In a separate analysis of frontline Cohort 3A of IOV-COM-202, six of seven patients with non-squamous mNSCLC, KRAS wild-type tumors, and a current or former smoking history responded to lifileucel plus pembrolizumab (without chemotherapy), yielding an ORR of 85.7%. HER2 status was not assessed in these patients. These findings provide additional rationale for prospective evaluation of lifileucel in the frontline setting.

Iovance plans to initiate OPTILISM, an innovative, frontline trial in biomarker-enriched non-squamous mNSCLC, in 2027. OPTILISM and the second-line POSITILITY trial are intended to evaluate lifileucel across two treatment settings and assess the role of biomarker-guided patient selection within the mNSCLC development program.

Across the patient populations enrolling into OPTILISM and POSITILITY, the prevalence of the biomarker-enriched population is estimated at approximately 45% of the cases of non-squamous mNSCLC diagnosed each year in the U.S., leading to more than 90,000 annual deaths and representing a significant market opportunity for lifileucel.

Additional details on the clinical results and development plans are available in a presentation posted to the Investor Relations section of www.iovance.com.

About IOV-LUN-202

IOV-LUN-202 is a Phase 2 study evaluating lifileucel in patients with previously treated mNSCLC. This update reports results from the 69 patients in Cohorts 1 and 2 with non-squamous histology who received a total viable cell count of at least 10 billion. Lifileucel remains investigational for the treatment of mNSCLC.

About Iovance Biotherapeutics

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at nearly 100 authorized treatment centers (ATCs). The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. Headquartered in Pennsylvania with offices and laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. For more information, please visit www.iovance.com.

Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Iovance owns patent rights and other intellectual property rights related to the biomarker-directed strategy described in this press release. Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.

References

1. Mugarza E, et al. Therapeutic KRASG12C inhibition drives effective interferon-mediated antitumor immunity in immunogenic lung cancers. Science Advances. 2022;8:eabm8780. https://doi.org/10.1126/sciadv.abm8780

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events, or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements.

Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the size of the addressable patient populations for, and the acceptance by the market of, our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our iCTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial supply or clinical supply; the risks related to our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates, including our biomarker-directed strategy; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates and any required companion diagnostics; whether clinical trial results from our clinical studies and cohorts, and meetings with regulatory authorities, may support registrational studies, including biomarker-selected studies such as POSITILITY, and subsequent approvals by regulatory authorities, and the risk that our clinical trials, including registrational trials, may experience delays in site activation, enrollment, or data readouts, may not meet their primary endpoints, or may not support approval; clinical results, whether preliminary, interim, or final, which may include efficacy and safety results, from clinical trials or cohorts, including retrospective subgroup analyses, may not be confirmed or reflected in independent review assessments or the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior or future trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials, including comparisons to other therapies, or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities or others; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control.

CONTACTS

Investors
IR@iovance.com
650-260-7120 ext. 150

Media
PR@iovance.com
650-260-7120 ext. 150