Author: Ravi Shankar

PALO ALTO, Calif., Nov. 13, 2026 (GLOBE NEWSWIRE) — Smartbird, Inc. (NASDAQ: BIRD), an AI infrastructure provider, has issued the following letter from Nadia Carlsten, CEO:

In August, I shared our vision for Smartbird. Three months later, we are rapidly moving from vision to execution.

We have established key technology relationships, secured data center capacity, and advanced commercial opportunities with prospective customers. Each represents an important milestone in its own right. Together, they are laying the foundation for Smartbird to deliver AI infrastructure at scale.

Building with the Best

In my first letter, I shared several principles guiding how we build Smartbird. One of them was Build with the best. This principle is particularly relevant today as we establish the relationships needed to deliver for our customers.

AI infrastructure is increasingly complex, and no single company has all the answers. Our approach is to combine the expertise of leading technology and infrastructure providers with our own capabilities to deliver complete solutions to our customers. This allows us to move faster, adapt as technology evolves, and focus our resources where we can create the most value.

On that front, we recently announced two important relationships:

Our collaboration with Supermicro gives us access to a broad portfolio of computing platforms and rack-scale systems, providing flexibility across processor architectures, system configurations, and deployment sizes. This flexibility is increasingly important as customer requirements diversify and new technologies enter the market.

Additionally, our partnership with WEKA brings advanced data and memory infrastructure to our managed AI offerings. McKinsey expects inference will supplant training as the dominant workload in AI data centers by 2030, while advancements in AI agents continue to accelerate. And as inference and agentic AI workloads become more demanding, efficient data access and movement are increasingly critical to system performance and cost. WEKA’s technology helps us address these requirements as part of an integrated solution.

These relationships mark the beginning of a broader technology partner network, bringing together proven technologies and specialized expertise, with Smartbird taking responsibility for designing, integrating, deploying, and operating the complete infrastructure stack.

Commercial Progress

Through my conversations with prospective customers, one observation stands out: customers are becoming more sophisticated in how they evaluate AI infrastructure. Their focus is shifting beyond GPU availability and headline pricing to the performance and economics of the entire system.

Simply, buyers want to understand how infrastructure will support their workloads, how quickly it can be deployed, and who will be responsible for operating it securely. They want a partner who can translate storage, networking, power and cooling, and software requirements into an integrated system that meets their performance, deployment, and operating-cost objectives.

My conversations at The Wall Street Journal’s recent Tech Live event reinforced this broader shift: attention is moving beyond the promise of AI toward the practical challenges of putting it to work. For us, this reinforces the growing importance of technical expertise and end-to-end accountability. Customers are not simply purchasing computing capacity; they are making long-term infrastructure decisions that will shape their ability to deploy AI and make it useful.

We are seeing the value of our focus on complete infrastructure solutions. Our commercial pipeline continues to develop across opportunities of varying sizes and requirements. Several discussions have advanced into detailed technical and commercial planning, including system configurations, deployment locations, financing structures, and delivery schedules. We are encouraged by the scale and maturity of these opportunities and remain focused on converting them into customer commitments and revenue.

Securing Data Center Capacity

As commercial discussions advance, securing suitable data center capacity becomes a prerequisite for converting opportunities into customer commitments. AI-ready facilities with the required power, cooling, and connectivity are increasingly difficult to secure globally, and availability directly affects deployment timelines. Securing capacity gives customers greater confidence in our ability to meet their requirements and deliver on schedule, helping move commercial opportunities toward execution.

Our agreement with Expedient secures U.S. data center capacity to support opportunities in our pipeline. Expedient is an established data center operator with experience supporting enterprise infrastructure, providing the facilities and operational environment needed for demanding AI deployments. The agreement provides a concrete foundation for deployment planning and represents an important step toward delivering infrastructure for our customers.

We intend to continue to secure capacity selectively, aligned with specific customer opportunities and their requirements. This allows us to advance commercial opportunities while managing capital commitments and execution risk.

Building in a Changing Market

The AI infrastructure market continues to attract extraordinary investment, driven by growing demand for computing capacity. At the same time, investors are paying closer attention to how projects are financed, when they will generate revenue, and whether returns will justify the capital committed.

I believe this scrutiny is a natural and necessary evolution of the market. The long-term opportunity remains substantial, but strong demand alone does not guarantee attractive returns. In a capital-intensive industry with rapidly evolving technology, success depends on carefully managing financing costs, deployment timelines, operating expenses, and equipment lifecycles. As the industry matures, the ability to manage these tradeoffs while delivering reliably will become a critical measure of success.

For Smartbird, this reinforces our approach to building the business. We intend to align major purchases and financing commitments with customer contracts, rather than invest heavily in speculative capacity. We also recognize that the right commercial and financing structure will differ by customer. Some may prefer to own their infrastructure while relying on Smartbird to design and operate it; others may favor a fully managed capacity model. This flexibility allows us to pursue opportunities based on their underlying economics while managing our capital requirements.

Looking Ahead

Our priorities for the coming quarters are clear: convert commercial opportunities into customer commitments, execute our initial deployments, and build the operational capabilities needed to support sustainable growth. We cannot control the broader financing environment, but we can control how we evaluate opportunities, commit resources, and execute. The milestones we have achieved give me confidence in our direction, and I look forward to sharing what comes next.

Sincerely,

Nadia Carlsten
CEO
Smartbird

Access the CEO letter on our website or as a PDF

Investor Contact:

ir@smartbird.ai

Media Contact:

Press@smartbird.ai

FDA lifted clinical hold on ARD-101 for the treatment of hyperphagia in Prader-Willi Syndrome (PWS)

Meeting with the FDA scheduled for the first quarter of 2027 to discuss the Company’s proposed clinical development plan for ARD-101; Company expects to resume PWS clinical activities in 2027

Exploratory data from the terminated HERO and OLE trials showed numerically greater HQ-CT score reductions with ARD-101 than placebo, with a generally well-tolerated safety profile

$60.3 million in cash, cash equivalents and short-term investments as of September 30, 2026, supports projected operations through 2027

SAN DIEGO, Nov. 13, 2026 (GLOBE NEWSWIRE) — Aardvark Therapeutics, Inc. (Aardvark or the Company) (Nasdaq: AARD), a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases, today reported financial results for the third quarter ended September 30, 2026, and provided business updates.

“The lifting of the clinical hold and the FDA’s agreement that we may conduct an open-label trial at 200 mg twice daily are important steps toward resuming clinical development of ARD-101 in PWS,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “We have developed a proposed clinical development plan and look forward to discussing it with the FDA. We remain committed to advancing ARD-101 for patients and families affected by PWS.”

Pipeline Updates

• In October 2026, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the Company’s Investigational New Drug (IND) application for ARD-101 for the treatment of hyperphagia in PWS. As required by the FDA, the Company conducted an electrocardiogram (ECG) study in healthy volunteers and an in vitro cardiac sodium channel (NaV1.5) study. No prolongation of the QRS interval or the QT interval was observed at ARD-101 doses of 200 mg or 400 mg twice daily (BID). The FDA has agreed that Aardvark may conduct an open-label trial at 200 mg BID in patients with PWS.
• In October 2026, Aardvark reported exploratory data from the terminated Phase 3 Hunger Elimination or Reduction Objective (HERO) trial and the open-label extension (OLE) trial. The HERO trial randomized 67 of the planned 90 participants before it was terminated early; as such, all efficacy data are considered exploratory, observational, inconclusive and too limited to support reliable interpretation. Highlights included:
  • Hyperphagia Questionnaire for Clinical Trials (HQ-CT) scores decreased in both treatment groups, with numerically greater reductions for ARD-101 than placebo at Weeks 2, 4, and 8. Due to early termination, evaluable participants declined from 30 (ARD-101) and 31 (placebo) at Week 2 to 11 and 13, respectively, at Week 12, limiting interpretation of the exploratory findings.
  • In the HERO intent-to-treat population with baseline HQ-CT scores of 13 or greater, the mean improvement from baseline in the clinician-rated Clinical Global Impression of Severity (CGI-S) score was numerically greater with ARD-101 than with placebo at every scheduled visit, including Week 12.
  • In the OLE cohort, participants who switched from placebo to ARD-101 had an observed average additional reduction of 6 points in HQ-CT score after four weeks of treatment. Among OLE participants who received either placebo or ARD-101 in the HERO trial, there was an average 11.8-point reduction in HQ-CT score relative to their baseline score at the start of the HERO trial. The OLE trial was open-label and did not include a control group.
  • ARD-101 was generally well tolerated, with most adverse events being mild to moderate. In the HERO trial, treatment-emergent adverse events were reported in 52% of ARD-101 participants and 50% of placebo participants, and treatment-related adverse events were reported in 15% of ARD-101 participants and 21% of placebo participants. One serious cardiac adverse event was observed in the HERO trial at 800 mg BID in a participant who was also taking pitolisant, a CYP2D6 substrate. The FDA concurred that this event was due to a drug-drug interaction with pitolisant. ARD-101 inhibits CYP2D6, the enzyme that metabolizes pitolisant. As with other approved drugs that inhibit CYP2D6, Aardvark believes this risk may be able to be managed through measures such as restricting, or adjusting the dose of, concomitant medications that are CYP2D6 substrates.
• Following the lifting of the clinical hold, Aardvark requested a meeting with the FDA, which has been scheduled for the first quarter of 2027, to discuss its proposed clinical development plan for ARD-101 in PWS. The Company intends to provide further details on the development pathway following FDA feedback. The Company expects to resume PWS clinical activities in 2027, subject to alignment with the FDA.

Corporate Update

• In October 2026, Aardvark appointed David Zhang, Ph.D., MBA, to its Board of Directors as an independent director. Dr. Zhang brings more than 25 years of experience in clinical strategy, biostatistics and regulatory submissions, including oversight of the pivotal trial design, readout and New Drug Application for CAMZYOS® (mavacamten) at MyoKardia. He currently serves as Chief Strategy Officer of Abivax S.A.

Third Quarter 2026 Financial Highlights

• Cash Position: As of September 30, 2026, Aardvark had cash, cash equivalents and short-term investments of $60.3 million, compared to $73.9 million as of June 30, 2026. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations through 2027.
• Research & Development (R&D): R&D expenses for the third quarter of 2026 were $15.7 million, compared to $13.7 million for the third quarter of 2025. The $1.9 million increase for the three months ended September 30, 2026 as compared to the three months ended September 30, 2025 resulted primarily from costs associated with the FDA-required cardiac safety study of ARD-101 and higher personnel-related costs, partially offset by lower clinical trial costs following the termination of the HERO and OLE trials.
• General & Administrative (G&A): G&A expenses were $4.0 million for each of the third quarters of 2026 and 2025.
• Net Loss: Aardvark reported a net loss of $19.2 million for the third quarter of 2026, compared to $16.3 million for the third quarter of 2025.

About Aardvark Therapeutics, Inc.

Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. For more information, visit www.aardvarktherapeutics.com.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, the path forward for ARD-101, including the anticipated resumption of dosing of ARD-101 in patients with PWS and anticipated doses to be used in future trials, the timing, design and outcome of the planned open-label trial, the anticipated timing of Aardvark’s meeting with the FDA, the timing for resuming clinical activities, and Aardvark’s planned engagement with the FDA regarding its Phase 3 program and the potential for any future Phase 3 trial to support a future marketing application or regulatory approval, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release also include statements regarding Aardvark’s anticipated cash runway; Aardvark’s belief that risks related to drug-drug interactions may be able to be managed through concomitant medication restrictions or dose adjustments; the interpretation and potential implications of exploratory data from the HERO and OLE trials; the potential of ARD-101 as a treatment option for patients with PWS; and Aardvark’s future plans for its PWS program. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk that the FDA may not agree with Aardvark’s proposed Phase 3 program or may require additional studies; the risk that the timing of Aardvark’s meeting with the FDA may be delayed; the timing of resuming dosing and activating clinical sites; uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk of additional safety findings, including risks related to cardiac safety and drug-drug interactions; limitations in interpreting data from the HERO trial and its OLE trial, which were terminated early and were not powered to assess efficacy, including the risk that exploratory, subgroup and uncontrolled analyses may not be confirmed in future trials; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; Aardvark’s ability to raise sufficient capital to fund its planned Phase 3 program; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; the possibility that the past track records of Aardvark and its personnel may not be repeated or indicative of future success; risks related to Aardvark’s dependence on third parties for manufacturing, shipping and production of drug product for use in clinical trials and preclinical studies; risks related to competition; Aardvark’s ability to obtain, maintain and enforce intellectual property protection for ARD-101; Aardvark’s ability to retain key personnel following its June 2026 workforce reduction; general economic, market and industry conditions; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.

Investor and Media Contact
Argot Partners
(212) 600-1902
Aardvark@Argotpartners.com

Aardvark Therapeutics, Inc. Unaudited Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts)
				Three Months Ended September 30,								Nine Months Ended September 30,
				2026				2025				2026				2025
Operating expenses:
Research and development		$		15,670			$	13,737		$		42,692			$	34,637
General and administrative				4,047				3,966				14,573				9,384
Total operating expenses				19,717				17,703				57,265				44,021
Loss from operations				(19,717		)		(17,703	)			(57,265		)		(44,021	)
Total other income, net				531				1,387				2,104				4,028
Net loss		$		(19,186		)	$	(16,316	)	$		(55,161		)	$	(39,993	)
Net loss per share of common stock, basic and diluted		$		(0.88		)	$	(0.75	)	$		(2.52		)	$	(2.12	)
Weighted-average shares used in net loss per share calculation				21,886,684				21,713,858				21,849,902				18,897,489

Aardvark Therapeutics, Inc. Condensed Consolidated Balance Sheets (in thousands)
		September 30,
		2026 (unaudited)			December 31, 2025
Assets
Current assets:
Cash and cash equivalents	$	60,335		$	47,051
Short-term investments		13			62,976
Prepaid expenses and other current assets		3,758			1,859
Total current assets		64,106			111,886
Operating lease right-of-use asset		532			355
Other assets		162			4,940
Total assets	$	64,800		$	117,181
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,589		$	2,072
Accrued liabilities		5,032			8,035
Operating lease liability, current portion		413			441
Total current liabilities		7,034			10,548
Operating lease liability, net of current portion		159			—
Total liabilities		7,193			10,548
Commitments and contingencies
Stockholders’ equity:
Preferred stock		—			—
Common stock		—			—
Additional paid-in-capital		228,686			222,470
Accumulated other comprehensive income		—			81
Accumulated deficit		(171,079	)		(115,918	)
Total stockholders’ equity		57,607			106,633
Total liabilities and stockholders’ equity	$	64,800		$	117,181

Not for distribution to United States Newswire Services or for dissemination in the United States

VANCOUVER, British Columbia, Nov. 13, 2026 (GLOBE NEWSWIRE) — Brixton Metals Corporation (TSX- V: BBB, OTCQX: BBBXF) (the “Company” or “Brixton”) is pleased to announce that it has closed a third and final tranche of a non-brokered private placement offering (the “Offering”) of national flow-through shares in the capital of Brixton (the “FT Shares”) and critical mineral flow-through shares in the capital of Brixton (the “CMFT Shares”). In connection with closing the third and final tranche of the Offering, the Company issued 147,059 FT Shares and 1,456,339 CMFT Shares for combined gross proceeds of $1,134,000.81. In total, the Company has issued 3,676,504 FT Shares and 6,561,638 CMFT Shares across all tranches of the Offering for aggregate gross proceeds of $7,158,785.70.

The gross proceeds from the sale of FT Shares will be used to incur “Canadian exploration expenses” and “flow-through mining expenditures” as defined in the Income Tax Act (Canada) (the “Act”). The gross proceeds from the CMFT Shares will be used to incur “flow-through critical mineral mining expenditures” as defined in subsection 127(9) of the Act. Exploration expenditures are mainly for exploration and drilling at the Company’s Thorn Copper-Gold Project in British Columbia and the Langis Silver-Cobalt Project in Ontario.

In connection with closing the third tranche of the Offering, the Company paid $66,840.01 and issued 94,513 non-transferable common share purchase warrants (each, a “Compensation Warrant”) to arm’s length parties who assisted in introducing subscribers to the third tranche of the Offering. Each Compensation Warrant is exercisable to acquire one common share in the capital of the Company at an exercise price of $0.68 until November 12, 2028. In total, the Company paid $123,840.75 and issued 178,150 Compensation Warrants across all tranches of the Offering.

All securities issued in connection with the Offering are subject to a hold period of four months and one day expiring on March 13, 2027 pursuant to applicable Canadian securities laws.

About Brixton Metals Corporation

Brixton Metals is a Canadian exploration company focused on advancing its mining projects. Brixton wholly owns five exploration projects: the Langis and Hudson Bay silver Projects in Ontario; the Thorn copper-gold-silver-molybdenum Project in NW British Columbia; the Hog Heaven copper-silver-gold Project in NW Montana, USA, which is optioned to Ivanhoe Electric Inc.; and the Atlin Goldfields Project in northwest BC. Brixton holds an option to acquire a 100% interest in the silver-focused Silvergruvan Project in Sweden. Brixton Metals Corporation shares trade on the TSX-V under the ticker symbol BBB, and on the OTCQX under the ticker symbol BBBXF. For more information about Brixton, please visit our website at www.brixtonmetals.com.

On Behalf of the Board of Directors

Mr. Gary R. Thompson, Chairman and CEO
info@brixtonmetals.com

For Investor Relations inquiries, please contact: Mr. Michael Rapsch, Vice President Investor Relations. email: michael.rapsch@brixtonmetals.com or call Tel: 604-630-9707.

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

Information set forth in this news release may involve forward-looking information under applicable securities laws. Forward-looking information are statements and information that relate to future, not past, events. In this context, forward-looking information often addresses expected future business and financial performance, and often contains words such as “anticipate”, “believe”, “plan”, “estimate”, “expect”, and “intend”; information and statements that an action or event “may”, “might”, “could”, “should”, or “will” be taken or occur, or other similar expressions. All information other than information of historical fact included herein are forward-looking information, including, without limitation, information regarding the Company’s business plans and strategies of operations; and use of proceeds of the Offering. By its nature, forward-looking information involves known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others, the following risks: the need for additional financing; operational risks associated with mineral exploration; fluctuations in commodity prices; title matters and the additional risks identified in the annual information form of the Company or other reports and filings with the TSXV and applicable Canadian securities regulators. Forward-looking information is based on management’s beliefs, estimates and opinions on the date that such information is provided and the Company undertakes no obligation to update forward-looking information if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable securities laws. Investors are cautioned against attributing undue certainty to forward-looking information. Brixton does not undertake to update any forward-looking information except in accordance with applicable securities laws.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws, unless an exemption from such registration is available.

Name changed from Quince Therapeutics, Inc. to IRulya Therapeutics Inc.; common stock began trading on the Nasdaq Capital Market under the ticker “IRLA” on October 12, 2026

Phase 2 data in bronchiolitis obliterans syndrome (BOS) post lung transplant anticipated in the first quarter of 2027

Cash, cash equivalents and investments of $105.2 million as of September 30, 2026 expected to fund operations through the end of 2028 with multiple Phase 2 clinical data readouts

NEW HAVEN, Conn., Nov. 13, 2026 (GLOBE NEWSWIRE) — IRulya Therapeutics Inc. (Nasdaq: IRLA), a clinical stage biopharmaceutical company focused on the development of novel, disease modifying therapies for serious, underserved diseases, today reported financial results for the third quarter ended September 30, 2026.

“This has been a transformative quarter for our company as we relaunched with a new name and sharpened focus on LAM-001, a potentially first in class inhaled formulation of rapamycin for serious pulmonary diseases,” said Brigette Roberts, M.D., Chief Executive Officer of IRulya Therapeutics. “By targeting the mTOR pathway directly in the lungs, LAM-001 holds promise as a potentially disease modifying intervention designed to simultaneously minimize systemic exposure and side effects in these conditions. With a cash runway sufficient to deliver Phase 2 clinical results from multiple indications, we believe IRulya is in a great position to realize LAM-001’s potential.”

Clinical and Scientific Update

• The Company continues to progress LAM-001 development across three clinical indications:
  • Bronchiolitis Obliterans Syndrome Post Lung Transplant (BOS): The Phase 2 trial of LAM-001 in BOS is fully enrolled, with data anticipated in the first quarter of 2027.
  • Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD): The Phase 2b trial of LAM-001 in PH-ILD is ongoing, with data anticipated in the first quarter of 2028.
  • Sarcoidosis Associated Pulmonary Hypertension (SAPH): The Company plans to initiate a Phase 2 study of LAM-001 in SAPH in the fourth quarter of 2026, with data anticipated in the fourth quarter of 2028.

• KOL event: On September 28, 2026, the Company hosted a virtual key opinion leader event on the treatment landscape for PH-ILD and BOS, featuring Aaron B. Waxman, M.D., Ph.D., Paul Yu, M.D., Ph.D., and Steven Hays, M.D. A replay of the event is available here.

Corporate update

• Relaunched as IRulya Therapeutics: Effective October 9, 2026, the Company changed its name from Quince Therapeutics, Inc. to IRulya Therapeutics Inc. Common stock began trading on the Nasdaq Capital Market as “IRLA” on October 12, 2026.
• Approved Series C Conversion: Stockholders approved the conversion on October 6, 2026, and the Series C preferred stock converted to common stock on October 9, 2026, subject to beneficial ownership limitations set by each holder. Following the Series C preferred conversion, our outstanding common stock is 10,841,470 as of November 5, 2026.
• Appointed New Leadership Team: Brigette Roberts, M.D., appointed Chief Executive Officer; John Militello, CPA, appointed Chief Financial Officer; and Keith Fandrick, Ph.D., appointed Chief Operating Officer.
• Strengthened Board of Directors: Catherine Bonuccelli, M.D., Leone Patterson, James Valentine, J.D., M.H.S., and Drayton Wise joined the Board.

Third Quarter 2026 Financial Results

Cash position: Cash, cash equivalents and investments were $105.2 million as of September 30, 2026. The Company expects that its cash position will be sufficient to fund operations through the end of 2028.

Research and development (R&D) expense: R&D expense for the three months ended September 30, 2026 was $5.9 million, compared to $8.1 million for the three months ended September 30, 2025. The decrease in R&D expenses is primarily due to the decrease in eDSP program costs of $6.9 million due to the wind down of the Quince program, partly offset by an increase in LAM-001 costs of $3.8 million due to PH-ILD Phase 2b study start-up costs.

General and administrative (G&A) expense: G&A expense for the three months ended September 30, 2026 was $9.0 million, compared to $3.3 million for the three months ended September 30, 2025. The increase in G&A expenses is primarily due to $3.0 million in post-acquisition professional fees and an increase in personnel related costs of $2.7 million primarily due to one-time severance and retention bonuses for terminated employees.

Net loss: IRulya reported a net loss of $27.7 million, or net loss per share of $2.31 per basic and diluted share, for the three months ended September 30, 2026, compared to a net loss of $13.4 million, or net loss per share of $49.83 per basic and diluted share for the three months ended September 30, 2025.

Shares outstanding: 1,017,063 shares of common stock were outstanding as of September 30, 2026.

About LAM-001

LAM-001 is a proprietary, once-daily dry powder inhaled formulation of rapamycin (also known as sirolimus) designed to enhance pulmonary delivery and reduce systemic exposure relative to oral or systemic administration. The mTOR pathway is a central regulator of cell growth, repair, and response to stress. Hyperactivated mTOR is implicated in multiple pulmonary diseases, where inhibition of mTOR with rapamycin has been shown in nonclinical models to reduce or reverse the disease process. IRulya is currently focused on developing LAM-001 in the following indications:

• Pulmonary hypertension associated with interstitial lung disease (PH-ILD): a condition which leads to thickening and narrowing of pulmonary blood vessels and progressive cardiopulmonary failure. PH-ILD affects an estimated ~200,000 patients in the US and Europe. Inhibition of mTOR with rapamycin has been shown in nonclinical models of pulmonary hypertension to reverse smooth muscle cell hyperproliferation, to attenuate pulmonary vascular remodeling, and to reduce fibrotic disease activity. A Phase 2a study of LAM-001 achieved clinically meaningful improvements across functional, hemodynamic and biomarker measures in patients with PH-ILD and pulmonary arterial hypertension. A Phase 2b trial (NCT05798923) in PH-ILD is ongoing, and data is anticipated in the first quarter of 2028.
• Bronchiolitis obliterans syndrome post lung transplant (BOS): the most common form of chronic transplant rejection in lung transplant patients, with no approved therapy and a median survival of 2.5 years after diagnosis. BOS prevalence is estimated at ~30,000 patients in the US and Europe by 2032. In nonclinical models, rapamycin was shown to reduce epithelial injury, limit fibrocyte migration, and boost anti-inflammatory cell infiltration, attenuating the dysregulated fibrocyte trafficking in BOS that drives airway obstruction. LAM-001 is being evaluated in an ongoing Phase 2 trial in BOS (NCT06018766). The trial is fully enrolled, and data is anticipated in the first quarter of 2027.
• Sarcoidosis-associated pulmonary hypertension (SAPH): a severe complication of pulmonary sarcoidosis with no approved therapy, affecting an estimated ~60,000 patients in the US and Europe. SAPH exhibits the same core mTOR-linked pulmonary vascular remodeling seen in PH-ILD, including smooth muscle hyperproliferation and fibrosis, which drive increased pulmonary pressures and progressive right-heart dysfunction. In addition, hyperactive mTOR in SAPH can promote pulmonary granuloma formation and contribute to vascular distortion, and mTOR inhibition has been demonstrated to reduce granuloma development. The Company plans to initiate a Phase 2 study in SAPH in the fourth quarter of 2026, with data anticipated in the fourth quarter of 2028.

About IRulya Therapeutics Inc.

IRulya Therapeutics Inc. is committed to transforming the lives of patients facing serious, underserved diseases by developing disease-modifying therapies to treat their conditions. The company is currently developing LAM-001 for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), bronchiolitis obliterans syndrome post lung transplant (BOS), and sarcoidosis associated pulmonary hypertension (SAPH). A Phase 2a clinical study in PH patients has been completed, a Phase 2 clinical study in BOS patients is ongoing, a Phase 2b clinical study in PH-ILD is ongoing, and a Phase 2 clinical study in SAPH is anticipated to begin in the fourth quarter of 2026. By pioneering innovative approaches, the company aims to offer new hope and improved quality of life to patients worldwide.

Forward-Looking Statements

Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to the design and potential benefits of LAM-001, including as a disease-modifying therapy for pulmonary disease; anticipated regulatory and development processes and timelines, including the expected timing to initiate the planned Phase 2 trial of LAM-001 in SAPH; the expected timing for data readouts from the ongoing Phase 2 trial of LAM-001 in BOS and the ongoing Phase 2b trial of LAM-001 in PH-ILD and the planned Phase 2 trial of LAM-001 in SAPH; the estimated patient populations in the U.S. and Europe for PH-ILD, BOS and SAPH; the potential advantages of mTOR inhibitors in PH-ILD, BOS and SAPH; and the Company’s anticipated cash runway, including to fund operations through the end of 2028. Forward-looking statements are based on IRulya’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to LAM-001; the ability to obtain and maintain regulatory approval; competition in the company’s industry; the scope, progress and expansion of developing LAM-001; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the company’s ability to attract or retain key management, members of the board of directors and other personnel; the company’s ability to fund its operations and clinical development plans, including its anticipated cash runway; the impacts of general macroeconomic and geopolitical conditions on the company’s business and financial position; and other risks and uncertainties described in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on August 14, 2026 and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and IRulya undertakes no duty to update such information except as required under applicable law.

		Three Months Ended September 30,								Nine Months Ended September 30,
			2026				2025				2026				2025
Operating expenses:
Research and development		$	5,851			$	8,083			$	18,158			$	22,781
Acquired in-process research and development			—				—				59,000				—
General and administrative			9,022				3,281				29,919				11,412
Gain on Orphai Acquisition			—				—				(1,305	)			—
Gain on sale of subsidiary			(1,731	)			—				(1,731	)			—
Intangible asset impairment charge			—				—				67,808				—
Fair value adjustment for contingent consideration			—				2,066				(64,330	)			4,522
Total operating expenses			13,142				13,430				107,519				38,715
Loss from operations			(13,142	)			(13,430	)			(107,519	)			(38,715	)
Fair value adjustment for debt			—				(549	)			12,168				(1,494	)
Fair value adjustment for warrants			(14,308	)			291				21,315				(4,173	)
Warrant issuance costs			—				(42	)			(874	)			(914	)
Interest income			1,024				300				1,768				1,017
Other (expense) income, net			(1,620	)			(58	)			255				(174	)
Net loss before income tax expense			(28,046	)			(13,488	)			(72,887	)			(44,453	)
Income tax benefit (expense)			302				46				5,567				(68	)
Net loss		$	(27,744	)		$	(13,442	)		$	(67,320	)		$	(44,521	)
Net loss per share – basic and diluted (1)		$	(2.31	)		$	(49.83	)		$	(10.79	)		$	(184.60	)
Weighted average shares of common stock and in-substance common stock outstanding – basic and diluted (1)			12,004,791				269,757				6,241,440				241,172
		September 30, 2026				December 31, 2025
Cash, cash equivalents, and investments		$	105,241			$	17,752
Total assets			106,472				93,523
Total liabilities			28,366				129,237
Series C Redeemable Convertible Preferred Stock			143,811				—
Total stockholders’ equity (deficit)			(65,705	)			(35,714	)
(1) Adjusted prior period net loss per share and weighted average of common shares outstanding to reflect the 1-for-10 reverse stock split effected on April 10, 2026 and the 1-for-20 reverse stock split effected on June 29, 2026

Contact

Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

PRINCETON, N.J., Nov. 13, 2026 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a clinical-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a business and clinical programs update and reported financial results for the quarter ended September 30, 2026.

“During our third quarter, we continued to execute our strategic prioritization of PDS0301, our investigational tumor-targeted IL-12 immunocytokine, as our lead development program,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We believe the ongoing clinical trials of PDS0301 at the NCI, along with those of our cancer vaccine platform, support our view that targeted T cell immunotherapy has the potential to change how solid tumors are treated. We are pleased to have the support of Dr. Soon-Shiong and NantWorks, who share our belief in the promise of our immunotherapy platforms and led our PIPE financing of up to $22.3 million, the initial closing of which we completed this quarter.”

Clinical and Corporate Update

• Announced the initial closing of a PIPE financing of up to $22.3 million led by Nant Capital, LLC with additional participation from current investors.
  • The PIPE includes a contingent milestone closing triggered by the Company’s submission to the FDA of a registrational Phase 3 clinical trial protocol for PDS0301 designed in collaboration with NantWorks, subject to the satisfaction or waiver of applicable closing conditions.
  • In connection with the PIPE, the Company entered into an option agreement granting NantWorks, LLC a one-year exclusive right to negotiate an exclusive license for the PDS0101 program.
  • Dr. Patrick Soon-Shiong, founder of NantWorks, and James Banaag appointed to the Company’s Board of Directors as Nant Capital designees.
• Appointed three pharma veterans to the Company’s Board of Directors, effective October 18, 2026:
  • John Dawson CBE, Deborah Ramsdell, and Bruce Wendel bring deep corporate development, commercialization, and regulatory expertise to the Company.
• Hosted a Key Opinion Leader (KOL) event discussing PDS0301 Phase 2 trials and projected clinical progress.
  • The event featured Jonathan M. Hernandez, M.D., an investigator with the Surgical Oncology Program at the National Cancer Institute’s Center for Cancer Research. Dr. Hernandez joined company management to discuss clinical outcomes from PDS0301 in the treatment of advanced liver-associated cancers, with a focus on the metastatic colorectal cancer (mCRC) cohort.
  • A replay of the event is available here.
• Announced publication of VERSATILE-002 Phase 2 clinical trial results of PDS0101 with pembrolizumab in HPV16-positive recurrent and/or metastatic (R/M) head and neck cancer in JAMA Oncology.
• Received issuance of a Japanese patent, JP Patent No.7909860, titled Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes. The patent broadly covers compositions and use of the Versamune® technology platform broadly for use as a T cell activating immunotherapy. A related US patent, US Patent No. 12,551,460, issued earlier in 2026.
• Received issuance of patents titled HPV16 Non-HLA Restricted T Cell vaccines, Compositions and Methods of Use Thereof in both India and Israel, IN Patent No. 603830 and IL Patent No. 265833. The patents cover the composition and use of PDS0101 being developed to treat HPV16-positive cancers. A related US patent, US Patent No. 11,401,306, issued in 2022.

Third Quarter 2026 Financial Results

The Company’s cash and cash equivalents as of September 30, 2026 were $15.2 million.

Reported net loss was $7.6 million, or $0.11 per basic and diluted share, for the three months ended September 30, 2026, compared to $9.0 million, or $0.19 per basic and diluted share, for the three months ended September 30, 2025.

Research and development expenses were $2.1 million for the three months ended September 30, 2026, compared to $4.6 million for the three months ended September 30, 2025. The decrease of $2.5 million was primarily attributable to decreases of $1.6 million in clinical trial costs, $0.6 million in personnel costs and $0.3 million in manufacturing costs.

General and administrative expenses increased to $3.8 million for the three months ended September 30, 2026 from $3.6 million for the three months ended September 30, 2025. The increase of $0.2 million was primarily attributable to an increase of $0.3 million in professional fees, an increase of $0.1 million in personnel costs offset by a decrease of $0.2 million in stock based compensation costs.  

Total operating expenses were $5.9 million for the three months ended September 30, 2026, compared to $8.1 million for the three months ended September 30, 2025.

Net interest expenses were $1.7 million for the three months ended September 30, 2026, compared to $0.9 million for the three months ended September 30, 2025.

About PDS Biotechnology

PDS Biotechnology is a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer. The Company’s lead development program, PDS0301 (also referred to as PDS01ADC & NHS-IL12), is an investigational tumor-targeted interleukin-12 (IL-12) immunocytokine designed to deliver IL-12 preferentially to the tumor microenvironment, with the goal of enhancing anti-tumor immune activity while limiting systemic exposure. PDS0301 has been clinically evaluated across multiple solid tumors, including metastatic colorectal cancer and prostate cancer. The Company is focused on advancing PDS0301 in indications where its tumor-targeted mechanism may help address and overcome mechanisms of resistance to immunotherapy. PDS Biotechnology owns the Versamune® cancer vaccine platform, including PDS0101, which has been evaluated in HPV16-positive cancers. The Company intends to pursue strategic partnerships or other externally funded opportunities for the Phase 3 development of PDS0101.

For more information, please visit www.pdsbiotech.com

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s the Company’s ability to identify, negotiate or consummate strategic partnerships or other externally funded opportunities for PDS0101, including under its option agreement with NantWorks, LLC; the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0301, PDS0101 (Versamune® HPV), PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0301, PDS0101 (Versamune® HPV), PDS0103 (Versamune® MUC1) and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; the Company’s ability to regain and maintain compliance with Nasdaq continued listing requirements, including the minimum bid price requirement, and the risk of delisting; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents the Company files with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Jude Gorman / Kiki Torpey
Collected Strategies
PDS-CS@collectedstrategies.com

—tables to follow—

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Operating expenses:
Research and development expenses		$	2,051,213			$	4,576,389			$	8,773,832			$	14,620,308
General and administrative expenses			3,844,891				3,563,753				10,140,094				10,248,943
Total operating expenses			5,896,104				8,140,142				18,913,926				24,869,251
Loss from operations			(5,896,104	)			(8,140,142	)			(18,913,926	)			(24,869,251	)
Interest income (expense)
Interest income			41,630				281,109				353,850				992,582
Interest expense			(1,766,451	)			(1,150,378	)			(6,160,480	)			(4,225,737	)
Interest income (expense), net			(1,724,821	)			(869,269	)			(5,806,630	)			(3,233,155	)
Loss before income taxes			(7,620,925	)			(9,009,411	)			(24,720,556	)			(28,102,406	)
Benefit from income taxes			–				–				–				1,169,820
Net loss and comprehensive loss			(7,620,925	)			(9,009,411	)			(24,720,556	)			(26,932,586	)
Per share information:
Net loss per share, basic and diluted		$	(0.11	)		$	(0.19	)		$	(0.40	)		$	(0.60	)
Weighted average common shares outstanding basic and diluted			71,936,955				46,869,531				61,145,055				44,648,508

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Selected Balance Sheet Data
(Unaudited)
		September  30,				December 31,
			2026				2025
Cash and cash equivalents		$	15,245,081			$	26,711,969
Working capital			13,297,920				18,770,871
Total assets			18,571,942				30,494,083
Long term debt			–				11,733,350
Accumulated deficit			(241,327,060	)			(216,606,504	)
Total stockholders’ equity			13,495,140				9,251,833

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2026 (GLOBE NEWSWIRE) — Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a biotechnology company pioneering targeted therapeutics to harness the power of Wnt signaling to address the underlying drivers of disease in sight-threatening ophthalmic conditions, today announced the pricing of an underwritten offering of 1,894,540 shares of its common stock at an offering price of $31.67 per share. The gross proceeds to Surrozen from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Surrozen, are expected to be $60 million. All the shares in the offering are being sold by Surrozen. The offering is expected to close on or about November 16, 2026, subject to the satisfaction of customary closing conditions.

The offering includes participation from Access Biotechnology, Boxer Capital Management, Perceptive Advisors, RTW Investments, Venrock Healthcare Capital Partners, and other new and existing life sciences focused investors.

Morgan Stanley, Guggenheim Securities and Cantor are acting as joint book-running managers for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-294542) that was previously filed with the U.S. Securities and Exchange Commission (“SEC”) on March 23, 2026 and was declared effective by the SEC on March 30, 2026. This offering is being made only by means of a prospectus supplement to be filed with the SEC and an accompanying prospectus that form a part of the effective registration statement. When available, copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8^th Floor, New York, NY 10017, telephone: (212) 518-9544, email: GSEquityProspectusDelivery@guggenheimsecurities.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59^th Street, 6^th Floor, New York, NY 10022; email: prospectus@cantor.com.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Surrozen
Surrozen is a biotechnology company, pioneering a new class of Wnt-based therapeutics designed to harness the power of Wnt signaling to treat sight-threatening ophthalmic conditions. Built on deep scientific expertise and a proprietary antibody-engineering platform, Surrozen develops multifunctional biologics that selectively activate Wnt signaling in combination with other key disease pathways. Our approach aims to deliver best-in-class, durable therapies that have the potential to transform patient outcomes in some of the most pressing unmet medical needs in ocular diseases.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the completion of the offering. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the uncertainties related to the satisfaction of customary closing conditions for the offering, and all other factors discussed in the prospectus supplement and accompanying prospectus, Surrozen’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 23, 2026 and Surrozen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, filed with the SEC on November 9, 2026, under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen’s expectations, plans, or forecasts of future events and views as of the date of this press release. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law.

Investor and Media Contact:
Investorinfo@surrozen.com

SINGAPORE, Nov. 13, 2026 (GLOBE NEWSWIRE) — BitFuFu Inc. (“BitFuFu” or the “Company”) (NASDAQ: FUFU), a world-leading Bitcoin miner and mining services innovator, today announced that it will release its third quarter financial results for the quarter ended September 30, 2026, before the U.S. market open on November 20, 2026.

The Company’s management team will hold an earnings conference call at 8:00 a.m. U.S. Eastern Standard Time on Friday, November 20, 2026 (9:00 p.m. Singapore Time on the same day).

All participants must register in advance of the conference call using the link provided below. Upon registration, each participant will receive a confirmation email containing dial-in numbers and a unique access PIN, which will be used to join the conference call.

Registration Link: BitFuFu Third Quarter 2026 Earnings Conference Call

Additionally, a live and archived webcast of the conference call will also be available on the Company’s investor relations website at https://ir.bitfufu.com.

About BitFuFu Inc.
BitFuFu Inc. is a world-leading Bitcoin miner and mining services innovator. BitFuFu is committed to empowering the global Bitcoin network through its industry-leading cloud mining platform, rapidly scaling infrastructure, and innovative mining services.

For more information, visit ir.bitfufu.com or follow BitFuFu on X @BitFuFuOfficial.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of BitFuFu’s management and are not predictions of actual performance. These statements involve risks, uncertainties and other factors that may cause BitFuFu’s actual results, levels of activity, performance, or achievements to be materially different from those expressed or implied by these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained in this press release, the Company cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. All information provided in this press release is as of the date of this press release and the Company does not undertake any duty to update such information, except as required under applicable law.

Investor Contact:
BitFuFu Investor Relations
ir@bitfufu.com

Liane Tang
liane.tang@bitfufu.com

Media Contact:
BitFuFu Media Relations
pr@bitfufu.com

• Novel GH001 Aerosol Delivery System (ADS) device: final results of the GH001-HV-106 trial support going from 3 → 1 doses per treatment visit
• TRD pivotal program — positive initial feedback from FDA, End-of-Phase 2 meeting expected in Q1 2027, initiation shortly after
• PPD pivotal program — initiation targeted for H2 2027
• Vanina Popova, MD, appointed Chief Development Officer — Formerly Clinical Development at J&J, lead author of pivotal Spravato® trial publication
• Cash, cash equivalents and marketable securities of $350.6 million as of September 30, 2026

DUBLIN, Nov. 13, 2026 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the quarter ended September 30, 2026, and provided a business update.

Business Updates

Global Pivotal Program of GH001 in TRD

The final results of our Phase 1 trial GH001-HV-106 in healthy volunteers support one fixed dose of GH001 per treatment visit with our novel GH001 Aerosol Delivery System (ADS). Our Phase 2b trial, which used a third-party vaporizer, titrated patients to a peak experience with an individualized dosing regimen (IDR) of up to three doses per treatment visit: 23% of patients had reached a peak experience after the 6 mg dose, 62% after the 6 mg and 12 mg doses and 86% after the 6 mg, 12 mg and 18 mg doses (19, 50 and 70 of 81 patients). The ADS delivers a consistent dose through reduced variability (82% to 89% of the loaded dose in bench testing, compared with 55% to 79%). In GH001-HV-106, peak experience rates across increasing single doses showed a consistent dose response, up to 88% of participants (7 of 8) at a dose we plan to take into the pivotal program. We expect the single fixed dose allows for a ~1-hour fixed treatment visit in clinical practice.

We have received positive initial feedback from the U.S. Food and Drug Administration (FDA) on the design of our pivotal program in treatment-resistant depression (TRD) using the novel GH001 ADS. As currently planned, the pivotal trials will be randomized and double-blind, comparing parallel fixed-dose arms with placebo, with one fixed dose per treatment visit, a primary endpoint of Montgomery-Åsberg Depression Rating Scale (MADRS) change from baseline at Week 4 and a 12-week double-blind period. We expect to hold an End-of-Phase 2 meeting with the FDA in Q1 2027 to finalize the design and to initiate the pivotal program in TRD shortly thereafter, subject to final alignment.

GH001 in Postpartum Depression
In our open-label Phase 2a trial of GH001 in postpartum depression (PPD) (GH001-PPD-203), all ten patients were in remission at 2 hours, on Day 2 and on Day 8 after a single administration day with the IDR, and the primary endpoint was met with a MADRS reduction from baseline of -35.4 points on Day 8 (p<0.0001). We plan to advance GH001 in PPD into a pivotal program with one fixed dose per treatment visit via the ADS and are targeting initiation in the second half of 2027, subject to final regulatory alignment.

“Women with postpartum depression need treatments that work quickly and ask little of them at a time when they are caring for a newborn. In the Phase 2a trial, every patient was in remission within hours of a single treatment day. A single dose given in a visit of about an hour would fit the lives of new mothers, and I am glad to see GH001 move toward a pivotal program in postpartum depression,” said Kristina M. Deligiannidis, MD, of the Feinstein Institutes for Medical Research at Northwell Health.

Corporate Update
In a separate press release issued today, we announced the appointment of Vanina Popova, MD, as Chief Development Officer, to lead the clinical development of GH001 into our pivotal programs. Dr. Popova was previously at Johnson & Johnson, where she worked on the clinical development of Spravato® (esketamine) and was the lead author of the publication of TRANSFORM-2, its pivotal Phase 3 trial in TRD.

Scientific Presentations
In September 2026, we presented a poster at the International Society for Bipolar Disorders (ISBD) 2026 Annual Conference with data from our Phase 2a GH001-BD-202 trial in patients with bipolar II disorder showing rapid and clinically meaningful improvement in anhedonia.

In October 2026, we hosted an industry symposium on rapid-acting antidepressants in TRD and presented three posters at the 39th European College of Neuropsychopharmacology (ECNP) Congress, including data from our Phase 2b GH001-TRD-201 trial showing improvements on Day 8 in patient-reported quality of life (Q-LES-Q-SF change from baseline, 20.6 points, p<0.0001) and in MADRS anhedonia factor score (change from baseline, -9.9 points, p<0.0001), both maintained at Month 6 with infrequent treatment in the open-label extension, as well as efficacy and safety data from GH001-BD-202.

Third Quarter 2026 Financial Highlights

Cash position

Cash, cash equivalents and marketable securities were $350.6 million as of September 30, 2026, compared to $280.7 million as of December 31, 2025. Marketable securities are comprised of investment grade bonds.

Research and development expenses

R&D expenses were $10.1 million for the quarter ended September 30, 2026, compared to $10.6 million for the same quarter in 2025. The decrease is primarily due to decreased technical development and clinical development expenses.

General and administrative expenses

G&A expenses were $5.3 million for the quarter ended September 30, 2026, compared to $6.0 million for the same quarter in 2025. The decrease is primarily due to a decrease in professional fees.

Net loss

Net loss was $12.5 million, or $0.18 loss per share, for the quarter ended September 30, 2026, compared to $14.0 million, or $0.23 loss per share, for the same quarter in 2025.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC’s initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with TRD.

About GH001

Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a Montgomery-Åsberg Depression Rating Scale (MADRS) reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has the potential to change the way TRD is treated today.

Forward-Looking Statements

This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our plans and expectations with respect to the initiation, timing, progress and design of our global Phase 3 pivotal program for GH001; our plans and expectations with respect to seeking FDA alignment on the pivotal program design; our plans and expectations with regard to advancing GH001 in PPD into a pivotal program, including initiation, timing, progress and design of such program; our future results of operations and financial position, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned nonclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, our expectations related to commencing trials in the United States, research and development costs, cash runway, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, the risk that we may not be able to initiate or complete our global Phase 3 pivotal program for GH001 on the timelines we are targeting or at all; the risk that we may not obtain FDA alignment on the pivotal program design on favorable terms or at all; the risk that we may not be able to initiate or complete a pivotal program of GH001 in PPD on the timelines we are targeting or at all; the risk that results from our Phase 1 trial in healthy volunteers and our open-label Phase 2a trial may not be predictive of results in our pivotal trials, the risk that future clinical trials of GH001 or clinical trials of GH002 or other product candidates we propose in future INDs are placed on clinical hold by the FDA; the risk that we may not be able to commence clinical trials in the United States on the timelines we are targeting; and those other risks described in our filings with the U.S. Securities and Exchange Commission from time to time. No assurance can be given that such future results, plans, or expectations or targets will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations

Magnus Halle
GH Research PLC
investors@ghres.com

GH RESEARCH PLC Condensed Consolidated Interim Statement of Comprehensive Loss (Unaudited) (in thousands, except share and per share amounts)
	Three months ended September 30,			Nine months ended September 30,
	2026	2025		2026	2025
	$’000	$’000		$’000	$’000
Operating expenses
Research and development	(10,071)	(10,567)		(34,849)	(27,377)
General and administration	(5,285)	(5,998)		(18,711)	(16,624)
Loss from operations	(15,356)	(16,565)		(53,560)	(44,001)
Finance income	2,992	2,783		7,843	8,616
Finance expense	(75)	(21)		(242)	(373)
Movement of expected credit loss	4	30		12	24
Foreign exchange (loss)/gain	(15)	(247)		(616)	1,613
Total other income	2,906	2,545		6,997	9,880
Loss before tax	(12,450)	(14,020)		(46,563)	(34,121)
Tax charge/(credit)	–	–		–	–
Loss for the period	(12,450)	(14,020)		(46,563)	(34,121)
Other comprehensive (expense)/income
Items that may be reclassified to profit or loss
Fair value movement on marketable securities	(38)	(33)		(167)	(55)
Currency translation adjustment	(52)	(63)		(1,791)	926
Total comprehensive loss for the period	(12,540)	(14,116)		(48,521)	(33,250)
Attributable to owners:
Loss for the period	(12,450)	(14,020)		(46,563)	(34,121)
Total comprehensive loss for the period	(12,540)	(14,116)		(48,521)	(33,250)
Loss per share
Basic and diluted loss per share (in USD)	(0.18)	(0.23)		(0.71)	(0.56)

GH RESEARCH PLC Condensed Consolidated Interim Balance Sheet (Unaudited) (in thousands)
	At September 30,	At December 31,
	2026	2025
	$’000	$’000
ASSETS
Current assets
Cash and cash equivalents	345,088	246,251
Marketable securities	5,501	34,457
Other current assets	6,523	5,268
Total current assets	357,112	285,976
Non-current assets
Property, plant and equipment	519	620
Other non-current assets	2,281	1,634
Total non-current assets	2,800	2,254
Total assets	359,912	288,230
LIABILITIES AND EQUITY
Current liabilities
Trade payables	5,339	3,773
Lease liability	283	365
Other current liabilities	5,263	4,242
Total current liabilities	10,885	8,380
Non-current liabilities
Lease liability	7	147
Total non-current liabilities	7	147
Total liabilities	10,892	8,527
Equity attributable to owners
Share capital	1,717	1,551
Additional paid-in capital	542,946	431,061
Other reserves	17,909	13,292
Foreign currency translation reserve	(13,567)	(11,776)
Accumulated deficit	(199,985)	(154,425)
Total equity	349,020	279,703
Total liabilities and equity	359,912	288,230

WEST PALM BEACH, Fla., Nov. 13, 2026 (GLOBE NEWSWIRE) — Dycom Industries, Inc. (NYSE: DY) will host a conference call to discuss fiscal 2027 third quarter results on Tuesday, November 24, 2026, at 9:00 a.m. ET. Dycom will issue a press release reporting its results earlier that morning.

Interested parties may participate in the question-and-answer session of the conference call by registering at https://register-conf.media-server.com/register/BIe75472311bf040b6b6f780ef907d233e. Upon registration, participants will receive a dial-in number and unique PIN to access the call. Participants are encouraged to join approximately ten minutes prior to the scheduled start time.

For all other attendees, a live listen-only audio webcast of the call, including an accompanying slide presentation, can be accessed directly at https://edge.media-server.com/mmc/p/xowq4aqb/. A replay of the live webcast and the related materials will be available on the Company’s Investor Center website at https://ir.dycomind.com for approximately 120 days following the event.

About Dycom Industries, Inc.
Dycom is a leading provider of specialty contracting services to the telecommunications infrastructure and utility industries throughout the United States. These services include program management, planning, engineering and design; aerial, underground, and wireless construction; maintenance; and fulfillment services for telecommunications providers. Additionally, Dycom provides electrical contracting services for data centers and other vital industries, underground facility locating services for various utilities, including telecommunications providers, as well as other construction and maintenance services for electric and gas utilities.

For more information, contact:
Callie Tomasso, Vice President Investor Relations & Corporate Communications
Email: investorrelations@dycomind.com
Phone: (561) 627-7171

CONSHOHOCKEN, Pa., Nov. 13, 2026 (GLOBE NEWSWIRE) — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) today announced that the company will participate in fireside chats at three upcoming investor conferences:

The fireside chats will be webcast live and can be accessed by visiting Madrigal’s Investor Relations Events page.

Jefferies Global Healthcare Conference in London
Tuesday, Nov. 17, 2026 at 10:30 A.M. GMT (5:30 A.M. ET)

9th Annual Evercore Healthcare Conference
Tuesday, Dec. 1, 2026 at 8:20 A.M. ET

Piper Sandler 38^th Annual Healthcare Conference
Wednesday, Dec. 2, 2026 at 8:30 A.M. ET

About Madrigal
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com and follow us on LinkedIn.

Investor Contact
Tina Ventura, IR@madrigalpharma.com

Media Contact
Christopher Frates, media@madrigalpharma.com