Microbix Schedules Release of Results for Q4 Fiscal 2025

Microbix Schedules Release of Results for Q4 Fiscal 2025




Microbix Schedules Release of Results for Q4 Fiscal 2025

Results Release and Webinar Discussion on Morning of December 18, 2025

MISSISSAUGA, Ontario, Dec. 11, 2025 (GLOBE NEWSWIRE) — Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it expects to file the financial statements, management disclosure and analysis, and results news release for its fourth quarter of fiscal 2025 ended September 30, 2025 (“Q4 2025”) prior to the start of trading on December 18, 2025. At 10:00 AM ET that day, Microbix intends to hold a webinar discussion of Q4 2025 results with its CEO, CFO, and COO.

Investor and shareholders can participate in the webinar, hosted by Adelaide Capital, by registering at: https://us02web.zoom.us/webinar/register/WN_uKFYZc_DTZinjJoUP46rcA.

It will also be live-streamed to YouTube at: https://www.youtube.com/channel/UC7Jpt_DWjF1qSCzfKlpLMWw.

Or join via audio:  +1 587 328 1099 Canada

A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.

About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 120 skilled employees and revenues of C$ 25.4 million in its last reported fiscal year (2024). It enables the worldwide commercialization of diagnostic assays by making a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) and reference materials (QUANTDx™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs or QUANTDx are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides IVDR-compliant CE marked products.

Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots, and reagents or media to support molecular diagnostic testing (e.g., its DxTM™ for patient-sample collection). Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.

Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, expected timing of release of financial results, intended discussion of financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those referenced herein, access to and sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain, and that actual performance may be affected by many material factors, some of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information except as required by applicable law.

Please visit www.microbix.com or www.sedarplus.ca for recent Microbix news and filings.

For further information, please contact Microbix at:

Cameron Groome,
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793
ir@microbix.com

Copyright © 2025 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, QAPs™, and QUANTDx™ are trademarks of Microbix Biosystems Inc.

Terns Announces Closing of Public Offering of Common Stock, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

Terns Announces Closing of Public Offering of Common Stock, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares




Terns Announces Closing of Public Offering of Common Stock, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

FOSTER CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced the closing of its previously announced underwritten public offering of 18,687,500 shares of its common stock, including 2,437,500 shares sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares, at a public offering price of $40.00 per share, before underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Terns, are $747.5 million. All of the securities were offered by Terns.

Jefferies, TD Cowen and Leerink Partners acted as lead book-running managers for the offering. Mizuho, Citizens Capital Markets and Oppenheimer & Co. acted as co-managers for the offering.

Terns intends to use the net proceeds from the offering to fund research, clinical trials, development and manufacturing of key product candidates, including TERN-701, initial activities in preparation for the potential future commercial launch of TERN-701 and for working capital and general corporate purposes. The public offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-292016) that was filed with the Securities and Exchange Commission (the “SEC”) on December 9, 2025 and automatically became effective on such date. A prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus relating to this offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at prospectus_department@jefferies.com, TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com, or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-800-808-7525 ex. 6105, or by email at syndicate@leerink.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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification of these securities under the securities laws of any such state or other jurisdiction.

About Terns Pharmaceuticals

Terns Pharmaceuticals is a clinical-stage oncology company reimagining known biology to deliver high impact medicines. Our lead program TERN-701 is a highly selective, allosteric BCR-ABL inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing treatments for CML.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the use of proceeds of the offering and the potential clinical profile and relative benefits of TERN-701. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company and the offering, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and its prospectus supplement. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Contacts for Terns

Investors
Justin Ng
investors@ternspharma.com

Media
Jenna Urban
CG Life
media@ternspharma.com

Dyne Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares

Dyne Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares




Dyne Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares

WALTHAM, Mass., Dec. 11, 2025 (GLOBE NEWSWIRE) — Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced the closing of its previously announced upsized underwritten public offering of 21,827,549 shares of its common stock at a public offering price of $18.44 per share, which includes 2,847,071 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The gross proceeds to Dyne from the offering were approximately $402.5 million, before deducting underwriting discounts and commissions and offering expenses payable by Dyne. All of the shares in the offering were sold by Dyne.

Morgan Stanley, Jefferies, Stifel and Guggenheim Securities acted as joint book-running managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (“SEC”) on March 5, 2024 and became automatically effective upon filing. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and 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; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.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 Dyne Therapeutics

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

Contacts:
 
Investors

Mia Tobias
ir@dyne-tx.com
781-317-0353

Media

Stacy Nartker
snartker@dyne-tx.com
781-317-1938

BBOT Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

BBOT Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)




BBOT Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (NASDAQ: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced it awarded an inducement grant on December 10, 2025 under BBOT’s 2025 Inducement Plan as a material inducement to the employment of an individual hired by BBOT in November 2025.

The employee received non-qualified stock options to purchase 53,060 shares of BBOT common stock, par value $0.0001 per share, with an exercise price of $12.88 per share, the closing price of BBOT’s common stock as reported by Nasdaq on the effective date of the grant, which will vest 1/4 on the first anniversary of the employee’s applicable start date and in 36 equal monthly installments thereafter, subject to the employee’s continued service with the Company through each applicable vesting date, or collectively, the Awards.

All of the above-described Awards were granted outside of BBOT’s stockholder-approved equity incentive plans and are pursuant to BBOT’s 2025 Inducement Plan, which was adopted by BBOT’s board of directors in October 2025. The Awards were approved by the compensation committee of the board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with BBOT in accordance with Nasdaq Listing Rule 5635(c)(4).

About BBOT
BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3Kα malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information, please visit www.bbotx.com and follow us on LinkedIn.

BBOT Contacts:

Investor Contact:
Heather Armstrong, Head of Investor Relations
BBOT
Investors@BBOTx.com

Media Contact:
Jake Robison
Inizio Evoke Comms
Jake.robison@inizioevoke.com

Crinetics Announces First Patient Dosed in Pivotal Adult Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH)

Crinetics Announces First Patient Dosed in Pivotal Adult Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH)




Crinetics Announces First Patient Dosed in Pivotal Adult Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH)

Phase 3 study builds on positive phase 2 results showing rapid and sustained reductions in key disease biomarkers and clinical measures of CAH

SAN DIEGO, Dec. 11, 2025 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the first patient has been dosed in the CALM-CAH Phase 3 trial evaluating investigational candidate atumelnant, a novel, once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH).

“Dosing the first patient in this Phase 3 study underscores our commitment to addressing the unmet needs of people living with CAH and our excitement about the potential of atumelnant,” said Dana Pizzuti, M.D., Chief Medical and Development Officer of Crinetics. “Through the CALM-CAH study, we will evaluate atumelnant’s ability to normalize adrenal androgen levels while simultaneously reducing glucocorticoid levels to the physiologically normal range. With a unique endpoint measuring both of these objectives, CALM-CAH sets a new standard in terms of assessing overall disease control.”

Atumelnant is the first-and-only small molecule ACTH receptor antagonist in late-stage clinical development and is designed to block the pathway in the adrenal gland that leads to the production of excess androgens associated with classic CAH. In a Phase 2 study in adults with classic CAH, treatment with atumelnant was associated with reductions in key biomarkers, including androstenedione and 17-hydroxyprogesterone, as well as other clinical measures of disease activity including adrenal size and resumption of menses. Based on Phase 2 results, Crinetics has advanced the registrational CALM-CAH Phase 3 trial in adults.

The CALM-CAH Phase 3 study is a randomized, placebo-controlled trial evaluating atumelnant in adults with classic CAH, designed to assess reductions in excess androgens, improvements in glucocorticoid use, and other clinical outcomes that reflect disease control.

Crinetics recently received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for atumelnant in the treatment of classic CAH.

For more information, visit https://clinicaltrials.gov/study/NCT07159841.

About Atumelnant
Investigational atumelnant is the first in class and only once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland in late-stage clinical development. Diseases associated with excess ACTH can have a significant impact on physical and mental health. Novel atumelnant has exhibited strong binding affinity for MC2R in preclinical models and has demonstrated suppression of adrenally derived glucocorticoids and androgens that are under the control of ACTH. Data from a 12-week Phase 2 study consistently demonstrated compelling treatment benefits of atumelnant, evidenced by the rapid, substantial and sustained statistically significant reductions in key CAH disease related biomarkers, including A4 and 17-hydroxyprogesterone, in a diverse population. Currently in Phase 3 clinical development, atumelnant holds the potential to offer transformational care for individuals living with congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome. This breakthrough could revolutionize the management of these conditions, providing hope for unprecedented improvements in quality of life.

About Crinetics Pharmaceuticals
Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties.

Crinetics’ lead product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics’ deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat SST2 expressing neuroendocrine tumors and other SST2 expressing solid tumors. Additional discovery programs address a variety of endocrine conditions such as neuroendocrine tumors, Graves’ disease (including Graves’ hyperthyroidism and Graves’ orbitopathy, or thyroid eye disease), polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the Phase 3 program for atumelnant for CAH and for a Phase 2/3 program of atumelnant for ACTH-dependent Cushing’s syndrome; the plans and timelines for the clinical development of our drug candidates, including the therapeutic potential and clinical benefits or safety profile thereof or the expected timing of the advancement of those programs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, data that we report may change following completion or a more comprehensive review of the data related to the clinical studies; we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical studies and nonclinical studies; regulatory developments or political changes, including the policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development; Crinetics may use its capital resources sooner than expected or our cash burn rate may accelerate; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Media:
Natalie Badillo
Head of Corporate Communications
nbadillo@crinetics.com
(858) 345-6075

Investors:
Gayathri Diwakar
Head of Investor Relations
gdiwakar@crinetics.com
(858) 345-6340

Tenaya Therapeutics Announces Proposed Public Offering

Tenaya Therapeutics Announces Proposed Public Offering




Tenaya Therapeutics Announces Proposed Public Offering

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (Nasdaq: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that it intends to offer and sell units consisting of common stock and warrants to purchase shares of common stock. Tenaya may also sell to certain investors, in lieu of units, pre-funded units consisting of pre-funded warrants to purchase shares of common stock at a purchase price of $0.001 per share and warrants to purchase shares of common stock. The pre-funded warrants will be immediately exercisable and will not expire. All of the securities in this offering will be sold by Tenaya. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Leerink Partners and Piper Sandler are acting as joint bookrunning managers for the proposed offering.

The units and pre-funded units are being offered by Tenaya pursuant to a Registration Statement on Form S-3, which was previously filed and declared effective by the SEC, and Tenaya will file a preliminary prospectus supplement relating to and describing the terms of the proposed offering with the SEC. These documents can be accessed for free through the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1 (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; or Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at prospectus@psc.com.

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

About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, and multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions.

Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include, but are not limited to, statements relating to the offering, including the terms of the offering, the securities being offered and the timing of the closing of the offering. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: whether or not Tenaya will be able to raise capital through the sale of securities or consummate the offering; the final terms of the offering on the anticipated terms or at all, including the satisfaction of customary closing conditions; the anticipated use of the proceeds of the offering which could change as a result of market conditions or for other reasons; general economic and market conditions as well as geopolitical developments; and other risks. For further information regarding the foregoing and additional risks that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Tenaya in general, see Tenaya’s recent Quarterly Report on Form 10-Q filed on November 10, 2025, the prospectus supplement related to the proposed public offering we plan to file and subsequent filings with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact
Michelle Corral
Vice President, Investor Relations and Corporate Communications
Tenaya Therapeutics
IR@tenayathera.com

Investors
Anne-Marie Fields
Precision AQ (formerly Stern Investor Relations)
annemarie.fields@precisionaq.com

Media
Wendy Ryan
Ten Bridge Communications
wendy@tenbridgecommunications.com

Nusano Receives “Best Companies to Work For” Award from Utah Business

Nusano Receives “Best Companies to Work For” Award from Utah Business




Nusano Receives “Best Companies to Work For” Award from Utah Business

State’s top workplaces identified by employee survey data

WEST VALLEY CITY, Utah, Dec. 11, 2025 (GLOBE NEWSWIRE) — Nusano, physics company working to transform radioisotope production and enable industries ranging from healthcare to nuclear energy, today received a Best Companies to Work For award from Utah Business.

Each year, Utah Business anonymously surveys thousands of individuals to identify workplaces where employees feel engaged, recognized and appreciated. Firms rising to the top of the survey data receive a Best Companies to Work For award.

“Nusano has assembled some of the most talented, forward-thinking teams in all of science and industry,” said Chris Lowe, CEO of Nusano. “As we strive to make the world better, we start at home with our people. This award is special because it is based on direct feedback from our employees. We will continue investing in our teams to ensure next-generation solutions are built in Utah and delivered globally.”

The complete list of 2025 Best Companies to Work For honorees is available on the Utah Business website.

About Nusano
Headquartered in West Valley City, Utah, Nusano is a privately held physics company working to stabilize supply chains, advance American national security by reducing dependency on foreign supply, and enable once-in-a-generation innovations in fields ranging from healthcare to nuclear energy. The company is commercializing platform technologies for radioisotope production, stable isotope enrichment, and advanced separation techniques. Together, these proprietary systems and methods are poised to supply the fight against cancer, fuel the nuclear renaissance, and deliver critical minerals for the modern world. For more, visit nusano.com

Contacts:

Kestra Medical Technologies Reports Second Quarter Fiscal 2026 Financial Results

Kestra Medical Technologies Reports Second Quarter Fiscal 2026 Financial Results




Kestra Medical Technologies Reports Second Quarter Fiscal 2026 Financial Results

KIRKLAND, Wash., Dec. 11, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today reported financial results for the second quarter fiscal 2026, which ended October 31, 2025.

Financial Highlights

  • Generated revenue of $22.6 million in Q2 FY26, an increase of 53% compared to the prior year period.
  • Expanded gross margin to 50.6% in Q2 FY26 compared to 39.6% in the prior year period.
  • Increased FY26 revenue guidance to $91 million, which would represent growth of 52% compared to FY25.

“Kestra delivered another strong quarter of financial performance, generating revenue growth of 53% while expanding gross margin to over 50%, an important milestone for the company,” said Brian Webster, President and CEO. “We also continued to make progress on several key operational objectives, including growing the commercial organization, announcing compelling primary results from our post-approval study at the American Heart Association annual meeting, and fortifying our balance sheet with an equity offering earlier this month. As we progress on our journey to category leadership, our team remains focused on growing the wearable defibrillator market and executing on our commitments to patients and their prescribers.”

Second Quarter Fiscal 2026 Financial Results

  • Total revenue was $22.6 million, an increase of 53% compared to the prior year period.
    • 4,696 prescriptions were written for the ASSURE® system, an increase of 54% compared to the prior year period.
    • Revenue growth was driven by higher market share and continuing WCD market expansion. Revenue also benefited from a higher mix of in-network patients and continued improvements in revenue cycle management capabilities.
  • Gross profit was $11.4 million compared to $5.8 million in the prior year period.
    • Gross margin expanded to 50.6% compared to 39.6% in the prior year period, driven by volume leverage and a higher mix of in-network patients.
  • GAAP operating expenses were $43.2 million and included $1.0 million of non-recurring costs. GAAP operating expenses were $25.0 million in the prior year period.
    • Excluding non-recurring costs and share-based compensation expense, operating expenses were $33.5 million in Q2 FY26 compared to $23.8 million in Q2 FY25. The increase was attributable to growth in expenses related to commercial expansion and public company costs.
  • GAAP net loss and comprehensive loss was $32.8 million compared to GAAP net loss and comprehensive loss of $20.6 million in the prior year period.
    • Adjusted EBITDA* loss was $19.7 million compared to an adjusted EBITDA loss of $16.1 million in the prior year period.
  • Cash and cash equivalents totaled $175 million as of October 31, 2025.
    • The above cash and cash equivalents balance does not include the $148 million of net proceeds Kestra received from an underwritten public offering of 6.9 million common shares, which closed on December 4, 2025.
       

*Adjusted EBITDA is a non-GAAP financial measure. See “Use of Non-GAAP Financial Measures” below for additional information. A reconciliation of Adjusted EBITDA to the most directly comparable GAAP measure is included in this press release.

Fiscal Year 2026 Revenue Guidance
Kestra is increasing its FY26 revenue guidance to $91 million, which would represent growth of 52% compared to FY25. This compares to prior FY26 revenue guidance of $88 million and initial FY26 guidance of $85 million.

Webcast and Conference Call
Kestra will host a conference call today at 4:30 p.m. ET to discuss financial results. A live and archived webcast of the event will be available in the “Events” section of the investor relations website.

Use of Non-GAAP Financial Measures
This press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (“GAAP”), including Adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Kestra’s financial measures presented in this press release that are calculated and presented in accordance with GAAP. 

Adjusted EBITDA, which is calculated as net income (loss), as adjusted to exclude other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, share-based compensation expense, and non-recurring new public company costs, is presented because management believes it allows investors to view the Company’s performance in a manner similar to the method used by management to evaluate the Company’s performance for both strategic and annual operating planning. Management believes that in order to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of Adjusted EBITDA, in addition to considering the Company’s GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of our ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare our period-over-period results. 

The non-GAAP financial measures used by Kestra may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Kestra’s financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of Adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers.

Forward-Looking Statements
Except where otherwise noted, the information contained in this press release is as of December 11, 2025. Statements in this press release and on the related teleconference that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; business plans, strategy, goals and prospects; and expectations for our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Kestra’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; risks and uncertainties related to market conditions; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025 and other filings filed or to be filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/.

About Kestra
Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com.

 
KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
 
(in thousands, except share and per share amounts)
(unaudited)
 
  Three Months Ended October 31,     Six Months Ended October 31,  
  2025     2024     2025     2024  
                       
Revenue $ 22,565     $ 14,710     $ 41,937     $ 27,492  
Cost of revenue   11,141       8,880       21,661       17,462  
Gross profit   11,424       5,830       20,276       10,030  
Operating expenses:                      
Research and development   4,878       3,509       8,878       6,913  
Selling, general and administrative   38,301       21,455       72,029       40,682  
Total operating expenses   43,179       24,964       80,907       47,595  
Loss from operations   (31,755 )     (19,134 )     (60,631 )     (37,565 )
Other expense (income):                      
Interest expense   1,901       2,317       3,814       4,191  
Interest income   (1,796 )     (878 )     (3,962 )     (915 )
Other expense (income)   891       40       (1,939 )     88  
Net loss before provision for income taxes   (32,751 )     (20,613 )     (58,544 )     (40,929 )
Provision for income taxes   34       8       67       15  
Net loss and comprehensive loss   (32,785 )     (20,621 )     (58,611 )     (40,944 )
Net loss attributable to non-controlling interest         (253 )           (692 )
Net loss and comprehensive loss attributable to Kestra Medical Technologies, Ltd.   (32,785 )     (20,368 )     (58,611 )     (40,252 )
Less: Undeclared preferred stock dividends         3,323             5,706  
Net loss attributable to common shareholders, basic and diluted $ (32,785 )   $ (23,691 )   $ (58,611 )   $ (45,958 )
                       
Net loss per share attributable to common shareholders, basic and diluted $ (0.64 )   $ (1.19 )   $ (1.14 )   $ (2.31 )
Weighted-average shares of common shares outstanding, basic and diluted   51,376,278       19,885,382       51,340,438       19,885,382  


RECONCILIATION OF GAAP NET LOSS AND COMPREHENSIVE LOSS TO ADJUSTED EBITDA
 
(in thousands)
(unaudited)
 
  Three Months Ended October 31,     Six Months Ended October 31,  
  2025     2024     2025     2024  
                       
GAAP Net loss and comprehensive loss $ (32,785 )   $ (20,621 )   $ (58,611 )   $ (40,944 )
Non-GAAP Adjustments:                      
Interest expense   1,901       2,317       3,814       4,191  
Interest income   (1,796 )     (878 )     (3,962 )     (915 )
Other expense (income)   891       40       (1,939 )     88  
Provision for income taxes   34       8       67       15  
Depreciation expense   2,372       1,869       4,401       4,244  
Share-based compensation expense   8,653       1,122       13,232       1,499  
Non-recurring expenses   1,048             3,914        
Adjusted EBITDA $ (19,682 )   $ (16,143 )   $ (39,084 )   $ (31,822 )


KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
 
(in thousands, except share and per share amounts)
(unaudited)
 
  October 31,     April 30,  
  2025     2025  
           
Assets          
Current assets          
Cash and cash equivalents $ 175,424     $ 237,595  
Accounts receivable, net   10,413       8,081  
Disposable medical equipment supplies   6,918       6,572  
Prepaid expenses and other current assets   2,659       3,080  
Total current assets   195,414       255,328  
           
Right-of-use assets   1,960       2,078  
Deposits   1,858       2,021  
Restricted cash   334       334  
Property and equipment, net   45,932       34,830  
Other long-term assets   1,203       1,153  
Total assets $ 246,701     $ 295,744  
           
Liabilities and Shareholders’ Equity          
Current liabilities          
Accounts payable $ 20,209     $ 23,961  
Accrued liabilities   15,494       13,829  
Operating lease liabilities, current portion   53       187  
Total current liabilities   35,756       37,977  
           
Operating lease liabilities, net of current portion   2,874       3,026  
Warrant liabilities   1,977       8,097  
Other long-term liabilities   140       140  
Long-term debt, net   41,873       41,098  
Total liabilities   82,620       90,338  
           
Commitments and contingencies          
           
Shareholders’ equity          
           
Common shares, $1.00 par value; 100,000,000 shares authorized as of October 31, 2025 and April 30, 2025; 51,449,053 issued and outstanding as of October 31, 2025 and 51,348,656 shares issued and outstanding as of April 30, 2025   51,449       51,349  
Additional paid-in capital   691,492       674,306  
Accumulated deficit   (578,860 )     (520,249 )
Total shareholders’ equity   164,081       205,406  
Total liabilities and shareholders’ equity $ 246,701     $ 295,744  

KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 
(in thousands)
(unaudited)
 
  Six Months Ended October 31,  
  2025     2024  
Cash flows from operating activities          
Net loss $ (58,611 )   $ (40,944 )
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   4,401       4,244  
Loss on disposal of property and equipment   560       580  
Reserve for lost equipment and supplies   901       477  
Provision for uncollectible accounts receivable   1,150       1,074  
Interest paid-in-kind         467  
Amortization of debt discounts and issuance costs   937       861  
Share-based compensation expense   13,232       1,499  
Non-cash lease expense   148       242  
Change in fair value of warrant liabilities   (2,065 )      
Changes in operating assets and liabilities:          
Disposable medical equipment supplies   (596 )     (1,117 )
Prepaid expenses and other current assets   953       (53 )
Accounts receivable   (3,482 )     (4,470 )
Accounts payable   (2,372 )     (345 )
Accrued liabilities   520       1,786  
Operating lease liabilities   (313 )     124  
Other long-term assets   20       20  
Net cash used in operating activities   (44,617 )     (35,555 )
Cash flows from investing activities          
Purchases of property and equipment   (15,431 )     (11,484 )
Deposits for medical rental equipment   (338 )     (197 )
Refund of deposits for medical rental equipment:   117       227  
Net cash used in investing activities   (15,652 )     (11,454 )
Cash flows from financing activities          
Proceeds from issuance of redeemable preferred stock         103,400  
Proceeds from issuance of stock to non-controlling interest         17,100  
Deemed dividend for payments to third party on behalf of shareholder         (1,598 )
Payment of equity issuance costs:   (1,902 )     (3,224 )
Net cash provided by (used in) financing activities   (1,902 )     115,678  
Net increase (decrease) in cash, cash equivalents and restricted cash   (62,171 )     68,669  
Cash, cash equivalents and restricted cash          
Beginning of period   237,929       8,583  
End of period $ 175,758     $ 77,252  
Reconciliation of cash, cash equivalents and restricted cash reported in the condensed consolidated balance sheets          
Cash and cash equivalents $ 175,424     $ 76,918  
Restricted cash:   334       334  
Cash, cash equivalents and restricted cash $ 175,758     $ 77,252  
Non-cash investing and financing activities:          
Purchases of property and equipment in accrued liabilities and accounts payable $ 8,313       7,914  
Exercise of liability classified warrant   4,055        
Supplemental disclosure of cash flow information          
Income taxes paid (refunds received) $ (18 )   $ 43  
Interest paid   2,846       2,451  

CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com

Tenaya Therapeutics Reports Positive Interim Data from Cohort 1 of RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 Gene Therapy for Adults with PKP2-associated ARVC

Tenaya Therapeutics Reports Positive Interim Data from Cohort 1 of RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 Gene Therapy for Adults with PKP2-associated ARVC




Tenaya Therapeutics Reports Positive Interim Data from Cohort 1 of RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 Gene Therapy for Adults with PKP2-associated ARVC

TN-401 was Well Tolerated at 3E13 vg/kg dose 

Robust Transduction and Demonstrated Increases in PKP2 Protein Levels in First Two Patients at Week 8

Clinically Meaningful Reductions in Arrhythmia Burden Observed in First Two Patients with More Than Six Months of Follow-Up

Tenaya Management to Host a Webcast Conference Call Thursday, December 11 at 5:00 pm ET to Review Preliminary Results

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced interim data from the ongoing RIDGE™-1 Phase 1b/2 clinical trial of TN-401 gene therapy for the potential treatment of adults with arrhythmogenic right ventricular cardiomyopathy (ARVC), a form of arrhythmogenic cardiomyopathy (ACM) that primarily impacts the right ventricle, caused by mutations in the plakophilin-2 gene, PKP2.

Data reported today include safety, biopsy and arrhythmia results from three patients who received TN-401 at a dose of 3E13 vg/kg. Patient follow-up at the time of data cut off ranged from 20-40 weeks post-dose. TN-401 was well tolerated, increased PKP2 protein expression from baseline in two of three patients and demonstrated evidence of meaningful improvements in arrhythmia burden as measured by premature ventricular contractions (PVCs) and non-sustained ventricular tachycardias (NSVTs) for those patients with greater than six months follow up.

“We are excited by the strength of the data for TN-401 at this relatively early timepoint in the RIDGE-1 trial. Less than a year after dosing, initial data indicate a promising safety profile, consistent transduction of the gene therapy in cardiomyocytes and RNA and protein expression, and meaningful reductions in PVCs and NSVTs, well-established risk factors for dangerous sustained arrhythmias,” said Whit Tingley, M.D., Ph.D., Tenaya’s Chief Medical Officer. “These findings are an important milestone in TN-401’s development and we’re eager to build on this momentum as we continue monitoring patients in Cohort 1 and Cohort 2.”

PKP2 gene mutations result in insufficient levels of critical proteins needed to maintain the structural integrity and cell-to-cell signaling of heart muscle cells. TN-401 gene replacement therapy is designed to address the underlying cause of disease by delivering a functional PKP2 gene into heart muscle cells using an adeno associated virus serotype 9 (AAV9) capsid. The RIDGE-1 clinical trial designed to assess the safety, tolerability and activity of a one-time dose of TN-401 at two dose levels, 3E13 vg/kg and 6E13vg/kg. To date, Tenaya has dosed three patients at the 3E13 vg/kg dose level (Cohort 1). Initial results reported today focus on interim data for Cohort 1 as of an October 2025 data cut off. Key findings include:

  • TN-401 was well tolerated at the3E13 vg/kg dose and no dose-limiting toxicities were observed
    • Adverse events (AEs) were generally mild, asymptomatic and manageable and deemed unrelated to TN-401 treatment.
    • Among those AEs related to treatment, there was a transient, asymptomatic Grade 1 event of elevated cardiac troponin levels categorized as a serious AE (SAE) only due to inpatient monitoring.
    • No incidents of thrombotic microangiopathy (TMA) or cardiotoxicities were observed.
    • To date, no implantable cardioverter-defibrillator (ICD) shocks or arrhythmias associated with TN-401 have occurred
    • All patients have tapered off immunosuppressive medicines.

Enrollment and dosing of three patients at the 6E13 vg/kg dose (Cohort 2) is complete with no new SAEs related to TN-401 reported in the cohort to date.

  • Biopsies demonstrate robust transduction and expression detected in all patients within first eight weeks
    • Patients 1 and 2 provided consistent evidence that TN-401 transduced the heart (3.4 vg/dg and 5.0 vg/dg). A biopsy analysis of TN-401 DNA for Patient 3 was not available at the time of data cut off.
    • Consistently high TN-401 mRNA expression, ranging from 1.4×104 – 2.9×105 copies per microgram of RNA, were detected for all three patients in Cohort 1 as early as eight weeks.
    • Post-treatment protein levels of PKP2 increased significantly in Patients 1 and 2 by a mean of 10% from baseline to Week 8
      • These data are based on rigorous methods to measure protein increases using liquid chromatography–mass spectrometry (LC-MS) normalized to myosin heavy chain, a motor protein in the sarcomere found exclusively in cardiomyocytes.
      • Change from baseline in PKP2 protein levels for Patient 3 fell within the standard deviation of these methods despite having the highest levels of TN-401 mRNA expression across Cohort 1, which may be due to the inherent variability in sampling biopsies. A second post-dose biopsy will be collected and analyzed from Week 52 per protocol.
    • The changes in PKP2 protein levels were also apparent using multiplexed immunofluorescent imaging, which provided visual evidence of protein level increases and colocalization of other proteins associated with intracellular stability and electrical signaling.
  • Clinically meaningful improvements in electrical instability were observed in the first two patients with greater than 6 months follow-up after TN-401 dosing
    • Patient 1 PVC counts decreased by 46% as of their most recent (Week 40) visit, while Patient 2 PVC counts decreased by 89% by their most recent visit (Week 32).
    • Patient 2 also had a substantial NSVT burden of 78 counts per 24-hour period at baseline that dropped all the way to zero and remained stable by Week 32. Patient 1 had low NSVT count at baseline which remained low at Week 40.
    • For Patient 3, meaningful changes in PVCs or NSVTs were not expected nor observed as of the data cut off, which was less than six months following treatment with TN-401.
    • Other measures of clinical response including QRS duration, T wave inversions, heart function and New York Heart Association (NYHA) class were in the normal range or remained stable for all three Cohort 1 patients during the post-dose follow-up period.

“We extend our heartfelt gratitude to the patients and investigators involved in the RIDGE-1 clinical trial and our RIDGE natural history study of PKP2-associated ARVC. Their continued support and dedication have been instrumental in achieving the substantial progress we’ve made thus far,” continued Dr. Tingley.

Webcast Conference Call
Tenaya management will host a conference call on Thursday, December 11, 2025, at 5:00 pm ET/2:00 pm PT to discuss the TN-401 data shared today.  The webcast conference call, including an accompanying slide presentation, can be accessed from the Investor section on the “Events and Presentations” page of the Tenaya website at www.tenayatherapeutics.com.

About PKP2-Associated ARVC
Plakophilin-2 (PKP2) mutations are the most common genetic cause of arrhythmogenic right ventricular cardiomyopathy (ARVC, also known as arrhythmogenic cardiomyopathy or ACM), occurring in approximately 40 percent of the overall ARVC population. The prevalence of PKP2-associated ARVC is estimated at more than 70,000 people in the U.S. alone.

In PKP2-associated ARVC, mutations of the PKP2 gene results in insufficient expression of a protein needed for the proper functioning of the desmosomal complex that maintains physical connections and electrical signaling between heart muscle cells. As the desmosome structure degrades, cardiac muscle cells are replaced by fibrofatty tissue and electrical pulses in the heart become unstable, resulting in irregular heart rhythms. ARVC symptoms include arrhythmias, palpitations, lightheadedness, dizziness and fainting. It is typically diagnosed before age 40, and sudden cardiac arrest due to life-threatening ventricular arrhythmias is frequently the first manifestation of disease. Current treatments include anti-arrhythmic medications, implantable cardioverter-defibrillators (ICDs) and ablation procedures, which do not address the underlying genetic cause of disease.

About TN-401 Gene Therapy and the RIDGE-1 Clinical Trial
TN-401 is an investigational AAV9-based gene therapy being developed for the treatment of ARVC due to mutations in the PKP2 gene. AAV9 was selected as the vector for delivery of Tenaya’s PKP2 gene therapy based on its extensive clinical and commercial safety record and demonstrated ability to target heart muscle cells. TN-401 has received Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration. Tenaya’s development of TN-401 is supported in part by a grant from the California Institute of Regenerative Medicines (CIRM).

The RIDGE-1 Phase 1b/2 clinical trial of TN-401 in patients with PKP2-associated ARVC is a multi-center, open-label, dose escalation study being conducted in the U.S. and UK. RIDGE-1 is intended to assess the safety, tolerability and preliminary clinical efficacy of a one-time intravenous infusion of TN-401. RIDGE-1 will seek to enroll up to fifteen adults who have been diagnosed with PKP2-associated ARVC, have an ICD and are at increased risk for arrhythmias as determined by premature ventricular count (PVC) during screening.

To learn more about gene therapy for ARVC and the RIDGE-1 clinical trial, please visit ARVCstudies.com or ClinicalTrials.gov (NCT06228924).

About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, and multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. For more information, visit www.tenayatherapeutics.com.

Forward Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “potential,” promising,” “look forward,” “continue,” “encouraging,” “anticipated,” “suggest,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the planned timing to report additional data from RIDGE-1; the clinical, therapeutic and commercial potential of, and expectations regarding the safety and efficacy of TN-401; the value of additional RIDGE-1 data to inform the potential of TN-401; the inferences regarding transduction, translation and expression of TN-401; statements regarding the continued development TN-401 and TN-401 clinical outcomes, which may materially change as more patient data become available; and statements made by Tenaya’s Chief Medical Officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: availability of RIDGE-1 data at the referenced time; the timing and progress of RIDGE-1; the potential failure of TN-401 to demonstrate safety and/or efficacy in clinical testing; the potential for any RIDGE-1 clinical trial results to differ from preclinical, interim, preliminary or expected results; the potential for the U.S. Food and Drug Administration and/or other regulatory agencies to conclude at any time that TN-401 may not have an appropriate risk/benefit profile; Tenaya’s ability to enroll and maintain patients in clinical trials, including RIDGE-1; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in Tenaya’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025 and other documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Tenaya Contacts
Michelle Corral
VP, Corporate Communications and Investor Relations
IR@tenayathera.com

Investors
Anne-Marie Fields
Precision AQ
annmarie.fields@precisionaq.com

Media
Wendy Ryan
Ten Bridge Communications
wendy@tenbridgecommunications.com

Structure Therapeutics Announces Closing of Upsized $747.5 Million Public Offering of ADSs and Pre-Funded Warrants and Full Exercise of the Underwriters’ Option to Purchase Additional ADSs

Structure Therapeutics Announces Closing of Upsized $747.5 Million Public Offering of ADSs and Pre-Funded Warrants and Full Exercise of the Underwriters’ Option to Purchase Additional ADSs




Structure Therapeutics Announces Closing of Upsized $747.5 Million Public Offering of ADSs and Pre-Funded Warrants and Full Exercise of the Underwriters’ Option to Purchase Additional ADSs

SAN FRANCISCO, Dec. 11, 2025 (GLOBE NEWSWIRE) — Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced the closing of its previously announced upsized underwritten public offering of 9,961,538 American depositary shares (ADSs), each representing three ordinary shares, which includes the full exercise of the underwriters’ option to purchase up to 1,500,000 additional ADSs at a price to the public of $65.00 per ADS and pre-funded warrants to purchase 1,538,462 ADSs at a price to the public of $64.9999 per pre-funded warrant. All of the securities in the offering were sold by Structure Therapeutics.

The gross proceeds to Structure Therapeutics from the offering were approximately $747.5 million, before deducting underwriting discounts and commissions and offering expenses.

Jefferies, Leerink Partners, Goldman Sachs & Co. LLC, Morgan Stanley, Guggenheim Securities and BMO Capital Markets acted as joint book-running managers for the offering. LifeSci Capital and Citizens Capital Markets acted as co-managers for the offering.

The offering was made pursuant to an automatic shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (SEC) on August 6, 2025 and became effective upon filing. Copies of the final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and can be accessed at no charge through the SEC’s website located at www.sec.gov. Copies of the final prospectus relating to the offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649, or by email at prospectus@morganstanley.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; and BMO Capital Markets Corp., Attn: Equity Syndicate Department, 151 W 42nd Street, 32nd Floor, New York, NY 10036, or by email at bmoprospectus@bmo.com.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, 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 Structure Therapeutics
Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world.

Investors:
Danielle Keatley
Structure Therapeutics Inc.
ir@structuretx.com

Media:
Dan Budwick
1AB
Dan@1abmedia.com