Daré Bioscience Reports Third Quarter 2025 Financial Results and Provides Corporate Update




Daré Bioscience Reports Third Quarter 2025 Financial Results and Provides Corporate Update

DARE to PLAY™ Sildenafil Cream on Track to Launch Before Year End via 503B Pathway, Paving the Way for Near-Term Product Revenue

Positive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued Enrollment

Multiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting as well as Non-Hormonal Contraception

Four Commercially Available Solutions for Women Expected Over the Next Two Years

• In addition to DARE to PLAY™ Sildenafil Cream, Commercialization of DARE to RESTORE™ Vaginal Probiotics in the Consumer Health Market Targeted to follow DARE to PLAY Sildenafil Cream availability and DARE to RECLAIM™ Monthly Hormone Therapy via 503B Compounding Pathway Targeted for Early 2027
• DARE to RECLAIM™ Will Establish Entry into the Estimated $4.5 Billion Compounded Hormone Therapy Market While Daré Continues Building Toward FDA-Approval Opportunity

Conference Call Today at 4:30 p.m. ET

Q3 2025 Highlights; Near-Term Revenue and Long-Term Value Creation Through Dual-Path Execution:

• DARE to PLAY™ Sildenafil Cream: Near-Term Commercial Opportunity
  • On track for initial prescription fulfillment in December through a 503B-registered outsourcing facility
  • November 17th webinar to feature leading clinicians discussing clinical data and potential impact in women’s sexual health; Registration and Access: https://cvent.me/KO1obd
  • Represents near-term revenue generation opportunity and an important proof point for the Company’s 503B compounding strategy
• Sildenafil Cream, 3.6%
  • Discussions with FDA ongoing regarding endpoint assessment for Phase 3 clinical studies of Sildenafil Cream, 3.6%
• Ovaprene®: Investigational Hormone-Free Intravaginal Contraceptive; Positive Interim DSMB Recommendation Highlights Potential
  • Independent data safety monitoring board (DSMB) reviewed interim safety data in July 2025 and recommended the pivotal Phase 3 multicenter, single-arm, open-label study (ClinicalTrials.gov ID # NCT06127199) continue without modification
  • Interim pregnancy rate of women treated in the study was consistent with the Company’s expectations based on prior postcoital test study of Ovaprene
  • Enrollment in the study is ongoing; primary endpoint is assessment of typical use pregnancy rate over 13 menstrual cycles (Pearl Index)
• DARE-HPV, DARE-NHC, and DARE-LARC1: Progress in Grant-Funded Women’s Health Innovation
  • DARE-HPV: Currently funded by an ARPA-H award and NIH grant; in development as a novel intravaginal therapy to treat persistent high-risk genital human papillomavirus (HPV) infections in women and reduce risk of cervical disease
  • DARE-LARC1: Preclinical development expected to be fully funded by a foundation grant; investigational long-acting contraceptive intended to offer multi-year protection with remote pause/resume capability; $6 million grant installment received in July 2025 and $4 million grant installment received in October 2025
  • DARE-NHC: A preclinical research program that will aid in the identification and development of a novel non-hormonal intravaginal contraceptive product candidate. The grant funding supports activities to de-risk the development of a novel non-hormonal intravaginal contraceptive, suitable for and acceptable to women in low- and middle-income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy. A $3.6 million installment under a November 2024 grant agreement is anticipated to be received in November 2025.
• Ongoing Actions to Make Three Additional Solutions Available Commercially
  • DARE to RESTORE™: Targeted for availability in the first quarter of 2026, two non-prescription vaginal probiotics designed to support vaginal microbiome health, intended to be complementary to Daré’s prescription offerings
  • DARE to RECLAIM™: Proprietary monthly bio-identical estradiol and progesterone intravaginal ring targeted to be available for prescription fulfillment in early 2027 via the 503B compounding pathway to accelerate patient access; Daré is continuing in parallel on pathway to seek FDA approval of DARE-HRT1 for the treatment of moderate-to-severe vasomotor symptoms due to menopause, conducting activities to enable submission of an Investigational New Drug (IND) application to the FDA for a pivotal Phase 3 clinical study.

SAN DIEGO, Nov. 13, 2025 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today reported financial results for the quarter ended September 30, 2025 and provided a company update.

“Daré is executing a disciplined, multi-pronged value creation strategy — preparing to generate revenue from DARE to PLAY™ Sildenafil Cream beginning in December, while advancing a pipeline that spans both clinical innovation and near-term commercial solutions,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.

“With four women’s health products expected to become commercially available over the next two years, and multiple grant-supported programs, we believe Daré is well positioned to deliver meaningful impact for women and strong value creation for shareholders.”

“Women’s health remains an underfunded and underserved market — and we believe the coming weeks will represent a historic inflection point for Daré and for women seeking new options. We are proud to lead with science, collaboration, and purpose,” stated Johnson.

Financial Highlights for the Quarter Ended September 30, 2025

• Cash Position: As of September 30, 2025, Daré had approximately $23.1 million in cash and cash equivalents, and working capital of approximately $3.8 million.
• General and Administrative Expenses: $2.5 million in Q3 2025 compared to $2.0 million in Q3 2024, with the year-over-year change primarily attributable to increases in professional services expense and commercial-readiness expenses driven by execution against the Company’s expanded business strategy, which includes earlier market access for select proprietary solutions via 503B compounding and bringing to market non-prescription consumer health products.
• Research and Development (R&D) Expenses: $1.2 million in Q3 2025 compared to $2.7 million in Q3 2024, reflecting a decrease of 56%, primarily due to an increase in contra R&D expenses (reductions to R&D expenses due to non-dilutive funding awards), as well as decreases in manufacturing costs related to Ovaprene and in personnel costs, partially offset by increases in costs related development activities for other clinical- and preclinical-stage R&D programs, including DARE-HPV, DARE-LARC1, Sildenafil Cream, 3.6%, DARE to PLAY Sildenafil Cream, and DARE-PTB1.

References to Section 503B, 503B, 503B compounding, 503B compounding pathway, and similar terms refer to Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) and the production and supply of compounded drugs by Section 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B. Daré encourages investors to review the more detailed discussion of its financial condition, results of operations, liquidity, capital resources, and risk factors included in its Form 10-Q for the quarter ended September 30, 2025, filed today with the U.S. Securities and Exchange Commission (SEC).

Conference Call

Daré will host a conference call and live webcast today, November 13, 2025, at 4:30 p.m. Eastern Time to review its financial results for the quarter ended September 30, 2025 and to provide a company update.

To access the conference call via phone, dial (646) 307-1963 or (800) 715-9871 (toll free). The conference ID number for the call is 5794075. The live webcast can be accessed under “Presentations, Events & Webcasts” in the Investors section of the company’s website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under the same section of the company’s website and available for replay until November 27, 2025.

About Daré Bioscience

Daré Bioscience is a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions. Every innovation Daré advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Daré is working to close critical gaps in care using science that serves her needs.

For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. Daré was founded to change that. As a female-led health biotech company, Daré is accelerating the development of credible, science-based solutions that meet the high standards of clinical rigor – randomized, controlled trials; validated endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements.

To learn more about Daré’s mission to deliver differentiated therapies for women and its innovation pipeline, please visit www.darebioscience.com. 

Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré’s CEO has been honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space.

Daré may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, products and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.

Forward-Looking Statements

Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “positioned,” “pursue,” “seek,” “execute,” “prepare,” “should,” “would,” “target,” “on track,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Daré’s go-to-market strategies; Daré’s plans and timing for making solutions for women available by prescription in the U.S. as compounded drugs via Section 503B or without a prescription as branded consumer health products; the market opportunity for those products and their ability to gain market acceptance; expected timing of revenue from sales of those products; Daré’s intent to continue to pursue an FDA approval pathway for those product candidates it brings to market under Section 503B; plans and expectations with respect to Daré’s product candidates, including clinical development plans, trial design, timelines, costs, milestones, targeted indications, clinical trials and results, regulatory strategy, and U.S. Food and Drug Administration (FDA) communications, submissions and review of applications; the clinical potential of and market opportunities for Daré’s product candidates; Ovaprene’s potential to be the first FDA-approved hormone-free intravaginal monthly contraceptive; the importance of the DSMB’s recommendation and the interim results from the ongoing Phase 3 clinical study of Ovaprene to Daré and Ovaprene; expectations regarding existing collaborations; the sufficiency of non-dilutive grant and other financial award funding to advance development of specified product candidates or programs, including through specified milestones; Daré’s ability to meaningfully impact women and create value for its shareholders; and the potential impact of DARE to PLAY Sildenafil Cream for Daré and women. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s reliance on Section 503B-registered outsourcing facilities and other third parties to bring DARE to PLAY™ Sildenafil Cream and other solutions to market as compounded drugs or as consumer health products and facilitate access to such products and the risk that those third parties do not perform as expected; difficulties in establishing and sustaining relationships with third-party collaborators; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound the drug substances in the proprietary formulations Daré intends to bring or brings to market or changes the conditions under which those drug substances may used in compounding or the compounded products may be distributed; the ability of Daré’s outsourcing facility partners to maintain their registration with the FDA under Section 503B; the timing of establishing, and ability to maintain, state-required licensure or registration to enable fulfillment of prescriptions for DARE to PLAY™ Sildenafil Cream and other solutions brought to market via the Section 503B pathway; Daré’s inexperience, as a company, in and lack of infrastructure for commercializing products; the degree of market demand and acceptance for the products Daré brings to market; competitive product launches; greater than expected costs to bring compounded drug products to market and marketing costs; shifts in consumer spending or behavior; Daré’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; Daré’s dependence on grants and other financial awards from governmental entities and a private foundation; limitations on Daré’s ability to raise additional capital through sales of its common stock or other equity securities due to restrictions under SEC and Nasdaq rules and regulations or contractual limitation; Daré’s reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future FDA-approved products, if any; the risk that the current regulatory pathway known as the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risks that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates, or that the duration of a study or number of study subjects must be significantly greater than anticipated; the loss of, or inability to attract, key personnel; product pricing and coverage and reimbursement from third-party payors; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; disputes or other developments concerning Daré’s intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; changes in healthcare, pharmaceutical, consumer protection or privacy laws and regulatory policies; increased scrutiny from regulators; global trends toward health care cost containment; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; Daré’s ability to maintain compliance with Nasdaq’s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; and cybersecurity incidents or similar events that compromise Daré’s technology systems and/or significantly disrupt Daré’s business or those of third parties on which it relies. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts:

Daré Bioscience Investor Relations
innovations@darebioscience.com

Source: Daré Bioscience, Inc.

Amneal Receives U.S. FDA Approval for Iohexol Injection




Amneal Receives U.S. FDA Approval for Iohexol Injection

First-to-market complex injectable with expected launch in Q1 2026

BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque^® (iohexol) injection. Amneal expects to launch the product in the first quarter of 2026.

Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients two weeks of age and older.

“We are very proud to introduce the first-to-market generic version of this critical and widely used injectable contrast agent for patients and healthcare providers,” said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. “This approval reinforces Amneal’s growing leadership in differentiated, complex injectables and our ongoing commitment to improving access to high-quality, affordable medicines.”

According to IQVIA^® U.S. annual sales for iohexol injection for the 12 months ended September 2025 were approximately $652 million.

Important Safety Information
Boxed Warning: Serious adverse reactions, including risk of death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema, have been associated with Intrathecal administration of iohexol of a wrong iodine concentration.

The most commonly reported adverse reactions based on route of administration are:
•        Intrathecal: Headache, nausea, back/neck pain, dizziness
•        Intra-arterial / venous: Chest pain, arrhythmias, blurred vision, photomas, altered taste
•        Oral: Nausea, vomiting, diarrhea, abdominal discomfort
•        Body Cavity: Local pain, swelling, heat sensation

For full prescribing information, see package insert here.

Note: OMNIPAQUE is a registered trademark of GE HealthCare or one of its subsidiaries.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com

Amneal Receives U.S. FDA Approval for Iohexol Injection




Amneal Receives U.S. FDA Approval for Iohexol Injection

First-to-market complex injectable with expected launch in Q1 2026

BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque^® (iohexol) injection. Amneal expects to launch the product in the first quarter of 2026.

Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients two weeks of age and older.

“We are very proud to introduce the first-to-market generic version of this critical and widely used injectable contrast agent for patients and healthcare providers,” said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. “This approval reinforces Amneal’s growing leadership in differentiated, complex injectables and our ongoing commitment to improving access to high-quality, affordable medicines.”

According to IQVIA^® U.S. annual sales for iohexol injection for the 12 months ended September 2025 were approximately $652 million.

Important Safety Information
Boxed Warning: Serious adverse reactions, including risk of death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema, have been associated with Intrathecal administration of iohexol of a wrong iodine concentration.

The most commonly reported adverse reactions based on route of administration are:
•        Intrathecal: Headache, nausea, back/neck pain, dizziness
•        Intra-arterial / venous: Chest pain, arrhythmias, blurred vision, photomas, altered taste
•        Oral: Nausea, vomiting, diarrhea, abdominal discomfort
•        Body Cavity: Local pain, swelling, heat sensation

For full prescribing information, see package insert here.

Note: OMNIPAQUE is a registered trademark of GE HealthCare or one of its subsidiaries.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com

Fennec Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update




Fennec Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update

~ Q3 2025 Total Net Product Sales of $12.5 Million, 79% Year Over Year Growth ~ 

~ Q3 2025 Positive Cash Flow from Operations, Cash Position Grew to $22 Million ~

~ Japan Clinical Trial (STS-J01) Preliminary Results Expected in Q4 2025 ~

RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2025 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the third quarter ended September 30, 2025 and provided a business update.

“Today marks an inflection point for Fennec as we delivered the strongest quarter in our history. Record net product sales, four consecutive quarters of double-digit growth, and our first profitable quarter from operations, clearly demonstrate that our strategy is working,” said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. “What began as a rebuild in the first half of 2025 is now translating into tangible performance. The actions we took to strengthen our commercial organization, drive broader adoption, and reinforce our balance sheet are firmly taking hold. With continued discipline in executing against our strategic priorities, we believe we are well positioned to sustain the growth trajectory of PEDMARK^®.”

Business Highlights:

• Continued Growth Within Key PEDMARK^® Accounts: Last quarter, Fennec announced that one of the largest oncology provider networks added PEDMARK^® to its formulary. Since then, adoption has accelerated across numerous accounts within the network, including multiple Adolescent and Young Adult (AYA) patients across several tumor types receiving PEDMARK^®. This adoption reflects growing confidence in PEDMARK^®’s clinical value and reinforces its potential to help reshape the standard of care for patients receiving cisplatin-based treatment.
• Clinical Data Generation: Robust engagement with key opinion leaders underscores strong external validation of PEDMARK^® and its potential in broader oncology care. Multiple investigator-initiated studies have already been submitted to Fennec and are currently under review, with several others in advanced contracting or evaluation stages. These collaborations are expected to further strengthen our clinical and commercial foundation, with additional details to be shared as they materialize.
• STS-J01 in Japan: In Japan, preliminary results from the investigator-initiated clinical trial (STS-J01) evaluating PEDMARK^® are expected in the fourth quarter of 2025. If the data are positive, the Company will pursue registration in Japan and will also explore partnering or licensing opportunities for PEDMARK^®.

Upcoming Events:

• 16th Annual Craig-Hallum Alpha Select Conference: The management team will host one-on-one investor meetings at the 16^th Annual Craig-Hallum Alpha Select Conference, which will be held on Tuesday, November 18, 2025 at the Sheraton New York Times Square Hotel in New York City.

Financial Results for the Third Quarter 2025 Fiscal Year Ended September 30, 2025

• Net Product Sales – For the third quarter of 2025, the Company recorded net product sales of approximately $12.5 million compared to $7.0 million in the third quarter of 2024, the highest quarterly net product sales in Fennec’s history. In the first nine months of 2025, net product sales surpassed total net product sales for full year of 2024. The increase in net product sales is attributable to growth across both new and existing accounts with notable success in adherence of PEDMARK^® patients.
• Selling and Marketing Expenses – The Company recorded $5.2 million in selling and marketing expenses in the third quarter of 2025 compared to $4.4 million in the second quarter of 2025 and $4.6 million in the third quarter of 2024.
• General and Administrative (G&A) Expenses – The Company recorded $6.8 million in G&A expenses in the third quarter of 2025 compared to $7.0 million in the second quarter of 2025 and $6.1 million in the third quarter of 2024.
• Cash Position – Cash and cash equivalents were $21.9 million as of September 30, 2025 compared to $18.7 million as of June 30, 2025.

Financial Update

The selected financial data presented below is derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended September 30, 2025, and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

About Cisplatin-Induced Ototoxicity
Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.¹

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy.² Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.³ Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.^4,5 While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK^® (sodium thiosulfate injection)

PEDMARK^® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK^® is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK^® is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.^6,7 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK^®, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.^8,9

PEDMARK^® has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage
PEDMARK^® (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use
The safety and efficacy of PEDMARK^® have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK^® may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information
PEDMARK^® is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK^® and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK^®. PEDMARK^® may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK^® is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK^® in patients with baseline serum sodium greater than 145 mmol/L.
Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m².

Administer antiemetics prior to each PEDMARK^® administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK^® at: www.PEDMARK.com.

About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK^® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK^® received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI^®.

In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI^® in Europe, U.K., Australia and New Zealand. PEDMARQSI^® is now commercially available in the U.K. and Germany.

PEDMARK^® has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI^® has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Further, Fennec has patents providing protection for PEDMARK^® until 2039 in both the U.S. and internationally.

For more information, please visit www.fennecpharma.com and follow on LinkedIn.

Forward Looking Statements
Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK^®/PEDMARQSI^®, the market opportunity for and market impact of PEDMARK^®/ PEDMARQSI^®, its potential impact on patients and anticipated benefits associated with its use, and future commercial and regulatory milestones, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2024. Fennec disclaims any obligation to update these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.

PEDMARK^®, PEDMARQSI^® and Fennec^® are registered trademarks of Fennec Pharmaceuticals Inc.

©2025 Fennec Pharmaceuticals Inc. All rights reserved.

For further information, please contact:

Investors:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299

Corporate and Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com

____________________
¹ Sheth S et al. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Frontiers in Cellular Neuroscience. 2017, Vol. 11.
² Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Understanding platinum-induced ototoxicity. Trends Pharmacol Sci. 2013;34(8):458-469
³ Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.
⁴ Clemens E, van den Heuvel-Eibrink MM, Mulder RL, et al. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol. 2019;20(1):e29-e41
⁵ Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.
⁶ Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;19
⁷ Freyer DR et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(1):63-74.
⁸ Rajput K, Edwards L, Brock P, Abiodun A, Simpkin P, Al-Malky G. Ototoxicity-induced hearing loss and quality of life in survivors of paediatric cancer. Int J Pediatr Otorhinolaryngol. 2020;138:110401. doi:10.1016/j.ijporl.2020.110401
⁹ Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.

Fennec Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update




Fennec Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update

~ Q3 2025 Total Net Product Sales of $12.5 Million, 79% Year Over Year Growth ~ 

~ Q3 2025 Positive Cash Flow from Operations, Cash Position Grew to $22 Million ~

~ Japan Clinical Trial (STS-J01) Preliminary Results Expected in Q4 2025 ~

RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2025 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the third quarter ended September 30, 2025 and provided a business update.

“Today marks an inflection point for Fennec as we delivered the strongest quarter in our history. Record net product sales, four consecutive quarters of double-digit growth, and our first profitable quarter from operations, clearly demonstrate that our strategy is working,” said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. “What began as a rebuild in the first half of 2025 is now translating into tangible performance. The actions we took to strengthen our commercial organization, drive broader adoption, and reinforce our balance sheet are firmly taking hold. With continued discipline in executing against our strategic priorities, we believe we are well positioned to sustain the growth trajectory of PEDMARK^®.”

Business Highlights:

• Continued Growth Within Key PEDMARK^® Accounts: Last quarter, Fennec announced that one of the largest oncology provider networks added PEDMARK^® to its formulary. Since then, adoption has accelerated across numerous accounts within the network, including multiple Adolescent and Young Adult (AYA) patients across several tumor types receiving PEDMARK^®. This adoption reflects growing confidence in PEDMARK^®’s clinical value and reinforces its potential to help reshape the standard of care for patients receiving cisplatin-based treatment.
• Clinical Data Generation: Robust engagement with key opinion leaders underscores strong external validation of PEDMARK^® and its potential in broader oncology care. Multiple investigator-initiated studies have already been submitted to Fennec and are currently under review, with several others in advanced contracting or evaluation stages. These collaborations are expected to further strengthen our clinical and commercial foundation, with additional details to be shared as they materialize.
• STS-J01 in Japan: In Japan, preliminary results from the investigator-initiated clinical trial (STS-J01) evaluating PEDMARK^® are expected in the fourth quarter of 2025. If the data are positive, the Company will pursue registration in Japan and will also explore partnering or licensing opportunities for PEDMARK^®.

Upcoming Events:

• 16th Annual Craig-Hallum Alpha Select Conference: The management team will host one-on-one investor meetings at the 16^th Annual Craig-Hallum Alpha Select Conference, which will be held on Tuesday, November 18, 2025 at the Sheraton New York Times Square Hotel in New York City.

Financial Results for the Third Quarter 2025 Fiscal Year Ended September 30, 2025

• Net Product Sales – For the third quarter of 2025, the Company recorded net product sales of approximately $12.5 million compared to $7.0 million in the third quarter of 2024, the highest quarterly net product sales in Fennec’s history. In the first nine months of 2025, net product sales surpassed total net product sales for full year of 2024. The increase in net product sales is attributable to growth across both new and existing accounts with notable success in adherence of PEDMARK^® patients.
• Selling and Marketing Expenses – The Company recorded $5.2 million in selling and marketing expenses in the third quarter of 2025 compared to $4.4 million in the second quarter of 2025 and $4.6 million in the third quarter of 2024.
• General and Administrative (G&A) Expenses – The Company recorded $6.8 million in G&A expenses in the third quarter of 2025 compared to $7.0 million in the second quarter of 2025 and $6.1 million in the third quarter of 2024.
• Cash Position – Cash and cash equivalents were $21.9 million as of September 30, 2025 compared to $18.7 million as of June 30, 2025.

Financial Update

The selected financial data presented below is derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended September 30, 2025, and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

About Cisplatin-Induced Ototoxicity
Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.¹

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy.² Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.³ Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.^4,5 While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK^® (sodium thiosulfate injection)

PEDMARK^® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK^® is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK^® is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.^6,7 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK^®, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.^8,9

PEDMARK^® has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage
PEDMARK^® (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use
The safety and efficacy of PEDMARK^® have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK^® may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information
PEDMARK^® is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK^® and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK^®. PEDMARK^® may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK^® is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK^® in patients with baseline serum sodium greater than 145 mmol/L.
Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m².

Administer antiemetics prior to each PEDMARK^® administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK^® at: www.PEDMARK.com.

About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK^® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK^® received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI^®.

In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI^® in Europe, U.K., Australia and New Zealand. PEDMARQSI^® is now commercially available in the U.K. and Germany.

PEDMARK^® has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI^® has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Further, Fennec has patents providing protection for PEDMARK^® until 2039 in both the U.S. and internationally.

For more information, please visit www.fennecpharma.com and follow on LinkedIn.

Forward Looking Statements
Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK^®/PEDMARQSI^®, the market opportunity for and market impact of PEDMARK^®/ PEDMARQSI^®, its potential impact on patients and anticipated benefits associated with its use, and future commercial and regulatory milestones, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2024. Fennec disclaims any obligation to update these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.

PEDMARK^®, PEDMARQSI^® and Fennec^® are registered trademarks of Fennec Pharmaceuticals Inc.

©2025 Fennec Pharmaceuticals Inc. All rights reserved.

For further information, please contact:

Investors:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299

Corporate and Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com

____________________
¹ Sheth S et al. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Frontiers in Cellular Neuroscience. 2017, Vol. 11.
² Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Understanding platinum-induced ototoxicity. Trends Pharmacol Sci. 2013;34(8):458-469
³ Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.
⁴ Clemens E, van den Heuvel-Eibrink MM, Mulder RL, et al. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol. 2019;20(1):e29-e41
⁵ Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.
⁶ Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;19
⁷ Freyer DR et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(1):63-74.
⁸ Rajput K, Edwards L, Brock P, Abiodun A, Simpkin P, Al-Malky G. Ototoxicity-induced hearing loss and quality of life in survivors of paediatric cancer. Int J Pediatr Otorhinolaryngol. 2020;138:110401. doi:10.1016/j.ijporl.2020.110401
⁹ Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.

Bionano Reports Third Quarter 2025 Results and Highlights Recent Business Progress




Bionano Reports Third Quarter 2025 Results and Highlights Recent Business Progress

Conference call today, November 13, 2025, at 4:30 PM ET

SAN DIEGO, Nov. 13, 2025 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (Nasdaq: BNGO) today reported financial results for the third quarter ended September 30, 2025.

“Over the last year, we have taken decisive steps to transform our business model by focusing on driving consumables and software utilization among our existing routine use customers. We believe our performance in the third quarter and year-to-date validates this strategic shift and demonstrates our turn toward sustainable growth as our business stabilizes. This quarter we delivered sustained margins, disciplined operating expense management, and increased utilization from routine users. We continue to see strong momentum in our key geographies and expanding utilization in new regions, including Japan, where researchers are leveraging optical genome mapping (OGM) to address complex questions in genetics. These developments strengthen our confidence in Bionano’s long-term growth trajectory,” commented Erik Holmlin, PhD, president and CEO of Bionano.

Q3 2025 Financial Results

For the three-month period ended September 30, 2025, as compared to the same period of 2024:

• Reported total revenue of $7.4 million, representing an increase of 21% from $6.1 million in Q3 2024.
  • The prior year period included a $0.5 million write-down in revenue from clinical services, which were discontinued.
  • Consumables and software revenues increased 15%.
  • The prior year period also included $1.4 million in instrument revenue, compared to $1.6 million in the third quarter of 2025.
• Sold 8,390 nanochannel array flowcells in the third quarter of 2025, which was an increase of 7% over the 7,835 flowcells sold in the third quarter of 2024.
• Installed 7 new OGM systems and brought 1 back to reach an installed base of 384 at quarter-end, representing a 4% increase over the 368 installed systems reported at the end of the third quarter of 2024.
• Generated gross margin of 46%, compared to (139)% for the third quarter of 2024, and non-GAAP gross margin¹ of 46%, compared to 26% for the third quarter of 2024. Non-GAAP gross margin in the prior year period excludes a $9.8 million impairment, disposal of reagent rentals and inventory charge, as well as stock-based compensation and restructuring expenses.
• Reduced operating expenses by 66% to $11.9 million and non-GAAP operating expense¹ by 40% to $9.7 million.
• Ended the third quarter with cash, cash equivalents, available-for-sale securities, and restricted short-term investments of $31.8 million.

¹”Non-GAAP gross margin” and “non-GAAP operating expense” are non-GAAP financial measures. Please refer to the section titled “Non-GAAP Financial Measures” below for a description of the non-GAAP financial measures used herein. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial tables accompanying this release.

Recent Business Highlights:

• Completed a public offering of common stock in September 2025, raising $10 million of aggregate gross proceeds.
• Highlighted global momentum and the effectiveness of OGM through nine studies, including oral presentations and posters, at the American Society of Human Genetics (ASHG) Meeting.
• Announced Centers for Medicare & Medicaid Services (CMS) posted the preliminary payment determination for the Category I Current Procedural Terminology (CPT) code for the use of OGM in cytogenomic genome-wide analysis to detect structural and copy number variations relative to constitutional genetic disorders.
• Announced multiple studies highlighting OGM utility for analysis of cancer biomarker chromoanagenesis were published in Methods in Molecular Biology.

• Announced a new publication showing how OGM can overcome key limitations of targeted RNA-Sequencing for cytogenetic investigation in acute leukemia, representing the first comparison of OGM and RNA-sequencing in cancer.
• Demonstrated the growing utilization of OGM with 97 peer-reviewed publications in the third quarter.

2025 Outlook

We anticipate the following results for Q4 2025 and the full year:

• Reiterating full year 2025 revenue in the range of $26.0 to $30.0 million.
• Initiating Q4 2025 revenue in the range of $7.5 to $7.9 million.
• Expecting new OGM system installations to surpass 25 in full year 2025, compared to prior expectations of 20 to 25.

Webcast Details

Webcast Details
Date: Thursday, November 13, 2025
Time: 4:30 p.m. Eastern Time
Participant Registration: Registration – Click Here
Webcast: https://edge.media-server.com/mmc/p/4jh5a49o

Participants should register at the link above in advance of the call, and then click the webcast link before the call begins. An archived version of the webcast will be available for replay in the Investors section of the Bionano website.

About Bionano

Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services.

For more information, visit www.bionano.com or www.bionanolaboratories.com.

Bionano’s products are for research use only and not for use in diagnostic procedures.

Non-GAAP Financial Measures

To supplement Bionano’s financial results reported in accordance with U.S. generally accepted accounting principles (GAAP), the Company has provided non-GAAP gross margin and non-GAAP operating expense in this press release and the accompanying conference call, each of which is a non-GAAP financial measure. Non-GAAP gross margin excludes from gross margin reported in accordance with GAAP: stock-based compensation and restructuring expenses, and impairment and disposal of reagent rentals and inventory. Non-GAAP operating expense excludes from operating expense reported in accordance with GAAP: stock-based compensation, amortization of intangibles, changes in fair value of contingent consideration, transaction-related expenses, and loss on disposals. In addition, our reconciliation table provided at the end of this release contains certain additional non-GAAP metrics, including non-GAAP cost of revenue, non-GAAP selling, general and administrative expense, non-GAAP research and development expense, non-GAAP intangible assets and other long-lived assets impairment and non-GAAP restructuring costs, each with adjustments as presented in the table.

Bionano believes that each of these non-GAAP metrics is useful to investors and analysts as a supplement to its financial information prepared in accordance with GAAP for analyzing the Company’s performance and identifying trends in its business. Bionano uses these non-GAAP metrics internally to facilitate period-to-period comparisons and analysis of its performance in order to understand, manage and evaluate its business, to make operating decisions, and for forecasting and budgeting. Accordingly, Bionano believes presentation of these non-GAAP measure allows for greater transparency with respect to key financial metrics it uses in assessing its own operating performance and making operating decisions.

These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, each non-GAAP financial measure as used by Bionano in this press release and the accompanying reconciliation table has limits in its usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

For a reconciliation of non-GAAP gross margin to gross margin reported in accordance with GAAP and non-GAAP operating expense to operating expense reported in accordance with GAAP, please refer to the financial tables accompanying this press release.

Forward-Looking Statements of Bionano Genomics
This press release and the accompanying conference call contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our expectations regarding market adoption of our products, our commercial prospects and future financial and operating results, including our full year 2025 and Q4 2025 guidance, and our ability to meet our stated goals and commercial opportunities. Each of these forward-looking statements involves risks and uncertainties. Accordingly, investors and prospective investors are cautioned not to place undue reliance on these forward-looking statements as they involve inherent risk and uncertainty (both general and specific) and should note that they are provided as a general guide only and should not be relied on as an indication or guarantee of future performance. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to: our ability to improve our margins, extend our cash runway and reach a potential pathway to profitability; our ability to continue as a going concern within 12 months of the filing of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, which requires us to manage costs and obtain significant additional financing to fund our strategic plans and commercialization efforts; our ability to execute on our strategy and achieve our objectives; the impact and utility of our cost savings initiative and our recent financing; our ability to continue to drive OGM (as defined above) adoption by potential customers for routine use in genomic analysis; the impact, or lack thereof, of Category I CPT codes to accelerate or increase the adoption of OGM; continued research, presentations and publications involving OGM and its utility compared to traditional cytogenetics and our technologies; the impact of our Stratys™ system and VIA™ software to increase throughput and simplify analysis of OGM data; our ability to drive adoption of OGM and our technology solutions; our ability to further deploy new products and applications for our technology platforms; our expectations and beliefs regarding future growth of the business and the markets in which we operate; our ability to consummate any strategic alternatives including the risk that if we fail to obtain additional financing we may seek relief under applicable insolvency laws; the size and growth potential of the markets for our products, and our ability to serve those markets; the rate and degree of market acceptance of our products; our ability to manage the growth of our business and integrate acquired businesses; our ability to expand our commercial organization to address effectively existing and new markets that we intend to target; the impact from future regulatory, judicial, and legislative changes or developments in the U.S. and foreign countries; our ability to compete effectively in a competitive industry; the introduction of competitive technologies or improvements in existing technologies and the success of any such technologies; the performance of our third-party contract sales organizations, suppliers and manufacturers; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, reimbursement rates, capital requirements and needs for additional financing; the impact of adverse geopolitical and macroeconomic developments, such as recent and future bank failures, the ongoing conflicts between Ukraine and Russia and in the Middle East, and related sanctions, regional or global pandemics, inflation, tariffs, increased cost of goods, supply chain issues, and global financial market conditions; on our business and operations, as well as the business or operations of our suppliers, customers, manufacturers, research partners and other third parties with whom we conduct business and our expectations with respect to the duration of such impacts and the resulting effects on our business; our ability to realize the anticipated benefits and synergies of our prior and any future acquisitions or other strategic transactions; our ability to attract collaborators and strategic partnerships; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Reports on Form 10-Q and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as may be required by law.

CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionano.com

Investor Relations:
Kelly Gura
Gilmartin Group
+1 (212) 229-6163
IR@bionano.com

Bionano Reports Third Quarter 2025 Results and Highlights Recent Business Progress




Bionano Reports Third Quarter 2025 Results and Highlights Recent Business Progress

Conference call today, November 13, 2025, at 4:30 PM ET

SAN DIEGO, Nov. 13, 2025 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (Nasdaq: BNGO) today reported financial results for the third quarter ended September 30, 2025.

“Over the last year, we have taken decisive steps to transform our business model by focusing on driving consumables and software utilization among our existing routine use customers. We believe our performance in the third quarter and year-to-date validates this strategic shift and demonstrates our turn toward sustainable growth as our business stabilizes. This quarter we delivered sustained margins, disciplined operating expense management, and increased utilization from routine users. We continue to see strong momentum in our key geographies and expanding utilization in new regions, including Japan, where researchers are leveraging optical genome mapping (OGM) to address complex questions in genetics. These developments strengthen our confidence in Bionano’s long-term growth trajectory,” commented Erik Holmlin, PhD, president and CEO of Bionano.

Q3 2025 Financial Results

For the three-month period ended September 30, 2025, as compared to the same period of 2024:

• Reported total revenue of $7.4 million, representing an increase of 21% from $6.1 million in Q3 2024.
  • The prior year period included a $0.5 million write-down in revenue from clinical services, which were discontinued.
  • Consumables and software revenues increased 15%.
  • The prior year period also included $1.4 million in instrument revenue, compared to $1.6 million in the third quarter of 2025.
• Sold 8,390 nanochannel array flowcells in the third quarter of 2025, which was an increase of 7% over the 7,835 flowcells sold in the third quarter of 2024.
• Installed 7 new OGM systems and brought 1 back to reach an installed base of 384 at quarter-end, representing a 4% increase over the 368 installed systems reported at the end of the third quarter of 2024.
• Generated gross margin of 46%, compared to (139)% for the third quarter of 2024, and non-GAAP gross margin¹ of 46%, compared to 26% for the third quarter of 2024. Non-GAAP gross margin in the prior year period excludes a $9.8 million impairment, disposal of reagent rentals and inventory charge, as well as stock-based compensation and restructuring expenses.
• Reduced operating expenses by 66% to $11.9 million and non-GAAP operating expense¹ by 40% to $9.7 million.
• Ended the third quarter with cash, cash equivalents, available-for-sale securities, and restricted short-term investments of $31.8 million.

¹”Non-GAAP gross margin” and “non-GAAP operating expense” are non-GAAP financial measures. Please refer to the section titled “Non-GAAP Financial Measures” below for a description of the non-GAAP financial measures used herein. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial tables accompanying this release.

Recent Business Highlights:

• Completed a public offering of common stock in September 2025, raising $10 million of aggregate gross proceeds.
• Highlighted global momentum and the effectiveness of OGM through nine studies, including oral presentations and posters, at the American Society of Human Genetics (ASHG) Meeting.
• Announced Centers for Medicare & Medicaid Services (CMS) posted the preliminary payment determination for the Category I Current Procedural Terminology (CPT) code for the use of OGM in cytogenomic genome-wide analysis to detect structural and copy number variations relative to constitutional genetic disorders.
• Announced multiple studies highlighting OGM utility for analysis of cancer biomarker chromoanagenesis were published in Methods in Molecular Biology.

• Announced a new publication showing how OGM can overcome key limitations of targeted RNA-Sequencing for cytogenetic investigation in acute leukemia, representing the first comparison of OGM and RNA-sequencing in cancer.
• Demonstrated the growing utilization of OGM with 97 peer-reviewed publications in the third quarter.

2025 Outlook

We anticipate the following results for Q4 2025 and the full year:

• Reiterating full year 2025 revenue in the range of $26.0 to $30.0 million.
• Initiating Q4 2025 revenue in the range of $7.5 to $7.9 million.
• Expecting new OGM system installations to surpass 25 in full year 2025, compared to prior expectations of 20 to 25.

Webcast Details

Webcast Details
Date: Thursday, November 13, 2025
Time: 4:30 p.m. Eastern Time
Participant Registration: Registration – Click Here
Webcast: https://edge.media-server.com/mmc/p/4jh5a49o

Participants should register at the link above in advance of the call, and then click the webcast link before the call begins. An archived version of the webcast will be available for replay in the Investors section of the Bionano website.

About Bionano

Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services.

For more information, visit www.bionano.com or www.bionanolaboratories.com.

Bionano’s products are for research use only and not for use in diagnostic procedures.

Non-GAAP Financial Measures

To supplement Bionano’s financial results reported in accordance with U.S. generally accepted accounting principles (GAAP), the Company has provided non-GAAP gross margin and non-GAAP operating expense in this press release and the accompanying conference call, each of which is a non-GAAP financial measure. Non-GAAP gross margin excludes from gross margin reported in accordance with GAAP: stock-based compensation and restructuring expenses, and impairment and disposal of reagent rentals and inventory. Non-GAAP operating expense excludes from operating expense reported in accordance with GAAP: stock-based compensation, amortization of intangibles, changes in fair value of contingent consideration, transaction-related expenses, and loss on disposals. In addition, our reconciliation table provided at the end of this release contains certain additional non-GAAP metrics, including non-GAAP cost of revenue, non-GAAP selling, general and administrative expense, non-GAAP research and development expense, non-GAAP intangible assets and other long-lived assets impairment and non-GAAP restructuring costs, each with adjustments as presented in the table.

Bionano believes that each of these non-GAAP metrics is useful to investors and analysts as a supplement to its financial information prepared in accordance with GAAP for analyzing the Company’s performance and identifying trends in its business. Bionano uses these non-GAAP metrics internally to facilitate period-to-period comparisons and analysis of its performance in order to understand, manage and evaluate its business, to make operating decisions, and for forecasting and budgeting. Accordingly, Bionano believes presentation of these non-GAAP measure allows for greater transparency with respect to key financial metrics it uses in assessing its own operating performance and making operating decisions.

These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, each non-GAAP financial measure as used by Bionano in this press release and the accompanying reconciliation table has limits in its usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

For a reconciliation of non-GAAP gross margin to gross margin reported in accordance with GAAP and non-GAAP operating expense to operating expense reported in accordance with GAAP, please refer to the financial tables accompanying this press release.

Forward-Looking Statements of Bionano Genomics
This press release and the accompanying conference call contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our expectations regarding market adoption of our products, our commercial prospects and future financial and operating results, including our full year 2025 and Q4 2025 guidance, and our ability to meet our stated goals and commercial opportunities. Each of these forward-looking statements involves risks and uncertainties. Accordingly, investors and prospective investors are cautioned not to place undue reliance on these forward-looking statements as they involve inherent risk and uncertainty (both general and specific) and should note that they are provided as a general guide only and should not be relied on as an indication or guarantee of future performance. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to: our ability to improve our margins, extend our cash runway and reach a potential pathway to profitability; our ability to continue as a going concern within 12 months of the filing of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, which requires us to manage costs and obtain significant additional financing to fund our strategic plans and commercialization efforts; our ability to execute on our strategy and achieve our objectives; the impact and utility of our cost savings initiative and our recent financing; our ability to continue to drive OGM (as defined above) adoption by potential customers for routine use in genomic analysis; the impact, or lack thereof, of Category I CPT codes to accelerate or increase the adoption of OGM; continued research, presentations and publications involving OGM and its utility compared to traditional cytogenetics and our technologies; the impact of our Stratys™ system and VIA™ software to increase throughput and simplify analysis of OGM data; our ability to drive adoption of OGM and our technology solutions; our ability to further deploy new products and applications for our technology platforms; our expectations and beliefs regarding future growth of the business and the markets in which we operate; our ability to consummate any strategic alternatives including the risk that if we fail to obtain additional financing we may seek relief under applicable insolvency laws; the size and growth potential of the markets for our products, and our ability to serve those markets; the rate and degree of market acceptance of our products; our ability to manage the growth of our business and integrate acquired businesses; our ability to expand our commercial organization to address effectively existing and new markets that we intend to target; the impact from future regulatory, judicial, and legislative changes or developments in the U.S. and foreign countries; our ability to compete effectively in a competitive industry; the introduction of competitive technologies or improvements in existing technologies and the success of any such technologies; the performance of our third-party contract sales organizations, suppliers and manufacturers; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, reimbursement rates, capital requirements and needs for additional financing; the impact of adverse geopolitical and macroeconomic developments, such as recent and future bank failures, the ongoing conflicts between Ukraine and Russia and in the Middle East, and related sanctions, regional or global pandemics, inflation, tariffs, increased cost of goods, supply chain issues, and global financial market conditions; on our business and operations, as well as the business or operations of our suppliers, customers, manufacturers, research partners and other third parties with whom we conduct business and our expectations with respect to the duration of such impacts and the resulting effects on our business; our ability to realize the anticipated benefits and synergies of our prior and any future acquisitions or other strategic transactions; our ability to attract collaborators and strategic partnerships; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Reports on Form 10-Q and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as may be required by law.

CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionano.com

Investor Relations:
Kelly Gura
Gilmartin Group
+1 (212) 229-6163
IR@bionano.com

Legend Biotech Celebrates Official Opening of New State-of-the-Art Cell Therapy Research and Development Facility in Philadelphia




Legend Biotech Celebrates Official Opening of New State-of-the-Art Cell Therapy Research and Development Facility in Philadelphia

31,000-square-foot site expands Legend’s U.S. R&D footprint and strengthens its position as a global leader in cell therapy innovation

The facility will support CAR-T R&D in potential oncology and immunology indications

A Media Snippet accompanying this announcement is available by clicking on this link.

SOMERSET, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) — Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a U.S.-based global leader in cell therapy, today announced the official opening and ribbon cutting of its new, state-of-the-art research and development (R&D) facility in Philadelphia, Pennsylvania.

Located at 2300 Market Street, the 31,000-square-foot facility is now fully operational and will support Legend’s expanding pipeline of next-generation cell therapies. The site features cutting-edge laboratories and collaborative workspaces designed to foster innovation and accelerate research programs across Legend’s oncology and immunology portfolios.

“This new facility marks an exciting milestone for Legend Biotech as we continue to invest in our future and strengthen our leadership in cell therapy innovation,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “We are proud to officially open our doors in Philadelphia, a world-class hub for life sciences, where we can attract top-tier talent, collaborate with premier research institutions, and advance our mission to bring transformative therapies to patients.”

The Philadelphia R&D center expands Legend’s American presence, which includes over 1,400 employees in the United States. The site will employ approximately 55 full-time team members and complements Legend’s existing R&D presence in Piscataway, New Jersey. Headquartered in Somerset, N.J., Legend also has manufacturing activities in Raritan and Morris Plains, N.J.

“The opening of our new facility represents an exciting new chapter for our research organization,” said Guowei Fang, Ph.D., President of Research and Development at Legend Biotech. “Our Philadelphia team will play a critical role in advancing our sustainable pipeline of innovative cell therapies, while strengthening collaborations within one of the nation’s most dynamic biotech ecosystems.”

Local officials, academic partners, patient advocacy groups, and members of the Philadelphia biotech community gathered with Legend Biotech leadership to celebrate the ribbon-cutting ceremony and tour the new facility.

“Legend Biotech’s decision to expand its R&D footprint in Philadelphia reflects the strength and momentum of our city’s life sciences ecosystem,” said Dr. Rebecca L. Grant, Director of Life Sciences & Innovation for the City of Philadelphia’s Department of Commerce. “Philadelphia is home to world-class scientific talent and research institutions, and we are proud to welcome an organization committed to pioneering therapies that change patient lives. We look forward to supporting Legend Biotech as they grow here and contribute to the continued advancement of cell and gene therapy innovation in our city.”

“Philadelphia continues to be a magnet for innovation and scientific excellence,” said Chris Molineaux, CEO of Life Sciences Pennsylvania. “We are thrilled to welcome Legend Biotech to our city’s thriving life sciences community. Their investment brings high-quality jobs, research opportunities, and further reinforces Philadelphia’s growing reputation as a global leader in healthcare innovation.”

About Legend Biotech
With over 2,900 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI^®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. To date, CARVYKTI has been administered to over 9,000 patients with multiple myeloma at 132 treatment centers spanning 44 states across the U.S. Headquartered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

Learn more at www.legendbiotech.com and follow us on LinkedIn.

CAUTIONARY NOTE REGARDING 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, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives, and the potential benefits of Legend Biotech’s product candidates. The words “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 identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 11, 2025. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
jessie.yeung@legendbiotech.com

PRESS CONTACT:
Alexandra Ventura
Tel: (732) 850-5598
media@legendbiotech.com

Ramsay Sante : Interim results at the end of September 2025




Ramsay Sante : Interim results at the end of September 2025

        PRESS RELEASE
                Paris, 13^th November 2025

Interim results at the end of September 2025

Revenue growth of 2.6% and Group EBITDA up 6.5% despite
reduction in public funding; resilient operating performance

Activity growth and cost control compensate constrained funding

• Unaudited group revenue for the quarter ending 30 September 2025 increased by 2.6% to 1.21bn€ supported by activity volume growth, price indexation in Sweden and favourable foreign exchange movements. Revenue growth of 1.9% on a like-for-like basis.
• Acute hospitals admission volume growth in France and Sweden despite 1 less business day this quarter compared to the same period last year, reflecting sustained patient need for healthcare and the capacity of the group’s facilities to provide more quality care services in a competitive landscape.
• Unaudited group EBITDA for the quarter ending 30 September 2025 increased 7m€ or 6.5% to 112m€, despite the end of the French revenue guarantee curtailing subsidies income by 7m€. Cost inflation remains underfunded by governments and continues to outstrip revenue rates indexation. Recent decision on imaging tariffs in France shows that pressure on price of services fixed by public payors will remain a key challenge.
• This increase in EBITDA is mainly due to a strong performance in Sweden where all our activities, especially primary care, contributed to the growth.
• Operational performance sustained through continued cost saving efforts on administrative costs and agency staff, productivity improvements from staffing levels better matching activity volumes and optimizing procurement costs. The portfolio of facilities is continuously reviewed to adjust specialty offering within our geographical clusters to local constraints, needs and opportunities and to enhance the quality of healthcare services to the population they care for.
• Net financial debt as of 30 September 2025 amounted to €3,819m, including €1,867m of IAS17 (pre-IFRS16) net debt. Pre-IFRS16 unaudited net leverage amounts to 5.2x as of September 2025 vs. 5.3x as of September 2024.

Mission-led strategy drives tangible profitable growth and medical excellence

• The implementation of new models of care continues in France, notably through the expansion of day hospitals in medicine, closely aligned with patients’ healthcare needs.
• Further progress was made to develop out of hospital and outpatient activities with the opening of 2 primary care centres in Norway based on a new public partnership model, 2 new mental health outpatient settings in France (10 as of today), and the set-up of a new imaging heavy equipment in France during the quarter. Concomitantly, the integration of the former Cosem primary care in France is progressing well as an enabler of our objective to coordinate care pathways where we operate.

Activity and revenue:

Ramsay Santé Group reported a consolidated revenue of €1,207m for the quarter ending 30 September 2025, up 2.6% on a reported basis. Adjusted for changes in the consolidation scope and at constant currency exchange rates, revenue for the period was up with a 1.9% organic sales growth.

France revenue has grown by 1.4% (1.9% on a like-for-like basis) on the back of increased volumes, despite one less business day this quarter compared to last year, and including the +0.5% indexation of MSO tariffs since March 2025.   France hospital admissions in our hospitals rose vs. the same quarter last year, mainly through a +2.0% increase in MSO (medicine, surgery and obstetrics) patient stays driven by a +3.5% increase in ambulatory care stays.

Nordic countries revenue grew by +2.6% on a like-for-like and constant exchange rate bases, with a reported revenue growth of +5.4% benefitting from 9m€ (or 2.6%) favourable foreign exchange rate fluctuations (appreciation of SEK vs EUR on average vs the same quarter last year). Solid organic growth in Sweden underpinned by primary care activity benefitting from a long-term increasing trend of listed patients as well as growing volumes in St Göran with a reducing length of stay. Softer activity in Denmark primary care units whilst the Danish hospitals revenue stabilised following the merger and consolidation of our facilities in Copenhagen.

EBITDA:

EBITDA increased 7m€ or 6.5% to 112m€ for the quarter ending 30 September 2025 vs. the prior corresponding period. The Group’s EBITDA growth has been negatively impacted by the end of the French government’s revenue guarantee from 1 January 2025, representing a 7m€ shortfall vs. the same quarter last year. Funding otherwise received through French tariff increases and various public payors in the Nordics still only partially covered inflation from medical staff salary and wages as well as overall procurement and outsourced services price increases, putting pressure on operating margins.   Productivity efforts and cost control across all geographies already initiated last year have been reinforced and allowed the Group operations to offset cost inflation, growing EBITDA by 7m€ and improving EBITDA margin by 0.3 pts. The corresponding actions range from increasing staffing productivity, optimising medical purchases and consumption, to saving on administrative costs and carefully adjusting hiring structure (eg. agency staff), while also pursuing revenue development initiatives such as in day medicine and imaging activities.

Reported EBITDA of 112m€ for the quarter ending 30 September 2025 in accordance with IFRS16 excludes contracted lease expenses for 69m€ (vs. 66m€ last year) which are instead recorded as amortisation of the right-of-use asset and interest on the lease debt. The increase in the lease accounting impact vs. prior year primarily came from the effect of rents indexation and the impact of a stronger SEK vs the EUR this quarter for c. 0,6m€.

Cash flow & financing:

Net cash flow from operating activities of -44m€ in this quarter reflects the lower seasonality of our medical, surgical and obstetrical activities over the summer months, and its 13m€ decrease versus -31m€ in the prior corresponding period primarily arises from the negative working capital variation linked to the repayment of French government cash advances over the summer. These were extended in April and May both in 2024 and 2025 to compensate the billing hold caused by the late publication of French DRG tariffs in each year. However, their repayment over the July to September period was higher in this years’ quarter, driving the decrease in working capital variation vs. last year’s comparable quarter.

Reported net financial debt as of 30 September 2025 amounted to 3,819m€, of which 1,867m€ on a restated basis (i.e. restated from the IFRS16 impact on operating or non-financial rents). Restated net leverage amounts to 5.2x as of September 2025, vs. 5.3x as of September 2024. Focus remains on cash flow generation through operational efficiency and working capital improvement.

Pascal Roché, CEO of Ramsay Santé says:

“At Ramsay Santé, our purpose – Improving health through constant innovation – is at the heart of everything we do, and we continue implementing the Company’s ‘Yes We Care 2025’ strategy of providing integrated care services to patients across all populations throughout the entire care pathways to deliver on our mission. Despite funding pressures headwinds from government payors, disciplined cost management and focus on productivity have lifted operating profitability in the first quarter of this new financial year. We have achieved an EBITDA growth of 6,5% and an EBITDA margin improvement of                       0,3 pts with an organic revenue growth of 1,9 %. We will continue to transform Ramsay Santé as a partner of choice for patients, doctors, staff and other stakeholders whilst ensuring its sustainable and profitable growth.”

The Board of Directors that met on 13 November 2025 approved this unaudited trading update for the quarter ended 30 September 2025.

About Ramsay Santé

Ramsay Santé is the leader in private hospitalisation and primary care in Europe. The Group has 38,000 employees and works with nearly 9,300 practitioners to treat more than 12 million patients per year in its 465 facilities and 5 countries: France, Sweden, Norway, Denmark and Italy. Ramsay Santé offers almost all medical and surgical specialities in three domains: Medicine, Surgery, Obstetrics (MSO), Follow-up Care and Rehabilitation (FCR) and Mental Health. 

Legally, Ramsay Santé is a mission-driven company committed to constantly improving the health of all patients through innovation. Wherever it operates, the Group contributes to public health service missions and the healthcare network. Through its actions and the constant dedication of its teams, Ramsay Santé is committed to ensuring the entire patient care journey, from prevention to follow-up care. 

Every year, the group invests over 200 million euros to support the evolution and diversity of care pathways, in medical, hospital, digital, and administrative aspects. Through this commitment, our Group enhances access to care for all, commits to provide best-in-class healthcare, systematically engages in dialogue with stakeholders and strives to protect the planet to improve health. 

Facebook: https://www.facebook.com/RamsaySante 
Instagram: https://www.instagram.com/ramsaysante 
Twitter: https://twitter.com/RamsaySante 
LinkedIn: https://www.linkedin.com/company/ramsaysante 
YouTube: https://www.youtube.com/c/RamsaySante 

Code ISIN and Euronext Paris: FR0000044471 
Website:  www.ramsaysante.fr 

Investor / Analyst Relations        Press Relations

Clément Lafaix        Brigitte Cachon
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clement.lafaix@ramsaysante.fr        brigitte.cachon@ramsaysante.fr

Summary of unaudited results as at 30 September 2025

Changes in revenue between 30 September 2025 vs. previous corresponding period in €m

Restated aggregates from the IFRS16 impact on operating rents

Profit & Loss Statement

Net financial debt

Cash flow Statement

Glossary

• Constant perimeter, or like-for-like comparison
  • The cancelation of incoming entities consists in:
    • for entries in the current year’s scope, deducting the contribution of the acquisition on the current year’s aggregates;
    • for entries in the previous year’s scope, deducting in the current year’s aggregates, the contribution of the acquisition prior to the month of acquisition.
  • The cancelation of outgoing entities consists in:
    • for exits in the current year’s scope, deducting in the previous year’s aggregates, the contribution of the exiting entity from the month of exit;
    • for exits in the previous year, deducting the contribution of the exiting entity for the entire previous year’s aggregates.
• The change at constant exchange rates reflects a change after translation of the current period’s foreign currency figure at the exchange rates of the comparative period.
• The change on a constant accounting basis reflects a change in the figure excluding the impact of changes in accounting standards during the period.
• Current operating profit refers to operating profit before other non-recurring income and expenses consisting of restructuring costs (charges and provisions), gains or losses on disposals or significant and unusual impairments of non-current assets, whether tangible or intangible, and other unusual operational income and expenses.
• EBITDA corresponds to current operating profit before depreciation (expenses and provisions in the income statement are grouped according to their nature).
• Net financial debt is gross financial debt less financial assets.
  • The gross financial debts are made up of:
    • borrowings from credit institutions, including interest incurred;
    • lease liabilities falling within the scope of IFRS 16;
    • fair value of hedging instruments recorded in the balance sheet, net of tax;
    • current financial debt relating to financial current accounts with minority investors;
    • bank overdrafts.
  • Financial assets consist of:
    • the fair value of hedging instruments recorded in the balance sheet, net of tax;
    • current financial receivables relating to financial current accounts with minority investors;
    • Cash and cash equivalents, including treasury shares held by the Group (considered as marketable securities);
    • financial assets directly related to the loans contracted and recognized in gross financial debt.

• Restated aggregates are calculated based on reported aggregates that have been restated from the IFRS16 impact on operating rents or non-financial rents (but not from the IFRS16 impact on leasing and lease financing that is still included). As an illustration:
  • Restated EBITDA includes operating rents or non-financial rents (as compared with reported EBITDA)
  • Restated Net Debt does not include current and non-current lease debt linked to operating rents or non-financial rents (as compared with the reported Net Debt)
  • Restated net leverage ratio derives from restated Net Debt and restated LTM EBITDA

Attachment

• RAMSAY SANTE – Interim results as of 30 Sept 2025

Persephone Biosciences Announces Topline Results from AMBROSIA Food as Medicine Study with Kroger Health




Persephone Biosciences Announces Topline Results from AMBROSIA Food as Medicine Study with Kroger Health

– AMBROSIA is the largest study to evaluate the impact of Medical Nutrition Therapy (MNT) on diet quality and the gut microbiome, with 546 participants enrolled –

– Topline results from the study identified three enterotypes, one of which was associated with increased BMI and poorer diet, and demonstrated that MNT can successfully improve microbiome composition and enable patients to switch enterotypes –

– The U.S.-based study was run in collaboration with Kroger Health, the healthcare division of The Kroger Co –

SAN DIEGO, Nov. 13, 2025 (GLOBE NEWSWIRE) — Persephone Biosciences, a pioneering biotech company focused on unlocking the potential of the microbiome to impact human health, today announced topline results from its AMBROSIA Food as Medicine clinical study (NCT06091813), which was run in collaboration with Kroger Health to investigate how the microbiome is impacted by diet and lifestyle factors. Topline results from the study identified three enterotypes, one of which was associated with increased BMI and poorer diet and demonstrated that Medical Nutritional Therapy (MNT) can successfully improve microbiome composition, enabling subjects to switch enterotypes.

“We’re thrilled to have completed the AMBROSIA study, the largest study to evaluate the impact of Medical Nutrition Therapy on diet quality and the gut microbiome. I would like to express my deep gratitude to the participants, and to Kroger Health for joining with us in this groundbreaking study,” said Stephanie Culler, CEO and Co-founder of Persephone Biosciences. “While the role of gut microbes in human health, and the impact of diet on microbiome composition, has been recognized for decades, today’s study finally brings us closer to understanding that complex interaction.”

Culler continued: “In the AMRBOSIA study, we were able to demonstrate that Medical Nutrition Therapy can help patients rebuild and improve their microbiome composition by switching enterotypes, which could in turn lead to better health outcomes. Further research could validate this and unlock opportunities to offer testing options at retail to support customers’ health and wellness journeys.”

AMBROSIA is the largest study to date evaluating the impact of MNT on diet quality and the gut microbiome. 546 participants aged between 18-64 years old at high risk of colorectal cancer (CRC) were enrolled in the study. Subjects were allowed to enroll if they have had previous colonoscopy findings, were in remission from CRC, or if they had any of the following three conditions: they were obese or overweight; a parent or sibling had developed colon cancer; or they had been a smoker for 10 or more years.

Subjects were randomized across two arms in equal number. Subjects in the first cohort underwent MNT for a period of 4 months, while subjects in the second cohort received no directed dietary modifications and are referred to as the control group. Microbiome composition and diet score were evaluated at baseline and again after 4 months.

Results

• Microbiome analysis indicates that participants fall into one of three general categories (enterotypes), each of which is characterized by a high concentration of different bacterial species.
• Enterotype 3, which is dominated by the genus Prevotella, was found to be associated with higher body mass index (BMI), lower diet score, and lower microbial diversity.
• At four months, the MNT cohort had higher final diet scores and higher movement between enterotypes than the control cohort.
• Furthermore, the study found that the number of MNT visits and the percentage of goals attained were found to be directly correlated with diet score.
• Functional analysis also demonstrated that each enterotype is enriched in gene functions enabling consumption of a particular type of fiber. Based on this, Persephone hypothesizes that no enterotype is inherently unhealthy, but rather that each enterotype is best suited for a particular diet.
• Importantly, these findings point to benefits of incorporating MNT, coupled with microbiome analysis, into personalized nutrition, to potentially lead to better health outcomes.

“Kroger Health is excited to share topline results from the AMBROSIA study, alongside Persephone Biosciences, an investment we made as part of our commitment to advancing Food as Medicine as one of our health initiatives,” said Jim Kirby, Chief Commercial Officer, Kroger Health. “Having demonstrated the positive benefits to the microbiome of providing one-on-one virtual nutrition coaching visits, we would love to use this information to unlock new avenues for personalized healthcare and, potentially, improved well-being for all.”

According to the CDC, colorectal cancer is one of the leading killers in the U.S., of cancers that affect both men and women. Approximately nine out of ten people whose colorectal cancers are found early and treated appropriately are still alive five years later. A growing body of evidence shows the bacteria living in the gut may influence an individual’s risk of developing colorectal cancer; the data collected from the AMBROSIA trial will additionally be used to assess the extent to which this is true.

About Persephone Biosciences
Persephone is a pioneering biotech company reimagining infant and patient health using rigorous clinical research to unlock the potential of the gut microbiome to prevent and treat disease. Persephone is backed by notable investors including Y Combinator, Fifty Years, Susa Ventures, American Cancer Society’s BrightEdge Fund, Pioneer Fund, First Bight Ventures, Propel Bio Partners, Ocampo Capital, Mesa Verde Partners and Capita3. Our My Baby Biome study uncovered the widespread gaps in modern infant gut health. Learn more at www.persephone.bio.

Investor Contact

Laurence Watts

laurence@newstreetir.com