Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio




Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio

INSIDE INFORMATION
REGULATED INFORMATION

Correction and Replacement

Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio

Financings are comprised of equity investments, including from Cochlear, Resmed and Nyxoah’s Chairman and Management, and a convertible bond.

This press release replaces the press release issued on November 13, 2025, at 10:11 pm CET / 4:11 pm ET in order to replace and correct the gross proceeds of the private placement and registered direct offering and to add a paragraph under the header “Additional Information” (statutory auditor’s assessment)

Mont-Saint-Guibert, Belgium – November 14, 2025, 1:30 am CET / November 13, 7:30 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA) through neuromodulation, today announced a €17 million private placement of equity, a U.S. $5.6 million registered direct offering, combined with a convertible bond financing of up to €45 million.

The private placement consists of the issuance of 4,265,714 new ordinary shares at a subscription price per share of €4.00 (approximately U.S. $4.6304 at current exchange rates) with gross proceeds totaling €17 million (approximately U.S. $20 million at current exchange rates). The closing of the private placement is expected to occur on or about November 17, 2025, subject to customary closing conditions. Degroof Petercam acted as the sole book runner for this private placement.

The ordinary shares are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Additionally, the registered direct offering consists of the issuance of 1,215,964 new ordinary shares at a price per share of U.S. $4.6304 with gross proceeds totaling approximately U.S. $5.6 million. The closing of the registered direct offering is expected to occur on or about November 18, 2025, subject to customary closing conditions.

The registered direct offering is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333- 268955) which was declared effective by the Securities and Exchange Commission (the “SEC”) on January 6, 2023. The offering is being made only by means of a prospectus which is part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.

Additionally, the Company entered into a subscription agreement with an international financial services firm for the issuance of convertible bonds for an aggregate maximum principal amount of up to €45 million (approximately U.S. $52 million at current exchange rate). The financing consists of a first tranche of up to €22.5 million with an option to issue a second tranche of €22.5 million at Nyxoah’s discretion, during the 30 days beginning seven months from the closing date subject to certain conditions. The closing for the first tranche of bonds is expected to occur in December 2025, subject to customary closing conditions. The first tranche of bonds will be issued at 92 per cent of their principal amount and carry an interest rate of 6.5 per cent per annum, payable every quarter in arrears. The bonds have a three-year maturity from issuance with quarterly amortization payments of principal and interest. The default conversion price for the first tranche of bonds, which can be modified on a downward basis, shall be equal to EUR 5.00, which represents 125 per cent of the placement price of the Shares being issued pursuant to the private placement.

The net proceeds from the convertible bonds together with the net proceeds of the private placement, will be used (i) to support commercialization activities in the United States and advance the commercialization of the Genio system in the Company’s initial target markets outside the United States; (ii) to continue gathering clinical data and to support physician-initiated clinical research projects related to OSA patient treatments; (iii) to further finance research and development activities related to Genio system upgrades, re-designing the Company’s products for manufacturability and cost reduction initiatives; (iv) to continue to build a pipeline of new technologies and explore potential collaboration opportunities in the field of monitoring and diagnostics for OSA; and (v) for other general corporate purposes, including, but not limited to, working capital, capital expenditures, investments, acquisitions, should the Company choose to pursue any, and collaborations.

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

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

ADDITIONAL INFORMATION

The following information is provided pursuant to article 7:97 of the Belgian Code on companies and associations. The investors that have participated in the private placement include, among others, (either directly or through entities controlled by them) Robert Taub, who is the chairman of the board of directors, Jürgen Hambrecht and Daniel Wildman (permanent representative of Wildman Ventures LLC), who are independent directors, Olivier Taelman, CEO and director of the Company, John Landry, CFO of the Company and Scott Holstine, Chief Commercial Officer of the Company. Together, these investors have subscribed to 356,250 new shares for EUR 1.425 million in gross proceeds at an issue price equal to EUR 4.00.

As Robert Taub, Jürgen Hambrecht, Daniel Wildman, Olivier Taelman, John Landry and Scott Holstine qualify as related parties of the Company, the board of directors applied the related parties procedure of article 7:97 of the Belgian Code on companies and associations in connection with the participation of the aforementioned related parties in the private placement. Within the context of the aforementioned procedure, prior to resolving on the private placement, a committee of three independent directors of the Company consisting of Rita Johnson-Mills, Virginia Kirby and Kevin Rakin (the “Committee”) issued an advice to the board of directors in which the Committee assessed the participation of the six aforementioned investors in the private placement. In its advice to the board of directors, the Committee concluded the following: “Based on the information provided, the Committee considers that the proposed Transaction is in line with the strategy pursued by the Company, will be done on market terms, and is unlikely to lead to disadvantages for the Company and its shareholders (in terms of dilution) that are not sufficiently compensated by the advantages that the Transaction offers the Company”.

The Company’s board of directors approved the principle of the private placement and did not deviate from the Committee’s advice.

The Company’s statutory auditor’s assessment of the Committee’s advice and the minutes of the meeting of the Company’s board of directors, is as follows: “Based on our assessment, nothing has come to our attention that causes us to believe that the financial and accounting data included in the opinion of the committee of independent directors dated 13 November 2025 and in the minutes of the board of directors dated 13 November 2025, justifying the proposed transaction, are not fair and adequate in all material respects in light of the information available to it in connection with its engagement. Our assignment was carried out solely within the framework of the provisions of Article 7:97 of the Companies and Associations Code and our report cannot therefore be used in any other context.”

IMPORTANT INFORMATION

THIS ANNOUNCEMENT IS NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN ANY JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW. THIS ANNOUNCEMENT IS FOR GENERAL INFORMATION ONLY AND DOES NOT FORM PART OF ANY OFFER TO SELL OR PURCHASE, OR THE SOLICITATION OF ANY OFFER TO SELL OR PURCHASE, ANY SECURITIES. THE DISTRIBUTION OF THIS ANNOUNCEMENT AND THE OFFER, SUBSCRIPTION, SALE AND PURCHASE OF SECURITIES DESCRIBED IN THIS ANNOUNCEMENT IN CERTAIN JURISDICTIONS MAY BE RESTRICTED BY LAW. ANY PERSONS READING THIS ANNOUNCEMENT SHOULD INFORM THEMSELVES OF AND OBSERVE ANY SUCH RESTRICTIONS.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the closings of the private placement, the registered direct offering and the convertible bond financing; the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company’s commercialization strategy and entrance to the U.S. market; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the satisfaction of the closing conditions required for the closing of each of the private placement, the registered direct offering and the convertible bond financing and the consummation of the respective closings, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
IR@nyxoah.com

Attachment

• Financing PR – correction (final)

“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in the United Kingdom




“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in the United Kingdom

TOKYO and CAMBRIDGE, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI^®” (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

In August 2024, LEQEMBI was approved for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers in the United Kingdom. With this latest approval for IV maintenance dosing, after 18 months of a dosing regimen of 10 mg/kg once every two weeks patients may be transitioned to the maintenance dosing regimen of 10 mg/kg once every four weeks, or the regimen of 10 mg/kg once every two weeks may be continued.

AD is a progressive, relentless disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein in the brains of people living with AD. It is caused by a continuous underlying neurotoxic process that begins before amyloid plaque accumulation and continues after plaque removal.^1,2 The data show that amyloid-beta protofibrils and tau tangles play roles in the neurodegeneration process,^2,3 and only LEQEMBI fights AD in two ways – targeting both amyloid plaque and protofibrils**, which can impact tau downstream. Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped,^3-5 continuing maintenance treatment after the initial 18-month therapy is essential to slow the progression of AD and extend the therapeutic benefits, helping patients maintain who they are for longer.

In the United Kingdom, it is estimated that 982,000 people are living with dementia,⁶ and AD is the cause in 60-70% of people with dementia.⁷ These numbers are expected to rise, as the population ages.^6,7

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

* Apolipoprotein E is a protein involved in the metabolism of lipid in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience ARIA than people with two ApoE ε4 copies (homozygous).⁸
** Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.³ The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially slowing the progression of AD.⁴

Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (LEQEMBI); the potential benefits, safety and efficacy of LEQEMBI; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance”, “hope,” ”intend,” “may,” “objective,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would”: and other words and terms of similar meaning. Drug development and commercialisation involve a high degree of risk, and only a small number of research and development programmes result in commercialisation of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realised in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialise or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosures
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

1. Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer’s disease at Clinical Trials on Alzheimer’s Disease (CTAD) conference. Available at: https://www.eisai.co.jp/news/2022/news202285.html
2. Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer’s disease. Mol Psychiatry. 2021;26(10):5481-5503.
3. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
4. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
5. Eisai presents long-term administration data of lecanemab at the Alzheimer’s Association International Conference (AAIC) 2024. Available at: https://www.eisai.co.jp/ir/library/presentations/pdf/4523_240731_1.pdf
6. Alzheimer’s Society. 2024. The economic impact of dementia. Available at: https://www.alzheimers.org.uk/about-us/policy-and-influencing/dementia-scale-impact-numbers. Last accessed: August 2024.
7. World Health Organization. 2023. Dementia. Available at: https://www.who.int/news-room/fact-sheets/detail/dementia. Last accessed: August 2024
8. van Dyck, C.H., et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.

“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in the United Kingdom




“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in the United Kingdom

TOKYO and CAMBRIDGE, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI^®” (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

In August 2024, LEQEMBI was approved for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers in the United Kingdom. With this latest approval for IV maintenance dosing, after 18 months of a dosing regimen of 10 mg/kg once every two weeks patients may be transitioned to the maintenance dosing regimen of 10 mg/kg once every four weeks, or the regimen of 10 mg/kg once every two weeks may be continued.

AD is a progressive, relentless disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein in the brains of people living with AD. It is caused by a continuous underlying neurotoxic process that begins before amyloid plaque accumulation and continues after plaque removal.^1,2 The data show that amyloid-beta protofibrils and tau tangles play roles in the neurodegeneration process,^2,3 and only LEQEMBI fights AD in two ways – targeting both amyloid plaque and protofibrils**, which can impact tau downstream. Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped,^3-5 continuing maintenance treatment after the initial 18-month therapy is essential to slow the progression of AD and extend the therapeutic benefits, helping patients maintain who they are for longer.

In the United Kingdom, it is estimated that 982,000 people are living with dementia,⁶ and AD is the cause in 60-70% of people with dementia.⁷ These numbers are expected to rise, as the population ages.^6,7

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

* Apolipoprotein E is a protein involved in the metabolism of lipid in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience ARIA than people with two ApoE ε4 copies (homozygous).⁸
** Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.³ The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially slowing the progression of AD.⁴

Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (LEQEMBI); the potential benefits, safety and efficacy of LEQEMBI; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance”, “hope,” ”intend,” “may,” “objective,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would”: and other words and terms of similar meaning. Drug development and commercialisation involve a high degree of risk, and only a small number of research and development programmes result in commercialisation of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realised in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialise or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosures
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

1. Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer’s disease at Clinical Trials on Alzheimer’s Disease (CTAD) conference. Available at: https://www.eisai.co.jp/news/2022/news202285.html
2. Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer’s disease. Mol Psychiatry. 2021;26(10):5481-5503.
3. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
4. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
5. Eisai presents long-term administration data of lecanemab at the Alzheimer’s Association International Conference (AAIC) 2024. Available at: https://www.eisai.co.jp/ir/library/presentations/pdf/4523_240731_1.pdf
6. Alzheimer’s Society. 2024. The economic impact of dementia. Available at: https://www.alzheimers.org.uk/about-us/policy-and-influencing/dementia-scale-impact-numbers. Last accessed: August 2024.
7. World Health Organization. 2023. Dementia. Available at: https://www.who.int/news-room/fact-sheets/detail/dementia. Last accessed: August 2024
8. van Dyck, C.H., et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.

Novo Nordisk A/S: Candidate for the Board of Directors will not seek election




Novo Nordisk A/S: Candidate for the Board of Directors will not seek election

Bagsværd, Denmark, 13 November 2025 – Today, it was announced that Mikael Dolsten will not seek election to the Board of Directors at the upcoming extraordinary general meeting on 14 November 2025, as otherwise announced in the notice convening the Extraordinary General Meeting.

Earlier today, Mikael Dolsten, who most recently served as the Head of R&D at Pfizer, informed Novo Nordisk that, in spite of his desire to join, he has decided to withdraw his candidacy to the Novo Nordisk Board of Directors, both as a member and as observer, due to recent personal circumstances unrelated to Novo Nordisk A/S and the Novo Nordisk Foundation.

The Novo Nordisk Foundation and Novo Holdings A/S have informed Novo Nordisk that they will not propose the election of another candidate instead of Mikael Dolsten at the Extraordinary General Meeting. Instead, the Novo Nordisk Foundation and Novo Holdings A/S intend for the incoming Novo Nordisk Board of Directors to identify and nominate two candidates in addition to the already nominated Helena Saxon to the Board of Directors at Novo Nordisk’s Annual General Meeting on 26 March 2026. The other Board candidates standing for election at the 14 November 2025 extraordinary general meeting remain as announced in the 21 October 2025 convening notice.

If all proposed candidates are elected, the Board of Directors will, after the extraordinary general meeting on 14 November 2026, consist of Lars Rebien Sørensen (Chair), Cees de Jong (Vice Chair), Britt Meelby Jensen, Kasim Kutay and Stephan Engels (shareholder-elected Board members) and Elisabeth Dahl Christensen, Liselotte Hyveled, Mette Bøjer Jensen and Thomas Rantzau (employee-elected Board members).

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.  

Contacts for further information

Company announcement No 34 / 2025

Attachment

• CA251113- Mikael-Dolsten

Novo Nordisk A/S: Candidate for the Board of Directors will not seek election




Novo Nordisk A/S: Candidate for the Board of Directors will not seek election

Bagsværd, Denmark, 13 November 2025 – Today, it was announced that Mikael Dolsten will not seek election to the Board of Directors at the upcoming extraordinary general meeting on 14 November 2025, as otherwise announced in the notice convening the Extraordinary General Meeting.

Earlier today, Mikael Dolsten, who most recently served as the Head of R&D at Pfizer, informed Novo Nordisk that, in spite of his desire to join, he has decided to withdraw his candidacy to the Novo Nordisk Board of Directors, both as a member and as observer, due to recent personal circumstances unrelated to Novo Nordisk A/S and the Novo Nordisk Foundation.

The Novo Nordisk Foundation and Novo Holdings A/S have informed Novo Nordisk that they will not propose the election of another candidate instead of Mikael Dolsten at the Extraordinary General Meeting. Instead, the Novo Nordisk Foundation and Novo Holdings A/S intend for the incoming Novo Nordisk Board of Directors to identify and nominate two candidates in addition to the already nominated Helena Saxon to the Board of Directors at Novo Nordisk’s Annual General Meeting on 26 March 2026. The other Board candidates standing for election at the 14 November 2025 extraordinary general meeting remain as announced in the 21 October 2025 convening notice.

If all proposed candidates are elected, the Board of Directors will, after the extraordinary general meeting on 14 November 2026, consist of Lars Rebien Sørensen (Chair), Cees de Jong (Vice Chair), Britt Meelby Jensen, Kasim Kutay and Stephan Engels (shareholder-elected Board members) and Elisabeth Dahl Christensen, Liselotte Hyveled, Mette Bøjer Jensen and Thomas Rantzau (employee-elected Board members).

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.  

Contacts for further information

Company announcement No 34 / 2025

Attachment

• CA251113- Mikael-Dolsten

Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2026




Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2026

New NIAID Non-Dilutive Funding Award of up to US $40Million with US$90 Million in Pending Proposals Across Multiple Infectious Disease Programs

LIKMEZ® (ATI-1501): Building Commercial Momentum in the U.S. Through Re-Launch and Increasing Sales Growth

HALIFAX, Nova Scotia, Nov. 13, 2025 (GLOBE NEWSWIRE) — Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the second quarter of its fiscal year 2026, which ended on September 30, 2025. All figures are in Canadian dollars unless otherwise stated.

“Strategic government partnerships are foundational to Appili’s impact in infectious disease and biodefense,” said Dr. Don Cilla, President and CEO of Appili. “The recent award of up to US$40 million for VXV-01, developed in collaboration with Vitalex Biosciences, highlights the confidence the NIAID placed in our execution, and empowers us to accelerate the development of much-needed solutions for urgent public health threats as we pursue additional high-value opportunities”.

Non-Dilutive Government Funding Strategy

Appili has submitted multiple funding proposals to U.S. government and other agencies, representing a combined potential award value of approximately US$90 million. If awarded, the awards would support critical development activities, including manufacturing optimization, preclinical and non-clinical studies, regulatory activities, IND submissions, and Phase 1 clinical trials. The Company anticipates that awards from multiple proposals may be announced in the first quarter of calendar 2026.

To date, Appili and its partners have secured over US$66 million in government contracts and grants, demonstrating the strength of its non-dilutive funding model. This strategic approach leverages public sector support for high-priority anti-infective and biodefense programs, providing sustainable capital to accelerate pipeline development without diluting shareholder value. By combining these historic achievements with current proposal submissions, Appili is well-positioned to advance infectious disease and biodefense products while maintaining financial flexibility.

ATI-1801 – Topical Antiparasitic Program with an Aligned Regulatory Path

ATI-1801 is a novel topical formulation of paromomycin (15% w/w), currently in development for the treatment of cutaneous leishmaniasis, a serious and disfiguring skin disease that affects hundreds of thousands of individuals worldwide each year.

Encouraged by recent positive FDA feedback on its scientific bridging strategy, Appili is progressing ATI-1801 toward NDA submission. The Company is pursuing non-dilutive funding from global health organizations and strategic partners to accelerate the FDA-aligned development pathway, expedite regulatory filing, and provide patient access in neglected tropical disease markets.

Additionally, Appili believes that ATI-1801 may be eligible for a Priority Review Voucher (“PRV”), when approved by the FDA. PRVs have recently been monetized for amounts in excess of US$150 million.

LIKMEZ™ (ATI-1501), Commercial Momentum Building in U.S. Market

Saptalis Pharmaceuticals, Appili’s manufacturing and commercialization partner, successfully re-launched LIKMEZ^® (metronidazole oral suspension, 500 mg/5 mL) in the U.S. market, the first and only FDA-approved liquid oral formulation of metronidazole. Since the re-launch in May 2025, LIKMEZ has seen a steady increase in sales, reflecting strong demand among clinicians and patients seeking improved anti-infective therapy options.

Under the terms of the partnership with Saptalis, Appili is eligible to receive both milestone payments and ongoing royalties from the sales of LIKMEZ in the U.S., creating a growing source of commercial revenue for the Company.

ATI-1701 – Biodefense Vaccine Candidate Achieves Key Manufacturing and Scientific Milestones

ATI-1701, a live-attenuated vaccine candidate for tularemia, progressed through activities funded under the Company’s US$11.6 million Cooperative Agreement with the U.S. Air Force Academy.

During the quarter, Appili achieved a key operational milestone with the successful GMP manufacture of ATI-1701 drug substance and drug product at its contract manufacturing organization. The GMP drug product may be used in a Phase 1 clinical trial. 

In September 2025, Dr. Carl Gelhaus presented new ATI-1701 data at the NATO Chemical, Biological, Radiological and Nuclear Conference, showcasing its promise as a first-in-class tularemia vaccine for biodefense. A new peer-reviewed publication, co-authored by Dr. Gelhaus, reinforced these findings by demonstrating ATI-1701’s durable protection in primate models, further advancing its momentum as a leading biodefense candidate.

Appili has recently submitted a new application for non-dilutive funding to enable the completion of activities needed to advance ATI-1701 to IND submission with the FDA.

Appili believes that ATI-1701 will be eligible for a PRV, when approved by the FDA, subject to renewal of pending legislation in the U.S., representing the Company’s second potentially PRV-eligible asset.

VXV-01 – Collaborated Vaccine Program with Exclusive Acquisition Option and Major U.S. Funding

During the quarter, Appili entered into an agreement with Vitalex to develop and submit a proposal to advance VXV-01, Vitalex’s first-in-class, dual-antigen vaccine targeting multidrug-resistant Candida species. The National Institute of Allergy and Infectious Diseases (“NIAID’), part of the National Institutes of Health selected this proposal to award and the project is now under a U.S. government contract. The NIAID contract is valued at up to US$40 million over five years and supports development through IND-enabling activities, IND, and Phase 1 clinical studies.

VXV-01 is designed to address the urgent global need for improved fungal infection prophylaxis, especially in high-risk, immunocompromised groups, where current antifungal treatments are limited by resistance and toxicity.

Under the executed agreement with Vitalex, Appili holds an exclusive option to acquire worldwide rights to the VXV-01 program. If this option is exercised, Appili would own the rights to the product and its intellectual property, enabling control over development, commercialization, and partnering activities. Appili’s leadership on VXV-01 diversifies the diseases that Appili is addressing and exemplifies its strategy to expand with minimal upfront risk and to maximize future growth opportunity through U.S. government partnerships and exclusive acquisition rights.

Financial Results

The Company prepares its financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are in Canadian dollars unless otherwise stated.

For the three months ending September 30, 2025, the Company reported a net and comprehensive loss of $1.0 million ($0.01 per share), representing an increase of $0.3 million compared to the net loss of $0.7 million ($0.01 per share) for the same period in 2024. The higher loss was mainly driven by a $2.1 million reduction in government assistance and a $0.2 million increase in foreign exchange loss, partially offset by a $1.2 million decrease in research and development expenses, $0.7 million decrease in financing costs and a $0.1 million decrease in general and administrative expenses. As of September 30, 2025, the Company’s cash balance was $0.3 million, down from $1.2 million as of March 31, 2025.

As of September 30, 2025, the Company had 121,266,120 issued and outstanding Common Shares, 11,910,281 stock options, and 34,930,000 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the second quarter of the 2026 fiscal year and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial resistant infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

Forward looking statements
This news release contains “forward-looking statements”, including with respect to potential value of awards, timing of when awards will be announced, eligibility of ATI-1801 for a PRV, results if awards are received, . Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, (i) the risk that the Company may not secure any government funding in respect of any proposal submitted prior to the date hereof, (ii) risks relating to the ability of the Company to repay the LZH Loan and the Bloom Burton Loan as and when they become due, and (iii) those risks listed in the annual information form of the Company dated June 25, 2025, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Media Contact:
Jenna McNeil, Communications Manager
Appili Therapeutics
E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:
Don Cilla, President and CEO
Appili Therapeutics
E: Info@AppiliTherapeutics.com

Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2026




Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2026

New NIAID Non-Dilutive Funding Award of up to US $40Million with US$90 Million in Pending Proposals Across Multiple Infectious Disease Programs

LIKMEZ® (ATI-1501): Building Commercial Momentum in the U.S. Through Re-Launch and Increasing Sales Growth

HALIFAX, Nova Scotia, Nov. 13, 2025 (GLOBE NEWSWIRE) — Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the second quarter of its fiscal year 2026, which ended on September 30, 2025. All figures are in Canadian dollars unless otherwise stated.

“Strategic government partnerships are foundational to Appili’s impact in infectious disease and biodefense,” said Dr. Don Cilla, President and CEO of Appili. “The recent award of up to US$40 million for VXV-01, developed in collaboration with Vitalex Biosciences, highlights the confidence the NIAID placed in our execution, and empowers us to accelerate the development of much-needed solutions for urgent public health threats as we pursue additional high-value opportunities”.

Non-Dilutive Government Funding Strategy

Appili has submitted multiple funding proposals to U.S. government and other agencies, representing a combined potential award value of approximately US$90 million. If awarded, the awards would support critical development activities, including manufacturing optimization, preclinical and non-clinical studies, regulatory activities, IND submissions, and Phase 1 clinical trials. The Company anticipates that awards from multiple proposals may be announced in the first quarter of calendar 2026.

To date, Appili and its partners have secured over US$66 million in government contracts and grants, demonstrating the strength of its non-dilutive funding model. This strategic approach leverages public sector support for high-priority anti-infective and biodefense programs, providing sustainable capital to accelerate pipeline development without diluting shareholder value. By combining these historic achievements with current proposal submissions, Appili is well-positioned to advance infectious disease and biodefense products while maintaining financial flexibility.

ATI-1801 – Topical Antiparasitic Program with an Aligned Regulatory Path

ATI-1801 is a novel topical formulation of paromomycin (15% w/w), currently in development for the treatment of cutaneous leishmaniasis, a serious and disfiguring skin disease that affects hundreds of thousands of individuals worldwide each year.

Encouraged by recent positive FDA feedback on its scientific bridging strategy, Appili is progressing ATI-1801 toward NDA submission. The Company is pursuing non-dilutive funding from global health organizations and strategic partners to accelerate the FDA-aligned development pathway, expedite regulatory filing, and provide patient access in neglected tropical disease markets.

Additionally, Appili believes that ATI-1801 may be eligible for a Priority Review Voucher (“PRV”), when approved by the FDA. PRVs have recently been monetized for amounts in excess of US$150 million.

LIKMEZ™ (ATI-1501), Commercial Momentum Building in U.S. Market

Saptalis Pharmaceuticals, Appili’s manufacturing and commercialization partner, successfully re-launched LIKMEZ^® (metronidazole oral suspension, 500 mg/5 mL) in the U.S. market, the first and only FDA-approved liquid oral formulation of metronidazole. Since the re-launch in May 2025, LIKMEZ has seen a steady increase in sales, reflecting strong demand among clinicians and patients seeking improved anti-infective therapy options.

Under the terms of the partnership with Saptalis, Appili is eligible to receive both milestone payments and ongoing royalties from the sales of LIKMEZ in the U.S., creating a growing source of commercial revenue for the Company.

ATI-1701 – Biodefense Vaccine Candidate Achieves Key Manufacturing and Scientific Milestones

ATI-1701, a live-attenuated vaccine candidate for tularemia, progressed through activities funded under the Company’s US$11.6 million Cooperative Agreement with the U.S. Air Force Academy.

During the quarter, Appili achieved a key operational milestone with the successful GMP manufacture of ATI-1701 drug substance and drug product at its contract manufacturing organization. The GMP drug product may be used in a Phase 1 clinical trial. 

In September 2025, Dr. Carl Gelhaus presented new ATI-1701 data at the NATO Chemical, Biological, Radiological and Nuclear Conference, showcasing its promise as a first-in-class tularemia vaccine for biodefense. A new peer-reviewed publication, co-authored by Dr. Gelhaus, reinforced these findings by demonstrating ATI-1701’s durable protection in primate models, further advancing its momentum as a leading biodefense candidate.

Appili has recently submitted a new application for non-dilutive funding to enable the completion of activities needed to advance ATI-1701 to IND submission with the FDA.

Appili believes that ATI-1701 will be eligible for a PRV, when approved by the FDA, subject to renewal of pending legislation in the U.S., representing the Company’s second potentially PRV-eligible asset.

VXV-01 – Collaborated Vaccine Program with Exclusive Acquisition Option and Major U.S. Funding

During the quarter, Appili entered into an agreement with Vitalex to develop and submit a proposal to advance VXV-01, Vitalex’s first-in-class, dual-antigen vaccine targeting multidrug-resistant Candida species. The National Institute of Allergy and Infectious Diseases (“NIAID’), part of the National Institutes of Health selected this proposal to award and the project is now under a U.S. government contract. The NIAID contract is valued at up to US$40 million over five years and supports development through IND-enabling activities, IND, and Phase 1 clinical studies.

VXV-01 is designed to address the urgent global need for improved fungal infection prophylaxis, especially in high-risk, immunocompromised groups, where current antifungal treatments are limited by resistance and toxicity.

Under the executed agreement with Vitalex, Appili holds an exclusive option to acquire worldwide rights to the VXV-01 program. If this option is exercised, Appili would own the rights to the product and its intellectual property, enabling control over development, commercialization, and partnering activities. Appili’s leadership on VXV-01 diversifies the diseases that Appili is addressing and exemplifies its strategy to expand with minimal upfront risk and to maximize future growth opportunity through U.S. government partnerships and exclusive acquisition rights.

Financial Results

The Company prepares its financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are in Canadian dollars unless otherwise stated.

For the three months ending September 30, 2025, the Company reported a net and comprehensive loss of $1.0 million ($0.01 per share), representing an increase of $0.3 million compared to the net loss of $0.7 million ($0.01 per share) for the same period in 2024. The higher loss was mainly driven by a $2.1 million reduction in government assistance and a $0.2 million increase in foreign exchange loss, partially offset by a $1.2 million decrease in research and development expenses, $0.7 million decrease in financing costs and a $0.1 million decrease in general and administrative expenses. As of September 30, 2025, the Company’s cash balance was $0.3 million, down from $1.2 million as of March 31, 2025.

As of September 30, 2025, the Company had 121,266,120 issued and outstanding Common Shares, 11,910,281 stock options, and 34,930,000 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the second quarter of the 2026 fiscal year and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial resistant infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

Forward looking statements
This news release contains “forward-looking statements”, including with respect to potential value of awards, timing of when awards will be announced, eligibility of ATI-1801 for a PRV, results if awards are received, . Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, (i) the risk that the Company may not secure any government funding in respect of any proposal submitted prior to the date hereof, (ii) risks relating to the ability of the Company to repay the LZH Loan and the Bloom Burton Loan as and when they become due, and (iii) those risks listed in the annual information form of the Company dated June 25, 2025, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Media Contact:
Jenna McNeil, Communications Manager
Appili Therapeutics
E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:
Don Cilla, President and CEO
Appili Therapeutics
E: Info@AppiliTherapeutics.com

BioStem Technologies Reports Third Quarter 2025 Financial Results




BioStem Technologies Reports Third Quarter 2025 Financial Results

POMPANO BEACH, Fla., Nov. 13, 2025 (GLOBE NEWSWIRE) — BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today reported financial results for the third quarter ended September 30, 2025.

Recent Business Highlights

• Achieved 40% growth in product volume quarter-over-quarter
• Reported positive top-line randomized controlled trial results demonstrating superior outcomes with BioREtain^® Allografts in diabetic foot ulcers as published in the International Journal of Tissue Repair and submitted to CMS for consideration for inclusion in local coverage determinations (LCDs)
• Continued enrollment of subjects in the BioREtain® venous leg ulcer randomized controlled trial ahead of schedule, supporting progress toward top line read out in Q1 2026
• Established a partnership with a Service-Disabled Veteran-Owned Small Business (SDVOSB) to serve the Department of Veterans Affairs (VA) through the launch of our American Amnion product in Q4
• Secured land purchase at the Research Park at Florida Atlantic University in Boca Raton for future headquarters
• Remediated all concerns noted from FDA’s prior 2023 inspection and the associated Form 483. The FDA conducted a new 361 inspection this quarter, which was completed with no nonconformances, comments or observations
• Appointed KPMG LLP (“KPMG”) as the Company’s independent registered public accounting firm

Financial Highlights

• Reported restated financials in accordance with US GAAP accounting standards that reflect adjustments to the accounting treatment for the Company’s bona fide services fees paid to its commercial partner, Venture Medical
• Generated net revenue of $10.5 million for the third quarter 2025; revenue is now reported inclusive of the contra revenue, or net of the Bonafide Services Fees paid to Venture Medical
• Reported $0.8 million net income for the third quarter 2025, and achieved seventh consecutive quarter of positive adjusted EBITDA

“This quarter underscored the resilience of our business model, the discipline of our operations, and the strength of our team as we continued to execute through an evolving reimbursement landscape. BioStem remains well positioned financially, operationally, and clinically to lead through this transition and emerge even stronger,” said Jason Matuszewski, CEO and Chairman of the Board of BioStem. “We have taken important steps to position the company for the future, including advancing our BioREtain clinical program, expanding access through new payers and sites of care, completing our restated financial statements, and continuing to evaluate strategic acquisitions that would diversify our product portfolio and commercial channels. We continue to establish a foundation that we believe will drive market share gains and ongoing success in any future market environment.”

Third Quarter 2025 Financial Results

The following financial results are unaudited and may change pending the completion of our financial statement independent audit, including an audit of our restated financial statements which were released earlier today.

Net revenue was $10.5 million, a 43% decrease compared to Q3 2024. The decrease was primarily driven by lower volume in our wound care portfolio as a result of reimbursement uncertainty and increased competition.

Gross profit was $9.3 million, or 88.5% of net revenue, compared to $14.2 million or 77.0% of net revenue in Q3 2024. The increase reflects a product mix shift towards our products that do not carry a licensing fee in the third quarter of this year.

Operating expenses totaled $7.8 million, up from $4.9 million in Q3 2024, primarily driven by increased clinical trials activities and investments in infrastructure as the Company scales for future growth.

GAAP net income was $0.8M or $0.05 per share, compared to net income of $6.8 million or $0.42 per share in Q3 2024. 

Adjusted EBITDA for the third quarter was $2.7 million, compared to $10.4 million in Q3 2024. The decline reflects lower revenue and  gross profit, and higher operating expenses.

As of September 30, 2025, cash and cash equivalents totaled $27.2 million.

Conference Call & Webcast Information:

• Conference ID: 9695874
• North America Toll-Free: (800) 715-9871
• International Toll: +1 (646) 307-1963
• Webcast Link: https://events.q4inc.com/attendee/951812886

The live and archived webcast will be available on the BioStem Technologies website under the Investor Relations section, HERE.

About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain^® processing method. BioREtain^® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE^®, VENDAJE AC^®, VENDAJE OPTIC^®, American Amnion, and American AC. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and LinkedIn.

Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign up for the Company’s email distribution list HERE, and follow us on X and LinkedIn.

Forward-Looking Statements:

Certain statements in this press release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to expectations or forecasts of future events including with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate”, “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical fact. Forward-looking statements in this release include, among other things, statements regarding: the financial results for the third quarter 2025; the Company’s expectations regarding clinical trial results, including the anticipated timing of current and planned clinical trials; the timing of enrollment and publication of data from such trials; the anticipated commercial benefits from such clinical trials; the expectation that such trials will demonstrate the clinical superiority of the Company’s products, and the estimated addressable market growth for the Company’s products; the Company’s expectations regarding its ability to uplist to Nasdaq; the Company’s strategic initiatives; third quarter and full year 2025 projections; continued financial growth; and the market penetration of the Company’s core products.

Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the impact of any changes to the reimbursement levels for the Company’s products; significant and continuing competition, which could adversely affect the Company’s business, results of operations and financial condition; rapid technological change, which could cause the Company’s products to become outdated or obsolete, harming the Company’s ability to effectively compete; the Company’s ability to convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; the risk that the Company may be unable to successfully market is products to the end users of such products; the Company’s ability to obtain coverage of its products when, or if, the LCDs are implemented; the risk that the Company may be unable to raise capital on terms acceptable to it, or at all, which could have a material adverse impact of the Company’s business, financial condition, and prospects; the audit of the Company’s restated financial statements and the impact of any changes to the accounting treatment of the Company’s revenue and expenses; the Company’s ability to obtain financing to expand its business; the Company has incurred significant losses since inception and may incur losses in the future; the impact of any changes in applicable laws or regulations; the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and the possibility that the Company may be adversely affected by other general economic, business, and/or competitive factors. There may be additional risks about which the Company is presently unaware of or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company undertakes no duty to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact BioStem Technologies, Inc.:
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies
Phone: 954-380-8342

Investor Relations:
Philip Trip Taylor, Gilmartin Group
ir@biostemtech.com

Non-GAAP Financial Measures:

Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA, which we calculate as net income less interest, taxes, depreciation and amortization and share-based compensation expense, to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA helps identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

The following is a reconciliation of GAAP net income (loss) to non-GAAP EBITDA and non-GAAP Adjusted EBITDA for each of the periods presented:

BioStem Technologies Reports Third Quarter 2025 Financial Results




BioStem Technologies Reports Third Quarter 2025 Financial Results

POMPANO BEACH, Fla., Nov. 13, 2025 (GLOBE NEWSWIRE) — BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today reported financial results for the third quarter ended September 30, 2025.

Recent Business Highlights

• Achieved 40% growth in product volume quarter-over-quarter
• Reported positive top-line randomized controlled trial results demonstrating superior outcomes with BioREtain^® Allografts in diabetic foot ulcers as published in the International Journal of Tissue Repair and submitted to CMS for consideration for inclusion in local coverage determinations (LCDs)
• Continued enrollment of subjects in the BioREtain® venous leg ulcer randomized controlled trial ahead of schedule, supporting progress toward top line read out in Q1 2026
• Established a partnership with a Service-Disabled Veteran-Owned Small Business (SDVOSB) to serve the Department of Veterans Affairs (VA) through the launch of our American Amnion product in Q4
• Secured land purchase at the Research Park at Florida Atlantic University in Boca Raton for future headquarters
• Remediated all concerns noted from FDA’s prior 2023 inspection and the associated Form 483. The FDA conducted a new 361 inspection this quarter, which was completed with no nonconformances, comments or observations
• Appointed KPMG LLP (“KPMG”) as the Company’s independent registered public accounting firm

Financial Highlights

• Reported restated financials in accordance with US GAAP accounting standards that reflect adjustments to the accounting treatment for the Company’s bona fide services fees paid to its commercial partner, Venture Medical
• Generated net revenue of $10.5 million for the third quarter 2025; revenue is now reported inclusive of the contra revenue, or net of the Bonafide Services Fees paid to Venture Medical
• Reported $0.8 million net income for the third quarter 2025, and achieved seventh consecutive quarter of positive adjusted EBITDA

“This quarter underscored the resilience of our business model, the discipline of our operations, and the strength of our team as we continued to execute through an evolving reimbursement landscape. BioStem remains well positioned financially, operationally, and clinically to lead through this transition and emerge even stronger,” said Jason Matuszewski, CEO and Chairman of the Board of BioStem. “We have taken important steps to position the company for the future, including advancing our BioREtain clinical program, expanding access through new payers and sites of care, completing our restated financial statements, and continuing to evaluate strategic acquisitions that would diversify our product portfolio and commercial channels. We continue to establish a foundation that we believe will drive market share gains and ongoing success in any future market environment.”

Third Quarter 2025 Financial Results

The following financial results are unaudited and may change pending the completion of our financial statement independent audit, including an audit of our restated financial statements which were released earlier today.

Net revenue was $10.5 million, a 43% decrease compared to Q3 2024. The decrease was primarily driven by lower volume in our wound care portfolio as a result of reimbursement uncertainty and increased competition.

Gross profit was $9.3 million, or 88.5% of net revenue, compared to $14.2 million or 77.0% of net revenue in Q3 2024. The increase reflects a product mix shift towards our products that do not carry a licensing fee in the third quarter of this year.

Operating expenses totaled $7.8 million, up from $4.9 million in Q3 2024, primarily driven by increased clinical trials activities and investments in infrastructure as the Company scales for future growth.

GAAP net income was $0.8M or $0.05 per share, compared to net income of $6.8 million or $0.42 per share in Q3 2024. 

Adjusted EBITDA for the third quarter was $2.7 million, compared to $10.4 million in Q3 2024. The decline reflects lower revenue and  gross profit, and higher operating expenses.

As of September 30, 2025, cash and cash equivalents totaled $27.2 million.

Conference Call & Webcast Information:

• Conference ID: 9695874
• North America Toll-Free: (800) 715-9871
• International Toll: +1 (646) 307-1963
• Webcast Link: https://events.q4inc.com/attendee/951812886

The live and archived webcast will be available on the BioStem Technologies website under the Investor Relations section, HERE.

About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain^® processing method. BioREtain^® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE^®, VENDAJE AC^®, VENDAJE OPTIC^®, American Amnion, and American AC. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and LinkedIn.

Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign up for the Company’s email distribution list HERE, and follow us on X and LinkedIn.

Forward-Looking Statements:

Certain statements in this press release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to expectations or forecasts of future events including with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate”, “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical fact. Forward-looking statements in this release include, among other things, statements regarding: the financial results for the third quarter 2025; the Company’s expectations regarding clinical trial results, including the anticipated timing of current and planned clinical trials; the timing of enrollment and publication of data from such trials; the anticipated commercial benefits from such clinical trials; the expectation that such trials will demonstrate the clinical superiority of the Company’s products, and the estimated addressable market growth for the Company’s products; the Company’s expectations regarding its ability to uplist to Nasdaq; the Company’s strategic initiatives; third quarter and full year 2025 projections; continued financial growth; and the market penetration of the Company’s core products.

Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the impact of any changes to the reimbursement levels for the Company’s products; significant and continuing competition, which could adversely affect the Company’s business, results of operations and financial condition; rapid technological change, which could cause the Company’s products to become outdated or obsolete, harming the Company’s ability to effectively compete; the Company’s ability to convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; the risk that the Company may be unable to successfully market is products to the end users of such products; the Company’s ability to obtain coverage of its products when, or if, the LCDs are implemented; the risk that the Company may be unable to raise capital on terms acceptable to it, or at all, which could have a material adverse impact of the Company’s business, financial condition, and prospects; the audit of the Company’s restated financial statements and the impact of any changes to the accounting treatment of the Company’s revenue and expenses; the Company’s ability to obtain financing to expand its business; the Company has incurred significant losses since inception and may incur losses in the future; the impact of any changes in applicable laws or regulations; the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and the possibility that the Company may be adversely affected by other general economic, business, and/or competitive factors. There may be additional risks about which the Company is presently unaware of or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company undertakes no duty to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact BioStem Technologies, Inc.:
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies
Phone: 954-380-8342

Investor Relations:
Philip Trip Taylor, Gilmartin Group
ir@biostemtech.com

Non-GAAP Financial Measures:

Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA, which we calculate as net income less interest, taxes, depreciation and amortization and share-based compensation expense, to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA helps identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

The following is a reconciliation of GAAP net income (loss) to non-GAAP EBITDA and non-GAAP Adjusted EBITDA for each of the periods presented:

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.