On August 18, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy (Press release, Iovance Biotherapeutics, AUG 18, 2025, View Source [SID1234655338]). Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, and who have no satisfactory alternative treatment options.

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"This approval in Canada is our first marketing authorization outside the U.S. and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. "We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-U.S. strategy for Amtagvi in additional markets."

Market authorization in Canada under the NOC/c guidance was granted based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable. The market authorization is conditional, pending the results of trials to confirm its clinical benefit.

About the C-144-01 Clinical Trial
C-144-01 is a global, multicenter Phase 2 study in which patients received treatment with lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation‑positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR), and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025.

Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor types.

On August 15, 2025 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported that the US Food and Drug Administration (FDA) has approved PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted PAPZIMEOS full approval, which does not require a confirmatory clinical trial. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. PAPZIMEOS is delivered via four subcutaneous injections over a 12-week interval.

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RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. Management of RRP has primarily consisted of repeated surgeries, which do not address the root cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden.

"For more than a century, since RRP was first recognized as a distinct disease, patients have had to rely on repeated surgeries to manage this relentless condition. Today marks a historic turning point. With the landmark FDA approval of PAPZIMEOS and broad label, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease," said Helen Sabzevari, PhD, President and CEO of Precigen. "This milestone affirms the power of our AdenoVerse platform and the exceptional capabilities of our team to rapidly advance a wholly novel therapy from discovery to approval considerably faster than industry benchmarks. We are profoundly grateful to the NIH clinicians, the FDA, and—most importantly—the patients and families who made this breakthrough possible. We look forward to swiftly delivering PAPZIMEOS to the RRP community and ushering in a new era of treatment that targets the underlying cause of the disease rather than just managing its symptoms."

"This long-awaited FDA approval represents a momentous milestone for the RRP community," said Kim McClellan, President of the Recurrent Respiratory Papillomatosis Foundation. "For the first time, adult patients with RRP have access to an FDA-approved therapy that offers the potential to reduce—or even eliminate—endless repeated surgeries. This breakthrough brings long-overdue hope to patients and families who have endured so much. We are deeply grateful to the teams at Precigen and the NIH, and above all, to the patients and caregivers whose courage, advocacy, and perseverance have made this historic moment possible."

The approval is supported by data from the open-label, single-arm, pivotal study in adult patients with RRP:

The pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints.
51% (18 out of 35) of study patients achieved Complete Response, requiring no surgeries in the 12 months after treatment with PAPZIMEOS. These Complete Responses remained durable for over 12 months. Of the 18 patients with a Complete Response in the ongoing study, 15 patients evaluated at 24 months demonstrated continued Complete Response.
PAPZIMEOS was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.
PAPZIMEOS induced HPV 6/11-specific T cell responses in RRP study patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders.
The pivotal study was led by lead investigators, Clint T. Allen, MD, and Scott M. Norberg, DO, at the National Institutes of Health. Pivotal data were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and published in The Lancet Respiratory Medicine.

Precigen will begin promoting PAPZIMEOS immediately and is committed to helping patients with RRP access the therapy. Precigen has established Papzimeos SUPPORT, a comprehensive patient support program offering personalized services, including insurance navigation, financial assistance, and ongoing access support, which can be accessed by calling 866-827-8180. Healthcare professionals interested in learning more about PAPZIMEOS or accessing provider support services are encouraged to visit www.PAPZIMEOS.com.

Conference Call
The Company will host a conference call on Monday, August 18 at 8:00 AM ET to provide additional details regarding the approval, including key aspects of the label and commercialization. Event details can be found on Precigen’s website in the Events & Presentations section at investors.precigen.com/events-presentations.

About RRP
RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airway, and recurrent post-obstructive pneumonias. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. Management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. As the number of lifetime surgeries increases, the risk for irreversible iatrogenic laryngeal injury increases with each surgery, and patients may undergo hundreds of these surgeries over their lifetimes. RRP can impact patients’ work and social lives, financial stability, and mental health. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US.

About PAPZIMEOS (zopapogene imadenovec-drba), for subcutaneous injection only
PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first and only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen’s labs using Precigen’s proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP.

Indication and Important Safety Information

What is PAPZIMEOS?
PAPZIMEOS is a type of immunotherapy used to treat a condition called recurrent respiratory papillomatosis (RRP) in adults.

What is the most important information I should know about PAPZIMEOS?
Some people may have a reaction to the shot. Signs and symptoms may include redness, pain, swelling, itching, or warmth where the shot was given. After your first treatment, your healthcare provider will watch you for at least 30 minutes to make sure you’re feeling okay.

Please contact your doctor immediately if you develop an infection, the reaction to your shot worsens, or you experience any of the below symptoms, which may indicate a systemic allergic reaction:

Difficulty breathing
Widespread rash
Facial swelling
Thrombotic events (blood clots that block your blood vessels) may occur after your PAPZIMEOS shot. Please notify your doctor immediately if you have the following symptoms:

Shortness of breath
Chest pain
Leg swelling
Persistent abdominal pain
Severe or persistent headaches
Blurred vision
What should I know before taking PAPZIMEOS?
Before taking PAPZIMEOS, tell your healthcare provider about all of your medical conditions, including:

If you are pregnant or plan to become pregnant because it is not known if PAPZIMEOS will harm the unborn baby.
If you are breastfeeding or plan to breastfeed. It is unknown if PAPZIMEOS is present in breast milk, or how it affects the breastfeeding child or milk production. Talk to your healthcare provider about the best way to feed your baby during treatment with PAPZIMEOS.
What are the most common side effects of PAPZIMEOS?
The most common side effects include:

Pain, redness, or swelling where the shot was given
Feeling tired
Chills
Fever
Muscle aches
Nausea (feeling sick)
Headache
Increased heart rate
Diarrhea
Vomiting
Sweating a lot
These are not all of the possible side effects of PAPZIMEOS. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777).

(Press release, Precigen, AUG 15, 2025, View Source [SID1234662311])

On August 15, 2025 CStone Pharmaceauticals reported Interim Results.

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(Presentation, CStone Pharmaceauticals, AUG 15, 2025, View Source [SID1234661764])

On August 15, 2025 Asta Bio and Alpha Nuclide reported that it will combine expertise in targeted alpha radiotherapy and radionuclide manufacturing to accelerate the discovery and development of novel cancer treatments (Press release, Asta Bio, AUG 15, 2025, View Source [SID1234656370]).

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BOSTON, Aug. 15, 2025 /PRNewswire-PRWeb/ — Asta Bio, a biopharmaceutical company developing next-generation targeted alpha radiotherapies, reported a discovery and development partnership with Alpha Nuclide, a leading provider of specialized radionuclide manufacturing and radiopharmaceutical supply chain solutions.

Under the agreement, Alpha Nuclide will support Asta Bio on clinical translation of Asta Bio’s pipeline through coordinated efforts in discovery research and drug product manufacturing for preclinical and clinical studies. The collaboration is designed to ensure accelerated entry into human trials for Asta Bio’s lead 211-Astatine-RadiobodyTM drug candidates targeting solid tumors. This collaboration is part of Alpha Nuclide’s broader mission to provide logistical solutions to enable drug developers worldwide to bring targeted alpha therapies into the clinic and accelerate their discoveries.

"We are honored to partner with Alpha Nuclide, whose team has the deepest technical expertise and track record in 211-Astatine radionuclide production and chemistry and makes them an ideal collaborator for advancing our programs" said Ahmad-Reza Saadat, Co-Founder and CEO of Asta Bio. "This collaboration is a critical step toward bringing our 211-Astatine-Radiobody therapies to patients and ensuring that we can scale production and delivery as we move into clinical development."

Alpha Nuclide brings specialized experience in the production, purification, and delivery of alpha-emitting isotopes, including 211-Astatine, which must be manufactured with precision and coordinated timing for clinical use. The company will provide key infrastructure to support radioisotope supply chain logistics, contract preclinical research services, GMP compliance, and study coordination with clinical sites.

"We are excited to collaborate with Asta Bio as they pioneer a new generation of targeted alpha therapies" said Dr. Yutian Feng, CEO of Alpha Nuclide. "Their Radiobody platform represents a truly novel way to harness the power of 211-Astatine, and we are committed to supporting their mission to improve outcomes for patients with aggressive cancers."

The collaboration between Asta Bio and Alpha Nuclide will support preclinical studies and clinical readiness for the first human trials.

On August 15, 2025 The Board of Directors of Xspray Pharma AB (publ) ("Xspray", "Xspray Pharma" or the "Company") reported, by virtue of the authorization from the annual general meeting held on 13 May 2025, resolved to carry out a new issue of shares of approximately SEK 130 million, with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Xspray, AUG 15, 2025, View Source [SID1234655395]). The Rights Issue could be increased with up to SEK 20 million as an over-allotment issue (the "Over-allotment Issue"). The Company has received subscription undertakings and an intention to subscribe for shares of approximately SEK 89 million from its largest shareholders and a new institutional investor (the "Institutional Investor"). Furthermore, the Company has refinanced its existing loan, whereby Fenja Capital II A/S ("Fenja", the "Lender") takes over the entire loan with an extended maturity of 18 months and an increase of the loan with SEK 25 million (the "Refinancing", and together with the Rights Issue, the "Financing"). As part of the Refinancing, the Board of Directors of Xspray will issue warrants to the Lender following the outcome of the Rights Issue. As a result of the Financing, the Company is bringing forward its interim report, which will be published today, 15 August 2025, at 08:00 CEST.

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Summary of the Rights Issue and Over-allotment Issue

The Board of Directors of Xspray has resolved to carry out a new issue of shares of approximately SEK 130 million, with preferential rights for the Company’s existing shareholders. The Rights Issue could be increased with up to SEK 20 million through the Over-allotment Issue, mainly to accommodate the external interest from the Institutional Investor but also in the Board of Directors’ sole discretion. Following allocation to the Institutional Investor, if necessary, in the Over-allotment Issue, the remaining shares in the Overallotment Issue shall be allocated to strategic and/or qualified investors.
The Financing is carried out to support the launch of Dasynoc in the U.S. market, to advance the regulatory FDA process and sales readiness for XS003-nilotinib, to finance the continued development of the project portfolio, and to secure the Company’s funding through to the expected cash flow break-even point in the second half of 2026. The Company’s capital requirements depend on several factors, including the launch date of Dasynoc, as well as market uptake.
The Rights Issue is covered to approximately 60 percent by subscription undertakings from, among others, Flerie, Ribbskottet, the Fourth AP fund, the Third AP fund, the Second AP fund and the Institutional Investor and to 8 percent by a declaration of intent to subscribe for shares from Unionen. The Institutional Investor’s commitment to subscribe for shares amounts to SEK 10 million without preferential rights in the Rights Issue. Should the Institutional Investor not receive full allocation in the Rights Issue, it shall receive sufficient allocation in the Over-allotment Issue to ensure that it receives full allocation. In total, subscription undertakings and the intention to subscribe for shares amount to approximately 68percent of the Rights Issue.
For each existing share held on the record date of 22 August 2025, one (1) subscription right is received. Ten (10) subscription rights entitle to subscription of one (1) new share, corresponding to a subscription ratio of 1:10.
The subscription price in the Rights Issue of SEK 35 per share corresponds to a discount of approximately 27 percent compared to the theoretical price (so called TERP – theoretical ex-rights price) based on the closing price of Xspray’s share on Nasdaq Stockholm on 14 August 2025.
The subscription period in the Rights Issue is expected to run from 26 August 2025 up to and including 9 September 2025.

Summary of the Refinancing

The Company’s has refinanced its existing loan of SEK 100 million, whereby Fenja takes over the entire loan previously held by both Fenja and Buntel AB. As part of the Refinancing, the maturity has been extended 18 months from the date of the Refinancing and the loan has been increased with SEK 25 million. Furthermore, the Company will issue new warrants to Fenja equaling in total 2.5 percent dilution of the shares in the Company immediately following the Rights Issue.

Xspray’s CEO Per Andersson comments: "This proposed step in our financing plan will secure our financing needs for the upcoming product launch and commercialization of Dasynoc upon FDA market approval, as well as continued development of XS003-nilotinib and other product candidates in our portfolio. I would like to again express my gratitude to the many shareholders and investors who, through their commitments in connection with the rights issue, demonstrate continued confidence in our commercialization plan."

Background and reasons
Xspray Pharma is a pharmaceutical company with multiple product candidates in clinical development. Xspray uses its patented HyNap technology to develop improved versions of marketed protein kinase inhibitors ("PKI"), known as original drugs, for the treatment of cancer. The segment is the largest in the field of oncology and drug prices are typically high.

Xspray’s technology platform is used to create a project portfolio of cancer products based on amorphous formulations (HyNap) of selected drugs where the original drug contains a poorly soluble crystalline drug substance. Xspray’s overall strategy is to apply its technology to develop and commercialize its own project portfolio consisting of carefully selected product candidates. The Company selects product candidates for further development and potential future launch by thoroughly reviewing, among other things, the original drug’s patent situation, pricing, market size, competitive landscape and improvement potential.

Xspray’s announced product candidates Dasynoc, XS003, XS008, and XS025 are being developed as improved versions of Sprycel (dasatinib), Tasigna (nilotinib), Inlyta (axitinib) and Cabometyx (cabozantinib). The Company is preparing to launch its first product candidate, Dasynoc, which could be approved by the FDA in the second half of 2025. With its first four product candidates, Xspray is targeting original drugs that together sold for USD 4.9 billion in the US alone in 2024.1 When the primary patents for the original drugs expire, the Company believes that its patented HyNap technology will enable Xspray to introduce its product candidates to the market in parallel with the originator drugs, with or without generic competition.

In August 2025, Xspray announced a licensing agreement with Handa Therapeutics, relating to a dasatinib product. This was the first licensing agreement signed by the Company. Further licensing agreements will be considered on a case-by-case basis as a complementary business model.

Use of proceeds from the Financing
The Financing is carried out to support the launch of Dasynoc in the U.S. market, to advance the regulatory FDA process and sales readiness for XS003-nilotinib, to finance the continued development of the project portfolio, and to secure the Company’s funding through to the expected cash flow break-even point in the second half of 2026. The Company’s capital requirements depend on several factors, including the launch date of Dasynoc, as well as market uptake.

Terms of the Rights Issue
The Board has resolved on the Rights Issue by virtue of the authorization from the annual general meeting held on 13 May 2025. Those who are registered as shareholders in the share register of Xspray on the record date 22 August 2025 have preferential rights to subscribe for new shares in Xspray in relation to their current shareholding in the Company. Shareholders receive one (1) subscription right for each share held in the Company. The subscription rights entitle the holder to subscribe for new shares in the Rights Issue, whereby ten (10) subscription rights entitle the shareholder the right to subscribe for one (1) new share. In addition, investors are offered the possibility to apply for subscription of shares without subscription rights.

If all of the shares in the Rights Issue are not subscribed for by virtue of subscription rights, the Board of Directors shall resolve on the allocation of shares which have not been subscribed for by virtue of subscription rights. In such case, shares shall: (i) firstly be allocated to those who have applied for subscription and subscribed for new shares by virtue of subscription rights, regardless if the subscriber was a shareholder on the record date or not, and in the event of oversubscription, in relation to the number of subscription rights each have exercised for subscription of new shares, and, to the extent that this is not possible, by drawing lots, and (ii) secondly, shares are allocated to others whom have applied for subscription of shares without exercising subscription rights, and in the event of oversubscription, in relation to the number of new shares specified in the subscription application, and, to the extent that this is not possible, by drawing lots.
The subscription price in the Rights Issue is SEK 35 per share. Provided that the Rights Issue is fully subscribed, Xspray will receive issue proceeds of approximately SEK 130 million before deduction of transaction costs. Provided that the Rights Issue is fully subscribed, the number of shares will increase by 3,713,849 shares, from 37,138,491 shares to 40,852,340 shares and the share capital will increase by SEK 3,713,849, from SEK 37,138,491 to SEK 40,852,340. Shareholders who choose not to participate in the Rights Issue will through the Rights Issue have their ownership share diluted by up to approximately 9.1 percent (based on the total maximum amount of shares after the Rights Issue but excluding any shares issued as part of the Over-allotment Issue). These shareholders may have an opportunity to compensate themselves financially for the dilution effect by selling their subscription rights received.

Full terms of the Rights Issue and information about the Company will be presented in a disclosure document in accordance with Article 1.4 db of the Regulation (EU) 2017/1129 of the European Parliament and of the Council (the "Prospectus Regulation"). The disclosure document, prepared in accordance with Annex IX to the Prospectus Regulation, is expected to be published on or around 25 August 2025.

Over-allotment Issue
In addition to the Rights Issue, the Board may resolve on the Over-allotment Issue by virtue of the authorization from the annual general meeting held on 13 May 2025 as a directed share issue. The Over-allotment Issue amounts to a maximum of SEK 20 million. In case the Over-allotment Issue is fully exercised, the total proceeds, including the Rights Issue, will amount to approximately SEK 150 million before deduction of transaction costs.

The Institutional Investor has committed to subscribe for shares without preferential rights in the Rights Issue corresponding to a total amount of SEK 10 million, without remuneration. The Over-allotment Issue will be exercised in case the Rights Issue is subscribed to such an extent that the Institutional Investor will not be allocated their full commitment of SEK 10 million in the Rights Issue. The Institutional Investor’s subscription in the Over-allotment Issue will thereby be determined by the difference between its total commitment of SEK 10 million and its actual subscription in the Rights Issue, meaning that the Institutional Investor’s total commitment within the Rights Issue and Over-allotment Issue will be SEK 10 million. The Board of Directors may also, in their sole discretion, exercise the remaining part of the Over-allotment Issue to enable additional capital contributions. Following allocation, if any, to the Institutional Investor in the Over-allotment Issue, the remaining shares in the Overallotment Issue shall be allocated to strategic and/or qualified investors. The subscription price in the Over-allotment Issue will be SEK 35 per share.

Terms of the Refinancing
The Company has refinanced its existing loan of SEK 100 million, whereby Fenja takes over the entire loan previously held by both Fenja and Buntel AB. As part of the Refinancing, the maturity has been extended 18 months from the date of the Refinancing and the loan has been increased with SEK 25 million. The loan is unsecured.

The Refinancing includes an arrangement fee of 4 percent and bears an annual interest rate at STIBOR 3M (however minimum 3 percent) plus an interest margin of 8 percent. Furthermore, the Company will issue new warrants free of charge, equaling in total 2.5 percent dilution of the shares in the Company immediately following the Rights Issue. Assuming that the Rights Issue is fully subscribed, the Company would issue 1,047,495 warrants to Fenja. The warrants can be exercised to subscribe for the equivalent number of shares in the Company from and including the day of registration of the warrants with the Swedish Companies Registration Office and up to and including 30 November 2029, at a subscription price of SEK 50 per share from registration with the Swedish Companies Registration Office up to and including 6 November 2025, as well as from and including 7 November 2025 at a subscription price of SEK 60. The warrants will not be re-calculated as a result of the Rights Issue but are otherwise subject to customary re-calculation provisions. The Board of Directors will issue the warrants by virtue of the authorization from the annual general meeting held on 13 May 2025.

Subscription undertakings and subscription intentions in the Rights Issue
Flerie, Ribbskottet, the Fourth AP fund, the Third AP fund, the Second AP fund, the Institutional Investor and other investors have undertaken to subscribe for shares corresponding to approximately 60 percent of the Rights Issue. Unionen has submitted a declaration of intent for subscription of shares in the Rights Issue, covering approximately 8 percent of the Rights Issue. The Institutional Investor’s commitment to subscribe for shares amounts to SEK 10 million without preferential rights in the Rights Issue. Should the Institutional Investor not receive full allocation in the Rights Issue, it shall receive sufficient allocation in the Over-allotment Issue to ensure that it receives full allocation. In total, these subscription undertakings and the intention represent approximately 68 percent of the Rights Issue, corresponding to approximately SEK 89 million.

The subscription undertakings are not secured by bank guarantees, blocked funds, pledging, or similar arrangements.

Lock-up undertakings
Prior to the execution of the Rights Issue, all shareholding members of the Board of Directors and senior executives of the Company have towards Zonda Partners undertaken, subject to certain customary exceptions, not to sell shares in the Company for a period of 90 days from the day after the outcome of the Rights Issue has been announced, a so-called lock-up undertaking.

Furthermore, the Company has undertaken towards Zonda Partners, subject to customary exceptions and except for the issue of warrants to the Lender, not to issue additional shares or other share-related instruments for a period of 90 days from the day after the outcome of the Rights Issue has been announced.