Alligator Bioscience carries out a rights issue of units of approximately SEK 120 million and raises bridge loans

On October 22, 2025 The Board of Directors of Alligator Bioscience AB ("Alligator Bioscience" or the "Company") reported, subject to approval by an extraordinary general meeting on 25 November 2025, resolved to carry out an issue of ordinary shares and warrants ("units") with preferential rights for the Company’s existing shareholders of initially approximately SEK 120 million (the "Rights Issue"). The Company has received subscription undertakings and subscription intentions amounting to a total of approximately SEK 6 million, corresponding to approximately 5 percent of the Rights Issue. Furthermore, the Company has received guarantee commitments amounting to a total of approximately SEK 72 million, corresponding to approximately 60 percent of the Rights Issue, which in total is covered by subscription undertakings, subscription intentions and guarantee commitments of approximately SEK 78 million, corresponding up to approximately 65 percent of the Rights Issue. Alligator Bioscience intends to use the proceeds from the Rights Issue, after repayment of the bridge loans and part of the outstanding loan that Alligator Bioscience raised from Fenja Capital II A/S ("Fenja Capital") in 2024, to support the ongoing process to secure a partnership for mitazalimab as well as for furthering other pipeline projects and general corporate purposes. The Rights Issue is subject to approval by an extraordinary general meeting on 25 November 2025. The notice of the extraordinary general meeting will be announced in a separate press release. To secure the Company’s liquidity needs until the completion of the Rights Issue, the Company has entered into bridge loan agreements of SEK 17 million in total on market terms. In connection with the Rights Issue, Alligator Bioscience has also renegotiated the outstanding loan from Fenja Capital. As part of the renegotiation, Alligator Bioscience has undertaken to issue warrants to Fenja Capital, free of charge.

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Summary
• The Rights Issue includes units and will initially, if fully subscribed, provide Alligator Bioscience with approximately SEK 120 million before issue costs. Each unit consists of two (2) ordinary shares and one (1) warrant series TO 14. The warrants series TO 14 are intended to be admitted to trading on Nasdaq Stockholm.
• One (1) warrant series TO 14 entitles the holder to subscription of one (1) ordinary share in the Company during the period from and including 5 March 2026 up to and including 19 March 2026. Thus, the Company may receive additional proceeds in March 2026 if the warrants series TO 14 are exercised for subscription of new ordinary shares.
• The exercise price for the warrants series TO 14 shall correspond to 70 percent of the volume-weighted average price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 10 February 2026 up to and including 27 February 2026, however not lower than the quota value of the share and not higher than 125 percent of the subscription price per ordinary share in the Rights Issue.
• Final terms of the Rights Issue, including subscription price, increase of the share capital and number of ordinary shares and warrants issued, are intended to be published no later than 24 November 2025. The subscription price for each unit is intended to be set based on a discount to TERP (theoretical share price after separation of unit rights) of approximately 35 percent based on the volume-weighted average share price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 18 November 2025 up to and including 24 November 2025, however not less than the new quota value of the share subject to resolution by the extraordinary general meeting on 25 November 2025 (i.e. SEK 0.20) and not more than SEK 1.89, multiplied by two (2) (the "Subscription Price").
• The Rights Issue is covered to approximately 5 percent by subscription undertakings and subscription intentions, and to approximately 60 percent by guarantee commitments, corresponding to a total of approximately 65 percent of the Rights Issue in total.
• Provided that the Rights Issue is approved by the extraordinary general meeting on 25 November 2025, the record date for the Rights Issue will be 2 December 2025, and the subscription period will run from and including 4 December 2025 up to and including 18 December 2025.
• The last day of trading in the Company’s shares including right to receive unit rights in the Rights Issue is 28 November 2025 and the first day of trading in the Company’s shares without the right to receive unit rights in the Rights Issue is 1 December 2025.
• Trading in unit rights will take place on Nasdaq Stockholm from and including 4 December 2025 up to and including 15 December 2025.
• To secure the Company’s liquidity needs until the completion of the Rights Issue, the Company has entered into bridge loan agreements of SEK 17 million in total on market terms.
• In connection with the Rights Issue, Alligator Bioscience has renegotiated the outstanding loan raised in 2024 from Fenja Capital.
• The Company intends to publish a prospectus regarding the Rights Issue around 28 November 2025 (the "Prospectus").

Søren Bregenholt, CEO of Alligator Bioscience, comments:
"The upcoming Rights Issue and the renegotiated loan agreement with Fenja Capital will provide Alligator Bioscience with 6–9 months of additional financial runway in 2026. This will enable us to continue advancing mitazalimab towards Phase 3 development, progress our broader pipeline, and pursue our ongoing business development activities. In a challenging market environment, we remain appreciative of the continued trust and support shown by our shareholders."
Background and reason for the Rights Issue
Alligator Bioscience is a research-based biotechnology company developing antibody-based pharmaceuticals for cancer treatment. The Company specializes in the development of tumor-directed immunotherapies, in particular agonistic mono- and bispecific antibodies. In immunotherapy, the patients’ immune system is activated to cure cancer. The term tumor-directed means that the drug is administered or designed such that the pharmacological effect is localized to the tumor. This results in an advantageous efficacy and safety profile.

The clinical drug candidate mitazalimab (previously ADC-1013) is an agonistic, or stimulatory, antibody that targets CD40, a receptor on the dendritic cells of the immune system, which are the cells that detect enemies such as cancer cells. In preclinical experimental models, mitazalimab has been shown to induce a potent tumor-targeted immune response and provide long-lasting tumor immunity. In addition, preclinical data have demonstrated how mitazalimab can be used against multiple types of cancer. The study OPTIMIZE-1 is an open-label, multi-center trial assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFOLFIRINOX) in patients with first line metastatic pancreatic cancer. The trial was initiated in Q3 2021, and top line data was announced on 29 January 2024 showing that the trial met the primary endpoint. On 22 September 2025, the Company announced final 30-month data. The final readout confirms data maturity, demonstrating both primary and secondary efficacy endpoints that compare favorably with historical controls. As previously reported, the objective response rate (ORR) was 54.4 percent (42.1 percent confirmed). The median duration of response was 12.6 months, with a median progression-free survival (PFS) of 7.8 months. Median OS reached 14.9 months, with OS rates of 58 percent, 37 percent, 26 percent, and 21 percent at 12, 18, 24, and 30 months, respectively—an unprecedented outcome in this hard-to-treat cancer. These results underscore a durable benefit, with a meaningful proportion of patients achieving long-term survival beyond two years. These results further strengthen the rationale for advancing mitazalimab into a pivotal Phase 3 trial in metastatic pancreatic cancer together with a partner.

Given the capital needs that the Company’s development and commercialization plans give rise to, Alligator Bioscience assesses that its existing working capital is not sufficient to cover the Company’s capital needs. To ensure continued successful progress in accordance with the Company’s business plan and strategy, including the ongoing process to secure a partnership for mitazalimab and further develop other pipeline projects, the Board of Directors has decided to carry out the Rights Issue.

Upon full subscription in the Rights Issue, the Company will initially receive approximately SEK 120 million before issue costs. The costs related to the Rights Issue are estimated at full subscription, to amount to a maximum of approximately SEK 17 million, of which approximately SEK 9 million is attributable to guarantee compensation (provided that all guarantors choose to receive the compensation in cash). The expected net proceeds from the Rights Issue are thus estimated to amount to approximately SEK 103 million. The net proceeds from the Rights Issue, after repayment of the bridge loans and part of the loan that Alligator Bioscience raised from Fenja Capital in 2024 (as detailed below), are intended to support the ongoing process to secure a partnership for mitazalimab as well as for furthering other pipeline projects and general corporate purposes.

In March 2026, the Company may receive additional proceeds if the warrants series TO 14 issued in the Rights Issue are exercised for subscription of new ordinary shares. The net proceeds from the exercise of warrants series TO 14 are intended to be used with up to 50 percent of the part exceeding SEK 6 million to repay the outstanding loan from Fenja Capital (as detailed below) and the remaining part as working capital for the Company.

Terms of the Rights Issue
The Board of Directors has today, subject to the approval by the extraordinary general meeting on 25 November 2025, resolved on an issue of units consisting of ordinary shares and warrants series TO 14, with preferential rights for existing shareholders. Through the Rights Issue, Alligator Bioscience may receive initial issue proceeds of approximately SEK 120 million, excluding the additional proceeds that may be received upon exercise of the warrants series TO 14 that are issued in the Rights Issue. Those who are registered as shareholders in the Company on the record date 2 December 2025 are entitled to subscribe for units with preferential rights.

Final terms of the Rights Issue, including Subscription Price, increase of the share capital and number of ordinary shares and warrants issued, are intended to be published no later than 24 November 2025. Each unit consists of two (2) ordinary shares and one (1) warrant series TO 14. The warrants series TO 14 are issued free of charge. The Subscription Price is intended to be set based on a discount to TERP (theoretical share price after separation of unit rights) of approximately 35 percent based on the volume-weighted average share price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 18 November 2025 up to and including 24 November 2025, however not less than the new quota value of the share subject to resolution by the extraordinary general meeting on 25 November 2025 (i.e. SEK 0.20) and not more than SEK 1.89, multiplied by two (2). The warrants series TO 14 are intended to be admitted to trading on Nasdaq Stockholm.

Subscription of units with or without preferential rights shall be made during the period from and including 4 December 2025 up to and including 18 December 2025. Unit rights that are not exercised during the subscription period will become invalid and lose their value. Trading in unit rights takes place on Nasdaq Stockholm during the period from and including 4 December 2025 up to and including 15 December 2025 and trading in BTU (paid subscribed units, "BTU") during the period from and including 4 December 2025 up to and including 13 January 2026.

One (1) warrant series TO 14 entitles the holder the right to subscribe for one (1) new ordinary share in the Company at a subscription price corresponding to 70 percent of the volume-weighted average price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 10 February 2026 up to and including 27 February 2026, however not lower than the quota value of the share and not higher than 125 percent of the Subscription Price per ordinary share in the Rights Issue. Subscription of ordinary shares by exercise of warrants series TO 14 shall be made during the period from and including 5 March 2026 up to and including 19 March 2026.

If not all units are subscribed for by exercise of unit rights, allotment of the remaining units shall be made within the highest amount of the issue: firstly, to those who have subscribed for units by exercise of unit rights (regardless of whether they were shareholders on the record date or not) and who have applied for subscription of units without exercise of unit rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of unit rights that each and every one of those, who have applied for subscription of units without exercise of unit rights, have exercised for subscription of units; secondly, to those who have applied for subscription of units without exercise of unit rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of units the subscriber in total has applied for subscription of units; and thirdly, to those who have provided guarantee commitments with regard to subscription of units, in proportion to such guarantee commitments. To the extent that allotment in any section above cannot be done pro rata, allotment shall be determined by drawing of lots.

Subscription undertakings, subscription intentions and guarantee commitments
The Company has received subscription undertakings from a number of existing shareholders, amounting in total to approximately SEK 5.2 million, corresponding to approximately 4.4 percent of the Rights Issue. In addition, the Company’s Chairman of the Board of Directors, Hans-Peter Ostler, CEO, Søren Bregenholt, and CFO, Johan Giléus, have expressed their intention to subscribe for units in the Rights Issue for their respective pro rata share of the Rights Issue, amounting in total to approximately SEK 0.7 million, corresponding to approximately 0.6 percent of the Rights Issue. Members of the Company’s Board of Directors and management are prevented, under applicable rules on market abuse, from entering into undertakings to subscribe for units in the Rights Issue, as a result of the Company being in a so-called closed period until the publication of the interim report for the third quarter of 2025, and are expected to enter into binding subscription undertakings after the closed period has ended. No compensation will be paid for subscription undertakings or subscription intentions.

The Company has also entered into agreements with certain existing larger shareholders and a number of external investors on guarantee commitments of a total of approximately SEK 72 million, corresponding to approximately 60 percent of the Rights Issue. According to the guarantee agreements, cash compensation is paid with 12 percent of the guaranteed amount, corresponding to a total of approximately SEK 8.7 million, or 14 percent of the guaranteed amount in the form of newly issued units in the Company, with the same terms and conditions as for units in the Rights Issue, including the Subscription Price in the Rights Issue.

In total, the Rights Issue is covered by subscription undertakings, subscription intentions and guarantee commitments amounting up to approximately SEK 78 million, corresponding to approximately 65 percent of the Rights Issue. Neither the subscription undertakings, the subscription intentions, nor the guarantee commitments are secured by bank guarantees, blocked funds, pledges or similar arrangements.

In order to enable issue of units as guarantee compensation to the guarantors who choose to receive guarantee compensation in the form of newly issued units, the Board of Directors has proposed that the extraordinary general meeting on 25 November 2025, among other things, resolves on approval of the Rights Issue and authorization for the Board of Directors to resolve on issue of such units to guarantors.

A subscription of units in the Rights Issue (other than by exercising preferential rights) which result in an investor acquiring a shareholding corresponding to or exceeding a threshold of ten (10) percent or more of the total number of votes in the Company following the completion of the Rights Issue, must prior to the investment be filed with the Inspectorate of Strategic Products (Sw. Inspektionen för strategiska produkter, "ISP"). To the extent any guarantors’ fulfilment of their guarantee commitment entails that the investment must be approved by the ISP in accordance with the Swedish Screening of Foreign Direct Investments Act (Sw. lagen (2023:560) om granskning av utländska direktinvesteringar), such part of the guarantee is conditional upon notification that the application of the transaction is left without action or that approval has been obtained from the ISP.

In addition, pursuant to the guarantee commitment provided by Fenja Capital, Fenja Capital’s obligation to fulfil its guarantee commitment in connection with the Rights Issue may be postponed in order to secure that Fenja Capital’s shareholding in the Company does not amount to or exceed 30 per cent of the Company’s votes after the completion of the Rights Issue.

Preliminary time plan for the Rights Issue

24 November 2025 Publication of final terms of the Rights Issue, including Subscription Price
25 November 2025 Extraordinary general meeting
28 November 2025 Estimated publication of the Prospectus
28 November 2025 Last day of trading incl. preferential rights
1 December 2025 First day of trading excl. preferential rights
2 December 2025 Record date in the Rights Issue
4 – 15 December 2025 Trading in unit rights
4 – 18 December 2025 Subscription period
22 December 2025 Estimated publication of the outcome of the Rights Issue
4 December 2025 – 13 January 2026 Trading in paid subscribed units (BTU)
Lock-up agreements
In connection with the Rights Issue, all shareholding members of the Board of Directors and senior management in Alligator Bioscience have undertaken towards Vator Securities AB, subject to customary exceptions, not to sell or carry out other transactions with a similar effect as a sale unless, in each individual case, first having obtained written approval from Vator Securities AB. Decisions to give such written consent are resolved upon by Vator Securities AB and an assessment is made in each individual case. Consent may depend on both individual and business reasons. The lock-up undertakings only cover the shares held prior to the Rights Issue and the lock-up period lasts for 180 days after the announcement of the Rights Issue.

Extraordinary general meeting and voting commitments
The Board of Directors’ resolution on the Rights Issue is subject to approval by the extraordinary general meeting on 25 November 2025. The resolution on the Rights Issue is subject to and conditional upon that the extraordinary general meeting also resolves to reduce the share capital to cover loss, to amend the Articles of Association in accordance with the Board of Directors’ proposal to the extraordinary general meeting, as well as to authorize the Board of Directors to resolve on issue of units to the guarantors and warrants to Fenja Capital. Notice of the extraordinary general meeting will be announced in a separate press release.

The Company has received irrevocable voting commitments from certain of the Company’s major shareholders, who together hold approximately 4.4 percent of the votes in the Company. The voting commitments mean that the shareholders have committed to vote in favor of the Rights Issue and all relevant resolutions at the extraordinary general meeting on 25 November 2025.

Bridge loans and renegotiation of previous loan
In order to secure the Company’s liquidity needs until the Rights Issue has been completed, the Company has raised bridge loans of SEK 17 million in total from Fenja Capital, Linus Berger and Philip Olsson. As compensation for the loans, an arrangement fee of 3 percent and a monthly interest rate of 0.75 percent are paid. Pursuant to the bridge loan agreements, the lenders are not obliged to disburse the bridge loans until the extraordinary general meeting on 25 November 2025 has approved the Rights Issue but may nonetheless resolve to do so. According to the bridge loans, the loans shall be repaid in connection with the Rights Issue or no later than 31 January 2026.

In June 2024, Alligator Bioscience entered into a financing agreement with Fenja Capital pursuant to which Fenja Capital provided loans with an aggregate nominal amount of SEK 68 million and furthermore also subscribed for convertibles with an aggregate nominal amount of SEK 12 million (the "Initial Financing"). For further details on the Initial Financing, please see the Company’s press release from 25 June 2024. In connection with the rights issue carried out during December 2024 – February 2025, the Company renegotiated the Initial Financing, which led to the arrangement of a new loan (the "Previous Loan") as well as the repayment of all outstanding convertibles. The Previous Loan has subsequently been renegotiated in May 2025 and September 2025, respectively. As a result of the renegotiations, the repayment structure was amended and the maturity date of the Previous Loan was extended to 31 December 2025. In addition, the parties agreed that Fenja Capital could choose to convert all or part of the outstanding nominal amount under the Previous Loan into new ordinary shares in the Company through set-off. For further information on the renegotiations of the Previous Loan, please see the Company’s press releases from 9 May 2025 and 8 September 2025, respectively.

The outstanding amount under the Previous Loan amounts to approximately SEK 23.1 million. In connection with the Rights Issue, Alligator Bioscience has renegotiated the Previous Loan with Fenja Capital. The Company will, in connection with the Rights Issue, repay a total amount of approximately SEK 11.2 million (including a repayment fee of approximately SEK 0.5 million), after which the remaining nominal amount under the loan will be SEK 12.5 million (the "New Loan"). In connection with the Rights Issue, Fenja Capital has provided a guarantee commitment of SEK 30 million, as well as a bridge loan of SEK 10 million (as detailed above). Pursuant to the bridge loan agreement, the arrangement fee of the bridge loan as well as the repayment fee and the amendment fee pursuant to the New Loan agreement plus any additional outstanding interest of the New Loan will be deducted from the bridge loan upon disbursement of the bridge loan to the Company. Furthermore, to the extent the guarantee commitment is exercised, Fenja Capital shall be entitled and obliged to pay for the amount so exercised through set-off against the bridge loan, the repayment amount and the amendment fee pursuant to the New Loan agreement as well as the accrued interest outstanding under the bridge loan and the New Loan (provided that such amounts have not been deducted already in connection with the disbursement of the bridge loan as described above), subject to the provisions of the New Loan agreement. To the extent the guarantee commitment is exercised for an amount in excess of the above-mentioned set-off amounts, the remaining part of the guarantee commitment shall be paid in cash. Furthermore, the previous right for Fenja Capital to request conversion of all or part of the outstanding nominal loan amount into new ordinary shares in the Company through set-off has been terminated through the New Loan agreement.

The New Loan is subject to an arrangement fee of approximately SEK 0.6 million and bears an annual interest rate at STIBOR 3M (however minimum 3 percent) plus an interest margin of 10 percent, paid on a quarterly basis. In addition to the repayment in connection with the Rights Issue, the Company shall, upon exercise of warrants series TO 14, use up to 50 percent of the part of the net proceeds that exceeds SEK 6 million for repayment of the New Loan, including the repayment fee and accrued interest on the amount so paid. Furthermore, to the extent that the outstanding New Loan at the end of a calendar quarter, after the exercise of the warrants series TO 14, exceeds 10 percent of the Company’s market capitalization, the Company shall repay an amount of SEK 2 million. The maturity date for the New Loan is 30 September 2026.

In connection with the New Loan, Alligator Bioscience has also undertaken to issue warrants series 2025/2030 to Fenja Capital, free of charge. The number of warrants to be issued shall correspond to a total dilution of five percent calculated on the total number of ordinary shares outstanding in the Company immediately after the completion of the Rights Issue (including any ordinary shares issued as part of the units issued to guarantors that have chosen to receive remuneration in units). The exercise price for the warrants shall correspond to 140 percent of the Subscription Price, rounded to the nearest whole öre. The warrants will be subject to terms and conditions that contain customary recalculation terms. The Board of Directors intends to resolve on the issue of warrants series 2025/2030 to Fenja Capital pursuant to an authorization from the extraordinary general meeting intended to be held on 25 November 2025, no later than five business days following the registration of the Rights Issue with the Swedish Companies Registration Office. The warrants will be exercisable for subscription of ordinary shares in the Company from the date of registration of the warrants with the Swedish Companies Registration Office up to and including 31 October 2030. The warrants will not be admitted to trading.

Prospectus
Full terms and conditions for the Rights Issue, as well as other information about the Company and information about subscription undertakings, guarantee commitments and lock-up agreements will be presented in the Prospectus that the Company is expected to publish on or around 28 November 2025.

Advisers
Vator Securities AB acts as Sole Global Coordinator and bookrunner in connection with the Rights Issue. Setterwalls Advokatbyrå AB is legal adviser to Alligator Bioscience in connection with the Rights Issue. Vator Securities AB acts as the issuing agent in connection with the Rights Issue.

(Press release, Alligator Bioscience, OCT 22, 2025, View Source [SID1234656891])

Flagship Pioneering Unveils Expedition Medicines To Expand The Boundaries Of Small Molecule Medicines With Generative Design

On October 22, 2025  Flagship Pioneering, a scientific innovation engine for transformative platforms and products, reported the company unveiled Expedition MedicinesTM, a company pioneering generative covalent chemistry to expand the boundaries of medicine (Press release, Expedition Medicines, OCT 22, 2025, View Source [SID1234656887]). Following three years of in-house development, Flagship has committed an initial $50 million to support scaling Expedition’s platform for generating small molecule medicines to any target and to further develop its discovery programs in oncology, immunology, and other well-defined diseases. In addition, Expedition recently initiated a multi-target exploration agreement to identify novel therapeutic candidates for prostate cancer under Flagship’s strategic collaboration with Pfizer.

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"Today, the majority of proteins known to be involved in disease have no medicines that can reach them. By harnessing AI and quantum covalent chemistry to rewrite what’s possible in drug design, Expedition is transforming these undruggable proteins into tractable targets," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering and Co-Founder and board director of Expedition Medicines. ​"Expedition is able to explore entirely new territory thanks to a unique insight from the quantum chemistry of protein-small molecule interactions, generative AI, and a team that bridges medicinal chemistry, artificial intelligence, and therapeutic development to redefine the drug discovery paradigm."

Proteins with smooth surfaces have been considered undruggable because they lack the features for small molecules to latch onto and reversibly bind. Rather than this traditional ​"binding-first" approach, Expedition’s approach is driven by its discovery of a ​"reaction-first" covalent chemical insight, where quantum interactions between small molecules and reactive parts of protein surfaces enable high potency binding even in shallow pockets of proteins.

Grounded in this insight, Expedition is building a quantum chemistry AI platform that is fueled by an industry-leading chemoproteomic screening and data generation engine. The platform has enabled Expedition to access new protein targets, create high-quality quantitative molecular interaction data at scale, and train generative chemistry models to deliver de novo small molecules that effectively interact with the most elusive targets in the proteome, such as transcription factors, adaptor proteins, regulators, and protein-protein interfaces – mechanisms that have been implicated as central regulators of a wide range of diseases.

"AI is transforming biology by learning the grammar of proteins and DNA. At Expedition, we are pioneering the same leap for small molecules grounded in the quantum chemistry of covalent interactions and fueled by unprecedented experimental data," said Molly Gibson, Ph.D., Co-Founder, CEO, and board director of Expedition and Origination Partner at Flagship Pioneering. ​"Our models are learning the rules of how molecules react and bind to any protein surface in order to make small molecule programmability a reality."

Expedition has initiated research to identify new potential therapeutic candidates for prostate cancer as part of Flagship’s strategic partnership with Pfizer, which seeks to create a pipeline of innovative medicines. The research, which is subject to the terms of the 2023 agreement between Flagship and Pfizer, will leverage Expedition’s platform in an effort to identify novel targeted molecules for previously undruggable targets with known correlation to prostate cancer disease progression and treatment resistance.

Together with Afeyan and Gibson, Expedition is led by Nathan Stebbins, Ph.D., Co-Founder and Chief Strategy Officer and Senior Principal at Flagship Pioneering; Dean Stamos, Ph.D., Co-Founder and CSO — Chemistry & Proteomics and Flagship Science Partner; Todd Kinsella, Ph.D., CSO — Discovery and Translation and Flagship Science Partner; Henry van den Bedem, Ph.D., Chief Technology Officer; and Marie Yurkovich, Ph.D., Co-Founder and Head of Strategy and Operations at Expedition and Operating Principal at Flagship. Kinsella and Stamos previously led biology and chemistry innovation, respectively, at Vividion Therapeutics, and van den Bedem previously led Machine Learning at Atomwise. Geoffrey von Maltzahn, Ph.D., Co-Founder of Expedition and General Partner at Flagship Pioneering, will serve on the company’s board.

Ipsen delivers strong sales in the first nine months of 2025 and further upgrades its full-year guidance

On October 22, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its sales for the year to date and the third quarter of 2025.

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YTD 2025 YTD 2024 % change Q3 2025 Q3 2024 % change
€m €m Actual CER €m €m Actual CER
Oncology 1,912.0 1,829.8 4.5 % 6.6 % 624.0 604.0 3.3 % 7.0 %
Rare Disease 255.4 129.7 97.0 % 101.0 % 102.0 50.8 100.8 % 109.1 %
Neuroscience 567.3 536.4 5.8 % 9.5 % 188.9 181.9 3.9 % 9.1 %
Total Sales 2,734.8 2,495.9 9.6 % 12.1 % 915.0 836.6 9.4 % 13.7 %

"We have demonstrated strong momentum through the first nine months of 2025, with solid growth across all three therapeutic areas and increasing contributions from our rare liver disease franchise. As a result, we are further upgrading our full-year guidance to reflect this performance." said David Loew, Chief Executive Officer, Ipsen.
"This quarter, we were also pleased with the data from the Phase II LANTIC trial in aesthetics, with a differentiated first-in-class long-acting molecule, IPN10200. With the proposed acquisition of ImCheck Therapeutics announced this morning, we are adding a first-in-class asset to expand our oncology pipeline. Our efforts remain focused on advancing science with purpose to bring the benefits patients are looking for, as we believe everyone deserves a life fully lived."

Full-year 2025 guidance
Based on the strong performance in the third quarter, Ipsen further upgrades its financial guidance for 2025:

Total sales growth of around 10.0%, at CER (prior guidance greater than 7.0%). Based on the average level of exchange rates in September 2025, an adverse impact on total sales of around 3% from currencies is expected
Core operating margin of around 35.0% of total sales (prior guidance greater than 32.0%)
This guidance assumes a limited impact from lanreotide generic on Somatuline sales and an accelerated sales growth from the rest of the portfolio.

Pipeline update for Q3 2025
On 22 September 2025 Ipsen announced that the LANTIC Phase II trial in aesthetics delivered a first-in-class, differentiated long-acting clinical profile for IPN10200, a recombinant, first-in-class molecule uniquely engineered to generate increased receptor affinity and internalization that produces a longer duration of action. Data showed a rapid onset of action, peak effect superior to placebo and a substantial majority of patients experiencing clinically significant longer duration of effect vs placebo and vs Dysport, defined as a score of "none" or "mild" of line severity at Week 24. The data will be presented at an upcoming scientific conference in H1 2026, and Phase III start-up activities have been initiated.

On 19 September 2025 Ipsen announced regulatory approval for Bylvay (odevixibat) for the treatment of pruritus associated with progressive familial intrahepatic cholestasis (PFIC) in Japan, offering a non-surgical treatment option for infants, young children and adults.

On 23 July 2025, Ipsen received European Commission approval for Cabometyx (cabozantinib) in previously treated advanced neuroendocrine tumors (NETs), based on positive outcomes from the Phase III CABINET trial.

Business development
On 22 October 2025 Ipsen announced a definitive share purchase agreement to acquire ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The acquisition is focused on the lead Phase I/II program ICT01 in first line unfit acute myeloid leukemia (AML) with a Phase IIb/III to start in 2026. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and which has received Orphan Drug Designation from the U.S. Food and Drug Administration and Orphan designation from the European Medicines Agency in July 2025.

Under the terms of the agreement, shareholders of ImCheck Therapeutics will receive a €350m cash payment at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones. The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions.

Conference call
A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

(Press release, Ipsen, OCT 22, 2025, View Source [SID1234656869])

Ipsen to acquire ImCheck Therapeutics, expanding its leadership in oncology, strengthening its pipeline

On October 22, 2025 Ipsen (Euronext: IPN; ADR: IPSEY) and ImCheck Therapeutics reported they have entered into a definitive share purchase agreement in which Ipsen will acquire all issued and outstanding shares of ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The anticipated acquisition is focused on the lead Phase I/II program ICT01 in first line acute myeloid leukemia (AML)3 patients who are ineligible for intensive chemotherapy. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.

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Many AML patients are unable to tolerate intensive chemotherapy and must rely on lower-intensity options, which often deliver limited and short-lived benefit.2 This high-risk, unfit population continues to face a significant unmet medical need, highlighting the urgency for new therapies that can improve survival and quality of life.

"At completion, the acquisition of ImCheck Therapeutics presents an opportunity for us to expand our pipeline in oncology and reinforces our commitment to deliver transformative therapies to the people who need them most," said David Loew, CEO, Ipsen. "We feel confident that with the ICT01 promising data combined with Ipsen’s global development and commercialization expertise, we are well positioned to start a Phase IIb/III trial in 2026."

Interim data (n=45) orally presented at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 20251 from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard of care (Ven-Aza).2 ICT01 in combination with Ven-Aza was also shown to be well tolerated, underscoring ICT01’s potential as a novel immunotherapy to improve outcomes for patients with AML.

"We are thrilled to become part of Ipsen, a company whose ambition for transformative care matches our commitment to bringing innovative treatments to patients. This transaction recognizes groundbreaking science originating from French academia," said Pierre d’Epenoux, CEO, ImCheck Therapeutics. "It also highlights the exceptional work the ImCheck team and our partners have achieved to advance the understanding of butyrophilns and gamma delta T cells. Joining Ipsen will help us accelerate ICT01 toward registrational studies and commercialization. I remain grateful to the patients and investors for their contributions to furthering ImCheck’s pioneering science."

Transaction details
Under the terms of the agreement, through a wholly owned affiliate of Ipsen SAS, shareholders of ImCheck Therapeutics will receive a 350 million euros payment on a cash-free and debt-free basis at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones, for a total potential consideration up to 1 billion euros.

The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions including the expiration or termination of any required regulatory and governmental approvals under French and U.S. regulations.

Advisors
Allen & Overy Shearman (Paris) is acting as legal counsel to Ipsen. Centerview Partners is acting as exclusive financial advisor to ImCheck Therapeutics with Goodwin (London) and Dentons (Paris) acting as legal counsel.

About the EVICTION trial
EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About ICT01
ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, ICT01 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in patients across several cancer indications.

(Press release, Ipsen, OCT 22, 2025, View Source [SID1234656868])

Hanmi Reports 2025 Third Quarter Results

On October 21, 2025 Hanmi reported third quarter financial results for the year 2025 (Press release, Hanmi, OCT 21, 2025, View Source [SID1234661651]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!