Nuvalent (NUVL) Update / Briefing June 24, 2025 08:00 AM ET Speaker0 Good morning, and welcome to New Zealand's conference call. At this time, all participants are in a listen only mode. There will be a question and answer session after the prepared remarks. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Alex Stalcom, CFO of Nuvalent. You may begin. Speaker1 Thank you all for joining us today. Earlier this morning we issued a press rele ...

PRESS RELEASE In addition to patent protection, AB8939 is also eligible for regulatory data protection in Canada, preventing generic competition for a period of 8 years following initial approval. AB8939 has also received orphan drug designation for AML from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This orphan drug designation provides 10 and 7 years of market exclusivity in Europe and the United States, respectively, after product approval. A separate secondar ...

PRESS RELEASE AB SCIENCE ANNOUNCES EMA APPROVAL OF MASIVET® SHELF-LIFE EXTENSION TO 4 YEARS Paris, June 9, 2025, 8am CET AB Science SA (Euronext - FR0010557264 - AB) today announced that the European Medicine Agency (EMA) has approved the extension of the shelf-life of its veterinary medicine MASIVET® from 36 months to 48 months. This shelf-life extension applies to the 50mg tablet strength of MASIVET® currently available in the EU. MASIVET® is currently approved for the treatment of non-resectable dog mast ...

Core Viewpoint - AB Science S.A. successfully completed a private placement raising EUR 1.8 million to finance ongoing activities, particularly focusing on the clinical development of the AB8939 program [1][3]. Group 1: Private Placement Details - The private placement involved the issuance of 1,538,463 new ordinary shares, each with one share warrant attached, without preferential subscription rights [4]. - The issue price of one ABSA was set at EUR 1.17, reflecting a 24.8% discount to the volume-weighted average price over the three trading days prior [6][7]. - The total share capital post-placement will be EUR 661,764.30, comprising 59,368,757 ordinary shares, with potential increases if all BSAs are exercised [11]. Group 2: Use of Proceeds - The net proceeds from the private placement will primarily be allocated to the clinical development of the AB8939 program [3]. Group 3: Shareholder Impact - The issuance of ABSAs will result in a dilution of existing shareholders' stakes, with specific percentages outlined for major shareholders before and after the placement [12][14]. - The theoretical value of each BSA is estimated at EUR 0.4053, based on a volatility of 34.355% [9]. Group 4: Trading and Listing - The new shares are expected to be admitted to trading on Euronext Paris on May 22, 2025, and will be assimilated to existing shares [16]. - The BSAs are anticipated to be listed on Euronext Growth Paris by May 26, 2025 [10]. Group 5: Company Overview - AB Science specializes in the research, development, and commercialization of protein kinase inhibitors, targeting diseases with high unmet medical needs [25]. - The lead compound, masitinib, is being developed for various medical applications, including oncology and inflammatory diseases [25][23].

Financial and Corporate Situation - AB Science reported an operating deficit of €6.1 million as of December 31, 2024, a decrease of 55% compared to €13.4 million in 2023 [6][26] - The cash position stood at €8.0 million as of December 31, 2024 [6] - Operating income increased by 10% to €1.072 million in 2024 from €0.970 million in 2023 [27] - Operating expenses decreased by 50%, amounting to €7.244 million less than in 2023 [27][28] Clinical Development - AB Science provided updates on the AB8939 microtubule program, which targets relapsed/refractory acute myeloid leukaemia (AML) [3][4] - The Phase 1 study of AB8939 included 28 patients, assessing the maximum tolerated dose after 3 consecutive days of treatment, with a second stage nearing completion for 14 consecutive days [4][5] - AB8939 showed a 50% response rate against the MECOM gene rearrangement, which is associated with poor prognosis in AML [7][8] Masitinib Platform - Positive results were reported from the Phase 2 study of masitinib in COVID-19, with an odds ratio of 2.4 in favor of the treatment arm after 15 days [16][18] - The European Medicines Agency (EMA) issued a negative opinion for the conditional marketing authorization of masitinib in ALS [19] - A new confirmatory study for masitinib in ALS will be launched, targeting the best responders [21] Intellectual Property Developments - AB Science secured intellectual property rights for AB8939 in AML until 2036 and potentially until 2044 for specific chromosomal abnormalities [8] - New patents were granted for masitinib in the treatment of severe systemic mastocytosis, sickle cell disease, and other indications, extending protection until 2041 or 2042 [23][25][24] Capital Increase and Financial Strategy - A capital increase of €5 million was announced through the issuance of 5,368,725 new ordinary shares [31][34] - The proceeds from the capital increase will support AB Science's activities over the next twelve months [36] - The company has engaged in a Term Capital Increase Program (PACT) with Alpha Blue Ocean, which has provided additional funding [37] Market Position and Analyst Coverage - AB Science has received coverage initiation from DNA Finance and In Extenso Finance, with strong buy opinions indicating a compelling investment opportunity in the biotech sector [41][42]

Company Announcement - AB Science SA has postponed the publication of its 2024 annual financial report from April 30, 2025, to May 9, 2025, to allow auditors to complete their work [1][2] Company Overview - AB Science, founded in 2001, is a pharmaceutical company focused on the research, development, and commercialization of protein kinase inhibitors (PKIs) targeting diseases with high unmet medical needs [3] - The company's lead compound, masitinib, is registered for veterinary medicine and is being developed for human medicine in areas such as oncology, neurological diseases, inflammatory diseases, and viral diseases [4] Additional Information - AB Science is headquartered in Paris, France, and is listed on Euronext Paris under the ticker AB [4] - Further information can be found on the company's website [5]