Core Viewpoint - Karolinska Development AB's portfolio company SVF Vaccines has entered into a reverse acquisition agreement with Novakand Pharma, valued at approximately SEK 55 million, pending various approvals [1][3]. Group 1: Transaction Details - The reverse acquisition agreement allows Novakand to acquire all shares in SVF Vaccines, with payment made in newly issued shares of Novakand [1]. - SVF Vaccines shareholders will hold 66.7% of the combined company, while Novakand shareholders will hold 33.3% [3]. - The transaction is expected to be completed in the first quarter of 2026, subject to approval from an extraordinary general meeting of Novakand and regulatory authorities [1][3]. Group 2: Company Focus and Financials - Post-transaction, the combined company will concentrate on developing innovative vaccine therapies based on SVF's technology, while retaining Novakand's existing fractalkine program [4]. - The combined entity is projected to have sufficient working capital for the next 12 months, with plans for a capital raise to fund a Phase 1 study for the vaccine candidate SVF-001, estimated to cost SEK 30 million [4]. Group 3: Strategic Importance - The CEO of Karolinska Development emphasized that the stock market listing could accelerate SVF Vaccines' vaccine development, highlighting the company's commitment to supporting the capital raising process for the upcoming Phase 1 study [5]. - Karolinska Development holds a 33% ownership stake in SVF Vaccines, indicating a significant interest in the success of the combined entity [5].

Core Viewpoint - Vaxcyte Inc. (NASDAQ:PCVX) is identified as a promising mid-cap healthcare stock with significant upside potential, supported by positive analyst ratings and upcoming clinical trials [1][4]. Group 1: Analyst Ratings and Price Targets - BTIG analyst Thomas Shrader has reiterated a Buy rating for Vaxcyte Inc. with a target price of $85, indicating an upside of over 83% from current levels [1]. - Consensus ratings show all 7 analysts have assigned Buy ratings, with a median 1-year price target of $100.80 per share, representing a potential upside of 117.2% [4]. Group 2: Clinical Trials and Product Development - Positive results from Phase 2 trials for the VAX-31 vaccine are expected to support the critical Phase 3 trials, which have a robust design and stringent success criteria [2]. - The target market for VAX-31 includes individuals aged 50 to 65, suggesting strong potential for market adoption [3]. - Vaxcyte Inc. focuses on developing next-generation vaccines using innovative synthetic methods and advanced chemistry to enhance immunological benefits [5].

Core Insights - Evaxion A/S has announced promising new data for its AML vaccine candidate, EVX-04, which shows strong T-cell responses and effective tumor growth prevention in preclinical models [1][5][10] - The data was presented at the American Society of Hematology Annual Meeting, highlighting the company's engagement with the scientific community and potential business partners [2] - The AI-Immunology™ platform has been instrumental in identifying novel ERV tumor antigens, which are targeted by EVX-04, showcasing the platform's unique capabilities in cancer vaccine development [3][4][11] Company Overview - Evaxion A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines, with a commitment to transforming patient care through innovative immunotherapies [12] - The company’s proprietary AI platform enables the identification of therapeutically relevant tumor antigens, which are crucial for the development of effective cancer vaccines [11][12] Product Details - EVX-04 is designed as an off-the-shelf therapeutic cancer vaccine specifically for acute myeloid leukemia (AML), addressing a significant unmet medical need due to the high mortality rates associated with the disease [10] - The vaccine targets non-conventional ERV tumor antigens, which are selectively expressed in tumors but absent in normal tissues, making them ideal candidates for cancer immunotherapy [4][10] AML Context - Acute myeloid leukemia (AML) is characterized by high mortality rates and limited treatment options, with a median age of diagnosis at 68 years [8][9] - Approximately 50% of AML patients are not fit for intensive treatment, leading to a low overall survival rate of 25% over three years for those receiving standard low-intensity chemotherapy [9]

Core Insights - Vaxart has entered into an exclusive license agreement with Dynavax for its COVID-19 oral pill vaccine candidate, potentially generating up to $700 million in cumulative proceeds plus royalties [1][4][3] - The company has completed enrollment of approximately 5,400 participants in its COVID-19 Phase 2b trial, with topline data expected in late 2026 and data from a 400-person sentinel cohort anticipated in the first quarter of 2026 [1][9] - Vaxart reported positive data from its Phase 1 clinical trial for its second-generation oral norovirus vaccine, indicating improved protection against infection [1][3] COVID-19 Vaccine Developments - The exclusive agreement with Dynavax includes a $25 million upfront license fee and a $5 million equity investment, with additional potential payments of $50 million and up to $195 million in regulatory milestone payments [4] - Vaxart retains operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the ongoing Phase 2b clinical trial [4] - The company has received $125.9 million in cash payments associated with its COVID-19 vaccine program as of September 30, 2025 [9] Norovirus Vaccine Developments - Vaxart's second-generation oral pill norovirus vaccine constructs have shown significantly stronger antibody responses compared to first-generation constructs [3][9] - The company plans to publish complete results of the Phase 1 study in a peer-reviewed journal and is exploring partnership opportunities for its norovirus candidate [3][9] Financial Results for Q3 2025 - Vaxart reported revenue of $72.4 million for Q3 2025, a significant increase from $4.9 million in Q3 2024, primarily from government contracts [9][15] - Research and development expenses rose to $75.9 million in Q3 2025 from $15.1 million in Q3 2024, mainly due to increased clinical trial expenses [9][15] - The net loss for Q3 2025 was $8.1 million, an improvement from a net loss of $14.1 million in Q3 2024, with a net loss per share of $0.04 compared to $0.06 [9][15] Cash Position and Runway - As of September 30, 2025, Vaxart had cash, cash equivalents, and investments totaling $28.8 million, with a current runway extended into the second quarter of 2027 following the Dynavax agreement [1][9]

Core Points - Vaxart, Inc. will host a conference call to discuss its third quarter 2025 financial results on November 13, 2025, at 4:30 p.m. ET [2] - A stockholder fireside chat is scheduled for November 18, 2025, at 4:30 p.m. ET, where senior management will address frequently asked questions from stockholders [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform that allows for non-refrigerated storage and eliminates needle-stick injury risks [5] - The company's vaccine development programs include oral vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [5] - Vaxart has filed extensive domestic and international patent applications for its oral vaccination technology, which utilizes adenovirus and TLR3 agonists [5]

Core Insights - Evaxion A/S has made significant advancements in its AI-Immunology™ powered vaccine development, particularly in cancer and infectious diseases, showcasing strong data from its lead asset, EVX-01, and successfully out-licensing EVX-B3 to MSD [2][8][20] Business Highlights - The company has validated its technology and strategy through impressive data from EVX-01, which targets multiple neoantigens in cancer vaccines, and the out-licensing of EVX-B3 confirms its capabilities in infectious disease vaccines [2][8] - Evaxion's cash runway has been extended to the second half of 2027, bolstered by a $7.5 million payment from MSD and $7.2 million raised from capital market activities [8][25] - The appointment of Dr. Helen Tayton-Martin as the new CEO is expected to bring over 30 years of experience in biotech M&A and business development [8] Research & Development Update - The phase 2 trial of EVX-01 in advanced melanoma patients showed an Objective Response Rate (ORR) of 75%, with 12 out of 16 patients responding clinically, and 92% of patients still responding at the two-year follow-up [6][10] - Evaxion has expanded its pipeline with EVX-04, targeting non-conventional ERV tumor antigens for acute myeloid leukemia (AML), developed using the AI-Immunology™ platform [12][15] - The company has developed an automated vaccine design module to enhance the efficiency and quality of vaccine development, reducing design time from months to days [17][18] Financial Performance - For Q3 2025, Evaxion reported a net income of $4.6 million, a significant improvement from a net loss of $1.9 million in Q3 2024, driven by revenue from MSD's option exercise [27][28] - Revenue for the quarter was $7.5 million, primarily from the MSD option exercise and included contributions from the Gates Foundation [28] - Research and development expenses were $3.1 million for Q3 2025, compared to $2.6 million in the same period last year, while general and administrative expenses decreased to $1.4 million from $2.1 million [29][30] Equity and Cash Position - As of September 30, 2025, cash and cash equivalents were $10.6 million, up from $6.0 million at the end of 2024, with total equity improving to $16.6 million from a negative equity of $(1.7) million [32][34] - The company has successfully managed its financial strategy, resulting in improved equity and extended cash runway, with an operational cash burn expected to be approximately $14 million in 2025 [34]

Core Insights - Evaxion A/S is set to provide a business update and report its Q3 2025 financial results on October 31, 2025, before the Nasdaq CM opens [1] - The company's Executive Management will host a conference call and webcast on the same day at 14:30 CET/08:30 EST, which is open to the public [2] - Evaxion specializes in AI-Immunology™ powered vaccines, focusing on developing novel immunotherapies for cancer, bacterial diseases, and viral infections [4] Company Overview - Evaxion A/S is a pioneering TechBio company utilizing its AI platform, AI-Immunology™, to decode the human immune system [4] - The company has developed a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting bacterial and viral diseases with high unmet medical needs [4] - Evaxion aims to transform patients' lives by providing innovative and targeted treatment options [4]

Financial Position - Evaxion A/S has raised a total of $7.2 million recently, with $4.5 million from an at-the-market offering and $2.7 million from the exercise of investor warrants [2][7] - The company now has sufficient cash to fund its operations and R&D programs into the second half of 2027, extending from the first half of 2027 [1][7] Debt Management - By the end of the second quarter of 2025, Evaxion had cash on hand of $14.7 million and a debt of $9.2 million [4] - The debt was reduced by $4.1 million through a debt-to-equity conversion agreement with the European Investment Bank in July 2025, enhancing the company's equity position [4] Operational Insights - Evaxion expects to incur an operational cash spend of $14 million in 2025 [4] - The recent exercises of investor warrants have decreased the number of outstanding warrants to purchase Evaxion American Depositary Shares (ADSs) by 1.0 million, leaving a total of 2.8 million outstanding warrants [3][7] Company Overview - Evaxion is a clinical-stage TechBio company that utilizes its AI-Immunology™ platform to develop vaccines targeting cancer, bacterial diseases, and viral infections [5] - The company is focused on creating novel personalized vaccines and has a pipeline addressing high unmet medical needs in infectious diseases [5]

Core Insights - Vaxart, Inc. is presenting research on its second-generation norovirus oral pill vaccine candidate at IDWeek 2025, highlighting advancements in its vaccine development efforts [1][2] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [2] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, thus eliminating the risk of needle-stick injuries [2] - Vaxart's current development programs include vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [2] - The company has filed broad domestic and international patent applications for its proprietary technology related to oral vaccination using adenovirus and TLR3 agonists [2] Presentation Details - The presentation at IDWeek 2025 will feature an open-label Phase 1 clinical trial demonstrating improved immune responses to norovirus strains GI.1 and GII.4 from a next-generation oral bivalent vaccine candidate [2] - The session is scheduled for October 20, 2025, from 1:45 PM to 3:00 PM ET at the Georgia World Congress Center in Atlanta [2]

Core Insights - Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant pill vaccines, with significant advancements in norovirus and COVID-19 programs to be presented at the World Vaccine Congress Europe 2025 [1][2] Company Overview - Vaxart aims to enhance global public health through its innovative oral pill vaccine platform, addressing serious health challenges such as norovirus and COVID-19 [2] - The company’s proprietary delivery platform has shown the ability to generate systemic and mucosal immune responses, along with a favorable safety profile in clinical trials [2][4] - Vaxart's vaccine candidates include oral vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4] Presentation Details - Vaxart will present two key research updates at the World Vaccine Congress: 1. Title: Oral bivalent vaccine for norovirus protection, focusing on recent improvements in immunogenicity and efficacy, presented by Dr. Sean Tucker on October 15 at 11:45 a.m. CEST [3] 2. Title: Oral Covid Vaccine - Clinical update from phase 1 to phase 2B, also presented by Dr. Sean Tucker on October 15 at 3:45 p.m. CEST [3]