NEW YORK, June 13, 2025 (GLOBE NEWSWIRE) -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: CureVac N.V. (NASDAQ: CVAC)’s sale to BioNTech SE. Under the terms of the proposed transaction, each CureVac share will be exchanged for approximately $5.46 in BioNTech ADSs. Upon closing of the proposed transaction, CureVac shareholders are expected to own b ...

Biotech stock CureVac NV (NASDAQ:CVAC) was last seen up 32.2% at $5.37, after news that BioNTech (BNTX) is acquiring the company in all-stock deal worth $1.25 billion. The merger is still awaiting review from the German Economy Ministry.Today's pop has CVAC trading at 52-week highs, conquering resistance at the $5 level, which kept it in penny stock territory for the last year. Since the start of 2025, the equity is up 63.5%. CureVac stock's typically quiet options pits are booming today. The stock has alre ...

mRNA Technology and Development - The company has a broad portfolio of mRNA-based medicines in preclinical and clinical development stages, with a focus on efficacy, safety, and protein expression at relatively low doses[380]. - The company has developed proprietary lipid nanoparticle (LNP) delivery systems that improve mRNA vaccine activity and thermostability, with candidates shown to be stable for over 12 months at room temperature[382]. - The company has made significant advancements in its mRNA technology platform over the past 24 years, focusing on optimizing mRNA for higher efficacy, greater speed, and lower production costs[387]. - The mRNA technology platform allows for rapid development and production of vaccines without the need for live pathogens, enhancing safety and efficiency[460]. - The optimization of the open reading frame (ORF) is crucial for maximizing protein expression, with engineered ORFs showing higher protein levels in mouse liver compared to wild-type[442]. - The mRNA optimization process includes enhancing translation, stability, and immunogenicity, with specific elements like the 5' cap and poly-A tail being critical for mRNA efficacy[429]. - The company employs a combinatorial approach to identify and create optimized UTR combinations for specific constructs, improving therapeutic mRNA performance[434]. - The company is developing proprietary lipid-nanoparticle (LNP) delivery systems tailored for specific therapeutic areas, enhancing the efficacy of mRNA-based treatments[449]. Clinical Trials and Studies - The company announced positive interim data from the COVID-19 Phase 2 clinical study for the monovalent mRNA vaccine candidate, CV0601, and the bivalent mRNA candidate, CV0701, completed in August 2024[381]. - In oncology, the candidate CVGBM, featuring a multi-epitope design, is currently being tested in a Phase 1 study for patients with resected glioblastoma, with preliminary results showing 77% of evaluable patients induced cancer antigen-specific T-cell responses[381]. - The Phase 2 study for a COVID-19 mRNA vaccine candidate was completed in August 2024, showing favorable reactogenicity and meaningful titers of neutralizing antibodies[385]. - The company has initiated a Phase 1 study for CVGBM, targeting newly diagnosed glioblastoma patients, with 16 patients recruited across four dose levels[474]. - Preliminary results show that 77% of evaluable patients developed cancer antigen-specific T-cell responses after treatment with CVGBM[475]. - The treatment was well tolerated, with 91% of treatment-related adverse events being mild to moderate, resolving within 1-2 days post-injection[479]. - The company has initiated a Phase 2 study for a multivalent influenza vaccine candidate, with promising interim data reported on April 4, 2024[461]. - The Phase 1 part of the combined seasonal influenza/COVID-19 vaccine study initiated by GSK in November 2024 aims to assess safety and immunogenicity[505]. Intellectual Property and Licensing - As of February 28, 2025, the company owns approximately 619 issued patents worldwide, including 119 issued U.S. patents and 36 issued European patents, making it one of the leaders in mRNA intellectual property[382]. - The company plans to strengthen and expand its intellectual property portfolio to protect advancements in its technology platform and product candidates[388]. - The company has trademark registrations for CureVac and its logo in the United States and certain foreign jurisdictions[587]. - The company relies on trade secrets and know-how, protected through confidentiality agreements with collaborators and employees[588]. - The company has entered into a new licensing agreement with GSK, known as the 2024 GSK Agreement, which became effective on July 11, 2024, after receiving approval from German Antitrust Authorities[523]. - GSK paid the company an upfront payment of €400 million and the company is eligible to receive up to €1.05 billion in development, regulatory, and sales milestones under the 2024 GSK Agreement[528]. Strategic Partnerships and Collaborations - The company is selectively seeking strategic partnerships to develop and commercialize product candidates, aiming to mitigate drug development risk while retaining economic rights to strategically important candidates[388]. - The collaboration with M.D. Anderson Cancer Center aims to develop differentiated cancer precision immunotherapy candidates for high unmet medical needs[469]. - The company has established a consortium with GSK for pandemic preparedness, which includes a framework agreement to provide production capacities for mRNA vaccines, allowing for 80 million doses per year until 2029[533]. - The company has received $1 million in development cost reimbursements from Genmab, with no additional fees or milestone payments received as of December 31, 2024[535]. Financials and Milestones - The company achieved regulatory milestones with its manufacturing system, obtaining a manufacturing license for an mRNA construct in cancer precision immunotherapy in November 2023 and a drug substance framework manufacturing license in December 2023[388]. - The company has received a total of €15.1 million in payments from CRISPR Therapeutics and has invoiced €1.9 million for various costs as of December 31, 2024[548]. - The Gates Foundation has provided up to $3.0 million in funding for the development of a vaccine for rotaviruses, with the company having received the full amount as of December 31, 2024[551]. - The company received a $40 million equity investment from the Gates Foundation to support the development of its RNA technology platform and the construction of a cGMP production facility[552]. Regulatory and Compliance - The company expects its product candidates to be regulated as biological products under U.S. law, with compliance required throughout the development process[591]. - The submission of an IND application is required before human clinical trials can begin, which becomes effective 30 days after receipt by the FDA unless concerns are raised[593]. - Clinical trials must be conducted under GCP requirements and include detailed study protocols submitted to the FDA as part of the IND[595]. - An IRB must review and approve each clinical trial, considering design, patient consent, and safety factors[597]. - The FDA may impose a clinical hold on trials at any time, delaying the study until concerns are resolved[594].

Financial Data and Key Metrics Changes - The company closed 2024 with a strong cash position of EUR482 million, reaffirming its expected financial runway into 2028 [14][74]. - Revenues for the full year 2024 increased significantly by EUR481.4 million to EUR535.2 million compared to the same period in 2023, primarily driven by a new licensing agreement with GSK [66][67]. - Operating loss for the fourth quarter of 2024 was EUR43.8 million, an improvement from an operating loss of EUR88 million in the same quarter of 2023 [67]. Business Line Data and Key Metrics Changes - In oncology, the Phase 1 study for glioblastoma completed enrollment of Part B, with promising dose escalation data indicating acceptable tolerability and immune responses [10][16]. - The off-the-shelf precision immunotherapy program for squamous non-small cell lung cancer achieved IND clearance from the FDA, with the first patient expected to be treated in the second half of 2025 [11][20]. - In infectious diseases, a new licensing agreement with GSK for prophylactic vaccines progressed, with a EUR10 million milestone payment received for a combined influenza and COVID-19 vaccine [12][62]. Market Data and Key Metrics Changes - The company anticipates significant market opportunities in oncology and infectious diseases, particularly with its proprietary mRNA technology [9][21]. - The licensing agreement with GSK, valued up to EUR1.45 billion plus royalties, is expected to leverage GSK's expertise in infectious diseases for successful development and commercialization [15][62]. Company Strategy and Development Direction - The company has refocused on technology innovation and R&D, streamlining operations and reducing workforce by approximately 30% to enhance efficiency [8][15]. - Future strategies include advancing mRNA therapeutics in oncology and infectious diseases, with a focus on early-stage interventions to improve patient outcomes [19][37]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of mRNA technology to transform medicine, emphasizing the importance of agility and strategic partnerships [73][75]. - The company plans to continue focusing on high-value mRNA opportunities supported by a strong financial position and a broad IP portfolio [75]. Other Important Information - The European Patent Office upheld the validity of the company's split poly-A tail patent, which is crucial for its mRNA vaccine technology [13][21]. - The company has successfully terminated all remaining raw material commitments related to its first-generation COVID-19 vaccine, ensuring no further related payments [65]. Q&A Session Summary Question: What are the early signs of activity for the squamous program? - Management highlighted extensive validation assays for antigens, expressing optimism based on preclinical evidence of immune responses [82][84]. Question: What is the regulatory path for the CVGBM asset? - Management indicated that discussions with regulators would occur after Phase 1 data, aiming for a randomized Phase 2 study if results are promising [95][96]. Question: What criteria will be used to make go/no-go decisions for GBM? - A threshold of overall survival of 50 months or longer and an overall response rate of about 20% will guide decisions [103]. Question: How does the cash runway guidance into 2028 account for ongoing pipelines? - The cash runway includes core programs and clinical phases, but not all Phase 1 and Phase 2 costs are prior to potential cash out [108]. Question: What is the strategy for collaboration in oncology and infectious diseases? - The company aims to focus on early development and technology innovation, with plans to partner for late-stage development in oncology [114]. Question: What are the timelines for the European Patent proceedings? - Upcoming hearings for patent validity and infringement are scheduled, with potential appeals from opposing partners [120][122].

Fourth Quarter and Full-Year 2024 Financial Results and Business Update Dr. Alexander Zehnder Chief Executive Officer Program Update Dr. Myriam Mendila Chief Scientific Officer April 10, 2025 CureVac Speakers Business Update Financial Update Axel Malkomes Chief Financial Officer CureVac N.V. │ Fourth Quarter and Full-Year 2024 Results 2 Forward Looking Statements The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein ...

Core Points - The European Patent Office confirmed the validity of CureVac's European patent EP 3 708 668 B1, subject to amendments [1] - The opposition by BioNTech SE against the patent was largely dismissed, marking a significant development in the patent dispute between CureVac and BioNTech [2] - The Regional Court Düsseldorf will determine if the amended patent has been infringed, with an infringement hearing scheduled for July 1, 2025 [3] Patent Details - The patent EP 3 708 668 B1 relates to CureVac's split poly-A tail technology, which enhances medical efficacy by improving protein expression on mRNA constructs [3] - A previous lawsuit involving Acuitas Therapeutics and CureVac was settled regarding credit for inventions related to COVID-19 vaccines [3][4] - A German court invalidated a patent central to CureVac's lawsuit against BioNTech concerning compensation for the use of CureVac's intellectual property in the Comirnaty vaccine [5] Market Reaction - Following the news, CureVac's stock (CVAC) increased by 17.5%, reaching $3.29 in premarket trading [5]

Core Insights - Small-cap stocks are experiencing significant gains in bullish markets due to their growth-oriented profiles and sensitivity to improving economic conditions [1][2] - The iShares Russell 2000 ETF has increased over 13% this quarter, indicating strong investor interest in small-cap opportunities [2] Company Summaries CureVac - CureVac, a biopharmaceutical company, has a strong pipeline including mRNA-based vaccines and therapies, with a recent revenue increase of 3000% year-over-year to $520 million, largely due to a $423.5 million payment from GSK [3][4] - The company has a current P/E ratio of 5.75 and a price target of $10, suggesting a potential upside of over 200% despite a 24% decline in stock price year-to-date [4][5] - CureVac's balance sheet shows $583.4 million in cash, extending its runway beyond 2028 [4] HeartCore Enterprises - HeartCore Enterprises, a Japan-based software company, has shifted towards recurring revenue through multi-year licensing agreements, enhancing its customer experience offerings [7] - The company has seen a stock increase of 150% year-to-date, with Q3 results showing an EPS of $0.53, exceeding estimates by over 50% [8][9] - HeartCore has a client retention rate of 25.9% over ten years and projects a 12% sales increase from CMS customers in FY 2025, although it remains under the radar with low institutional ownership [9]

Group 1 - The stock of CureVac N.V. (CVAC) is experiencing significant attention due to high implied volatility in the options market, particularly for the Dec 20, 2024 $06.00 Call option [1] - Implied volatility indicates the market's expectation of future price movement, suggesting that investors anticipate a substantial move in CureVac's stock, potentially due to an upcoming event [2] - CureVac currently holds a Zacks Rank 3 (Hold) in the Medical-Biomedical and Genetics industry, which is in the top 25% of the Zacks Industry Rank, with recent analyst estimates for the current quarter increasing from 53 cents to 61 cents per share [3] Group 2 - The high implied volatility surrounding CureVac may indicate a developing trading opportunity, as options traders often seek to sell premium on options with high implied volatility to capture decay [4]

Revenue and Profitability - Revenue for Q3 2024 reached €493,902 thousand, a significant increase from €16,483 thousand in Q3 2023, representing a growth of approximately 2,895%[4] - Net profit for Q3 2024 was €338,043 thousand, compared to a net loss of €48,681 thousand in Q3 2023, indicating a turnaround in profitability[4] - The company reported a total comprehensive income of €338,167 thousand for Q3 2024, a significant improvement from a loss of €48,711 thousand in Q3 2023[4] - Operating profit for Q3 2024 was €368,379 thousand, a substantial increase from an operating loss of €54,036 thousand in Q3 2023[4] - The company recognized total revenues of €520,711 thousand for the nine months ended September 30, 2024, compared to €31,191 thousand for the same period in 2023, reflecting a growth of 1,670%[4] Research and Development - Research and development expenses increased to €49,979 thousand in Q3 2024 from €27,245 thousand in Q3 2023, reflecting a growth of 83% as the company invests in new technologies[4] - The company plans to continue investing in research and development to enhance its product pipeline and expand market presence[4] - Research and development expenses for the nine months ended September 30, 2024, increased to EUR 108,896k from EUR 82,363k in the same period of 2023, reflecting a rise of 32%[32] Financial Position - Cash and cash equivalents rose to €550,862 thousand as of September 30, 2024, up from €402,452 thousand at the end of 2023, marking an increase of 37%[9] - Total assets increased to €854,188 thousand as of September 30, 2024, compared to €788,249 thousand at the end of 2023, showing a growth of 8.34%[9] - The accumulated deficit decreased to €1,371,035 thousand as of September 30, 2024, down from €1,565,981 thousand at the end of 2023, indicating improved financial health[9] Shareholder Information - Common shares outstanding increased from 223,988,675 on December 31, 2023, to 224,338,257 on September 30, 2024, reflecting share issuances for option exercises and RSU releases[40] - The weighted-average number of diluted common shares for the three months ended September 30, 2024, was 225,219,981, an increase from 223,914,164 in the same period of 2023[71] - The weighted-average number of diluted common shares for the nine months ended September 30, 2024, was 225,380,701, compared to 219,781,884 in the same period of 2023[71] - Dievini Hopp BioTech holding GmbH & Co. KG held approximately 37% of shares and voting rights in CureVac over the last twelve months, making it the de facto parent of the Group[72] Expenses and Liabilities - General and administrative expenses decreased to EUR 51,723k for the nine months ended September 30, 2024, down from EUR 64,106k in the same period of 2023, a reduction of 19%[35] - The increase in personnel expenses for the three months ended September 30, 2024, was primarily due to restructuring costs amounting to EUR 4,823k[33] - The Group recorded restructuring accruals of EUR 9,861k as of September 30, 2024, related to a workforce reduction of approximately 30%[63] - Trade and other payables decreased by EUR 34,617k to EUR 13,416k as of September 30, 2024, primarily due to payments to raw material suppliers[58] Taxation - Tax expenses for the three months ended September 30, 2024, increased to EUR 32,529k, primarily due to current tax expenses across various entities[65] - The effective tax rate for the nine months ended September 30, 2024, was approximately 9% for CureVac N.V., 12% for CureVac SE, and 39% for CureVac Corporate Services GmbH[67] Other Financial Information - The Company received a non-refundable upfront payment of EUR 400,000k from GSK in August 2024, which was fully recognized as revenue in Q3 2024[23] - The Company recognized EUR 508,323k in revenue from agreements with GSK for the nine months ending September 30, 2024[26] - The Company reached a development milestone of EUR 10,000k under the GSK collaboration in Q3 2024, compared to EUR 1,087k in the same period of 2023[26] - A full impairment of a production line was recognized amounting to EUR 36,641k due to strategic restructuring, included in other operating expenses[51] - The decrease in inventories was EUR 24,331k, primarily due to the write-down of raw materials that would have been recoverable under a previous collaboration with GSK[54] - Cash and cash equivalents as of September 30, 2024, included USD 25,204k and CHF 142k, exposing the Group to foreign currency exchange risk[69] - The Group acquired intangible assets worth EUR 4,094k during the nine months ended September 30, 2024, compared to EUR 2,610k in the same period of 2023, indicating a 56.8% increase[47] Legal and Compliance - CureVac incurred a cost of EUR 107k related to a settlement agreement with Antony Blanc in 2023, and paid EUR 101k under this agreement during the nine months ended September 30, 2024[74] - No significant impact from entities controlled by Dievini Hopp BioTech on the unaudited interim condensed consolidated financial statements for the nine months ended September 30, 2024[73] - No subsequent events requiring disclosure were identified after the balance sheet date up to the issuance of the financial statements[75]

Financial Data and Key Metrics Changes - The company reported a strong cash position of €551 million at the end of September 2024, significantly up from €402.5 million at the end of 2023, primarily due to a €400 million upfront payment from a licensing agreement with GSK [14][60]. - Revenues increased by €477.4 million to €493.9 million for the third quarter of 2024, and by €489.5 million to €520.7 million for the nine months ended 2024 compared to the same period in 2023, driven mainly by the GSK licensing agreement [61]. - Operating profit for the third quarter was €368.4 million, compared to an operating loss of €54 million for the same quarter in 2023, indicating a significant turnaround in financial performance [62]. Business Line Data and Key Metrics Changes - The oncology pipeline includes a Phase I study for glioblastoma, which has shown promising preliminary data, and a new off-the-shelf cancer vaccine program targeting squamous non-small cell lung cancer [10][27]. - In infectious diseases, a new program targeting urinary tract infections (UTIs) was launched, addressing a critical unmet medical need due to rising antibiotic resistance [11][49]. Market Data and Key Metrics Changes - The company is focusing on high unmet medical needs in oncology and infectious diseases, with a strategic emphasis on proprietary programs for non-respiratory diseases while licensing respiratory disease programs to GSK [21][41]. - The U.S. market for UTIs presents a significant opportunity, with over 50% of patients requiring antibiotic therapy and high rates of recurrence, leading to substantial direct medical costs [43]. Company Strategy and Development Direction - The company is undergoing a corporate redesign, including a 30% workforce reduction, aimed at improving operational efficiency and focusing on R&D [9][13]. - Future development priorities include advancing off-the-shelf and personalized cancer vaccines, with a strong emphasis on leveraging mRNA technology for innovative health solutions [15][30]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategic alignment and financial strength, positioning it well for ongoing growth and success in addressing major health challenges [15][68]. - The company anticipates a substantial reduction in operating expenses starting in 2025, with a focus on maintaining R&D capabilities while streamlining operations [58][67]. Other Important Information - The company has successfully terminated all remaining raw material commitments and closed contract manufacturing organizations related to its first-generation COVID-19 vaccine, ensuring no further related payments [59]. - The new Chief Financial Officer, Axel Malkomes, brings over 30 years of experience and is expected to contribute significantly to the company's strategic initiatives [19][20]. Q&A Session Summary Question: Discussion on business opportunities outside of mRNA - Management remains focused on oncology and infectious diseases, with ongoing collaborations with GSK and MD Anderson, while exploring new opportunities within these areas [71]. Question: Update on litigation - Ongoing litigation includes a U.S. court case scheduled for March 2025, with preparations underway [72]. Question: Plans for developing a combo vaccine for flu and COVID - Development efforts for a combination vaccine are ongoing, with a Phase I study starting soon and data expected next year [73]. Question: Reasoning for selecting lung cancer as a new indication - The selection is based on scientific data and the identification of novel antigens relevant to squamous non-small cell lung cancer, addressing a high unmet need [76]. Question: Recent litigation updates in Europe - European litigation is complex and ongoing, with rulings expected in the second quarter of next year [78]. Question: Comments on prior protein-based program and differentiation - The company has validated its approach with conserved antigens in UPEC bacteria, showing superior immunogenicity compared to previous programs [80][82].