CureVac Continues to Make Pipeline Progress on mRNA Candidates; $15.40 FVE

Equity Analyst

Rachel Elfman

CureVac was founded in 2000, and its focus is on developing vaccines and therapies using messenger ribonucleic acid, or mRNA. mRNA offers several advantages, including cell-free, rapid, large-scale manufacturing and the ability to substitute new genetic sequences to create novel vaccines. Vaccines are typically composed of weakened viruses or proteins (antigens) that they express. In mRNA vaccines, the genetic code for an antigen is administered to patients who then manufacture the antigen themselves, which triggers an immune response.

CureVac's portfolio includes clinical and preclinical candidates across multiple diseases in prophylactic vaccines, oncology, and molecular therapies. CureVac’s first attempt to develop a COVID-19 vaccine did not have sufficient efficacy data and was discontinued in October 2021. The company is collaborating with GlaxoSmithKline to develop a second-generation COVID-19 vaccine using a broad technology approach with unmodified and modified mRNA constructs. CureVac and Glaxo are evaluating both types of mRNA to determine which will have stronger efficacy against COVID-19. Further, it is evaluating advanced vaccine formats to create combination vaccines with an initial focus on combining COVID-19 and influenza. Management expects there will be a suitable second-generation COVID-19 vaccine candidate by the end of 2022 to then start late-stage trials. 

The company’s other early-stage pipeline candidates include mRNA prophylactic vaccines for several diseases, such as influenza, rabies, and malaria. CureVac also has enhanced its oncology vaccine capabilities through the 2022 acquisition of Frame Cancer Therapeutics, which is focused on identifying neoantigens across different cancer types. In addition, CureVac established a partnership with Belgium-based myNEO to develop mRNA-based cancer vaccines using myNEO’s tumor antigen discovery platform. CureVac has collaborations with several organizations, including the Bill & Melinda Gates Foundation and CRISPR Therapeutics to develop some of its pipeline candidates. While CureVac does not currently have approved products, it provides long-term investors with pure-play exposure to mRNA.

Business Strategy & Outlook

We assign CureVac a no-moat rating. We think the company has the funding and technological capabilities to potentially bring several of its pipeline mRNA programs to market. However, we see significant uncertainty related to regulatory approvals for CureVac’s early-stage portfolio and a range of potential outcomes. We also see substantial uncertainty around CureVac’s defenses against other novel mRNA vaccine makers due to Moderna and BioNTech’s first-mover status in the mRNA COVID-19 vaccine market. 

The narrow moat definition states that excess normalized returns must more likely than not be positive 10 years from now. There also must not be any substantial threat of major value destruction for a narrow moat company. CureVac’s extreme Uncertainty Rating highlights the substantial threat of major value destruction for the company, so a no-moat rating is appropriate. 

CureVac was founded in 2000, and its focus is on developing vaccines and therapies using messenger ribonucleic acid, or mRNA. Researchers discovered mRNA in the early 1960s, and since then it has been studied as the basis for novel vaccines. mRNA offers several advantages, including cell-free, rapid, large-scale manufacturing and the ability to substitute new genetic sequences to create novel vaccines. Vaccines are typically composed of weakened viruses or proteins (antigens) that they express. In mRNA vaccines, the genetic code for an antigen is administered to patients who then manufacture the antigen themselves, which triggers an immune response. In addition, mRNA therapy doesn't affect DNA or result in permanent genetic changes, so it affords more flexibility with dose changes and local tissue production compared with gene therapies.

There are many challenges with mRNA that companies must overcome to achieve regulatory approval. mRNA is very fragile, and it needs to be stored at cold temperatures to prevent deterioration. Once administered, mRNA is quickly recognized as foreign genetic material, and it’s targeted by our immune system for destruction. This immune response can also lead to side effects that can limit dosing. 

CureVac began development of its mRNA COVID-19 vaccine in January 2020. The vaccine candidate selected for clinical development, Caving, was a non-chemically modified mRNA encoding the spike protein of the SIRS-Cv-2 virus and formulated within Lipid Nonpareils (Lineups). CureVac established a vaccine manufacturing partnership with Buyer to produce its COVID-19 vaccine so it could be readily available for mass distribution if successful in clinical trials. However, CureVac reported late-stage phase ba/3 results in June 2021 with overall vaccine efficacy of 48% against COVID-19 of any severity. Participants in the age group of 18 to 60 had an efficacy of 53% while participants above 60 years did not have a statistically significant determination of efficacy. The efficacy results were quite disappointing, especially compared with Moderna and BioNTech’s very strong efficacies of 94.1% and 95%, respectively. 

CureVac decided to discontinue its first-generation COVID-19 vaccine candidate in October 2021 and focus its efforts on its second-generation COVID-19 vaccine, which it partnered with GlaxoSmithKline to develop. CureVac’s results from its first-generation COVID-19 study found a favorable safety profile of CVnCoV in all age groups. The key issue was low efficacy, especially among participants above 60 years. Management attributes the lower efficacy results to the 15 different COVID-19 variants that were part of its clinical trial data readout. However, we are skeptical that the low efficacy results from CureVac’s first-generation trial can be largely attributed to the variants since Moderna and BioNTech’s approved vaccines still have high efficacy against multiple variants. Despite the disappointing results, the favorable safety profile should help expedite CureVac and Glaxo’s development of a COVID-19 vaccine. 

Unlike Moderna and BioNTech’s COVID-19 vaccines, CureVac’s first-generation candidate had the advantage of being stored at standard refrigerator temperatures. Moderna and BioNTech’s first-generation COVID-19 vaccines require very cold freezers, which makes it more difficult to transport and store. Additionally, CureVac’s first-generation vaccine required a lower dose, which would have allowed for more expedited and less costly mass production. We will closely watch the development of CureVac and Glaxo’s second-generation COVID-19 vaccine to see if it will also allow for storage at standard refrigerator temperatures and have low doses. 

CureVac’s second-generation COVID-19 vaccine candidate, CV2CoV, is taking a broader approach using both unmodified mRNA and modified mRNA constructs. We think CureVac will have a higher likelihood of approval for the second-generation COVID-19 vaccine thanks to its partnership and support from Glaxo, combined with its knowledge and experience from the first-generation COVID-19 trial. CureVac and Glaxo’s unmodified and modified mRNA constructs are intended to target variants. Further, it is evaluating advanced vaccine formats to create combination vaccines with an initial focus on combining COVID-19 and influenza. CureVac is also trying to create immune responses at lower doses, which should help enable the development of multivalent and combination vaccines.

Even though CureVac and Glaxo’s COVID-19 vaccine is in the early stages of development, we assign a probability of approval of 35%. This probability is higher than our typical weighting for early-stage pipeline candidates at other companies due to the favorable safety profile established in CureVac’s first-generation COVID-19 vaccine. The higher-than-typical probability weighting is also attributed to its broad technology approach using unmodified and modified mRNA constructs. The companies are evaluating both types of mRNA to determine which will have stronger efficacy data against COVID-19. Management expects there will likely be a suitable candidate by the end of 2022 to then start late-stage trials. 

CureVac’s ability to successfully launch differentiated mRNA therapies in addition to COVID-19, ranging from prophylactic vaccines (including rabies, rotavirus, and malaria) to oncology treatments, and therapies for ocular and lung diseases will be key to the firm's ability to potentially establish a moat in the future. Multiple competitors are making advancements in mRNA technologies, which could interfere with CureVac’s potential to see the kind of monopoly pricing power enjoyed by other innovative vaccines, such as GlaxoSmithKline's Shingrix and Pfizer's Prevnar, which were launched in recent years. We would reconsider our no-moat assessment if CureVac receives approval for several of its pipeline candidates and gains market share to establish itself as a leader in the mRNA field.

We are closely watching the development of CureVac’s second-generation COVID-19 vaccine and how its pipeline will progress beyond COVID-19 for signs of competitive advantages. The surge of investments in vaccine development during the pandemic and the existence of several mRNA vaccine players that have competing technologies, including Moderna and BioNTech’s already-approved mRNA COVID-19 vaccines, have made this space more competitive. The competition in mRNA, CureVac’s early-stage pipeline, and the wide range of outcomes depending on the results of CureVac’s clinical trials lead us to an extreme level of uncertainty. The substantial threats of major value destruction make a no-moat rating appropriate.

None

Economic Moat

CureVac B.V

CureVac BV is a clinical-stage biopharmaceutical company, which engages in developing transformative medicines based on messenger ribonucleic acid (mRNA). Its product portfolio includes clinical and preclinical candidates across multiple disease indications in prophylactic vaccines, oncology, and protein therapy. The company was founded by Ingmar Hoerr and Florian von der Mülbe in 2000 and is headquartered in Tübingen, Germany.

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The mean of analysts' price targets for CureVac N.V. (CVAC) points to a 191.7% upside in the stock.

Can CureVac N.V. (CVAC) Climb 191.74% to Reach the Level Wall Street Analysts Expect?

CureVac N.V. (NASDAQ:CVAC ) Q3 2023 Earnings Conference Call November 14, 2023 9:00 AM ET Company Participants Sarah Fakih - VP, Corporate Communications and IR Alexander Zehnder - CEO Pierre Kemula - CFO Myriam Mendila - CDO Marcus Dalton - Head, Intellectual Property Conference Call Participants Evan Wang - Guggenheim Ellie Merle - UBS Eun Yang - Jefferies Charlie Yang - Bank of America Operator Greetings and welcome to the CureVac Financial Results for Third Quarter and First Nine Months of 2023 Business Update.

CureVac N.V. (CVAC) Q3 2023 Earnings Call Transcript

CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2023 and Provides Business Update Enrollment completed for Phase 2 COVID-19 study with mono- and bivalent vaccine candidates; study on track for data read-out in early 2024 First participant dosed in seasonal flu Phase 2 study with potentially differentiated multivalent candidate; €15 million milestone payment by GSK triggered Phase 1 study in glioblastoma well on track with opening of third dose level for CVGBM, CureVac's multiepitope cancer vaccine candidate Preclinical data with multiepitope construct in oncology shows strong T cells responses and significantly extended survival in checkpoint-inhibitor resistant melanoma model Infringement ruling on four intellectual property rights postponed by Regional Court Düsseldorf pending separate validity ruling in German patent litigation against BioNTech; postponement suggests court will find all four rights to be infringed The RNA Printer® achieved first milestone, obtaining manufacturing license for GMP-grade mRNA manufacturing in cancer vaccine development Chief Business and Commercial Officer to leave CureVac at the end of his term, effective November 30, 2023 Cash and cash equivalents position of €464.1 million as of September 30, 2023 CureVac to host conference call and webcast today at 9 a.m. ET / 3 p.m.

CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2023 and Provides Business Update

COVID-19 Phase 2 clinical trial fully enrolled Study compares mono- and bivalent vaccine candidates against licensed comparator COVID-19 vaccine First participant dosed in seasonal flu Phase 2 part of combined Phase 1/2 study Study compares a potentially differentiated, multivalent vaccine candidate with broad antigen coverage against licensed comparator vaccine TÜBINGEN, GERMAN and BOSTON, MA / ACCESSWIRE / November 1, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced solid progress in its clinical vaccine development programs in COVID-19 and seasonal flu, conducted in collaboration with GSK.

CureVac Announces Solid Progress in Phase 2 COVID-19 and Seasonal Flu Clinical Development Programs in Collaboration with GSK

CureVac previously failed to develop a successful COVID-19 vaccine, but filed a lawsuit last year against BioNTech alleging intellectual property violations. On Thursday a German court paused proceedings in the lawsuit while it awaits the outcome of BioNTech's challenge to the validity of that IP.

Why CureVac Stock Plunged Today

Regional Court Düsseldorf postpones infringement ruling on four intellectual property rights in lawsuit filed by CureVac against BioNTech Ruling on infringement to be provided latest once the validity of the intellectual property rights in suit has been determined by the relevant patent offices expected in 2024 As German infringement courts only suspend the proceedings if an intellectual property right is infringed and its validity has been challenged, it may be concluded that the Regional Court Düsseldorf found all four intellectual property rights to be infringed Ruling on infringement of a fifth intellectual property right scheduled for December 28, 2023 TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / September 28, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the Regional Court Düsseldorf has decided to suspend proceedings on four intellectual property rights in the infringement lawsuit filed by CureVac against BioNTech.

CureVac Reports Progress in Intellectual Property Infringement Case Against BioNTech in Germany

CureVac NV CVAC, -3.85% said Tuesday that it has selected an mRNA flu vaccine candidate for continued clinical development, based on positive results from an early-stage study conducted in collaboration with GSK PLC GSK, +1.29%. The investigational vaccine provides broad antigen coverage against flu strains recommended by the World Health Organization and will advance to a phase 2 study, with dosing of the first study participant expected in the fourth quarter of this year, the company said in a release.

CureVac signals progress on mRNA flu vaccine

Phase 1 part of combined Phase 1/2 study assessed comprehensive series of flu vaccine candidates, featuring up to eight separate mRNA constructs per candidate Best-performing candidate providing broad antigen coverage against WHO-recommended flu strains selected for Phase 2, following positive data from Phase 1 interim analysis Dosing of first Phase 2 participant anticipated in Q4 2023; Phase 2 to include older adults and standard-of-care comparison TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / September 12, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced selection of a promising vaccine candidate for continued clinical development based on positive data from an interim analysis of the ongoing Phase 1 part of a combined Phase 1/2 study, conducted in collaboration with GSK.

CureVac Advances Seasonal Flu Study to Phase 2 in Collaboration with GSK Following Selection of Promising mRNA Vaccine Candidate with Broad Coverage

Initiated Phase 2 study in COVID-19 with monovalent and bivalent, modified mRNA vaccine candidates; continued execution on infectious disease development program in collaboration with GSK Initiated Phase 1 study of cancer vaccine candidate, CVGBM, for surgically resected glioblastoma; recruitment of second dose cohort well on track Broadened position in patent litigations by expanding the scope and asserting new intellectual property rights in Germany and the U.S. Public hearing held before the Regional Court Düsseldorf as part of German patent litigation against Pfizer/BioNTech Cash and cash equivalents position of €537.9 million as of June 30, 2023 TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / August 17, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced financial results for the second quarter and first half of 2023 and provided a business update.

CureVac Announces Financial Results for the Second Quarter and First Half of 2023 and Provides Business Update

Phase 2 study initiated at clinical sites in Australia with monovalent and bivalent mRNA COVID-19 vaccine candidates Vaccine candidates developed in collaboration with GSK within COVID-19 vaccine development program TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / August 1, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the first participant was dosed in the Phase 2 study of monovalent and bivalent modified mRNA COVID-19 vaccine candidates, developed in collaboration with GSK.

CureVac Announces Dosing of First Participant in Phase 2 Study of Modified COVID-19 mRNA Vaccine Candidates Developed in Collaboration with GSK

CureVac's unique dual-variant mRNA approach and robust financials position it at the forefront of biopharmaceutical research and development (R&D), despite recent dips in earnings and widened operating loss. The company's cash reserves rose to €617.5 million at the end of Q1 2023, enabling it to cover operational costs and invest in R&D; it also initiated a clinical study for its experimental cancer vaccine, CVGBM. CureVac's mRNA technology offers a unique edge over competitors like Moderna and Pfizer-BioNTech, as it uses both unmodified.

CureVac's CVGBM Trial: Promising Results Progress Pipeline

NEW YORK--(BUSINESS WIRE)--Yarrow Biotechnology, Inc. (“Yarrow”), an RTW Investments, LP (“RTW”) -incubated company developing nucleic acid therapeutics and other modalities for severe, genetically defined diseases including those of the central nervous system (“CNS”), today announced the appointment of Dr. Igor Splawski as Chief Scientific Officer. Dr. Splawski was previously the Chief Scientific Officer and a member of the Executive Board of CureVac (Nasdaq: CVAC), where he led a team of 150.

Dr. Igor Splawski Appointed as Chief Scientific Officer of Yarrow Biotechnology

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / July 14, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that Dr. Igor Splawski, CureVac's Chief Scientific Officer, will step down effective July 14, 2023 to return to early-stage research in the United States.

CureVac Announces Update to the Management Team

Cases in Germany and the U.S. broadened by asserting additional, new intellectual property rights Three new intellectual property rights added to infringement lawsuit against Pfizer/BioNTech in Germany, increasing number of asserted intellectual property rights to eight Tenth patent added to CureVac's counterclaim against Pfizer/BioNTech in the U.S., covering innovations in mRNA purification methods highly relevant to the manufacturing of Comirnaty® TÜBINGEN, GERMANY / ACCESSWIRE / July 13, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that it has strengthened its position in the ongoing patent litigations with Pfizer/BioNTech in Germany and the U.S. by expanding the scope of both cases by asserting new intellectual property rights.

CureVac Strengthens Ongoing Patent Litigations Bringing Additional Cases Under New Intellectual Property Rights

CureVac has an ongoing collaboration with GlaxoSmithKline. It just launched the first clinical study of a vaccine using CureVac's next-generation mRNA platform.

Why Shares of CureVac Jumped This Week

The European biotech delivered some promising news from the laboratory. It has dosed its first patient in a crucial phase 1 trial of its cancer vaccine.

Why CureVac Stock Leaped 12% Higher Today

Cancer vaccine candidate CVGBM utilizes single mRNA, encoding eight epitopes of tumor-associated antigens with demonstrated relevance in glioblastoma Study designed to evaluate safety and immunogenicity in patients with glioblastoma after surgical resection and radiotherapy First study to apply CureVac's second-generation mRNA backbone in oncology TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / June 20, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that it has dosed the first patient with its investigational cancer vaccine CVGBM in a Phase 1 study.

CureVac Doses First Patient in Phase 1 Study of Cancer Vaccine Candidate for Surgically Resected Glioblastoma

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / June 20, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the appointment of Michael Brosnan as an independent director to the company's Supervisory Board.

CureVac Appoints International Financial Expert Michael Brosnan to Supervisory Board

TÜBINGEN, GERMANY and BOSTON, USA / ACCESSWIRE / June 19, 2023 / CureVac N.V. (Nasdaq:CVAC), a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the voting results of the Company's annual general meeting.

CureVac Announces Voting Results of General Meeting

Initiated Phase 1/2 study in seasonal flu with multivalent, modified mRNA vaccine candidates; continued execution on infectious disease development program in collaboration with GSK Filed infringement counterclaim in U.S. patent litigation with Pfizer/BioNTech; case filed under nine CureVac patents; litigation timeline expected to be accelerated by successful court transfer Received positive preliminary opinion of German Federal Patent Court supporting validity of German patent challenged in nullity action by Pfizer/BioNTech; German litigation broadened by additional CureVac patent Cash and cash equivalents position of €617.5 million as of March 31, 2023 TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / May 30, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced financial results for the first quarter of 2023 and provided a business update.

CureVac Announces Financial Results for the First Quarter of 2023 and Provides Business Update

The Boston-based fund has emerged as a force to be reckoned with in the world of biotech investments.

Peter Kolchinsky-led RA Capital's New Positions Feature CureVac, Mineralys, Pilant, Enliven Therapeu

CureVac NV said on Friday it had filed an expanded patent infringement claim against Pfizer Inc and BioNTech over the use of mRNA technology and that a U.S. court had granted its request to transfer the trial.

CureVac files expanded patent lawsuit against Pfizer/BioNTech over mRNA technology

Motion to transfer U.S. litigation to Eastern District of Virginia granted at CureVac's request and expected to significantly accelerate U.S. litigation timeline CureVac is filing counterclaim in U.S. court under nine patents covering foundational mRNA innovations highly relevant to the design, formulation and manufacturing of Comirnaty® German Federal Patent Court issued preliminary opinion in April 2023 supporting validity of a German patent corresponding to one of the patents enforced against Pfizer/BioNTech in the U.S. TÜBINGEN, GERMANY / ACCESSWIRE / May 19, 2023 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that its motion to transfer the ongoing patent litigation filed by Pfizer/BioNTech in the federal district court of Massachusetts has been granted, moving the case to the Eastern District of Virginia.

CureVac Announces Developments in Patent Litigation with Pfizer/BioNTech

Initial Phase 1 part started with multivalent modified mRNA influenza vaccine candidates Candidates developed in collaboration with GSK within broad infectious disease vaccine program encode for antigens covering four WHO-recommended flu strains TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / May 8, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GSK.

CureVac Announces Dosing of First Participant in Combined Phase 1/2 Study of Multivalent, Modified Influenza Vaccine Candidates Developed in Collaboration with GSK

CureVac N.V. (CVAC) Q4 2022 Earnings Call Transcript.

News for CureVac B.V Stock (CVAC)