On April 28, 2022 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the company has scheduled the release of its first quarter 2022 financial results after the market closes on Thursday May 5, 2022 (Press release, Sangamo Therapeutics, APR 28, 2022, View Source [SID1234613236]). The press release will be followed by a conference call at 4:30 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the company will review its financial results and provide business updates.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 3090098. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A replay will be available for one week following the conference call via the replay numbers for domestic and international callers: (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 3090098.

On April 28, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon) ), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported financial results for the twelve month period ending December 31, 2021 and provided an update on its corporate progress (Press release, Vivoryon Therapeutics, APR 28, 2022, View Source [SID1234613086]). The report is available on the Company’s website View Source." target="_blank" title="View Source." rel="nofollow">View Source

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"2021 was a truly outstanding year for Vivoryon, marked by a number of hugely important achievements in the clinical development of our lead candidate varoglutamstat for the treatment of Alzheimer’s disease. Despite the pandemic-related challenges, we have met the recruitment objectives for our European Phase 2b VIVIAD study and initiated our Phase 2a/b study VIVA-MIND in the U.S. as planned. Clinical development in the U.S. is further supported by the Fast Track designation the FDA has granted for varoglutamstat last December. In addition, the regulatory achievements of our Chinese partner Simcere, enabling near-term clinical development in China, broadens the tremendous opportunity we have to make varoglutamstat available to as many patients as possible. All of these highlights are a testimony to our team’s unwavering dedication to making a difference for those affected by Alzheimer’s disease worldwide," said Dr. Ulrich Dauer, CEO of Vivoryon. "As an oral small molecule designed to target all hallmarks of AD, varoglutamstat is truly differentiated from all other approaches and we are convinced that its unique mode of action positions it as an urgently needed alternative to solely Abeta-focused, antibody-based treatments. For the remainder of the year, we are looking at a number of key milestones and inflection points that we believe will further substantiate the potential of varoglutamstat in AD. The successful placement of new shares amounting to EUR 21 million at the beginning of April this year, with participation of a number of high-quality institutional investors from Europe and the U.S., will enable us to reach these milestones, and we are extremely grateful to all our shareholders for their continued support."

Clinical Portfolio Highlights

In December, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Vivoryon’s lead product candidate varoglutamstat. Varoglutamstat, an oral QPCT/L inhibitor, is the Company’s lead product candidate and the first small molecule and only project in clinical development selectively targeting the de novo production of neurotoxic N3pE amyloid, a toxic Abeta variant shown to play a pivotal role in the development and progression of Alzheimer’s disease (AD). Fast Track is a process designed to facilitate the development, and expedite the review of drugs with the potential to treat serious conditions and fill an unmet medical need, aiming to bring important new drugs to the patient earlier. With Fast Track designation, the development of varoglutamstat can benefit from more frequent engagement with the FDA to discuss varoglutamstat’s development plan and ensure collection of the appropriate data needed to successfully advance varoglutamstat through clinical development.
In September 2021, Vivoryon initiated its U.S. Phase 2a/b VIVA-MIND study (NCT03919162) for varoglutamstat in patients with early AD. VIVA-MIND is a combined Phase 2a/b study which seeks to enroll 180 patients into the Phase 2a adaptive dose finding part. If predefined criteria are fulfilled, the trial will pass a stage-gate into the Phase 2b part, enrolling an additional 234 patients treated at the selected dose for at least 72 weeks. Thus, taken together, a total of 414 patients will be treated on stable doses of varoglutamstat for 18 months in the course of the study. The primary endpoint for this study is CDR-SB (clinical dementia rating scale – sum of boxes), an established approvable endpoint measuring a combination of cognitive abilities and activities of daily living. The study is coordinated by the Alzheimer’s Disease Cooperative Study (ADCS), and supported by a US$15 million grant from the National Institute on Aging (NIA award number R01AG061146). The study is actively enrolling patients, with currently eleven sites open and on track for an interim futility analysis planned for the first half of 2023.
Vivoryon’s ongoing European VIVIAD study (NCT04498650) is a state-of-the-art Phase 2b study designed to yield important results in early AD for varoglutamstat. Mitigating the effects of the ongoing pandemic, Vivoryon has more than doubled the originally planned number of study centers. The study is enrolling a total of 250 patients with mild cognitive impairment (MCI) and mild AD. Objectives are to evaluate the long-term efficacy (primary endpoint subset of Cogstate NTB), safety and tolerability of oral varoglutamstat. The first 90 patients are randomised 1:1:1 (600 mg twice daily, (BID) or 300 mg BID varoglutamstat or placebo BID). An independent data safety monitoring board (DSMB) will unblind safety results after 90 patients have completed 24 weeks of treatment and select the final varoglutamstat dose to be carried forward for the remainder of the study. Here, all patients will be randomized 1:1 between the final dose of varoglutamstat and placebo and continue treatment up to 48-96 weeks dependent on their study entry date. In addition to the full composite Neuropsychological Test Battery (NTB) score administered throughout the study to assess cognition, a set of exploratory read-outs including cognitive tests, functional electroencephalogram (EEG), magnetic resonance imaging (MRI) assessments and the analysis of new molecular biomarkers in the cerebrospinal fluid (CSF) will be used to evaluate the compound’s effect on disease pathology. Secondary endpoints include long-term safety and tolerability of varoglutamstat and its effect on brain activity, cognition and activities of daily living. Details on the study background and design were published in the Journal "Alzheimer’s Research & Therapy" (Vijverberg et al., View Source). With 22 active study sites VIVIAD remains on track for an interim safety readout in mid-22 and Vivoryon continues to anticipate final data in the second half of 2023.
Further substantiating the rationale for evaluating varoglutamstat in combination with monoclonal antibodies to treat AD, in October 2021, Vivoryon and its collaboration partners published data providing strong preclinical evidence of treatment with a combination of the Company’s small molecule QPCT/L inhibitor varoglutamstat and its N3pE amyloid-specific antibody PBD-C06 having an additive effect on reducing brain Abeta pathology in transgenic mice. The data, published in the "International Journal of Molecular Sciences" (Hoffmann et al., View Source), support the hypothesis of a potential benefit of a combination therapy designed to simultaneously target two different and independent molecular pathways, namely reducing N3pE amyloid production by QPCT/L inhibition and clearing existing Abeta deposits through anti-N3pE-immunotherapy.
Also in October 2021, the Company announced the expansion of its manufacturing capabilities for production of active pharmaceutical ingredient (API) by initiating a second line of manufacturing with an additional partner to ensure sustainable study drug supply with varoglutamstat for VIVA-MIND beyond the ongoing Phase 2a adaptive dose finding part, as well as for potential future studies in other geographies, with the added benefit of increasing flexibility to react to global challenges such as the ongoing pandemic.
Corporate Development Highlights

In June 2021, Vivoryon and Simcere Pharmaceutical Group Ltd entered into a strategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat AD in Greater China. The agreement grants Simcere a regional license to develop and commercialize varoglutamstat (PQ912), Vivoryon’s Phase 2b-stage N3pE amyloid-targeting oral small molecule glutaminyl cyclase (QPCT) inhibitor with disease-modifying potential for AD, as well as the Company’s preclinical monoclonal N3pE antibody PBD-C06 in the Greater China region.
In March 2021, the Extraodinary General Meeting of Vivoryon re-appointed Dr. Ulrich Dauer as CEO and appointed Florian Schmid as CFO as of April 1, 2021. Mr. Schmid joined Vivoryon from InflaRx, where he served as Director Finance & Controlling. In Vivoryon’s 2021 Ordinary Annual General Meeting held June 28, 2021, all items presented for resolution by the Board of Directors were approved with a large majority, including the re-appointment of Dr. Michael Schaeffer as CBO.
Throughout 2021, Vivoryon further expanded its patent portfolio with a total of 55 additional patents that have been granted from January to December for the Company’s small molecule inhibitors and antibody-based medicines in development to treat AD and other diseases with exceptionally high medical need.
Post-period Events

On April 1, 2022, Vivoryon announced that it had successfully completed a private placement by way of accelerated bookbuilding, raising gross proceeds of EUR 21 million. The Company placed 2,000,000 registered shares at an offering price of EUR 10.50 per share. The new shares from the capital increase represent 10% of Vivoryon’s existing issued share capital and have been issued from the Company’s authoritzed capital under exclusion of the existing shareholders’ pre-emptive rights. As a consequence, the Company’s issued share capital has increased to EUR 22,050,482.00. Vivoryon intends to use the net proceeds from the offering to support the ongoing clinical development of its lead candidate varoglutamstat, as well as for general corporate purposes. The new shares have been admitted to trading on Euronext Amsterdam on April 5, 2022. The capital raise was supported by a number of high-quality institutional investors from Europe and the U.S. as well as members of Vivoryon’s Executive and Non-Executive Boards.
On February 28, 2022, Vivoryon and its partner Simcere announced that China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has approved the Clinical Trial Application for varoglutamstat for the development in Greater China by Simcere. Simcere intends to start the clinical Phase 1 study in China in the first half of 2022.
In line with the Company’s efforts to meet international best practice standards, Vivoryon plans to expand and diversify its Non-Executive Board, intending to propose two additional candidates for nomination at its 2022 Annual General Meeting to be held later this year.
Financial Results for the Full Year 2021

The Company generated license revenues of EUR 10.8 million in 2021 from a regional licensing partnership with Simcere Pharmaceutical Group Ltd for Greater China (Mainland China, Hong Kong, Macao and Taiwan) signed on June 29, 2021. No revenues were generated in 2020, respectively.

Research and development expenses increased in 2021 by EUR 4.2 million compared to the year ended December 31, 2020. This increase is primarily attributable to a EUR 3.7 million higher expenses for our clinical trial, VIVIAD, and the related production of PQ912, as well as EUR 0.8 million higher expenses for share-based payments

General and administrative expenses increased by EUR 1.7 million largely attributable to EUR 0.8 million higher expenses for share based payments as well as EUR 0.6 higher expesenses for legal and consulting services in connection with preparation of a US listing.

Net loss for the twelve months ended December 31, 2021 was EUR 12.7 million, compared to EUR 16.5 million for the twelve months ended December 31, 2020. The Company held EUR 14.7 million in cash and cash equivalents as of December 31, 2021, compared to EUR 26.3 million as of December 31, 2020.

Financial Guidance Following the capital raise completed in April 2022, according to current planning and estimates, Vivoryon expects that its existing cash and cash equivalents will be sufficient to fund its research and development expenses as well the general and administrative expenses and cash flows from investing and financing activities at least through end of May 2023. This guidance does not include potential milestone payments from development partnerships, potential payments from licensing agreements and/or additional financing measures, as far as such payments have not yet been recognized in revenues. The financial guidance takes into account all costs to ensure sustainable study drug supply with varoglutamstat for the VIVA-MIND U.S. study.

Annual Financial Report 2021

The financial statements of Vivoryon have been prepared in accordance with International Financial Reporting Standards (IFRS) of the International Accounting Standards Board, as adopted by the European Union (EU-IFRS) and with Section 2:362(9) of the Netherlands Civil Code. The auditor KPMG has issued an unqualified auditor’s report for both statements. The reports are available on the Company’s website (View Source).

Conference Call and Webcast

Vivoryon will host a conference call and webcast today, April 28, 2022, at 3:00 pm CEST (09:00 am EDT). A Q&A session will follow the presentation of the full year results.

Please dial in ten minutes prior to commencement.

A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/

Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/

On April 28, 2022 Chimera Bioengineering ("Chimera") a biotherapeutics company building next-generation CAR-T therapeutics focused primarily on solid tumors, reported the appointment of Vlad Hogenhuis, M.D., as Chief Executive Officer (CEO) (Press release, Chimera Bioengineering, APR 28, 2022, View Source [SID1234613107]). Previously, Dr. Hogenhuis was Chief Operating Officer at Ultragenyx Pharmaceuticals and Head of Specialty Pharma and Oncology at GSK. The Company also announced it won AFCR’s 2021 BRACE Award Venture Competition, in recognition of Chimera’s breakthrough science for the development of transformative cancer therapeutics. Chimera’s lead candidate, CBIO-007, is a conditionally armed CAR-T cell therapy in preclinical development as a potential treatment for major solid tumors, such as lung, breast, colorectal, pancreatic, prostate, and ovarian cancers. CBIO-007 was generated from Chimera’s proprietary GOLD Platform(TM) technology, which creates conditional, location-specific activation of tumor microenvironment (TME)-modifying payloads by CAR-T cell therapies.

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"When I was evaluating opportunities, I was immediately struck by the elegance and enormous potential impact of Chimera’s approach to enhance CAR-T efficacy while minimizing their toxicity," said Dr. Hogenhuis. "We are thrilled to have won AFCR’s BRACE Award, which has not only connected us to investors and advisors, it also has provided key funding and validation of our approach and current dataset. We’ve generated compelling preclinical data confirming delivery of potent immunomodulatory payloads to solid tumors without systemic exposure, and this data gives us confidence that Chimera’s GOLD Platform technology can unlock the potential of CAR-T to treat a broad range of cancers, including solid tumors."

AFCR’s BRACE Award is a first-of-its-kind program for early stage oncology technology companies focused on Asian-prevalent cancers. With this honor, AFCR, Bluedot Bio, and other new investors contributed $7.5 million of new capital, joining Chimera’s existing investors, including Viking Global Investors, Founders Fund, and Illumina Accelerator, to bring the company’s total amount raised to $26 million, since the company was founded in 2015. Since that time, Chimera has established a pipeline of therapies from its proprietary GOLD Platform technology, which creates conditional, location-specific activation of tumor microenvironment (TME)-modifying payloads by CAR-T therapies. The company’s preclinical dataset on its lead candidate, CBIO-007, in pancreatic, prostate, and triple negative breast cancer xenograft tumor models, demonstrates that CBIO-007 efficiently eliminates tumors, while unarmed CAR-T cells are unable to control them.

AFCR’s Chief Executive Officer and Founder Sujuan Ba, Ph.D., said, "AFCR’s BRACE Award Venture Competition is designed to accelerate the commercialization of innovative cancer research discoveries for cancer patients, in Asia and worldwide, and we believe Chimera’s novel approach to spatially controlling CAR-T cells, for safer, more potent therapies, has the potential to improve the treatment of a broad range of cancers from hematologic cancers to solid tumors."

"During the evaluation of Chimera for AFCR’s BRACE Award, I was impressed with Chimera’s insightful approach to counteract the suppressive tumor microenvironment by leveraging natural mechanisms in the engineering of T cells to selectively deliver a payload only when they are activated by tumor cells," said Raju Kucherlapati, Ph.D., Paul C. Cabot Professor of Genetics at Harvard Medical school, who led the committee for the AFCR’s BRACE Award Venture Competition and founded several biotechs, including Cell Genesys, Abgenix (acquired by Amgen) and Millennium (acquired by Takeda). "Furthermore, Chimera’s initial data in preclinical models provides support for the ability of their GOLD Platform technology to direct the curative potential of CAR-T therapies to treating solid tumors, which continues to be a leading cause of death around the world."

About Chimera’s GOLD(TM) Platform Technology

Chimera’s GOLD Platform harnesses programmable, RNA-based gene regulation circuits inherent to immune cells to control CAR-T therapies conditionally armed with therapeutic payloads that target the tumor microenvironment (TME). Chimera applies its proprietary GOLD Platform to engineer potent CAR-T cell therapies for solid tumors that target the immunosuppressive TME, which has historically limited conventional CAR-T therapeutic efficacy. In preclinical studies, the GOLD Platform spatially restricts to the site of solid tumors the delivery of high levels of powerful therapeutic payloads by armed CAR-T cells, weakening the TME and maximizing CAR-T potency. Specifically, Chimera demonstrated in head-to head preclinical experiments with unarmed as well as a constitutively armed IL-12 payload that GOLD-controlled CAR-Ts eliminated xenograft tumors from prostate, pancreas, and triple negative breast cancer cell lines. Chimera’s chimeric receptor engagement-dependent payload delivery approach is designed to prevent toxic, systemic payload exposures that can decrease the therapeutic index of armed CAR-T cells.

On April 28, 2022 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended April 2, 2022 (Press release, Thermo Fisher Scientific, APR 28, 2022, https://corporate.thermofisher.com/content/tfcorpsite/us/en/index/newsroom/press-releases/2022/Apr/28-Thermo-Fisher-Scientific-Reports-First-Quarter-2022-Results.html [SID1234613127]).

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First Quarter 2022 Highlights

First quarter revenue was $11.82 billion.
First quarter GAAP diluted earnings per share (EPS) was $5.61.
First quarter adjusted EPS was $7.25.
Delivered very strong financial results in the first quarter, with 16% Core organic growth and $1.68 billion of COVID-19 testing revenue.
Launched high-impact new products including the Applied Biosystems SeqStudio Flex Series genetic analyzer to improve clinical research and advance scientific discovery and the new Thermo Scientific TRACE 1600 Series Gas Chromatograph, one of four new instruments in our Gas Chromatography (GC) and GC-Mass Spectrometry (MS) Product Portfolio advancing analytical testing for food, environmental, industrial and pharmaceutical applications.
Strengthened our unique customer value proposition with the opening of a new biorepository in Vacaville, California, to advance our cell and gene therapy services. We also brought additional bioproduction capacity online for single-use containers and cell culture media.
Reflecting the customer value proposition for our pharma and biotech customers, and as an example of our trusted partner status, Moderna announced a 15-year strategic collaboration agreement with Thermo Fisher to enable large-scale U.S. manufacturing of future mRNA-based vaccines and therapies.
Building on our environmental, social and governance priorities and enabling broad adoption of sustainable solutions, we exceeded the milestone of shipping more than one million readily recyclable paper coolers to transport cold-chain products without the use of traditional polystyrene foam coolers.
Repurchased $2.0 billion of stock and increased our dividend by 15 percent.
"We are very pleased to deliver another quarter of excellent performance," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We started the year with great momentum, executing our proven growth strategy and continuing to be a trusted partner for our customers. Our PPD clinical research business is performing very well, the integration is going smoothly and we are even more excited about the opportunities we have to further enable the success of our pharma and biotech customers."

Casper added, "The strong execution by our team in the first quarter positions us to deliver another outstanding year."

First Quarter 2022

Revenue for the quarter grew 19% to $11.82 billion in 2022. Organic revenue growth was 3%, acquisitions increased revenue by 18% and currency translation decreased revenue by 2%. Core organic growth was 16%. COVID-19 testing revenue was $1.68 billion.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2022 was $5.61, versus $5.88 in the same quarter last year. GAAP operating income for the first quarter of 2022 was $2.82 billion, compared with $3.05 billion in the year-ago quarter. GAAP operating margin was 23.9%, compared with 30.8% in the first quarter of 2021.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2022 was $7.25, versus $7.21 in the first quarter of 2021. Adjusted operating income for the first quarter of 2022 was $3.45 billion, compared with $3.51 billion in the first quarter of 2021. Adjusted operating margin was 29.2%, compared with 35.4% in the first quarter of 2021.

Annual Guidance for 2022

The company will provide updated 2022 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Daylight Time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, April 28, at 8:30 a.m. Eastern Daylight Time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The access code is 310385. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financials." An audio archive of the call will be available under "News and Events" through Friday, May 13, 2022.

On April 28, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported financial results for the fourth quarter and full-year 2021 and provided a business update (Press release, CureVac, APR 28, 2022, View Source [SID1234613143]).

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"Going into 2022, we are strengthening our competitive position as a central mRNA player by leveraging our three core competencies: broad technology platform, solid product develop­ment pipeline, and large GMP manu­facturing capacities," said Franz-Werner Haas, Chief Executive Officer of CureVac. "We are extending our technology platform into multivalent as well as modified mRNA approaches to further advance our vaccines pipeline. Together with GSK, we initiated the clinical evaluation of COVID-19 and multi­valent influenza vaccine candidates. Leveraging our broad learnings, we are getting prepared to also drive broad innovation in oncology. Our fully owned subsidiary to advance The RNA Printer is now established and the system is expected to support our oncology pipeline by enabling personalized therapy approaches. Overall, the progress made with our technology as well as our manufacturing capabilities will enable us and GSK to execute on our contract for pandemic preparedness with the German government, validating our ability to help safeguard public health today and into the future."

"While we have resolved most of the commitments associated with the withdrawal of our first-generation COVID-19 candidate, CVnCoV, we have been working to close the final associated negotiations," said Pierre Kemula, Chief Financial Officer of CureVac. "Importantly, we have received confirmation from the European Union that the upfront payment of €450 million associated with the now terminated Advanced Purchase Agreement for CVnCoV is not to be repaid. For 2022, our priorities lie in the execution of our second-generation development program. Programs for COVID-19 and influenza have advanced into the clinic, and the latter is on track to generating development and regulatory milestone pay­ments. We believe our solid cash position at the end of 2021 of €811.5 million sets us up well to execute on our priorities in 2022."

Selected Business Updates

Prophylactic Vaccines

Executing on Broad Second-Generation mRNA Vaccine Program, Jointly Developed with GSK

CureVac aims to be at the forefront of delivering second-generation mRNA-based vaccines against a range of relevant infectious diseases and is executing on a broad mRNA vaccine program in collaboration with GSK. The optimized second-generation mRNA backbone targets improved intracellular mRNA translation for increased and extended protein expression, resulting in earlier and stronger immune responses compared to CureVac’s first-generation candidate, CVnCoV. Second-generation mRNA-based vaccines are expected to allow for flexible protection against one or more emerging COVID-19 variants and to offer new mRNA approaches to other infectious disease vaccines, such as influenza, and potential combination vaccines against different viruses.

CV2CoV –Second-Generation COVID-19 Vaccine Candidate

CV2CoV is the first representative of the COVID-19 vaccine program, jointly developed with GSK, based on CureVac’s second-generation mRNA backbone. Following a successful preclinical study of the non-chemically modified candidate in non-human primates, published in Nature in November 2021, CV2CoV entered a clinical Phase 1 dose-escalation trial in March 2022. The Phase 1 study is being conducted at clinical sites in the U.S. and is expected to enroll up to 210 participants to evaluate the safety, reactogenicity and immunogenicity of CV2CoV at six different dose levels ranging from 2 to 20µg per dose. Data from the Phase 1 study are expected in the second half of 2022.

In 2022, CureVac and GSK broadened their development strategy to test chemically modified mRNA technologies in addition to unmodified mRNA. This approach will ensure a data-driven selection of the best performing candidate. A clinical program to evaluate a variant-specific COVID-19 vaccine candidate with chemically modified mRNA is expected to start later this year.

CV2CoV-Beta/Delta – Bivalent Second-Generation COVID-19 Candidate

On April 21, 2022, CureVac strengthened its COVID-19 vaccine program based on a technology expansion into multivalent approaches combining different mRNAs in one vaccine. A bivalent second-generation COVID-19 vaccine candidate encoding for the Beta and the Delta variants is jointly being developed with GSK.

A recently completed preclinical study, conducted in collaboration with the Friedrich-Loeffler-Institut, Germany, assessed a 0.5 µg dose of the bivalent Beta/Delta candidate, composed of 0.25 µg of each mRNA, in comparison to 0.5 µg doses of the corresponding monovalent vaccine controls in a mouse model. Despite containing only half the dose per variant mRNA, the combined Beta/Delta candidate performed comparably to the monovalent vaccine controls to either Beta or Delta. Notably, the bivalent Beta/Delta vaccine candidate induced two-fold higher virus neutralizing antibody titers against the Omicron variant than against the Delta variant in a rat model. This finding provides evidence for a potentially increased breadth of immune responses resulting from the bivalent approach. The full manuscript of the preclinical data is available on the preprint server bioRxiv.

CVSQIV – Second-Generation Influenza Vaccine Candidate

The first candidate from the broad infectious disease program developed in collaboration with GSK is CVSQIV, a multivalent seasonal influenza vaccine candidate also based on the advanced second-generation mRNA backbone. This differentiated vaccine candidate features multiple, separate non-chemically modified mRNA constructs to induce immune responses against four different influenza strains. Rapid manufacturing and the ability to feature even short-notice strain updates for the approaching influenza season are expected to enable mRNA technology to deliver improved influenza candidates that better meet the challenge of providing highly effective seasonally updated vaccines.

A clinical Phase 1 dose-escalation study was initiated in February 2022 to evaluate the safety, reactogenicity and immunogenicity of CVSQIV at five dose levels ranging from 3 to 28 µg per dose. The study is fully recruited with 240 participants. Dose-escalation was monitored for each dose and approved without safety concerns following review by the Integrated Scientific Review Committee (iSRC). Preliminary data on the safety and tolerability confirm CVSQIV to be well tolerated. No serious adverse events or other dose-limiting effects were observed at any dose level.

As in the joint COVID-19 vaccine program, chemically modified mRNA will also be tested in the influenza program to ensure data-driven selection of the best performing candidate. A clinical program with chemically modified mRNA for influenza is expected to start later this year.

Oncology

Strategic Pillars to Increase Momentum in Oncology Pipeline

CureVac plans to build a meaningful portfolio and create long-term value in oncology to accelerate growth beyond the recent progress in prophylactic vaccines. Developing new oncology candidates is characterized by similar medical challenges as in infectious diseases, including selection and accessibility of disease-relevant antigens, enhancing antigen-induced immune activation, and triggering immune responses led by a strong induction of tumor-killing T cells.

Taking advantage of recent technology platform advances, particularly its second-generation mRNA backbone in infectious diseases, CureVac is evaluating targeted expansions of its unique mRNA approaches for the development of cancer vaccines based on three strategic pillars:

Validation and optimization of its broad mRNA technology approach for T cell mediated tumor control against different classes of cancer antigens
Build-up of a pipeline of cancer vaccine candidates targeting antigens predicted to be immuno­genic and presented on tumors in cancer patients
Addition of comple­mentary platform technologies for improved antigen discovery, validation and optimization of vaccine design focusing on T cell activation
In this context, CureVac is committed to drive innovation in oncology by leveraging The RNA Printer, CureVac’s automated end-to-end manufacturing solution for GMP-grade mRNA vaccines and thera­peutics. The highly standardized system is expected to allow for rapid and highly flexible availability of mRNA to screen new targets and transition promising mRNA product candidates more efficiently into the clinic. Designed for small-scale quantities, the automated GMP-grade output of The RNA Printer is designed to open avenues for personalized mRNA-based cancer therapies.

Corporate Development and Business Transformation

Advancing The RNA Printer

On March 1, 2022, CureVac announced the establishment of CureVac RNA Printer GmbH, a fully owned CureVac company to advance The RNA Printer. The RNA Printer is CureVac’s solution for integrated and automated manufacturing of GMP-grade RNA vaccines and therapeutics. The new entity is designed as a platform and services company, providing a dedicated operational environment to further develop and establish The RNA Printer as a manufacturing end-to-end solution. The system is powered by a proprietary and advanced manu­facturing technology designed to cover all steps for rapid and standardized manufacturing of smaller scale mRNA medicines. Engineered in collaboration with Tesla Automation, The RNA Printer aims to facilitate broad access to mRNA technology and accelerate the transition of innovative product concepts into the clinic across different therapeutic areas e.g., for rapid supply of new mRNA-based vaccines in pandemic situations or patient access to advanced and personalized mRNA-based therapies in oncology.

The company is led by Dr. Markus Bergmann, who joined CureVac RNA Printer GmbH as General Manager on March 1, 2022. Prior to this position, Dr. Bergmann held various management positions at ZF Group, Germany, and Rolls Royce plc, UK, building up a strong background in developing targeted product strategies, transforming businesses and increasing business efficiency. He started his career as a doctor at the University Hospital in Tübingen, Germany, in the Department of Hematology and Oncology. His medical background as well as his experience in a high-tech field represent a perfect fit to advance this manufacturing technology.

Pandemic Preparedness Contract with German Federal Government

In April 2022, CureVac and GSK entered a contract with the German federal government to supply mRNA vaccine doses at short notice and reserve manufacturing capacity in case of a public health emergency. Following a setup phase of up to two years, the contract grants the German federal government access to CureVac’s manufacturing capacity until 2029, enabling rapid availability of 80 million mRNA-based vaccine doses developed by CureVac and GSK during the remainder of the current pandemic or in future infectious disease outbreaks. By reserving this manufacturing capacity, the tender seeks to mitigate risks associated with potential supply challenges in a pandemic situation.

Under the contract, the federal government will pay CureVac and GSK an annual standby fee after successful completion of the setup period, which requires the companies to maintain manufacturing capacity at constant readiness. By ensuring the availability of manufacturing capacity in Germany, the arrangement will significantly contribute to strengthening pandemic preparedness.

Financial Update for the Fourth Quarter and Full-Year of 2021

Cash Position

Cash and cash equivalents decreased to €811.5 million as of December 31, 2021, from €1,322.6 billion as of December 31, 2020. In 2021, cash used in operations was mainly allocated to the advancement of all R&D activities and preparing for the supply of CVnCoV, CureVac’s first-generation COVID-19 vaccine candidate, which was withdrawn from the regulatory approval process in October 2021.
Cash inflows were mainly provided by the raising of €404 million in net proceeds in a follow-on public offering in the first quarter of the year, an upfront payment of €75 million received in May 2021 related to the COVID-19 collaboration with GSK and €93.5 million in grant funds from the German Federal Ministry of Education and Research (BMBF).

Revenues

Revenues amounted to €41.2 million and €103.0 million for the three and twelve months ended December 31, 2021, respectively, representing an increase of €35.2 million and €54.1 million, or 587% and 111%, from €6.0 million and €48.9 million for the same periods in 2020.

The increase was primarily driven by revenues from the two collaborations we have with GSK and the termination of the Boehringer Ingelheim collaboration agreement. For both GSK collaboration agreements, total revenues of €74.3 million were recognized for the year ended December 31, 2021, compared to €8.8 million in the prior year. The termination of the Boehringer Ingelheim collaboration agreement accelerated the recognition of the remaining contract liability related to the upfront payment. In addition, an option fee payment of €5 million and the additional €7 million development milestone were recognized. For the year ended December 31, 2021, €26.0 million were recognized as revenues as a consequence of the termination of the Boehringer Ingelheim collaboration, compared to €1.9 million for the full year 2020.

In the year ended December 31, 2020, revenue primarily consisted of €34.9 million recognized from the former collaboration with Eli Lilly, including €33.1 million in contract liabilities.

Operating Result

Operating loss amounted to €5.5 million and €412.3 million for the three and twelve months ended December 31, 2021, representing a decrease of €41.1 million and an increase of €302.5 million, from €46.6 million and €109.8 million for the same periods in 2020.

The operating result was affected by several key drivers:

Cost of sales increased primarily due to the recognition of expenses related to contract manufacturing organization (CMO) set-up activities and, to a lesser extent, write-offs related to inventory in the period preceding the withdrawal of the EMA application for CVnCoV.
Research and development expenses increases were primarily attributable to significantly higher development expenses related to the Phase 2b/3 clinical trial for CVnCoV with 40,000 subjects. These expenses were mainly composed of costs incurred to clinical research organizations, an onerous contract provision for the remaining CVnCoV clinical trial costs and personnel costs involved in the remaining CVnCoV development. In addition, the increase was also driven by the recognition of settlement costs related to the termination of several CMO contracts and write-offs of CVnCoV-related prepayments and inventory.
General and administrative expenses increased due to consulting services for CVnCoV product launch readiness, personnel related costs with increased headcount and higher expense recognized on share-based payments awards made in 2021.
These impacts were partially compensated by income related to the release of governmental contract liabilities, related to the upfront payment from the European Commission (EC) and the grant from the BMBF, the German Federal Ministry of Education and Research.

On November 30, 2020, CureVac entered into an Advance Purchase Agreement (APA) with the EC for 225 million doses of CVnCoV on behalf and in the name of all member states of the European Union. Pursuant to the APA, an upfront payment was provided to support CureVac’s operations in the accelerated efforts to develop a safe and effective vaccine. The upfront payment of €450 million was paid by the EC and was included in contract liabilities as of December 31, 2020. The APA automatically terminated when CureVac notified the EC of the withdrawal of CVnCoV from the regulatory approval process in October 2021. Since CureVac was able to demonstrate that the upfront payment was spent in accordance with the contract, no repayment was required. The contract liability amounting to €450 million was released and recognized as income related to the release of governmental contract liabilities in the fourth quarter of 2021.

In July 2020, CureVac applied for a grant from the BMBF, provided as part of a special program to accelerate the research and development of urgently needed vaccines against SARS-CoV-2. Under the grant, CureVac was eligible for up to €252 million and payments were contingent on reaching predefined milestones. Based on the terms and conditions, the arrangement consisted of a separate grant component and a supply component with the German Federal Ministry of Health. The amount attributed to the supply of future deliveries was presented in contract liabilities as of December 31, 2020. CureVac reached all the predefined milestones for 2020. CureVac was not able to reach all predefined milestones for 2021 due to the withdrawal of CVnCoV from the EMA approval process.

In November 2021, CureVac notified the German Federal Ministry of Health of the inability to supply CVnCoV, triggering the automatic termination of the supply component of the agreement. As a result, the contract liability of €124.5 million was released and recognized as income in the fourth quarter of 2021. In addition, in 2021, other income of €67.7 million was mostly recognized from grants from government agencies, primarily the BMBF. From 2020 to December 2021, CureVac received a total of €196.3 million under this grant.

Financial Result (Finance Income and Expenses)

Financial result, on a net basis, for the three and twelve months ended December 31, 2021, was a gain of €1.0 million and a loss of €0.2 million, respectively, representing an increase of €11.7 million and €19.8 million, from a loss of €10.7 million and €20.0 million for the same periods in 2020. Financial result for the twelve months ended December 31, 2021, was mainly driven by negative interest on cash, held in liquid funds to support the development and manufacturing activities of CVnCoV and CV2CoV. Negative interest on cash was almost fully offset by foreign exchange gains. The financial result for the twelve months ended December 31, 2020, was mainly driven by interest recognized on convertible loans, which were fully repaid in August 2020.

Pre-Tax Loss

Pre-tax losses were €4.5 million and €412.5 million for the three and twelve months ended December 31, 2021, respectively, compared to €57.3 million and €129.8 million in the same respective periods of 2020.

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