On May 14, 2020 Moffitt Cancer Ctr reported that Chimeric antigen receptor T-cell therapy, or CAR T, has become a game changer for lymphoma and leukemia patients who have relapsed or become resistant to previous treatments (Press release, Moffitt Cancer Ctr, MAY 14, 2020, View Source [SID1234558108]). The therapy uses a patient’s own immune cells that are re-engineered in the lab to seek out and kill cancer cells when infused back into the patient. Yescarta (axicabtagene ciloleucel) was the first CAR T-cell therapy approved for the treatment of adults with large B cell lymphoma. The pivotal ZUMA-1 clinical trial that led to its approval showed that 83% of patients responded to the therapy, with 58% having a complete response. But clinical trials often have stringent eligibility criteria and the outcomes observed may not match what physicians see in a real-world clinical setting.

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Moffitt Cancer Center organized a consortium of 16 cancer treatment facilities across the U.S. that offer Yescarta as a standard-of-care therapy for patients with relapsed/refractory large B cell lymphoma. They wanted to determine if the safety and effectiveness seen in the ZUMA-1 clinical trial were similar for patients treated with the now commercially available CAR T therapy. Their findings were published in the Journal of Clinical Oncology.

The consortium pooled retrospective data on 298 patients who completed apheresis, the process to remove a patient’s T cells, with the intent of having Yescarta manufactured and administered. It is important to point out that of this group, 129 patients (43%) would not have qualified for CAR T-cell therapy based on the ZUMA-1 comorbidity eligibility criteria. Overall, 275 patients (92%) received a Yescarta infusion. In the ZUMA-1 trial, 108 patients received Yescarta.

"Our analysis found that the overall response rate of 82%, and estimated 12 month durable response rate of 47%, for our group of patients compared favorably to the ZUMA-1 trial results," said Frederick Locke, M.D., corresponding author of the study and vice chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy and co-leader of the Immunology Program at Moffitt. "Durable response rates were encouraging even in patients with significant comorbidities, suggesting that patients need not meet ZUMA-1 eligibility criteria to benefit from axicabtagene ciloleucel."

One adverse reaction that can occur following CAR T therapy is cytokine release syndrome (CRS). This occurs when a large number of cytokines, which are small proteins released by immune cells, are rapidly released into the blood. This can cause a patient to have a fever, increased heart rate, difficulty breathing and low blood pressure. In the ZUMA-1 trial, 11% of patients treated with Yescarta experienced severe CRS. However, in the commercial setting, that number was lower at 7%.

"We believe this observation is due to the greater use of tocilizumab and corticosteroids compared to ZUMA-1, in line with evolving practice patterns for toxicity management," said Michael Jain, M.D., Ph.D., co-first author and assistant member of the Blood and Marrow Transplant and Cellular Immunotherapy Department at Moffitt.

The authors believe this study suggests that patients do not need to meet the ZUMA-1 eligibility criteria to benefit from Yescarta, including upper age limits and those with underlying conditions.

This study was funded by the National Cancer Institute through grants to Locke (K23CA201594) and Moffitt (P30CA076292).

On May 14, 2020 bluebird bio, Inc. (Nasdaq: BLUE) reported that data from its gene therapy programs for sickle cell disease (SCD), transfusion-dependent β-thalassemia (TDT) and its cell therapy program for relapsed and refractory multiple myeloma (RRMM) will be presented during the Virtual Edition of the 25thEuropean Hematology Association (EHA25) Annual Congress (Press release, bluebird bio, MAY 14, 2020, View Source [SID1234557991]).

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New data from the company’s Phase 1/2 HGB-206 study of LentiGlobin gene therapy for SCD will be presented, including updated data from patients in Group C.

bluebird bio will also present data from its ongoing clinical studies of betibeglogene autotemcel (formerly LentiGlobin gene therapy for β-thalassemia), including the Phase 3 Northstar-2 (HGB-207) study in patients who do not have a β0/β0 genotype and the Phase 3 Northstar-3 (HGB-212) study in patients who have β0/β0, β0/β+IVS-I-110, or β+IVS-I-110/β+IVS-I-110 genotypes.

Data from studies of idecabtagene vicleucel (ide-cel; bb2121), the company’s anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy in development with Bristol Myers Squibb, will be presented, including an encore presentation of results from the pivotal Phase 2 KarMMa study.

Sickle Cell Disease Data at EHA (Free EHA Whitepaper)25

Oral Presentation: Outcomes in patients treated with LentiGlobin for sickle cell disease (SCD) gene therapy: Updated results from the Phase 1/2 HGB-206 group C study
Presenting Author: Julie Kanter, M.D., University of Alabama at Birmingham, Birmingham, Ala.

Transfusion-Dependent β-Thalassemia Data at EHA (Free EHA Whitepaper)25

Oral Presentation: Improvement in erythropoiesis in patients with transfusion-dependent β-thalassemia following treatment with betibeglogene autotemcel (LentiGlobin for β-thalassemia) in the Phase 3 HGB-207 study
Presenting Author: John B. Porter, MA, M.D., FRCP, FRCPath, University College London Hospital, London, UK

Poster: Betibeglogene autotemcel (LentiGlobin) in patients with transfusion-dependent β-thalassemia and β0/β0, β+IVS-I-110/β+IVS-I-110, or β0/β+IVS-I-110 genotypes: Updated results from the HGB-212 study
Presenting Author: Evangelia Yannaki, M.D., George Papanicolaou Hospital, Thessaloniki, Greece

Multiple Myeloma Data at EHA (Free EHA Whitepaper)25

Oral Presentation: Phase II KarMMa study: Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T cell therapy, in patients with relapsed and refractory multiple myeloma
Presenting Author: Jesus San-Miguel, M.D., Ph.D., Clinica Universidad de Navarra, Navarra, Spain

Poster: Quality of life in patients with relapsed and refractory multiple myeloma treated with the BCMA-targeted CAR T cell therapy Idecabtagene vicleucel (ide-cel; bb2121): results from the KarMMa Trial
Presenting Author: Michel Delforge, M.D., Ph.D., Leuven University College, Brussels, Belgium

Poster: Matching-adjusted indirect comparisons of efficacy outcomes for idecabtagene vicleucel from the KarMMa study vs selinexor PLUS dexamethasone (STORM part 2) and belantamab mafodotin (DREAMM-2)
Presenting Author: Paula Rodriguez-Otero, M.D., Clinica Universidad de Navarra, Navarra, Spain

Poster: Baseline and postinfusion pharmcodynamic biomarkers of safety and efficacy in patients treated with idecabtagene vicleucel (ide-cel; bb2121) in the KarMMa study
Presenting Author: Justine Dell’Aringa, Bristol Myers Squibb, Seattle, Wash.

Poster: Correlation of tumor BCMA expression with response and acquired resistance to idecabtagene vicleucel in the KarMMa study in relapsed and refractory multiple myeloma
Presenting Author: Nathan Martin, Bristol Myers Squibb, Seattle, Wash.

Abstracts outlining bluebird bio’s accepted data at the EHA (Free EHA Whitepaper)25 Virtual Congress have been made available on the EHA (Free EHA Whitepaper)25 conference website. On Friday, June 12 at 8:30 AM CEST, the embargo will lift for poster and oral presentations accepted for EHA (Free EHA Whitepaper)25.

About betibeglogene autotemcel
The European Commission granted conditional marketing authorization (CMA) for betibeglogene autotemcel, marketed as ZYNTEGLO gene therapy, for patients 12 years and older with TDT who do not have a β0/β0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available. On April 28, 2020, the European Medicines Agency (EMA) renewed the CMA for ZYNTEGLO, supported by data from 32 patients treated with ZYNTEGLO including three patients with up to five years of follow-up.

TDT is a severe genetic disease caused by mutations in the β-globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT maintain Hb levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Betibeglogene autotemcel adds functional copies of a modified form of the β-globin gene (βA-T87Q-globin gene) into a patient’s own hematopoietic (blood) stem cells (HSCs). Once a patient has the βA-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.

Non-serious adverse events (AEs) observed during the clinical studies that were attributed to betibeglogene autotemcel were abdominal pain, thrombocytopenia, leukopenia, neutropenia, hot flush, dyspnoea, pain in extremity, and non-cardiac chest pain. One serious adverse event (SAE) of thrombocytopenia was considered possibly related to LentiGlobin for β-thalassemia for TDT.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

The CMA for ZYNTEGLO is only valid in the 28 member states of the EU as well as Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. Food and Drug Administration granted betibeglogene autotemcel Orphan Drug status and Breakthrough Therapy designation for the treatment of TDT. Betibeglogene autotemcel is not approved in the United States.

Betibeglogene autotemcel continues to be evaluated in the ongoing Phase 3 Northstar-2 and Northstar-3 studies. For more information about the ongoing clinical studies, visit www.northstarclinicalstudies.com or clinicaltrials.gov and use identifier NCT02906202 for Northstar-2 (HGB-207), NCT03207009 for Northstar-3 (HGB-212).

About LentiGlobin for Sickle Cell Disease
LentiGlobin for sickle cell disease is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bio’s clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the β-globin gene that leads to the production of abnormal sickle hemoglobin (HbS), causing red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive crises (VOCs). For adults and children living with SCD, this means unpredictable episodes of excruciating pain due to vaso-occlusion as well as other acute complications—such as acute chest syndrome (ACS), stroke, and infections, which can contribute to early mortality in these patients.

LentiGlobin for SCD received Orphan Medicinal Product designation from the European Commission for the treatment of SCD.

The U.S. Food and Drug Administration (FDA) granted Orphan Drug status and Regenerative Medicine Advanced Therapy designation for LentiGlobin for the treatment of SCD.

LentiGlobin for SCD is investigational and has not been approved by the European Medicines Agency (EMA) or FDA.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel and LentiGlobin for SCD. For more information visit: View Source or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

About idecabtagene vicleucel (ide-cel; bb2121)
Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3-ζ chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

In addition to the pivotal KarMMa trial evaluating ide-cel in patients with relapsed and refractory multiple myeloma, bluebird bio and Bristol Myers Squibb’s broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority Medicines (PRIME) designation, as well as Accelerated Assessment status, by the European Medicines Agency for relapsed and refractory multiple myeloma.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio.

Ide-cel is not approved for any indication in any geography.

About KarMMa
KarMMa (NCT03361748) is a pivotal, open-label, single-arm, multicenter, multinational, Phase 2 study evaluating the efficacy and safety of ide-cel in adults with relapsed and refractory multiple myeloma in North America and Europe. The primary endpoint of the study is overall response rate as assessed by an independent review committee (IRC) according to the International Myeloma Working Group (IMWG) criteria. Complete response rate is a key secondary endpoint. Other efficacy endpoints include time to response, duration of response, progression-free survival, overall survival, minimal residual disease evaluated by Next-Generation Sequencing (NGS) assay and safety. The study enrolled 140 patients, of whom 128 received ide-cel across the target dose levels of 150-450 x 10P6P CAR+ T cells after receiving lymphodepleting chemotherapy. All enrolled patients had received at least three prior treatment regimens, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and were refractory to their last regimen, defined as progression during or within 60 days of their last therapy.

On May 14, 2020 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, TCR2 Therapeutics, MAY 14, 2020, View Source [SID1234558007]).

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"Based on our clinical progress to date and a growing confidence in our TRuC platform, we are advancing a third mono TRuC-T cell candidate targeting CD70, a clinically validated target which will allow us to make further inroads into both solid tumors and hematological malignancies," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "In addition, the expression of CD70 in tumors where CD19 and mesothelin are overexpressed represents a good opportunity for our dual TRuCs. With this new program and the strengthening of our Board with the appointments of Axel Hoos and Stephen Webster, we are well-positioned to deliver on the near- and long-term value opportunities of our platform as we approach data for our lead assets in 2020."

"Despite steps taken to protect our lead programs from the impact of COVID-19, we are updating our TC-210 guidance to expect an interim update from the Phase 1 portion in mid-2020, allowing for additional time to work with clinical investigators and patients on activities that require visits to clinical sites, including data monitoring. We look forward to presenting on the efficacy, safety and translational data in the very near future," added Dr. Menzel.

Recent Developments

The U.S. Food and Drug Administration granted orphan drug designation to TC-110 for the treatment of acute lymphoblastic leukemia.

TCR2 nominated a CD70 targeted TRuC-T cell product candidate designed to treat patients with either hematological malignancies or solid tumors, including potential indications such as acute myeloid leukemia, non-Hodgkin lymphoma, renal cell carcinoma, nasopharyngeal cancer, glioblastoma, and malignant pleural/peritoneal mesothelioma.

TCR2 announced the appointment of Axel Hoos, M.D., Ph.D., to its Board of Directors. Dr. Axel Hoos is Senior Vice President, R&D Governance Chair, and Therapeutic Area Head for Oncology at GlaxoSmithKline Pharmaceuticals. He is responsible for technical and funding decisions and leads the Oncology business including discovery and development with the four focus areas of immuno-oncology, epigenetics, cell & gene therapy and synthetic lethality.

TCR2 announced the appointment of Stephen Webster to its Board of Directors. Mr. Stephen Webster served as Chief Financial Officer of Spark Therapeutics until its acquisition by Roche and brings nearly 30 years of experience in raising capital, business development transactions and operations.

COVID-19 Update

As the Company balances the commitment to treat our cancer patients while mitigating the risk of viral spread to patients, employees and their families, TCR2 has instituted protective policies consistent with guidelines provided by the Centers for Disease Control and Prevention at all TCR2 facilities.

COVID-19 has significantly impacted the global healthcare system, including the conduct of clinical trials as medical institutions prioritize the treatment of those afflicted with COVID-19. TCR2 continues to closely monitor the adverse impact of the COVID-19 pandemic on operations and ongoing clinical and preclinical development.

While the Company believes it has been able, to date, to mitigate some of the impact from the COVID-19 pandemic on its ongoing clinical programs, the Company is committed to providing an interim update of the Phase 1 portion of the TC-210 Phase 1/2 clinical trial in mid-2020 and the Phase 1 portion of the TC-110 Phase 1/2 clinical trial in the second half of 2020.

Anticipated Milestones

TCR2 anticipates an interim update from the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors in mid-2020.

TCR2 anticipates an interim update from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in 2H20.

TCR2 anticipates clinical production of TRuC-T cells at its manufacturing facility in Stevenage, UK, in 2H20.

TCR2 anticipates a target IND filing for the third mono TRuC-T cell program targeting CD70 in 1H21.

Financial Highlights

Cash Position: TCR2 ended the first quarter of 2020 with $140.7 million in cash, cash equivalents, and investments compared to $158.1 million as of December 31, 2019. Net cash used in operations was $16.4 million for the first quarter of 2020 compared to $10.8 million for first quarter of 2019. TCR2 projects net cash use of $60-70 million for 2020.

R&D Expenses: Research and development expenses were $12.0 million for the first quarter of 2020 compared to $7.9 million for the first quarter of 2019. The increase in R&D expenses is primarily related to increase in headcount, activities related to the Phase 1/2 clinical trial of TC-210 and activities related to the Phase 1/2 clinical trial of TC-110.

G&A Expenses: General and administrative expenses were $4.3 million for the first quarter of 2020 compared to $2.9 million for the first quarter of 2019. The increase in general and administrative expenses was primarily due to an increase in personnel costs and costs associated with operations as a public company.

Net Loss: Net loss was $15.5 million for the first quarter of 2020 compared to $9.9 million for the first quarter of 2019, driven predominantly by increased R&D expenses.

Upcoming Events

TCR2 Therapeutics management is scheduled to participate at the following upcoming conference.

Jefferies Global Healthcare Conference: Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics, and Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will participate in a fireside chat using a virtual platform on Tuesday, June 2, 2020 at 9:00am ET

On May 14, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL platform to address genetic diseases, reported its financial results for the three and six month periods ended March 31, 2020 (Press release, NeuBase Therapeutics, MAY 14, 2020, View Source [SID1234558036]).

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"We have generated a solid foundation of data that we expect will enable us to produce mutation-specific genetic medicines for a multitude of diseases. The positive non-human primate pharmacokinetic (biodistribution) and patient-derived cell line pharmacodynamic (activity) data released on March 31st illustrate our ability to create a new class of mutation silencing therapies. In addition, our proprietary targeting technology enables our PATrOL compounds to achieve therapeutically relevant drug concentrations throughout the body, including in the brain," said Dietrich A. Stephan, Ph.D., chief executive officer of NeuBase.

"Our therapeutic development programs continue to drive forward, despite the difficult macroenvironment, as evidenced by the recent positive platform validation data and well-received public offering. As we look ahead, our initial focus is to continue advancing our Huntington’s disease ("HD") and myotonic dystrophy type 1 ("DM1") programs through lead optimization and IND-enabling studies. We expect to announce the lead candidate for the NT0100 Program for HD by the end of calendar year 2020, followed by the initiation of IND-enabling studies during the first half of calendar year 2021. Finally, our unique biodistribution profile allows us the opportunity to develop therapies against targets and organ systems that we believe other antisense companies cannot currently reach in the body, including into the brain after systemic delivery, which is one of the grand challenges in drug delivery of macromolecules. We believe this unique ability validates our large opportunity in the antisense space," continued Dr. Stephan.

Second Fiscal Quarter of 2020 and Recent Operating Highlights

·Announced positive, preclinical pharmacokinetic ("PK") and pharmacodynamic ("PD") data validating the first-in-class genetic therapy PATrOL platform:
oPK studies of the PATrOL-enabled compound in non-human primates (NHPs) demonstrated, among other things, rapid uptake of the compound out of the body’s circulation after systemic intravenous administration, penetration by the compound into every organ and tissue system studied, and retention of therapeutically relevant doses for greater than one week after single-dose injection;
oPD studies in patient-derived cell lines demonstrated, among other things, activity in engaging target disease-causing transcripts and knocking-down resultant malfunctioning mutant protein levels preferentially over normal protein knock-down; and dose-limiting toxicities were not observed relative to a control either at or above the doses demonstrating activity in human cells in vitro; and
oPATrOL enabled compounds were generally well-tolerated in vivo after systemic administration, both after single dose administration in NHPs and multi dose administration in mice for over a month.

Financial Results for the Fiscal Quarter Ended March 31, 2020:

·At March 31, 2020, the Company had cash and cash equivalents of approximately $5.8 million, compared with cash and cash equivalents of approximately $10.3 million at September 30, 2019. Subsequent to the end of the fiscal second quarter of 2020, the Company completed a public equity offering that generated net proceeds of approximately $33.3 million. The Company believes that its current cash balance will provide sufficient capital to fund operations into the second calendar quarter of 2022;
·For the three month period ended March 31, 2020, the Company reported a net loss of approximately $4.4 million, or a net loss of $0.26 per share, compared with a net loss of approximately $2.0 million, or a net loss of $0.33 per share, for the same period last year; and
·For the three month period ended March 31, 2020, total operating expenses were approximately $4.4 million, consisting of approximately $2.8 million in general and administrative expenses and $1.6 million of research and development expenses. This compares with total operating expenses of $1.9 million for the same period last year, which was comprised of approximately $1.9 million in general and administrative expenses and $0.03 million in research and development expenses.

Financial Results for the Six Month Period Ended March 31, 2020:

·For the six month period ended March 31, 2020, the Company reported a net loss of approximately $8.9 million, or a net loss of $0.52 per share, compared with a net loss of approximately $3.5 million, or a net loss of $0.59 per share, for the same period last year; and
·For the six month period ended March 31, 2020, total operating expenses were approximately $8.1 million, consisting of approximately $5.3 million in general and administrative expenses and $2.8 million of research and development expenses. This compares with total operating expenses of $3.4 million for the same period last year, which was comprised of approximately $2.3 million in general and administrative expenses and $1.1 million in research and development and research and development- license acquired expenses.

On May 14, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results and business progress for the first three months of 2020 (Press release, Bavarian Nordic, MAY 14, 2020, View Source [SID1234558052]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "The beginning of 2020 has been a productive period for Bavarian Nordic with continued progress on our strategic initiatives. Upon completion of the acquisition of Rabipur/RabAvert and Encepur from GSK, we entered the new year as a commercial vaccine company and are today reporting revenues of the acquired products for the first time. While we see increased uncertainties in certain markets and segments due to the COVID-19 situation, we are pleased to maintain our full-year guidance, supported by strong outlook in other parts of our business, including the recent large smallpox vaccine order from the U.S. government. With strong support as well as appreciation of our updated strategy from existing and new shareholders, we also completed the planned rights issue to finance the acquisition from GSK. As a company engaged in public health and preparedness, we feel the urgency to pursue a viable vaccine for COVID-19 and are extremely pleased to support AdaptVac and an international consortium in pursuing a capsid virus like particle-based vaccine, which we believe has the real possibility to meet the WHO criteria of a single shot vaccine to protect all populations from COVID-19."

Financial highlights from the first quarter

Revenues of DKK 365 million comprised of DKK 321 million from sale of the new products, Rabipur/RabAvert and Encepur and DKK 44 million from contract work
Other operating income of DKK 628 million from sale of Priority Review Voucher
EBITDA of DKK 641 million
Cash flow from financing activities was positive with DKK 1,363 million following completion of rights issue in March generating DKK 2,824 million in gross proceeds, partly offset by repayment of DKK 1,382 million bridge financing for upfront payment to GSK (including amortized costs of DKK 9 million)
Strong cash position of DKK 2,205 million at end of the quarter, excluding unutilized credit facilities of DKK 244 million
Outlook for the year maintained with revenues of approximately DKK 1,900 million and EBITDA of approximately DKK 675 million.
DKK million Q1 2020 Q1 2019 2020 Guidance
Revenue 365 127 1,900
EBITDA 641 (90) 675
Securities, cash and cash equivalents 2,205 1,928 1,350
Events after the reporting date

In April, the Company was awarded a new USD 202 million order for JYNNEOS smallpox vaccine from the U.S. government with manufacturing and deliveries occurring in 2020 and 2021. This in addition to the USD 299 million order for delivery of freeze-dried doses and brings the total value of current orders and options beyond USD 500 million.
In May, the Company signed an exclusive heads of agreement with AdaptVac to license their proprietary capsid virus like particle (VLP) based SARS-CoV-2 subunit (COVID-19) vaccine. A final license agreement is expected to be in place by end of first half 2020. As part of the agreement, Bavarian Nordic will be responsible for the clinical development and global commercialization of the vaccine.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 5654328.