On August 22, 2023 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results and business progress for the first half of 2023 and released its financial calendar for 2024 (Press release, Bavarian Nordic, AUG 22, 2023, View Source [SID1234634629]).

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Revenue increased by 278% to DKK 3,239 million for the first half and the operating profit (EBITDA) increased to DKK 1,171 million.
For the first half, revenue comprised of DKK 2,182 million from sale of JYNNEOS/IMVANEX/IMVAMUNE mpox/smallpox vaccine, DKK 555 million from sale of Rabipur/RabAvert, DKK 299 million from sale of Encepur, DKK 35 million from sale of Vivotif and Vaxchora, DKK 81 million from sale of third-party products, and DKK 87 million in other revenue.
Revenue for the second quarter was DKK 1,987 million and comprised of DKK 1,334 million from sale of JYNNEOS/IMVANEX/IMVAMUNE mpox/smallpox vaccine, DKK 313 million from sale of Rabipur/RabAvert, DKK 211 million from sale of Encepur, DKK 35 million from sale of Vivotif and Vaxchora, DKK 38 million from sale of third-party products, and DKK 56 million in other revenue.
Cash and cash equivalents at end of the period was DKK 1,385 million.
Financial guidance for the full year is maintained at revenue of approximately DKK 6,900 million and EBITDA of approximately DKK 2,300 million.
DKK million

Q2 2023

Q2 2022

H1 2023

H1 2022

FY 2023 Guidance *

Revenue

1,987

537

3,239

857

6,900

EBITDA

690

(118)

1,171

(212)

2,300

* Numbers are approximate

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "The strong results are a resounding endorsement of our commercial strategy that has allowed us to report our best half year results to date. As guided, our mpox vaccine continues to generate a significant revenue stream in 2023, but importantly our travel vaccines have performed stronger quarter by quarter as result of market growth and strong brand performance. We are looking to further expand and diversify this business via our recent acquisition, adding two marketed vaccines and a promising vaccine candidate against chikungunya, creating the world’s largest travel vaccine company. With two successful Phase 3 readouts for our chikungunya vaccine, we are forging ahead towards licensure, and this will be a significant future asset when launched in 2025 preventing a severe and incapacitating disease. While the disappointing Phase 3 results from our RSV program has led to the discontinuation of the program, we have established a strong foundation for further growth, and we remain focused on a continued strong commercial execution."

Highlights from the period

In May, Bavarian Nordic completed its acquisition of the travel vaccine portfolio from Emergent BioSolutions, thereby assuming ownership of two marketed vaccines – Vivotif for the prevention of typhoid fever and Vaxchora for the prevention of cholera as well as CHIKV VLP, a Phase 3 vaccine candidate for the prevention of chikungunya virus. The acquisition further included a Swiss-based manufacturing facility and US-based research and development facilities and personnel. Upon closing, Bavarian Nordic made a cash payment to Emergent BioSolutions of USD 274 million, which included estimated adjustments for net working capital, debt and other customary closing adjustments.
In June, Bavarian Nordic reported Phase 3 topline results of its COVID-19 booster vaccine candidate, ABNCoV2. While the study met its primary objective, demonstrating non-inferiority to an approved mRNA-vaccine in terms of neutralizing antibodies against the original SARS-CoV-2 virus (Wuhan wild type), this may be insufficient to support licensure as the ability of the vaccine to provide efficacy at more distant circulating variants will also be important in the assessment by the authorities of the overall efficacy of ABNCoV2. Also, long-term follow-up results from a Phase 2 trial of ABNCoV2 were reported, showing persistent antibody levels associated with protection against the SARS-CoV2 index virus (Wuhan) 12 months post the booster vaccination with ABNCoV2, while lower levels were seen against a circulating Omicron variant (XBB.1.1), associated with a reduced level of efficacy.
In June, Bavarian Nordic reported initial results from the first Phase 3 trial of CHIKV VLP, showing that CHIKV VLP was immunogenic in healthy adults ≥65 years of age, as demonstrated by a strong induction of CHIKV neutralizing antibodies against chikungunya in 87% of vaccinees 22 days after vaccination, thus meeting the primary endpoint of the study.
In June, Bavarian Nordic announced a contract award of EUR 10 million to supply smallpox vaccines to rescEU, a strategic reserve within the European Union (EU) which aims to strengthen the EU’s ability to respond to biological threats in the future.
Events after the reporting date

In July, Bavarian Nordic announced that the Phase 3 trial of MVA-BN RSV, its respiratory syncytial virus (RSV) vaccine candidate for adults ≥60 years of age did not meet all the primary endpoints of preventing lower respiratory tract disease (LRTD) from RSV. Based on this outcome, the RSV program has been discontinued, including the partnership with Nuance Pharma to develop and launch the vaccine for selected Asian markets.
In August, Bavarian Nordic announced positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of CHIKV VLP in adults and adolescents aged 12 to 64 years of age. The study met its primary endpoint, demonstrating a strong induction of chikungunya neutralizing antibodies in 98% of vaccinees in the active group 22 days post vaccination. Importantly, neutralizing antibodies were observed in 97% of the subjects at 2 weeks post vaccination, confirming a rapid onset of protective levels of immunity. The results from this study and the Phase 3 study in older adults, reported in June, will form basis for submissions to the U.S. and EU regulatory authorities in 2024.
In August, Bavarian Nordic received a new contract valued at USD 120 million from the U.S. government. The contract will support manufacturing of new bulk vaccine to partly replenish the inventory used for the mpox outbreak, which will enable the Company to fulfil its long-term commitment to supply a freeze-dried vaccine to strengthen the U.S. smallpox preparedness.
Financial calendar 2024

2023 Annual Report March 6, 2024

Three-month report (Q1) May 8, 2024

Half-year report (Q2) August 22, 2024

Nine-month report (Q3) November 15, 2024

Conference call and webcast
The management of Bavarian Nordic will host an investor/analyst 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 and presentation slides can be accessed via https://bit.ly/3KdbHjU. To join the Q&A session, please register in advance via https://bit.ly/44ULhLC.

On August 22, 2023 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VIP943 (Press release, Vincerx Pharma, AUG 22, 2023, View Source [SID1234634628]). Vincerx expects to enroll the first patient in the study early in the fourth quarter of 2023.

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"The IND clearance by the FDA is a significant step forward for the VIP943 development program, our first candidate from our antibody-drug conjugate (ADC) platform to enter clinical trials," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "Our next-generation platform is designed to improve efficacy and address safety challenges associated with many ADCs. It combines an internalizing antibody binding to CD123, a novel KSPi payload, a selective and stable linker, and exclusive CellTrapper technology. We believe VIP943 has the potential to become a much needed treatment option for patients with acute myeloid leukemia (AML). We’re eager to start the clinical program and unlock the potential therapeutic benefits of this compound."

Dr. Hamdy concluded by saying, "2023 is shaping up to be a very positive year for Vincerx. Within the last eight months, we successfully filed two INDs (VIP236 and VIP943) and swiftly garnered clearance from the FDA within 30 days. We believe these accomplishments highlight the strength of our development, drug manufacturing, and regulatory expertise. Looking ahead, in addition to beginning our Phase 1 trial for VIP943, we also expect to provide preliminary results for VIP236 by late 2023 or early 2024. Collectively, these milestones support the potential for our strategy to develop small molecule and antibody-based conjugate therapies to improve the care of patients with cancer."

About VIP943

VIP943 is a novel ADC developed using Vincerx’s next-generation ADC technology designed to enhance intracellular accumulation of the KSPi payload (kinesin spindle protein inhibitor), potentially leading to higher efficacy, while limiting unwanted side effects. VIP943 binds to CD123, a validated target in myeloid malignancies. Once inside of the cell, it releases its KSPi payload. Vincerx’s CellTrapper technology ensures that the KSPi payload accumulates in the target cells, limiting uptake into non-target, non-dividing cells.

VIP943 has demonstrated increased survival and reduced tumor burden in AML (acute myelogenous leukemia) cell lines and patient-derived tumor models. In addition, Vincerx presented preclinical data on VIP943 at ASH (Free ASH Whitepaper) 2022 demonstrating superiority against Mylotarg, an approved ADC, with significantly improved safety in monkeys and better efficacy in a mouse model of acute leukemia. Preclinical data suggest that VIP943 does not induce significant cytokine release and demonstrated favorable safety in monkeys with an optimal drug, metabolism and pharmacokinetics profile.

The Phase 1 trial of VIP943 is intended to assess safety, pharmacokinetics/phamacodynamics, and preliminary efficacy of VIP943 in patients with advanced AML and myelodysplastic syndrome (MDS).

On August 22, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published in JCO Precision Oncology suggest that gene expression signatures derived from the company’s Decipher Genomics Resource for Intelligent Discovery (GRID) database may help advance understanding of the genomic drivers impacting patient response to treatment for recurrent prostate cancer (Press release, Veracyte, AUG 22, 2023, View Source [SID1234634627]). The findings, from the Phase 2 STREAM study, suggest the potential to use transcriptomic signatures to identify patients in this setting who may benefit from more intensive salvage therapy as well as those who may need alternative care such as chemotherapy.

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"The STREAM study showed that, despite treatment with six months of androgen deprivation therapy and enzalutamide, nearly 50% of patients receiving radiation therapy for prostate cancer that has returned experience relapse within three years," said Andrew Armstrong, M.D., ScM, professor of Medicine and director of Research, Duke Cancer Institute Center for Prostate and Urologic Cancers, and senior/corresponding author for the manuscript. "Using the Decipher GRID database, we found that men in the STREAM study with luminal differentiated genotypes had excellent outcomes, while those whose tumors had a basal, luminal proliferating genotype or other specific genomic characteristics such as PTEN loss had a higher risk of recurrence despite these therapies."

The three-center, prospective Phase 2 STREAM study was led by Dr. Armstrong and Duke University colleague Rhonda L. Bitting, M.D. The trial evaluated the safety and efficacy of adding six months of enzalutamide to androgen deprivation therapy (ADT) and salvage radiotherapy in patients with rising prostate-specific antigen (PSA) following radical prostatectomy and radiotherapy (RT). A previous publication demonstrated that 51% of men remained free of disease at three years following treatment.

Using prostatectomy tissue from 31 study participants, all of whom had NCCN intermediate- (12.9%) or high-risk (87.1%) disease, researchers conducted a retrospective analysis using the Decipher GRID database to determine whether specific genomic signatures could help predict which patients would benefit from the aggressive therapy regimen, and which may require additional or alternative care.

Results suggest that patients in the study who experienced shorter progression-free survival (PFS) over three years had a luminal proliferating tumor subtype, loss of the PTEN gene and/or higher homologous recombination deficiency (HRD) signature scores. Patients with luminal differentiated or luminal A-type tumors and/or higher postoperative ADT responsiveness genomic signature scores were more likely to have durable responses and long-term remissions with the aggressive systemic regimen of ADT and enzalutamide combined with salvage radiotherapy.

"This study provides further evidence that the Decipher GRID database is a valuable tool to help researchers better understand the specific genomic signatures and factors that impact prostate cancer disease progression and individual responses to various treatment approaches," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology.

The Decipher GRID database includes more than 100,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis.

On August 22, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the second quarter and six months ended June 30, 2023 (Press release, Purple Biotech, AUG 22, 2023, View Source [SID1234634626]).

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"During the second quarter of 2023 we continued to advance our lead clinical programs, CM24 in the treatment of pancreatic cancer and NT219 for head and neck cancer, while prudently managing our development and operating expenses. Our financial results in the first half of 2023 represent our clinical trials’ progress with recruitment at a pace faster than expected in our CM24 study. As we reprioritize our objectives from time to time, we have extended our cash runway into the first half of 2025," stated Purple Biotech CEO, Gil Efron.

"In the coming months, we look forward to announcing milestones including interim data from our randomized Phase 2 CM24 study as well as results from our Phase 1 NT219 dose escalation study. In addition, we are excited to commence work on IM1240, our newly acquired tri-specific antibody."

"I am excited to return to working with our dedicated team after my medical leave. I would like to thank Isaac Israel, the management, and our employees for their great work during my absence," Gil Efron added.

Financial Results for the three Months Ended June 30, 2023

Research and Development Expenses were $3.7 million, an increase of $1.7 million or 85%, compared to $2 million in the same period of 2022 mainly due to higher enrollment rate to our clinical trials.

Selling, General and Administrative Expenses were $1.4 million, a decrease of $0.1 million or 7%, compared to $1.5 million in the same period of 2022.

Operating Loss was $5.1 million, an increase of $1.5 million or 42% compared to $3.6 million in the same period of 2022 mainly due to higher research and development expenses.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $4.6 million, an increase of $1.6 million or 53%, compared to $3 million in the same period of 2022 mainly due to higher research and development expenses.

Net Loss for the three months ended June 30, 2023 was $5.2 million, or $0.25 loss per basic and diluted ADS, compared to a net loss of $3.6 million, or $0.2 loss per basic and diluted ADS, in the three months ended June 30, 2022. Adjusted net loss for the three months ended June 30, 2023 was $4.7 million, an increase of $1.7 million or 57% compared to $3 million in the three months ended June 30, 2022.

Financial Results for the Six Months Ended June 30, 2023

Research and Development Expenses were $7.2 million, a decrease of $0.8 million, or 10%, compared to $8 million in the same period of 2022. The decrease was mainly due to a decrease of $3.4 million in chemistry, manufacturing, and controls (CMC) expenses representing batch manufacturing in 2022, offset by an increase of $2 million in clinical expenses and $0.6 million in other research and development expenses in support of our growing clinical and development activities.

Sales, General and Administrative Expenses were $3.0 million, compared to $2.9 million in the same period of 2022, an increase of $0.1 million.

Operating Loss was $10.3 million, a decrease of $0.6 million, or 6%, compared to $10.9 million in the same period of 2022.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $9 million, a decrease of $1 million, compared to $10 million in the same period of 2022, mainly due to a decrease in research and development expenses.

Net Loss for the six months ended June 30, 2023 was $10.0 million, or $0.49 loss per basic and diluted ADS, compared to a net loss of $10.9 million, or $0.61 loss per basic and diluted ADS, in the same period of 2022. The decrease in net loss was mainly due to a decrease of $0.6 million in operating expenses. Adjusted net loss for the six months ended June 30, 2023 was $8.8 million, a decrease from $10.0 million in the six months ended June 30, 2022.

As of June 30, 2023, Purple Biotech had cash and cash equivalents and short-term deposits of $18.0 million. This cash position provides a cash runway into the first half of 2025.

During the six months ended June 30, 2023, the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 479,000 ADSs, at an average price of $1.83 per ADS. Net proceeds to the Company were approximately $0.85 million, net of direct issuance expenses.

On August 22, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in the therapeutic monoclonal antibody space, reported that the Company has been cleared by the FDA to begin Phase II clinical trials for brain cancer (Press release, Nascent Biotech, AUG 22, 2023, View Source [SID1234634625]). This milestone allows the Company to continue advancing Pritumumab through the regulatory clinical processes in its use against Brain Tumors including Glioblastoma.

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Nascent CEO, Sean Carrick, commented, "this is an exciting development milestone for Nascent. Phase I data was shown to be safe in five ascending independent cohorts. The data also suggested favorable clinical outcomes in various stages of disease development, that we hope to build upon in Phase II and better understand just how effective this treatment can be for patients suffering with brain cancer". The summarized Phase I data can be seen here in the poster presented at ASCO (Free ASCO Whitepaper) 2023.

Nascent Biotech therapeutic antibody Pritumumab (PTB) is a natural human antibody originally isolated from lymph nodes of a patient with cervical cancer. This monoclonal antibody targets cell surface Vimentin (also referred to as ectodomain vimentin), shown to be expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy that binds to the tumor and recruits the immune system to eliminate cancer cells.