On November 12, 2021 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results for the first nine months of 2021 and business progress for the third quarter of 2021 (Press release, Bavarian Nordic, NOV 12, 2021, View Source [SID1234595439]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We continued to experience a challenging market environment for our travelers vaccine business during the third quarter, due to COVID-19. Despite these headwinds, we remain on track to meet our guidance as both our smallpox and Ebola vaccine sales remain unaffected. This truly highlights the importance of a broader and more diversified product portfolio. We are very pleased with the strong pipeline progress seen during the quarter, where highly promising results for our COVID-19 booster vaccine candidate were reported and funding for the remaining phases was secured. Likewise, we have presented strong results for our RSV vaccine candidate, which showed remarkable efficacy in reducing symptomatic RSV infections in a challenge study. These assets provide an encouraging outlook for Bavarian Nordic, and we look forward to providing more updates as the work progresses."

Financial highlights

Total revenue in the first nine months was DKK 1,354 million comprised of DKK 1,323 million from combined product sales and DKK 31 million from contract work.
Revenue in the third quarter totaled DKK 449 million comprised of DKK 214 million from sales of MVA-BN smallpox vaccine, DKK 160 million from sales of Rabipur/RabAvert, DKK 72 million from sales of Encepur and DKK 3 million from contract work.
EBITDA in the first nine months was DKK 44 million.
Strong cash position of DKK 2,182 million** at the end of the period.
Full-year guidance maintained with expected revenue of approximately DKK 1,900 million, EBITDA of approximately DKK 100 million and securities, cash and cash equivalents at year-end of approximately DKK 1,400 million.

EBITDA in the first nine months of 2020 was positively impacted by the sale of the Priority Review Voucher (DKK 628 million).
** Unutilized credit facilities of DKK 243 million not included. Repo pledged securities deducted.

Other highlights

In August, initial results from the first-in-human trial of the COVID-19 vaccine candidate, ABNCoV2 were reported, which demonstrated that the vaccine candidate was well tolerated and induced a strong antibody response, higher than currently approved vaccines. Results from the high dose groups are now available and suggest a plateau in the responses as similar high antibody titers were shown for these groups. Importantly, a strong neutralization response was demonstrated against SARS-CoV-2 variants, including the Delta variant.
In August, Bavarian Nordic initiated a phase 2 clinical trial of ABNCoV2 to investigate the vaccine’s potential as a universal booster vaccine for individuals with existing immunity from prior COVID-19 disease or vaccination. Initial results from the study are expected in December 2021.
In August, Bavarian Nordic entered a funding agreement with the Danish Ministry of Health, under which the Company will be eligible to receive up to DKK 800 million to further advance the development of ABNCoV2 as a booster vaccine for COVID-19. The agreement was finally executed in September upon approval from the Finance Committee of the Danish Parliament.
In September, Bavarian Nordic reported positive results from the human challenge trial of MVA-BN RSV. The trial achieved the primary endpoint of the pivotal study by demonstrating a statistically significant reduction in viral load in vaccinated versus control (placebo) treated volunteers. The vaccine demonstrated a 79% efficacy in reducing symptomatic RSV infections. Preparations for a phase 3 trial in 2022 continue, pending a final decision driven by regulatory discussions and feedback on the trial design and funding/partnering considerations.
Events after the reporting date

In accordance with the shareholder authorization for the board of directors and the Company’s remuneration policy, the board of directors has today decided to issue warrants to executive management and certain employees in the Bavarian Nordic Group. In accordance with the Company’s remuneration policy, President and CEO, Paul Chaplin will receive an extraordinary grant as further explained on page 6 in the interim report. A total of 716,256 warrants have been issued, which entitle the warrant holders to subscribe for up to 716,256 shares in total, with a nominal value of DKK 10 each at an exercise price of DKK 353.06 per share.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) 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 2839609.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, [email protected], Tel: +1 781 686 9600

Company Announcement no. 35 / 2021

On November 12, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that Susan Molineaux, Ph.D., the company’s founder, president and chief executive officer, will present at the 2021 Jefferies London Healthcare Conference (Press release, Calithera Biosciences, NOV 12, 2021, View Source [SID1234595428]).

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The presentation will be available for on-demand viewing starting Thursday, November 18 at 3:00 a.m. Eastern Time, and can be accessed through the Investors section of the Company’s website at www.calithera.com. The replay of the webcast will be available on the Company’s website for 30 days.

On November 12, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported a trial-in-progress poster on SBT6050-201 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, held virtually from November 10-14, 2021 (Press release, Silverback Therapeutics, NOV 12, 2021, View Source [SID1234595411]). SBT6050-201 is a Phase 1/2 study evaluating SBT6050 in combination with trastuzumab deruxtecan (Enhertu), or with trastuzumab (Herceptin) and tucatinib (Tukysa) with or without capecitabine, in patients with HER2-expressing or HER2-amplified gastroesophageal, non-small cell lung, breast, and colorectal cancers.

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"SBT6050 was designed to enable combinations with trastuzumab-containing regimens, which are foundational in the standard of care for HER2-positive solid tumors," said Naomi Hunder, M.D., chief medical officer of Silverback Therapeutics. "There is compelling scientific and clinical rationale to combine SBT6050 with these regimens. Importantly, in addition to the trastuzumab component of these regimens, they each contain a cytotoxic component that drives immunogenic cell death, releasing tumor neoantigens. SBT6050 activates dendritic cells, potentially enhancing neoantigen presentation to T cells and amplifying the anti-tumor response. SBT6050 may also enhance trastuzumab-mediated antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. We look forward to initiating clinical evaluation of these combinations in the first quarter of 2022."

The poster is now available on the SITC (Free SITC Whitepaper) website and on the Silverback website here. Details are as follows:

Poster Title: A phase 1/2 study of SBT6050 combined with trastuzumab deruxtecan (T-DXd) or trastuzumab and tucatinib with or without capecitabine in patients with HER2-expressing or HER2-amplified cancers
Presenter: Sam J. Klempner, MD
Category: Clinical Trials in Progress
Abstract Number: 393

About SBT6050

SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. TLR8 is expressed in myeloid cell types prevalent in human tumors and TLR8 agonism can activate a broad spectrum of anti-tumor immune mechanisms, including pathways involved in the innate and adaptive immune response. SBT6050 was specifically designed to bind to the HER2 sub-domain II, the pertuzumab epitope, to enable combinations with trastuzumab-containing therapies. SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.

On November 12, 2021 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported the first preclinical data for SNS-101, its anti-VISTA (V-domain Ig suppressor of T cell activation) product candidate (Press release, Sensei Biotherapeutics, NOV 12, 2021, View Source [SID1234595410]). The data will be presented during a poster session on November 13, 2021, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC 2021) 36th Annual Meeting in Washington, D.C. and virtually .

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"VISTA has been recognized for years as an important immune checkpoint but has been difficult to drug due to its unique pH-dependent biology," said Robert Pierce, M.D. chief scientific officer of Sensei Biotherapeutics. "VISTA is primarily expressed on myeloid cells, a hub of immunosuppressive activity, and functions as a checkpoint exclusively under acidic conditions where it binds to its receptor, PSGL-1. Our scientific team has been evaluating VISTA for several years. Accordingly, we believe, the key to unlocking the power of this checkpoint lies with the development of an antibody that selectively binds the active form of VISTA that is only present within the low pH of the tumor microenvironment. At SITC (Free SITC Whitepaper), we are excited to share the preclinical data demonstrating that SNS-101 binds active VISTA with high affinity and significant selectivity (~600-fold increase at pH 6.0 versus 7.4)."

Dr. Pierce continued, "We are also encouraged by early in vivo evidence from a human VISTA knock-in mouse model showing improved immune responses, including the anticipated combination effect with anti-PD1 in a PD1 blockade responsive tumor model. We continue to expand on this research and are looking forward to sharing more in vivo data at a future medical conference. IND-enabling studies are already underway to evaluate the potential of SNS-101 to become a novel treatment for solid cancers, as both a monotherapy and in combination, that overcomes on-target/off-tumor toxicities seen today with other I/O approaches."

Preclinical data for SNS-101 are being presented in a poster (#228) titled: "Antagonistic pH-selective VISTA antibody SNS-101 potentiates anti-PD-1/PD-L1-induced anti-tumor immunity." A summary of data in the poster include:

Preclinical data demonstrated that SNS-101 successfully blocked the interaction of VISTA with its PSGL-1 receptor, demonstrating high-affinity binding to low pH-VISTA sub-nanomolar affinity with exemplary (>600-fold) pH-selectivity vs. physiologic pH-VISTA.
SNS-101, in combination with an anti-PD-1 inhibitor, led to superior anti-tumor activity compared to PD-1 alone.
SNS-101 is a fully human IgG1 and has entered IND-enabling studies.
Sensei will host a virtual science symposium on Tuesday, November 16, 2021, at 4:00 p.m. Eastern Time to discuss the potential of the VISTA checkpoint inhibitor to address current limitations of immune checkpoint therapy. The event will be hosted by Sensei’s management team and will include a presentation on VISTA biology by Robert Schreiber, Ph.D., the Andrew M. Bursky and Jane M. Bursky Distinguished Professor of Pathology and Immunology, Professor of Molecular Microbiology and co-leader of the tumor immunology program at the Siteman Comprehensive Cancer Center and Founding Director of the Center for Human Immunology and Immunotherapy Programs at the Washington University School of Medicine.

A live webcast of the symposium will be available under "Events & Presentations" in the Investors section of the company’s website at www.senseibio.com. An archived replay will be available for approximately 90 days following the event.

About VISTA (V-domain Ig suppressor of T cell activation)

VISTA (B7-H5) is recognized as an important immune checkpoint regulator that is expressed primarily on myeloid cells, a hub of immunosuppressive activity, and acts via binding to its receptor on T-cells (PSGL-1) at sub physiologic pH. Disrupting the interaction of VISTA and its receptor on T-cells has been shown to enhance T-cell activation and tumor cell death. The VISTA-PSGL-1 T-cell checkpoint is activated under low pH conditions such as the tumor microenvironment. VISTA is found to be expressed in numerous cancer types and appears to be associated with PD-1 resistance.

The therapeutic hypothesis that Sensei believes differentiates its VISTA program is that an effective and safe inhibitory anti-VISTA antibody must demonstrate: (1) selective binding to the active form of VISTA (protonated/low pH) in order to avoid target mediated drug disposition and on-target/off-tumor effects; (2) effective inhibition of active VISTA’s interaction with PSGL-1; and (3) Fc-mediated activation of tumor resident myeloid cells to facilitate conversion from an immunosuppressive to an immune-activating phenotype.

About SNS-101
SNS-101 is a potent, pH-dependent fully human monoclonal antibody designed to block the interaction of VISTA, a novel immune checkpoint that is expressed primarily on myeloid cells, with its receptor, PSGL-1. Selectivity is achieved because SNS-101 targets the active (i.e., protonated) VISTA present in the low pH tumor microenvironment. SNS-101 was selected based on 1) the lack of significant binding to VISTA at physiologic pH (i.e., deprotonated VISTA in the blood), and 2) its high-affinity binding to active VISTA (pH 6.0), which yielded a > 600-fold selectivity. Based on the biochemical properties of SNS-101, Sensei anticipates tumor microenvironment selective activity for this preclinical product candidate. VISTA has been shown to be expressed in numerous tumor types, including non-small cell lung cancer (NSCLC).

On November 12, 2021 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported its financial results for the quarter ended September 30, 2021 and provided a business update (Press release, Sellas Life Sciences, NOV 12, 2021, View Source [SID1234595409]).

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"During the third quarter of 2021, in addition to continuing to enroll patients in the United States and Europe for our Phase 3 REGAL study of galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients, we also commenced clinical and regulatory preparations for a potential new Phase 2/3 study of GPS in AML patients following a bone marrow transplant (BMT) who harbor minimal residual disease (MRD)," said Angelos M. Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "We are excited to begin exploring GPS as a treatment option for this post-BMT population which, based on the retrospective outcomes data published earlier in the summer, remains an area of unmet need. We believe there is significant opportunity for GPS to become the key antileukemic vaccine immunotherapy in various AML settings, with the potential to treat patients who have undergone a BMT as well as patients who have achieved second remission in AML (CR2), the indication of our REGAL study."

Dr. Yair Levy, Director of Hematologic Malignancies at the Baylor University Medical Center, stated "I look forward to a clinical trial in transplanted patients that would address the high relapse rate among MRD positive (MRD+) AML patients. Although BMT remains the only truly curative treatment for AML patients with any significant disease risk, its benefit is limited by relapses in about 50% of patients who enter transplant with MRD. The trial being planned by SELLAS would explore whether GPS could be a treatment option for a much larger population of AML patients – i.e., those patients who have undergone BMT whose chances of remaining in remission could significantly improve as well as the large number of MRD+ patients who have been shown to have a high relapse rate after BMT or who do not undergo a BMT because they are considered unlikely to benefit from it."

Pipeline Update and Corporate Highlights:

Phase 3 REGAL Study:
Additional sites in the United States and European Union were activated during the third quarter with enrollment continuing. In addition, regulatory approval to commence the REGAL study was received in both Hungary and Taiwan during the quarter.
The final statistical analysis plan (SAP) for the REGAL study provides for a planned interim safety and futility analysis after 80 events (deaths) which the Company had anticipated would take place in the first half of 2022, provided that the ongoing COVID-19 pandemic did not significantly adversely impact our projected timeline for enrollment. Over the last 12 to 18 months, the Company has monitored the impact of the COVID-19 pandemic on the projected timeline for the REGAL study. During this period, the Company took several steps to mitigate possible and actual delays due to the COVID-19 pandemic, including increasing the number of clinical sites and the number of countries in which sites are located in order to maintain the original timeline. Despite these mitigation steps, the Company now anticipates that the interim analysis will take place in the second half of 2022, provided that the ongoing COVID-19 pandemic does not continue to adversely impact the projected timeline for enrollment. In addition to the planned interim analysis under the SAP, the final charter for the Independent Data Monitoring Committee for the REGAL study provides for enrollment-based safety, futility, and efficacy analyses prior to the planned interim analysis.

Planning for Potential Phase 2/3 GPS Study in AML Post-Transplant Patients: In August 2021, SELLAS hosted a Virtual Investor Symposium which focused on the potential for GPS in AML patients following a BMT. SELLAS management, Dr. Stergiou and Dr. Dragan Cicic, SVP, Clinical Development, were joined by leading cancer researcher Dr. Yair Levy, Director of Hematologic Malignancies at the Baylor University Medical Center. To access the event replay, click here. The Company is currently in the regulatory and clinical planning stages for a potential Phase 2/3 clinical trial of GPS in this patient population.

Red Door Community Award: On November 11, 2021, Angelos M. Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS, was honored on behalf of SELLAS by the Red Door Community (formerly Gilda’s Club) with the Red Door Award for Advances in Research.
Financial Results for the Third Quarter 2021:

Licensing revenue: There was no licensing revenue for the third quarter of 2021 and $7.6 million for the nine months ended September 30, 2021, which consists of the recognition of revenue from the Company’s license agreement with 3D Medicines. The Company did not record any licensing revenue for the first nine months of 2020.

R&D Expenses: Research and development expenses for the third quarter of 2021 were $4.5 million, as compared to $2.4 million for the same period in 2020. Research and development expenses for the nine months ended September 30, 2021 were $12.3 million as compared to $6.5 million for the same period in 2020. The increase was primarily due to an increase in clinical trial expenses related to the Company’s Phase 3 REGAL clinical trial of GPS in AML patients and a ramp up of the manufacture of clinical trial materials and registration batches of GPS, a technology transfer to a new contract manufacturer, clinical drug supply purchase costs in the European Union in preparation for opening sites and enrolling patients in EU countries, and personnel related expenses due to increased headcount.

G&A Expenses: General and administrative expenses for the third quarter of 2021 were $2.4 million, as compared to $2.1 million for the same period in 2020. General and administrative expenses for the nine months ended September 30, 2021 were $8.8 million, as compared to $6.3 million for the same period in 2020. The increase was primarily due to amortization expense associated with the capitalized contract acquisition costs of the 3D Medicines license agreement, an increase in legal fees as compared to the same period in 2020 during which the majority of legal expenses were offset by a reimbursement credit, and personnel related expenses due to increased headcount.

Net Loss: Net loss attributable to common stockholders was $7.1 million for the third quarter of 2021, or a basic and diluted loss per share attributable to common stockholders of $0.45, as compared to a net loss attributable to common stockholders of $4.5 million for the same period in 2020, or a basic and diluted loss per share attributable to common stockholders of $0.53. Net loss attributable to common stockholders was $14.1 million for the nine months ended September 30, 2021, or a basic and diluted loss per share attributable to common stockholders of $0.92, as compared to a net loss attributable to common stockholders of $13.1 million for the same period in 2020, or a basic and diluted loss per share attributable to common stockholders of $1.83.

Cash Position: As of September 30, 2021, cash and cash equivalents totaled approximately $26.3 million.