On November 12, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported the presentation of interim data further demonstrating the tolerability and antitumor activity potential of CUE-101 as a monotherapy as part of the Company’s ongoing clinical trial for the treatment of recurrent/metastatic HPV+ head and neck cancer in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021) (Press release, Cue Biopharma, NOV 12, 2021, View Source [SID1234608267]). Early data from the CUE-101 combination study with pembrolizumab will also be discussed, supporting the potential for mechanistic activity in frontline HPV+ HNSCC patients. SITC (Free SITC Whitepaper) 2021 will be held in Washington, D.C. and virtually November 10-14.

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Additionally, the Company will present two posters highlighting the broad potential of the interleukin 2 (IL-2)-based CUE-100 series for treating multiple cancers. This includes representative preclinical data from CUE-102, Cue Biopharma’s next clinical candidate developed to selectively target Wilms’ Tumor 1 (WT1) cancers, and preclinical progress on the Company’s Neo-STAT and RDI-STAT (Re-Directed Immuno-STAT) platforms, which provide modularity, flexibility and scalability and address tumor heterogeneity and tumor resistance or escape mechanisms.

SITC 2021 Presentation Highlights:

Title: A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer
Poster #: 438
Presenter: Dr. Sara I. Pai, M.D., Ph.D., associate professor, Department of Surgery; Director, Translational Research in Head and Neck Cancer Massachusetts General Hospital, Harvard Medical School, Boston MA
Date: Saturday, November 13, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

Data as of November 2, 2021, include:

A durable partial response (PR) with an ongoing duration of 30 weeks and five durable stable disease responses (SD), as determined by RECIST 1.1. criteria, out of the 13 evaluable patients dosed at the recommended Phase 2 dose of 4mg/kg as part of the monotherapy trial.
Pharmacodynamic (PD) signals of expansion of HPV16+ cytotoxic T cells were observed in the monotherapy trial, which confirm CUE-101 mechanism of action by activation of tumor-specific T cells.
Demonstrated favorable tolerability to date, with more than 190 cumulative doses administered. Reported mild adverse events resolved while patients continued therapy.
Early signs of clinical activity of CUE-101 in combination with pembrolizumab with 3 out of 3 patients from cohort 2 at 2mg/kg, demonstrating tumor reductions in target lesions on their first scan after having received two cycles of therapy. Cohort 3 is currently enrolling.
"I am encouraged by the preliminary anti-tumor activity of CUE-101 and the positive tolerability profile, which are necessary to improve the survival and quality of care for this relatively young patient population," said Sara Pai M.D., Ph.D., associate professor of surgery and director of Translational Research in Head and Neck Cancer at the Massachusetts General Hospital, and principal investigator of the CUE-101 Phase 1 clinical trial. "Until this trial we haven’t seen an ‘off-the-shelf‘ HPV-targeted biologic administered in an outpatient setting with such durable responses in the second- and third-line treatment for recurrent/metastatic HPV16+ head and neck cancer patients and it is a significant advancement, presenting a potential path forward for a new therapeutic standard."

Ken Pienta, acting chief medical officer of Cue Biopharma, added, "We are very pleased by the emerging clinical data and growing body of evidence demonstrating the clinical potential of CUE-101 as a monotherapy in a highly pretreated, refractory, metastatic HPV+ HNSCC setting. In addition, we are encouraged by the promising, albeit early, emerging data from our combination study with pembrolizumab demonstrating potential mechanistic activity with the prospects of expanding patient reach and enhancing therapeutic responses. It is also encouraging to observe histology data demonstrating enhanced penetration of cytotoxic CD8+ T cells or "killer" T cells within the tumor and anti-tumor activity in patients failing 2-3+ previous lines of treatment."

Title: CUE-102 selectively activates and expands WT1-specific T cells for the treatment of patients with WT1+ malignancies
Poster #: 720
Presenter: Dr. Christie Zhang, Ph.D., senior scientist, discovery and translational immunology, Cue Biopharma
Date: Friday, November 12, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

Multiple in vitro assessments demonstrated that CUE-102 selectively activated and expanded WT1-specific CD8+ T cells from peripheral blood mononuclear cells (PBMC) of healthy donors.
These CUE-102-expanded CD8+ T cells exhibited polyfunctional and cytotoxic responses upon challenge with WT1-presenting target cells.
Data showed that the attenuation of the interleukin 2 (IL-2) domains of CUE-102 led to a reduction of indiscriminate IL-2 activity, similar to results obtained with CUE-101.
In vivo studies in human leukocyte antigen (HLA)-A2 transgenic mice confirmed that CUE-102 elicited and expanded WT1-specific CD8+ T cells from naïve mice without significantly altering the frequencies of other immune lineages.
The WT1-specific CD8+ T cells expanded in vivo exhibited polyfunctionality and selectively killed WT1-presenting target cells in vivo.
Title: Targeting engineered interleukin-2 (IL-2) to antigen specific T cells via novel biologic platforms
Poster #: 793
Presenter: Raymond J. Moniz, associate director, discovery and translational immunology, Cue Biopharma
Date: Friday, November 12, 2021, Poster Hall (Hall E) 7 a.m.– 8:30 p.m. EST

Data demonstrated that the Company’s Neo-STAT (NST) biologics can be engineered with a diversity of T cell epitopes by efficient conjugation into an empty HLA-binding pocket, and that these molecules activated and expanded antigen specific T cells in vitro.
Data additionally demonstrated that the Company’s RDI-STAT biologics, were able to expand anti-viral T cell repertoires and drive anti-viral T cell redirected killing of tumor-associated antigen (TAA)-expressing cells.
In contrast to pan anti-CD3 bispecific molecules, RDI-STATs demonstrated significantly lower induction of pro-inflammatory cytokines, thus avoiding systemic activation of all T cells and offering a superior safety profile.
Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, said, "The demonstration of CUE-102 to activate and expand WT1-specific cytotoxic CD8+ T cells in vivo further supports the modularity of our platform and enhances the potential of our CUE-100 series to address a diversity of cancers, supporting the advancement of CUE-102 into the clinic. An Investigational New Drug filing for CUE-102 is scheduled for the first quarter of 2022. In addition, the data presented on our Neo-STAT and RDI-STAT platforms continue to demonstrate the versatility and modularity of our biologics to potentially address multiple cancers with flexibility and scalability. We are highly encouraged as we continue to explore the breadth of opportunities with our Immuno-STAT, Neo-STAT and RDI-STAT biologics platforms, to develop novel therapies that address diverse patient populations, tumor heterogeneity and tumor escape mechanisms."

For more information on all three posters please visit: View Source

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (IL-2) molecules. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About the CUE-101 Clinical Trial
The trial (NCT03978689) is a multi-center, first-in-human, open-label Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect and immunogenicity of CUE-101 as a monotherapy in second-line patients with confirmed human papilloma virus positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HPV+ HNSCC) and HLA-A*02:01 serotype. Patients receive CUE-101 as a monotherapy ranging from 0.06 mg/kg to 8 mg/kg. The maximum tolerated dose (MTD) has not been identified and a Phase 2 4 mg/kg dose has been selected. The company has expanded the study to evaluate CUE-101 in combination with 200 mg of KEYTRUDA (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC. Enrollment continues in both monotherapy and combination cohorts.

About CUE-102
Leveraging the Immuno-STAT (Selective Targeting and Alteration of T cells) platform of targeted interleukin 2 (IL-2) therapies and the ongoing development of CUE-101, CUE-102 is being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to treat Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain.

About the Neo-STAT and RDI-STAT (Re-Directed Immuno-STAT) Platforms
Immuno-STAT biologics are rationally engineered Fc fusion proteins comprised of bivalent tumor-peptide-human leukocyte antigen (pHLA) complexes and four affinity-attenuated interleukin 2 (IL-2) molecules to preferentially engage and activate tumor-specific T cells directly in the patient. Building on the CUE-100 series framework, our Neo-STAT (NST) platform contains HLA molecules manufactured with an "empty" peptide-binding pocket, into which diverse tumor-peptides can be chemically conjugated, hence addressing tumor heterogeneity in a cost- and time-efficient manner. Our RDI-STAT (Re-Directed Immuno-STAT) platform further expands on the Immuno-STAT biologics by redirecting the pre-existing protective viral-specific T cell repertoire to target tumor cells via scFv moieties. RDI-STATs are designed to circumvent potential tumor escape mechanisms linked to HLA loss or defects in antigen-presenting pathways.

About SITC (Free SITC Whitepaper)
The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy.

SITC is a 501(c)(3) not-for-profit medical professional society of influential research scientists, physician scientists, clinicians, patients, patient advocates, government representatives and industry leaders dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Through educational programs that foster scientific exchange and collaboration, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere.

Currently, SITC (Free SITC Whitepaper) has more than 4,650 members who represent over 35 medical specialties in 63 countries around the world.

Through emphasis on high-caliber scientific meetings; dedication to education and outreach activities; focus on initiatives of major importance in the field; and commitment to collaborations with like-minded domestic and international organizations, government and regulatory agencies, associations and patient advocacy groups, SITC (Free SITC Whitepaper) brings together all aspects of the cancer immunology and immunotherapy community.

On November 12, 2021 Candel Therapeutics, Inc. ("Candel" or "the Company") (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Candel Therapeutics, NOV 12, 2021, View Source [SID1234595385]).

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"With the completion of our IPO in August 2021 and multiple data readouts across our product candidates expected over the next 12 months, we are well-capitalized and in a strong position to advance on the Company’s goal to bring novel oncolytic viral immunotherapies to patients with cancer," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. "In the quarter and recent weeks, we expanded visibility of our technology and clinical programs with six presentations at medical conferences, highlighting clinical observations for our lead product candidate from our adenoviral platform, CAN-2409, in prostate cancer and our lead product candidate from our HSV platform, CAN-3110, in high-grade glioma, two areas of significant unmet need."

Third Quarter 2021 & Recent Highlights

In September, Scott E. Eggener, MD, principal investigator, presented data at the AdMeTech Foundation’s Fifth Global Summit on Precision Diagnosis and Treatment of Prostate Cancer, highlighting safety observations from the Company’s phase 2 clinical trial of CAN-2409 in patients with localized, low to intermediate risk prostate cancer undergoing active surveillance.
Also in September, E. Antonio Chiocca, MD, PhD, FAANS, principal investigator, presented clinical and immunological biomarker data from the phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma at the 16th Meeting of the European Association of Neuro-Oncology.
In October, Dr. Tak provided a technology overview at the Cambridge Healthtech Institute’s 9th Annual Immuno-Oncology Summit in a session titled Novel Oncolytic Viral Immunotherapies for Solid Tumors.
Separately, at the Hanson Wade 6th Annual Oncolytic Virotherapy Summit held in October, Dr. Tak highlighted Candel’s approach with its novel oncolytic viral immunotherapies, CAN-2409 and CAN-3110, to immunize against a patient’s own tumor neo-antigens. Also at this conference, Dr. Chiocca presented on the Company’s CAN-3110 program in glioblastoma.
In October, the Company announced the appointment of Mace L. Rothenberg, MD, as a senior advisor to Dr. Tak. Dr. Rothenberg, an industry veteran with more than 30 years of experience across government, academia and industry, will help support the Company’s continued growth and acceleration.
Also in October, the Company’s Chief Medical Officer, Laura K. Aguilar, MD, PhD, presented data on patient-reported tolerability of intraprostatic injections at the 28th Annual Prostate Cancer Foundation Scientific Retreat. These data further support patient receptiveness to intra-prostatic injection of CAN-2409 and its comparability, in terms of tolerance, to routine intra-prostatic biopsies.
In early November, the Company had two presentations at the 13th International Oncolytic Virus Conference Meeting. Dr. Chiocca provided details on the first-in-human clinical trial of CAN-3110 in glioblastoma. Dr. Tak gave a talk in a Special Session, titled Leveraging Viral Oncolytic Immunotherapy Platform to Tip the Balance in Favor of the Immune System that highlighted recent advancements of CAN-2409 and CAN-3110 development, including the enrollment completion and patient tolerability data from the phase 3 trial in prostate cancer, and the blinded safety data from the phase 2 clinical trial in patients with prostate cancer undergoing active surveillance.
Also in November, the Company’s Vice President, Head of Research, Francesca Barone, MD, PhD, presented novel biomarker data from the ongoing phase 1 open-label, dose-escalation clinical trial of CAN-3110 in patients with recurrent high-grade glioma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting. The presentation focused on the biological findings of this study, showed the ability of CAN-3110 to induce immune activation both locally, in the tumor microenvironment, and systemically in peripheral blood of treated patients.
Key Upcoming Milestones

Patrick Y. Wen, MD, principal investigator, will present initial safety data on CAN-2409 in combination with nivolumab from a phase 1 clinical trial in high-grade glioma at the 26th Annual Meeting of the Society for Neuro-Oncology (SNO) in November.
Financial Results for the Third Quarter Ended September 30, 2021

Cash Position: Cash and cash equivalents as of September 30, 2021 were $88.4 million, as compared to $35.1 million as of December 31, 2020. The increase was due to successful completion of the Company’s initial public offering in August 2021, which provided net proceeds of $71.3 million, after deducting underwriting discounts and commissions and offering expenses and the use of $18.3 million to fund operating activities and capital expenditures for the nine months ended September 30, 2021. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2023.

Research & Development Expenses: Research and development expenses were $5.3 million and $11.3 million for the three and nine months ended September 30, 2021, respectively, as compared to $1.8 million and $5.2 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount to support the ongoing clinical trials for Candel’s product candidates as well as increased clinical development costs. Excluding stock-based compensation expense of $1.5 million for the three months ended September 30, 2021, and $2.0 million for the nine months ended September 30, 2021, research and development expenses for the three and nine months ended September 30, 2021, were $3.8 million and $9.3 million, respectively.

General and Administrative Expenses: General and administrative expenses were $2.8 million and $6.8 million for the three and nine months ended September 30, 2021, respectively, as compared to $1.0 million and $2.6 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021 and costs associated with operating as a public company. Excluding stock-based compensation expense of $0.4 million for the three months ended September 30, 2021, and $1.4 million for the nine months ended September 30, 2021, general and administrative expenses for the three and nine months ended September 30, 2021, were $2.4 million and $5.4 million, respectively.

Total Operating Expenses: Total operating expenses were $8.1 million and $18.1 million for the three and nine months ended September 30, 2021, respectively, as compared to $2.8 million and $7.8 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021, an increase in costs associated with operating as a public company and increased clinical development costs. Excluding stock-based compensation expense of $1.9 million for the three months ended September 30, 2021, and $3.4 million for the nine months ended September 30, 2021, total operating expenses for the three and nine months ended September 30, 2021, were $6.2 million and $14.7 million, respectively.

Net Loss: Net loss was $16.2 million and $37.7 million for the three and nine months ended September 30, 2021, respectively, as compared to $2.6 million and $7.2 million for the comparable periods of 2020. The net loss for the three and nine months ended September 30, 2021, includes a noncash charge of $8.3 million and $20.6 million for the change in the fair value of the Company’s warrant liability and stock-based compensation of $1.9 million and $3.4 million, respectively. Excluding the noncash charges for the change in the warrant liability and excluding the stock-based compensation, the net loss for the three and nine months ended September 30, 2021, was $6.0 million and $13.7 million, respectively.

On November 12, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported its financial results for the third quarter of 2021 (Press release, NexImmune, NOV 12, 2021, View Source [SID1234595401]).

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"We had another strong quarter as characterized by our continued progress developing the AIM technology platform," said Scott Carmer, Chief Executive Officer. "Our primary focus remains on completing enrollment in our Phase I/II clinical trials for NEXI-001 and NEXI-002. We plan to provide clinical updates for the NEXI-001 trial in AML during the first half of 2022 and will update the NEXI-002 trial in relapsed / refractory multiple myeloma at the upcoming ASH (Free ASH Whitepaper) conference. Additionally, we are presenting the antigen peptide targets to be included in our first solid tumor IND application for HPV-associated malignancies at the SITC (Free SITC Whitepaper) Annual Meeting. Finally, we’re very excited with the progress of our research collaboration with the lab of Professor Kevan Herold at Yale University, which explores the effects of our AIM injectable nanoparticle as a therapeutic for Type 1 Diabetes. Our team looks forward to providing future updates on these and other important projects as we continue to progress the development of our AIM technology across a range of therapy areas and with multiple modalities."

Select 3Q 2021 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Robust immune responses across all dose levels with signs of increased clinical activity associated with higher doses
NEXI-001 continues to be well tolerated across all dose levels administered to date, with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Due to the favorable emerging clinical profile, plans are underway to expand the addressable population with an additional study arm to include patients with haplo-identical donors
Ongoing enrollment in the Phase I/II trial has been affected by higher than anticipated patient replacements between the enrollment and 28-day DLT clearance period due to non-treatment-related events; updated clinical results expected to be announced in the first half of 2022
NEXI-002

Safety cohort completed and expansion phase continues to enroll and dose
NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Further clinical data from the Phase I/II trial is expected to be announced at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
NEXI-003

Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors is being presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2021) in November 2021
Investigational New Drug (IND) submission planned for mid-year 2022
Other R&D

First collaboration in autoimmune diseases announced with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles as a therapeutic in Type 1 diabetes
Business Updates

Announced the appointments of Dr. Jack Ragheb as SVP, Translational Medicine, and Matthew Schiller as Head of Business Development
Select 3Q 2021 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of September 30, 2021 were $93.2M compared to $102.8M for quarter ending June 30, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements through 4Q22.

Research and development expenses were $11.3M in the third quarter of 2021, compared to $4.9M for the same period in the prior year. The increase in R&D expenses was mainly attributable to costs for the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $4.2M, compared to $2.8M for the same period the prior year. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $14.6M for the quarter, or a basic and diluted GAAP loss per share of $0.65. This compared to a net loss of $8.6M, or a basic and diluted GAAP loss per share of $7.52, for the same period the prior year.

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 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported its financial results and business highlights for the quarter ended September 30, 2021 (Press release, Aptevo Therapeutics, NOV 12, 2021, View Source [SID1234595456]).

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Business Highlights

Enrollment and dosing have commenced in Part 2 (Expansion Phase) of Company’s multicenter 5001 Phase 1B clinical trial to evaluate APVO436 in adult patients with acute myeloid leukemia (AML).
Reported 3 publications in two peer-reviewed journals ( Cancers[Basel]) and Frontiers in Aging) regarding the salient features of the data obtained during Part 1 (Dose escalation phase) of the 5001 APVO436 Phase 1B trial.
Participated in Euroleukemia2021 Meeting with an oral and a poster presentation.
Showcased the Company’s preclinical assets, APVO442 and APVO603, and their potential to improve efficacy in the treatment of solid tumors and participated in discussions about risk mitigation in cell engager candidates at the Virtual Cell Engager Summit.
Presented the unique aspects of the Company’s proprietary ADAPTIR AND ADAPTIR-FLEX platforms at the Cambridge Health Institute PEGS Virtual Conference.
platforms at the Cambridge Health Institute PEGS Virtual Conference.
"I am excited about our clinical progress in the third quarter, as we initiated enrollment and dosing in our APVO436 Phase 1b expansion trial. We look forward to receiving data from this trial in the first half of next year and will use the outcomes to inform our go-forward clinical strategy for this promising lead clinical candidate with the potential to impact existing standard of care for acute myeloid leukemia," said Marvin White, President and CEO of Aptevo. "During the quarter we were fortunate to present our clinical work in two peer-reviewed journals and to showcase our ADAPTIR and ADAPTIR-FLEX platforms at multiple industry conferences. We are well funded to continue our work for the next twelve months and look forward to reporting our progress."

Third Quarter 2021 Financial Results Summary

Cash Position : Aptevo had cash and cash equivalents as of September 30, 2021 totaling $53.4 million, including restricted cash of $1.3 million. The restricted cash is expected to be released over the next twelve months.

Royalty Revenue: Royalty revenue was $3.1 million for the three months ended September 30, 2021, related to the royalty from Pfizer on global net sales of RUXIENCE , a biosimilar to the drug RITUXAN , launched by Pfizer in early 2020. RUXIENCE is a trademark of Pfizer; RITUXAN is a trademark of Biogen. Due to our continuing involvement under the Definitive Agreement originally between Trubion and Wyeth, we continue to recognize royalty revenue on net sales of RUXIENCE and record the royalty payments to HCR as a reduction of the liability when paid. As such payments are made to HCR, the balance of the liability will be effectively repaid over the life of the Royalty Purchase Agreement.

Research and Development Expenses : Research and development expenses decreased to $4.4 million for the three months ended September 30, 2021 from $4.5 million for the three months ended September 30, 2020. Costs associated with APVO436 clinical trial increased as we continued to advance that trial and have now started dosing in our Phase 1b Expansion program. This increase was offset by lower spending on preclinical projects.

General and Administrative Expenses : For the three months ended September 30, 2021, general and administrative expenses increased to $3.5 million from $3.2 million for September 30, 2020, with higher costs related to responding to stockholder activism matters and higher employee costs.

Other Expense, Net: Other expense, net consists primarily of costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other expense, net was $2.3 million for the three months ended September 30, 2021 and $0.7 million for the three months ended September 30, 2020. The increase in other expense, net is primarily related to interest expense and accrued exit fees for the MidCap Credit Agreement, as well as non-cash interest expense for the HCR Purchase Agreement.

Discontinued Operations: Income from discontinued operations was approximately $0.1 million for the three months ended September 30, 2021 and September 30, 2020, related to collection of deferred payments from Medexus earned on second quarter 2021 and 2020 IXINITY sales.

Net Loss : Aptevo’s net loss for the three-month period ended September 30, 2021 was $7.0 million or $1.43 per share, as compared to a net loss of $6.8 million or $2.10 per share for the corresponding period in 2020.

Liability Related to Sale of Future Royalties: We treat the Royalty Purchase Agreement with HCR as a debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liabilities related to sale of future royalties and the debt amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. We will periodically assess the expected royalty payments using projections from external sources. To the extent our estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. We are not obligated to repay the proceeds received under the Royalty Purchase Agreement with HCR.