On November 9, 2021 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, reported the third quarter 2021 financial results and provided an operational update (Press release, Evaxion Biotech, NOV 9, 2021, View Source [SID1234594843]).

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Lars Wegner, CEO of Evaxion, said: "Evaxion has continued to make very encouraging clinical progress in the third quarter of 2021, reporting data in July 2021 which we believe support advancing two of our lead programs into Phase 2b clinical trials. Phase 1/2a clinical trial data on our lead product candidate, EVX-01, showed that 67% of the patients benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from the check point inhibitor alone. In addition, EVX-02 showed T-cell activation in adjuvant melanoma and appeared to be well tolerated. We plan to initiate a Phase 2b clinical trial for EVX-01 in melanoma by the end of 2021 in collaboration with Merck and initiate a Phase 2b clinical trial of EVX-02, in conjunction with our third product candidate, EVX-03, in Q2 2022. Our cash reserves of $11.9 million as of the end of the third quarter, combined with the follow-on financing provide a solid financial foundation and will facilitate the continued development of our lead programs."

Operational and Business Highlights in Q3 2021

Reported new clinical data in early July 2021 from Phase 1/2a clinical trials of EVX-01 and EVX-02.

EVX-01, our peptide-based patient-specific cancer therapy, demonstrated anti-tumor effect in combination with anti-PD-1 treatment, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b clinical trial of EVX-01 is planned to start by the end of 2021.
Preliminary data with EVX-02, our DNA-based patient-specific cancer therapy, demonstrated T-cell activation induced by EVX-02 and appeared to be well tolerated. We intend to submit a regulatory filing for a Phase 2b clinical trial of EVX-02 and EVX-03, in combination with anti-PD-1 in adjuvant melanoma in a three-arm trial, in the first half of 2022.
Events after the Reporting Period

Announced clinical trial and supply agreement with subsidiaries of Merck & Co., Inc. (known as MSD outside of the United States and Canada) to evaluate the combination of Evaxion’s cancer immunotherapy EVX-01 with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a new Phase 2b clinical trial in patients with metastatic melanoma
Awarded this year’s Enabling Technology Leadership Award in the artificial intelligence-enabled drug discovery industry by global research and consulting firm Frost & Sullivan
Presentation at the Immuno UK 2021 conference held in London in October
Announced pricing of our FPO on November 5, 2021, and expect to raise gross proceeds of $27.6 million before deducting underwriting discounts and commissions and other offering expenses.
Expected milestones in 2021 & 2022

Phase 2b Investigational New Drug (IND) / Clinical Trial Application (CTA) of EVX-01 in metastatic melanoma – H2 2021.
Phase 2b IND / CTA filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – H1 2022.
Phase 1a IND / CTA filing for EVX-B1 for S. aureus in skin and soft tissue infections (SSTIs) – H2 2022.
First viral candidate selected from RAVEN platform – H2 2022.
Third Quarter 2021 Financial Results

Cash position: As of September 30, 2021, cash and cash equivalents were $11.9 million compared to $5.8 million as of December 31, 2020. On February 9, 2021, we closed our IPO raising net proceeds of $27.9 million after deducting underwriting discounts and commissions, but before offering expenses.
Research and Development expenses were $4.4 million for the quarter ended September 30, 2021, compared to $3.0 million for the same period in 2020. The increase of $1.4 million was primarily related to increased spending, net of grant income, for ongoing development utilizing our AI platforms, preclinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
General and Administrative expenses were $1.5 million for the quarter ended September 30, 2021, compared to $1.7 million for the same period in 2020. The decrease of $0.2 million was primarily related to higher share-based compensation in the period ended September 30, 2020 due to accelerated vesting period and sign-on warrants issued associated with the IPO.
Net loss was $5.3 million for the quarter ended September 30, 2021 or ($0.27) loss per basic and diluted share, compared to $4.0 million, or ($0.26) loss per basic and diluted share, for the same period in 2020.
Guidance

We expect the net proceeds from our IPO and FPO combined with our existing cash reserves will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12 months from September 30, 2021.
Webcast and Conference Call

Evaxion will host a webcast and conference call today, November 9, at 8:30 a.m. EST.

On November 9, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that preclinical data for BT7480, a novel Bicycle tumor-targeted immune cell agonist (Bicycle TICA), and BT7455, an EphA2/CD137 Bicycle TICA, will be presented in four poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, being held in Washington D.C. and virtually on November 10-14, 2021 (Press release, Bicycle Therapeutics, NOV 9, 2021, View Source [SID1234594859]).

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"The totality of the preclinical data to date, including that reflected in these four posters to be presented at SITC (Free SITC Whitepaper), support our decision to explore the clinical development of BT7480 and BT7455, our novel, Bicycle TICAs" said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "We are encouraged by these early data and by the potential for these programs to one day provide a new treatment option for patients with cancer."

Preclinical results that will be presented at SITC (Free SITC Whitepaper) support Bicycle’s decision to initiate a Phase I/II clinical trial of BT7480 and its prioritization of potential indications to target. Additionally, Bicycle has developed a pharmacokinetic/pharmacodynamic (PK/PD) modelling framework to predict preclinical biomarker level and tumor growth inhibition in response to changes in the BT7480 dose and dosing schedule. Bicycle found that plasma and tumor drug concentration levels may be associated with tumor growth inhibition. EphA2/CD137 Bicycle TICA results in syngeneic mouse tumor models produced complete anti-tumor responses in vivo. These results reveal that costimulatory molecules that exploit intermittent rather than continuous exposure may promote optimal anti-tumor activity.

Together, pre-clinical data to be presented at SITC (Free SITC Whitepaper) demonstrate the broad potential for Bicycle TICAs, with a Nectin-4/CD137 Bicycle TICA and an EphA2/CD137 Bicycle TICA exhibiting similar anti-tumor activity and immune modulation. Details on Bicycle’s poster presentations at SITC (Free SITC Whitepaper) are as follows:

Poster Title: Quantitation of CD137 and Nectin-4 expression across multiple-tumor types to support indication selection for BT7480, a Bicycle tumor-targeted immune cell agonist (Bicycle TICA)
Poster #: 2
Date and Time: Friday, November 12 at 8 a.m. ET

Poster Title: Establishing the preclinical/translational PK/PD relationship for BT7480, a Nectin-4/CD137 Bicycle tumor-targeted immune cell agonist (Bicycle TICA)
Poster #: 826
Date and Time: Friday, November 12 at 8 a.m. ET

Poster Title: Generation of a Bicycle NK-TICA, a novel NK cell engaging molecule to enhance targeted tumor cytotoxicity
Poster #: 789
Date and Time: Friday, November 12 at 8 a.m. ET

Poster Title: An integrative approach to optimize a synthetic EphA2/CD137 agonist: balancing potency, physiochemical properties, and pharmacokinetics to achieve robust anti-tumor activity
Poster #: 888
Date and Time: Friday, November 12 at 8 a.m. ET

On November 9, 2021 Seagen Inc. (Nasdaq:SGEN), reported the presentation of two new vedotin-based antibody-drug conjugate (ADC) programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Anniversary Annual Meeting, taking place in Washington, D.C. and virtually, November 10-14, 2021 (Press release, Seagen, NOV 9, 2021, View Source [SID1234594875]). Each program combines antibodies targeted to an immune checkpoint [PD-(L)1 or B7-H4] with the cytotoxic properties of the vedotin payload. Preclinical data demonstrate promising antitumor activity. Both ADCs are set to enter first-in-human phase 1 studies in 2022.

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"We are excited to advance two novel immune checkpoint vedotin ADCs, SGN-PDL1V and SGN-B7H4V, into phase 1 studies. These programs utilize a clinically validated payload and have the potential to be first in class ADCs," said Roger Dansey, M.D., Chief Medical Officer at Seagen.

SGN-PDL1V is a novel, investigational vedotin ADC directed to the T cell checkpoint ligand, PD-(L)1. PD-(L)1 is a target with limited normal tissue expression and clinically validated expression across a variety of malignancies, including non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinomas (HNSCC). SGN-PDL1V is engineered for efficient delivery of the therapeutic payload, monomethyl auristatin E (MMAE), and is proposed to have distinct mechanisms of action from other PD-(L)1-directed therapeutics, including direct cytotoxicity against PD-(L)1-expressing cells, bystander killing, and immunogenic cell death. SGN-PDL1V demonstrates robust antitumor activity in xenograft models, including in tumors with low, heterogenous PD-(L)1 expression, supporting the potential to treat patients across a wide range of PD-(L)1 expression levels. (Abstract #783)

SGN-B7H4V is a novel, investigational vedotin ADC directed to the T cell checkpoint ligand, B7-H4. B7-H4 expression is limited on normal tissue and overexpressed on a variety of solid malignancies, including breast, ovarian, and endometrial tumors. SGN-B7H4V is designed to bind and internalize the B7-H4/ADC complex from the surface of the tumor cells and release the therapeutic payload MMAE, inducing MMAE-mediated direct cytotoxicity, bystander killing, and immunogenic cell death, as well as antibody-dependent cellular cytoxicity (ADCC) and phagocytosis (ADCP). SGN-B7H4V demonstrates strong activity in xenograft models, including models with heterogenous B7-H4 expression. (Abstract #854)

The abstracts published in advance of the SITC (Free SITC Whitepaper) Annual Meeting can be found here. All data presentations will be available on-demand starting on November 9.

On November 9, 2021 Asgard Therapeutics AB ("Asgard"), a private biotech company pioneering in vivo cell reprogramming approaches to elicit potent anti-cancer immune responses, reported the completion of a EUR 6 million seed financing round (Press release, Asgard Therapeutics, NOV 9, 2021, View Source [SID1234594891]). The financing was co-led by Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.

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Asgard is developing a paradigm-shifting cancer immunotherapy approach, based on its proprietary TrojanDC technology, to reinstate cancer immunogenicity. TrojanDC is a gene therapy that reprograms cancer cells into type-1 conventional dendritic cells, allowing the presentation of their own antigens to the immune system, thereby eliciting potent anti-cancer immune responses. Designed as an off-the-shelf gene therapy, TrojanDC induces a personalized immune response, and overcomes many of the logistic and manufacturing hurdles of conventional cell-based therapies.

The Company originated from Lund University’s Cell Reprogramming and Immunity lab, led by Professor Filipe Pereira PhD, who is also Asgard’s Co-Founder and Head of Innovation. Cristiana Pires PhD and Fábio Rosa PhD established the seminal work describing direct reprogramming of somatic cells published in the prestigious science journal Science Immunology .

Cristiana Pires, PhD, Co-Founder and Chief Executive Officer of Asgard Therapeutics, said: "At Asgard, we are committed to surpassing the challenges of current cancer immunotherapies, making them available for every patient. The support we have received from such a strong syndicate of life science investors, is a strong endorsement to the potential of our TrojanDC technology. The financing will enable us to expand our pipeline of preclinical assets and build on our commitment to making personalized cancer immunotherapies optimized to each unique patient."

João Ribas from Novo Seeds commented: "We are very pleased to co-lead this financing and support the translation of the founders’ scientific research at Lund University. While reprogramming approaches have been mainly restricted to regenerative medicine, the work of Filipe, Cristiana and their team opens exciting opportunities to merge the fields of cell reprogramming and cancer immunotherapy that can be applied to several cancers, representing a platform technology with enormous potential. We look forward to working with the Asgard team as they pioneer a new generation of cancer immunotherapy".

Philipp Müller from Boehringer Ingelheim Venture Fund commented: "We are excited to support Asgard Therapeutics and its founder team as co-lead of this seed investment. The seminal work conducted at Lund University by Cristiana Pires, Filipe Pereira, and Fábio Rosa enables the direct conversion of non-related somatic cells into antigen presenting cells with a completely novel cellular identity. We believe this approach holds the potential to significantly impact the way cancer immunotherapy will evolve in the future and to bring new treatment options with true breakthrough potential to cancer patients in need."

Bita Sehat from Industrifonden said: "Asgard’s novel gene therapy approach to reprogram cancer cells into antigen-presenting cells holds great promise to open up new avenues within the immune-oncology space. We are pleased to co-lead this round and look forward to partnering with this strong group of investors and distinguished scientists as the co-founding team to advance what we believe will be a broadly applicable new cancer treatment platform."

Asgard Therapeutics has received support from LU Innovation and several translational grants, including from the Novo Nordisk Foundation, the European Commission’s Horizon 2020 and the Swedish Innovation Agency Vinnova. Asgard Therapeutics is also supported by the BioInnovation Institute in Copenhagen, and a member of the Nordic Mentor Network for Entrepreneurship (NOME) mentoring program. Being a SmiLe incubator company, Asgard is now setting up a new lab at SmiLe, Medicon Village, and will be expanding its research and drug development teams.

As part of the transaction, Søren Møller (Novo Holdings), Philipp Müller (BIVF) and Jonas Jendi (Industrifonden) join current Board Members Filipe Pereira and Lars Hedbys. João Ribas (Novo Holdings) and Fábio Rosa (Asgard Therapeutics) will also join as Board Observers.

On November 9, 2021 Prenetics Group Limited ("Prenetics" or the "Company"), a global leader in genomic and diagnostic testing, reported its financial results for the six months ended June 30, 2021 (Press release, Prenetics, NOV 9, 2021, View Source [SID1234594907]). Prenetics delivered significant revenue growth, driven by continued demand across the world for its genomic and diagnostic testing services, including increased demand for COVID-19 testing as travel gradually resumes globally.

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The Company has publicly filed a registration statement on Form F-4 ("the Registration Statement") with the U.S. Securities and Exchange Commission ("SEC"), which contains a preliminary proxy statement/prospectus in connection with its previously announced proposed business combination with Artisan, a special purpose acquisition company founded by Adrian Cheng. The planned business combination continues to progress and is expected to close in the first quarter of 2022.

"We are pleased with our progress toward becoming a publicly-traded company, which we expect to occur in the first quarter of 2022. Prenetics again passed many milestones in the first half of 2021, growing revenue by 1,039% year on year, indicating a strong increase in demand for our testing services and the robustness of our technology. Going forward, we will continue to execute our growth strategy to put us amongst the fastest growing healthcare companies worldwide." said Danny Yeung, Group CEO & Co-founder of Prenetics.

He continued, "But I believe we are just getting started. We are at an inflection point within the healthcare ecosystem on how healthcare is to be delivered. Prenetics has a strong product pipeline and, as part of our global M&A strategy, we have already identified international targets in the area of rapid diagnostics and in digital health which would be highly complementary to our mission of decentralizing healthcare and bringing healthcare closer to millions of people globally."

Prenetics has a strong existing business and a robust product pipeline which include:

Circle HealthPod – Health Monitoring System providing rapid, lab-quality molecular testing for COVID-19 — anytime, anywhere. Circle HealthPod has received CE-IVD mark for point-of-care use. A usability study was completed in the U.S. and a clinical validation is in progress with aim to receive EUA from U.S. FDA by the first half of 2022. The Company has already begun developing assays to expand Circle HealthPod’s testing capacity to cover a range of tests traditionally conducted in clinical laboratories such as tests for influenza and STDs.

Circle ColoClear – Non-invasive stool-based FIT-DNA test for colorectal cancer screening. To be launched in the first half of 2022.

Circle SnapShot – At-home blood test with a user-friendly blood sample collection and result delivery system. To be launched in 2022.
Financial Highlights for the Six Months ended June 30, 2021

(1) For a reconciliation to the most directly comparable IFRS measure see the section titled "Unaudited Financial Information and Non-IFRS Financial Measures."

Revenue reached an all-time-high of US$136.5 million, an increase of 1,039% from US$12.0 million in the same period in 2020. This uplift was driven by increased demand for laboratory testing, including travel related COVID-19 testing.

For the six months ended June 30, 2021, Prenetics’ clients for its COVID-19 testing services include the Hong Kong government, Hong Kong International Airport, Multiple UK Airports, English Premier League and several global corporates including Virgin Atlantic, Carnival Cruise Line, and Sky TV.

Adjusted gross profit was US$57.0 million, an increase of 1,257%, from US$4.2 million in the same period in 2020, delivering a gross margin of 41.8%.

Adjusted EBITDA was US$31.5 million, increased by US$34.6 million year-over-year, due to increased operating efficiencies and scalability of the business.

As of June 30, 2021, the Company had cash and trade receivables of US$97.9 million, consisting of US$37.6 million of cash and US$60.3 million of trade receivables.
Recent Business Highlights

Prenetics announced on September 16, 2021 that it had entered into a definitive merger agreement with Artisan, a special purpose acquisition company privately founded by Adrian Cheng. The completion of the transaction is estimated to be by the first quarter of 2022. Upon completion of the transaction, the combined company ("PubCo")’s securities are expected to be traded on the Nasdaq under the ticker symbol "PRE".

Prenetics has now processed more than 6 million laboratory tests. On October 19, 2021, the Company announced that it was appointed as the official RT-PCR COVID-19 testing partner for the Standard Chartered Hong Kong Marathon 2021 that took place on October 24, 2021.

The Company continues to expand the utility and opportunity of next generation sequencing technologies in both consumer and clinical settings. In November 2021, the Company announced the addition of PacBio’s SMRT HiFi sequencing technology to its genetic screening services. PacBio’s technology will be a key component of Prenetics’ Circle Medical offering, a genetic test geared towards addressing the diagnostic needs of physicians and improving the accuracy of detecting mutations.

The Company has signed a strategic partnership agreement with EC Healthcare (stock code: 2138 Hong Kong), Hong Kong’s largest non-hospital medical group, to integrate all of Prenetics testing services as a service offering to EC Healthcare’s patients.

Prenetics has also made additions to its senior management team to support the company’s rapid growth. Yvonne Wong joined as the Chief Corporate Development Officer and is responsible for leading the company’s corporate development, ESG and CSR efforts. She has over 28 years of experience working in top-tier financial institutions and advising family offices and NGOs. CY Chan joined as the Chief People Officer and is responsible for leading the company’s people operations and culture strategy. He was formerly the CPO of HKBN Ltd. leading its HR and CSR functions.

Outlook

Based on its robust performance in the first half of 2021, Prenetics expects its revenue for 2021 to be ahead of its previous forecast of $205 million stated in the Investor Presentation of Artisan and Prenetics dated September 15, 2021. Whilst the Company is encouraged by the growth trajectory it has achieved, it maintains its projected annual revenues of more than US$600 million in 2025.