Adaptimmune to Report Q2 2021 Financial Results and Business Update on Monday, August 9, 2021

On July 28, 2021 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that it will report financial results and provide a business update for the second quarter ended June 30, 2021, after the US markets close on Monday, August 9, 2021 (Press release, Adaptimmune, JUL 28, 2021, View Source [SID1234585268]). Following the announcement, the Company will host a live teleconference and webcast at 4:30 p.m. EDT (9:30 p.m. BST) that same day (details below).

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The press release will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/3zFas59.

To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (7867634).

Perrigo To Release Second Quarter 2021 Financial Results On August 11, 2021

On July 28, 2021 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its second quarter 2021 financial results on Wednesday, August 11, 2021 (Press release, Perrigo Company, JUL 28, 2021, View Source,-2021 [SID1234585287]). The Company will also host a conference call beginning at 8:00 A.M. (EDT).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 5573644. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EDT) Wednesday, August 11, until midnight Wednesday, August 18, 2021. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10158927.

Bio-Techne and PROGEN Introduce New Simple Plex AAV2 Immunoassay

On July 28, 2021 Bio-Techne Corporation (NASDAQ: TECH) and PROGEN reported the launch of the Simple Plex Adeno-Associated Virus (AAV2) viral titer assay for AAV2 total capsid quantification (Press release, Bio-Techne, JUL 28, 2021, View Source [SID1234585304]). Bio-Techne, owner of the leading ProteinSimple branded protein analysis portfolio of products, and PROGEN will offer the Simple Plex AAV2 viral titer assay on Ella instruments, its multiplexing immunoassay system. Combining the efficiency and reproducibility of the established AAV2 ELISAs from PROGEN with the convenient workflow and robustness of the Ella platform, the Simple Plex AAV2 viral titer assay offers a broad dynamic range and hands-free automation to accelerate cell and gene therapy process development. Featuring antibodies from PROGEN, the Simple Plex AAV2 viral titer assay detects assembled viral capsids as well as the comprehensively characterized AAV2 standard to deliver industry leading specificity.

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AAV2 is commonly used in gene transduction because of its ability to readily infect a variety of cell types. During the viral vector production process, a series of robust analytical measurements are required to determine the viral titer. The Simple Plex AAV2 assay features an automated workflow designed to minimize variability and ensure optimum and consistent quantitation throughout the viral purification process.

Available on the Ella platform, the Simple Plex AAV2 assay utilizes the recombinant AAV2 antibody (A20R) from industry leader PROGEN to quantify assembled AAV2 capsids. The AAV2 assay offers the same proven specificity as the industry standard PROGEN ELISA along with the convenience and simplicity of the fully automated Ella platform.

"As the cell and gene therapy field continues to expand, the ability to meet increased throughput and safety demands is critical," said Dave Eansor, President of BioTechne’s Protein Sciences division. "The Simple Plex AAV2 assay’s high sensitivity and broad dynamic range is particularly useful for AAV2 quantitation, providing researchers with a fully automated and quantitative method of vector analysis."

"Working with ProteinSimple to develop the Simple Plex AAV2 assay was a great experience," said Katja Betts, CEO of PROGEN. "As the leader in AAV capsid titer quantification and exclusive manufacturer of the most commonly used AAV antibodies and accompanying AAV ELISA kits, we are delighted to drive forward the development of robust & reliable quantification methods for the gene therapy community."

The Ella platform allows users to perform high-quality immunoassays with no manual intervention, delivering results in just 90 minutes and requiring only 50 µL of diluted sample. Factory calibration of each Simple Plex assay cartridge minimizes setup time and user error. Setting up an assay simply requires loading diluted samples into the cartridge. Once loaded, the Ella platform performs every step of the immunoassay automatically, from wash steps to final quantification of results.

PROGEN provides an exclusive portfolio of AAV antibodies including antibodies against intact AAV virus particles of which the A20R, used for the PROGEN AAV2 ELISAs as well as the Simple Plex AAV2 assay represents the most frequently used example. The AAV antibodies are also used for the analysis of AAV capsid integrity, purification and represent a suitable positive control for neutralization assays to analyze pre-existing AAV antibodies in patient sera. Due to their high affinity and specific binding to fully assembled AAV particles the PROGEN antibodies are well-established tools for AAV gene therapy R&D and quality control.

Macomics, the Macrophage-based Drug Discovery company, secures £4.24m expansion financing, and appoints CEO, CSO and VP Immunology

On July 28, 2021 Macomics Ltd, an immuno-oncology company with world-leading expertise in macrophage biology, reported that it has closed a follow-on financing of £4.24 million from its 2020 Seed round, bringing the total amount raised to £7.44m (Press release, Macomics, JUL 28, 2021, View Source [SID1234585321]).

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The additional investment brings in new investor Caribou Property Limited alongside existing investors Epidarex Capital, who led the round, and Scottish Enterprise. It will be used to accelerate the company’s growth, including expansion of the team.

Macomics is developing precision medicines to modulate macrophages for the treatment of cancer. The company was co-founded in 2019 by Prof Jeffrey Pollard and Dr Luca Cassetta, University of Edinburgh, internationally recognised leaders in macrophage biology. It is progressing a diversified portfolio of therapies targeting disease specific tumour associated macrophages (‘TAMs’) towards the clinic. Its target discovery platform enables identification and validation of novel macrophage therapeutic targets and is based on its deep understanding of macrophage biology. The new investment and planned Series A will enable the company to accelerate progress of its antibody programs towards the clinic, expand its portfolio, and further invest in its target discovery technology.

Cancer cells are known to be able to evade destruction by the immune system and TAMs are a key component of this immuno-suppressive and pro-tumoral ecosystem. Modulating TAMs will alter the tumour microenvironment enhancing the body’s ability to fight cancer. The tumour microenvironment changes macrophage behaviour, and the company is exploiting disease specific TAM biology to selectively target these immunosuppressive cells.

Alongside the financing, the company announces the expansion of its leadership team with the appointment of Dr Myatt as Chief Executive Officer and Dr Ries as Chief Scientific Officer, as well as Dr Cassetta who will join as VP Immunology on 1 August.

Dr Steve Myatt, CEO who joined Macomics in February 2021 said:

"Macomics has made great progress since formation, and I am excited to lead Macomics in driving forward its vision to become a leading immuno-oncology company pioneering macrophage-based therapies for the treatment of cancer. Our diversified portfolio of antibody programs combined with our proprietary target identification approach and world-class team uniquely positions us to deliver on this vision."

Dr Carola Ries, who joins as Chief Scientific Officer from 16 years at Roche added:

"It is an exciting time to be joining Macomics. In recognising disease specific TAM populations Macomics is taking a new approach to macrophage-based drug discovery, one that I believe has potential to deliver significant benefit to patients. By combining analysis of human disease tissue, in silico data mining, and functional data from our state-of-the-art cellular models we are well placed to identify and validate new drug targets in diseases where macrophages play a central role. I look forward to applying my extensive industry experience gained at Roche to driving our programs towards the clinic."

Commenting on his full-time move into the company, Dr Luca Cassetta, said:

"Macomics was founded based on leading academic research around macrophage biology, particularly in cancer, from the laboratory of Professor Jeffrey Pollard, Director of the MRC Centre for Reproductive Health at the University of Edinburgh, as well as my own research studying TAMs. I am delighted to be joining the company full-time to exploit the potential of macrophage-based approaches to developing novel immuno-oncology therapies that have the potential to change the lives of patients with cancer."

Dr Elizabeth Roper, Partner at Epidarex Capital and Investor Director at Macomics said:

"We are delighted with the progress that Macomics has made since we made our initial investment last year. The company has demonstrated the power of its platform and approach and has already moved two of its programs into antibody discovery and identified a series of additional targets. We are excited about its potential, reflected in our increased commitment to the company."

She added "On behalf of the board, I am pleased to welcome Steve, Carola and Luca to the team. Their experience in biotech, pharma and academia are highly complementary and broaden and deepen the skills of the leadership team."

Georges Aboud, Chief Investment Officer at Caribou Property, commented: "We are pleased to join the investment round, having seen the progress Macomics has made in just over 12 months. Our goal is to back exciting and innovative companies that can make an impact on patients’ lives. Macomics has shown that its knowledge of macrophage biology can deliver innovative approaches to treat cancer and it has assembled an experienced team to maximise its potential."

Jan Robertson, Interim Director of Growth Investments at Scottish Enterprise, added: "This funding round secured by Macomics is testament to the company’s pioneering macrophage-based therapies for the treatment of cancer as well as the talent in Scotland. Scottish Enterprise is pleased to support this leading biotech firm that is now set to accelerate its research and development programmes, and expand its facilities in Edinburgh."

Macomics has expanded its R&D and office facilities on the Cambridge Science Park and has taken additional laboratory and cell culture space within Edinburgh University, and will be expanding its scientific team to support its accelerated R&D.

Inventiva Reports First-Half of 2021 Financial Information

On July 28, 2021 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, reported its cash position as of June 30, 2021 and its revenues for the first half of 20211 (Press release, Inventiva Pharma, JUL 28, 2021, View Source [SID1234585338]).

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Cash Position

As of June 30, 2021, Inventiva’s cash and cash equivalents stood at €93.6 million compared to €107.8 million as of March 31, 2021 and €113.02 million as of December 31, 2020.

Net cash used in operating activities amounted to €19.8 million in the first half of 2021 compared to €7.2 million for the same period in 2020. R&D expenses for the first half of 2021 were up 56% compared to the first half of 2020, mainly driven by the development of lanifibranor in NASH and costs linked to the preparation for the initiation of NATiV3, the Company’s Phase III clinical trial evaluating lanifibranor in NASH. This amount includes the payment received on June 30, 2021 of €8.0 million of Research Tax Credit (CIR – Crédit Impôt Recherche) (€3.8 million related to complementary filings following the 2020 Conseil d’État judgement covering prior years, and €4.2 million related to the 2020 Research Tax Credit), while the first half of 2020 had been positively impacted by the receipt of a €4.2 million non-recurrent late payment of the 2018 Research Tax Credit and a €4.2 million payment in respect of the 2019 Research Tax Credit.

Net cash used from investing activities amounted to €1.2 million in the first half of 2021 compared to 1.0 million for the same period in 2020.

No net cash from financing activities was generated over the first half of 2021 while Inventiva recorded
€24.6 million of net cash from financing activities for the same period in 2020, notably related to the issuance of €15 million (gross proceeds) of ordinary shares in February 2020 and the entry into a €10.0 million State-guaranteed loan, with a syndicate of French banks in May 2020.

Over the first semester of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalent of €1.2 million.

Considering its current R&D and clinical development programs, and excluding additional financial resources, Inventiva’s cash runway will allow to fund its operating activities through the third quarter of 2022.

Revenues

The Company’s revenues for the first half of 2021 amounted to €0.2 million, as compared to €0.1 million for the same period in 2020.

As part of its collaboration with Abbvie in auto-immune diseases3, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant before the end of 2021.

Next key milestones expected

First patient first visit of NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the third quarter of 2021
Initiation by AbbVie of a Phase IIb clinical trial with cedirogant – expected in the second half of 2021
Strategy update on the development of odiparcil – planned for the second half of 2021
Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2DM) – planned for the first half of 2022
Upcoming investor conference participation

Citi’s 16th Annual BioPharma Conference 2021, September 8-9, 2021
KBC Virtual Life Science Conference, September 7-9, 2021
H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15, 2021
Lyon Pôle Bourse Forum, September 27-28, 2021
HealthTech Innovation Days 2021, October 4-5, 2021
Portzamparc Health Biotech Seminar 2021, October 6, 2021
Guggenheim CV&M Disease Day, October 7, 2021
H.C. Wainwright 5th Annual NASH Investor Conference, October 11, 2021
Stifel Healthcare Conference 2021, November 16-17, 2021
Jefferies 2021 London Healthcare Conference, November 16-18, 2021
Upcoming scientific conference participation

Paris NASH Meeting, October 22-23, 2021
AASLD The Liver Meeting, November 12-15, 2021
Next financial results publication

H1 2021 Financial results: Monday, September 20, 2021 (after U.S. market close)