On July 22, 2021 LUMICKS, a leading next generation life science tools company renowned for its innovative platforms for Dynamic Single-Molecule and Cell Avidity analysis, reported that it has installed its ground-breaking z-Movi Cell Avidity Analyzer at INmune Bio (NASDAQ: INMB) (Press release, LUMICKS, JUL 22, 2021, View Source;utm_medium=rss&utm_campaign=inmune-bio-acquires-lumicks-z-movi-cell-avidity-analyzer-to-accelerate-the-selection-of-nk-cell-products-for-cancer-treatments [SID1234586006]).

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INmune Bio is a clinical stage biotechnology company developing new therapies that modulate the innate immune system to treat cancer and neurodegenerative diseases, such as Alzheimer’s. Its Natural Killer Cell Priming Platform, INKmune is a "pseudokine" which drives a patient’s own natural killer (NK) cells to memory-type NK cells which kill persistent tumors that survive initial treatments.

INmune Bio is employing the z-Movi cell avidity analysis platform to demonstrate that the mechanism of action of the tumor-priming is the increase in NK cell:tumor cell avidity. Early data acquired by the z-Movi support their hypothesis that increased cell avidity enhances NK cell killing of tumor cells. This allows screening of batches of INKmune for potency and provides a potential biomarker of in vivo activity by measuring the tumor avidity of NK cells isolated from patients before and after INKmune treatment.

"The z-Movi is the first high throughput tool I have seen to reliably measure cell:cell avidity, allowing us to dissect the temporal nature of the formation of NK cell:tumor cell synapse as well as the critical components required for synapse stability and NK cell triggering. These data are incredibly valuable for our continued development of INKmune but, equally importantly, establishing the mechanism of action of INKmune as "increasing NK avidity" gives us a perfect tool and assay to measure potency of batches of INKmune, which is required by drug regulatory agencies" said Professor Lowdell, CSO of INmune Bio.

The z-Movi Cell Avidity Analyzer is a unique platform that measures the binding strength between target and immune cells, which is a key event in the mode of action of immune products. Furthermore, the z-Movi platform provides these measurements across a large population of cells, rapidly, with single-cell resolution. Cell avidity solutions have the potential to shorten the drug development cycle for adoptive cell therapies and other immune-therapies and reduce failure rates in clinical trials.

"We are excited to work together with INmune Bio, a pioneer in immunotherapy that harnesses the innate immunity of patients to combat solid and liquid cancers," said Dr. Andrea Candelli, CSO and co-founder of LUMICKS. "We strive to provide the benefits of fast, predictive, and reproducible cell avidity measurements to partners like INmune, in order to continue to advance science and accelerate the entry of cell-based therapies into clinical trials."

On July 22, 2021 The Board of GSK (GSK) reported that Brian McNamara, the CEO of GSK Consumer Healthcare (a Joint Venture between GSK and Pfizer) has been appointed as CEO Designate of the new, listed Consumer Healthcare company which will result from the proposed demerger of Consumer Healthcare from GSK in 2022 (Press release, GlaxoSmithKline, JUL 22, 2021, https://www.gsk.com/en-gb/media/press-releases/brian-mcnamara-appointed-ceo-designate-of-new-independent-consumer-healthcare-company/ [SID1234585076]).

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As set out at GSK’s Investor Update on 23 June 2021, subject to approval from shareholders, the separation of Consumer Healthcare will be by way of a demerger in mid-2022 of at least 80% of GSK’s holding to shareholders. The new resulting Consumer Healthcare company is expected to attain a premium listing on the London Stock Exchange.

The company will be a new world-leader in Consumer Health with a portfolio which generated annual sales of more than £10 billion in 2020. The company will have a strong portfolio of brands including Sensodyne, Voltaren, Panadol and Centrum and will hold category leadership positions and major sales presences in the US and China.

Sir Jonathan Symonds, GSK Chairman, said: "We are delighted to announce Brian’s appointment to lead the proposed new Consumer Healthcare company, following a thorough process conducted by the Board. Brian is an exceptional leader, and through two global integrations, has successfully transformed GSK Consumer Healthcare into a category-leading business. His strong track record of success and deep experience of fast moving consumer goods and consumer health, proven at P&G, Novartis and GSK, means he is the right choice to unlock the potential of Consumer Healthcare as an independent company and deliver its strong prospects for sustainable sales and profit growth, high cash generation and attractive returns for shareholders."

Brian joined GSK from Novartis in 2015, where he was head of the Over the Counter (OTC) division. He has been a driving force behind two successful Joint Ventures, first between GSK and Novartis and more recently with Pfizer to create a new world-leading Consumer Healthcare business.

Brian McNamara, CEO Designate, Consumer Healthcare, said: "I am honoured to have this opportunity. Together with the many talented people we have in our business, I am looking forward to our exciting future as an independent company. I am confident we are well positioned for growth, building on our brands and innovation, with leading-edge science and human understanding, to deliver better everyday health."

Appointment and selection process

As previously communicated, the Board of GSK conducted an extensive search and selection process to appoint a CEO Designate for the new Consumer Healthcare company. The process, conducted over six months and supported by two leading global search firms, was overseen by the Nominations & Corporate Governance Committee and resulted in direct evaluation and interview of several external and internal candidates for the position.

Consumer Healthcare Board

With the separation of Consumer Healthcare, the Board of GSK has been preparing for two separate, appropriately qualified, independent boards at the point of separation. A formal process to appoint a Chair and to form a Board of Directors for the new Consumer Health company is well underway. The appointment of a Chair is expected in the second half of 2021 who will then, in accordance with best practice, lead the process of appointments to establish the new Board. This new Board will include the appropriate mix of skills, experience, diversity and continuity, relevant to Consumer Health, to represent and maximise the value of this new business for shareholders.

Notes to Editors

Brian McNamara – additional information

Brian began his career at P&G and, over a 16-year tenure, gained extensive experience in product supply, brand marketing, and customer leadership before moving to Novartis in 2004.

Brian is a Board member of the Consumer Goods Forum (CGF). He previously served as a Board Member of the Global Self Care Federation (GSCF) for seven years, acting as Chairman from February 2017 to March 2019 and, for three years was an active member of the Board of Trustees for Treloar’s – a trust providing support and independence education for young people with physical disabilities.

Brian has an undergraduate degree in Electrical Engineering from Union College in Schenectady, New York and an MBA in Finance from University of Cincinnati.

On July 22, 2021 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in creating transformative technology solutions to be utilized in drug discovery and development, reported its financial results for the year and fourth fiscal quarter ended April 30, 2021 (Press release, Champions Oncology, JUL 22, 2021, View Source [SID1234585091]).

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Fourth Quarter and Fiscal Year 2021 Financial and Recent Business Highlights:
•Record annual revenue of $41.0 million, an increase of 28% year-over-year
•Developed in house computational target discovery expertise to discover novel therapeutic targets
•Continued expansion of our Lumin SaaS platform

Ronnie Morris, CEO of Champions, commented, "Our year was highlighted by new strategic initiatives that have the potential to be transformative for Champions. This year, we launched our SaaS business and we’re encouraged by the early adoption by our customers. As we close out fiscal year 2021, we’re excited to announce the expansion of our platforms for use in drug discovery and development. Relying heavily on AI and machine learning algorithms, we’re using Lumin’s capabilities to interrogate our data sets to discover novel therapeutic targets. Monetizing our unique and comprehensive data set has always been a goal which we’ve been working towards behind the scenes. Turning the goal into a reality is a significant accomplishment for Champions and we’re enthusiastic about its prospects."

David Miller, CFO of Champions added, "FY 2021 was another year of significant financial progress for Champions. We reached a record of $41 million in revenue, representing 28% year over year growth. The stability and growth of our service business has allowed us to invest in new business lines with considerable revenue growth potential."

Fourth Fiscal Quarter Financial Results

For the fourth quarter of fiscal 2021, revenue increased 21% to $10.6 million compared to $8.8 million for the fourth quarter of fiscal 2020. The overall increase in revenue was due to increased sales, both in number and size of studies, the growth of our platforms, and an expansion of our product lines. Total costs and operating expenses for the fourth quarter of fiscal 2021 were $11.0 million compared to $10.7 million for the fourth quarter of fiscal 2020, an increase of $293,000 or 3%.

For the fourth quarter of fiscal 2021, Champions reported a loss from operations of $456,000, which includes $161,000 in stock-based compensation and $302,000 in depreciation and amortization compared to a loss from operations of $2.0 million, inclusive of $163,000 in stock-based compensation, $246,000 in depreciation and amortization, and goodwill impairment of

Exhibit 99.1
$335,000, in the fourth quarter of fiscal 2020. Excluding stock-based compensation and depreciation and amortization, Champions reported income from operations for the quarter of $7,000, compared to a loss from operations of $1.2 million in the prior year period.

Cost of oncology solutions was $5.7 million for the three months ended April 30, 2021, an increase of $662,000, or 13% compared to $5.0 million for the three months ended April 30, 2020. The increase in cost of sales was primarily due to an increase in supply costs in advance of study performance and an increase in rent resulting from lab expansion. For the three months ended April 30, 2021, gross margin was 47% compared to 43% for the three months ended April 30, 2020.
Research and development expense was $2.1 million for the three months ended April 30, 2021 an increase of $251,000, or 14% compared to $1.8 million in the prior year. The increase was due to the investment in our drug discovery program and expanding existing services. Sales and marketing expense for the three months ended April 30, 2021 was $1.5 million, an increase of $384,000, or 35% compared to $1.1 million for the three months ended April 30, 2020. The increase was mainly due to an increase in compensation expenses stemming from the continued expansion of our sales force, including a dedicated Lumin SaaS team. General and administrative expense was $1.8 million for the three months ended April 30, 2021 compared to $2.5 million for the three months ended April 30, 2020, a decrease of $670,000 or 27%. The decrease was mainly attributed to the prior year’s one-time remuneration to the CEO for salary not taken in prior years. Excluding this one time, prior year expense, general and administrative expenses increased $80,000 or 5%, compared to the prior year period.

Net cash used in operations was $2.0 million for the three months ended April 30, 2021. The decrease in cash from operations was the result of changes in working capital accounts in the ordinary course of business including an increase in accounts receivable and prepaid expenses. The company ended the quarter, and year, in a cash position of $4.7 million and has no debt.

Year-to-Date Financial Results

For the twelve months of fiscal 2021, revenue increased 28% to $41.0 million, as compared to $32.1 million for the twelve months of fiscal 2020. The overall increase in revenue is due to increased sales, both in number and size of studies, and the expansion of both our platform and product lines. For the twelve months of fiscal 2021, total operating expenses increased 20% to $40.7 million, as compared to $34.0 million for the twelve months of fiscal 2020.

For the twelve months ended April 30, 2021, Champions reported net income from operations of $338,000, which includes $598,000 in stock-based compensation and $1.2 million in depreciation and amortization compared to a net loss from operations of $1.9 million, inclusive of $600,000 in stock-based compensation, $825,000 in depreciation and amortization, and goodwill impairment of $335,000, for the twelve months ended April 30, 2020. Excluding stock-based compensation and depreciation and amortization, Champions reported operating income of $2.1 million for the twelve months ended April 30, 2021 compared to a loss of $111,000 in the year ago period.

Cost of oncology solutions was $21.5 million for the twelve months ended April 30, 2021 compared to $17.0 million for the twelve months ended April 30, 2020, an increase of $4.5 million or 27%. The increase in cost of oncology services was mainly due to an increase in compensation, supplies, and outsourced lab services expenses. Gross margin was 48% for the twelve months ended April 30, 2021 compared to 47% for the twelve months ended April 30, 2020, and in the current year, was pressured by outsourced lab services.

Exhibit 99.1

Research and development expense was $7.2 million for the twelve months ended April 30, 2021 an increase of $1.3 million, or 23% compared to $5.9 million for the twelve months ended April 30, 2020. The increase was mainly due to the investment in new service capabilities and our discovery programs with the increase coming primarily from compensation and lab supply expenses. Sales and marketing expense for the twelve months ended April 30, 2021 was $5.5 million, an increase of $1.3 million, or 30% compared to $4.2 million for the twelve months ended April 30, 2020. The increase was mainly due to compensation expense driven by the continued expansion of our business development teams. General and administrative expense was $6.5 million for the twelve months ended April 30, 2021, a decrease of $102,000 or 2% compared to $6.6 million for the twelve months ended April 30, 2020. General and administrative expenses were primarily comprised of compensation, insurance, professional fees, IT, and depreciation and amortization expenses. In 2020, the CEO received a one-time remuneration for salary not taken in prior years, resulting in the general and administrative expense decrease in 2021. Excluding the one-time payment, general and administrative expense increased $650,000 which was used to support the overall infrastructure growth of the company.

Net cash used in operations was $1.7 million for the twelve months ended April 30, 2021. Cash used in operations was primarily due to an increase in accounts receivable and prepaid expenses and a decrease in accounts payable. Our accounts payable balance declined even though our total expenses increased. The changes in these working capital accounts occurred in the ordinary course of business.

Conference Call Information:

The Company will host a conference call today at 8:30 a.m. EDT (5:30 a.m. PDT) to discuss its fourth quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available on, or before, Wednesday July 28, 2021 in the Company’s Form 10-K at View Source

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP to non-GAAP Net Income (Loss) (Unaudited) for an explanation of the amounts excluded to arrive at non-GAAP net income (loss) and related non-GAAP net income (loss) per share amounts for the three and twelve months ended April 30, 2021 and 2020. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income (loss) and non-GAAP income (loss) per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive income (loss) per share amounts as non-GAAP net income (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net income (loss) and non-GAAP diluted income (loss) per share may differ from similarly named measures used by others.

On July 22, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported data presentations on two of its skin cancer gene expression profile tests at the Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference 2021, taking place from July 22-25, 2021 (Press release, Castle Biosciences, JUL 22, 2021, View Source [SID1234585109]).

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DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors. Castle presented new data assessing the clinical utility of the DecisionDx-Melanoma test through a poster entitled "Clinical Utility of the 31-Gene Expression Profile Test on the Management of Cutaneous Melanoma by Nurse Practitioners and Physician Assistants." The study highlights nurse practitioners’ and physician assistants’ (NP/PAs) attitudes toward the clinical use of DecisionDx-Melanoma in patients diagnosed with cutaneous melanoma. The poster can be accessed here.

Study methods and findings:

In 2020, an institutional review board (IRB)-approved, 20-question study was conducted to understand the perception and clinical use of DecisionDx-Melanoma by clinicians, including NP/PAs.
Of the 711 survey respondents, 266 self-identified as NP/PAs, with 50% of those (n=133) reporting ordering DecisionDx-Melanoma within the previous year.
89% of the NP/PAs responded that comprehensive prognostic testing (including DecisionDx-Melanoma) could improve patient care.
Most NP/PAs who use DecisionDx-Melanoma (97%) would recommend additional prognostic testing to close friends or family members compared to just 58% of those who do not use DecisionDx-Melanoma.
Among the NP/PAs who ordered DecisionDx-Melanoma in the previous year:
99% would recommend the test to a colleague.
Most would consider patient management changes for patients with a T1 tumor (82%) or stage I melanoma (81%) who received a high-risk Class 2B DecisionDx-Melanoma test result.
"We are pleased that the study results reinforce the clinical utility of DecisionDx-Melanoma in patients diagnosed with cutaneous melanoma," said Bob Cook, Ph.D., senior vice president of research and development. "The study data demonstrate that the majority of NP and PA respondents would consider altering patient management for a thin (T1) tumor or Stage 1 melanoma that received a high-risk DecisionDx-Melanoma result."

DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors. Castle presented data on DecisionDx-SCC through a poster entitled "Real-world clinical usage data demonstrates appropriate utilization of the prognostic 40-gene expression profile test for cutaneous squamous cell carcinoma with one or more risk factors." The poster can be found here.

Study methods and findings:

The objective of the study was to demonstrate the independent prognostic value of DecisionDx-SCC within existing risk assessment methods and report on the early clinical usage of DecisionDx-SCC.
Summary metrics were generated on the first 1000 samples received for DecisionDx-SCC testing that met clinical testing criteria. Metrics on early clinical usage include:
Technical reliability of DecisionDx-SCC was 96.3%.
69.0% of samples received DecisionDx-SCC Class 1 results, 26.0% received DecisionDx-SCC Class 2A results and 1.3% received DecisionDx-SCC Class 2B results.
52% of tested patients had three or more risk factors.
This study demonstrated that the intended use population (high-risk SCC patients with one or more risk factors) aligns with the cases that were submitted for clinical testing.
The study also found that DecisionDx-SCC results can be applied as an adjunct to enhance SCC risk stratification and contribute to risk-appropriate surveillance and treatment decisions.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through March 31, 2021, DecisionDx-Melanoma has been ordered more than 73,396 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

On July 22, 2021 Anocca AB reported that it raised $47 million in a series B round to advance its T-cell-based immunotherapies expressing recombinant T-cell receptors (TCRs) toward clinical trials in cancer and to build out its manufacturing capacity at its base in Södertälje, Sweden (Press release, Anocca, JUL 22, 2021, View Source [SID1234591028]).

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The company is by no means a newcomer to the immunotherapy space, but it has consciously adopted a low profile since its formation in 2014. "We’ve been working on our technology for nearly eight years now," co-founder and CEO Reagan Jarvis told BioWorld.

Its ability to do so was a function of its investors. Jarvis, a New Zealander who had been working as a post-doctoral researcher at the Heidelberg-based German Cancer Research Center (DKFZ), sketched out the company’s technology from what he calls "ideas on paper." This was enough to get the backing of seed investor and co-founder Mikael Blomqvist, a serial entrepreneur, who put $30 million into the fledgling company. Another early investor – and current chairman – is Hans Stråberg, one of Sweden’s most high-profile business leaders, who spent almost a decade as CEO of the Stockholm-based appliance maker Electrolux AB.

In all, Anocca has now raised more than $100 million in equity finance, and it is developing "dozens of assets" based on its industrialized approach to generating TCR-T cell therapies. "What we’ve disclosed publicly in our pipeline is just a fraction of what we’re working on," Jarvis said. Many firms have limited their TCR- based therapies to a fraction of the dominant human leukocyte antigen (HLA) haplotypes, whereas Anocca plans to achieve broad HLA coverage, in order to address a majority of the world’s population.

Disclosed projects include therapies targeting shared tumor antigens, including New York esophageal squamous cell carcinoma 1 (NY-ESO-1), L antigen family member 1A (LAGE1A) and melanoma-associated antigen 4 (MAGE-A4), among others. It has several projects that target prominent oncogenic cancer drivers, including the KRAS mutations G12D and G12V, neither of which is targeted by Amgen Inc.’s recently approved small- molecule KRAS G12C inhibitor, Lumakras (sotorasib), as well as RAC1P29S and BRAFV600E. It is developing multiple therapies directed at antigens associated with Epstein-Barr virus- transformed cancers. It is also engaged in discovering TCRs that target tumor neoantigens that occur in individual patients.

Its technology platform has been consciously designed to address indication areas outside of cancer, including vaccines against infectious disease and the inducing tolerance in patients with autoimmune disease. The company has active projects in these areas and in the development of immunosurveillance toolsets for patient monitoring and stratification.

Key to its approach has been the development of libraries of engineered human T cells and antigen presenting cells, which enable it to screen and validate T-cell targets and TCRs at scale. The reproducibility of its cell-based assays avoids the variability that can arise from approaches based on material from patients and healthy donors. "It’s just very low signal, very high noise," Jarvis said. Anocca’s approach is informed by empirical cell biology work, rather than genomics. "We barely touch next- generation sequencing," he said. "This is real biological data – there’s no AI."

The company’s long-term vision is to develop allogeneic cell therapies, but it will start with autologous therapies initially. The privately held firm already has 65 staff on the payroll, a large majority of whom are scientists, and it is operating from a former Astrazeneca plc research site for central nervous system disorders, which is about 20 miles southwest of Stockholm. It has 3,000 square meters of lab space and another 5,000 square meters for manufacturing. "We’re built for scale," Jarvis said.

It aims to be ready to move its first projects into clinical trials by the end of 2022. The big push to produce COVID-19 vaccines has had a knock-on effect on timelines, because of the manufacturing supply chain constraints it has introduced.

Anocca has yet to enter any licensing deals. "That’s a matter of opportunity and timing," Jarvis said. The company is engaged in a research collaboration with the Johnson & Johnson subsidiary Janssen Research and Development LLC, which is exploring its technology. It is also part of a European Commission-backed project in rheumatoid arthritis, RTCure, which is funded by the Innovative Medicines Initiative. And it is engaged in project with Solna-based Scilifelab on the biophysical and structural characterization of the interactions between TCRs and the major histocompatibility complex.

The present round was limited to Nordic investors – it could have been bigger had the company wanted to take on more capital at this time. "We’ve not been greedy," Jarvis said. The process was led by advisers Danske Bank and brought in new investors Swedbank Robur Ny Teknik, a managed equity fund, investment managers Ramsbury Invest AB, and several family offices, including those of veteran venture capital investors Harald Mix and Robert Andreen. Existing investors, including Mellby Gård, Nidoco and Blomqvist’s investment vehicle, Michano, also participated.