On July 30, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported the publication of a comprehensive preclinical in vitro and in vivo data package of its innate cell engager (ICE) AFM24 (CD16A/EGFR) in mAbs (Press release, Affimed, JUL 30, 2021, View Source [SID1234585476]). The published data were the basis for the Investigational New Drug (IND) clearance for Affimed’s ongoing Phase 1/2a study with AFM24 monotherapy in patients with EGFR expressing solid tumors. The preclinical data demonstrates AFM24’s unique mechanism of action that harnesses the innate immune system to induce tumor cell killing via antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP).

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"These pre-clinical data are encouraging as they demonstrate the potential for AFM24 to effectively target a broad set of tumors expressing varying levels of EGFR, regardless of their mutational status, and with the potential for less pronounced EGFR-related toxicities than current treatment options," said Arndt Schottelius, M.D., Ph.D., Chief Scientific Officer at Affimed. "This could be highly relevant for many patients with different tumor types despite existing EFGR-targeting therapies as these have limitations in efficacy and safety."

Highlights of the recently published results include:

AFM24 binds with high affinity to CD16A on NK cells and macrophages in vitro.
AFM24 potently induces ADCC via NK cells, and ADCP via macrophages in vitro.
AFM24 is effective against many EGFR-positive tumor cells, regardless of EGFR expression level and KRAS/BRAF mutational status within in vitro studies.
AFM24 is well tolerated up to the highest dose level (75 mg/kg) with no skin and other toxicities in cynomolgus monkeys.
The full manuscript is available here: https://bit.ly/3zLDq3i

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Affimed is evaluating AFM24 as a monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101 is a first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. In addition, Affimed is planning to initiate further studies evaluating AFM24 in combination with Roche’s atezolizumab, an anti-PD-L1 checkpoint inhibitor and, separately, an investigation of AFM24 in combination with NKGen Biotech’s autologous NK cell product.

On July 30, 2021 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported financial results for the first quarter of fiscal year 2021 (period ended June 30, 2021). Based on the solid first-quarter results, the Company also confirmed its fiscal year 2021 management guidance and forecast. Fiscal year 2021 remains a year of inflection with Takeda positioned for topline acceleration and continued pipeline progress, including critical regulatory submissions, potential approvals and additional new molecular entities (NMEs) advancing in pivotal studies.

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Costa Saroukos, Chief Financial Officer, commented:
"With the Shire integration behind us and continued transformation over the last two years, we’ve pivoted towards accelerating topline growth and investing in R&D to fuel our highly innovative pipeline. Takeda’s first-quarter results demonstrate the continued strength of our 14 global brands and, with the business momentum from this strong start to our fiscal year, we remain on track towards our full-year management guidance."

"FY2021 is an inflection year for our pipeline as we ramp up strategic R&D investments and the pipeline starts to deliver. We anticipate having five to six Wave 1 pipeline regulatory submissions by the end of this fiscal year, with the potential for five approvals by end of H1 FY2022. The resilience of Takeda’s business model is a testament to our unwavering commitment to serving patients, our people and the planet. We are focused on discovering and delivering life-transforming treatments to people around the world to create and maximize long-term value for society."

FINANCIAL AND BUSINESS HIGHLIGHTS

Results for Q1 FY2021 Ended June 30, 2021

(a) Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source." target="_blank" title="View Source." rel="nofollow">View Source
(b) Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.
(c) Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as non-recurring items, purchase accounting effects and transaction related costs.
(d) Free Cash Flow represents cash flows from operating activities, excluding acquisition of plant, property and equipment, intangible assets and investments, and any other cash that is not available to Takeda’s immediate or general business use, and including proceeds from sales of property, plant, sales and redemption of investments and businesses, net of cash and cash equivalents divested.
View Source

Reported Revenue increased +18.4% to 949.6 billion yen ($8.6B); Underlying Core Revenue increased +3.8% vs. FY2020 Q1, driven by the 14 global brands

Takeda’s 14 global brands, with an aggregate reported revenue of 335.6 billion yen ($3.0B), posted year-over-year underlying revenue growth of +6.8% despite quarterly phasing headwinds for TAKHZYRO and IG. Takeda’s 5 key business areas with 708.0 billion yen ($6.4B) in reported revenue represented 87% of core revenues1.
GI with 210.5 billion yen ($1.9B) in reported revenue, with underlying revenue growth of +8% spearheaded by gut-selective ENTYVIO.
Rare Diseases with 155.5 billion yen ($1.4 B) in reported revenue declining -3% on an underlying basis, with HAE growth impacted by phasing, but remains in line with the current plan.
Plasma Derived Therapy (PDT) Immunology with 107.2 billion yen ($1.0B) in reported revenue declining -2% on an underlying basis, impacted by quarterly phasing of Immunoglobulin products, with full-year outlook unchanged.
Oncology with 121.4 billion yen ($1.1B) in reported revenue, with underlying revenue growth +9% driven by indication expansion across the portfolio.
Neuroscience with 113.4 billion yen ($1.0B) in reported revenue, with underlying revenue growth +3% driven by strong rebound of Vyvanse following impact of COVID-19 in the prior year.
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1 Percentage of sales are based on Core revenue; adjusted to remove JPY 133.0B from sale of Japan diabetes portfolio recorded in revenue

Reported Operating Profit increased 48.6% Underlying Core Operating Profit Margin was 30.5% for Q1

Reported operating profit increased 48.6% to 248.6 billion yen ($2.2B) compared to FY2020 Q1, driven by a gain on the sale of the diabetes portfolio in Japan, lower purchase price accounting expenses and lower integration costs. These items more than offset a decrease in other operating income due to a one-time gain recorded in FY2020 Q1.
Underlying core operating profit for the current period declined -2.1% reflecting an increase in R&D investment and is expected to recover to "mid-single digit" growth for the full year.
Continued progress in debt pre-payment with approximately 242.9 billion yen toward $2.2 billion paid in FY2021 Q1.
Achieved several critical pipeline milestones to date in FY2021

Moderna’s COVID-19 Vaccine, approved in Japan for adults in May and expanded age indication to adolescents 12+ years old in July, with distribution underway.
Mobocertinib (TAK-788) filing under review in US, China, and other countries.
Maribavir’s (TAK-620) filing and acceptance in the US and EU, with FDA granting priority review.
Orexin (TAK-994) granted Breakthrough Therapy designation by the FDA for Narcolepsy Type 1.
TAK-999 granted Breakthrough Therapy designation by the FDA for AATD2 Liver Disease
Collaboration with Frazier Healthcare Partners to launch HilleVax, Inc., a biopharmaceutical company to develop and commercialize TAK-214, Takeda’s norovirus vaccine candidate.
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2 AATD = Alpha-1 antitrypsin deficiency

Important recognition in Q1

Two of Takeda’s facilities in Japan and Ireland were recognized by the International Society for Pharmaceutical Engineering (ISPE) with the 2021 Facility Of the Year Awards for the use of digital and innovative technologies to enhance manufacturing capabilities.
FY2021 Guidance

On track towards full-year FY2021 guidance (Unchanged from May 2021)

Key assumptions in FY2021 forecast

Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, underlying revenue growth of its 14 global brands, and accelerated realization of cost synergies, while continuing to invest in R&D.

FY2021 guidance reflects the following key assumptions, including (1) Takeda expects at least one 505(b)2 competitor for subcutaneous VELCADE to launch in the U.S. around mid FY2021; (2) Takeda does not expect to restart sales of Natpara in the U.S. market in FY2021; and (3) FY2021 guidance does not include the impact of any potential further divestitures beyond what has already been disclosed by Takeda.

To date, Takeda has not experienced a material effect on its financial results as a result of the global spread of the novel coronavirus infectious disease (COVID-19). Based on currently available information, Takeda believes that its financial results for FY2021 will not be materially affected by COVID-19 and, accordingly, Takeda’s FY2021 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2021, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in an additional impact on Takeda’s business, results of operations or financial condition, as well as result in significant deviations from Takeda’s FY2021 forecast.

For more details on Takeda’s Q1 FY2021 results and other financial information, please visit: View Source

More information on Takeda’s Environmental, Social and Governance (ESG) approach and values-based corporate governance can be found in the 2021 Annual Integrated Report for FY2020, which ended March 31, 2021. This report can be accessed on Takeda’s website at: View Source

On July 29, 2021 panCELLa, a privately held biotechnology company focused on developing safe therapeutic cell products for a broad range of diseases, reported the issuance of the FailSafeTM patent in Israel (Press release, panCELLa, JUL 29, 2021, View Source [SID1234591513]). This patent issued to the Sinai Health System (SHS) protects the exclusive panCELLa technology known as FailSafeTM. FailSafeTM is a superior safety switch compared to other suicide systems as it will not become "lost" or "shut down" during a "mutation" or if the therapeutic cells become deregulated or "go rogue". FailSafeTM can be controlled both prior to or after transplantation in a patient. As well, it is the only quantifiable safety switch on the market allowing patients and clinicians to make an informed decision regarding the risk of a cell therapy going awry.

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FailSafeTM is a valuable therapeutic platform technology that may be applied in numerous indications. Currently, panCELLa is developing therapeutic products through our subsidiaries – Ankarys Therapeutics and Implant Therapeutics – in the areas of immunology, mesenchymal stem cell and pancreatic islets while we continue to seek collaborative and strategic partnerships to develop and monetize additional applications in the area of regenerative medicine.

panCELLa currently has 52 issued or pending patents and has in-licensed the rights to a further 67 issued or pending patents.

On July 29, 2021 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies against difficult-to-treat cancers, reported that members of IMV’s executive management team will be participating at the BTIG Virtual Biotechnology Conference which will be held on August 9-10 and will be participating in a fireside chat hosted by BTIG’s research team (Press release, IMV, JUL 29, 2021, View Source [SID1234585350]).

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BTIG Virtual Biotechnology Conference Fireside Chat: Tuesday, August 10 at 11:00 am (ET)

A link to this presentation will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website at the above-mentioned time and for approximately 30 days thereafter.

On July 29, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the second quarter ended June 30, 2021, and provided an update on recent business progress (Press release, Veracyte, JUL 29, 2021, View Source [SID1234585366]).

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"Our business demonstrated significant momentum in the second quarter, with particularly strong growth in our thyroid and urologic cancer product lines," said Marc Stapley, Veracyte’s chief executive officer. "The pending HalioDx acquisition is expected to further fuel our global cancer diagnostics growth and leadership. Importantly, we also added key new hires to the executive team and are well-positioned to execute on our compelling vision of improving outcomes for patients all over the world at every step of their journey."

Second Quarter 2021 Financial Results

For the second quarter of 2021, as compared with the second quarter of 2020:

Total Revenue was $55.1 million, an increase of 166%;
Gross Margin was 68%, an increase of 500 basis points;
Operating Expenses, Excluding Cost of Revenue, were $45.1 million, an increase of 87%;
Net Loss and Comprehensive Loss was $9.0 million, an improvement of 18%;
Basic and Diluted Net Loss Per Common Share was $0.13, an improvement of 41%;
Net Cash Provided by Operating Activities was $1.9 million, an improvement of 122%; and
Cash and Cash Equivalents were $327.5 million at June 30, 2021.
For the six months ended June 30, 2021, compared to the prior year:

Total Revenue was $91.8 million, comprising $89.6 million in testing and product revenue and $2.2 million in biopharmaceutical partnership and collaboration revenue, an increase of 77%;
Gross Margin was 67%, an increase of 500 basis points;
Operating Expenses, Excluding Cost of Revenue, were $114.8 million, including $39.5 million of acquisition-related expenses, an increase of 108%;
Net Loss and Comprehensive Loss was $50.9 million, including $39.5 million of acquisition-related expenses, an increase of 124%;
Basic and Diluted Net Loss Per Common Share was $0.78, including $0.60 per share attributable to the acquisition-related expenses recorded in general and administrative expenses, an increase of 73%; and
Net Cash Used in Operating Activities was $38.7 million.
Second Quarter 2021 and Recent Business Highlights

Commercial Growth:

Grew total volume to 20,856 genomic tests, an increase of 215% compared to the same period in 2020 and 44% compared to the first quarter of 2021.
Achieved key managed care milestones for our genomic tests:
Received final Medicare coverage policy for the Decipher Bladder test from Noridian, our Medicare Administrative Contractor, through the MolDX program.
Signed a managed care contract with a major health plan, making the Decipher Prostate test an in-network benefit for eligible patients among the plan’s approximately 20 million members nationally.
Granted reimbursement for the Prosigna breast cancer test in Germany for eligible patients with HR+/HER2- early-stage breast cancer, enabling hospitals and laboratories in Germany to perform the test locally.
Evidence Development and Pipeline Advancement:

Presented 14 abstracts demonstrating the performance and utility of our current and pipeline genomic tests at the American Thoracic Society (ATS), American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer annual meetings. This included the presentation of pivotal clinical validation data at the ASCO (Free ASCO Whitepaper) meeting demonstrating the ability of the Percepta Nasal Swab test to improve the early assessment of lung cancer.
Published data demonstrating the prognostic utility of Veracyte’s Decipher Prostate genomic classifier:
Data published in JAMA Oncology suggest that, among men with non-metastatic castration-resistant prostate cancer (nmCRPC), the Decipher test can help identify those patients most likely to benefit from treatment with apalutamide, a second-generation androgen receptor signaling inhibitor (ARSi), in addition to androgen-deprivation therapy (ADT).
Findings from a study published in Prostate Cancer and Prostatic Diseases suggest the Decipher test may help guide treatment decisions for men with early-stage prostate cancer who are candidates for active surveillance.
Global Expansion Progress:

Announced the planned acquisition of HalioDx to further accelerate growth and strengthen Veracyte’s global leadership in cancer diagnostics. The acquisition is intended to provide three strategic benefits to Veracyte:
Accelerate IVD test development and manufacturing operations in Europe;
Expand the company’s scientific expertise into the emerging immuno-oncology field; and
Broaden Veracyte’s cancer diagnostics scope into eight of the top 10 cancers by U.S. incidence.
Added key new hires to further strengthen the executive team and position the company to scale globally:
Rebecca Chambers as executive vice president and chief financial officer;
Rob Brainin as executive vice president and chief business officer; and
Bill Zondler as senior vice president and chief information officer.
2021 Financial Outlook

Veracyte is increasing its 2021 annual total revenue guidance to a range of $200 million to $208 million from its previous guidance range of $190 million to $200 million. This range represents 69% to 76% total revenue growth for fiscal 2021 compared to fiscal 2020, and increased from Veracyte’s prior estimate of 61% to 69% total revenue growth.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source