On November 10, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (the "Company") reported that the company will deliver a corporate presentation during the 2021 Jefferies London Healthcare Conference — November 16-19, 2021 (Press release, Aurinia Pharmaceuticals, NOV 10, 2021, View Source [SID1234595089]). The presentation will be available to all conference attendees on demand (link here) beginning on Thursday, November 18 at 8 am GMT/3 am EST through Friday, November 19 at 5 pm GMT/12 pm EST.

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Interested parties can also register and access the on-demand webcast through the Investor section of the Aurinia corporate website – www.auriniapharma.com, under "News/Events."

On November 10, 2021 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT, MXCN), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, reported third quarter ended September 30, 2021 financial results (Press release, MaxCyte, NOV 10, 2021, View Source [SID1234595105]).

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Third Quarter and Recent Highlights

Total revenue was $10.1 million in the third quarter of 2021, representing 50% growth compared to the same period in 2020.
Excluding Strategic Platform License (SPL) Program-related revenue, revenue from cell therapy customers was $6.2 million for the third quarter, an increase of 38% compared to the same period in 2020.
SPL Program-related revenue was $2.0 million in the third quarter — the highest SPL Program-related revenue we have received in any quarter to-date — as compared to $0.3 million for the same period in 2020.
Revenue from drug discovery customers was $1.9 million in the third quarter, a decrease of 5% compared to the same period in 2020, but up sequentially from the second quarter of 2021.
With the addition of Myeloid Therapeutics, Inc., Celularity, Inc., Sana Biotechnology, Inc., and Nkarta, Inc. signed year-to-date, the total number of SPLs now stands at 15.
"We are pleased to report very strong third quarter results driven by ongoing strength in sales to cell therapy customers and robust SPL Program-related revenue." said Doug Doerfler, President and CEO of MaxCyte.

"We continue to expand our customer base and increase the number of strategic partnerships, now with 15 SPL agreements in place following the announcement of our agreement with Nkarta in early November. The vast majority of our SPL agreements enable MaxCyte to participate in pre-commercial milestones and post-commercial sales-based payments on SPL-related Programs. We remain bullish around the potential for our SPL partnerships to generate meaningful revenue for the business over the next 12 to 18 months and beyond as our partners continue to see clinical success.

We are also making important and strategic investments in our business, expanding our marketing, R&D and product development capabilities, launching innovative solutions to drive future growth, bolstering our leading internal and field-based cell engineering expertise, expanding our manufacturing capabilities as our customers move closer to commercialization, and adding strong talent across all facets of our business."

"Overall, MaxCyte remains well-positioned to support growing adoption of the ExPERT platform technology for cellular-based research and next-generation therapeutic development."

Third Quarter Financial Results

Total revenue for the third quarter of 2021 was $10.1 million, compared to $6.8 million in the third quarter of 2020, representing growth of 50%. Sales to cell therapy customers, across both instruments and single use disposables, were collectively up 38% compared to the same period last year.

Success in recognizing revenue from our SPL Programs was also a primary source of strength in the quarter. The Company recognized $2.0 million in SPL Program-related revenue in the quarter (comprised of pre-commercial milestone revenues) as compared to $0.3 million in SPL Program-related revenue in the third quarter of 2020.

Gross profit for the third quarter of 2021 was $9.2 million (91% gross margin), compared to $6.0 million (89% gross margin) in the same period of the prior year. The increase in gross margin was driven by the higher SPL Program-related revenues; excluding SPL Program-related revenues, gross margin was relatively unchanged.

Operating expenses for the third quarter of 2021 were $11.6 million, compared to operating expenses of $8.9 million in the third quarter of 2020. The overall increase in operating expense was principally driven by a $3.4 million increase in compensation expense associated with increased headcount and higher stock-based compensation (principally due to stock-price appreciation), as well as a $1.2 million increase in legal, public company and professional service expenses.

Partially offsetting this expense growth was a $2.5 million decline in CARMA-related expenses compared with the same period last year. As of March 2021, all pre-clinical and clinical activities related to the CARMA platform were substantially completed.

Third quarter 2021 net loss was ($2.7) million compared to net loss of ($3.1) million for the same period in 2020.

Total cash, cash equivalents and short-term investments were $255.9 million as of September 30, 2021.

Preliminary 2021 Revenue

We are updating our revenue projection for fiscal year 2021. We now expect to achieve at least $33.0 million in revenue for fiscal year 2021, up from our prior guidance of greater than $30 million in revenue for the year.

Executive Leadership Addition

James Lovgren has joined MaxCyte as Senior Vice President of Global Marketing. Mr. Lovgren brings deep experience in cell therapy to the role, where he will help grow adoption of the MaxCyte ExPERT platform in cellular-based research and next-generation drug development. Most recently, Mr. Lovgren served as Vice President at Berkeley Lights, where he was responsible for cell therapy strategy, including product development and marketing. Previously, he served as General Manager at Thermo Fisher Scientific in the cell and gene therapy business, overseeing the launch of several strategic products. He also held leadership positions at Minerva Biotechnologies, ORGN3N and Life Technologies. Mr. Lovgren earned his master’s degree in business administration at North Carolina State University and his bachelor’s degree in biology at University of North Florida.

Webcast and Conference Call Details

MaxCyte will host a conference call today, November 10, 2021, at 4:30 p.m. Eastern Time. Interested parties may access the live teleconference by dialing (844) 679-0933 for domestic callers or (918) 922-6914 for international callers, followed by Conference ID: 5098687. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

Form 10-Q

MaxCyte expects to file its Quarterly Report on Form 10-Q for the period ended September 30, 2021 with the SEC on November 10, 2021. When filed, a copy of the Form 10-Q will be available on the SEC’s website at www.sec.gov and will also be available under the "SEC filings" page of the Investors section of the Company’s website, View Source

On November 10, 2021 Intima Bioscience, a clinical stage biotechnology company developing genetically engineered cell therapies for solid tumor cancers, reported the appointment of Alessandro Riva, M.D. as Chief Executive Officer (Press release, Intima Bioscience, NOV 10, 2021, View Source [SID1234595138]). Dr. Riva is a veteran biotech executive who has held senior leadership positions at Novartis Pharmaceuticals and Gilead Sciences, where he was responsible for the company’s hematology and oncology programs and managed the U.S. and EU approvals of multiple innovative cancer treatments including Yescarta, a CAR-T cell therapy.

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"Alessandro is an extremely accomplished biopharma leader who has played an important role in some of the biggest moments in the field of cell therapy during his tenures at Novartis and Gilead," said Gerald Chan of Morningside Ventures and Intima board member. "Alessandro has unmatched experience when it comes to bringing potentially curative cell therapies to patients with cancer and I look forward to working with him as he joins Intima."

Dr. Riva most recently served as Chief Executive Officer at Ichnos Sciences, where he built a biotechnology company focused on bi- and tri-specific antibodies in oncology and biologics in autoimmune diseases. Before Ichnos, he was EVP and Global Head of Oncology Therapeutics and Cell & Gene Therapy at Gilead Sciences, where he was instrumental in the $12 billion acquisition of Kite Pharma and led its integration and growth. He also managed the U.S. and EU approvals of Yescarta, the first approved CAR-T cell therapy for adult patients with diffuse large B cell lymphoma and the therapy’s development in additional indications. Prior to Gilead, Dr. Riva was EVP and Global Head of Oncology Development and Medical Affairs at Novartis Pharmaceuticals, where he contributed significantly to the creation of the Cell and Gene Therapy Unit. He was also President ad interim of Novartis Oncology during the $16B acquisition of GSK Oncology. Dr. Riva is an author and co-author of more than 100 papers and abstracts in the field of oncology. He is currently on the Board of Directors for Century Therapeutics. He received his bachelor’s degree in medicine and surgery from the University of Milan and a certificate board in oncology and hematology from the same institution.

"Intima Bioscience has made impressive and significant progress advancing genetically engineered cell therapies for difficult-to-treat solid tumor cancers, an area in which there remains a significant unmet need for patients," Dr. Riva said. "By combining advances in the development of cell therapies with the targeting of the novel intracellular immune checkpoint CISH, Intima’s scientific approach is exceptionally promising for the treatment of a variety of cancers. I have been fortunate to contribute to gene and cell therapy in cancer at pivotal moments in its evolution. This is the natural next step in my own personal and professional journey. I look forward to working with the impressive team and advancing the company’s efforts towards meaningful curative intent on behalf of the patients we serve."

Intima recently shared a study showing that the deletion of the intracellular immune checkpoint CISH from primary human T cells can enhance anti-tumor activity across a broad range of cancer types regardless of the cancers’ PD-L1 biomarker status. This approach potentially offers novel treatment paradigms and possibilities to extend the efficacy of current cell surface checkpoint inhibitors such as PD-1 and TIGIT.

About CISH

CISH is a gene found in humans and many other mammals that controls T cell receptor signaling. A member of a new class of intra-cellular immune checkpoint molecules, CISH functions downstream of the T cell receptor to regulate antigen-specific effector functions, including reactivity to cancer neoantigens. Intima is investigating the anti-tumor impact of CISH inhibition through the use of CRISPR gene editing in tumor infiltrating lymphocytes in a Phase 1/2 clinical trial.

On November 10, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the 2021 annual Cowen IO Summit at 2:15 p.m. ET on Monday, Nov. 15, 2021 (Press release, Amgen, NOV 10, 2021, View Source [SID1234595154]). David M. Reese, M.D., executive vice president of Research and Development at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On November 10, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported financial results for the third quarter ended September 30, 2021 and provided recent business highlights (Press release, iTeos Therapeutics, NOV 10, 2021, View Source [SID1234595275]).

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"We continued to make significant clinical progress advancing our next-generation immunotherapies in multiple cancer indications. We officially closed our transformational collaboration with GSK, allowing us to initiate novel immunotherapy combinations with the potential to improve outcomes for patients. This includes pairing GSK’s recently approved anti-PD-1, Jemperli (dostarlimab) with our anti-TIGIT monoclonal antibody, EOS-448, and with both EOS-448 and our highly differentiated clinical-stage A2A adenosine receptor antagonist, inupadenant," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "We are pleased to have started executing our accelerated clinical development plans, initiating dosing in cohorts evaluating EOS-448 in combination with pembrolizumab and with inupadenant. We have also begun dosing patients with PD-1 resistant melanoma in a trial evaluating inupadenant plus pembrolizumab. We remain focused on converting our scientific innovation into improved clinical outcomes for patients and plan to initiate multiple trials of additional combinations in the coming months."

Program Highlights

EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through a multifaceted mechanism.

In July 2021, iTeos closed its development and commercialization collaboration agreement with GSK for EOS-448 which was first announced in June 2021. iTeos received the full $625 million upfront payment and is eligible to receive up to $1.45 billion in potential milestone payments upon the achievement of certain development and commercial milestones as part of the agreement.
iTeos and GSK are advancing various novel combinations of potential next generation immuno-oncology agents. Two trials will be initiated in the coming months. The first, assessing the doublet of GSK’s anti-PD-1, (dostarlimab), with EOS-448 and the second, a triplet of this combination adding inupadenant.
In September, iTeos dosed the first patients in a clinical trial of EOS-448 in combination with pembrolizumab and in combination with inupadenant in patients with solid tumors.
The company will initiate a clinical trial in the first quarter of 2022 evaluating EOS-448 as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in patients with multiple myeloma.
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment.

iTeos has completed patient enrollment in the cohort evaluating the safety of inupadenant in combination with chemotherapy and with pembrolizumab as well as the monotherapy expansion cohort in prostate cancer.
The company has initiated an expansion cohort evaluating inupadenant in combination with pembrolizumab in patients with PD-1-resistant melanoma.
Based on results presented at ASCO (Free ASCO Whitepaper) in June 2021, demonstrating that A2A receptor expression is associated with clinical outcomes in patients with solid tumors treated with single agent inupadenant, iTeos plans to explore a patient selection biomarker in the ongoing Phase 1b/2a trial.
The company plans to advance inupadenant into randomized controlled trials in combination based on the established safety and tolerability profile in combinations and encouraging clinical data observed to date.
Preclinical programs: iTeos continues to progress research programs focused on additional targets that address pathways of immunosuppression and complement the mechanism of action of the A2AR and TIGIT programs. As previously guided, iTeos has nominated an additional candidate targeting a new mechanism in the adenosine pathway for Investigational New Drug-enabling studies.

Upcoming Events

Piper Sandler 33rd Annual Healthcare Conference, November 30 – December 2, 2021
Third Quarter 2021 Financial Results

Cash Position: The Company had cash and cash equivalents of $899.8 million as of September 30, 2021, compared to $340.0 million as of September 30, 2020. This cash balance provides a runway into 2026.
License Revenue: License revenue was $104.3 million for the quarter ended September 30, 2021, compared with $0 million for the same quarter of 2020. This revenue was due to the recognition of a portion of the upfront payment received as a result of the license and collaboration agreement with GSK during the quarter. Additional information regarding revenue recognition related to the collaboration agreement will be included in the company’s Form 10-Q for the quarter ended September 30, 2021.
Research and Development (R&D) Expenses: R&D expenses were $16.1 million for the quarter ended September 30, 2021, compared to $8.7 million for the same quarter of 2020. This increase was primarily due to an increase in activities related to clinical trials for EOS-448 and inupadenant, increased spending for the company’s preclinical programs and increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $8.8 million for the quarter ended September 30, 2021, compared to $4.8 million for the same quarter of 2020. This increase was primarily due to increased headcount, professional fees and other costs associated with becoming a public company
Net Income/Loss: Net income attributable to common shareholders was $69.6 million, or a net income of $1.98 per basic share and $1.86 per diluted share, for the quarter ended September 30, 2021, as compared to a net loss attributable to common shareholders of $11.6 million, or a net loss of $0.48 per basic and diluted share, for the same quarter of 2020.
Conference Call Details:
iTeos Therapeutics will host a conference call and webcast today, Wednesday, November 10th, at 4:30 p.m. ET. To access the live conference call, please dial 833-927-1758 (domestic) or 929-526-1599 (international) and refer to conference access code 861337. A live audio webcast of the event will also be accessible from the News and Events page of the Company’s website at View Source The archived webcast will be available approximately two hours after the completion of the event and for one week following the call.