On November 8, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the third quarter ended September 30, 2021 (Press release, Invitae, NOV 8, 2021, View Source [SID1234594728]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Year-over-year growth continued at a fast pace in the third quarter as volumes remained strong across the platform," said Sean George, Ph.D., co-founder and CEO of Invitae. "In particular, progress in the oncology group is reflected in current volumes and preparations for high-value, high-margin product introductions over the coming year, supported by multiple ongoing studies. We saw continued progress in our data and platform services, underscored by the integration of Medneon and the Ciitizen technology platform that bolster our ability to collect, house and deliver benefits from patient data collected on their behalf. We look forward to continued robust volume growth in the coming periods as we introduce new testing capabilities and increase access to our lifelong testing and data platform."

Third Quarter 2021 Financial Results

Generated revenue of $114.4 million in the quarter, a more than 66% increase compared to $68.7 million in the same period in 2020.
Reported billable volume of 296,000 in the quarter, approximately 89% increase compared to 157,000 in the same period in 2020.
Reported average cost per billable unit of $296 in the quarter compared to $297 average cost per billable unit in the same period in 2020. Non-GAAP average cost per unit was $249 in the quarter.
Achieved gross profit for the third quarter of 2021 of $26.7 million, compared to $22.1 million in the same period in 2020. Non-GAAP gross profit was $40.7 million in the third quarter.
Total operating expense, which excludes cost of revenue, for the third quarter of 2021 was $220.0 million compared to $102.9 million in the same period in 2020. Non-GAAP operating expenses for the quarter was $201.8 million.

Net loss for the third quarter of 2021 was $198.2 million, or a $0.91 net loss per share, compared to a net loss of $102.9 million, or a $0.78 net loss per share, in the third quarter of 2020. Non-GAAP net loss for the quarter was $175.9 million, or a $0.81 non-GAAP net loss per share.

At September 30, 2021, cash, cash equivalents, restricted cash and marketable securities totaled $1.25 billion as compared with $1.54 billion as of June 30, 2021. Net increase in cash, cash equivalents and restricted cash for the quarter was $186.1 million. Cash burn was $286.0 million for the quarter. Cash burn for the quarter would have been $148.1 million excluding the cash paid for acquisitions, primarily related to the cash paid to acquire Medneon and Ciitizen.

Corporate and Scientific Highlights

Acquired patient-centric consumer health tech company Ciitizen to enhance Invitae’s platform by providing patients an easy-to-use, centralized hub for their genomic and clinical information, which together comprise a powerful dataset with the potential to drive research and improve healthcare decision-making.
Announced new data from the TRACERx lung cancer research collaboration. The data further validate the value of liquid biopsy as a less invasive and more comprehensive approach to guiding personalized cancer treatment. The data underscore previous findings from the TRACERx cohort that monitoring for cancer circulating tumor DNA (ctDNA) based minimal residual disease (MRD) detected relapse of non-small cell lung cancer (NSCLC) up to three years earlier than standard of care imaging surveillance in some instances.
Presented research demonstrating that genetic findings informed clinical management changes that led to improved seizure control and outcomes in the majority of epilepsy patients with actionable findings. The findings were presented in September at the National Society of Genetic Counselors 40th Annual Conference.
Outlook and Guidance
The company has adjusted its 2021 annual revenue guidance to $450 million – $475 million, or year-over-year revenue growth of between 60% and 70%. The change in revenue outlook was primarily due to greater than expected seasonal impact in Q3.

Webcast and Conference Call Details
Management will host a conference call and webcast today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss financial results and recent developments. To access the conference call, please register at the link below:

View Source

Upon registering, each participant will be provided with call details and a conference ID.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

On November 8, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that the first patient has been dosed in a Phase 2 study evaluating NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with atezolizumab (Tecentriq) as a first-line (1L) treatment for patients with PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, NeoImmuneTech, NOV 8, 2021, View Source [SID1234594745]).

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NSCLC accounts for approximately 85% of all cases of lung cancer. Lung cancer is the second most commonly diagnosed cancer worldwide – in 2020, an estimated 2.2 million new cases of lung cancer were diagnosed globally, accounting for approximately 11.4% of the global cancer burden. An estimated 1.8 million lung cancer deaths occurred in 20201. Atezolizumab has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the US. Atezolizumab now has five approved indications in NSCLC in the US, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy) and the first approved cancer immunotherapy for adjuvant NSCLC.

"Following preclinical studies which showed promising evidence that adding NT-I7 to atezolizumab increased the anti-tumor activity, we are pleased to have commenced this Phase 2 trial," said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT. "NT-I7’s T cell-amplifying properties may make it an excellent partner in combination with a checkpoint inhibitor, like atezolizumab, and this study could bring us closer to a new chemo-free treatment option for patients with PD-L1-expressing NSCLC. We look forward to evaluating how the addition of NT-I7 impacts the effects of single-agent atezolizumab in frontline locally advanced or metastatic NSCLC."

This multicenter Phase 2 study will evaluate the efficacy and safety of the combination therapy. Roche will supply NeoImmuneTech with atezolizumab for the clinical trial. More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT04984811.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On November 8, 2021 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the third quarter of 2021 (Press release, Sana Biotechnology, NOV 8, 2021, View Source [SID1234594793]).

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"We continue to make progress in building the company, progressing our pipeline, and growing our people and capabilities," said Steve Harr, Sana’s President and Chief Executive Officer. "The recent licensing of genome editing technology to enable multiple pipeline programs is an example of our continued focus on augmenting our innovative capacity. As our pipeline progresses, we look forward to presenting data from our in vivo CAR T and ex vivo allogeneic CAR T cell programs at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December."

Recent Corporate Highlights

Announced an agreement for non-exclusive commercial rights to Beam’s CRISPR Cas12b nuclease system for certain ex vivo engineered cell therapy programs. Engineering cells for therapeutic applications requires technologies for precise editing of their genome sequence. We plan to use the technology with certain product candidates, including many of our allogeneic CAR T and pluripotent stem cell programs.
Third Quarter 2021 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2021 were $866.1 million compared to $412.0 million as of December 31, 2020, an increase of $454.1 million. The increase was primarily driven by net proceeds of $626.4 million received in Sana’s initial public offering in February 2021, partially offset by cash used in operations of $141.0 million and cash used for the purchase of property and equipment of $24.7 million.

Research and Development Expenses: For the three and nine months ended September 30, 2021, research and development expense, inclusive of non-cash expenses, was $53.2 million and $140.2 million, respectively, compared to $40.1 million and $96.5 million, respectively, for the same periods in 2020. The increases of $13.1 million and $43.6 million, respectively, for the three and nine months ended September 30, 2021 were due to an increase in personnel expenses related to increased headcount to expand Sana’s research and development capabilities, costs for laboratory supplies, costs for preclinical studies and external manufacturing, and facility costs. Research and development expenses include non-cash stock-based compensation of $4.1 million and $9.9 million, respectively, for the three and nine months ended September 30, 2021 and $1.0 million and $2.6 million, respectively, for the same periods in 2020.

Research and Development Related Success Payments and Contingent Consideration: For the three and nine months ended September 30, 2021, we recognized non-cash expenses of $16.8 million and $67.8 million, respectively, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration, compared to $4.5 million and $57.3 million, respectively, for the same periods in 2020.

General and Administrative Expenses: General and administrative expenses for the three and nine months ended September 30, 2021, inclusive of non-cash expenses, were $13.4 million and $37.7 million, respectively, compared to $7.1 million and $19.1 million, respectively, for the same periods in 2020. The increases of $6.3 million and $18.6 million, respectively, in the three and nine months ended September 30, 2021 were primarily due to increased personnel-related expenses attributable to an increase in headcount to build our infrastructure, legal fees to support our patent portfolio and license arrangements, insurance associated with being a public company, consulting fees, and facility costs. General and administrative expenses include stock-based compensation of $1.9 million and $5.2 million, respectively, for the three and nine months ended September 30, 2021 and $0.2 million and $0.5 million, respectively, for the same periods in 2020.

Net Loss: Net loss for the three and nine months ended September 30, 2021 were $83.3 million, or $0.46 per share, and $245.2 million, or $1.53 per share, respectively, compared to $51.5 million, or $3.76 per share, and $172.1 million, or $14.05 per share, respectively, for the same periods in 2020.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the nine months ended September 30, 2021 was $146.4 million compared to $87.2 million for the nine months September 30, 2020. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities excluding cash inflows from financing activities, cash outflows from business development activities, and the purchase of property and equipment.

Non-GAAP Research and Development Expenses: Non-GAAP research and development expenses for the three and nine months ended September 30, 2021 were $53.2 million and $140.1 million, respectively, compared to $31.6 million and $86.5 million, respectively, for the same periods in 2020. Non-GAAP research and development expenses excludes one-time costs to acquire technology.

Non-GAAP Net Loss: Non-GAAP net loss for the three and nine months ended September 30, 2021 was $66.5 million, or $0.37 per share, and $177.4 million, or $1.11 per share, respectively, compared to $38.5 million, or $2.81 per share, and $104.9 million, or $8.56 per share, respectively, for the same periods in 2020. Non-GAAP net loss exclude one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of contingent consideration and success payment liabilities.
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

On November 8, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector, will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on Monday, November 15, 2021, at 2:00 p.m. ET (Press release, Alector, NOV 8, 2021, View Source [SID1234594697]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

On November 8, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported that Khursheed Anwer, Ph.D., executive vice president and chief science officer, will be making a presentation on the company’s GEN-1 interleukin 12 (IL-12) immunotherapy program at the Cytokine-Based Cancer Immunotherapies Summit being held in Boston on November 30 to December 2, 2021 (Press release, Celsion, NOV 8, 2021, View Source [SID1234594713]). Dr. Answer will also be participating in two panel discussions.

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In his presentation, Dr. Anwer will be discussing how local delivery of IL-12 without significant systemic toxicity is feasible with a non-viral gene therapy approach that involves administration of an IL-12 plasmid with a synthetic DNA delivery system (GEN-1). Dr. Anwer will also be discussing how weekly intraperitoneal administration of GEN-1 yields durable increases in IL-12 and IFN-g, and why repeated weekly administration of GEN-1 in combination with standard chemotherapy remodels the tumor immune environment to favor immune stimulation over immune suppression.

"Dr. Anwer’s presentation and panel discussions will highlight the strength of our GEN-1 immunotherapy program to some of the nation’s leading immunologists," said Michael H. Tardugno, chairman, president and chief executive officer of Celsion. "We look forward to interacting with attendees at one of the first in-person medical conferences we will be attending since the COVID-19 pandemic began."

Dr. Anwer will participate in a group panel discussion on November 30 at 7:40 a.m. Eastern time titled, "What Do We Know & Where Do We Want to Go?" and in another panel discussion on December 1 at 11:30 a.m. Eastern time titled "Side Effects – Mitigating Against Hypotension + Fever With Immune-Stimulating Agents (NK Cell Engagers, PD-1s, Cytokines, T-Cell Engagers) = Cytokine Release Syndrome (CRS)?" Dr. Anwer’s presentation, titled "A Non-Viral Gene Therapy Approach to IL-12 Delivery for The Treatment of Cancer," will be delivered on December 1 at 8:30 a.m. Eastern time.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The company previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. GEN-1 in combination with neoadjuvant chemotherapy is the subject of the ongoing Phase II OVATION 2 Study in subjects with advanced-stage ovarian cancer (Stage III/IV), with enrollment now exceeding 75% and full enrollment targeted by the first half of 2022.