Invitae Reports $123.7 Million in Revenue in First Quarter of 2022 and Extends Cash Runway

On May 3, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the first quarter ended March 31, 2022 (Press release, Invitae, MAY 3, 2022, View Source [SID1234613396]).

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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)

"The power of personal health information, enabled by a new breed of patient and clinician workflow tools, further combined with real world data, is an immense opportunity to shape the future of medicine. And while the proof points supporting our model of enabling a new era in healthcare continue to materialize, we are in an exceptionally volatile period in our economy, one that demands that we as a company accelerate our drive for operational efficiency and sustainable operating cash flows," said Sean George, Ph.D., co-founder and CEO of Invitae. "The Invitae team is resolute across the organization to execute and alter course where necessary. We communicated and exceeded our plan to reverse the cash burn trend in the business in the first quarter. Following that success, we are now taking more aggressive steps to accelerate our pathway to capital independence – continuing to drive revenue growth, stabilize operating expenses, optimize our portfolio, and invest in the most important strategic imperatives and near-term drivers of revenue and margin. We plan to substantially decrease our burn throughout this year and next, extending our cash runway through 2023. Invitae’s broad portfolio and scalable model enables us to begin driving further operating leverage and we look forward to updating you on our progress along the way."

First Quarter 2022 Highlights

Generated revenue of $123.7 million in the quarter, a 19.4% increase compared to $103.6 million in the first quarter of 2021. Q1 exit revenue trajectory tracking to annual revenue guidance.
Cash, cash equivalents, restricted cash and marketable securities were $885 million as compared with $1.06 billion as of December 31, 2021. Cash burn was $169 million, achieving a $26 million reduction for the first quarter of 2022, or over $100 million on an annualized basis.
Total active healthcare provider accounts in the first quarter of 2022 totaled 19,436, more than 31% growth over the first quarter of 2021.
Active pharma and commercial partnerships grew to 206, an increase of approximately 72% over the first quarter of 2021, driving continued revenue growth from Invitae’s data and data services platform to pharma, health system and software and services partners.
Total patient population is more than 2.8 million with nearly 62% available for data sharing.
Gross profit was $26.6 million, and non-GAAP gross profit was $45.2 million in the first quarter of this year.
*Includes cash, cash equivalents, restricted cash and marketable securities.

Total operating expense, which excludes cost of revenue, for the first quarter of 2022 was $239.8 million compared to $140.5 million in the prior year period. Compared to the fourth quarter of 2021, operating expense in the first quarter of 2022 decreased by $4.8 million while non-GAAP operating expense decreased by $6.7 million. Non-GAAP operating expense was $209.0 million in the first quarter of 2022 compared to $155.4 million in the prior year period.

Net loss for this year’s first quarter was $181.9 million, or a $0.80 net loss per share, compared to $109.5 million, or a $0.56 net loss per share, for the first quarter of 2021. Non-GAAP net loss for the first quarter of 2022 was $177.4 million, or a $0.78 non-GAAP net loss per share.

At March 31, 2022, cash, cash equivalents, restricted cash and marketable securities totaled $885 million as compared with $1.06 billion as of December 31, 2021. Cash burn in this year’s first quarter, including cash paid for acquisition related activities, was $169.3 million, a decrease of $26.3 million, or 13.5% from the fourth quarter of 2021.

Accelerated burn reduction to extend cash runway
Invitae is committed to reaching positive operating cash flow by the end of 2025 while driving industry-leading growth along the way. Building off of progress made to this year’s target of a $200+ million reduction in burn rate, the company will drive for additional reductions of $600 million over the next three years with continued OPEX controls, margin improvement, operating leverage and portfolio optimization. The result of these improvements is expected to push the current cash runway to the end of 2023 or beyond.

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 will be available shortly after the conclusion of the call and will be archived on the company’s website.

Affini-T Therapeutics’ KRAS TCR T Cell Therapy Program to be Presented at the Annual Meeting of the American Society of Gene and Cell Therapy

On May 3, 2022 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported that data from its KRAS program will be presented in an oral presentation at the 25th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Affini-T Therapeutics, MAY 3, 2022, View Source [SID1234613430]). The data from Affini-T Therapeutics will be delivered by Tijana Martinov, Ph.D. from the Greenberg Lab at Fred Hutchinson Cancer Center .

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"KRAS mutations are the most prevalent oncogenic drivers in solid tumor cancers with G12V and G12D variants representing the most common substitutions within this oncogene," said Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics. "We are excited that our TCR-engineered T cell therapies, designed to orchestrate a coordinated CD4 and CD8 T cell response while targeting these common mutant variants of KRAS, show promising preclinical safety and efficacy profiles that support clinical development for solid tumor patients with KRAS mutations who have high unmet medical needs."

Presentation details are as follows:

Title: Preclinical Development of Safe and Effective T Cell Receptors Specific for Mutant KRAS G12V and G12D Peptides
Presenting Author: Tijana Martinov, Ph.D.
Abstract Number: 103
Session Title: Cell-Based Cancer Immunotherapies I
Date & Time: Monday, May 16, 2022 at 4:45pm – 5:00pm ET

Intensity Therapeutics Announces New Clinical Data in Solid Tumors for its Lead Asset, INT230-6, were Accepted for Two Poster Discussion Sessions and Three Poster Presentations at the Upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 3, 2022 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that phase 2 sarcoma data, phase 2 breast cancer data and phase 1/2 solid tumor data from its ongoing cohort studies of lead asset, INT230-6, will be presented in two oral and three poster sessions at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held live at McCormick Place in Chicago, IL, and online, from June 3-7, 2022 (Press release, Intensity Therapeutics, MAY 3, 2022, View Source [SID1234613447]).

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Abstract Title: INT230-6 monotherapy and in combination with ipilimumab (IPI) across a broad spectrum of refractory soft tissue sarcomas (STS) [Intensity IT-01; BMS#CA184-592].
Presenter/First Author: Matthew Ingham, MD
Session Type/Title: Poster Discussion Session/Sarcoma
Poster Discussion Session Date and Time: Sunday, June 5, 2022, 12:30 PM – 2:00 PM EDT
Location: In-Person & On Demand | S404
Abstract Number: 11515
Poster: 420

Abstract Title: Effect of intratumoral INT230-6 on tumor necrosis and promotion of a systemic immune response: Results from a multicenter phase 1/2 study of solid tumors with and without pembrolizumab (PEM) [Intensity IT-01; Merck KEYNOTE-A10].
Presenter/First Author: Jacob Stephen Thomas, MD
Session Type/Title: Poster Discussion Session/Developmental Therapeutics—Immunotherapy
Poster Discussion Session Date and Time: Sunday, June 5, 2022, 12:30 PM – 2:00 PM EDT
Location: In-Person & Live Stream | Hall D2
Abstract Number: 2520
Poster: 176

Abstract Title: Intratumoral (IT) INT230-6 can cause tumor necrosis In Vivo: Preliminary results of a phase II randomized presurgical window-of-opportunity study in early breast cancers (the INVINCIBLE study).
First Author: Angel Arnaout, MD, FACS
Session Type/Title: Poster Session/Breast Cancer—Local/Regional/Adjuvant
Session Date and Time: Monday, June 6, 2022, 9:00 AM – 11:00 AM EDT
Location: In-Person & On Demand
Abstract Number: 605
Poster: 376

Copies of these materials will also be available on the Intensity Therapeutics website at View Source following completion of the live presentation.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

INT230-6 is currently being evaluated in several phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

10-Q – Quarterly report [Sections 13 or 15(d)]

MacroGenics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Akoya to Participate at Three Upcoming Investor Conferences

On May 3, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will be participating in three upcoming investor conferences (Press release, Akoya Biosciences, MAY 3, 2022, View Source [SID1234613381]).

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Bank of America 2022 Healthcare Conference
Presentation on Tuesday, May 10th at 10:40 AM PT
UBS Global Life Science Conference
Fireside chat on Monday, May 23rd at 7:45 AM ET
HC Wainwright Global Investment Conference
Virtual Presentation available on-demand May 24-26
Live and archived webcasts of the events will be available on the "Investors" section of the Akoya website at View Source