On February 24, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the fourth quarter and year ended December 31, 2021 (Press release, Invitae, FEB 24, 2022, View Source [SID1234608968]).

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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)

"2021 was another year of industry leading growth and the addition of almost 1 million patients onto the Invitae platform, providing further evidence that the Invitae vision and one-of-a-kind testing, digital health and data network are ushering in the era of genomic health management," said Sean George, Ph.D., co-founder and CEO of Invitae. "Looking into 2022, we intend to maintain our focus on driving that shift to a healthcare ecosystem underscored by genomic information and management, while demonstrating operational excellence and charting a clear path towards operating cash flows."

Full Year and Fourth Quarter 2021 Financial Results

Generated revenue of $460.4 million in 2021, including $126.1 million in the fourth quarter.
Reported billable volume of 1.17 million in 2021, including 327,000 in the fourth quarter.
Total active healthcare provider accounts in 2021 totaled 18,458, more than 50 percent growth since the beginning of 2020.
Active pharma and commercial partnerships grew to 178, an increase of approximately 170 percent since the beginning of 2020 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 2.5 million with over 62 percent available for data sharing.
Achieved gross profit of $111.8 million in 2021, including $30.0 million in the fourth quarter. Non-GAAP gross profit was $168.4 million in 2021, and $46.0 million in the fourth quarter.
Total operating expense, which excludes cost of revenue, for the full year 2021 was $503.4 million. Operating expense for the fourth quarter of 2021 was $244.6 million. Non-GAAP operating expense was $771.1 million for the full year 2021, and $215.7 million in the fourth quarter.

Net loss for the full year 2021 was $379.0 million, or a $1.80 net loss per share. For the fourth quarter of 2021, Invitae reported a net loss of $205.1 million, or a $0.90 net loss per share. Non-GAAP net loss was $654.3 million, or a $3.10 non-GAAP net loss per share in 2021. For the fourth quarter of 2021, Invitae reported a non-GAAP net loss of $184.7 million, or a $0.81 non-GAAP net loss per share.

At December 31, 2021, cash, cash equivalents, restricted cash and marketable securities totaled $1.06 billion as compared with $1.25 billion as of September 30, 2021. Net increase in cash, cash equivalents, restricted cash, and marketable securities was $695 million in 2021, and a net decrease of $196.7 million for the fourth quarter. Cash burn was $195.6 million in the fourth quarter of 2021. Cash burn for the quarter would have been $186.1 million excluding the cash paid for acquisitions.

Guidance
The company has issued 2022 annual revenue guidance of year-over-year revenue growth of 40 percent, or approximately $640 million. New guidance categories for 2022 include gross margin and cash burn measures. Gross margin for 2022 is expected to be between 42-45 percent with cash burn, including cash used for acquisition-related activities, expected to be in the range of $600-$650 million in 2022, a more than $200 million year-over-year reduction.

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:

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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.

On February 24, 2022 Relay Therapeutics, Inc.(Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported fourth quarter and full year 2021 financial results and corporate highlights (Press release, Relay Therapeutics, FEB 24, 2022, View Source [SID1234608984]).

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"2021 was the year that Relay Therapeutics showed clinical data for the first time, with the RLY-4008 disclosure supporting our belief that our approach of integrating experimental techniques and computational power can make the discovery of medicines more efficient and effective," said Sanjiv Patel, M.D., president and chief executive officer. "We also grew our team, continued to execute against our deep and broad precision medicine pipeline and pushed the boundaries of our Dynamo platform, through both internal innovation and the integration of an acquisition. We’ve entered 2022 with three clinical stage programs, a robust preclinical pipeline and a cash runway into at least 2025. We are excited to continue our efforts to achieve our goal of bringing life-changing therapies to patients."

2021 Corporate Highlights

RLY-4008

•Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting for RLY-4008, a highly selective irreversible and oral small molecule inhibitor of FGFR2
•Announced interim clinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference for RLY-4008 in a first-in-human trial in patients with FGFR2-altered cholangiocarcinoma, breast cancer and multiple other solid tumors

oThe data suggest that RLY-4008 is the first investigational therapy designed to selectively bind to FGFR2 to avoid off-isoform toxicities for the treatment of patients with FGFR2-altered tumors, with study investigators reporting robust inhibition of FGFR2 in the first 49 subjects that was not shown to be limited by off-target toxicities, including hyperphosphatemia and diarrhea
oThe interim clinical data included results from FGFR2-altered solid tumors, with approximately 80% of all patients treated achieving reductions in tumor size at the cut-off date of September 9, 2021
oIn pan-FGFRi treatment-naïve cholangiocarcinoma patients, RLY-4008 demonstrated tumor shrinkage in all six pan-FGFR treatment-naïve FGFR2 fusion positive cholangiocarcinoma patients, with three achieving confirmed partial responses, one of whom went on to surgery with curative intent
oRLY-4008 also demonstrated encouraging early activity in gene amplifications and mutations, such as the first reported objective response for an FGFR inhibitor in a patient with FGFR2-mutated breast cancer, based on publicly available information
•Initiated expansion cohorts at 70 mg once daily in December 2021
•In January 2022, the FDA granted orphan drug designation to RLY-4008 for the treatment of cholangiocarcinoma

RLY-2608

•Presented preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference and 2021 San Antonio Breast Cancer Symposium for RLY-2608, the first known allosteric, pan-mutant and isoform-selective PI3Kα inhibitor in a novel allosteric pocket
oThe data help support the clinical development of RLY-2608 both in single agent and combination clinical trials for patients with PIK3CA (PI3Kα) mutant tumors, including PI3Kα-mutant, HR+/HER2- breast cancer
oThe data indicate RLY-2608 synergizes with fulvestrant and the CDK4/6 inhibitor abemaciclib in cell viability assays in PIK3CAmut/ER+/HER2- cell lines
oOral administration of RLY-2608 in combination with fulvestrant or abemaciclib led to improved efficacy compared to either agent alone in ER+/HER2- xenograft models representing the most commonly observed PIK3CA mutations in breast cancer (H1047R, E542K, E545K)
oThe triple combination of all three agents resulted in deep regressions across all models, and additionally, the combination arms had similar tolerability to monotherapy arms
•Dosed the first patient in the dose escalation part of the RLY-2608 first-in-human trial in December 2021

Corporate Highlights

•Genentech initiated the cohort of RLY-1971/GDC-1971, an inhibitor of SHP2, in combination with GDC-6036, an inhibitor of KRAS G12C, in a Phase 1b trial in July 2021

•Extended leadership in integrating computational and experimental approaches, including by acquiring ZebiAI Therapeutics, Inc. and unlocking our ability to develop our machine learning powered DNA encoded library platform, REL-DEL (Relay DEL)

•Entered into a worldwide strategic collaboration with EQRx, Inc. to discover, develop and commercialize novel medicines against validated oncology targets, starting with one program and with the ability to mutually agree to add additional programs to the collaboration in the future

•Strengthened the executive team with multiple new appointments leveraging the experienced senior leaders from within Relay Therapeutics and greatly expanded the team through the addition of approximately 100 employees

2022 Anticipated Milestones and Objectives

•Continue to enroll patients in the RLY-4008 expansion cohorts and provide a clinical data update in the second half of 2022

•Continue to enroll patients in the RLY-2608 first-in-human trial and gain experience in the clinic while also progressing against the rest of the preclinical PI3Kα mutant franchise

•Disclose an additional target in the first half of this year

•Genentech to continue driving the development and disclosures of RLY-1971/GDC-1971 in combination with GDC-6036 in the ongoing Phase 1b trial

Fourth Quarter and Full Year 2021 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2021, cash, cash equivalents and investments totaled approximately $958.1 million, compared to $678.1 million as of December 31, 2020. The change in cash reflects the addition of $382.2 million in net proceeds from Relay Therapeutics’ public financing in October 2021. Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into at least 2025.

R&D Expenses: Research and development expenses were $51.9 million for the fourth quarter of 2021, as compared to $32.1 million for the fourth quarter of 2020. This increase was primarily due to $4.2 million of increased employee related costs, $7.9 million of increased outside and consulting expense and $6.9 million of increased clinical trial and related costs. Research and development expenses were $172.7 million for the full year 2021, as compared to $99.9 million for the full year 2020. The increase was primarily due to $30.0 million of increased employee related costs, including $10.2 million of additional stock-based compensation expense, $25.3 million of increased external R&D expenses and $10.9 million of increased clinical trial expenses.

G&A Expenses: General and administrative expenses were $15.5 million in each of the three-month periods ended December 31, 2021 and 2020. General and administrative expenses were $57.4 million for the full year 2021, as compared to $38.6 million for the full year 2020. The increase was primarily due to $12.8 million of increased employee related costs, including $6.3 million of additional stock-based compensation expense, and $6.0 million of other general and administrative expenses.

Net Income/Loss: Net loss was $67.5 million for the fourth quarter of 2021, as compared to net income of $35.3 million for the fourth quarter of 2020. Net loss was $363.9 million for the full year 2021, or a net loss per share of $3.82, as compared to a net loss of $52.4 million for the full year 2020, or a net loss per

share of $5.40. The increase in net loss included one-time expenses of $134.9 million in 2021 associated with the acquisition of ZebiAI Therapeutics, Inc.

On February 24, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, reported that Dr. Vuong Trieu, Oncotelic Chairman and CEO, will be presenting at MedInvest Pharmaceutical and Biotechnology Investor Conference (the "Conference"), from March 28 – April 1, 2022 (Press release, Oncotelic, FEB 24, 2022, View Source [SID1234609002]).

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The Conference will present companies specializing in drug development and delivery, in addition to biotech and therapeutics across many indications: oncology, immunology, neurology, cardiology, diabetes, infectious diseases, pulmonary diseases, autoimmune diseases, dermatology, and many others. Based on current management expectations, the Company intends to unveil the Joint Venture ("JV") between Company and Golden Mountain Partners, ("GMP") at the Conference or shortly thereafter.

In August 2021, the Company and GMP entered into a term sheet, including certain binding terms, to form a JV to develop Oncotelic’s drug portfolio and build out a manufacturing facility. Also, the Company had announced, and subsequently reported in our Quarterly Report on form 10-Q filed with the SEC on August 17, 2021, the intent to take the JV into an initial public offering ("IPO") at a future date. On February 14th, the Company and GMP agreed to extend the standstill terms of the term sheet until March 31, 2022 to permit the completion of the transaction.

"Oncotelic’s goal is to create novel immune-oncology therapies to treat oncology patients across a range of cancer types. Development of oncology drugs is an expensive endeavor, and the JV is intended to ensure sufficient financial resources to get the Company’s portfolio to marketing approval and beyond." said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.

On February 24, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that a poster will be presented at the 17th Annual HD Therapeutics Conference (hosted by CHDI Foundation) with its collaborator, Dr. Amber Southwell, on Wednesday, March 2, 2022 (Press release, Vaccinex, FEB 24, 2022, View Source [SID1234609029]). Please see Presentation details below:

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CHDI Conference

Date: March 2, 2022

Time: 1:00 p.m. PST/4:00 p.m. EST: Poster Section

Poster Title: Combination anti-semaphorin 4D immunotherapy and ASO-mediated total HTT lowering provide benefit beyond either individual therapy in humanized HD mice

Presenter:

Amber Southwell, Ph.D., Assistant Professor,
Burnett School of Biomedical Sciences
University of Central Florida, Orlando, FL

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Program Link: CHDI Meeting Information
For more information about the CHDI Foundation, please refer to the Foundation website.

On February 24, 2022, Amgen Inc. (the Company) reported that entered into accelerated stock buyback agreements, pursuant to the form of ASR Agreement filed herewith (hereinafter referred to as the ASR Agreements), with each of Bank of America, N.A., Morgan Stanley & Co. LLC, and Goldman Sachs & Co. LLC (each, a Financial Institution, and together, the Financial Institutions) to repurchase an aggregate of up to $6 billion of the Company’s common stock, as previously announced on February 8, 2022 (Filing, 8-K, Amgen, FEB 24, 2022, View Source [SID1234609057]). The Company is funding the share repurchases under the ASR Agreements with existing cash resources.

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Under the terms of the ASR Agreements, the Company will make payments in an aggregate amount of $6 billion to the Financial Institutions on February 25, 2022, and expects to receive on the same day initial deliveries of approximately 23,258,997 shares of the Company’s common stock in the aggregate from the Financial Institutions. The final number of shares to be repurchased by the Company will be based on the volume-weighted average stock price of the Company’s common stock during the term of the ASR Agreements, less a discount and subject to adjustments pursuant to the terms and conditions of the ASR Agreements. At settlement, under certain circumstances, one or more of the Financial Institutions may be required to deliver additional shares of common stock to the Company, or under certain circumstances, the Company may be required to deliver shares of common stock or to make a cash payment, at its election, to a Financial Institution. The final settlement under the ASR Agreements is scheduled to occur in the third quarter of 2022, subject to earlier termination under certain limited circumstances, as set forth in the ASR Agreements.

Each of the ASR Agreements contains customary terms for these types of transactions, including, but not limited to, the mechanisms to determine the number of shares or the amount of cash that will be delivered at settlement, the required timing of delivery of the shares, the specific circumstances under which adjustments may be made to the transactions, the specific circumstances under which the transactions may be terminated prior to their scheduled maturities and various acknowledgements, representations and warranties made by the Company.

From time to time, one or more of the Financial Institutions and/or their affiliates have directly and indirectly engaged, and may engage in the future, in investment and/or commercial banking transactions with the Company for which such Financial Institution has received, or may receive, customary compensation, fees and expense reimbursement.

The foregoing description of the ASR Agreements does not purport to be complete and is qualified in its entirety by reference to the form of the ASR Agreement, a copy of which is attached hereto as Exhibit 10.1, and is incorporated herein by reference.