On February 23, 2023 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 2022 financial results and corporate highlights (Press release, Relay Therapeutics, FEB 23, 2023, View Source [SID1234627627]).

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"We successfully executed against our strategy in 2022, advancing multiple clinical and pre-clinical programs and continuing to demonstrate the power of our Dynamo platform," said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. "We reported additional RLY-4008 interim data showing an overall response rate of 63% across all doses and 88% at the pivotal dose, building on the previously reported early data and supporting our belief that limiting off-target effects and toxicity can allow us to improve efficacy. We also expanded our breast cancer portfolio, continuing clinical development of RLY-2608 and announcing three new programs. With a robust pipeline and cash in hand to fund us into 2025, we are excited to continue to execute on our plans and deliver against our milestones this year, as we work toward our goal of bringing life-changing therapies to patients."

2022 Corporate Highlights

RLY-4008 (FGFR2 inhibitor)

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Presented additional interim data from patients with FGFRi-naïve FGFR2-fusion cholangiocarcinoma (CCA) at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. Key highlights included:
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All doses – 63% interim overall response rate (ORR): across all dose levels and schedules, 24 of 38 efficacy-evaluable patients experienced a partial response (22 confirmed, 2 unconfirmed)
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Pivotal dose (70 mg once daily) – 88% ORR: 15 of 17 efficacy-evaluable patients experienced a partial response (14 confirmed, 1 unconfirmed in an ongoing patient)
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13 out of these 15 responders remain on treatment; 1 responder came off study to be resected with curative intent

Most treatment emergent adverse events were expected FGFR2 on-target, low-grade, monitorable, manageable and largely reversible
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There were no observed Grade 4 or 5 adverse events, and off-target toxicities of hyperphosphatemia and diarrhea continued to be clinically insignificant
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Based on discussions with the U.S. Food and Drug Administration, moved forward with a single-arm pivotal trial design for patients with pan-FGFR (FGFRi) treatment-naïve FGFR2-fusion CCA at 70 mg once daily to potentially support accelerated approval
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Anticipate completing enrollment in pivotal cohort in the second half of 2023

Breast Cancer Portfolio

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RLY-2608 (pan-mutant and isoform-selective PI3Kα inhibitor)
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Monotherapy: Following December 2021 initiation of the first-in-human trial, continued to enroll dose escalation portion of trial assessing RLY-2608 as a single agent in patients with unresectable or metastatic solid tumors with PI3Kα mutation
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Combination: In April 2022, initiated dose escalation portion of a fulvestrant combination arm in patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer
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Anticipate disclosing initial clinical data from both dose escalation portions in the first half of 2023
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In June 2022, disclosed three new programs:
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Selective CDK2 inhibitor, anticipated clinical start in early 2024
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ERα degrader, development candidate nomination in 2023
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RLY-5836 (chemically distinct pan mutant-PI3Kα inhibitor), expected to enter the clinic in the second quarter of 2023

Corporate Highlights

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Appointed Sekar Kathiresan, M.D., CEO of Verve Therapeutics, to Board of Directors
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Raised $300.0 million of gross proceeds in an underwritten follow-on public offering

2023 Anticipated Milestones

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RLY-4008
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Full dose escalation data in the first half of 2023
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Complete enrollment of pivotal cohort in the second half of 2023
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Data from non-CCA expansion cohorts in the second half of 2023
•
Breast Cancer
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RLY-2608: initial clinical data from dose escalation portions of monotherapy and combination arms of trial in the first half of 2023
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RLY-5836: clinical start in the second quarter of 2023
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ERα degrader: development candidate nomination in 2023
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Selective CDK2 inhibitor: clinical start in early 2024

Fourth Quarter and Full Year 2022 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2022, cash, cash equivalents and investments totaled approximately $1 billion compared to $958.1 million as of December 31, 2021.

Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2025.

R&D Expenses: Research and development expenses were $67.3 million for the fourth quarter of 2022, as compared to $51.9 million for the fourth quarter of 2021. The increase was primarily due to $6.8 million of additional clinical trial expenses and $6.3 million of additional employee related costs, which includes $3.1 million of additional stock-based compensation expense. Research and development expenses were $246.4 million for the full year 2022, as compared to $172.7 million for the full year 2021. The increase was primarily due to $32.7 million of additional clinical trial expenses, $24.7 million of additional employee related costs, which includes $5.7 million of additional stock-based compensation expense, and $10.8 million of additional preclinical programs and platform technologies.

G&A Expenses: General and administrative expenses were $16.4 million for the fourth quarter of 2022, as compared to $15.5 million for the fourth quarter of 2021. The increase was primarily due to additional employee related costs, which includes $0.5 million of additional stock-based compensation expense. General and administrative expenses were $66.0 million for the full year 2022, as compared to $57.4 million for the full year 2021. The increase was primarily due to additional employee related costs, which includes $1.9 million of additional stock-based compensation expense.

Net Loss: Net loss was $67.5 million for the fourth quarter of 2022, or a net loss per share of $0.56, as compared to a net loss of $67.5 million for the fourth quarter of 2021, or a net loss per share of $0.64. Net loss was $290.5 million for the full year 2022, or a net loss per share of $2.59, as compared to a net loss of $363.9 million for the full year 2021, or a net loss per share of $3.82. Net loss for the full year 2021 included one-time expenses of $134.9 million associated with the acquisition of ZebiAI Therapeutics, Inc.

On February 23, 2023 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported financial results for the fourth quarter and full year 2022 (Press release, Prothena, FEB 23, 2023, View Source [SID1234627626]). In addition, the Company provided 2023 financial guidance and business highlights.

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"In 2022 we meaningfully advanced our protein dysregulation portfolio as we continue our transition to a fully integrated commercial company. The foundation we established in 2022 has positioned the next 24 months as a transformational period for Prothena, with many significant clinical milestones expected across six different programs in areas of high unmet patient need," said Gene Kinney, Ph.D., President and Chief Executive Officer Prothena. "For PRX012, we received clearance from the FDA for our IND application and Fast Track designation was granted. We also initiated the Phase 1 SAD and MAD study for PRX012 and completed the Phase 1 SAD and initiated the MAD study for PRX005. Additionally, we presented key data on birtamimab and PRX123 at ASH (Free ASH Whitepaper) and AD/PD, respectively. As we grew our organization’s capabilities to prepare for the future, we also added significant strategic depth to our board of directors through the appointment of an established biotech leader, Helen S. Kim, MBA."

2022 Business Highlights and Upcoming Milestones

Neurodegenerative Diseases Portfolio

Alzheimer’s Disease (AD)

PRX012, a potential best-in-class, next-generation subcutaneous antibody for the treatment of AD, that targets a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency
•Received clearance from the U.S. Food and Drug Administration (FDA) in March 2022 for the investigational new drug (IND) application
•FDA granted Fast Track designation in April 2022
•Initiated Phase 1 single ascending dose (SAD) and multi ascending dose (MAD) studies in healthy volunteers and patients with AD
•Significant presence at upcoming International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) in March/April 2023 highlighted by oral presentation of preclinical data showing superior binding characteristics of PRX012 and a symposium featuring key thought leaders
•Ongoing Phase 1 SAD and MAD studies; topline data expected year end 2023

PRX005, a potential best-in-class antibody, for the treatment of AD that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE), and other tauopathies. PRX005 is part of a global neuroscience research and development collaboration with Bristol Myers Squibb
•Topline data from Phase 1 SAD study announced January 2023 showing single doses of PRX005 across three dose cohorts were generally safe and well tolerated, meeting the primary objective of the study; results expected from the Phase 1 SAD study at an upcoming medical conference
•Ongoing Phase 1 MAD study; topline data expected year end 2023

PRX123, a potential first-in-class dual Aβ/tau vaccine, for the treatment and prevention of AD, that is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau to promote amyloid clearance and blockade of pathogenic tau
•Oral presentation on preclinical data at AD/PD 2022 demonstrated that Prothena’s dual Aβ/tau vaccine generated anti-Aβ and anti-MTBR-tau antibodies to enable clearance of Aβ and to inhibit cell-to-cell transmission of pathogenic tau species
•Investigational new drug (IND) application filing expected by year end 2023

Parkinson’s Disease (PD)

Prasinezumab, a potential first-in-class antibody, for the treatment of PD, that is designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of a worldwide collaboration with Roche
•Oral presentation by partner Roche at AD/PD 2022 of the Phase 2 PASADENA study further supports a potential effect on delaying motor progression in patients with early PD
•Ongoing Phase 2b PADOVA trial in patients with early PD is being conducted by Roche (NCT04777331); topline data expected in 2024

Rare Peripheral Amyloid Diseases Portfolio

AL Amyloidosis

Birtamimab, a potential best-in-class amyloid depleter antibody, for the treatment of AL amyloidosis, that is designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure
•Poster presented at the XVIII International Symposium on Amyloidosis (ISA) in September 2022 titled: Birtamimab in Patients with Mayo Stage IV AL Amyloidosis: Rationale for Confirmatory AFFIRM-AL Phase 3 trial
•Oral presentation at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2022: Consistent Survival Benefit Observed with Birtamimab in Mayo Stage IV AL Amyloidosis Patients in Phase 3 VITAL Study
•Published data on in-hospital mortality in amyloid light chain amyloidosis in Journal of Comparative Effectiveness Research
•Confirmatory Phase 3 AFFIRM-AL trial ongoing (NCT04973137); topline data expected in 2024

ATTR Amyloidosis

NNC6019 (formerly PRX004), a potential first-in-class antibody, for the treatment of ATTR cardiomyopathy, that is designed to deplete the pathogenic, non-native forms of the transthyretin (TTR) protein and is being developed by Novo Nordisk as part of their up to $1.2 billion acquisition of Prothena’s ATTR amyloidosis business and pipeline
•Received $40 million milestone payment from Novo Nordisk in December 2022 related to the continued advancement of NNC6019 in a Phase 2 study
•Ongoing Phase 2 study in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk (NCT05442047); topline data expected in 2024

2022 Organizational and Corporate Highlights

•Announced the appointment of Helen S. Kim, MBA, to its Board of Directors. With the appointment of Ms. Kim, Prothena expanded its Board to 10 directors
•Raised net proceeds of $172.4 million through an underwritten public follow-on offering of 3,250,000 ordinary shares in December 2022

Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

•Oppenheimer 33rd Annual Healthcare Conference on Monday, March 13, 2023; a fireside chat will be held at 10:00 AM ET
•Jefferies Biotech on the Bay Summit on Thursday, March 16, 2023; 1 on 1 investor meetings will be held

Fourth Quarter and Full Year of 2022 Financial Results
For the fourth quarter and full year of 2022, Prothena reported a net income of $6.3 million and a net loss of $116.9 million, respectively, as compared to a net loss of $33.2 million and a net income of $67.0 million for the fourth quarter and full year of 2021, respectively. Net income per share on a diluted basis was $0.12 for the fourth quarter of 2022 and net loss per share of for the full year of 2022 was $2.47, as

compared to net loss per share of $0.71 and net income per share on a diluted basis of $1.38 for the fourth quarter and full year of 2021, respectively.
Prothena reported total revenue of $49.9 million and $53.9 million for the fourth quarter and full year of 2022, respectively, as compared to total revenue of $1.2 million and $200.6 million for the fourth quarter and full year of 2021, respectively. Total revenue for the fourth quarter and full year of 2022 included a $40.0 million milestone payment from Novo Nordisk and revenue for fourth quarter and full year of 2022 included BMS collaboration revenue of $9.9 million and $13.9 million, respectively. This compares to total revenue of $1.2 million for the fourth quarter of 2021 from BMS collaboration revenue, and total revenue of $200.6 million for the full year of 2021, which included $79.7 million in collaboration revenue from BMS, a $60.0 million clinical milestone payment from Roche and $60.7 million from the sale of intellectual property and related rights to Novo Nordisk.
Research and development (R&D) expenses totaled $36.9 million and $135.6 million for the fourth quarter and full year of 2022, respectively, as compared to $22.1 million and $82.3 million for the fourth quarter and full year of 2021, respectively. The increase in R&D expense for the fourth quarter and full year of 2022 compared to the same periods in the prior year was primarily due to higher manufacturing costs, higher personnel related expenses, higher clinical trial expenses, higher consulting and other R&D expenses. For the full year of 2022, the higher costs were offset in part by lower collaboration expenses with Roche and lower manufacturing expenses related to the NNC6019 (formerly PRX004) program. R&D expenses included non-cash share-based compensation expense of $3.5 million and $14.8 million for the fourth quarter and full year of 2022, respectively, as compared to $2.9 million and $9.5 million for the fourth quarter and full year of 2021, respectively.
General and administrative (G&A) expenses totaled $13.1 million and $49.9 million for the fourth quarter and full year of 2022, respectively, as compared to $12.2 million and $46.3 million for the fourth quarter and full year of 2021, respectively. The increase in G&A expenses for the fourth quarter and full year of 2022 compared to the same periods in the prior year was primarily related to higher personnel related and consulting expenses offset in part by lower legal expenses. G&A expenses included non-cash share-based compensation expense of $3.9 million and $16.5 million for the fourth quarter and full year of 2022, respectively, as compared to $4.0 million and $15.1 million for the fourth quarter and full year of 2021, respectively.
Total non-cash share-based compensation expense was $7.4 million and $31.3 million for the fourth quarter and full year of 2022, respectively, as compared to $6.9 million and $24.7 million for the fourth quarter and full year of 2021, respectively.

As of December 31, 2022, Prothena had $712.6 million in cash, cash equivalents and restricted cash, and no debt.
As of February 17, 2023, Prothena had approximately 52.6 million ordinary shares outstanding.

2023 Financial Guidance

The Company expects the full year 2023 net cash used in operating and investing activities to be $213 to $229 million and expects to end the year with approximately $512 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2023 net cash used in operating and investing activities is primarily driven by an estimated net loss of $250 to $275 million, which includes an estimated $46 million of non-cash share-based compensation expense

Conference Call Details

Prothena management will discuss these results and its 2023 financial guidance during a live audio conference call today, Thursday, February 23, 2023, at 4:30 PM ET. The conference call will be made available on the Company’s website at www.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company’s website for at least 90 days.

To access the call via dial-in, please dial +1 (888) 350-3870 (U.S. and Canada toll free) or +1 (646) 960-0308 (international) five minutes prior to the start time and refer to conference ID number 92750. A replay of the call will be available until March 2, 2023, via dial-in at (800) 770-2030 (U.S. toll free) or +00 1 647 362-9199 (international), Conference ID Number 92750.

On February 23, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided recent business highlights (Press release, Personalis, FEB 23, 2023, View Source [SID1234627625]).

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Recent Business Highlights

Announced a continuing partnership with Moderna to provide genomic testing for their upcoming clinical studies evaluating mRNA-4157/V940, an investigational personalized cancer vaccine, jointly developed by Moderna and Merck

Partnered with Criterium and the Academic Breast Cancer Consortium (ABRCC) to conduct a prospective clinical trial to validate the clinical performance of the NeXT Personal assay to evaluate minimal residual disease (MRD) and subsequent recurrence in patients with early-stage, resectable triple negative breast cancer (TNBC)

Initiated a research collaboration with University Medical Center Hamburg-Eppendorf (UKE) and its new Fleur-Hiege Center for Skin Cancer Research, where Dr. Klaus Pantel, Dr. Christoffer Gebhardt, and team are using NeXT Personal to track tumor response to immunotherapy (IO) in patients with melanoma, with the aim of gathering evidence to advance the use of ultra-sensitive MRD detection in routine clinical practice for IO therapy monitoring

"We are excited to have completed our strategic review of the business, which has resulted in a new threefold focus on winning in MRD, leveraging our technology to power companies working on personalized cancer vaccines, and supporting pharmaceutical customers with clinical trials," said Aaron Tachibana, Interim Chief Executive Officer and Chief Financial Officer. "Our partnership with Moderna using our NeXT Platform to provide genomic testing is an example of how we enable customers. With our sharpened focus in both our clinical and biopharma businesses, we believe we are well-positioned to advance the standard of care by transforming cancer recurrence detection and ongoing therapy monitoring."

Fourth Quarter Highlights

Reported total company revenue of $16.7 million for the fourth quarter of 2022 and $65.0 million for the full year of 2022.

o
Revenue from pharma tests, enterprise, and other customers of $15.8 million in the fourth quarter of 2022 compared with $15.4 million in the fourth quarter of 2021; revenue from enterprise customers includes revenue from Natera of $8.2 million in the fourth quarter of 2022

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Revenue from population sequencing for the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $0.9 million in the fourth quarter of 2022, which is initial revenue from the new contract awarded in September 2022, compared with $5.3 million in the fourth quarter of 2021

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Cash, cash equivalents, and short-term investments of $167.7 million as of December 31, 2022

Fourth Quarter and Full Year 2022 Financial Results

•
Revenue of $16.7 million in the fourth quarter 2022; revenue of $65.0 million in the full year 2022
•
Net loss of $31.1 million, and net loss per share of $0.67 based on a weighted-average basic and diluted share count of 46.3 million in the fourth quarter 2022; net loss of $113.3 million, and net loss per share of $2.48 based on a weighted-average basic and diluted share count of 45.7 million in the full year 2022

First Quarter and Full Year 2023 Outlook

Personalis expects the following for the first quarter of 2023:

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Total company revenue of approximately $17.5 million
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Revenue from pharma tests, enterprise sales, and other customers of approximately $14.5 million
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Revenue from population sequencing of approximately $3.0 million

Personalis expects the following for the full year of 2023:

•
Total company revenue in the range of $68 million to $72 million, based on its strategic review of accounts and pruning of unprofitable business
•
Revenue from pharma tests, enterprise sales, and all other customers in the range of $59 million to $63 million
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Revenue from population sequencing of approximately $9.0 million
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Net loss of approximately $103 million, down from $113 million in 2022 due to realization of headcount reduction savings, partially offset by investments in clinical evidence generation and non-cash depreciation expense for the new facility
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Cash usage of approximately $75 million, down from $119 million in 2022

Webcast and Conference Call Information

Personalis will host a conference call to discuss the fourth quarter and full year 2022 financial results after market close on Thursday, February 23, 2023 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On February 23, 2023 OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended December 31, 2022 (Press release, Opko Health, FEB 23, 2023, View Source [SID1234627624]).

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Business highlights include the following:

Sales are underway by Pfizer for NGENLA (somatrogon) in 15 countries including Japan, Germany and the United Kingdom; Pfizer expects to launch in all priority ex-U.S. markets by year-end and is continuing to work with the FDA to obtain approval in the U.S. NGENLA treats pediatric patients with decreased growth due to insufficient growth hormone and reduces the injection frequency from once daily to once weekly. NGENLA is the first once-weekly product approved for the treatment of pediatric growth hormone deficiency in Japan, Canada, Australia, Taiwan, United Arab Emirates and Brazil. Its European Union marketing authorization is valid in all EU Member States, as well as in Iceland, Norway and Liechtenstein.

BioReference Health advances its cost-cutting initiatives. BioReference continues to implement significant initiatives to reduce costs and rationalize its business following the decline of COVID-19 testing volume. In addition, BioReference is driving innovation to its portfolio and exploring other revenue sources to return the business to profitability.
Fourth Quarter Financial Results

Pharmaceuticals: Revenue from products in the fourth quarter of 2022 increased to $37.9 million from $35.3 million in the fourth quarter of 2021, driven by sales in our international operating companies and revenue from sales of RAYALDEE. Revenue from sales of RAYALDEE in the fourth quarter of 2022 was $9.1 million compared with $7.7 million in the prior-year period. Revenue from the transfer of intellectual property was $8.1 million in the fourth quarter of 2022 compared with $3.2 million in the 2021 period. Furthermore, during the fourth quarter of 2022, OPKO received $2.5 million from Nicoya, tied to the first anniversary of the agreement’s effective date. Total costs and expenses were $68.0 million in the fourth quarter of 2022 compared with $53.3 million in the prior-year period. The increase was primarily attributable to higher amortization expenses related to the reclassification of NGENLA’s in-process research and development upon its approval in Europe and Japan, higher employee expenses associated with the ModeX acquisition and the impact of foreign exchange at our international operating companies. The operating loss was $22.0 million in the fourth quarter of 2022 compared with an operating loss of $14.8 million in the fourth quarter of 2021.

Diagnostics: Revenue from services in the fourth quarter of 2022 was $139.4 million compared with $362.8 million in the prior-year period. The decrease was primarily due to lower COVID-19 testing volume. BioReference processed approximately 0.1 million COVID-19 PCR tests in the fourth quarter of 2022 versus 2.7 million tests in the fourth quarter of 2021. Total costs and expenses were $162.5 million in the fourth quarter of 2022 compared with $381.4 million in the fourth quarter of 2021, resulting in an operating loss of $23.1 million compared with an operating income of $18.6 million in the 2021 period. BioReference continues to implement significant cost-reduction initiatives and has scaled back its digital health investments as it looks to return to profitability following the decline of COVID-19 testing.

Consolidated: Consolidated total revenues for the fourth quarter of 2022 were $185.4 million compared with $401.3 million for the comparable period of 2021. The operating loss for the fourth quarter of 2022 was $55.3 million compared with an operating loss of $63.1 million for the 2021 quarter. Net loss for the fourth quarter of 2022, which included a non-cash expense of $49.1 million due to a decrease in the fair value of OPKO’s GeneDx Holdings (formerly Sema4 Holdings Corp.) investment, was $85.2 million, or $0.11 per share, compared with a net loss of $73.8 million, or $0.11 per share, for the 2021 quarter. Net loss for the fourth quarter of 2021 included non-recurring legal expenses and expenses related to the sale of GeneDx, Inc.

Cash and cash equivalents: Cash and cash equivalents were $153.2 million as of December 31, 2022.
Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss fourth quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (833) 630-0584 (U.S.) or (412) 317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until March 2, 2023 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 3187296. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On February 23, 2023 VBL Therapeutics (Nasdaq:VBLT), a biotechnology company developing targeted medicines for immune-inflammatory diseases, and Notable Labs, Inc. ("Notable"), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, reported they have entered into a definitive merger agreement (Press release, VBL Therapeutics, FEB 23, 2023, View Source [SID1234627620]). The combined company will focus on the advancement of Notable’s proprietary Predictive Precision Medicines Platform ("PPMP") and therapeutic pipeline focused on cancer patients with high unmet medical needs. Immediately after the merger, Notable stockholders are expected to own approximately 76% and VBL Therapeutics shareholders are expected to own approximately 24% of the combined company, each on a fully-diluted basis and subject to adjustment. The combined company is expected to operate under the name Notable Labs, Ltd. with its shares listed on the Nasdaq Capital Market under the ticker symbol ‘NTBL.’

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"Following an extensive process to identify the best possible partner, we are very encouraged to have arrived at this proposed merger with Notable," remarked Prof. Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The caliber and track record of Notable’s management and their deep industry experience further adds to our excitement about developing Volasertib with Notable’s predictive platform technology to create value for our shareholders."

"The operational infrastructure, intellectual resources and investment capital that this merger brings will serve as both the foundation and a driver of potential best-in-class therapeutic assets out of our PPMP platform," commented Dr. Thomas A. Bock, Chief Executive Officer of Notable. "We are excited about the tremendous support of Notable’s top-tier investors including Builders VC, B Capital Group, Y Combinator, First Round Capital, and Founders Fund, further fueling our ambition to revolutionize oncology drug development with our ability to predict patient responses. This merger will serve to advance our lead clinical program with Volasertib, while in parallel accelerating our pursuit of additional targeted in-licensing opportunities."

Notable’s PPMP combines multi-dimensional biological assays and machine learning to bio-simulate a patient’s cancer treatment and predict their clinical response to the actual treatment. Three clinical validation studies with recognized academic centers have demonstrated PPMP’s high precision in accurately predicting clinical responders.

PPMP has guided Notable in the selection and development of two clinical-stage therapeutic candidates in platform-predicted responding patients with AML. Notable’s lead asset derived from PPMP is Volasertib, a highly potent PLK1 inhibitor proven to induce cell cycle arrest and apoptosis in various cancer cells. Phase 2a results for Volasertib in adult AML are expected in 3Q 2024. Notable expects to use PPMP to identify, in-license, and fasttrack additional undervalued assets as it builds out its development pipeline.

Concurrent with the execution of the merger agreement, a healthtech-focused investor syndicate, including existing Notable stockholders Builders VC, B Capital Group, Y Combinator, First Round Capital, and Founders Fund, have entered into a definitive securities purchase agreement with Notable to invest $10.3 million in gross proceeds prior to the close of the proposed merger. After completion of the merger, the combined company is expected to be capitalized with a cash runway into 2025.

About the Proposed Merger

Under the terms of the merger agreement, pending approval of the transaction by VBL Therapeutics’ shareholders and Notable’s stockholders, Notable will merge with a wholly-owned Delaware subsidiary of VBL Therapeutics, and stockholders of Notable will receive newly issued ordinary shares. Immediately after the merger, Notable stockholders are expected to own approximately 76% and VBL Therapeutics shareholders are expected to own approximately 24% of the combined company, in each case on a fully diluted basis as set forth in the merger agreement. The percentage of the combined company that the respective companies’ shareholders will own after completion of the merger is subject to adjustment based on the amount of VBL Therapeutics’ net cash at the closing date and the net proceeds from Notable’s pre-merger financing, among other adjustments, in each case as described in the merger agreement.

The merger agreement has been unanimously approved by the Board of Directors of each company. The merger is expected to close in the second quarter of 2023, subject to receipt of necessary approvals by the stockholders of each company and other customary closing conditions.

Chardan is serving as exclusive financial advisor to VBL Therapeutics and Goodwin Procter LLP and Horn & Co. are serving as legal counsel to VBL Therapeutics. JMP Securities, a Citizens Company, is serving as exclusive financial advisor for Notable and Wiggin and Dana LLP and Meitar are serving as legal counsel to Notable.

Management and Organization

The combined company will be led by Notable’s current management team and will be headquartered in Foster City, California. The Board of Directors of the combined company is expected to consist of up to seven members, one of which will be designated by VBL Therapeutics and the remainder of which will be designated by Notable.

Conference Call and Webcast Information

VBL Therapeutics and Notable will host a conference call and webcast today at 8:30 AM Eastern Time. The call can be accessed by dialing (877) 407-9208 (U.S. and Canada) or (201) 493-6784 (international) and entering passcode 13736622. A link to the live webcast, including the presentation of corporate slides, may be found here. To access a subsequent archived recording, visit the "Events & Presentations" section of the VBL website at www.vblrx.com, or the "News & Events" section of the Notable website at www.notablelabs.com