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Arcellx Announces Participation at the BofA Securities 2022 Healthcare Conference

On May 5, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that management will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on Wednesday, May 11, 2022, at 5:00 p.m. E.T (Press release, Arcellx, MAY 5, 2022, View Source [SID1234613727]).

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A live webcast of the discussion will be accessible from Arcellx’s website at www.arcellx.com in the Investor section. A replay of the webcast will be archived and available for 30 days following the event.

Illumina Reports Financial Results for First Quarter of Fiscal Year 2022

On May 5, 2022 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the first quarter of fiscal year 2022, which include consolidated financial results for GRAIL (Press release, Illumina, MAY 5, 2022, View Source [SID1234613725]).

"Illumina maintained strong momentum in the first quarter, particularly across oncology therapy selection, genetic disease testing, and pathogen surveillance," said Francis deSouza, Chief Executive Officer. "Our business fundamentals are robust. We saw record total orders and exited the quarter with record total backlog. GRAIL also continued to gain traction and has now entered more than 30 partnerships with health systems, employers, and insurers. We are advancing our innovation roadmap, delivering the sequencing breakthroughs that power genomic research and improve human health."

(a) See the tables included in "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP
and non-GAAP financial measures.

(b) Consolidated financial results for GRAIL are included in Q1 2022, but not in Q1 2021, as GRAIL was acquired
on August 18, 2021.

Capital expenditures for free cash flow purposes were $61 million during the first quarter of 2022. Cash flow from operations was $172 million compared to $282 million in the prior year period, with the year-over-year decrease primarily attributable to GRAIL’s operating loss. Free cash flow (cash flow from operations less capital expenditures) was $111 million for the quarter compared to $240 million in the prior year period. Depreciation and amortization expenses were $91 million during the first quarter of 2022. At the close of the quarter, the company held $1.4 billion in cash, cash equivalents and short-term investments, compared to $1.3 billion as of January 2, 2022.

First quarter segment results
Following the acquisition of GRAIL on August 18, 2021, we have two reportable segments, Core Illumina and GRAIL. GRAIL financial results are reflected for the period after the acquisition.

(a) See Table 5 included in "Results of Operations – Non-GAAP" section below for a reconciliation of these GAAP
and non-GAAP financial measures.

Key announcements by Illumina since Illumina’s last earnings release

Established partnership with Deerfield Management to identify drug targets and accelerate novel therapy development using genomics and artificial intelligence
Developed long-term strategic collaboration with Janssen Biotech, Inc. to accelerate the development of precision medicines by leveraging Illumina’s portfolio of next-generation sequencing (NGS) solutions
Launched TruSight Oncology (TSO) Comprehensive (EU) in Europe, a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient’s cancer
Invested in seven "omics" startup companies through Illumina Accelerator, advancing breakthrough therapeutics, diagnostics, DNA storage, mental wellness, and sustainable foods applications
Released annual Corporate Social Responsibility (CSR) Report, highlighting contributions of genomics to advances in public health and overall health of our planet
Opened State-of-the-Art Solution Center in São Paulo, Brazil, increasing access to genomics in Latin America
Expanded senior leadership team with Carissa Rollins joining as Chief Information Officer, and John Frank as Chief Public Affairs Officer
A full list of recent Illumina announcements can be found in the company’s News Center.

Key announcements by GRAIL since Illumina’s last earnings release

Announced a multi-year partnership with leading reinsurance provider, Munich Re Life US, to enable access to Galleri as a benefit to policyholders of U.S. life insurance carriers and distributors
Began collaboration with Point32Health, the combined organization of Harvard Pilgrim Health Care and Tufts Health plan, to collaborate on two-phased pilot of Galleri multi-cancer early detection test
Galleri named in Fast Company’s 2022 World Changing Ideas Awards List
Announced Galleri Classic golf tournament in partnership with PGA TOUR Champions, debuting March 20-26, 2023
A full list of recent GRAIL announcements can be found in the company’s Newsroom.

Financial outlook and guidance
The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance, including our Core Illumina and GRAIL segments. Please see our Reconciliation of Consolidated Non-GAAP Financial Guidance included in this release for a reconciliation of these GAAP and non-GAAP financial measures.

For fiscal 2022, the company continues to expect consolidated revenue growth in the range of 14% to 16%. We now expect GAAP earnings per diluted share of $2.33 to $2.53. The company continues to expect non-GAAP earnings per diluted share of $4.00 to $4.20. Core Illumina revenue growth is still expected to be in the range of 13% to 15%. GRAIL revenue is still expected to be in the range of $70 million to $90 million.

Conference call information
The conference call will begin at 2 p.m. Pacific Time (5 p.m. Eastern Time) on Thursday, May 5, 2022. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing (877) 502-9276 or +1 (313) 209-4906 outside North America, both using conference ID 7035119. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Tyra Biosciences Reports First Quarter 2022 Financial Results and Highlights

On May 5, 2022 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported financial results for the quarter ended March 31, 2022 and highlighted recent corporate progress (Press release, Tyra Biosciences, MAY 5, 2022, View Source [SID1234613724]).

"2022 is off to a great start at TYRA and we continue to focus our efforts on preparing for a successful transition to a clinical-stage company. We look forward to filing INDs for both TYRA-300 and TYRA-200 this year, while continuing to advance our platform and pipeline," said Todd Harris, CEO of TYRA.

First Quarter 2022 and Recent Corporate Highlights

INDs for TYRA-300 and TYRA-200 on Track. TYRA continued to advance TYRA-300, an FGFR3 inhibitor with an initial focus on patients with metastatic urothelial carcinoma of the bladder and urinary tract, and TYRA-200, an FGFR2 inhibitor with an initial focus on patients with intrahepatic cholangiocarcinoma. TYRA remains on track to submit an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for TYRA-300 in mid-2022 and for TYRA-200 in the second half of 2022.

Pipeline Progression. TYRA continued to progress its pipeline including programs targeting achondroplasia and other FGFR3-related skeletal dysplasias, REarranged during Transfection kinase (RET) and FGFR4-related cancers.
First Quarter 2022 Financial Results

First quarter 2022 net loss was $14.8 million compared to $4.2 million for the same period in 2021.
First quarter 2022 research and development expense was $9.6 million compared to $3.5 million for the same period in 2021.
First quarter 2022 general and administrative expense was $5.2 million compared to $0.7 million for the same period in 2021.
As of March 31, 2022, TYRA had cash and cash equivalents of $292.5 million.

Vanda Pharmaceuticals Reports First Quarter 2022 Financial Results

On May 5, 2022 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the first quarter ended March 31, 2022 (Press release, Vanda Pharmaceuticals, MAY 5, 2022, View Source [SID1234613722]).

"We are excited with our progress in improving patient access for HETLIOZ, especially for Medicaid beneficiaries with Non-24 and SMS diagnoses," said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. "Further, we now anticipate completing enrollment of the Fanapt bipolar disorder study by the end of this year and look forward to expanding our psychiatry franchise. Today we are sharing details of our advanced analysis of data from the tradipitant clinical program in gastroparesis, which support the efficacy of tradipitant, and we look forward to discussing our planned New Drug Application with the FDA."

Financial Highlights

Total net product sales from HETLIOZ and Fanapt were $60.2 million in the first quarter of 2022, a 4% decrease compared to $62.7 million in the first quarter of 2021.
HETLIOZ net product sales were $37.0 million in the first quarter of 2022, a 6% decrease compared to $39.3 million in the first quarter of 2021, due in part to the continued reimbursement challenges for prescriptions for patients with Non-24.
Fanapt net product sales were $23.2 million in the first quarter of 2022, a 1% decrease compared to $23.3 million in the first quarter of 2021.
Net loss was $6.4 million in the first quarter of 2022 compared to net income of $8.7 million in the first quarter of 2021.
Cash, cash equivalents and marketable securities (Cash) was $435.2 million as of March 31, 2022, representing an increase to Cash of $57.0 million compared to March 31, 2021 and an increase to Cash of $2.4 million compared to December 31, 2021.
Key Operational Highlights

HETLIOZ (tasimelteon)

Clinical trials for HETLIOZ in delayed sleep phase disorder (DSPD) and symptoms of autism spectrum disorder (ASD) are currently enrolling patients.
Since November 2021, more than 15 states have revised or agreed to revise their Medicaid prior authorization criteria to broaden access to HETLIOZ for patients with Non-24 and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).
In January 2022, Vanda settled its HETLIOZ patent litigation against one of the defendants. The trial for the consolidated lawsuit against the remaining defendants was held in March 2022. A decision is expected from the court in the second half of 2022.
Tradipitant

Tradipitant is a neurokinin-1 (NK-1) receptor antagonist in development for the treatment of idiopathic and diabetic gastroparesis. Earlier in the year, Vanda reported results of a clinical study and initial exploratory analysis. Vanda has now completed a pooled analysis of two clinical studies of tradipitant in gastroparesis consisting of 342 patients with relevant clinical endpoints. We believe these studies are adequate and well controlled and support substantial evidence of efficacy of tradipitant. Figure 1 and Table 1 show the results of such pooled analysis of all patients randomized in the two studies (intent to treat population, ITT) and Figure 2 and Table 2 show the results for the same parameters in the population of patients who were judged as compliant to treatment based on analysis of drug exposure (treatment compliant population).

Consistently, both pooled analyses show tradipitant to be superior to placebo in key clinical parameters including improvement in DD-Nausea (primary endpoint parameter), percent Nausea Free Days, Patient Global Impression scale change (PGI-C), Overall Benefit Score and Gastroparesis Cardinal Symptom Index (GCSI) score.

Vanda is continuing to conduct an open-label study of safety for tradipitant in gastroparesis and continues to receive requests from patients reaching out to gain access to tradipitant through the Expanded Access program which has multiple patients continuing to take tradipitant for more than a year.
Vanda has scheduled a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned New Drug Application submission for tradipitant in the short-term treatment of nausea in gastroparesis.
The Phase III study of tradipitant in the treatment of motion sickness has restarted enrollment and is already over 15% enrolled. A prior Phase II study of tradipitant in the treatment of motion sickness observed a significantly lower incidence of vomiting in tradipitant-treated patients as compared to placebo-treated patients.
Fanapt (iloperidone)

A Phase III study of Fanapt in acute manic episodes in patients with bipolar disorder is over 75% enrolled and expected to complete enrollment by the end of 2022.
GAAP Financial Results

Net loss was $6.4 million in the first quarter of 2022 compared to net income of $8.7 million in the first quarter of 2021. Diluted net loss per share was $0.11 in the first quarter of 2022 compared to diluted net income per share of $0.15 in the first quarter of 2021.

2022 Financial Guidance

Vanda expects to achieve the following financial objectives in 2022:

Conference Call

Vanda has scheduled a conference call for today, Thursday, May 5, 2022, at 4:30 PM ET. During the call, Vanda’s management will discuss the first quarter 2022 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode number 1355275. A replay of the call will be available on Thursday, May 5, 2022, beginning at 7:30 PM ET and will be accessible until Thursday, May 12, 2022 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 1355275.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

Cardiff Oncology Reports First Quarter 2022 Results and Provides Business Updates

On May 5, 2022 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported recent company highlights and financial results for the first quarter ended March 31, 2022 (Press release, Cardiff Oncology, MAY 5, 2022, View Source [SID1234613721]).

"With a strong balance sheet and clinical data highlighting onvansertib’s potential to improve patient outcomes by combining synergistically with the standard-of-care, we believe we are well positioned for success," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "Phase 1b/2 data from our lead KRAS-mutated metastatic colorectal cancer (mCRC) program show clear improvements in treatment response and durability compared to historical controls. These results also clinically demonstrate onvansertib’s KRAS-agnostic mechanism of action, setting it apart from competing agents that target only the G12C variant."

Dr. Erlander added, "We are also highly encouraged by recent data from our Phase 2 prostate cancer trial showing clinically meaningful disease control rates in patients who showed signs of progression on prior therapy, and preclinical studies that showed onvansertib-PARP inhibitor combination therapy leading to statistically significant survival benefits in patient-derived xenograft models of PARP-inhibitor-resistant ovarian cancer. These results further highlight how onvansertib’s ability to inhibit PLK1 positions it to target tumor vulnerabilities and overcome treatment resistance across a spectrum of indications. We look forward to building on these results as we move towards the second half of the year."

Program highlights for the quarter ended March 31, 2022, and recent business updates include:

KRAS-mutated mCRC Program:

Reported new Phase 1b/2 data showing treatment with onvansertib plus FOLFIRI/bevacizumab leading to an objective response rate (ORR) and median progression-free survival (mPFS) that substantially exceed those recorded in historical control trials

The data were announced on a webcast and conference call hosted by Cardiff Oncology, and a subset were presented by Heinz-Josef Lenz, M.D., FACP, principal investigator, USC Norris Comprehensive Cancer Center, in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI). Highlights from the webcast and conference call include:

Efficacy data in evaluable patients:

Among patients treated per protocol with onvansertib at the recommended Phase 2 dose (RP2D; 15 mg/m2) in combination with FOLFIRI/bevacizumab:
34% (12 of 35) achieved an initial complete response (CR) or partial response (PR)
29% (10 of 35) achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)
Historical control trials evaluating different drug combinations, including the standard-of-care of FOLFIRI with bevacizumab, in similar patient populations have shown ORRs of 5-13%1-4
Patients evaluable for response treated at onvansertib dose levels 12 mg/m2, 15 mg/m2, and 18 mg/m2
35% (17 of 48) achieved an initial CR or PR
27% (13 of 48) achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)
mPFS, biomarker, and safety data:

mPFS not yet reached in patients treated per protocol at the RP2D
mPFS across all response-evaluable patients (n = 48) is 9.4 months (95% confidence interval: 7.1 – not yet reached)
mPFS of ~4.5-5.7 months has been reported in historical control trials1-4
Complete or partial responses were observed across seven different KRAS mutation variants, including the 3 most commonly observed in colorectal cancer (G12D, G12V, G13D)
Onvansertib in combination with FOLFIRI/bevacizumab has been well-tolerated with only 11% (84/788) of reported treatment-emergent adverse events (TEAEs) being G3/G4
Metastatic Castration-resistant Prostate Cancer (mCRPC) Program:

Announced updated clinical and new biomarker data from Phase 2 trial evaluating onvansertib in combination with abiraterone/prednisone in mCRPC patients showing initial abiraterone resistance

Results from the trial, which were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, showed clinically meaningful disease control rates that rose with increasing onvansertib dose density. Additional highlights from the announcement include:

75% (15 of 20) evaluable patients in Arm C, which represents the trial’s most dose dense treatment schedule, showed disease control by radiographic stable disease (SD/PR) at 12-weeks, compared to 9 of 17 (53%) and 11 of 19 (58%) in the less dose-dense Arms A and B, respectively
Treatment response (SD/PR) was positively associated with mutations in PTEN and MTOR, key genes in the PI3K signaling pathway
Gene signatures correlating with treatment response included those corresponding to the ERG+ and Notch pathways, which are involved in cell-invasion, epithelial-mesenchymal transition, and metastasis
Genes related to mitochondrial and immune functions were downregulated in patients achieving SD or a PR compared to those showing progressive disease
Onvansertib in combination with abiraterone/prednisone has been well tolerated in the trial
Each arm in the trial has evaluated a different dosing schedule of onvansertib alongside abiraterone and prednisone administered throughout the respective treatment cycle. Arm A evaluated 24 mg/m2 onvansertib on Days 1-5 of 21-day cycles, Arm B evaluated 18 mg/m2 onvansertib on Days 1-5 of 14-day cycles, and Arm C is evaluating 12 mg/m2 onvansertib on Days 1-14 of 21-day cycles.

Preclinical Highlights:

Reported new preclinical data that show onvansertib combining with a PARP inhibitor to overcome PARP inhibitor (PARPi) resistance in BRCA1-mutant and wild-type patient-derived xenograft ovarian cancer models

Preclinical studies featured in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting evaluated onvansertib in combination with the PARPi olaparib in three olaparib-resistant patient-derived xenograft (PDX) ovarian cancer models. Two of the three PDX models studied were cisplatin-sensitive with a mutated BRCA1 gene, while the third was cisplatin-resistant with wild type BRCA1. Results showed that treatment with onvansertib plus olaparib led to a statistically significant survival benefit compared to treatment with either agent alone in each of the three evaluated PDX models. The combination regimen was also shown to be well tolerated in mice.

First Quarter 2022 Financial Results:

Liquidity and cash burn

As of March 31, 2022, Cardiff Oncology had approximately $129.4 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the first quarter of 2022 was approximately $10.2 million, an increase of approximately $4.3 million from $5.9 million for the same period in 2021.

The overall increase in research and development expenses was primarily due to costs associated with an increase in outside service costs related to chemistry, manufacturing, and controls ("CMC") and pharmacology for the development of our lead drug candidate, onvansertib. Salaries and staff costs increased due to a higher headcount in the current period, as compared to the prior period. The increase in stock-based compensation is due to additional stock option grants to employees granted subsequent to the prior period.

The overall increase in selling, general and administrative expense was primarily due to costs associated with outside services and stock-based compensation. The increase in outside services is related to strategic valuation consulting related to our lead drug candidate, onvansertib. The increase in stock-based compensation is due to additional stock option grants to employees and directors granted subsequent to the prior period.