On February 24, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported financial results for the fourth quarter and full year ended December 31, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, FEB 24, 2022, View Source [SID1234608960]).

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"In 2021, the Company significantly advanced its lead 186RNL program and expanded its pipeline," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our 2022 plan will build on our successful 2021 track record. This year we have planned an aggressive schedule of development activities in conjunction with continued strengthening of our balance sheet".

2021 AND RECENT HIGHLIGHTS

Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets

Announced positive interim data from the U.S. ReSPECT-GBM Phase 1/2 trial of 186RNL in patients with recurrent glioblastoma (GBM).
Announced plans to advance into Phase 2 development in 2022 for recurrent GBM.
Initiated ReSPECT-LM Phase 1 dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM).
Received U.S. Food and Drug Administration (FDA) Fast Track designation for 186RNL for the treatment of LM.
Entered into multiple manufacturing, analytical and supply agreements to produce Good Manufacturing Practice (cGMP) grade 186RNL for use in late-stage clinical trials planned for 2022.
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere ( 188 RNL-BAM), a novel radiotherapy in development for solid organ cancers

In the fourth quarter of 2021, in-licensed a novel targeted radioembolic technology for the treatment of many solid organ tumors.
The in-licensed technology is intended to make and use biodegradable alginate microspheres (BAM) combined with nanoliposomes and imaging and/or therapeutic payloads.
The Company will initially focus on developing 188RNL-BAM as a next-generation radioembolization therapy for rare solid organ cancers including liver cancer.
FULL YEAR 2021 FINANCIAL RESULTS

As of December 31, 2021, the Company’s cash balance was $18.4 million, compared to $8.3 million as of December 31, 2020. In 2021 and in 2022 to date, the Company strengthened its balance sheet by raising $28.5 million. As a result, at January 31, 2022, the Company’s cash balance was $23.0 million.
Through 2021, the Company continued to utilize the $3 million grant from the NIH/National Cancer Institute for funding of the clinical trials for the ReSPECT-GBM Phase 1/2 trial.
Total operating expenses for full year 2021 were $12.5 million, compared to total operating expenses of $9.9 million for full year 2020. This increase is primarily due to increased research and development expenses in 2021.
Net loss for full year 2021 was $13.4 million, or $(1.11) per share, compared to a net loss of $8.2 million, or $(1.86) per share, for full year 2020. The increase in net loss is primarily due to the aforementioned increase in research and development expenses.
UPCOMING EVENTS AND MILESTONES

The Company’s near- and mid-term business objectives include the following:

Recurrent GBM

Initiate a Phase 2 clinical trial in patients with recurrent GBM.
Complete FDA CMC and clinical meetings for the ReSPECT-GBM program.
Complete CMC activities for 186RNL for GMP Phase 2 drug supply.
Continue ReSPECT-GBM Phase 1 trial of 186RNL, dose escalation and report data.
Initiate ReSPECT-GBM retreatment protocol following FDA approval.
Other Indications

Complete initial cohort enrollment and feasibility assessment in ReSPECT-LM Phase 1 trial.
Obtain FDA approval of Investigational New Drug (IND) application for Phase 1 trial of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC).
Complete technology transfer and key CMC, FDA IND-enabling studies for 188RNL-BAM.
FOURTH QUARTER AND FULL YEAR 2021 RESULTS CONFERENCE CALL

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

Event: Plus Therapeutics Fourth Quarter and Full Year 2021 Results Conference Call
Date: February 24, 2022
Time: 5:00 p.m. Eastern Time
Live Call: 866-342-8591 (toll free); 203-518-9713 (Intl.); Conference ID: PSTVQ421
The webcast can be accessed live via the Investor Relations section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.

On February 24, 2022 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the full year 2021 (Press release, Morphic Therapeutic, FEB 24, 2022, View Source [SID1234608976]).

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2021 and Recent Corporate Highlights
•Presented positive phase 1 data supporting MORF-057’s target product profile as an oral bioavailable, potent and specific inhibitor of the α4β7 integrin at the European Crohn’s and Colitis Organisation (ECCO) Virtual Congress 2021
◦MORF-057 was well tolerated in all dose cohorts with no safety signals observed
◦Pharmacokinetic and pharmacodynamic data strongly supported MORF-057 progression into phase 2 with an oral twice daily dosing profile
◦Saturation (>99%) of the α4β7 receptor was observed in all subjects at all timepoints at trough concentrations using 100mg BID, our Ph2a dose
◦T-Cell concentration changes provided further evidence for MORF-057’s ability to replicate the known mechanism of the approved therapeutic, vedolizumab
◦Phase 2a trial of MORF-057 in patients with moderate to severe ulcerative colitis expected to begin in the first quarter of 2022 and Phase 2b to begin mid-year 2022
•Presented positive preclinical data from Morphic’s immuno-oncology program at the AACR (Free AACR Whitepaper) Annual Meeting 2021 demonstrating that potent and specific inhibition of αvβ8, in combination with checkpoint inhibitors, potentiated anti-tumor activity in tumors refractory to checkpoint inhibition monotherapy
◦Additional preclinical data presented at the SITC (Free SITC Whitepaper) Annual Meeting in November 2021 provided further rationale to explore αvβ8 inhibition in combination with immunotherapy to drive anti-tumor responses and survival benefits
•Focused research and development collaboration efforts with AbbVie and Janssen on higher-potential integrin targets in multiple therapeutic areas
◦The Janssen collaboration is now primarily focused on discovering activators of a specific integrin target, including antibody activators
◦Development activities by AbbVie for the αVβ6 target have been discontinued while research activities in the AbbVie collaboration continue on separate integrin targets
•Completed $245 million upsized public offering of common stock providing cash runway until the end of 2024
•Appointed Susannah Gray, a veteran leader in healthcare finance and strategy with three decades of experience, and Nisha Nanda, Ph.D., an experienced leader in preclinical and clinical-stage development strategy across multiple therapeutic areas, to the Morphic Board of Directors
•Thanked Nilesh Kumar, Ph.D., for his leadership and support as member of the Morphic Board of Director as he steps down from his role
◦Dr. Kumar has served as a Director of Morphic since 2017 when he was a Partner at Novo Ventures and Novo Ventures invested in Morphic as private company
◦Dr. Kumar has elected to transition off the Morphic Board of Directors after his transition from Novo Ventures to a new investment firm

"Morphic achieved each of its critical goals in 2021, and MORF-057 in particular significantly outpaced our expectations. The results from our Phase 1 studies with MORF-057 validate our proprietary MInT platform and have elevated our confidence as we embark on the global phase 2 clinical program in ulcerative colitis. We also presented exciting results from our immuno-oncology program demonstrating that αvβ8 inhibition, in combination with checkpoint inhibitors, has great potential to drive responses in checkpoint-refractory tumors," said Praveen Tipirneni, M.D., President and Chief Executive Officer of Morphic Therapeutic.

Financial Results for the full year 2021

•Net loss for the year ended December 31, 2021 was $95.5 million or $2.67 per share compared to a net loss of $45.0 million or $1.47 per share for the year ended December 31, 2020
•Revenue was $19.8 million for the year ended December 31, 2021, compared to $44.9 million for the year ended December 31, 2020. The decrease was mainly due to AbbVie’s option exercise on our αvβ6 integrin inhibitor program in the third quarter of 2020 for $20 million
•Research and development expenses were $87.8 million for the year ended December 31, 2021, as compared to $73.6 million for the year ended December 31, 2020. The increase was primarily attributable to higher manufacturing and development costs along with higher pre-clinical and clinical trial costs to support our lead product candidate MORF-057
•General and administrative expenses were $27.8 million for the year ended December 31, 2021, compared to $18.5 million for the year ended December 31, 2020. The increase was due to increased headcount and higher professional and consulting costs associated with ongoing business development activities and Morphic operating as a public company

As of December 31, 2021, Morphic had cash, cash equivalents and marketable securities of $408.1 million, compared to $228.3 million as of December 31, 2020. In the full year and fourth quarter 2021, Morphic raised net proceeds of $25.7 million and $1.1 million from the use of our At-The Market (ATM) facility. To date in 2022, Morphic has not issued any stock through its ATM facility. Morphic believes its cash, cash equivalents and marketable securities as of December 31, 2021, will be sufficient to fund operating expenses and capital expenditure requirements until the end of 2024.

On February 24, 2022 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), reported a summary of corporate accomplishments and reports its fourth quarter and full year 2021 financial results (Press release, Synta Pharmaceuticals, FEB 24, 2022, View Source [SID1234608991]).

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Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, "2021 was a year of significant progress for Madrigal as we continued to advance our industry-leading NASH clinical development program, setting up two critical readouts from our Phase 3 MAESTRO trials in 2022, one of which we have already delivered. Additionally, we expanded our leadership team, deepened relationships with the NASH community and enhanced our capabilities to support the commercialization of resmetirom."

Becky Taub, M.D., Chief Medical Officer and President of Research & Development at Madrigal stated, "The positive MAESTRO-NAFLD-1 safety study results we announced in January support our conviction that resmetirom has the potential to be the first medication approved for the treatment of patients with NASH. The data reinforce our expectation that the second Phase 3 trial of resmetirom, the MAESTRO-NASH liver biopsy study, will also produce positive safety and efficacy data later this year."

Clinical Trial Results and Updates

Primary and key secondary endpoints from the double-blind placebo-controlled 969-patient MAESTRO-NAFLD-1 safety study were achieved and demonstrate that resmetirom:

•
Was safe and well-tolerated at 80 and 100 mg in patients treated for 52 weeks;

•
Provided significant and, we believe, clinically relevant reductions in liver fat as measured by magnetic resonance imaging proton density fat-fraction (MRI-PDFF);

•
Significantly reduced atherogenic lipids, including LDLc, apolipoprotein B and triglycerides.

Adverse events were generally mild to moderate in severity. The frequency of serious adverse events was similar across placebo and active treatment arms and discontinuation for adverse events was low. Serious adverse events occurred at expected rates based on the patient population.

Madrigal will continue to generate safety and efficacy data from the MAESTRO-NAFLD-1 trial and intends to provide at least one additional public disclosure prior to publication/presentation at a major medical meeting.

LOGO

The Phase 3 MAESTRO-NASH trial continues to progress with the Subpart H cohort patients scheduled to complete the 52-week dosing regimen on time. Based on more conservative timeline assumptions for analysis of biopsies and other data from the trial, topline results are now expected in Q4 2022.

Leadership Team Expanded

Dominic F. Labriola, PhD, has joined Madrigal as Chief Data and Analytics Officer. Dr. Labriola has 35 years of experience in clinical development overseeing the global registration of 20 medicines. He spent more than 20 years at Bristol Myers Squibb as Head of Global Biometric Sciences where he was responsible for the team overseeing the company’s NASH program among many other programs. Prior to joining Bristol Myers Squibb, he held positions of increasing responsibility at DuPont Pharmaceutical Company, managing biostatisticians and programmers for multiple therapeutic areas. Dr. Labriola began his career as a research biostatistician at Memorial Sloan Kettering Cancer Center and earned his Ph.D. in Mathematical Statistics from the University of Delaware.

Sunil Kadam, PhD, has joined Madrigal as Senior Vice President of Global Regulatory Affairs. Dr. Kadam has successfully built and directed Global Regulatory Affairs teams at both large and emerging biopharmaceutical companies. Most recently, he was Senior Vice President of Global Regulatory Affairs at Telix Pharmaceuticals Limited. As the Regulatory Affairs lead for gastroenterology at Shire/Takeda, he led FDA Advisory Committee and secured FDA approval for Motegrity (prucalopride). As the Head of Regulatory Affairs for Takeda’s endocrine and metabolic rare disease products, he managed the global development of multiple pipeline projects. Prior to joining Takeda, he led Regulatory Affairs teams at IQVIA and Eli Lilly & Company.

Financial Results for the Three and Twelve Months Ended December 31, 2021

As of December 31, 2021, Madrigal had cash, cash equivalents and marketable securities of $270.3 million, compared to $284.1 million at December 31, 2020. The decrease in cash and marketable securities resulted primarily from cash used in operations of $183.9 million.

Operating expenses were $64.6 million and $242.5 million for the three and twelve month periods ended December 31, 2021, compared to $59.6 million and $206.7 million in the comparable prior year periods.

Research and development expenses for the three and twelve month periods ended December 31, 2021 were $52.9 million and $205.2 million, compared to $53.4 million and $184.8 million in the comparable prior year periods. The increases are primarily attributable to additional activities related to the Phase 3 clinical trials, an increase in manufacturing costs to support ongoing clinical trials and to prepare for commercialization, and an increase in head count and related expenses.

General and administrative expenses for the three and twelve month periods ended December 31, 2021 were $11.7 million and $37.3 million, compared to $6.1 million and $21.9 million in the comparable prior year periods. The increases are primarily attributable to an increase in non-cash stock compensation from stock option awards, head count and consulting costs.

Interest income for the three and twelve month periods ended December 31, 2021 was $0.1 million and $0.4 million, compared to $0.4 million and $4.3 million in the comparable prior year periods. The decreases in interest income for the latest three and twelve month periods were due primarily to lower average principal balances in our investment accounts in 2021, and decreased interest rates.

On February 24, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported the closing of its previously announced registered direct offering with an institutional investor of 1,496,400 shares of common stock (or common stock equivalents) at a price of $2.80 per share for gross proceeds of approximately $4.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company (Press release, Applied DNA Sciences, FEB 24, 2022, View Source [SID1234609010]). In a concurrent private placement, Applied DNA also issued to the institutional investor in the offering unregistered warrants to purchase up to an aggregate of 1,496,400 shares of common stock.

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Immediately following the closing of the registered direct offering and the concurrent private placement, the number of outstanding shares of common stock in the Company will be 8,234,320.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital and to advance the adoption of its LinearDNA manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The shares of common stock (or common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 21, 2020 and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On February 24, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the fourth quarter and the full year ended December 31, 2021 and provided recent corporate highlights (Press release, Y-mAbs Therapeutics, FEB 24, 2022, View Source [SID1234609067]).

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"In recent months, we have achieved significant progress on the omburtamab BLA, which we expect to resubmit to the FDA by the end of the first quarter of 2022," said Dr. Claus Moller, Chief Executive Officer. "We believe we now have a clear regulatory path in place and are one step closer to our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors. In parallel, we are continuing to advance SADA, our novel platform for targeted radioisotope delivery that can potentially be adapted to various tumor targets. We filed an IND for GD2-SADA, the first SADA construct for potential use in GD2 positive solid tumors and are now accelerating pre-clinical testing with plans to submit at least one IND per year for additional SADA targets. In the meantime, we are actively pursuing additional collaboration and partnership opportunities."

"We are very pleased with our 2021 financial results, especially with our continued execution of the DANYELZA commercial launch, which generated revenues of $32.9 million in its first year," said Thomas Gad, Founder, Chairman and President. "We continue to be focused on our oncology programs, supported by a strong balance sheet. We ended the year with $181.6 million in cash, that is anticipated to support us through multiple potentially value-creating catalysts by the end of 2023. We believe that we are well-positioned to elevate our business and we expect that 2022 will be another productive year for Y-mAbs."

Fourth Quarter 2021 and Recent Corporate Developments

Subsequent to the end of the fourth quarter, on February 11, 2022, Y-mAbs announced the completion of a Pre-BLA Meeting with FDA for omburtamab and confirmed the timeline for resubmission of the omburtamab BLA by the end of the first quarter of 2022.

On December 15, 2021, Y-mAbs announced a pipeline update, including compassionate use data from an investigational infusion protocol for naxitamab. It was observed that the protocol may help managing Grade 3 and Grade 4 adverse events.

On December 14, 2021, Y-mAbs appointed Sue Smith to the role of Senior Vice-President, Chief Commercial Officer, effective January 1, 2022. Ms. Smith brings more than 25 years of extensive commercial experience including several successful product launches within cancer, rare diseases, and endocrinology.

On October 7, 2021, Y-mAbs announced that the U.S. Food and Drug Administration ("FDA") had granted Rare Pediatric Disease Designation ("RPDD") for the Company’s lutetium labeled omburtamab antibody program for the treatment of medulloblastoma.
Financial Results

Revenues

Y-mAbs reported net revenue of $34.9 million for the year ended December 31, 2021, which consisted of product revenues of $32.9 million, generated from sales of DANYELZA, our first FDA approved product, and licensing revenues of $2.0 million related to a licensing agreement in Latin America. The gross margin for product revenues was 93% in 2021. Y-mAbs reported net revenues of $20.8 million for the year ended December 31, 2020, related to its licensing agreements in China and Israel. Y-mAbs did not have product revenues for the year ended December 31, 2020, as DANYELZA was not approved by the FDA until late November 2020.

For the fourth quarter of 2021, Y-mAbs incurred net revenues of $9.6 million, which consisted of product revenues from the sales of DANYELZA. Sales were up 7.1% from the third quarter 2021, and we have now delivered DANYELZA to 28 centers across the nation, an increase of four centers since the third quarter 2021. Treatment centers outside MSK accounted for approximately 40% of the product revenues during the fourth quarter of 2021. Y-mAbs incurred net revenues of $20.8 million for the quarter ending December 31, 2020, related to its licensing agreements in China and Israel.

Operating Expenses

Research and Development

Y-mAbs is anticipating a BLA resubmission for omburtamab by the end of the first quarter 2022 and at the same time, the Company is advancing its antibody constructs through the clinic; predominantly DANYELZA, omburtamab, and the SADA constructs. Research and development expenses were $93.2 million for the twelve months ended December 31, 2021, compared to $93.7 million for the twelve months ended December 31, 2020. The $0.5 million decrease in research and development expenses primarily reflects the following main items:

$4.8 million decrease in regulatory affairs expenses; and
$13.3 million decrease in milestones and license acquisition costs.
The decreases mentioned above were partially offset by the following increases:

$6.2 million increase in outsourced manufacturing expenses;
$4.1 million increase in personnel costs associated with research and development activities; and
$3.9 million increase in clinical trial expenses.
Selling, General, and Administration

Selling, general, and administrative expenses were $54.6 million for the twelve months ended December 31, 2021, compared to $44.8 million for the twelve months ended December 31, 2020, corresponding to an increase of $9.8 million. The increase in selling, general, and administrative expenses was primarily due to a $8.9 million increase in personnel costs, partly associated with the expansion of our commercial team that is poised to drive further adoption of DANYELZA in 2022.

Net Result

Y-mAbs reported a net loss of $55.3 million, or ($1.28) per basic and diluted share, for the year ended December 31, 2021, compared to a net loss of $119.3 million, or ($2.97) per basic and diluted share, reported for the year ended December 31, 2020. The decrease in net loss was primarily caused by the sale in January 2021 of the priority review voucher received upon the approval of DANYELZA and the DANYELZA revenues generated in 2021, partially offset by increases in operating expenses related to the commercialization of DANYELZA in the United States.

For the quarter ended December 31, 2021, Y-mAbs incurred a net loss of $36.9 million, or ($0.85) per basic and diluted share, which compares to a net loss of $19.9 million, or ($0.48) per basic and diluted share, incurred for the quarter ended December 31, 2020. The increase in net loss was primarily caused by the DANYELZA revenues in 2021 not fully offsetting the licensing income in the fourth quarter of 2020.

Cash and Cash Equivalents

The Company had approximately $181.6 million in cash and cash equivalents as of December 31, 2021.

Webcast and Conference Call

The Company will host a conference call on Friday, February 25, 2022, at 9 a.m. Eastern Time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the conference ID 13726652.

A webcast will be available at: View Source;tp_key=59e1f9cc51