Dynavax Announces Proposed Private Offering of $200 Million of Convertible Senior Notes

On May 10, 2021 Dynavax Technologies Corporation ("Dynavax") (Nasdaq: DVAX) reported that it intends to offer, subject to market conditions and other factors, $200 million aggregate principal amount of convertible senior notes due 2026 (the "notes") in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Dynavax Technologies, MAY 10, 2021, View Source [SID1234579552]). Dynavax also intends to grant the initial purchasers of the notes an option to purchase up to an additional $30 million aggregate principal amount of notes.

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The notes will be general unsecured obligations of Dynavax and will accrue interest payable semiannually in arrears. The notes will be convertible by the holders thereof into cash, shares of Dynavax’s common stock or a combination of cash and shares of Dynavax’s common stock, at Dynavax’s election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.

Dynavax expects to use the net proceeds from the offering of the notes, together with cash on hand, to repay in full the outstanding debt and other obligations under Dynavax’s term loan agreement and to pay the costs of the capped call transactions described below.

If the initial purchasers exercise their option to purchase additional notes, Dynavax expects to use a portion of the net proceeds from the sale of such additional notes to enter into additional capped call transactions. Dynavax expects to use any remaining net proceeds from the sale of such additional notes for general corporate purposes. Dynavax’s management will have broad discretion in the application of the net proceeds from this offering and investors will be relying on the judgment of Dynavax’s management regarding the application of the proceeds.

In connection with the pricing of the notes, Dynavax expects to enter into capped call transactions with one or more of the initial purchasers and/or their respective affiliates or other financial institutions (the "option counterparties"). The capped call transactions will cover, subject to customary adjustments, the number of shares of Dynavax’s common stock that initially underlie the notes. The capped call transactions are expected to offset the potential dilution to Dynavax’s common stock as a result of any conversion of notes, with such offset subject to a cap.

In connection with establishing their initial hedges of the capped call transactions, Dynavax has been advised that the option counterparties and/or their respective affiliates expect to enter into various derivative transactions with respect to Dynavax’s common stock concurrently with or shortly after the pricing of the notes and/or purchase shares of Dynavax’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Dynavax’s common stock or the trading price of the notes at that time.

In addition, the option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Dynavax’s common stock and/or purchasing or selling Dynavax’s common stock or other securities of Dynavax in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 30 trading day period beginning on the 31st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Dynavax’s common stock or the notes, which could affect a noteholder’s ability to convert its notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that a noteholder will receive upon conversion of such notes.

Neither the notes, nor any shares of Dynavax’s common stock issuable upon conversion of the notes, have been registered under the Securities Act or any state securities laws, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Veracyte, Inc. Announces CEO Succession Plan

On May 10, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported its executive leadership succession plan, with industry veteran Marc Stapley to succeed Veracyte cofounder, Bonnie Anderson, as chief executive officer (Press release, Veracyte, MAY 10, 2021, View Source [SID1234579579]). Ms. Anderson will move into an active executive chairman role, serving as a trusted advisor to Mr. Stapley, for the next few years to ensure a smooth transition, and will continue to serve on the board. Mr. Stapley will also join Veracyte’s board. The CEO succession is effective June 1, 2021, with Mr. Stapley joining the board after Veracyte’s 2021 Annual Meeting of Stockholders on June 7, 2021.

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"Since Veracyte’s beginning, we have set out on an ambitious vision to become a global genomic diagnostics enterprise that leverages deep insights to transform care at every step of the patient’s journey, from early detection of cancer and other diseases, to diagnosis and treatment decisions," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Today, the pieces are in place to execute and further build upon that vision. Our broad menu of current and pipeline tests span the care continuum across a wide range of diseases. Further, with exclusive access to our best-in-class diagnostics platform, we are uniquely poised to bring our highly differentiated and clinically impactful tests to benefit patients globally.

"Now is the perfect time to implement Veracyte’s CEO succession plan," continued Ms. Anderson. "We are thrilled that Marc has agreed to join Veracyte as CEO and I am excited to work closely with him to achieve our vision and guide the company to achieve its full potential."

Ms. Anderson cofounded Veracyte in 2008 and served as the company’s president and CEO until 2016, when she was also appointed chairman of the board. She led Veracyte’s initial public offering in 2013, has spearheaded commercialization of its market-leading products and has overseen the company’s global expansion.

"Veracyte is uniquely positioned in the genomic testing market with its breadth and depth of offerings, centralized and distributed tests, significant global opportunity and highly talented team," said Mr. Stapley. "Bonnie and the Veracyte team have put in place the key strategic pieces upon which to build and execute on multiple avenues of growth. I look forward to bringing my industry experience to bear as we forge ahead with our global expansion plans and improve outcomes for patients worldwide."

Mr. Stapley will join Veracyte from his current role as the chairman and chief executive officer of Helix, Inc., a leading population genomics company. Under Mr. Stapley’s leadership, Helix has built one of the largest COVID-19 testing labs in the United States and has become a national leader in viral surveillance. Mr. Stapley was appointed CEO in April 2019 and has been a member of Helix’s board of directors since 2015, when the company was founded.

Prior to Helix, Mr. Stapley served in key executive leadership positions at Illumina, Inc., the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. While at Illumina, Mr. Stapley served as chief financial officer, chief administrative officer, and executive vice president over the course of seven years, where he led many functions including G&A, corporate strategy, business development, population genomics and government affairs.

Before joining Illumina, Mr. Stapley was senior vice president, finance at Pfizer Inc. and was responsible for global financial processes and systems, leading integration efforts for key acquisitions and providing oversight to the company’s largest technology investment program. Prior to that he served in a variety of senior finance roles at Alcatel-Lucent, Cadence Design Systems, Inc, and Coopers & Lybrand.

John Bishop, Veracyte’s lead independent director and former chairman and CEO of Cepheid, said, "On behalf of the entire board of directors at Veracyte, we welcome Marc to the company in the CEO role. His broad global leadership experience, proven track record of strategic execution and strong commercial expertise makes him well suited to lead the company forward, with Bonnie at his side. There is a lot of work ahead of us and we are delighted to have Marc’s leadership as we enter this next phase of Veracyte’s growth."

Conference Call and Webcast Details

In a separate press release issued today, Veracyte announced its financial results for the first quarter ended March 31, 2021.

The company will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss its first quarter 2021 financial results, as well as the succession plan. The conference call will be webcast live from the company’s website and will be available via the following link: View Source A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

Rubius Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

On May 10, 2021 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported first quarter 2021 financial results and provided a business update (Press release, Rubius Therapeutics, MAY 10, 2021, View Source [SID1234579599]).

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"We had a great start to the year by reporting initial positive data from our ongoing Phase 1/2 clinical trial of RTX-240 in patients with advanced solid tumors, which provided evidence of the broad potential of the RED PLATFORM across our entire pipeline of cancer and autoimmune programs," said Pablo J. Cagnoni, M.D., president and chief executive officer of Rubius Therapeutics. "With several expected clinical milestones from our pipeline, the coming year is poised to be an exciting one for patients, our employees and shareholders."

Enabled by the RED PLATFORM, Red Cell Therapeutics’ (RCTs) are expected to provide advantages over other therapies by potentially generating a broad anti-tumor response with limited side effects and a wide therapeutic window given the biodistribution of RCTs to the vasculature and spleen. Additionally, RCTs do not have the complex supply chain and administration logistics of other cell therapies, as RCTs are designed to be prepared in the pharmacy, administered in an outpatient setting and do not require lymphodepletion prior to administration.

First Quarter 2021 Highlights

RTX-240 Phase 1/2 Clinical Program for Advanced Solid Tumors
On March 15, 2021, the Company reported preliminary safety (n=16) and efficacy (n=15) findings based on RECIST v1.1., with a data cutoff of February 28, 2021. The key takeaways from the initial data were:

RTX-240 demonstrated favorable emerging safety results across dose levels:
There were no treatment-related Grade 3/4 adverse events and no dose-limiting toxicities. The most common treatment-related Grade 1/2 adverse events were fatigue, chills, nausea, decreased appetite and arthralgias. There was a single Grade 1 event of liver toxicity.
Single-agent activity was observed with two partial responses:
A confirmed partial response (PR) in a patient with metastatic anal cancer and an unconfirmed PR in a patient with metastatic uveal melanoma. Both patients’ disease had progressed on prior anti-PD-1 therapy.
Stable disease (SD) was observed in six patients, including four individual patients with stable disease for at least 12 weeks, (one each with non-small cell lung cancer, soft tissue sarcoma, pancreatic cancer and prostate cancer).
Pharmacodynamic effects observed included the activation and/or expansion of the key natural killer (NK) and/or T cells types in all patients (n=16).
Observed evidence of immune cell trafficking of activated NK and T cells into the tumor microenvironment in two solid tumor biopsies and one AML biopsy.
Dose optimization and enrollment continues in the RTX-240 Phase 1/2 advanced solid tumor study. The Company plans to present additional data from the study this year.

Phase 1 Arm in Ongoing Phase 1/2 RTX-240 Clinical Trial in Relapsed/Refractory Acute Myeloid Leukemia (AML)

RTX-240 is currently being evaluated as a single-agent in a Phase 1 arm of the ongoing Phase 1/2 clinical trial of RTX-240 in patients with relapsed/refractory AML.
As of May 10, 2021, Rubius is enrolling patients in the third and fourth dose cohorts, in accordance with the statistical design of the study, which allows enrollment of two dose cohorts simultaneously.
On March 15, 2021, the Company presented preliminary trafficking data from the first patient in the trial, indicating strong accumulation of activated, granzyme B-positive NK and T cells in the bone marrow, which is the site of disease in AML.
RTX-321 Artificial Antigen-Presenting Cell (aAPC) Development Program for Human Papillomavirus (HPV) 16-Positive Cancers

Dosing additional patients in the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers, including cervical, head and neck and anal cancer.
RTX-321 has a unique frozen drug substance formulation, enabling a potential truly off-the-shelf product with a shelf life of up to several years.
Following liquid reformulation, RTX-321 has an in-vial shelf life of approximately 52 days.
Presentations at Medical Conferences

Preliminary safety and efficacy data from RTX-240 Phase 1/2 Clinical Trial for advanced solid tumors was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting on April 10, 2021.
Anticipated 2021 Catalysts and Operational Objectives

Present additional clinical data from the RTX-240 solid tumor Phase 1 clinical trial;
Select specific solid tumor types that will be pursued in the Phase 2 expansion cohort of RTX-240;
Report initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in relapsed/refractory AML;
Initiate the Phase 1 clinical trial of RTX-240 in combination with anti-PD-1 therapy in advanced solid tumors in the second half of 2021;
Report initial Phase 1 clinical data from RTX-321 for the treatment of HPV 16-positive cancers by the first quarter of 2022; and
Submit an Investigational New Drug Application for RTX-224 by year-end.
About RTX-240
RTX-240, Rubius Therapeutics’ lead oncology program, is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native forms. RTX-240 is designed to broadly stimulate the immune system by activating and expanding both NK and memory T cells to generate a potent anti-tumor response.

About RTX-321
RTX-321, Rubius Therapeutics’ second oncology program, is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions.

First Quarter 2021 Financial Results
Net loss for the first quarter of 2021 was $42.3 million or $0.51 per common share, compared to $48.5 million or $0.60 per common share in the first quarter of 2020.

In the first quarter of 2021, Rubius invested $27.7 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, compared to $36.2 million in the first quarter of 2020. This year-over-year decrease was driven primarily by a $4.9 million reduction in program expenses consisting of a $6.7 million reduction in rare disease program costs, following the deprioritization of the Company’s rare disease pipeline in March 2020, partially offset by an increase in costs incurred for the Company’s cancer programs, including, RTX-240 and RTX-321. Additionally, platform development, early stage research and other unallocated expenses decreased by $3.6 million due principally to $2.5 million in reductions in contract R&D, laboratory supplies and research materials driven primarily by a shift in activities to support the oncology clinical programs. Personnel-related costs also decreased as a result of non-recurring costs incurred in the first quarter of 2020.

G&A expenses were $13.2 million during the first quarter of 2021, compared to $12.7 million for the first quarter of 2020. The higher costs were primarily driven by an increase in professional and consultant fees related to increased patent costs and an increase in facility-related and other expenses due to higher building operating costs.

During the first quarter of 2021, other income and expenses decreased by $1.8 million, from net income of $0.4 million in the first quarter of 2020, to net expense of $1.4 million. The change was due to a lower average cash balance, lower prevailing interest rates and an increase in outstanding debt following the final borrowing under the Company’s debt facility in June 2020.

Cash Position
As of March 31, 2021, cash, cash equivalents and investments were $330.7 million, compared to $176.3 million as of December 31, 2020. During the quarter, the Company received net proceeds, after deducting underwriting discounts and commission, of $188.0 million in connection with its underwritten public offering completed in March 2021.

Thermo Fisher Scientific to Present at the BofA Securities 2021 Healthcare Conference on May 12, 2021

On may 10, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Marc N. Casper, chairman, president and chief executive officer, will present virtually at the BofA Securities 2021 Health Care Conference on Wednesday, May 12, 2021 at 8:45 a.m. (EDT) (Press release, Thermo Fisher Scientific, MAY 10, 2021, View Source [SID1234579620]).

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You can access the webcast of the presentation via the Investors section of our website, www.thermofisher.com.

GP (HK)’s Blockbuster Product SIR-Spheres® Y-90 Resin Microspheres Completes the First Patient Administration

On May 9, 2021 Grand Pharmaceutical and Healthcare Holdings Limited reported that the core product SIR-Spheres Y-90 resin microspheres of Sirtex Medical Pty Ltd ("Sirtex"), an associate company of the Group, has been successfully completed the first patient administration recently, following the approval by the US Food and Drug Administration ("FDA") to conduct a clinical trial for hepatocellular carcinoma ("HCC") (Press release, Grand Pharmaceutical, MAY 9, 2021, View Source [SID1234653971]).

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Sticking to patients-centered and innovation-driven, the Group will continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy. The Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and anti-tumor platform integrating diagnostics and treatment. The Group adopts the strategy of "global expansion and dual-cycle operation", forming a new pattern of domestic and international cycles that synergize with each other.

The SIR-Spheres Y-90 resin microspheres clinical study, DOORwaY90, is being conducted in the United States to evaluate the safety and efficacy of SIR-Spheres Y-90 resin microspheres as a first-line treatment for patients with unresectable or inoperable HCC patients in order to obtain approval for the HCC indication in the United States. The study will be conducted at 15 oncology centers, led by MD Anderson Cancer Center, and will enroll 100 patients in an open-arm study. The primary clinical endpoints will be the overall response rate (ORR) and duration of response (DoR). DOORwaY90 will be the first U.S. registration trial to utilize and delineate personalized dosimetry treatment planning and to define actionable post-treatment dosimetric verification for endpoint assessment, further providing high-quality supporting data for the use of SIR-Spheres Y-90 resin microspheres in HCC patients to benefit more HCC patients.

SIR-Spheres Y-90 resin microspheres is a targeted internal radionuclide product for liver malignant tumors, applying the world’s leading interventional technology is used to inject SIR-Spheres Y-90 resin microspheres into the blood vessels of liver tumors and release high-energy beta radiation to kill tumor cells. In 2002, this product was approved by the U.S. FDA for the treatment of unresectable colorectal cancer liver metastases (mCRC) based on the pivotal research CRI9101 (n=74), and in the same year it was approved by the European Union for the treatment of unresectable advanced liver malignancies.

SIR-Spheres Y-90 resin microspheres have been given to over 100,000 people in over 50 countries and regions around the world. With its remarkable clinical efficacy, it is recommended for treatment of hepatic malignant tumors by many authoritative guidelines, including National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper). It is also covered by medical insurance in places such as the United States and Europe. In addition, it is included in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) and Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis (2018 edition) , delineating clear clinical demands.

The registration of SIR-Spheres Y-90 resin microspheres in China is progressing smoothly. In August 2020, the National Medical Products Administration of the PRC was approved to file the new drug application for the treatment of colorectal liver metastases based on clinical trial data obtained overseas. The new drug application was accepted in November, 2020.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, "The successful completion of the first patient administration of SIR-Spheres Y-90 resin microspheres is an important progress made by the Group in the field of tumor treatment, laying the foundation for benefiting more liver cancer patients worldwide in the future. Looking ahead, the Group will make full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization process for innovative products and provide cancer patients with more advanced and diverse treatment options in the world."