On March 31, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy reported that the company will be presenting two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 being held in New Orleans, Louisiana, from April 8-13 (Press release, Immunomic Therapeutics, MAR 31, 2022, View Source [SID1234611267]). The posters to be presented at AACR (Free AACR Whitepaper) are developed from the investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression) for two vaccines, ITI-3000 for Merkel cell carcinoma and Her2/Neu-LAMP DNA vaccine, both which fuse a tumor associated antigen with lysosomal associated membrane protein 1 (LAMP-1). This proprietary lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response.

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"Both ITI-3000 and Her2/Neu-LAMP DNA vaccines are innovative and novel targeted approaches," says Teri Heiland, Ph.D., Immunomic’s Chief Scientific Officer. "We are highly encouraged by the data and look forward to a first-in-human trial for ITI-3000, a vaccine for Merkel cell carcinoma, and further pre-clinical development for Her2/Neu-LAMP vaccine."

Poster Title: LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses, tumor inhibition, and provides rationale for first-in-human trial

Session Category: Immunology

Session Title: Immune Response to Therapies 1

Session Date and Time: Monday April 11, 2022, 1:30 PM – 5:00 PM ET

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37

Poster Number: 10

Poster Title: Harnessing soluble CD40L to enhance anti-tumor efficacy of Her2-LAMP DNA vaccine using UNITE platform

Session Category: Immunology

Session Title: Vaccines: Oncolytic and Prophylactic

Session Date and Time: Tuesday April 12, 2022, 1:30 PM – 5:00 PM ET

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 40

Poster Number: 3

Poster Availability: e-Posters will be on display in the AACR (Free AACR Whitepaper) Gallery

About UNITE

ITI’s investigational UNITE platform, UNiversal Intracellular Targeted Expression, leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and used to create immune responses in tumor types that otherwise do not provoke an immune response.

On March 31, 2022 VBL Therapeutics (Nasdaq: VBLT) (VBL), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that it will host a key opinion leader (KOL) luncheon and seminar on ovarian cancer on Monday, April 11, 2022 at 12pm Eastern Time at the St. Regis Hotel in New York, NY (Press release, VBL Therapeutics, MAR 31, 2022, View Source [SID1234611247]).

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The seminar will feature presentations and a panel discussion with KOL’s Bradley J. Monk, MD, FACS, FACOG, of the University of Arizona College of Medicine and Creighton University School of Medicine, Richard Penson, MBBS, of Massachusetts General Hospital (Mass General), and Kathleen Moore, MD, of OU College of Medicine, who will discuss the current treatment landscape and unmet medical need in treating patients with ovarian cancer. The live event will be hosted by Dror Harats, MD, chief executive officer of VBL Therapeutics. A live question and answer session will follow.

VBL’s lead product candidate, ofra-vec (ofranergene obadenovec; VB-111), will be discussed as a potential treatment solution for platinum resistant ovarian cancer. Ofra-vec utilizes VBL’s novel VTS platform and is being evaluated in VBL’s registration enabling OVAL Phase 3 clinical trial. Ofra-vec’s unique mechanism of action is designed to combine the blockade of tumor microvasculature (the blood vessels required for tumor growth) with an anti-tumor immune response. OVAL is now fully enrolled with 409 patients globally, and topline data on the progression free survival primary endpoint are expected in the second half of 2022.

To register for the event, please click here. If you would like to attend in person, please indicate so when registering, and you will receive an email confirming your attendance closer to the event. The event will be webcasted for those who are unable to attend in person.

Bradley J. Monk, MD, FACS, FACOG is currently a Professor of Gynecologic Oncology at the University of Arizona College of Medicine, Phoenix and a Professor of Obsterics & Gynecology at the Creighton University School of Medicine, Phoenix. He is board certified in both Obstetrics & Gynecology and Gynecologic Oncology and practices at Virginia G. Piper Cancer Center. He is the Fellow of the American College of Surgeons (ACS) and the American College of Obstetricians and Gynecologists (ACOG). Prof. Monk also serves as a Co-Director for the Gynecologic Oncology Group (GOG) Research Consortium. Among his many professional contributions, Prof. Monk was the first to report the activity of anti-vascular growth factor (VEGF) therapy in gynecologic cancers and his papers in the New England Journal of Medicine have let to the global approvals of anti-VEGF therapy, PARP inhibitors and immunotherapy in ovarian and cervical cancers. He has published more than 350 peer-review manuscripts, written more than 30 book chapters and led countless successful clinical trials.

Richard Penson, MBBS came to Mass General from St Bartholomew’s Hospital, London, in 1997, and is the Clinical Director of Medical Gynecologic Oncology at Mass General. His practice is devoted almost exclusively to gynecologic oncology with the majority of patients having ovarian cancer. Dr. Penson attends on the Bigelow General Medical Service at Mass General, sits on the national Gynecologic Oncology Group (NRG GOG) committees for ovarian cancer and quality of life research, and the National Comprehensive Cancer Network (NCCN) Ovarian Committee. Dr. Penson serves as the chairman for panels C and F of the Institutional Review Board of Dana-Farber/Mass General Brigham CancerCare.

Kathleen N. Moore, MD, is an Associate Professor in the Section of Gynecologic Oncology; the Jim and Christy Everest Endowed Chair in Cancer Research; and the Director of the Oklahoma TSET Phase I Program for the Stephenson Cancer Center at the University of Oklahoma College of Medicine. She attended medical school at the University of Washington School of Medicine and completed her residency in obstetrics and gynecology at the University Health Center of Pittsburgh. Dr Moore completed a fellowship in gynecologic oncology at the University of Oklahoma Health Sciences Center while simultaneously earning a master’s degree in epidemiology. She is board certified in obstetrics and gynecology as well as gynecologic oncology and hospice and palliative care. She serves as the Associate Director of Clinical Research and Medical Director of the Clinical Trials Office for the Stephenson Cancer Center. She has published over 200 peer-reviewed publications and serves on the editorial board for four academic publications. She has a clinical research interest in drug development and Phase 1 trials.

On March 31, 2022 Selvita S.A. – [ticker: WSE: SLV] – one of the largest preclinical contract research organizations in Europe, reported that continues its dynamic development in Poland and abroad (Press release, Selvita, MAR 31, 2022, View Source [SID1234611246]). Following the acquisition of Fidelta, Selvita Group has more than doubled its sales revenues in 2021, as compared to the year before.

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Dynamic growth in all business segments

Selvita Group continued its dynamic development in every segment of its business activity. Commercial revenues from services executed in Poland reached EUR 32.3 million and were 30% higher compared to 2020, when they amounted to EUR 25.5 million. In the fourth quarter of 2021 alone, these revenues increased by as much as 50% y/y, to the level of EUR 9.5 million. In 2021, Fidelta, representing the segment of services executed in Croatia, recorded EUR 27.8 million in commercial revenues with EBITDA of EUR 8.6 million (30.8% margin). In the fourth quarter of 2021 alone, the Company achieved EUR 7.8 million in sales revenues, and EBITDA of EUR 2.5 million with a margin of 31.6%. The bioinformatics segment (Ardigen, a subsidiary company) closed 2021 with EUR 6.9 million of commercial revenues, compared to EUR 4.0 million in 2020 (an increase of 77% y/y). EBITDA was at the level of EUR 2.1 million (27.5% margin) and was 91% higher than in 2020.

Selvita Group continued its development on the key geographic markets. In 2021, revenues from the United States, the largest global market for CROs, increased by over 95% and amounted to EUR 18.9 million. The Group recorded also significant sales revenues from the clients in the United Kingdom, amounting in 2021 to EUR 8.3 million, as compared to EUR 3.1 million a year earlier, which indicates an increase of 171% y/y.

– The past year was a breakthrough one for us. Joining forces with Fidelta and continued dynamic organic growth allowed us to more than double our revenues while maintaining high profitability. Considering this, and the equally strong year 2020, we managed to implement the development strategy planned for four years, in just two. Along with such a dynamic development and a significant increase in the scale of operations, we are invariably able to generate high margins, and we enter the new year with a contract portfolio of over EUR 48 million that will ensure our further development in all segments.

We are not planning to slow down which is why we have already set ourselves new ambitious goals for the coming years – comments Bogusław Sieczkowski, co-founder, significant shareholder and Chief Executive Officer at Selvita.

Development Strategy for 2022-2025

The former Group’s development strategy, announced in April 2020, aimed at an increase in sales revenues up to app. EUR 70million, an increase in the scale of operations through acquisitions as well as over EUR 230 million in market capitalization. Since Selvita Group had achieved these goals by the end of 2021, the Company’s Management Board decided to present a new strategy for 2022-2025.

During the aforementioned period, Selvita Group plans to triple its sales revenues (up to EUR 200 million), while maintaining high profitability. The Group will work to implement its strategy through organic growth and acquisitions. Execution of the planned investments will allow Selvita to become the leading global preclinical CRO.

Selvita Group Development Strategy for 2022-2025 is based on three key principles:

Comprehensive services offer in the field of drug discovery and development – supplementing the drug discovery offer and building the drug development segment
Focusing on high-value services for the clients – specialization in selected therapeutic areas and development of unique competences
Development of the Group’s operations in the largest markets in the United States and United Kingdom – growing teams and potentially establishing new research locations

In the area of acquisitions, in 2020-2025, Selvita plans to acquire at least two preclinical CROs in Europe or North America providing services complementary to the Company’s offer or enabling expansion of the scale of its operations. The Company will allocate a total of EUR 110 million for this purpose, from the cash generated and the debt raised.

One of the basic assumptions of the new strategy is a consistent expansion of the services portfolio in the field of drug discovery and development, which will allow us to offer our clients support at every stage of the drug development process, from the early stage of discovery to the selection of a clinical candidate. Selvita also plans to develop further competences in selected therapeutic areas, attractive from a clients’ perspective, in order to strengthen its competitive advantage on the global CRO market. Moreover, the Company plans to continue development in the area of ​​drug development and contract testing studies.

In order to efficiently implement the assumptions of the new business development strategy, from March 31, 2022, Fidelta will fully migrate under Selvita brand. This will allow Selvita not only to benefit from the decades-long history of drug discovery experience held by the Croatian team, but also will facilitate communication with customers and strengthen business development activities.

As far as our further business development is considered, we are planning to continue strengthening our presence and position on the largest global markets, i.e. the U.S. and U.K. markets. For this purpose, we intend to hire new specialists in order to strengthen the local teams – comments Milosz Gruca, Ph.D., Chief Commercial Officer and Executive Vicepresident at Selvita.

The planned development of the Group will be supported by significant investments in the infrastructure. Selvita has already made the first step in this direction, commencing in 2021, the construction of its own research center. By 2025, the Company plans to complete the second stage of this investment, i.e. to build another laboratory building. To secure the possibility of further organic growth after 2025, Selvita acquired an additional, adjacent building plot in early March this year. In addition to investing in its own laboratories in Krakow, the Company plans to simultaneously increase the research space leased in Zagreb and Poznan.

Financing of the new Development Strategy

Selvita Group plans to allocate a total sum of approximately EUR 210 million for the implementation of the development strategy. The Group plans to spend EUR 40m on financing organic growth, another EUR 60m on laboratory infrastructure expansion and EUR 110m on acquisitions.

– We are a company with a stable and very good profitability, which, given the low level of debt we currently have, will allow us to finance the entirety of the planned investments. We consider the possible acquisition of additional capital as something extraordinary that could happen only in the event of financing major acquisitions – adds Sieczkowski.

– From the very beginning of Selvita, our aim was to build a strong brand with a solid position on the market. Years of effort and the commitment of the entire team are bringing us closer to our goal which is to become a large, global player. Organic growth will continue to be the major factor driving our growth, and to make it possible we will be investing in infrastructure expansion and strengthening our scientific team. Moreover, in the coming years, we intend to continue our development through acquisitions. The recent acquisition of Fidelta has shown us clearly what a great impact a well-selected partner can make on both the scale of operations and the scope of competences.

We firmly believe that thanks to the accomplishment of the goals of our development strategy, Selvita will become a leading global preclinical CRO company – sums up Boguslaw Sieczkowski.

*excluding the impact of the non-cash incentive program

On March 31, 2022 Sanofi reported that successfully priced yesterday, March 30, 2022, its offering of a dual-tranche EUR 1.5 billion of notes (the "Notes") (Press release, Sanofi, MAR 31, 2022, View Source [SID1234611245]). It comprises an inaugural issue of sustainability-linked bond for a nominal amount of EUR 650 million of notes, tied to Sanofi’s commitment to improve access to essential medicines in low- and lower-middle-income countries via its global health nonprofit unit. This transaction demonstrates Sanofi’s commitment to society, to ensure access to healthcare for the world’s vulnerable people.

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Jean-Baptiste de Chatillon
Chief Financial Officer of Sanofi
"A year after pioneering sustainable finance with our sustainability-linked revolving credit facilities, we further contribute to the development of the sustainable finance market through the successful pricing of our first sustainability-linked bond" said Jean-Baptiste de Chatillon, Chief Financial Officer of Sanofi. "We continue to make progress in our environmental, social and governance activities that are an essential part of our strategy and embedded into our business."

The Notes consist of two tranches:

€850 million fixed rate notes, due April 2025, bearing interest at an annual rate of 0.875%.
€650 million fixed rate notes, due April 2029, bearing interest at an annual rate of 1.250%. The coupon amounts are linked to the achievement of a sustainability performance target defined as the cumulative number of patients, being at least 1.5 million patients, provided with essential medicines by the global health unit, for the treatment of non-communicable diseases in 40 of the world’s poorest countries, between 2022 and 2026.
Sandrine Bouttier-Stref
Global Head of Corporate Social Responsibility of Sanofi
"Linking the cost of financing to the achievement of concrete targets in terms of access to medicines confirms our determination to put social responsibility at the center of our ambitions."

Sanofi’s expanded social impact strategy aims to build a healthier, more resilient world by ensuring access to healthcare for the world’s poorest people and bringing a much needed focus to the development of treatment for childhood cancer. Integrated into the company’s Play to Win business strategy, Sanofi’s commitment to society will continue the fight against infectious diseases such as sleeping sickness and poliomyelitis, while accelerating its goals to reduce the environmental impact of its products and its worldwide operations. Key to tackling the global challenges that face society are its people, who each have a role to play in building a diverse and inclusive workplace.

To become an issuer of sustainable finance instruments, Sanofi has established a dedicated Sustainability-Linked Bond Framework, designed as a living document to enable future bond issues in a sustainability-linked format.
The Sustainability-Linked Bond Framework is aligned with ICMA’s Sustainability-Linked Bond Principles (2020) and has received a Second Party Opinion from ISS ESG.

The proceeds of the bond issue will be used for general corporate purposes.

The transaction has been led by Morgan Stanley and Natixis CIB as Global Coordinators & Sustainability-Linked Structuring Advisors and, Barclays, MUFG and RBC Capital Markets, all as Joint Active Bookrunners.

On March 31, 2022 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the fiscal year ended December 31, 2021 and provided a business update on recent corporate and clinical developments (Press release, Protalix, MAR 31, 2022, View Source [SID1234611244]).

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"2021 was a year of continued progress towards our key operational, clinical and regulatory goals," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We had a productive Type A meeting with the FDA in the fall during which the FDA, in principle, agreed that the data package proposed to the FDA for the anticipated BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. We also, together with Chiesi, submitted an MAA to the EMA, which was subsequently validated by the EMA. The submission followed an October 2021 meeting with the EMA’s Rapporteur and Co-Rapporteur at which we and Chiesi discussed the scope of the anticipated submission, and the Rapporteur and Co-Rapporteur were generally supportive of a planned MAA submission."

"We are grateful to all of our key stakeholders for their dedication towards our mission of delivering new medicines to patients with high clinical unmet needs. 2022 has the potential to be a meaningful year for the company as we move towards our BLA resubmission in the United States, await feedback on our MAA submission in Europe and continue to advance our early stage pipeline. We look forward to updating you on our progress as the year moves on."

2021 Full-Year and Recent Business Highlights

Regulatory Advancements

●On February 24, 2022, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A, or Chiesi, announced the submission and subsequent validation of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for PRX-102, the Company’s product candidate, for the treatment of adults with Fabry disease. The MAA included final data from the Company’s phase III BRIDGE and BRIGHT clinical trials; 12-month interim data from the Company’s phase III BALANCE clinical trial; and final data from the Company’s phase I/II clinical trial data from naïve/untreated patients, including the extension study related thereto, using 1 mg/kg every other week dosing.
●On October 11, 2021, the Company, together with Chiesi, completed a Type A (End of Review) meeting with the U.S. Food and Drug Administration (FDA) regarding the biologics license application (BLA) for PRX-102 for the treatment of adult patients with Fabry disease, following the complete response letter received on April 27, 2021
from the FDA. The Company gained clarity regarding the FDA’s expectations and the FDA, in principle, agreed that the data package proposed to the FDA for the anticipated BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. A BLA resubmission is planned for the second half of 2022.
Clinical Advancements

●On March 18, 2022, the Company, together with Chiesi, announced positive final results from the phase III BRIGHT clinical trial, a multicenter, multinational open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of treatment with 2 mg/kg of PRX-102 administered every four weeks for 52 weeks (a total of 14 infusions) in adult patients previously treated with a commercially available enzyme replacement therapy (ERT) (Fabrazyme or Replagal). Results of the BRIGHT study indicate that 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks was well tolerated, and Fabry disease assessed by eGFR slope and plasma lyso-Gb3 was stable throughout PRX-102 treatment in adult Fabry patients.
●On October 15, 2021, the Company, together with Chiesi, announced the last patient from the phase III BALANCE clinical trial received the final dose in the study. The Company anticipates announcing top-line results from the study next week and final data in the second half of 2022.
● On June 2, 2021, the Company together Chiesi, announced topline results from an interim analysis of the phase III BALANCE clinical trial. The initial top-line results show that the lower boundary of the confidence interval for the mean difference between the two treatments (PRX-102 and Fabrazyme) was below the non-inferiority margin pre-specified for this interim analysis in the ITT analysis set and above such limit in the PP analysis set. At the time of this analysis, two patients had discontinued participation due to treatment emergent adverse events (TEAEs). Of these two patients, one discontinued participation due to a related adverse event. There were no deaths. Overall, safety data appears favorable and consistent with what was observed in previous clinical studies with PRX-102.
Corporate & Financial Developments

●On August 25, 2021, the Company strengthened its balance sheet through exchanges of a substantial majority of its then outstanding 7.50% Senior Secured Convertible Notes due 2021 for a combination of cash and new notes. The Company issued new 7.50% Senior Secured Convertible Notes due 2024 with a $28.75 million aggregate principal amount, and made principal and interest payments of approximately $27.00 million. The remaining 2021 Notes were repaid on the November 2021 maturity date.
●On July 2, 2021, the Company entered into a Sales Agreement with H.C. Wainwright & Co., LLC, as sales agent, or the Agent, pursuant to which the Company may sell from time to time up to $20.0 million worth of shares of its common stock in at-the-market transactions through the Agent. Upon execution of the Sales Agreement, the Company terminated the then existing ATM Equity OfferingSM Sales Agreement entered into on October 1, 2020 with BofA Securities.
●On May 13, 2021, the Company and Chiesi entered into a binding term sheet pursuant to which they amended the two exclusive license and supply agreements for PRX-102 in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million milestone payment to the Company in exchange for a $25.0 million reduction in a longer-term regulatory milestone payments in the Ex-US Exclusive License and Supply Agreement. All other regulatory and commercial milestone payments remained unchanged. The Company and Chiesi also agreed to negotiate certain manufacturing related matters. The Company received the payment in June 2021.
●On February 17, 2021, the Company successfully completed a public offering of its common stock raising gross proceeds of approximately $40.2 million at a price equal to $4.60 per share, before deducting the underwriting discount and estimated expenses of the offering, which was led by BofA Securities and Oppenheimer & Co.
Financial Results

For the year ended December 31, 2021, compared to the year ended December 31, 2020

●The Company recorded revenues from selling goods of $16.7 million for the year ended December 31, 2021, an increase of $0.5 million, or 3%, compared to revenues of $16.2 million for the same period of 2020.
●Revenue from licenses and R&D services for the year ended December 31, 2021 were $21.6 million, a decrease of $25.1 million, or 54%, compared to $46.7 million for the year ended December 31, 2020. Revenue from license agreements is recognized, mainly, in conjunction with the license and supply agreements with Chiesi. The decrease is primarily due to lower R&D costs related to PRX-102 incurred in the year ended December 31, 2021.
●Cost of goods sold for the year ended December 31, 2021 was $16.3 million, an increase of $5.4 million, or 50%, compared to cost of goods sold of $10.9 million for the same period in 2020. The increase was primarily the result of certain one-time manufacturing costs incurred while preparing for the then anticipated FDA approval of the PRX-102 BLA and higher manufacturing costs.
●Research and development expenses, net, for the year ended December 31, 2021 were $29.7 million, a decrease of $8.5 million, or 22%, compared to $38.2 million for the same period of 2020. The decrease is primarily due to the completion of the three phase III clinical trials of PRX-102.
●Selling, general and administrative expenses were $12.7 million for the year ended December 31, 2021, an increase of $1.6 million, or 14% from $11.1 million for the year ended December 31, 2020. The increase resulted primarily from an increase in corporate costs of $1.7 million related mainly to insurance.
●Financial expenses, net, were $7.1 million for the year ended December 31, 2021, a decrease of $2.1 million, or 23%, compared to financial expenses of $9.2 million for the year ended December 31, 2020. The decrease resulted primary from the exchange of our 2021 notes; a $0.7 million decrease in interest expenses; a $0.8 million
decrease in amortization of debt discount; and a $1.3 million decrease in related expenses, offset by a $0.8 million loss on extinguishment related to the Exchanges.
●Cash, cash equivalents and short-term bank deposits were approximately $39.0 million at December 31, 2021.
●Net loss for the year ended December 31, 2021 was approximately $27.6 million, or $0.62 per share, basic and diluted, compared to a net loss of $6.5 million, or $0.22 per share, basic and diluted, for the year ended December 31, 2020.
Conference Call and Webcast Information

The Company will host a conference call today, March 31, 2022, at 8:30 a.m. Eastern Daylight Savings Time, to review the corporate, clinical and regulatory developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.