On May 10, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, reported financial results for the quarter ended March 31, 2021 (Press release, BioNTech, MAY 10, 2021, View Source [SID1234579546]).

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"BioNTech has continued to execute the delivery of our COVID-19 vaccine globally to more than 90 countries and territories. Through our continued innovation, we are expanding access to new populations and geographies, and addressing emerging variants," said Ugur Sahin, BioNTech’s Co-founder and CEO. "We are moving into later stage testing for three of our oncology programs in the near future and plan to launch multiple new products over the next five years. Looking ahead, we will further optimize our technologies and expand our pipeline into additional therapeutic indications, as we meet our ambition to become a global, fully-integrated immunotherapy company."

First quarter 2021 and subsequent updates

Infectious disease

COVID-19 vaccine program – BNT162b2

In March 2021, BioNTech announced its Full Year 2020 Financial Results and Corporate Update as a part of the Annual Report filed on Form 20-F, highlighting developments relating to its COVID-19 vaccine program between January 1 and March 30, 2021 (Link to press release). A summary of these developments as well as full details of subsequent developments that occurred after March 30, 2021 is provided below.

As of May 6, 2021 BioNTech and Pfizer have shipped approximately 450 million doses of BNT162b2 to 91 countries and territories around the world.

To date, the companies have signed orders of approximately 1.8 billion doses for delivery in 2021, and they have also signed the first contracts for 2022 and beyond. Further discussions for additional dose commitments are ongoing for 2021 and beyond. BioNTech expects BNT162b2 annual manufacturing capacity to reach 3 billion doses by the end of 2021, and expects to have capacity to manufacture more than 3 billion doses in 2022.

Multiple clinical trials are ongoing to expand the authorization of BNT162b2 to additional population groups, such as children from 6 months to 11 years of age, and to collect further data in healthy pregnant women.

To date, there is no evidence that an adaptation of BioNTech’s current COVID-19 vaccine against key identified emerging variants is necessary. Despite this, BioNTech has developed a comprehensive strategy to address these variants should the need arise in the future. As part of BioNTech’s strategy to contend with the variant challenge, BioNTech submitted to the U.S. Food and Drug Administration (FDA), and the FDA has approved an additional amendment to the study protocol of the global Phase 1/2/3 trial which includes: (1) an assessment of the impact of a third dose of BNT162b2 in prolonging immunity against COVID-19 and in protecting against COVID-19 caused by potential newly emerging SARS-CoV-2 variants, and (2) an assessment of a modified, variant-specific version of BNT162b2. The aim of this study is to explore the regulatory pathway that BioNTech and Pfizer would pursue if SARS-CoV-2 were to change enough to require an updated vaccine. This trial started in March 2021.

In the first quarter of 2021, BioNTech also advanced its work to broaden access through improvements to its cold chain distribution systems and processes. Both the FDA and the European Medicines Agency (EMA) have approved the transportation and storage of undiluted frozen vials of BNT162b2 at temperatures (-20°C) commonly found in pharmaceutical freezers for a period of up to two weeks. Further stability data have been assessed and formulation optimization activities are ongoing, including a study to evaluate a lyophilized (or freeze-dried) and a ready-to-use formulation of BNT162b2.

BNT162b2 clinical development updates

On March 31, 2021, BioNTech and Pfizer announced that BNT162b2 demonstrated 100% efficacy and robust antibody responses in a Phase 3 trial in adolescents aged 12 to 15 with or without prior evidence of SARS-CoV-2 infection. The trial enrolled 2,260 adolescents in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT162b2 elicited high SARS-CoV-2 neutralizing antibody titers, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. BNT162b2 administration was generally well tolerated.
On March 31, 2021, BioNTech and Pfizer began evaluating the administration of a single booster dose five to seven months after receiving the second dose of BNT162b2. To demonstrate duration of protection, and protection against the emerging variants of concern, an additional dose of BNT162b2 or of BNT162b2SA (encoding for the spike protein of the variant B.1.351) is being given to about 600 Phase 3 participants. About 30 participants that received BNT162b2SA will be given another dose of BNT162b2SA. A new cohort of approximately 300 participants will be enrolled who are COVID-19 vaccine-naïve (i.e., including BNT162b2-naïve) and have not been infected with COVID-19. They will receive BNT162b2SA given as a two-dose series, separated by 21 days. The objective of this Phase 1/2/3 protocol amendment is to describe the safety and tolerability profile of BNT162b2SA, to evaluate its non-inferiority compared to BNT162b2, and to analyze the immune response generated by BNT162b2SA. By evaluating BNT162b2SA as a prototype vaccine, the companies aim to inform the development of an efficient regulatory pathway for testing future modified mRNA vaccines, using the current pathways for flu vaccines as models (blueprint study).
On April 1, 2021, BioNTech and Pfizer announced updated topline results confirming high efficacy and no serious safety concerns through up to six months following the second dose. Topline efficacy was based on an analysis of 927 confirmed symptomatic cases of COVID-19 observed in the pivotal Phase 3 study through March 13, 2021. BNT162b2 was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose. The vaccine was also 100% effective against severe disease, as that term is defined by the U.S. Centers for Disease Control and Prevention, and 95.3% effective against severe COVID-19 as that term is defined by the FDA. Safety data collected from more than 12,000 vaccinated participants who had a follow-up time of at least six months after the second dose demonstrated a favorable safety and tolerability profile.
In an additional exploratory analysis of 800 trial participants enrolled in South Africa, where the B.1.351 lineage is prevalent, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100%. Of these cases, eight were of the B.1.351 lineage, confirming efficacy against B.1.351 virus. These data support previous results from immunogenicity studies demonstrating that BNT162b2 induced a robust neutralizing antibody response to the B1.351 variant, and although lower than to the wild-type strain, it does not appear to affect the observed high efficacy against COVID-19 caused by this variant, as published in the New England Journal of Medicine.2

On April 1, 2021, BioNTech and Pfizer started a Phase 3, randomized, observer-blind study to evaluate the safety, tolerability, and immunogenicity of multiple formulations of BNT162b2, administered on a two-dose (separated by 21 days) schedule in adults aged 18 to 55. Part 1 of the study is comparing the safety and tolerability of lyophilized (or freeze-dried) BNT162b2 to the current frozen-liquid formulation of BNT162b2 and is evaluating non-inferiority of the immune response. Part 2 of the study will evaluate the safety and immunogenicity of a ready-to-use formulation of BNT162b2, and will be initiated in May 2021. The study, which is being conducted in the United States, will enroll approximately 610 participants. BioNTech and Pfizer expect to obtain results from both study parts in the third quarter of 2021.
Regulatory updates

On April 9, 2021, BioNTech and Pfizer requested amendments to the U.S. Emergency Use Authorization to expand the use of BNT162b2 to adolescents aged 12 to 15.
On April 30, 2021, BioNTech and Pfizer submitted to the EMA a variation to the European Conditional Marketing Authorization (CMA) for COMIRNATY to request an extension of the indication for use in adolescents 12 to 15 years of age. If the EMA approves the variation, the amended CMA will be valid in all 27 member states of the European Union.
On April 30 and May 4, 2021, BioNTech and Pfizer submitted new stability data of BNT162b2 to the FDA and EMA in order to update the product’s label to extend the storage at standard refrigerator temperatures of 2°C to 8°C to four weeks.
On May 5, 2021, BioNTech and Pfizer Canada announced that Health Canada has expanded the Interim Order authorization for BNT162b2 to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group.
On May 7, 2021, BioNTech and Pfizer announced the initiation of a Biologics License Application (BLA) with the FDA for approval of BNT162b2 to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
Commercial updates

On April 19, 2021, BioNTech and Pfizer announced an agreement with the European Commission (EC) to supply an additional 100 million doses of its COVID-19 vaccine, as a result of the EC’s decision to exercise its option. The total number of doses to be delivered to the European Union by the end of 2021 is now 600 million.
In April 2021, Pfizer and BioNTech entered into an agreement with Israel to supply several million doses in 2022, with an option to purchase additional doses. The companies also entered into an agreement with Canada to supply up to 125 million doses in 2022 and 2023, with options to purchase up to 60 million additional doses in 2024. Discussions for additional dose commitments with governments and territories worldwide are also ongoing for 2021 and beyond.
On May 6, 2021, BioNTech and Pfizer announced that they have signed a Memorandum of Understanding with the International Olympic Committee to donate doses of COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to take place in July 2021.
On May 7, 2021, the EC announced that BioNTech and Pfizer plan to supply the EC with 900 million doses of COMIRNATY, the Companies’ COVID-19 vaccine, to the 27 European Union (EU) member states beginning December 2021 through 2023, with an option for the EC to request up to an additional 900 million doses. This contract is expected to close upon final confirmation by the EC.
Manufacturing updates

BioNTech expects capacity to reach up to 3 billion doses by end of 2021, and expects to have capacity to manufacture more than 3 billion doses in 2022.
In March 2021, the EMA approved the manufacturing of BioNTech’s COVID-19 vaccine drug product at its facility in Marburg, Germany. This manufacturing facility is one of the largest mRNA vaccine manufacturing sites worldwide with an annual production capacity of up to one billion doses of COVID-19 vaccine, once fully operational. The first batches of vaccines manufactured at the Marburg facility were delivered in mid-April.
BioNTech plans to deliver up to 250 million doses of BNT162b2 in the first half of 2021.
Oncology

BioNTech is accelerating the development of a broad oncology pipeline, which has now advanced 14 product candidates in 15 ongoing trials. In April 2021 the Company started a first-in-human Phase 1 trial for the T cell therapy, targeting personalized neoantigens, named BNT221. Additional important milestones in the advancement of BioNTech’s immuno-oncology pipeline in the first quarter of 2021 included the initiation of first-in-human trials for CARVac (BNT211) and RiboCytokines (BNT151). BioNTech also expects to further advance its oncology pipeline in 2021 with up to three additional programs expected to move into randomized Phase 2 trials. Additionally, three preclinical programs are expected to move into Phase 1 trials in the second half of 2021.

During the remainder of 2021, BioNTech expects at least four data updates from its ongoing clinical trials.

mRNA programs

FixVac

BNT111 – In collaboration with Regeneron, a randomized Phase 2 trial for the treatment of patients with advanced melanoma progressing during or after prior therapy with a PD-1 inhibitor, utilizing a combination of BNT111 and Regeneron and Sanofi’s Libtayo (cemiplimab) is planned to start in the first half of 2021.
BNT113 – A Phase 2 trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma (HNSCC) expressing PD-L1, is planned to start in the first half of 2021 in the United States and the European Union. BNT113 has not been combined with anti-PD1 before and the Phase 2 trial will start with a run in portion designed to demonstrate the safety of the combination of BNT113 and pembrolizumab. These data are required to address the partial clinical hold on the subsequent randomized part of the Phase 2 trial.
Individualized neoantigen specific immunotherapy (iNeST)

BNT122 (Autogene Cevumeran) – BioNTech’s iNeST product candidate is partnered with Genentech.
For the adjuvant treatment of colorectal cancer, first patient dosing in a randomized Phase 2 trial in circulating tumor DNA positive, surgically resected Stage 2 (high risk)/Stage 3 colorectal cancer is now planned in the second half of 2021.

RiboCytokines

BNT151 – A Phase 1/2a dose escalation trial evaluating BNT151 with expansion cohorts in multiple solid tumor indications is ongoing.
BNT152+153 – BioNTech plans to start a Phase 1 trial for BNT152 (encoding IL-7) plus BNT153 (encoding IL-2) in multiple solid tumors in the first half of 2021.
RiboMabs

BNT141 – In February 2021, the FDA approved the IND for a Phase 1 first-in-human clinical trial for BNT141. BioNTech plans to start the trial in the second half of 2021.
BNT142 – BioNTech plans to start a Phase 1 clinical trial for BNT142 in the second half of 2021.
Antibodies

Next-generation checkpoint immunomodulators

BNT311 and BNT312 are partnered with Genmab.

BNT311/GEN1046 – A Phase 1/2a dose escalation trial with multiple expansion cohorts in patients with malignant solid tumors is ongoing. A data update for the trial is planned in the second half of 2021.
BNT312/GEN1042 – A Phase 1/2a dose escalation trial with expansion cohorts in patients with solid tumors is ongoing. The first data disclosure for the trial is planned in the second half of 2021.
Cell therapies

CAR-T cell immunotherapy

BNT211 – A first-in-human Phase 1/2a open-label, multi-center dose escalation and dose expansion basket trial of BNT211 with Claudin-6 CAR-T cells as monotherapy, or in combination of Claudin-6 CAR-T cells with Claudin-6 CARVac, is ongoing. The trial is enrolling patients with CLDN6-positive relapsed or refractory advanced solid tumors including ovarian, testicular, lung, gastric and endometrial cancers. The combination of CLDN6 CAR-T cell immunotherapy and CARVac is expected to improve expansion and persistence of CLDN6 CAR-T.
BioNTech plans to present early data from the ongoing BNT211 Phase 1/2a trial on three patients treated with a starting dose of CLDN6 CAR-T cells at the upcoming 18th Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) Annual Meeting 2021. In these heavily pretreated patients with solid tumors, neither acute nor dose-limiting toxicities were observed and all adverse events were transient and mild to moderate. Robust CAR-T cell engraftment could be detected in all three patients, as well as early signs of clinical activity. Following completion of the first dose level with CAR-T cell monotherapy, the trial is now progressing to the next dose level and a combination treatment involving CAR-T cells with an RNA vaccine, which BioNTech refers to as CARVac. A data update is planned in the second half of 2021.

Neoantigen-targeting T cell therapy

BNT221 – In April 2021, the first patient was dosed in a first-in-human Phase 1 dose escalation trial for the treatment of metastatic melanoma in patients who are refractory or unresponsive to checkpoint inhibitors. Part 1 consists of the monotherapy dose escalation of BNT221. In part 2, BNT221 will be added to anti-PD1 after first-line therapy. The primary objectives of the trial are to evaluate the safety and feasibility of administering BNT221, in addition to an evaluation of immunogenicity and clinical efficacy.
BNT221 (NEO-PTC-01) is a personal neoantigen-targeted T cell therapy candidate derived from patients’ peripheral blood cells. The product candidate consists of multiple CD8+ and CD4+ T cell populations targeting multiple selected neoantigens unique to each patient’s tumor. The proprietary stimulation process allows for the induction of T cells from the naïve as well as expansion of T cells from the memory compartment.

Small molecule immunomodulators

Toll-like receptor binding agonist

BNT411 – A Phase 1/2a dose-escalation trial of BNT411 as a monotherapy in patients with solid tumors, and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC) is ongoing. A data update from this trial is planned in the second half of 2021.
Corporate development

On May 9, 2021, BioNTech agreed the heads of terms with Fosun Pharma to establish a 50/50 Joint Venture (JV) to manufacture the COVID-19 vaccine in Mainland China. The establishment of a JV will be conditional on BioNTech receiving approval for its COVID-19 vaccine in Mainland China and agreement with Fosun Pharma on a definitive JV agreement, in addition to other conditions. As part of its global supply strategy, BioNTech believes that establishing local manufacturing capacity for the COVID-19 vaccine could substantially increase the Company’s ability to supply vaccines to China upon approval.
On May 10, 2021, BioNTech announced plans to expand its global footprint to Asia with the establishment of its first regional headquarters for south east Asia in Singapore. In addition to selecting Singapore as its future regional headquarters, BioNTech plans to establish a fully integrated mRNA manufacturing facility in Singapore with support from the Singaporean Economic Development Board (EDB). The new facility will leverage cutting-edge manufacturing and digital infrastructure and will be equipped to produce a range of novel mRNA vaccines and therapeutics. The envisioned site will bring highly automated and end-to-end mRNA production capabilities. The facility, with an estimated annual capacity of several hundred million doses, will provide regional and global supply capacity, as well as a rapid response capability for south east Asia to address potential pandemic threats. BioNTech plans to open its Singapore office and initiate construction of the manufacturing facility in 2021, subject to planning approval, and anticipates the site could be operational as early as 2023.
First quarter 2021 financial results (unaudited)

Revenues: Total revenues were estimated to be €2,048.4 million1 for the three months ended March 31, 2021, compared to €27.7 million for the three months ended March 31, 2020. The increase was mainly due to rapidly increasing the supply of COVID-19 vaccine worldwide. Under the collaboration agreements, territories have been allocated between BioNTech, Pfizer and Fosun Pharma based on marketing and distribution rights. BioNTech’s commercial revenues include an estimated amount of €1,751.9 million1 comprising BioNTech’s share of gross profit from COVID-19 vaccine sales in Pfizer’s territories, which represents a net figure, as well as sales milestones. In addition, €63.9 million sales to BioNTech’s collaboration partners of products manufactured by BioNTech and €199.8 million direct COVID-19 vaccine sales to customers in BioNTech’s territory have been recognized.

Cost of Sales: Cost of sales were estimated to be €233.1 million1 for the three months ended March 31, 2021, compared to €5.9 million for the three months ended March 31, 2020. Estimated cost of sales of €223.2 million1 were recognized with respect to BioNTech’s COVID-19 vaccine sales and include Pfizer’s share of gross profits earned by BioNTech.

Research and Development Expenses: Research and development expenses were €216.2 million for the three months ended March 31, 2021, compared to €65.1 million for the three months ended March 31, 2020. The increase was mainly due to an increase in research and development expenses for BioNTech’s BNT162 program, recorded as purchased services with respect to those expenses, which were initially incurred by Pfizer and subsequently charged to BioNTech under the collaboration agreement. The increase was further driven by an increase in wages, benefits and social security expenses from increasing headcounts and recognizing expenses incurred under the new share-based-payment arrangements.

General and Administrative Expenses: General and administrative expenses were €38.9 million for the three months ended March 31, 2021, compared to €15.8 million for the three months ended March 31, 2020. The increase was mainly due to higher expenses for professional services, an increase in wages, benefits and social security expenses from increasing headcounts and recognizing expenses incurred under the new share-based-payment arrangements as well as higher insurance premiums.

Income Taxes: Interim income taxes were €514.2 million for the first quarter of 2021 and were recognized using the estimated annual effective income tax rate of approximately 31%.

Net Profit / (Loss): Net profit was €1,128.1 million for the three months ended March 31, 2021, compared to €53.4 million net loss for the three months ended March 31, 2020.

Cash Position: Cash and cash equivalents as of March 31, 2021 were €891.5 million.

Shares Outstanding: Shares outstanding as of March 31, 2021 were 241,521,065.

Update on current signed COVID-19 vaccine order book:

Estimated COVID-19 vaccine revenues to BioNTech upon delivery of currently signed supply contracts of ~1.8 billion doses is ~€12.4 billion.

This revenue estimate reflects:

Expected revenues from direct COVID-19 vaccine sales to customers in BioNTech’s territory
Expected revenues from sales to collaboration partners of products manufactured by BioNTech
Expected sales milestone payments from collaboration partners
Expected revenues related to share of gross profit from COVID-19 vaccine sales in the collaboration partners’ territories

Additional revenues related to further supply contracts for deliveries in 2021 expected with first contracts in place for 2022 and beyond.

Full year 2021 manufacturing capacity now targeting 3 billion doses and more than 3 billion doses for the year 2022.
On Track with Previously Stated 2021 Financial Outlook:

Planned Full Year 2021 Expenses and Capex3
R&D expenses €750 million – €850 million
Ramp-up of R&D investment in the second half of 2021 and beyond planned to broaden and accelerate pipeline development.
SG&A expenses Up to €200 million
Capital expenditures €175 million – €225 million
Estimated Full Year 2021 Tax Assumptions
German tax group corporate tax rate ~31%
The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Quarterly Report on Form 6-K, filed today with the SEC and available at View Source

1 Estimated figures based on preliminary data shared between the collaboration partner and BioNTech as fully described in the Annual Report on Form 20-F as well as the Quarterly Report as of and for the Three Months Ended March 31, 2021, which is filed as an exhibit to BioNTech’s Current Report on Form 6-K. Changes in the share of the collaboration partners’ gross profit will be recognized prospectively.
2 New England Journal of Medicine. Neutralizing Activity of BNT162b2-Elicited Serum; March 8, 2021. Available at View Source
3 Figures reflect current base case projections.

On May 10, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the first quarter ended March 31, 2021, which were in line with its previously announced, preliminary first-quarter results (Press release, Veracyte, MAY 10, 2021, View Source [SID1234579573]). The company also provided an update on recent business progress.

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"We delivered strong financial results for the first quarter of 2021, with particular momentum in March, as our business continues to emerge from the COVID-19 pandemic," said Bonnie Anderson, chairman and chief executive officer of Veracyte. "On March 12, we completed our acquisition of Decipher Biosciences which, with its market-leading urologic cancer portfolio, expands our reach into 7 of the top 10 cancers in the U.S. and will accelerate revenue growth.

"Additionally, we are excited to unveil pivotal clinical validation data at ASCO (Free ASCO Whitepaper) for our Percepta Nasal Swab test for early lung cancer detection. We expect to launch it and the Percepta Genomic Atlas as part of our comprehensive lung cancer portfolio later this year. We also anticipate strengthening our global commercial footprint with the introduction of the Envisia classifier, for improved diagnosis of interstitial lung diseases, on the nCounter Analysis System by the end of this year."

First Quarter 2021 Financial Results

For the three months ended March 31, 2021, compared to the prior year (Decipher Biosciences one-time acquisition-related expenses in the first quarter of 2021 increased our operating expenses, net loss and net cash used in operations by $35.1 million and our net loss per share by $0.55):

Total Revenue was $36.7 million, including $3.8 million for urologic cancer testing, an increase of 18%;
Gross Margin was 66%;
Operating Expenses were $82.1 million. Operating Expenses, Excluding Cost of Revenue, were $69.7 million, including $35.1 million related to the acquisition of Decipher Biosciences;
Net Loss and Comprehensive Loss was $41.9 million, including $35.1 million of expenses related to the acquisition of Decipher Biosciences;
Basic and Diluted Net Loss Per Common Share was $0.66, including $0.55 per share attributable to the acquisition related expenses recorded in G&A;
Net Cash Used in Operating Activities was $40.6 million; and
Cash and Cash Equivalents were $324.1 million at March 31, 2021.
First Quarter 2021 and Recent Business Highlights

Commercial Growth:

Total genomic testing and product revenue was $36.1 million, an increase of 19%, compared to the first quarter of 2020.
Total genomic volume was 14,437 tests, an increase of 11%, compared to prior year, including 1,560 tests from Decipher Biosciences.
Continue to expect a mid-year Medicare coverage decision for Decipher Bladder test, which will allow us to leverage our urology sales footprint to accelerate commercial adoption.
Launched General Manager-based global structure, vertically aligning commercial teams within each clinical indication to provide enhanced focus and clinical expertise. Also added key new hires in marketing, managed care and international market access to support multiple new product launches and global expansion later this year.
Evidence Development and Pipeline Advancement:

Six abstracts for our pulmonology products accepted as posters at the American Thoracic Society (ATS) 2021 International Conference this month:
– Percepta Genomic Atlas – New data demonstrating the test’s ability to inform treatment decisions on the same sample used in diagnosis, in anticipation for product launch in Q4 2021.
– Envisia – New data from five abstracts demonstrates the test’s clinical utility and our ability to enable the CLIA lab-based test on the nCounter Analysis System, in anticipation of the test’s international launch later this year.
Six abstracts for our oncology tests accepted for the ASCO (Free ASCO Whitepaper) Annual Meeting in June, including:
– Percepta Nasal Swab – Pivotal, multicenter, double-blind clinical validation data for test to enable early lung cancer detection, setting the stage for anticipated product launch in 2H 2021.
– Decipher Prostate – Two abstracts, including an oral presentation showing test’s ability to identify African American men with higher likelihood of aggressive prostate cancer, will help further distinguish Decipher Prostate from other prostate cancer genomic tests.
– Afirma XA – New data demonstrate the test’s ability to identify patients with gene alterations who may benefit from targeted therapies – at the time of diagnosis.
Two abstracts presented as posters at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Virtual Congress 2021 meeting this month highlighted potential applications of the PAM50 biomarker on which the Prosigna test is based, as well as initial results from the PROCURE study, which aims to develop consensus around the use of breast cancer genomic tests, including Prosigna.
First patient enrolled and randomized in a study using Veracyte’s LymphMark lymphoma subtyping test to identify and enroll patients with untreated DLBCL who may benefit from Acerta Pharma and AstraZeneca’s Calquence in combination with a traditional chemoimmunotherapy regimen.
Financing:

Issued and sold 8,547,297 shares of common stock in February 2021, including 1,114,864 shares sold upon full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $74.00 per share. The net proceeds to Veracyte from the offering were approximately $593.8 million.
Veracyte used a portion of the net proceeds from the offering, together with its existing cash and cash equivalents, to finance its $600 million cash acquisition of Decipher, which was completed in March 2021. The company intends to use the remaining net proceeds of the offering for working capital and other general corporate purposes, which may include acquiring or investing in complementary businesses, technologies or other assets.
Additionally, in March 2021, the company announced the appointment of Muna Bhanji, a global senior healthcare executive, to its board of directors.

2021 Financial Outlook

Veracyte is reiterating its previous 2021 annual total revenue guidance of approximately $190 million to $200 million, representing growth of approximately 65% over 2020 at the midpoint of the range.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

On May 10, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended March 31, 2021 (Press release, ImmunoGen, MAY 10, 2021, View Source [SID1234579591]).

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"During the first quarter, we advanced our portfolio of innovative ADCs and accelerated preparations for two potential product launches next year," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We saw a limited delay in patient enrollment in the pivotal SORAYA trial for our lead program, mirvetuximab soravtansine, which has shifted the anticipated timing of top-line data from the third into the fourth quarter of this year and the projected submission of the BLA into the first quarter of 2022. We have also experienced some COVID-related impact on accrual to our confirmatory MIRASOL trial and now expect the read-out on the primary endpoint to move from the second into the third quarter of 2022. Beyond SORAYA and MIRASOL, we are commencing several studies to move mirvetuximab into earlier lines of ovarian cancer therapy, including an investigator-sponsored trial of mirvetuximab in combination with carboplatin in the neoadjuvant setting that initiated this quarter. We are also supporting a randomized study comparing mirvetuximab combined with carboplatin to standard of care in patients with recurrent platinum-sensitive disease and have submitted a protocol to FDA for a single-arm study of mirvetuximab monotherapy in later-line platinum-sensitive patients, with both studies anticipated to begin enrollment in the second half of this year. Finally, we were pleased to receive notice that mature data from our mirvetuximab plus Avastin doublet cohort in recurrent ovarian cancer, regardless of platinum status, have been selected for an oral presentation at ASCO (Free ASCO Whitepaper) in June."

Enyedy added, "We continued enrollment for our second pivotal program, IMGN632, in patients with frontline and relapsed/refractory BPDCN, with top-line data expected in the first half of 2022. IMGN632 is also in ongoing development in AML, both as a monotherapy and in combinations. Moving to our earlier-stage portfolio, we presented preclinical data at AACR (Free AACR Whitepaper) last month on IMGC936, our first-in-class ADAM9-targeting ADC, demonstrating anti-tumor activity in multiple solid tumor models, and we advanced dose escalation in the Phase 1 study for this program. IND-enabling activities for our next-generation anti-FRα ADC, IMGN151, are on track to submit an application to the FDA by the end of 2021. With pre-commercial activities underway, we look forward to a meaningful year ahead with a number of important milestones across the business as we work towards bringing our first two therapies to market next year."

RECENT PROGRESS

Further enrolled patients in the pivotal SORAYA and confirmatory MIRASOL trials.
Supported initiation of an investigator-sponsored trial of mirvetuximab plus carboplatin in the neoadjuvant setting.
Submitted to the US Food and Drug Administration (FDA) a single-arm study protocol for mirvetuximab monotherapy in later-line platinum-sensitive ovarian cancer patients.
Advanced accrual of the pivotal 801 Phase 1/2 study of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients.
Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in R/R and frontline acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
Presented preclinical data on IMGC936, our novel ADAM9-targeting ADC in co-development with MacroGenics, in a poster at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
Moved through dose-escalation cohorts in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed activities to support an investigational new drug (IND) application for IMGN151.
ANTICIPATED UPCOMING EVENTS

Generate top-line pivotal SORAYA data in the fourth quarter of 2021 and submit the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022.
Complete patient enrollment in MIRASOL and generate top-line data in the third quarter of 2022.
Present mature data from the Phase 1b FORWARD II cohort evaluating mirvetuximab in combination with Avastin (bevacizumab) in recurrent ovarian cancer in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Initiate a single-arm study of mirvetuximab monotherapy in recurrent platinum-sensitive ovarian cancer in the second half of 2021 to support potential label expansion.
Support the start of a randomized Phase 2 investigator-sponsored study of mirvetuximab plus carboplatin in recurrent platinum-sensitive ovarian cancer in the second half of 2021.
Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Complete dose escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in early 2022.
Submit the IND application for IMGN151 by the end of 2021.
FINANCIAL RESULTS

Revenues for the quarter ended March 31, 2021 were $15.7 million, compared with $13.3 million for the quarter ended March 31, 2020, which consisted primarily of non-cash royalty revenues.

Operating expenses for the first quarter of 2021 were $44.6 million, compared with $37.1 million for the same quarter in 2020. The increase was largely driven by research and development expenses, which were $34.4 million in the first quarter of 2021, compared with $27.4 million for the first quarter of 2020. This increase was primarily due to greater clinical trial expenses driven by costs related to the MIRASOL, SORAYA, and IMGC936 studies, greater external manufacturing costs, and greater personnel and temporary staffing costs. General and administrative expenses for the first quarter of 2021 increased to $10.2 million, compared to $8.9 million for the first quarter of 2020, primarily due to increased professional fees and personnel costs, including greater stock-based compensation. Operating expenses for the first quarter of 2020 included a $0.8 million restructuring charge related to retention costs.

Net loss for the first quarter of 2021 was $34.1 million, or $0.17 per basic and diluted share, compared to a net loss of $29.1 million, or $0.17 per basic and diluted share, for the first quarter of 2020. Weighted average shares outstanding increased to 198.8 million for the 2021 period from 166.9 million in the prior year.

ImmunoGen had $283.1 million in cash and cash equivalents as of March 31, 2021, compared with $293.9 million as of December 31, 2020, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $44.6 million for the first three months of 2021, compared with cash used in operations of $28.3 million for the same period in 2020. Capital expenditures were $(0.9) million for the first quarter of 2021, compared with net proceeds from the sale of equipment of $1.4 million for the first quarter of 2020.

FINANCIAL GUIDANCE

ImmunoGen’s financial guidance for 2021 remains unchanged:

revenues between $65 million and $75 million;
operating expenses between $200 million and $210 million; and
cash and cash equivalents at December 31, 2021 to be between $140 million and $150 million.
ImmunoGen expects that its current cash will fund operations into the second half of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 9982696. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

On May 10, 2021 Promega Corporation reported that Serious runners and casual walkers alike are invited to join a month-long Get Your Rear in Gear – Madison run/walk virtual event during May to raise money and awareness for colorectal cancer screening efforts (Press release, Promega, MAY 10, 2021, View Source [SID1234579609]). Colorectal cancer is the nation’s No. 2 cancer killer, but it is up to 95% preventable with proper screening. The number of people being screened has dropped drastically worldwide since the start of the COVID-19 pandemic. The event is aimed to help encourage this important, life-saving health screening.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"It is imperative that patients are encouraged to get back in with their primary doctor to get screening tests they may have missed," says Dr. Sam Lubner, an oncologist at the University of Wisconsin Carbone Cancer Center. "Without accurate diagnosis as early as possible, all of the advancements we have made in cancer research cannot be brought to bear for patients."

Get Your Rear in Gear – Madison is presented by Promega and Exact Sciences with the support of the Colon Cancer Coalition. This inaugural event is one of nearly 40 held annually across the country planned by local volunteers. Money raised will go to UW Carbone Cancer Center programs aimed at increasing colon cancer screening and early detection.

Registration is open during the entire month of May at www.ColonCancerCoalition.org/Madison. Event participation for colorectal cancer patients and survivors is free. Fundraising by participants is encouraged, but not required.

On May 10, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported financial results for the first quarter of 2021, along with recent product highlights and corporate updates (Press release, Zai Laboratory, MAY 10, 2021, View Source [SID1234579637]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Zai Lab continued to execute well in all aspects of the business during the first quarter," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We entered into several strategic collaborations to further strengthen our gastric and lung cancer disease strongholds; significantly bolstered our autoimmune franchise with an exclusive agreement with argenx for efgartigimod, a pipeline-in-a-product opportunity; advanced numerous clinical programs toward key data readouts; gained approval of QINLOCK by the National Medical Products Administration (NMPA), our third innovative oncology product approval in the last 15 months in China and the first commercial product in what we expect to become a world-class gastric cancer franchise; and generated solid revenue growth, in part from increased volume of ZEJULA driven by its recent inclusion on the National Reimbursement Drug List (NRDL). In addition, we recently received encouraging news on several key assets from our partners. The Biologics License Application (BLA) filing of efgartigimod in generalized myasthenia gravis (gMG) was accepted by the U.S. Food and Drug Administration (FDA). The Phase 3 pivotal LUNAR trial of Tumor Treating Fields in non-small cell lung cancer (NSCLC) was recommended to continue with reduced sample size based on an accelerated interim analysis. Bemarituzumab was granted Breakthrough Therapy Designation by the FDA as first-line treatment for gastric cancer patients who overexpress FGFR2b.

"With the completion of our recent global public offering with gross proceeds of nearly $860 million, we significantly strengthened our capital position. This new capital will allow us to accelerate our growth by entering into additional strategic partnerships, advancing our clinical development pipeline, and scaling our commercial and R&D organizations to drive strong revenue growth and enhance our global pipeline.

"We remain on target to advance all stages of our product pipeline throughout 2021. We continue to expect approval of Nuzyra for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) by the NMPA. We plan to file margetuximab for Her2-positive breast cancer, Tumor Treating Fields for mesothelioma and ZEJULA for late-line ovarian cancer in China. We are engaging with the NMPA on the regulatory filing strategy for efgartigimod in gMG in China. And we anticipate numerous data readouts, including for Tumor Treating Fields in liver cancer and ovarian cancer, for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in NSCLC and for TPX-0022 in NSCLC and gastric cancer.

"In our mission to address serious unmet medical needs for patients in China and around the world, we believe that we have built a sustainable platform that we can leverage," Dr. Du concluded. "Our team continues to deliver on our aggressive growth objectives. I believe that the future of Zai Lab has never been brighter."

Recent Product Highlights and Anticipated Milestones

Oncology

ZEJULA (niraparib)

ZEJULA is an oral, once-daily small-molecule poly ADP-ribose polymerase (PARP) 1/2 inhibitor. It is the only PARP inhibitor approved in the United States, the European Union and mainland China (hereinafter, "China") as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.

Anticipated 2021 Zai Milestones

Complete enrollment of the Phase 1b study of ZEJULA in combination with tebotelimab (PD-1 x LAG-3) in gastric cancer.

Announce topline results of the Phase 3 PRIME study of ZEJULA in patients with first-line ovarian cancer in China in the second half.

Submit the supplemental New Drug Application (sNDA) for late-line ovarian cancer treatment in the second half.

Continue to explore additional indications and combination opportunities.
Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cell death.

Recent Product Highlights

In April 2021, Zai Lab partner Novocure announced an update regarding its Phase 3 pivotal LUNAR trial in stage 4 NSCLC following failure on platinum-based chemotherapy. After a review by an independent data monitoring committee (DMC), Novocure was informed by the committee that the pre-specified interim analysis for the LUNAR trial had been accelerated given the length of accrual and the number of events observed. The DMC concluded that it is likely unnecessary and possibly unethical for patients randomized to the control arm to continue accrual to 534 patients with 18 months follow-up. The DMC further recommended a reduced sample size of approximately 276 patients with 12 months follow-up. Novocure has filed an IDE supplement with the FDA and is awaiting the agency’s response.

Zai Lab has initiated the LUNAR trial in Greater China and will help accelerate the development of Tumor Treating Fields for NSCLC and other cancer patients worldwide.
Anticipated 2021 Zai Milestones

Submit a Marketing Authorization Application (MAA) for malignant pleural mesothelioma.

Join the global Phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer, the Phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer and the Phase 3 pivotal METIS trial in brain metastases from non-small cell lung cancer.

Complete enrollment of the Phase 2 pilot trial in first-line gastric adenocarcinoma.
Anticipated 2021 Partner Milestones

Receive FDA response to IDE supplement incorporating recommended protocol changes to the Phase 3 pivotal LUNAR trial in NSCLC in the second quarter.

Obtain final data from the Phase 2 HEPANOVA trial in advanced liver cancer in the second quarter.

Complete the interim analysis of the Phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer in the second half.
QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFRα-mutated kinases. It is the only therapeutic approved in the United States for advanced GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.

Recent Product Highlight

In March 2021, Zai Lab announced that the NMPA approved its New Drug Application (NDA) for QINLOCK for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. This approval is the third innovative oncology product approval Zai Lab has received in the last 15 months in China.
Anticipated 2021 Zai Milestones

Commercial launch of QINLOCK for the treatment of fourth-line GIST in May, 2021.

Obtain regulatory approval in Taiwan in the second half.
Anticipated 2021 Partner Milestones

Obtain topline data from the INTRIGUE Phase 3 study of QINLOCK in patients with second-line GIST in the fourth quarter.
Odronextamab

Odronextamab is a bispecific monoclonal antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).

Anticipated 2021 Zai Milestone

Enroll the first patient in Greater China in the global Phase 2 potentially pivotal program, subject to feedback from the FDA.
Anticipated 2021 Partner Milestones

Resume enrollment of the Phase 2 potentially pivotal program in B-cell non-Hodgkin lymphoma (B-NHL) in the second quarter, pending FDA approval of the updated protocol.

Initiate confirmatory OLYMPIA Phase 3 trials in combination with chemotherapy in follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), and explore other combination opportunities.

Initiate development of a subcutaneous formulation.
Repotrectinib

Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C, with the potential to treat TKI-naïve or TKI-pretreated patients.

Anticipated 2021 Zai Milestone

Enroll the first patient in Greater China in the global TRIDENT-1 Phase 2 registrational study in the second quarter.
Anticipated 2021 Partner Milestones

Reach target enrollment of the ongoing TRIDENT-1 study in the ROS1-positive TKI-naïve NSCLC patient cohort. An FDA meeting is anticipated during the first quarter of 2022 to discuss topline blinded independent central review (BICR) results.

Initiate TRIDENT-2, a Phase 1b/2 combination study in KRAS-mutant solid tumors, mid-year.

Provide a clinical data update from the ongoing TRIDENT-1 study in the second half.

Report initial clinical data from the Phase 1/2 CARE study in pediatric and young adult patients in the second half.
MARGENZA (Margetuximab)

MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).

Anticipated 2021 Zai Milestone

Submit an NDA for pretreated metastatic HER2-positive breast cancer.
Anticipated 2021 Partner Milestones

Obtain initial data from Module A of the MAHOGANY study in the third quarter.

Complete the final overall survival analysis of the SOPHIA study, a randomized, open-label Phase 3 study evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have previously been treated with HER2-targeted therapies, in the third quarter.
Bemarituzumab

Bemarituzumab is a first-in-class antibody that is being developed in gastric and gastroesophageal junction cancer as a targeted therapy for tumors that overexpress FGFR2b.

Recent Product Highlight

In April 2021, the FDA granted Breakthrough Therapy Designation for bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2- (HER2-) negative metastatic and locally advanced gastric and gastroesophageal junction adenocarcinoma in combination with modified FOLFOX 6, based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.
Anticipated 2021 Zai Milestone

Initiate a pivotal Phase 3 trial in gastric cancer.
CLN-081

CLN-081 is an orally available, small-molecule, next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertions.

Anticipated 2021 Zai Milestone

Enroll the first patient in Greater China in the global potentially pivotal study in the second half.
Anticipated 2021 Partner Milestone

Provide a clinical data update from the Phase 1/2a global study.
TPX-0022

TPX-0022 is an orally bioavailable, multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases.

Anticipated 2021 Partner Milestones

Provide a clinical data update from the Phase 1 SHIELD-1 study and initiate the Phase 2 portion of the SHIELD-1 study in the second half, pending FDA feedback.

Initiate SHIELD-2, a Phase 1b/2 combination study with an EGFR targeted therapy, in the second half.
Tebotelimab

Tebotelimab is an investigational, first-in-class, bispecific, tetravalent DART molecule targeting PD-1 and LAG-3.

Anticipated 2021 Zai and Partner Milestone

Provide a clinical update, including future development plans.
Retifanlimab

Retifanlimab is an investigational monoclonal antibody that inhibits PD-1.

Recent Product Highlight

In January 2021, our partner Incyte announced that the FDA had accepted for Priority Review its BLA for retifanlimab in patients with pretreated advanced squamous cell anal cancer (SCAC), with a Prescription Drug User Fee Act (PDUFA) date of July 25, 2021.
Autoimmune Diseases

Efgartigimod

Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation.

Recent Product Highlight

Five Clinical Trial Applications (CTAs) accepted by the NMPA.
Anticipated 2021 Zai Milestones

Discuss with the NMPA a potential accelerated regulatory pathway for efgartigimod in gMG.

Continue to explore and advance additional indications in coordination with argenx.
Receive CTA approvals for additional indications.
Anticipated 2021 Partner Milestones

Potential FDA approval with a PDUFA target action date of December 17, 2021, and global commercial launch of efgartigimod for the treatment of patients with gMG.

Continue enrollment of the registrational ADHERE trial in chronic inflammatory demyelinating polyneuropathy (CIDP).

Initiate clinical trials in fifth and sixth indications.
Infectious Disease

NUZYRA (omadacycline)

NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with CABP and ABSSSI.

Anticipated 2021 Zai Milestone

Potential NMPA approval and commercial launch of NUZYRA for the treatment of CABP and ABSSSI.
Sulbactam-Durlobactam (SUL-DUR)

Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains.

Anticipated 2021 Zai and Partner Milestone

Complete patient enrollment in the global Phase 3 ATTACK trial, with a top-line data readout anticipated in the second half.
Internal Programs with Global Rights

ZL-2309 (CDC7)

ZL-2309 is an orally active, selective and ATP-competitive cell division cycle 7 (CDC7) kinase inhibitor.

Anticipated 2021 Zai Milestone

Initiate a biomarker-driven POC study in selected tumors.
ZL-1102 (IL-17)

ZL-1102 is a novel human nanobody targeting IL-17 with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for chronic plaque psoriasis (CPP).

Anticipated 2021 Zai Milestone

A top-line data readout is anticipated in the second half.
Business Development Updates

In January 2021, Zai Lab announced an exclusive license agreement with argenx for the development and commercialization of efgartigimod in Greater China. Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process, with potential application in myasthenia gravis, pemphigus vulgaris, immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy and several additional indications.

In January 2021, Zai Lab expanded its collaboration with Turning Point Therapeutics with an exclusive license agreement for the development and commercialization of TPX-0022 in Greater China. TPX-0022 is a multi-targeted kinase inhibitor that targets MET, SCF1R and SRC kinases, with potential uses in treating advanced or metastatic solid tumors.
Corporate Updates

In April 2021, Zai Lab announced the closing of a global offering of American depositary shares and ordinary shares, including the full exercise of the greenshoe option, for total gross proceeds to Zai Lab of $857.5 million. This offering was the first ever dual-tranche offering on both NASDAQ and the Hong Kong Stock Exchange.

ZEJULA has been listed in 67 commercial health insurance plans and 52 supplemental insurance plans initiated by provincial or municipal governments since its commercial launch in January 2020 in China. Optune has also been listed in 13 supplemental insurance plans since its commercial launch in June 2020 in China.

On May 7, 2021, Tao Fu took a new role as Chief Strategy Officer of Zai Lab, and transitioned out of his roles as President and Chief Operating Officer and resigned from the Board of Directors of Zai Lab, in order to focus on Zai Lab’s corporate development and other strategic objectives.

Zai Lab continues to expand and hire talented professionals. As of April 15, 2021, Zai Lab employed 1,354 full-time employees, including 514 and 683 employees engaged in R&D and commercial activities, respectively.
First-Quarter 2021 Financial Results

For the three months ended March 31, 2021, net product revenues were $20.1 million, compared to $8.2 million for the same period in 2020. Revenues for the period were comprised of $12.6 million for ZEJULA, compared to $6.3 million for the same period in 2020; and $7.1 million for Optune, compared to $1.9 million for the same period in 2020.

Research and Development (R&D) expenses were $203.9 million for the three months ended March 31, 2021, compared to $33.7 million for the same period in 2020. The increase in R&D expenses was primarily attributable to a $62.3 million upfront payment in Zai Lab equity (fair value of the shares on the closing date of the agreement due to certain restrictions) and a $75 million development cost-sharing payment to argenx; a $25 million upfront payment to Turning Point; expenses related to ongoing and newly initiated late-stage clinical trials; and payroll and payroll-related expenses from increased R&D headcount.

Selling, General and Administrative expenses (SG&A) were $35.8 million for three months ended March 31, 2021, compared to $18.7 million for the same period in 2020. The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and related costs, as Zai Lab continued to expand its commercial operations in China.

For the three months ended March 31, 2021, Zai Lab reported a net loss of $232.9 million, or a loss per share attributable to common stockholders of $2.64, compared to a net loss of $48.0 million, or a loss per share attributable to common stockholders of $0.66, for the same period in 2020. The increase in the net loss was primarily attributable to payments related to new business development activities with argenx and Turning Point recorded in R&D expenses.
As of March 31, 2021, cash and cash equivalents, short-term investments and restricted cash totaled $1,014.2 million compared to $1,187.5 million as of December 31, 2020. In addition, in April 2021, Zai Lab announced the closing of a global follow-on offering. The expected total proceeds to Zai Lab, including both the American depositary shares offering and the ordinary shares offering, net of underwriting fees and other offering expenses, are approximately $818.1 million.
Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast today, May 10, 2021, at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call. Details are as follows:

Registration Link: View Source

Conference ID: 2374839

All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive a dial-in number, Direct Event passcode and a unique access PIN, which can be used to join the conference call.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website at View Source