On March 28, 2022 Ginkgo Bioworks Holdings, Inc. (NYSE: DNA, "Ginkgo"), the leading horizontal platform for cell programming, reported its results for the fourth quarter and year ended December 31, 2021 (Press release, Ginkgo Bioworks, MAR 28, 2022, View Source [SID1234611239]). The update, including a webcast slide presentation with additional details on the fourth quarter and supplemental financial information, will be available at investors.ginkgobioworks.com.

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"The current market environment provides both challenges and opportunities, but I’ve never been more excited about Ginkgo’s future. We met or exceeded each of our publicly disclosed metrics in 2021, some significantly, and we believe we are in the strongest position that we’ve ever been in as a company," said Jason Kelly, co-founder and CEO of Ginkgo. "I couldn’t be prouder of our team and the way they have shown up to build our platform and deliver cell programs for our partners over the past year. Some of the greatest challenges of our generation – including climate change and food security – are fundamentally biological. Ginkgo is unique in our relative scale and our focus on the development of broad-based horizontal technologies to make biology easier to engineer – and on humankind’s ability to do so responsibly."

Recent Business Highlights & Strategic Positioning
Added 10 new Cell Programs to the Foundry platform in Q4 2021, for a total of 31 new programs in the full year, representing 72% growth over 2020.
Significantly exceeded outlook for both Foundry and Biosecurity revenue with full year revenue reaching $314 million, representing growth of 309% over 2020.
Continued to drive "Knight’s Law" Foundry scaling as we were able to increase our deployment of new technologies, including multiplexed strain tests.
Biosecurity offering, Concentric by Ginkgo, grew rapidly in Q4, reaching $201 million in revenue for the full year, and is seeing signs of longer-term opportunities.
Expanded offering with a lab network that has empowered communities with COVID-19 monitoring programs across the United States.
Since inception, Concentric has tested more than 7,200,000 samples, and now serves over 280,000 individuals per week.
Well-positioned to play a role in response to longer-term needs, including endemic COVID-19, broader pandemic preparedness, and biodefense.
Announced two tuck-in acquisitions year-to-date in 2022:
Project Beacon: a Boston-based social benefit organization focused on increasing the capacity, availability, accessibility and affordability of COVID-19 testing.
FGen: a Swiss company specializing in ultra-high-throughput strain development and optimization.
Fourth Quarter 2021 Financial Highlights
Fourth quarter 2021 Total revenue of $148 million, up from $32 million in the comparable prior year period, an increase of 363%.
Fourth quarter 2021 Foundry revenue of $34 million, up from $16 million in the comparable prior year period, an increase of 108%.
Fourth quarter 2021 Biosecurity revenue of $114 million with gross profit margin of 42%.
Fourth quarter 2021 Loss from operations of $(1.7) billion, inclusive of "catch-up" GAAP stock-based compensation expense of $1.7 billion, compared to Loss from operations of $(56) million in the comparable prior year period.
Fourth quarter 2021 Adjusted EBITDA of $1 million, improved from $(51) million in the comparable prior year period.
Cash and cash equivalents balance as of the end of the fourth quarter of over $1.5 billion puts Ginkgo in a strong financial position to pursue its strategic objectives.
Full Year 2021 Financial Highlights
Full year 2021 Total revenue of $314 million, up from $77 million in the prior year, an increase of 309%.
Full year 2021 Foundry revenue of $113 million, up from $59 million in the prior year, an increase of 91%.
Full year 2021 Biosecurity revenue of $201 million compares to our full year 2021 outlook of $110 million.
Full year 2021 Loss from operations of $(1.8) billion, inclusive of "catch-up" stock-based compensation expense of $1.7 billion, compared to $(137) million in the prior year.
Full year 2021 Adjusted EBITDA of $(106) million, improved from $(121) million in the prior year.
2022 Guidance
Ginkgo expects to add 60 new Cell Programs to the Foundry platform in 2022.
Ginkgo expects Total revenue of $325 to $340 million in 2022.
Ginkgo expects Foundry revenue of $165 to $180 million in 2022.
While Biosecurity remains an uncertain business, Ginkgo is committed to investing in the space and expects Biosecurity revenue in 2022 of at least $160 million.
Stock Based Compensation
In the fourth quarter, Ginkgo recognized $1.7 billion of stock-based compensation expense. Prior to becoming a public company in September 2021, Ginkgo granted restricted stock units ("RSUs") with both a service-based vesting condition and a performance-based vesting condition, defined as a change in control or an initial public offering (both as defined in the underlying award agreement). Ginkgo historically did not recognize any stock-based compensation expense associated with these awards due to the performance-based vesting condition.
As previously disclosed, on November 17, 2021 the board of directors modified the vesting terms of RSUs, such that Ginkgo’s business combination with Soaring Eagle Acquisition Corp. was deemed to have met the performance condition for vesting. This was accounted for as a modification and resulted in a catch-up adjustment of approximately $1.5 billion of incremental stock-based compensation expense in the fourth quarter of 2021 (calculated based on the number of RSUs impacted, which had been granted since 2015, at the share price of $13.59 on November 17, 2021). Stock-based compensation expense also increased by $173.5 million related to RSU earnout shares ("Earnout RSUs") which were also subject to the same performance condition as the underlying RSUs.
As of December 31, 2021, there was $2.2 billion of unrecognized stock-based compensation expense related to the above catch-up adjustment for those RSUs and Earnout RSUs that had not yet fully met the service-based vesting condition as of December 31, 2021. This amount will be recognized over a weighted-average period of 1.6 years.
Conference Call Details
Ginkgo will host a videoconference today, Monday, March 28, 2022, beginning at 4:30 p.m. ET. The presentation will include an overview of the fourth quarter and full year financial performance, recent business updates, a discussion on Ginkgo’s outlook, as well as a moderated question and answer session.

To ask a question ahead of the presentation, please submit your questions to @Ginkgo on Twitter (hashtag #GinkgoResults) or by sending an e-mail to [email protected].

A webcast link is available on Ginkgo’s Investor Relations website and a replay will be made available following the presentation.

Ginkgo Investor Website: View Source

Webinar ID: 961 0791 2467
If you experience technical difficulties with any of these dial-ins or if you need international dial-in numbers, please visit our web site at View Source for updated dial-in information.

On March 28, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported the closing of its previously announced global offering of an aggregate of 2,333,334 ordinary shares (including ordinary shares represented by American Depositary Shares ("ADSs")) (Press release, argenx, MAR 28, 2022, View Source [SID1234611129]). The gross proceeds from the global offering were approximately $700 million (approximately €637 million).

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J.P. Morgan, Morgan Stanley, Cowen and SVB Leerink acted as joint bookrunning managers for the offering. Wells Fargo Securities, Kempen & Co, H.C. Wainwright & Co., Raymond James and Wedbush PacGrow acted as co-managers for the offering.

The securities were offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities was filed with the SEC on March 22, 2022 and a final prospectus supplement relating to the securities was filed with the SEC on March 25, 2022 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; or from SVB Securities LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected].

In addition, argenx announces the listing of and the commencement of dealings in its 2,333,334 new ordinary shares on the regulated market of Euronext Brussels.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On March 28, 2022 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), is an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders (Press release, Vyant Bio, MAR 28, 2022, View Source [SID1234611128]). The Company’s central nervous system ("CNS") drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning . Today, Vyant Bio reported that an investor conference call and webcast will be hosted on Wednesday, March 30, 2022.

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Jay Roberts, Chief Executive Officer, Andy LaFrence, Chief Financial Officer and Robert T. Fremeau, PhD, Chief Scientific Officer of Vyant Bio will discuss the Year-End 2021 results. Management will provide additional corporate updates as well as answer questions. Please also visit the Investors section of the Vyant Bio web site for details on how to participate.

Event: Investor Conference Call and Webcast for the Fourth Quarter and Year-End 2021
Date: Wednesday, March 30, 2022
Time: 8:30am ET
Dial In: Toll Free: 1.877.545.0523 Conference ID: 449263
Webcast: View Source

The live event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.

On March 28, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported their participation in upcoming investor conferences and invites investors to participate in one-on-one meetings (Press release, ERYtech Pharma, MAR 28, 2022, View Source [SID1234611127]):

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Investor Access Event

Link to the event

Date: Monday, April 4th and Tuesday, April 5th
Place: Paris (France)
Participant: Eric SOYER (CFO-COO)

Kempen 14th Life Sciences Conference

Link to the event

Date: Thursday, April 21st
Place: Amsterdam (Netherlands)
Participants: Gil BEYEN (CEO) and Eric SOYER (CFO-COO)

If you are interested in arranging a one-on-one meeting, please contact your conference representative.

On March 28, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the fourth quarter of 2021 (Press release, Molecular Templates, MAR 28, 2022, View Source [SID1234611108]).

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"2022 is off to a very promising start, following a number of important developments across our pipeline of ETBs in 2021," said Eric Poma, Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates. "We continue to see differentiated pharmacodynamic effects and evidence of antigen seeding with MT-6402 with additional data expected throughout 2022. We continue dose finding for the MT-5111 and MT-0169 programs with clinical data expected this year. We plan to file an IND in 2H22 for our CTLA-4 program and are moving forward with our earlier stage pipeline of ETBs in preclinical development targeting TIGIT, TROP-2, and BCMA."

Company Highlights and Upcoming Milestones

Corporate

MTEM expects to provide periodic updates on MT-6402, MT-5111, and MT-0169 throughout 2022.
MTEM has had six abstracts accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting 2022, taking place from April 8-13, 2022.
Gabriela Gruia, M.D. appointed to the Board of Directors.
Megan Filoon promoted to General Counsel.
MT-6402 (PD-L1 ETB with Antigen Seeding Technology)

MTEM continues to enroll patients in the Phase 1 study of MT-6402 which began in July 2021. MT-6402 is the first of MTEM’s 3rd generation ETBs to enter the clinic. It was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of approved checkpoint inhibitors.
The Phase 1 study is a multi-center, open-label, dose escalation and dose expansion trial in the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment are eligible for enrollment.
The 16 mcg/kg cohort (cohort 1) was completed with no DLTs observed in the six patients treated. One patient in cohort 1 with non-small cell lung cancer (NSCLC) had evaluable-only multiple sites of bone disease that appeared to have resolved on bone scan with only one remaining site which showed decreased uptake. This patient remained on MT-6402 up to cycle 8 when increased uptake was noted on bone scan and treatment was discontinued.
Six patients have been treated in the 24 mcg/kg cohort (cohort 2). One DLT, a grade 3 dermatitis of two days duration, occurred six days after the first dose in cohort 2 in one patient. The patient was treated with systemic steroids and treatment with MT-6402 was held until cycle 2, dose 1, at which time the patient was re-challenged at the same dose without development of recurrent dermatitis.
Following a review of the safety data from cohort 2 (24 mcg/kg), patient enrollment in cohort 3 initiated at a dose of 32 mcg/kg.
MTEM continues to observe pharmacodynamic (PD) effects including monocyte depletion and T cell activation in the 24 mcg/kg cohort. The extent and timing of these PD effects appear dose-related with patients in the 24 mcg/kg generally showing a more rapid and profound PD effect.
Six patients remain on study with five patients awaiting their first efficacy assessment. Dose escalation continues as planned and following determination of the maximum tolerated dose (MTD), expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and PD-L1 positive basket tumor cohorts.
In 2021, MT-6402 was granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of patients with advanced NSCLC expressing PD-L1.
MT-5111 (HER2 ETB)

The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
The HER2-positive breast cancer expansion cohort initiated in November 2021 at a dose of 10 mcg/kg.
As of January 2022, 30 patients had been treated with MT-5111 across eight dose escalation cohorts ranging from 0.5 mcg/kg to 13 mcg/kg without any DLTs.
There have been no signs of capillary leak syndrome (CLS) or significant cardiotoxicity observed to date with MT-5111.
Enrollment has initiated for the next cohort at 17 mcg/kg. Dose escalation will continue to determine the MTD, while the breast cancer expansion cohort collects efficacy and safety data.
MT-0169 (CD38 ETB)

In August 2021, MTEM assumed full rights to MT-0169 from its former co-development partner, Takeda, including full control of MT-0169 clinical development, per the terms of the terminated collaboration agreement with Takeda. Upon approval of a revised protocol, MTEM will continue to conduct the ongoing Phase 1 study for MT-0169 in relapsed/refractory multiple myeloma and non-Hodgkin’s lymphoma and plans to open new sites for the Phase I study.
A more rapid and complete elimination of CD38+ NK cells (a known PD marker for CD38-targeting therapeutics) was observed in the first five patients than had been predicted from in vitro and in vivo models, suggesting that the starting dose of 50 mcg/kg is higher than required.
A revised protocol was submitted to explore a lower dose of MT-0169 to reduce the risk of adverse events observed at the initial dose and to enable patients to continue MT-0169 therapy for a longer duration that may drive tumor benefit. Importantly, the robust and rapid NK cell depletion that was observed at the starting dose is expected to be observed at lower doses.
Research

MTEM continues to advance its pipeline of next-generation ETBs targeting CTLA-4, TIGIT, TROP2, BCMA, SLAMF-7, and CD45.
IND filing of an ETB in the CTLA-4 program is expected in 2H22.
Lead selection for TIGIT, TROP-2, and BCMA is ongoing.
MTEM plans to present preclinical data on its ETB candidates at AACR (Free AACR Whitepaper) in April 2022 and expects to present further preclinical data throughout the year at medical and scientific conferences.
Financial Results for the Fourth Quarter of 2021

The net loss attributable to common shareholders for the fourth quarter of 2021 was $10.2 million, or $0.18 per basic and diluted share. This compares with a net loss attributable to common shareholders of $28.4 million, or $0.57 per basic and diluted share, for the same period in 2020.

Revenues for the fourth quarter of 2021 were $18.0 million, compared to $3.5 million for the same period in 2020. Revenues for the fourth quarter of 2021 were comprised of revenues from collaborative research and development agreements with Vertex and Bristol Myers Squibb. Total research and development expenses for the fourth quarter of 2021 were $19.3 million, compared with $22.3 million for the same period in 2020. Total general and administrative expenses for the fourth quarter of 2021 were $7.9 million, compared with $7.1 million for the same period in 2020.

As of December 31, 2021, MTEM’s cash and investments totaled $152.0 million. MTEM’s current cash and investments are expected to fund operations into the fourth quarter of 2023.