On May 18, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in two upcoming virtual conferences. An audio webcast of the presentations will be available live (Press release, BioMarin, MAY 18, 2021, View Source [SID1234580228]). You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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On May 18, 2021 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the first quarter ending March 31, 2021 (Press release, Akoya Biosciences, MAY 18, 2021, View Source [SID1234580197]).

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First Quarter Financial Highlights:

Total revenue for the first quarter of 2021 was $12.2 million, at the high end of the previously provided range of $12.0 million to $12.2 million.
Solid quarter of instrument sales, especially CODEX with 20 units sold: 28% increase in total company installed base over the last 12 months.
Gross profit was $7.4 million in the first quarter of 2021, compared to $6.7 million in the first quarter of 2020, resulting in a gross profit margin of approximately 61% in each period.
Akoya completed an initial public offering of 7.6 million shares of common stock in April, raising $151.3 million in gross proceeds, before deducting underwriting discounts and commissions and offering expenses.
First Quarter Business Highlights:

Record number of scientific publications related to our platforms: over 60 new publications in Q1, compared to 109 for all of 2020.
Aggressive hiring plans underway with 21 new employees in Q1 bringing the total headcount to 190; moving quickly to add personnel in all areas of the business, with Commercial and R&D being the near-term priorities.
Hired Frederic Pla as our Chief Operating Officer to accelerate our strong momentum across all of our spatial biology platforms.
Strong presence at AACR (Free AACR Whitepaper) including presentations by Dr. Garry Nolan from Stanford University and Akoya Founder, Dr. Janis Taube from Johns Hopkins University and Dr. Laura Esserman from University of California, San Francisco.
Announced collaboration agreement with Johns Hopkins University for immunotherapy biomarker discovery and validation, a co-marketing agreement with Zeiss, and the industry’s first Imaging Innovators (I2) Network to drive application innovation on CODEX.
"Akoya’s performance in the first quarter demonstrates the continued adoption of our Codex and Phenoptics solutions for discovery, translational and clinical research. Our dedicated team delivered strong financial results and important progress across of range of metrics which position Akoya for continued growth and leadership in spatial biology," said Brian McKelligon, CEO of Akoya. "We successfully completed our IPO in April and are now well positioned to execute on our mission of delivering a revolutionary new class of spatially derived biomarkers that empower life sciences researchers to better understand disease and response to therapy."

First Quarter Financial Results

Total revenue for the first quarter of 2021 was $12.2 million, compared to $11.0 million in the first quarter of 2020.

Product revenue was $10.0 million in the first quarter of 2021, compared to $8.9 million in the prior year period. Within product revenue, instrument revenue was $6.8 million in the first quarter 2021, compared to $6.7 million in the first quarter 2020. Reagent revenue was $2.5 million in the first quarter 2021, compared to $2.1 million in the first quarter 2020.

Services and other revenue totaled $2.2 million in the first quarter of 2021, as compared to $2.1 million in the first quarter of 2020.

We also monitor instruments sold and installed based as key performance indicators for our business:

We sold 37 instruments in Q1 2021; 20 Codex, 17 Phenoptics (includes Polaris, Vectra, and Mantra). The total of 37 exceeds the number sold in any quarter in 2020.
Instrument installed base of 587 as of March 31, 2021; Codex 132, Phenoptics 455
2021 Guidance

Akoya expects full year 2021 revenue to be at least $52.0 million. The second quarter of 2021 is expected to have revenue growth of approximately 45% over the prior year quarter. Also, as of April 30, 2021 the total common shares outstanding are 37.1 million, and the fully diluted common shares are 41.1 million.

Webcast and Conference Call Details

Akoya will host a conference call today, May 18, 2021, at 5:00 p.m. Eastern Time to discuss its first quarter 2021 financial results. The dial-in numbers are (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 7824008. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

On May 18, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie H. Anderson, chairman, chief executive officer and incoming executive chairman, and Marc Stapley, incoming chief executive officer, are scheduled to participate in two upcoming virtual investor conferences (Press release, Veracyte, MAY 18, 2021, View Source [SID1234580213]):

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UBS Global Healthcare Virtual Conference
Fireside Chat on Tuesday, May 25, 2021, at 10:00 a.m. EDT
7th Annual Truist Securities 2021 Life Sciences Summit
Fireside Chat on Thursday, May 27, 2021, at 12:30 p.m. EDT
Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days following the conclusion of each live presentation broadcast.

On May 18, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the first patient has been dosed in an abbreviated combination clinical study (NCT04202003) of lemzoparlimab (also known as TJC4) with azacitidine (AZA) in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) in China (Press release, I-Mab Biopharma, MAY 18, 2021, View Source [SID1234580229]).

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Lemzoparlimab is a differentiated anti-CD47 monoclonal antibody designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity. AZA is a chemotherapeutic drug that may synergize with lemzoparlimab to treat hematologic malignancies.

This phase 2 combination cohort expansion study builds on the dose escalation monotherapy trial in China and will evaluate the safety, tolerability and efficacy of lemzoparlimab in combination with AZA in patients with newly diagnosed AML who are intolerant to intensive chemotherapy or treatment-naïve patients with intermediate and high-risk myelodysplastic syndrome. Patient enrollment is expected to be completed by Q4 2021.

"Lemzoparlimab has already shown promising and differentiated features as a novel therapy in phase 1 studies. We look forward to advancing lemzoparlimab as a combination treatment in patients with AML and MDS to further validate its safety and clinical efficacy. A pivotal trial towards registration is anticipated immediately after this," said Dr. Joan Shen, CEO of I-Mab.

The Company is on track with its accelerated clinical development plan for lemzoparlimab with the ambition for NDA approval as the first CD47 antibody drug for the treatment of hematologic malignancies in China while advancing two ongoing clinical trials of lemzoparlimab in combination with Rituxan in patients with NHL and Keytruda in advanced solid tumors in the U.S. The NHL combination study also included clinical sites in China as an international multi-center trial (IMCT) to potentially bridge to a registrational clinical trial in China if approved by the NMPA. Patient enrollment of both the NHL and solid tumor trials will be completed by Q4 2021 with the preliminary topline data expected thereafter.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.

Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumors in the U.S. and with Rituxan for lymphoma in the U.S. and China, in addition to an on-going clinical trial in patients with AML in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China.

On May 18, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes, reported the close of its US$125 million Series C financing round (Press release, Hummingbird Bioscience, MAY 18, 2021, View Source [SID1234580198]). The financing was led by Novo Holdings, with significant participation from new investors including Frazier Healthcare Partners, Octagon Capital, EDBI, AMGEN Ventures, DROIA Ventures, Morningside Ventures, Pureos Bioventures, Polaris Partners, Affinity Asset Advisors, Ally Bridge Group and Altium Capital Management. Existing investors including SK Inc, Heritas Capital, SEEDS Capital and Mirae Asset Venture Capital also joined the round.

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"We are delighted to have the support and confidence of leading global healthcare investors to advance the development of our unique pipeline of precision therapies against important, yet hard-to-drug targets. We have made tremendous progress since closing our Series B in 2019 and this financing reflects strong support for our platform, people, and development strategy," said Piers Ingram, Chief Executive Officer and co-founder, Hummingbird Bioscience. "With our world-class team of researchers and proprietary technologies, Hummingbird is at the cutting-edge of scientific discovery. These new funds give us further resources to invest in our early stage pipeline, as well as supporting the clinical development of our two lead programs that we believe can deliver very meaningful benefit for patients."

Proceeds from the financing will be used to advance the clinical development of Hummingbird’s lead assets including, HMBD-001, a best-in-class HER3 antibody for NRG1-fusion and HER3-driven tumors, and HMBD-002, a first-in-class anti-VISTA neutralizing antibody for advanced solid tumors. The funds will also be used to expand the capabilities of Hummingbird’s proprietary Rational Antibody Discovery platform and progress the development of its next-generation pipeline of precision therapeutics including HMBD-009, a BCMA-TACI dual-specific T cell engager.

"We are delighted to lead this financing in Hummingbird and pleased to have attracted a syndicate of sophisticated investors to enable the acceleration of the company’s clinical development activities. We believe that Hummingbird’s novel data-driven, systems biology approach brings new precision to the field of antibody drug discovery and development, and we are proud to support the team in realizing their vision," said Kenneth Harrison, Partner, Novo Ventures.

Kenneth Harrison along with Dan Estes, General Partner, Frazier Healthcare Partners, and Kiel Kim, Vice President, SK Inc., will join Hummingbird’s board of directors.

"Hummingbird is at an exciting point, on the cusp of starting clinical studies for both HMBD-001 and HMBD-002. I look forward to working with the Hummingbird team in developing and building out its portfolio of drug candidates that have transformative potential for patients with cancer and autoimmune diseases," said Dan Estes.

Kiel Kim said: "There is significant potential for novel antibody-based therapeutics and through Hummingbird’s Rational Antibody Discovery platform, we can now discover high value antibodies for challenging targets. We look forward to continuing our partnership with Hummingbird to solve complex challenges in antibody development, and deliver highly differentiated therapies to patients in need."