On January 11, 2021 Harpoon Therapeutics, Inc. (Nasdaq: HARP) reported the closing of its underwritten public offering of 6,764,704 shares of its common stock, which includes 882,352 shares sold upon the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate gross proceeds of approximately $115.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Harpoon Therapeutics (Press release, Harpoon Therapeutics, JAN 11, 2021, View Source [SID1234573817]).

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SVB Leerink and Piper Sandler acted as joint bookrunning managers for the offering. Baird and Truist Securities acted as co-lead managers for the offering. Roth Capital Partners acted as co-manager for the offering.

The shares of common stock were offered pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by email at [email protected] or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

On January 11, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2020 (Press release, Personalis, JAN 11, 2021, View Source [SID1234573816]).

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Personalis estimates revenue of approximately $20.2 million for the fourth quarter of 2020 compared with $18.2 million in the fourth quarter of 2019, representing an increase of 11%. For the full year 2020, revenue is estimated to be approximately $78.6 million compared with $65.2 million for 2019, representing an increase of 21%.

Fourth Quarter Highlights

Preliminary revenue from biopharma and all other customers of an estimated $7.6 million in the fourth quarter of 2020 compared with $4.4 million in the fourth quarter of 2019, a 73% increase
Preliminary revenue from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of an estimated $12.6 million in the fourth quarter of 2020 compared with $13.8 million in the fourth quarter of 2019, a decrease of 9%
Preliminary cash, cash equivalents, and short-term investments were estimated to be $203 million as of December 31, 2020
A total of 45 customers have placed orders for NeXT as of December 31, 2020, with 6 of those customers placing their first orders in the fourth quarter of 2020
Achieved milestone of completing more than 100,000 whole human genomes sequenced under the VA MVP contract
Launch of SHERPA and NEOPS (neoantigen prediction capability) in the fourth quarter of 2020
"I’m proud to say that we were able to report record revenue once again this quarter and achieved our first $20 million revenue quarter, despite the impact from the COVID-19 pandemic. Biopharma revenue was strong and customer orders were once again above revenue reported," said John West, Chief Executive Officer. "In addition, we have several customers that have placed orders for our liquid biopsy offering, which we expect will be an important driver of growth in the future."

The above information is preliminary and subject to Personalis’ normal quarter and year-end accounting procedures and external audit by the company’s independent registered public accounting firm.

Webcast and Conference Call Information

Personalis will issue a press release with final financial results and host a conference call to discuss the fourth quarter and full year 2020 financial results after market close on Thursday, February 25, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 5065084. The live webinar can be accessed at View Source

On January 11, 2021 Novartis reporrted that it has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field (Press release, Novartis, JAN 11, 2021, View Source [SID1234573815]). Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

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Under the terms of the agreement, Novartis will obtain the development and commercialization rights to tislelizumab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront payment of USD 650 million plus royalties and milestone payments. BeiGene will retain the rights to tislelizumab in China and other countries. The transaction has been approved by the Boards of Directors of both companies.

More than 7,700 patients have been enrolled in 15 potentially registration-enabling clinical trials with tislelizumab in a dozen indications, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma, gastric cancer and nasopharyngeal carcinoma. The first ex-China regulatory filing is expected in 2021. In addition, Novartis and BeiGene have identified multiple tislelizumab plus Novartis therapy combination clinical trial opportunities in solid tumors.

"Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders. This agreement expands on our strategy as the only company pursuing four different approaches to treating cancer: targeted therapy, radioligand therapy, cell and gene therapy, and immunotherapy. No other company has this range of therapeutic approaches, and the opportunity to combine them to offer the best outcomes for each patient," said Susanne Schaffert, PhD, President, Novartis Oncology. "We are excited about collaborating with BeiGene, a leading global biotechnology company with roots in China, to bring tislelizumab to patients around the world, and pair it with our extensive portfolio and pipeline to develop transformative combination therapies for patients."

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for certain patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma. In addition, BeiGene has filed three supplemental new drug applications for tislelizumab in China for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable HCC.

Closing of the transaction is subject to expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

On January 11, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported a strategic collaboration with Illumina, Inc. (NASDAQ: ILMN) for Illumina to create a kit-based version of the myChoice companion diagnostic (CDx) test for international markets (Press release, Myriad Genetics, JAN 11, 2021, View Source [SID1234573814]).

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"Increasing access to our products and better serving patients and healthcare providers are critical components of our mission to improve outcomes and our transformation plan to drive growth. The agreement between Myriad and Illumina combines companion diagnostics and next-generation sequencing to advance comprehensive genomic profiling of tumor samples and drive improved outcomes in oncology," said Paul J. Diaz, president and CEO, Myriad Genetics. "This collaboration reflects our increasing focus on partnering with high-caliber healthcare leaders like Illumina to bring innovative solutions to the oncology market."

Strategic Partnership with Illumina
The strategic partnership with Myriad and Illumina consists of a time-limited exclusive agreement for Illumina to provide a kit-based version of the myChoice CDx test for international markets. Illumina will leverage its sequencing instrument install base and knowledge from increasing market adoption of its TruSight Oncology 500 next-generation sequencing assay to develop and commercialize distributed kits globally for the assessment of homologous recombination deficiency (HRD) along with other proprietary biomarkers while Myriad expands access and extends the reach of myChoice CDx through Myriad’s services offering.

"Illumina is committed to offering innovative diagnostic tools that power precision oncology," said Dr. Phil Febbo, M.D., Chief Medical Officer of Illumina. "The growing use of PARP inhibitor therapeutics to broader populations of patients with HRD is paramount in our work with Myriad Genetics as the future of healthcare looks to molecular-based testing to improve patient outcomes through standardized, best in class testing with myChoice CDx."

The myChoice CDx offering – through Myriad’s world-class laboratory – is the only companion diagnostic test extensively validated in clinical trials to predict response to poly-ADP ribose polymerase (PARP) inhibitor drugs commonly used in the treatment of ovarian, breast, pancreatic and prostate cancer. It utilizes proprietary technologies to measure genomic instability within tumors and help predict drug response. myChoice CDx test recently received both European CE Marking and Japanese regulatory approval for use as a companion diagnostic with Lynparza (olaparib) for first-line maintenance treatment in ovarian cancer in conjunction with bevacizumab. Lynparza is a PARP inhibitor jointly developed and commercialized by AstraZeneca and Merck.

On January 11, 2021 Aadi Bioscience (Aadi), a biopharmaceutical company focusing on precision therapies for genomically defined cancers and EOC Pharma (EOC), a leading oncology specialty biopharmaceutical company in China, repoted an exclusive license agreement for the development and commercialization of ABI-009 (FYARRO) in Greater China including mainland China, Hong Kong, Macau and Taiwan (Press release, Aadi, JAN 11, 2021, View Source [SID1234573813]).

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Under the terms of the agreement, EOC Pharma will obtain exclusive rights to develop and commercialize ABI-009 in Greater China. Aadi will receive an upfront payment, regulatory and sales-based milestone payments totaling up to $271M as well as tiered royalties based on annual net sales of ABI-009. EOC will be responsible for development, regulatory submissions, and commercialization in the territory. Aadi Bioscience retains full worldwide rights outside of the partnered territory.

"We are very excited to partner with the experienced team at EOC Pharma. Through this collaboration, we will work together to bring ABI-009, a potential best-in-class mTOR inhibitor targeted to inactivating mutations in tumor-suppressor genes in the mTOR pathway such as TSC1, TSC2 or PTEN, to patients globally including in Greater China", said Neil Desai, Ph.D., CEO and Founder of Aadi Bioscience.

"The mTOR pathway plays a major role in multiple critical cellular processes and mTOR activation is associated with specific mutations across a broad range of cancers and other diseases. We are happy to work with Aadi to advance ABI-009 to address unmet medical needs for Chinese patients with malignant PEComa, specific mutation-driven solid tumors and other mTOR driven conditions", said Xiaoming Zou, Ph.D., CEO of EOC Pharma

About ABI-009 (FYARRO)

FYARRO (ABI-009, sirolimus albumin-bound nanoparticles) is an mTOR inhibitor complexed with human albumin that has demonstrated significantly higher tumor accumulation, mTOR target suppression and superior efficacy over other mTOR inhibitors in preclinical models (Hou 2019, AACR (Free AACR Whitepaper) Abstract 348).

Aadi recently initiated a rolling NDA submission for ABI-009 to the FDA for treatment of advanced malignant PEComa, a rare type of sarcoma with high frequency of mutations in the TSC1 or TSC2 genes and no previously approved treatments. Long-term data on the AMPECT registrational trial in PEComa was presented at ASCO (Free ASCO Whitepaper) and CTOS (Wagner 2020, Abstract 11516 and Wagner 2020, Abstract 3463014 respectively). The study met its primary endpoint response rate with a manageable safety profile and durable responses on long-term follow-up. ABI-009 has received Breakthrough Therapy, Fast Track, and Orphan Designations from the FDA.

Based on emerging data for ABI-009 in other solid tumors with TSC1 or TSC2 mutations and following discussions with the FDA, Aadi is proceeding with a tumor-agnostic registrational trial in solid tumors harboring TSC1 or TSC2 pathogenic, inactivating mutations with planned initiation in 2021. TSC1 and TSC2 mutations occur across a broad range of cancers at an average frequency of 1-2% and are further enriched in specific types of cancer including bladder cancer, kidney cancer, melanoma, breast cancer and hepatocellular carcinoma.