On March 1, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the fiscal year ended December 31, 2021 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAR 1, 2022, View Source [SID1234609211]).

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"Last year was one of steady execution as we laid the groundwork for 2022, which we believe promises to be the most important catalyst year in the Company’s history, including key efficacy data for cinrebafusp alfa and PRS-060/AZD1402. We announced a collaboration with R&D leader Genentech, reported data from several clinical and preclinical programs, and initiated multiple clinical trials. Later this year, we expect to report topline data from the phase 2a trial of PRS-060/AZD1402, which has recently cleared the safety gate for the 1 mg and 3 mg dose cohorts. Beyond PRS-060/AZD1402, we currently have two bispecific immuno-oncology programs in clinical development and plan on initiating clinical development for our proprietary inhaled-delivery idiopathic pulmonary fibrosis (IPF) drug program, PRS-220, later this year, with generous grant support from the Bavarian government," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Through these initiatives, we have advanced our pipeline assets while strengthening our balance sheet through partnerships, grant funding, and focused utilization of our ATM facility, all with the focus of driving toward our key inflection point."

•PRS-060/AZD1402 and AstraZeneca Collaboration: Enrollment of part 2a (efficacy of 1 mg and 3 mg cohorts) and part 1b (safety of 10 mg cohort) has begun following successful completion of the sponsor safety review of part 1a (safety of 1 mg and 3 mg cohorts) of the multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated PRS-060/AZD1402. PRS-060/AZD1402 is an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Pieris and AstraZeneca expect to announce topline data from the phase 2a study this year, although the companies are actively evaluating the feasibility of study timelines in the current geopolitical environment and will update guidance in the orderly course of business, if needed. Upon completion of the study, which is being sponsored and funded by AstraZeneca, Pieris may choose to exercise its co-development option, which would be on a 25% cost-share basis with a cost cap or a 50% cost-share basis without a cost cap. Separately, Pieris will have a future option to co-commercialize PRS-060/AZD1402 in the United States.
•Cinrebafusp Alfa (PRS-343): In January 2022, the first patient was dosed in the phase 2 study of cinrebafusp alfa, a 4-1BB/HER2 Anticalin-based bispecific for the treatment of HER2-expressing gastric cancer. The two-arm, multicenter, open-label phase 2 study is evaluating the efficacy, safety, and tolerability of cinrebafusp alfa in combination with standard of care agents ramucirumab and paclitaxel in patients with HER2-high gastric cancer and in combination with tucatinib in patients with HER2-low gastric cancer. Pieris plans to report data from the HER2-low arm this year. Separately, the Company plans to disclose data from the HER2-high arm in 2023.

•PRS-344/S095012 and Servier Collaboration: The first patient was dosed in November 2021 in the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 Anticalin-based bispecific for the

treatment of solid tumors, triggering an undisclosed milestone payment to Pieris. Pieris holds exclusive commercialization rights for PRS-344/S095012 in the United States and will receive royalties on any ex-U.S. sales for this program. Additionally, Servier is continuing development of PRS-352, an undisclosed Anticalin-based bispecific beyond 4-1BB.
•PRS-220: Pieris remains on track to begin a phase 1 trial this year for PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor for the treatment of IPF.
Year End Financial Update:
Cash Position – Cash and cash equivalents totaled $117.8 million for the year ended December 31, 2021, compared to a cash and cash equivalents balance of $70.4 million for the year ended December 31, 2020. The increase since December 2020 is due to cash received from new and existing collaboration agreements, including milestone achievements. In addition, during 2021, the ATM program was utilized to raise a total of $38.5M in net proceeds at an average price of $4.85 per share. These increases were partially offset by cash used to fund operations in 2021.
R&D Expense – R&D expenses were $66.7 million for the year ended December 31, 2021, compared to $46.5 million for the year ended December 31, 2020. The increase reflects higher spending on preclinical and manufacturing activities for PRS-220, an increase in manufacturing costs across multiple immuno-oncology programs, higher clinical costs on cinrebafusp alfa and higher employee related costs. These increases were partially offset by lower manufacturing costs on PRS-060, which were fully reimbursed.
G&A Expense – G&A expenses were $16.5 million for the year ended December 31, 2021, compared to $16.7 million for the year ended December 31, 2020. Total G&A spending was consistent year-over-year as higher fixed and variable compensation and higher insurance costs in 2021 were offset by lower legal, accounting, and project management costs, along with lower one-time office and building equipment costs related to the move to the new R&D facility in Hallbergmoos, Germany in the prior year.
Other Income – For the year ended December 31, 2021, $3.7 million of other income was recorded for PRS-220 program costs that qualified for reimbursement under the Bavarian grant that was announced in June 2021. The Bavarian government reimburses these qualifying program costs as incurred over the PRS-220 development period.
Net Loss – Net loss was $45.7 million or $(0.71) per share for the year ended December 31, 2021, compared to a net loss of $37.2 million or $(0.68) per share for the year ended December 31, 2020.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM EST on Tuesday, March 1, 2022, to discuss the full-year financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). Alternatively, a listen-only audio webcast of the call can be accessed here.
For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

On March 1, 2022 Thermo Fisher and Symphogen reported that extend their collaboration using innovative and efficient workflows to improve data confidence, aiding the creation of new cancer treatments (Press release, Lifescience Newswire, MAR 1, 2022, View Source [SID1234609244])

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Thermo Fisher Scientific, the world leader in serving science, and Symphogen, an affiliate of and the antibody center of excellence within the international pharmaceutical company Servier, announce the continuation of their collaboration to provide biopharmaceutical discovery and development laboratories with innovative tools and streamlined workflows for efficient characterization of complex therapeutic proteins.

Since the collaboration began in 2018, Symphogen has adopted new and innovative instruments and software to improve data quality and processes to develop, test and routinely implement platform workflows for intact and native mass analysis of therapeutic monoclonal antibody (mAb) mixtures. Most recently, the implementation of the Thermo Scientific Orbitrap Exploris MX Mass Detector allows for the highest level of data confidence and an efficient workflow, with seamless method transfer from development instruments. This new system adds to Symphogen’s range of High-Resolution Accurate Mass (HRAM) mass spectrometry technologies, including the Thermo Scientific Q Exactive Plus Orbitrap Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) system and the Thermo Scientific Orbitrap Exploris 240 and 480 Mass Spectrometers. These systems will be controlled using the Thermo Scientific Chromeleon Chromatography Data System (CDS) software, allowing secure, remote operations and data processing from anywhere in the world, providing working flexibility and improved data protection.

"The extension of our collaborative relationship with Symphogen demonstrates our continued commitment to solve tangible scientific challenges within the biopharmaceutical industry," said Eric Grumbach, director biopharma, pharma business, chromatography and mass spectrometry, Thermo Fisher. "Further investment in this collaboration enables critical insights that feed directly into the development of new analytical tools, providing meaningful impact to the characterization of complex biotherapeutics."

Dan Bach Kristensen, principal investigator, Symphogen, said, "Mass spectrometry is playing an increasingly important role in biopharmaceutical development at Symphogen, as exemplified in 2021, when we analyzed over 10,000 biopharmaceutical samples by intact mass analysis on our Orbitrap mass spectrometers. A multitude of separation techniques are now routinely hyphenated to our mass spectrometers, providing unrivalled insight into product quality, from early discovery to late-stage clinical development."

For more information about Thermo Fisher’s chromatography and mass spectrometry workflows for biopharmaceutical characterization, please visit www.thermofisher.com/biopharma. To learn more about the collaboration between Thermo Fisher and Symphogen, please visit www.thermofisher.com/symphogen.

On March 1, 2022 HOOKIPA Pharma Inc. (Nasdaq: HOOK), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that it intends to offer and sell shares of its common stock and shares of its non-voting Series A convertible preferred stock in an underwritten public offering (the "Offering") (Press release, Hookipa Biotech, MAR 1, 2022, View Source [SID1234609270]). HOOKIPA also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the Offering, including the shares of common stock underlying the non-voting Series A convertible preferred stock. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the size or terms of the offering. All of the securities in the Offering are to be sold by HOOKIPA.

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SVB Leerink and RBC Capital Markets are acting as joint book-running managers of the Offering.

The securities described above are being offered by HOOKIPA pursuant to a shelf registration statement on Form S-3 (No. 333-238311), including a base prospectus filed with the Securities and Exchange Commission (the "SEC"), which was declared effective on May 27, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained, when available, from: SVB Securities LLC, Attention: 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]; RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, NY 10281, by telephone at 877-822-4089, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

On March 1, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported it has entered into a collaboration with Eli Lilly and Company (Lilly) to advance the diagnosis, monitoring and treatment of Alzheimer’s disease (Press release, Eli Lilly, MAR 1, 2022, View Source [SID1234609286]). As part of the collaboration, Quanterix will receive a non-exclusive, world-wide license to Lilly’s proprietary P-tau217 antibody technology for potential near-term use in research use only products and services, and future in vitro diagnostic applications. The parties have also entered into a collaboration agreement, which establishes a framework for future projects focused on the development of Simoa immunoassays. As part of this agreement, Lilly will fund $11 million of development with the Quanterix Accelerator group this year. The other financial terms were not disclosed.

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These new agreements represent a commitment to advance blood-based biomarkers into routine clinical use. Plasma biomarkers have recently emerged as potential tools to speed clinical trial enrollment, improve clinical trial outcomes, eliminate the invasive techniques required to monitor drug efficacy and lower clinical trial costs. The initial collaboration under the agreements is expected to be focused on P-tau217, a blood-based biomarker that has shown diagnostic promise for early Alzheimer’s detection.

For Alzheimer’s disease, current diagnostic testing techniques, including PET imaging and lumbar punctures, are often difficult to obtain, more invasive and late. Both Quanterix and Lilly see the compelling value of plasma-based diagnostic tools to broaden access to testing, facilitate earlier Alzheimer’s disease diagnosis, identify candidates for emerging therapeutics and monitor disease progression with a simple blood test. These tests can help address the urgent need of patients, their families, physicians and the broader healthcare system.

"We’re thrilled to collaborate with Lilly in developing innovative diagnostics solutions to revolutionize the diagnosis and treatment of Alzheimer’s," said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix and Founder of Powering Precision Health. "Our collaboration leverages Lilly’s advanced antibody technology with the ultra-sensitive Simoa technology, which we believe has the potential to identify Alzheimer’s early in the pathology, potentially before the onset of severe symptoms – a concept we call ‘neurodiagnostic therapy.’ We believe this collaboration has the potential to advance the field of Alzheimer’s research, treatment and diagnostics."

"Lilly has a long-standing commitment to patients and their families globally suffering from Alzheimer’s disease and other forms of dementia," said Mark Mintun, Lilly Senior Vice President, Research and Development – Neuroscience, and President of Avid Radiopharmaceuticals. "We’re excited about continuing our collaboration with Quanterix and combining Lilly’s P-tau217 and Quanterix’ Simoa technologies to propel the development of plasma-based biomarkers to facilitate Alzheimer’s disease diagnosis and enable access to treatment."

Last year, Lilly presented new data from the Phase 2 TRAILBLAZER-ALZ study at the Alzheimer’s Association International Conference generated through Quanterix’ highly sensitive Simoa technology. The study utilized the Simoa HD-X platform and assays developed by Quanterix using Lilly’s proprietary antibody technology to measure P-tau217, and reported a significant reduction in plasma levels of phosphorylated tau protein after treatment with donanemab, its investigational therapy for Alzheimer’s disease.

On March 1, 2022 ImmVira reported that its global first intravenous administered oncolytic herpes simplex virus ("oHSV") product MVR-T3011 IV has completed first dosing on March 1, 2022 and initiated Phase I clinical trial in a series of well-known domestic clinical study centers in China (Press release, Immvira, MAR 1, 2022, View Source [SID1234609304]).

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"Preliminary data from MVR-T3011 IV U.S. Phase I clinical study has demonstrated robust safety results. We have full confidence in its clinical application. With the completion of first dosing in China, we will rapidly advance the clinical development progress for MVR-T3011 IV in both the U.S. and China simultaneously. Leveraging its proprietary OvPENS platform which supports the development of next-generation oncolytic virotherapy, ImmVira will continue to create groundbreaking cancer treatment paradigms that reignites hope for cancer patients around the world." ImmVira’s Chairwoman and CEO Dr. Grace Zhou said.

MVR-T3011 IV is ImmVira’s proprietary 3-in-1 oHSV with novel virus backbone modification strategy, allowing the great breakthrough in intravenous administration. Intravenous injection ("IV") is an important approach for oncolytic virus to treat metastatic tumors. By overcoming the clinical application limitations of local injection, intravenous injection can provide a consistent local and systemic oncolytic virotherapy for patients and increase the flexibility of oncolytic virus in combination with other drugs. Leveraging the OvPENS new drug R&D platform, ImmVira, as a leader in oncolytic virus development industry, will continue to expand its pipelines, actively explore monotherapy and combination therapies of MVR-T3011 IV and broaden the administration methods of oncolytic virus, providing new treatment opportunities for patients with late-stage cancers.