On March 30, 2021 Pyxis Oncology ("Pyxis" or the "Company") reported the closing of a $152 million Series B financing, led by Arix Bioscience and co-led by RTW Investments, LP, with participation from additional new investors, including Perceptive Advisors, RA Capital Management, Pfizer Ventures, BVF Partners, L.P., Janus Henderson Investors, Cormorant Asset Management, HBM Healthcare Investments, funds managed by Tekla Capital Management LLC, Acuta Capital Partners, Ridgeback Capital Investments, Surveyor Capital (a Citadel company), Laurion Capital Management, Logos Capital, and LifeSci Venture Partners (Press release, Pyxis Oncology, MAR 30, 2021, View Source [SID1234577345]). This round brings Pyxis’ total funding to $174 million. The Longwood Fund-founded Company’s existing Series A investors including Leaps by Bayer, Longwood Fund, Agent Capital and Ipsen also participated in the offering.

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Pyxis will use the proceeds from the financing to advance its differentiated portfolio of ADCs, a growing class of therapies that deliver highly potent targeted treatments directly to cancer cells, including PYX-201 and PYX-203, both in-licensed from Pfizer, and PYX-202, recently in-licensed from LegoChem Biosciences. The Company will also continue advancing its I/O pipeline to pursue a broad range of therapeutic indications.

In conjunction with the Series B financing, Christian Schetter, Ph.D., Managing Director at Arix Bioscience, Gotham Makker, M.D., Head of Strategic Investments at RTW Investments, LP, and Chris O’Donnell, Partner at Pfizer Ventures, will join the Pyxis Board as Directors.

"We are grateful for the support of these highly sophisticated investors as we strive to improve the lives of patients with difficult-to-treat cancers by progressing a diverse portfolio of potentially groundbreaking ADCs and immunotherapies," said Lara Sullivan, M.D., Chief Executive Officer of Pyxis. "This financing strengthens our ability to build a differentiated portfolio of biologics and allows us to accelerate our efforts to advance multiple promising programs into Phase 1 clinical trials."

Christian Schetter, Ph.D., Managing Director of Arix Bioscience, added, "We are pleased to lead this funding round for Pyxis. Our investment reflects our enthusiasm for the strength of both the management team and the Company’s diverse pipeline of biologics, which have the potential to make a meaningful difference for patients. I/O and ADCs represent two of the most promising strategies for treating cancer and we look forward to supporting this team of industry veterans as they build on their history of advancing groundbreaking therapies for patients suffering from difficult-to-treat cancers."

Gotham Makker, M.D., Head of Strategic Investments at RTW Investments, LP, commented, "We are excited to co-lead this funding round. Under the leadership of its expert management team, the company has developed a robust strategy for growth through its multiple biologics platforms, programs and strategic partnerships. We believe that Pyxis will continue to execute its multi-asset multi-platform corporate strategy and quickly grow into an industry leader in oncology."

About PYX-201
PYX-201 is a first-in-class non-internalizing ADC that targets a tumor-restricted antigen that is overexpressed in several solid tumor types to selectively kill tumor cells while enhancing a robust anti-cancer immune response.

About PYX-202
PYX-202 targets a tumor cell surface antigen that is expressed in a range of solid tumors. PYX-202 is an ADC designed to reduce toxicity by using a highly stable linker and a well-understood cytotoxic agent.

About PYX-203
PYX-203 is an ADC that targets an antigen expressed in certain hematologic malignancies. PYX-203 utilizes a highly potent DNA-damaging agent designed to reduce the potential for development of drug resistance and disease relapse.

On March 30, 2021 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported financial results for the quarter and full year ended December 31, 2020 (Press release, Immatics, MAR 30, 2021, View Source [SID1234577334]).

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Harpreet Singh, Ph.D., CEO of Immatics commented, "The past year was exceptional for Immatics with the advancement of our pipeline programs, expansion of our leadership team and scientific advisory board and the completion of our listing on the Nasdaq. Building on this foundation, we have recently delivered encouraging data from three clinical TCR-T studies demonstrating first anti-tumor activity in heavily pre-treated solid cancer patients. This early data also constitutes a first clinical validation for our differentiated TCR therapeutics platform. We look forward to reporting further data from our Phase 1 ACTengine TCR-T trials as well as the progress in our TCR Bispecifics programs (TCER) in the latter part of this year."

Fourth Quarter 2020 and Subsequent Company Progress

Adoptive Cell Therapy Programs

·ACTengine IMA200 series – Immatics provided a clinical data update from three ongoing ACTengine Phase 1 trials for its engineered Adoptive Cell Therapy approach (also known as TCR-T) in March. The combined data readout during early phases of dose escalation for the ACTengine programs, IMA201, IMA202 and IMA203, indicated first anti-tumor activity with tumor shrinkage observed in 8 out of 10 patients including one unconfirmed partial response as of data cut-off. This was consistent with the observed robust engraftment, persistence and tumor infiltration of infused ACTengine T cells. Overall, all product candidates demonstrated a manageable safety and tolerability profile. An additional Phase 1a read-out for IMA201 and IMA203 and initial Phase 1b data for IMA202 from the dose expansion cohort is planned for H2 2021. Submission of a clinical trial application (CTA) for the fourth IMA200 series program, IMA204, remains anticipated for H2 2021. The company presented the first preclinical data for the program in September 2020, which is directed at a novel target, COL6A3 exon 6 that is expressed in the tumor stroma of a variety of solid cancers.

Immatics Press Release March 30, 2021 1 | 9

TCR Bispecifics Programs

·IMA401 – Immatics presented preclinical proof-of-concept data from its lead TCER program, IMA401, at the European Antibody Congress 2020 in November. IMA401 is an antibody-like, "off-the-shelf" biologic directed against a high-density peptide target derived from MAGEA4/8. Submission of a CTA for IMA401 remains on track by the end of 2021.

·IMA402 – Immatics plans to announce preclinical proof-of-concept data for its second TCER program, IMA402 in Q2 2021. GMP process development activities are targeted to begin at the same time to advance this program towards the Investigational New Drug (IND) stage and clinical development.

Corporate Developments

Scientific Advisory Board Update

·Immatics has established a new Scientific Advisory Board (SAB) comprised of several leaders and scientific pioneers in immuno-oncology, adoptive cell therapies, clinical oncology and cancer biology. The members of the new SAB include Gwendolyn Binder, Dirk Busch, Christoph Huber, Patrick Hwu, Roland Kontermann, Crystal Mackall, Hidde Ploegh, Hans-Georg Rammensee, and Cassian Yee. Patrick Hwu and Crystal Mackall will co-chair the SAB. Additional information about the members can be found on the Immatics website.

Amendment to Resale Registration Statement

·In connection with the filing of the Annual Report on Form 20-F, Immatics will file an amendment to its existing resale registration statement on Form F-1 to update certain information. This registration statement relates solely to the resale of shares by certain stockholders, and the filing of the amendment is not necessarily indicative of any sales by the holders of their shares. No shares will be issued or sold by Immatics pursuant to the registration statement.

Full Year 2020 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €232.0 million ($284.7 million1) as of December 31, 2020 compared to €119.4 million ($146.5 million1) as of December 31, 2019. The increase is mainly the result of the business combination with ARYA Sciences Acquisition Corporation completed in July 2020 (ARYA merger) and the concurrent PIPE Financing.

Immatics Press Release March 30, 2021 2 | 9

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €31.3 million ($38.4 million1) for the year ended December 31, 2020, compared to €18.4 million ($22.6 million1) for the year ended December 31, 2019.

Research and Development Expenses: R&D expenses were €67.1 million ($82.3 million1) for the year ended December 31, 2020, compared to €40.1 million ($49.2 million1) for the year ended December 31, 2019. The increase is mainly due to an increase in preclinical and clinical development expenses and an increase in share-based compensation (€14.5 million; $17.8 million1 for the year ended December 31, 2020 compared to €1.6 million; $1.9 million for the year ended December 31, 2019).

General and Administrative Expenses: G&A expenses were €34.2 million ($42.0 million1) for the year ended December 31, 2020, compared to €11.8 million ($14.5 million1) for the year ended December 31, 2019. The increase is mainly due to an increase in share-based compensation (€10.9 million; $13.4 million1 for the year ended December 31, 2020 compared to €0.5 million; $0.6 million for the year ended December 31, 2019) as well as one-time transaction costs of the NASDAQ listing in connection with the ARYA merger in July.

Net Loss: Net loss was €229.6 million ($281.7 million1) for the year ended December 31, 2020, compared to €32.5 million ($39.9 million1) for the year ended December 31, 2019, of which €152.8 million ($187.5 million1) resulted from a one-time, non-cash expense in connection with the ARYA merger. The main part of this €152.8 million ($187.5 million1) non-cash expense resulted from the share price increase between signing and closing of the ARYA merger.

Full financial statements can be found in the Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2020 (1 EUR = 1.2271 USD).

Upcoming Investor Conferences

·Kempen Life Science – April 28, 2021

·Bank of America Healthcare Conference – May 11-13, 2021

·Jefferies Virtual Healthcare Conference – June 1-3, 2021

To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

On March 30, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the fiscal year ended December 31, 2020 and provided a business update on recent corporate and clinical developments (Press release, Protalix, MAR 30, 2021, View Source [SID1234577333]).

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"2020 was an important year for Protalix, as we continued to strengthen the clinical profile of PRX–102 for the treatment of Fabry disease and advance towards potential commercialization of our lead pipeline program," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We advanced our earlier stage pipeline with the exclusive partnership we announced with SarcoMed USA for our PRX–110 asset, and we solidified our balance sheet to provide the financial backing to drive the Company through our 2021 milestones."

"We expect 2021 will also be an important year for Protalix as we await the FDA’s review of the PRX–102 BLA on the upcoming April 27, 2021 PDUFA date. We are grateful to our employees and external partners for their commitment and dedication during a very challenging time with the global pandemic. We look forward to continuing to build stockholder value," concluded Mr. Bashan.

2020 Full-Year and Recent Business Highlights

Regulatory Advancements

On August 11, 2020, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, announced that the FDA had accepted the BLA for PRX–102, and granted Priority Review designation for PRX–102, for the proposed treatment of adult patients with Fabry disease. The FDA indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application. The FDA set a PDUFA action date of January 27, 2021. However, as previously announced in November 2020, the FDA subsequently extended the PDUFA action date to April 27, 2021. As we disclosed last year, the FDA has advised that it will have to inspect our manufacturing facility and the facility of a third party in Europe that performs fill and finish processes for PRX-102 as part of its review of the BLA to ensure cGMP compliance. Due to COVID-19-related FDA travel restrictions, the FDA has advised that it may be unable to conduct the inspections prior to the PDUFA action date. The Company, together with Chiesi, is addressing this issue.
Clinical Advancements

On February 23, 2021, the Company, together Chiesi, announced positive topline results from the phase III BRIGHT clinical trial, a study designed to evaluate the safety, efficacy and pharmacokinetics of pegunigalsidase alfa, or PRX–102, treatment, 2 mg/kg every four weeks, in up to 30 patients with Fabry disease previously treated with a commercially available enzyme replacement therapy (ERT) (agalsidase alfa – Replagal or agalsidase beta – Fabrazyme). Topline results indicate that 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients.
On December 30, 2020, the Company, together with Chiesi, announced final study results from the phase III BRIDGE clinical trial, a 12–month open-label, single arm switch-over study evaluating the safety and efficacy of PRX–102, 1 mg/kg infused every two weeks, in up to 22 Fabry patients. Final results of the data generated in the study showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to PRX-102.
On October 2, 2020, the Company, together with Chiesi, announced the launch of an Expanded Access Program (EAP) in the United States for PRX–102 for the proposed treatment of Fabry disease.
Corporate & Financial Developments

On February 17, 2021, the Company successfully completed a public offering of its common stock raising gross proceeds of approximately $40.2 million at a price equal to $4.60 per share, before deducting the underwriting discount and estimated expenses of the offering, which was led by BofA Securities and Oppenheimer & Co.
On February 10, 2021, the Company entered into an exclusive partnership with SarcoMed USA for the worldwide development and commercialization of alidornase alfa, or PRX-110, for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis and other related diseases via inhaled delivery.
On March 18, 2020, the Company successfully completed a private placement of its common stock to certain existing and new institutional and other accredited investors raising aggregate net proceeds of approximately $41.3 million at a price equal to $2.485 per share. Each share of common stock issued in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.
On March 16, 2020, the Company announced that it had agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx. Kirin is providing research funding for Protalix scientists to conduct cell line engineering and protein expression studies on the target protein.
Financial Results

For the year ended December 31, 2020, compared to the year ended December 31, 2019

The Company recorded revenues from selling goods of $16.2 million for the year ended December 31, 2020 compared to revenues of $15.9 million for the same period of 2019.
Revenue from licenses and R&D services for the year ended December 31, 2020 were $46.7 million compared to $38.8 million for the year ended December 31, 2019. Revenue from license agreements is recognized in conjunction with the license and supply agreements with Chiesi. The increase is primarily due to revenues recognized in connection with an updated cost estimation of two completed phase III clinical trials of PRX-102.
Cost of goods sold was $10.9 million for the years ended December 31, 2020, and December 31, 2019.
Research and development expenses net for the year ended December 31, 2020 were $38.2 million compared to $44.6 million for the year ended December 31, 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 and reduced costs related to the phase III BALANCE study, as well as a decrease in costs related to manufacturing of the Company’s drug in development as some of the manufactured drug product and related costs have been recorded as inventory. The Company expects research and development expenses to continue to be its primary expense as it enters into a more advanced stage of preclinical and clinical trials for certain of its product candidates.
Selling, general and administrative expenses were $11.1 million for the year ended December 31, 2020, an increase of $1.2 million, or 12%, from $9.9 million for the year ended December 31, 2019. The increase resulted primarily from an increase in share-based compensation costs.
Financial expenses, net was $9.2 million for the year ended December 31, 2020 compared to $7.6 million for the same period of 2019.
Cash, cash equivalents and short-term bank deposits were approximately $38.5 million on December 31, 2020. During the first quarter of 2021, the Company raised gross proceeds of $8.8 million from the sale of common stock under its ATM program and gross proceeds of $40.2 million via the public offering of its common stock.
Net loss for the year ended December 31, 2020 was $6.5 million, or $0.22 per share, basic and diluted, compared to a net loss of $18.3 million, or $1.23 per share, basic and diluted, for the same period in 2019.
Conference Call and Webcast Information

The Company will host a conference call today, March 30, 2021 at 8:30 am Eastern Daylight Time, to review the clinical, corporate, and financial highlights, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source
Webcast Link: View Source
Conference ID: 13716316

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On March 30, 2021 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, 2020 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAR 30, 2021, View Source [SID1234577332]).

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"We are pleased to announce the achievement of our second clinical milestone for PRS-060/AZD1402, triggered by the initiation of phase 2a by our partner, AstraZeneca, who further demonstrated their commitment to our respiratory-focused alliance with an equity investment," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Within our immuno-oncology franchise, we look forward to presenting additional data for two of our 4-1BB-based bispecific programs at AACR (Free AACR Whitepaper), cinrebafusp alfa (PRS-343) and PRS-344, reinforcing our commitment to and leadership in the 4-1BB space. Following the generation of synergistic in vitro data for the combination of cinrebafusp alfa with TUKYSA (tucatinib), we plan to pursue this combination in lower HER2-expressing gastric cancer patients with Seagen. Seagen has also recently made an equity investment in Pieris, further strengthening the alliance we signed in 2018. Partnerships are an important part of our corporate strategy, and our recent announcements reinforce the value our current alliances continue to bring."

PRS-060 & AstraZeneca Collaboration: Pieris will receive a $13 million milestone payment from AstraZeneca for the initiation of patient enrollment in the phase 2a study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha inhibitor the companies are developing for the treatment of moderate-to-severe asthma. The global phase 2a study of PRS-060/AZD1402 is a two-part, multi-center, placebo-controlled clinical study that will evaluate the drug candidate at up to three dose levels using a dry powder formulation administered twice daily on top of standard of care. Additionally, the companies amended their existing agreement to restructure certain commercial economics for PRS-060/AZD1402 by adjusting various milestones and royalty provisions, while fundamentally maintaining the overall value split between AstraZeneca and Pieris. In connection with the amendment, AstraZeneca will make a $10 million equity investment in Pieris through the purchase of 3,584,230 newly-issued shares of Pieris common stock at a price of $2.79 per share.
Cinrebafusp Alfa (PRS-343): Pieris will present an updated dataset for cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific for the treatment of HER2-expressing solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (AACR) (Free AACR Whitepaper) on April 10, 2021. The presentation will include additional clinical benefit and safety data from cohort 13b (18 mg/kg, administered Q2W), as well as biomarker data across all active dose cohorts. The Company is preparing for the phase 2 study of cinrebafusp alfa, expected to begin in the summer of 2021. The phase 2 study will evaluate cinrebafusp alfa in combination with ramucirumab and paclitaxel in high HER2-expressing gastric cancer and in combination with tucatinib in low HER2-expressing gastric cancer. Collaboration partners Lilly and Seagen will supply ramucirumab and tucatinib, respectively, for these study arms.
Seagen Collaboration Expansion: Seagen made a $13 million equity investment in Pieris as part of an ongoing collaboration between the companies. Additionally, the companies have entered into a clinical trial and supply agreement to evaluate the safety and efficacy of combining Pieris’ cinrebafusp alfa with Seagen’s TUKYSA (tucatinib), a small-molecule tyrosine kinase HER2 inhibitor, for the treatment of gastric cancer patients expressing lower HER2 levels (IHC2+/ISH- & IHC1+) as part of the upcoming phase 2 study to be conducted by Pieris. The companies have also amended their existing immuno-oncology collaboration whereby Pieris’ option to co-develop and co-commercialize the second of three programs in the collaboration has been converted to a co-promotion option in the United States.
PRS-344 & Servier Collaboration: Pieris and Servier will present preclinical data for PRS-344/S095012, a 4-1BB/PD-L1 bispecific, as part of a poster session at the AACR (Free AACR Whitepaper) Annual Meeting 2021. The presentation will showcase synergistic data, including in vitro data evaluating potential effects of combining 4-1BB with PD-L1 and the effects of PRS-344 on CD8+ T cells, as well as dose-dependent anti-tumor response in in vivo preclinical models. PRS-344 is expected to enter phase 1 studies this year. Pieris holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales by Servier for this program. Additionally, Pieris completed non-GLP preclinical work for PRS-352, a preclinical-stage program addressing undisclosed targets for immuno-oncology, last quarter; Servier is fully responsible for further development of that program.
Preclinical Respiratory Pipeline: Pieris and AstraZeneca continue to advance each of the four programs in the collaboration beyond PRS-060/AZD1402. Pieris also continues to advance several proprietary discovery-stage respiratory programs and expects to share data and rationale for advancement of one of its proprietary programs this year.
AACR Details:

Cinrebafusp Alfa Oral Presentation:

Title: Clinical and biomarker activity of PRS-343, a bispecific fusion protein targeting 4-1BB and HER2, from a Phase 1 study in patients with advanced solid tumors
Abstract: CT017
Session: CTMS01 – Early Clinical Trials with New Anticancer Agents
Date/Time: The presentation will take place at 2:05 PM EDT on Saturday, April 10, 2021 on Channel 08.

PRS-344 Poster:

Title: Simultaneous costimulatory T-cell engagement and checkpoint inhibition by PRS-344/S095012, a PD-L1 / 4-1BB bispecific compound for tumor localized activation of the immune system
Abstract: LB135
Session: PO.ET01.08 – Targeting the Tumor Microenvironment in Drug Development
Date/Time: This poster will be available beginning at 8:30AM EDT on Saturday, April 10, 2021.

Fiscal Year Financial Update:

Cash Position – Cash and cash equivalents totaled $70.4 million for the year ended December 31, 2020, compared to a cash, cash equivalents, and investments balance of $104.2 million for the year ended December 31, 2019. The decrease was primarily due to funding operating and capital expenses in 2020, partially offset by ATM proceeds and milestone achievements during the year. The December 31, 2020 ending cash position excludes the $13 million received from Seagen in March 2021 and the $23 million to be received from AstraZeneca in connection with the phase 2a study initiation and equity investment.

R&D Expense – R&D expenses were $46.5 million for the year ended December 31, 2020, compared to $55.0 million for the year ended December 31, 2019. The decrease in R&D expenses was primarily due to lower clinical and manufacturing costs on our immuno-oncology programs, in part due to the partial clinical hold on cinrebafusp alfa, lower manufacturing spending on PRS-060 (which is fully reimbursed by AstraZeneca), and lower travel-related expenditures due to COVID-19 restrictions. The overall decrease was partially offset by an increase in allocated IT and facility costs due to the move to a new R&D facility in Hallbergmoos, Germany in early 2020.

G&A Expense – G&A expenses were $16.7 million for the year ended December 31, 2020, compared to $18.4 million for the year ended December 31, 2019. The decrease in G&A expenses was primarily due to lower personnel costs, lower audit and professional fees related to Sarbanes-Oxley readiness, and lower travel-related expenditures due to COVID-19 restrictions. These decreases were partially offset by higher allocated IT and facility costs due to the move to the new R&D facility.

Net Loss – Net loss attributable to common stockholders was $37.2 million or $(0.68) per share for the year ended December 31, 2020, compared to a net loss of $28.3 million or $(0.56) per share for the year ended December 31, 2019.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Tuesday, March 30, 2021, 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). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On March 30, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the publication of a peer-reviewed study titled "Engineered Antibody Fragment against the Urokinase Plasminogen Activator for Fast Delineation of Triple-Negative Breast Cancer by Positron Emission Tomography (Press release, Monopar Therapeutics, MAR 30, 2021, View Source [SID1234577331])." Urokinase plasminogen activator (uPA) is an established biomarker in current breast cancer clinical practice guidelines and its presence is used to select appropriate drug treatment. This study demonstrates the potential to identify breast cancers with uPA overexpression and monitor uPA activity during treatment using PET imaging and Monopar’s uPA antibody fragment radiotracer. Monopar has a panel of proprietary antibodies and antibody fragments to uPA and its receptor uPAR (such as MNPR-101).

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uPA and its receptor uPAR work together to drive aggressive tumor invasion, leading to metastasis, morbidity, and mortality in breast and other cancers. However, uPA is difficult to measure and currently requires a substantial amount of fresh frozen tissue. Monopar’s antibody fragment (ATN-291 F(ab’)2) conjugated to a copper radiotracer enabled rapid PET visualization of tumors with uPA overexpression in a human breast cancer model in mice. PET imaging may expand the current application of uPA as a breast cancer biomarker and enable the monitoring of tumor uPA expression during treatment.

"The publication demonstrates the potential utility of Monopar’s uPA antibody fragments as imaging agents in a model of aggressive triple negative breast cancer," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar and a co-author of the study. "Same-day PET imaging may guide treatment decisions for breast cancer, and potentially other solid cancers, given the established role of uPA in this disease."

"We are pleased with the results of this peer-reviewed study," said Chandler Robinson, MD, Chief Executive Officer of Monopar, "and we look forward to exploring the potential of our versatile panel of uPA/uPAR targeted monoclonal antibodies in cancer imaging, cancer treatment, and other possible applications."