On May 7, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the first quarter ended March 31, 2020 (Press release, Zymeworks, MAY 7, 2020, View Source [SID1234557297]).

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"While the COVID-19 pandemic has presented unprecedented global challenges, the entire Zymeworks team remains committed to our mission of returning patients home to their loved ones, disease free," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "The clinical trials for our lead candidates, ZW25 and ZW49, provide potential options for patients whose cancer has become refractory to the standard of care. I am extremely proud of how our team, our collaborators, and our clinical investigators have responded to ensure that patients enrolled in our studies continue to receive their treatments as we advance these therapies through the clinic."

Dr. Tehrani added, "With a strong balance sheet and runway into 2022, substantial drug supply, and clinical trials in diverse sites around the globe, Zymeworks is well-prepared to continue moving forward through these challenging times. We look forward to providing a corporate update midyear to share our progress."

COVID-19 Business Update

Zymeworks continues to closely monitor the COVID-19 pandemic and adapt its business operations while prioritizing the health and well-being of patients, clinical investigators, and personnel. In accordance with recommendations from health authorities, Zymeworks has transitioned to a remote working arrangement to protect employees and the broader community while maintaining business continuity. All clinical trial sites remain open and active with a heightened focus on patient safety and data integrity. While the effects of the pandemic are expected to slow the pace of patient recruitment due to the diversion of healthcare resources to COVID-19 response activities, they have not had a material impact on the company’s financial condition, liquidity, or longer-term strategic development and commercialization plans. Following the guidance of local health authorities, Zymeworks has begun implementing plans for employees to return working on site.

First Quarter 2020 Business Highlights and Recent Developments

•Strong Financial Position; Extended Runway
Zymeworks completed an upsized public financing with gross proceeds of US$320.8 million and ended the first quarter with $562.7 million in cash resources. Based on current operating plans, Zymeworks expects to have cash to fund research and development programs and operations into 2022 and potentially beyond.

•ZW25 Advances in Three New Global Clinical Trials
Zymeworks’ partner BeiGene dosed the first patient in a Phase 1b/2 trial evaluating ZW25 in combination with chemotherapy as a first-line treatment for patients with metastatic HER2-positive breast cancer and in combination with chemotherapy and BeiGene’s PD-1-targeted antibody tislelizumab as a first-line treatment for patients with metastatic HER2-positive gastroesophageal adenocarcinoma (GEA). In addition, Zymeworks initiated a Phase 2 trial and collaboration with Pfizer to evaluate ZW25 in combination with palbociclib and fulvestrant in HER2-positive, hormone receptor-positive breast cancer.

•ZW49 Continues to Advance in Phase 1 Dose-Escalation Study
An update in January highlighted that there had been no dose-limiting toxicities observed and the maximum tolerated dose had not been reached. The majority of treatment-related adverse events were grade 1 or 2, and were reversible and manageable on an outpatient basis. Preliminary results from these initial dose cohorts included anti-tumor activity.

•Strengthens Commercial Leadership and Board of Directors
James Priour recently joined as Senior Vice President, Commercial, providing invaluable direction as Zymeworks begins registration-enabling trials with ZW25 this year. Before joining Zymeworks he held various international commercial leadership roles with Procter & Gamble Pharmaceuticals, Bristol Myers Squibb, and most recently at Amgen where he was the Global Product General Manager for Kyprolis and the early myeloma pipeline. Zymeworks also appointed Dr. Kelvin Neu, Partner at Baker Bros. Advisors LP, to the Board of Directors adding clinical knowledge and partnering expertise.

Financial Results for the Quarter Ended March 31, 2020

Revenue for the three months ended March 31, 2020 was $8.3 million as compared to $11.9 million in the same period of 2019. Revenue for the first quarter of 2020 included recognition of a $5.0 million development milestone and $2.2 million in drug supply revenue under the license and collaboration agreements with BeiGene as well as $1.1 million in research support and other payments from Zymeworks’ partners. Revenue for the first quarter of 2019 related primarily to an $8.0 million development milestone payment under the license and collaboration agreement with Lilly, recognition of $3.5 million of deferred revenue from the licensing and collaboration agreement with BeiGene, as well as $0.4 million in research support payments.

For the three months ended March 31, 2020, research and development expenses were $36.5 million as compared to $17.5 million in the same period of 2019. The change was primarily due to an increase in clinical trial activity and associated drug manufacturing costs for ZW25, as well as an increase in other research and discovery activities as compared to the same period in 2019. Research and development expenses also included non-cash stock-based compensation expense of $2.0 million from equity classified equity awards and a $1.8 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.
For the three months ended March 31, 2020, general and administrative expenses were $7.6 million as compared to $9.0 million in the same period in 2019. The change was primarily due to a decrease in employee compensation expense relating to non-cash stock-based compensation, which was partially offset by an increase in head count in 2020 over 2019, associated with year-over-year corporate growth. General and administrative expenses included non-cash stock-based compensation expense of $2.2 million from equity classified equity awards and a $5.4 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.
Net loss for the three months ended March 31, 2020 was $31.1 million as compared to $13.6 million in the same period of 2019. This was primarily due to the decrease in revenue and increase in research and development expenses referred to above, partially offset by higher interest and other income as well as lower general and administrative expenses.
Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.
As of March 31, 2020, Zymeworks had $562.7 million in cash resources consisting of cash, cash equivalents, short-term investments and certain long-term investments.

On May 7, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the regulatory pathway for Vicinium in Europe (Press release, Sesen Bio, MAY 7, 2020, View Source [SID1234557296]). The Company’s lead program, Vicinium, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicinium to the United States Food and Drug Administration (FDA) under Rolling Review.

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"We are very pleased to have received positive guidance from the CHMP on the regulatory approval pathway for Vicinium," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We strongly believe that Vicinium is a highly differentiated product candidate that is well positioned to address the considerable unmet need in NMIBC. This encouraging progress reinforces our confidence in bringing Vicinium to market in Europe, which represents a tremendous opportunity for the company. We will continue working collaboratively with the EMA to move Vicinium through the approval process as expeditiously as possible."

Key Elements of CHMP Scientific Advice

The CHMP agreed that the Company’s nonclinical, clinical pharmacology and safety database are all sufficient to support a marketing authorization application (MAA). Furthermore, additional clinical trials were not requested by the CHMP in support of the MAA submission for Vicinium.
The CHMP agreed that due to the well-known impact of cystectomy on morbidity and quality of life of patients, a new local treatment that enables patients to avoid radical cystectomy would be meaningful, especially for patients who are contraindicated for cystectomy.
The CHMP provided guidance on additional data analyses they expect to be included in the MAA, and the Company is confident that these can be fully addressed with the completed Phase 3 dataset.
Based on the guidance received, the Company expects to submit the MAA for Vicinium to the EMA in early 2021, with potential approval anticipated in early 2022.
The Company expects to receive Scientific Advice from the CHMP on the Chemistry, Manufacturing and Controls (CMC) program for Vicinium at a later date.
The Company believes there is a significant commercial opportunity in Europe and projects European peak sales to be substantially greater than US peak sales, driven by the significantly higher incidence rates and strong pricing benchmarks in the region.

About Vicinium

Vicinium, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On May 7, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the first quarter 2020 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAY 7, 2020, View Source [SID1234557295]).

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"Bellicum entered the year with a renewed strategic focus on our novel GoCAR programs and we are pleased with the progress of our three development assets in the face of the COVID-19 pandemic," said Rick Fair, President and Chief Executive Officer of Bellicum. "Despite the public health challenges, we continued enrollment in our BPX-601 clinical trial, advanced our non-clinical research, and completed the strategically important sale of our facility to MD Anderson. Most importantly, we remain committed to the health and safety of our employees, our clinical collaborators, and patients involved in our clinical trials, and are closely monitoring and responding to public health guidance as we continue our important work."
PROGRAM HIGHLIGHTS AND CURRENT UPDATES

BPX-601 GoCAR-T
•Bellicum is currently enrolling patients in cohort 5C of the BPX-601 clinical trial in relapsed pancreatic cancer to evaluate the safety of repeat rimiducid dosing to re-activate BPX-601 cells over time. This is the first-in-human experience using the GoCAR platform as intended. Initial results from Cohort 5C are expected to be presented at a medical meeting by the end of 2020. Bellicum presented new Phase 1 translational data for BPX-601 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco in January 2020. Primary observations included tumor infiltration, GoCAR-T mediated immunomodulation, survival and persistence of cells for up to nine months, and changes in the tumor microenvironment gene expression consistent with a productive CAR-T cell immune response.

BPX-603 GoCAR-T
•Bellicum continues to conduct its investigational work in preparation of its response to the FDA’s request to further characterize this product candidate and support potential IND clearance. Management expects to provide an update on its progress for this program in the third quarter of 2020.

BCMA GoCAR-NK Program
•Preclinical development activities are continuing for Bellicum’s GoCAR-NK program targeting B-cell maturation antigen, or BCMA, for the treatment of multiple myeloma. Allogeneic GoCAR-NK cells may improve the durability of clinical responses while offering the anticipated advantages that an off-the-shelf product may provide, including faster and more certain time to treatment, greater scalability and convenience, and potentially lower cost. Management expects to present additional preclinical data for this program by the end of 2020.

Exhibit 99.1

Corporate Highlights
•In April 2020, Bellicum closed a transaction in which The University of Texas MD Anderson Cancer Center acquired Bellicum’s approximately 60,000-square-foot Houston facility, including manufacturing, office and laboratory space, for $15.0 million. In conjunction with the asset purchase agreement, Bellicum entered into a master services agreement with MD Anderson under which MD Anderson will manufacture Bellicum’s cellular therapy candidates, in addition to using the facility for its own internal programs. Concurrent with this transaction, Bellicum partially repaid approximately $7.0 million of its Oxford Finance debt obligations.

Potential for COVID-19 Impact
•Due to the COVID-19 pandemic, MD Anderson has temporarily closed its cell therapy manufacturing facilities. Bellicum does not currently expect the facility closure to significantly impact the company’s clinical trial progression and the timing of results, but such delays are possible depending on the duration of closure. The exact timing of potential delays and the overall impact of the COVID-19 pandemic on Bellicum’s business, its ability to obtain clinical material, and to conduct preclinical research and clinical trials in a timely manner is currently unknown. So far, the pandemic has not had a material impact on Bellicum’s ability to conduct its business activities, but that could change, and management is monitoring and responding to the crisis as it continues to evolve.

First Quarter 2020 Financial Results
R&D Expenses: Research and development (R&D) expenses were $10.4 million for the first quarter of 2020, compared to $16.8 million for the first quarter of 2019. The reduction in expenses in the first quarter of 2020 resulted primarily from reduced expenses related to rivo-cel and the reduction in force that was implemented during the second half of 2019, partially offset by an increase in expenses related to our GoCAR programs.

G&A Expenses: General and administrative (G&A) expenses were $4.2 million for the first quarter of 2020 compared to $7.5 million during the comparable period in 2019. The reduction in expenses in the first quarter 2020 relative to the comparable period in 2019 were primarily due to the reduction in rivo-cel related commercialization activities as well as the effects of the reduction in force that reduced employee-related charges.

Loss from Operations: Bellicum reported a loss from operations of $14.6 million for the first quarter of 2020 compared to a loss from operations of $23.9 million for the first quarter of 2019. Cash used in operating activities was $16.3 million for the first quarter of 2020, compared to cash used in operating activities of $24.6 million.
Net Income/Loss: Bellicum reported net income of $17.6 million for the first quarter of 2020 compared to a net loss of $24.5 million for the first quarter of 2019. The results included a non-cash gain of $32.8 million related to the change in fair value of warrant and private placement option liability in the first quarter of 2020.
Shares Outstanding: As of March 31, 2020, Bellicum had 5,049,892 shares of common stock outstanding and 534,000 shares of preferred stock outstanding. Each share of preferred stock can be converted into 10 shares of common stock.
Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $75.5 million as of March 31, 2020, compared to $93.8 million as of December 31, 2019. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second half of 2021. Management expects cash utilization of $55 to $65 million in 2020.

On May 7, 2020 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the first quarter ended March 31, 2020, and provided an update on recent clinical achievements (Press release, vTv Therapeutics, MAY 7, 2020, View Source [SID1234557294]).

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"In spite of the challenges presented by the COVID-19 pandemic, we are encouraged by the continued progress we made this past quarter with our two key late stage clinical programs for TTP399 for the treatment of type 1 diabetes and azeliragon for the treatment of Alzheimer’s disease in patients with type 2 diabetes," said Steve Holcombe, chief executive officer. "With respect to TTP399, we are engaging with the FDA regarding our proposed pivotal study development plan to seek regulatory approval for this oral adjunct therapy to insulin. Additionally, we continue to enroll patients in the Elevage study of azeliragon and are considering various strategies to maintain our expected timelines for announcing certain study results in the first half of next year."

Recent Achievements and Outlook

Type 1 Diabetes Study

Full results from the SimpliciT-1 Study to be presented at ADA. We will present posters detailing further results from the phase 2 Simplici-T1 Study of TTP399 in patients with type 1 diabetes at the 80th Scientific Sessions held virtually by the American Diabetes Association, June 12-16th.

Alzheimer’s Disease Study

Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv Therapeutics continues to enroll patients in the Phase 2 part of the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer’s disease (AD) and type 2 diabetes.

Financing Activities

During April, we entered into a pair of agreements in order to provide additional financial flexibility and availability of additional capital to fund our operations.

Amendment to the Loan Agreement. On April 1, 2020, we entered into the Second Amendment to our existing Loan Agreement to allow monthly, interest-only payments on the outstanding principal balance for three months beginning April 1, 2020 before reverting to the previous payment schedule. The Second Amendment also removes the requirement for the Company to maintain a minimum cash balance for the three months beginning April 1, 2020. Thereafter, the Company must maintain a minimum cash balance amount of up to $1.0 million.

ATM Offering. On April 24, 2020, we entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald under which we may offer and sell, from time to time, shares of our Class A common stock having an aggregate offering price of up to $13.0 million.

First Quarter 2020 Financial Results

Cash Position: The Company’s cash position as of March 31, 2020, was $2.9 million compared to $4.3 million as of December 31, 2019. Of these amounts, $2.5 million was restricted due to the requirements of its Loan Agreement. However, the requirement to maintain this level of minimum cash was temporarily eliminated effective April 1, 2020 in connection with the Second Amendment to the Loan Agreement discussed above.

Revenue: Revenues were insignificant for both the first quarter of 2020 and the fourth quarter of 2019.

R&D Expenses: Research and development expenses were relatively consistent between periods with $4.2 million in the first quarter of 2020 and $4.4 million in the fourth quarter of 2019.

G&A Expenses: General and administrative expenses were $2.5 million for the first quarter of 2020 and $2.0 million for the fourth quarter of 2019, respectively. The increase in these costs was primarily attributable to increased professional and legal fees incurred in the first quarter of 2020.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $7.2 million for the first quarter of 2020 compared to $6.9 million for the fourth quarter of 2019.

Net Loss Per Share: GAAP net loss per share was $0.11 and $0.13 for the three months ended March 31, 2020 and December 31, 2019, respectively, based on weighted-average shares of 43.5 million and 38.0 million for the three-month periods ended March 31, 2020 and December 31, 2019, respectively. Non-GAAP net loss per fully exchanged share was $0.11 for each of the three months ended March 31, 2020 and December 31, 2019, respectively, based on non-GAAP fully exchanged weighted-average shares of 66.6 million and 61.0 million for the three months ended March 31, 2020 and December 31, 2019, respectively.

On May 7, 2020 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported its financial results for the first quarter ended March 31, 2020, and provided an update on clinical development programs (Press release, Protagonist, MAY 7, 2020, View Source [SID1234557293]).

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"Based on the highly promising and consistent clinical responses achieved to date, we are pleased to announce polycythemia vera as the first indication for a pivotal study of PTG-300," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "With an orphan drug development regulatory path forward, we are focused on rapidly advancing PTG-300 as a first-in-class non-cytoreductive hepcidin hormone mimetic agent for this indication with significant unmet need. With a highly focused development effort forward with PTG-300 for polycythemia vera, and deferring PN-943 Phase 2 initiation due to the current COVID-19 environment, we have reduced our operational expenditures and now have an additional six months of cash runway estimated to extend through mid-2022."

Product Development Update

PTG-300: Injectable Hepcidin Mimetic
Initial Phase 2 results in patients with polycythemia vera from an ongoing study demonstrated that treatment with PTG-300 at individualized doses ranging from 10 mg to 80 mg for up to 28 weeks controlled hematocrit levels. All patients were phlebotomy free (except a single phlebotomy due to an unintended dose interruption in a patient who remains on study). Administration of PTG-300 was well tolerated and the safety profile was generally similar with results of prior studies, with injection site reactions and bruise as the only adverse events related to or possibly related to treatment. Results are available as of the May 1, 2020, cutoff date.
The results of the PTG-300 beta-thalassemia Phase 2 study will be presented at an upcoming medical conference in the second quarter of 2020.

Protagonist will redirect the majority of its PTG-300 efforts to the polycythemia vera indication, while also continuing its exploration of PTG-300 in hereditary hemochromatosis. The Company is discontinuing clinical development for PTG-300 in beta-thalassemia and myelodysplastic syndromes.

PTG-200 (JNJ-67864238): Oral IL-23 Receptor Antagonist for Inflammatory Bowel Disease

In collaboration with Janssen Biotech, we initiated a Phase 2 global study for PTG-200 (or JNJ-67864238) in moderate-to-severe Crohn’s disease in the fourth quarter of 2019. Because of the global COVID-19 pandemic, guidance has been currently suspended on a timeline for study completion.

PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory Bowel Disease

A Phase 2 study of PN-943 in approximately 150 patients with moderate-to-severe ulcerative colitis is currently planned.

In light of the global COVID-19 pandemic, Protagonist continues to review all aspects of the planned Phase 2 study and is currently suspending guidance on a timeline for study initiation. The Company is maintaining readiness to initiate the study as soon as conditions allow for safe accrual of subjects for the global study.

Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2020, were $117.5 million. Due to the focusing of efforts on polycythemia vera and the delay in PN-943 trial initiation caused by the ongoing global COVID-19 pandemic and a related internal reorganization, the company believes its adjusted operating plans now provide sufficient financial resources from its cash, cash equivalents, marketable securities and access to its debt facility to fund its currently planned operating and capital expenditures through mid-2022. The company will continue to monitor events closely and may further adjust its operating plans as warranted.
License and Collaboration Revenue: License and collaboration revenue of $3.6 million for the first quarter of 2020 increased in comparison to $1.6 million reported for the same period of 2019. License and collaboration revenue is generally earned over time as services are provided under the collaboration.
Research and Development ("R&D") Expenses: R&D expenses for the first quarter 2020 were $18.8 million as compared to $12.4 million for the same period of 2019. The increase was primarily due to increased clinical development costs related to PTG-300, PN-943 and our IL-23 receptor antagonist collaboration with Janssen Biotech to develop PTG-200 and the related research collaboration eff

General and Administrative ("G&A") Expenses: G&A expenses for the first quarter 2020 were $4.6 million, as compared to $3.8 million for the same period of 2019. The increase was primarily due to increases in salaries, employee-related expenses and professional services to support the growth in our operationsNet Loss: The first quarter 2020 net loss was $20.1 million, or a net loss of $0.72 per share, as compared to a net loss of $14.1 million, or a net loss of $0.58 per share, for the same period of 2019.

Conference Call and Webcast Information

Protagonist will host a conference call at 5 p.m. EDT / 2 p.m. PDT today to provide a corporate update. Ronald Hoffman, M.D., Director of the Myeloproliferative Diseases Program at The Icahn School of Medicine at Mount Sinai, will join the call to present initial results for PTG-300 in polycythemia vera. To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 4597494. A live and archived webcast will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.