On May 13, 2021 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, reported financial results for the year ended March 31, 2021, and provides corporate update (Press release, Processa Pharmaceuticals, MAY 13, 2021, View Source [SID1234579939]).

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Dr. David Young, CEO and chairman of Processa, commented, "During the first quarter we made substantial progress advancing our three clinical in-licensed drugs, each with a potential market exceeding $1 billion. We expect first patients to be dosed with PCS6422 and PCS499 within the next six weeks, and to receive interim data for PCS6422 near the end of the third quarter of 2021 and interim data for PCS499 during the first quarter of 2022."

Recent Highlights and New Developments

We have selected 5 U.S. clinical sites to enroll patients with ulcerative necrobiosis lipoidica and started the screening process for our first patient in our Phase 2B trial "A Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients who Have Necrobiosis Lipoidica." In order to expedite enrollment for this rare condition, we are evaluating additional clinical sites both within and outside the U.S.

We are initiating clinical sites to enroll patients into our Phase 1B trial "A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors."

We have received guidance from the FDA and plan to submit an IND application in the third quarter of 2021. PCS12852 is a small molecule drug in development for the treatment of gastroparesis and functional gastrointestinal motility disorders.

In February 2021, we closed a private placement with institutional and accredited investors for gross proceeds of $10.2 million. We sold 1,321,132 shares of the common stock at a purchase price of $7.75 per share and received net proceeds of $9.9 million.

Upcoming Clinical Drug Development Milestones

First half of 2021

Dose our first patient in our PCS499 (Ulcerative NL) Phase 2B trial.
Dose our first patient in our PCS6422 (cancer) Phase 1B trial.
Second half of 2021

Submit our IND application for PCS12852 in Gastroparesis to FDA.
Begin our interim cohort results for PCS6422.
First half of 2022

• Obtain interim results from our PCS499 Phase 2B trial.
• Dose our first patient in a Phase 2A trial for PCS12852.

Financial Results for the first quarter of 2021

Our cash and cash equivalents totaled $23 million as of March 31, 2021, compared to $15.4 million as of December 31, 2020. We had 15.5 million shares of common stock outstanding as of March 31, 2021.

Our research and development expenses for the three months ended March 31, 2021 were $1.5 million compared to $501 thousand for the three months ended March 31, 2020. General and administrative expenses for the three months ended March 31, 2021 were $717 thousand compared to $484 thousand for the three months ended March 31, 2020. We reported a net loss for the three months ended March 31, 2021 of $2.1 million compared to a net loss for the comparable prior year period of $874 thousand. Our net loss per share for the three months ended March 31, 2021 was $0.14 compared to net loss per share for the three months ended March 31, 2020 of $0.16.

Conference Call Information

To participate in this event, please dial in approximately 5 to 10 minutes before the beginning of the call.

On May 13, 2021 Systems Oncology, a biotechnology company, reported that Dr. Spyro Mousses, CEO and Co-Founder of Systems Oncology, will participate in a fireside chat at the 2021 RBC Capital Markets Global Healthcare Conference on Thursday, May 20th at 12:40pm EST (Press release, Systems Oncology, MAY 13, 2021, View Source [SID1234579956]).

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Management will host one-on-one investor meetings at the conference. To request a meeting with management, please contact your registered RBC representative or Andrew Matricaria, CFO of Systems Oncology, at [email protected].

On May 13, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of upcoming data presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held virtually June 4 – 8, 2021 and the European Hematology Association (EHA) (Free EHA Whitepaper) annual congress, to be held virtually June 9 – 17, 2021 (Press release, TG Therapeutics, MAY 13, 2021, View Source [SID1234580027]). Details of the data presentations are included below.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are excited to share updated data for TG-1701, our novel BTK inhibitor, as a monotherapy, and as a triple therapy with U2, at the upcoming ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual congresses. The EHA (Free EHA Whitepaper) abstract released yesterday included an update from the data most recently presented at the ASH (Free ASH Whitepaper) 2020 congress, and we are pleased to see with additional patients and longer follow-up the data continue to show TG-1701 to be efficacious and generally well tolerated in combination with U2. We look forward to updating the abstract data and presenting at both the upcoming ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual congresses."

Data to be presented at the ASCO (Free ASCO Whitepaper) meeting:

Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia (CLL) and Lymphoma

Abstract ID: 7525
Available on Demand: Friday, June 4, 2021 at 9:00 AM ET
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, Medical School, University of Western Australia, Crawley, Western Australia
The above abstract will be available on May 19, 2021, via the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org.

Data to be presented at the EHA (Free EHA Whitepaper) meeting:

Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ubituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia (CLL) and Lymphoma

Abstract Code: EP638
Available on Demand: Friday, June 11, 2021 at 9:00 CEST
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, Medical School, University of Western Australia, Crawley, Western Australia
The above abstract is now available via the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org.

At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm

On May 13, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported first quarter 2021 results and provided a corporate update (Press release, aTyr Pharma, MAY 13, 2021, View Source [SID1234580043]).

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"During the first quarter, we remained focused on advancing our lead therapeutic candidate, ATYR1923. We are tracking towards the readout from our Phase 1b/2a proof-of-concept study in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication, which is expected in the third quarter of this year," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We have key mechanistic insights regarding ATYR1923’s anti-inflammatory effects in patients from our Phase 2 study in COVID-19 related respiratory complications. This clinical data is consistent with what we have seen preclinically for key anti-inflammatory cytokines that are implicated in sarcoidosis and other ILD."

"Furthermore, we generated additional preclinical data for ATYR2810, our lead anti-Neuropilin-2 (NRP2) antibody and IND candidate, including research presented at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating tumor inhibitory effects in triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC), as both a single agent and in combination with chemotherapy and the targeted agent bevacizumab. Our manufacturing agreement with Lonza for the production of this antibody reflects our commitment to this program. We are off to a strong start in 2021 and look forward to building upon this progress throughout the year."

First Quarter 2021 and Subsequent Period Highlights

Progressed its Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. Data is expected in the third quarter of this year.

Reported positive results from its Phase 2 study of ATYR1923 in COVID-19 patients with severe respiratory complications, which provided proof-of-mechanism for ATYR1923. The study met its primary safety endpoint and demonstrated signals of clinical activity. Biomarker data showed that ATYR1923 reduced levels of several inflammatory cytokines and chemokines, including those that are implicated in sarcoidosis and other ILD, which is consistent with findings from animal models.

Appointed leading sarcoidosis advocate Andrea Wilson as a patient advisor to the company. Ms. Wilson, Co-Founder and former member of the Board of Directors for the Foundation for Sarcoidosis Research (FSR), will advise the company on patient strategies related to its clinical program for ATYR1923 in pulmonary sarcoidosis.

Participated in a Virtual Town Hall on Steroids and Sarcoidosis in collaboration with the FSR to discuss the burden of steroid treatment for patients with sarcoidosis and the need for new treatments.

Presented two posters at the AACR (Free AACR Whitepaper) Annual Meeting related to preclinical research for ATYR2810 in conjunction with the company’s scientific advisor Dr. Arthur Mercurio and his lab at the Department of Molecular, Cell and Cancer Biology at the University of Massachusetts Medical School. In models of TNBC, ATYR2810 administered in combination with widely used anti-cancer therapeutics, including chemotherapy or the targeted VEGF antibody bevacizumab, increased the anti-tumor effects of each agent. ATYR2810 also down-regulated epithelial-mesenchymal transition genes, which may be a mechanism that mediates its anti-tumor effects. In animal models of NSCLC, ATYR2810 inhibited tumor growth when administered both as a single agent and in combination with chemotherapy.

Entered into an agreement with Lonza, a leading contract development and manufacturing organization, for the manufacture of ATYR2810 to support the progression of ATYR2810 to clinical stage development.

Pangu BioPharma, the company’s Hong Kong subsidiary, together with the Hong Kong University of Science and Technology, achieved the milestones of the first year of a two-year project funded in part by the Hong Kong Government’s Innovation and Technology Commission to develop a high-throughput platform for the development of bispecific antibodies targeting NRP2.

Promoted Leslie Nangle, Ph.D., to Vice President, Research. Dr. Nangle will serve as a member of the company’s executive leadership team, managing research and scientific operations.
First Quarter 2021 Financial Results

Total revenues were $0 and $8.1 million for the three months ended March 31, 2021 and 2020, respectively. Revenues for the three months ended March 31, 2020 consisted primarily of license and collaboration agreement revenues under company’s license agreement with Kyorin. Research and development expenses were $4.5 million and $3.6 million for the three months ended March 31, 2021 and 2020, respectively. The increase was due primarily to manufacturing costs related to ATYR1923, increased research and development expenses related to ATYR2810 and increased expenses related to the research program between Pangu BioPharma, Hong Kong University and the Government of the Hong Kong Special Administration Region. General and administrative expenses were consistent between periods at $2.7 million and $2.6 million for the three months ended March 31, 2021 and 2020, respectively.

During the first quarter of 2021, the company raised gross proceeds of $9.9 million through its at-the-market offering program with H.C. Wainwright & Co., LLC and $15.3 million through its common stock purchase agreement with Aspire Capital Fund, LLC. As of March 31, 2021, aTyr had $50.6 million in cash, cash equivalents and investments.

The company expects its expenses to continue to increase in 2021 as research and development of ATYR1923 and ATYR2810 progress.

Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 6867948. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung disease. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of Neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr recently completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr completed a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study was a randomized, double blind, placebo-controlled study that was designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.

On May 13, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company developing tumor infiltrating lymphocytes, or TIL, therapies for the treatment of patients with cancer, reported its first quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, MAY 13, 2021, View Source [SID1234583996]).

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"In March of 2021, Instil completed an initial public offering to support the development of our TIL therapies. We believe that our continued investment in cell manufacturing and process science will enable the development of our current and future product candidates, with a goal of providing broad patient access," said Bronson Crouch, Chief Executive Officer of Instil. "We recently presented clinical data from our compassionate use program at the AACR (Free AACR Whitepaper) conference and received orphan drug designation from the U.S. Food and Drug Administration for ITIL-168 in melanoma. We continue to advance ITIL-168 towards a potentially registration-enabling Phase 2 clinical trial in advanced melanoma, which we expect to initiate in the second half of this year."

First Quarter 2021 Highlights and Upcoming Anticipated Milestones

Corporate:

Completed Initial Public Offering: On March 23, 2021, Instil closed its initial public offering of 18,400,000 shares of common stock, including the full exercise of the underwriters’ option to purchase an additional 2,400,000 shares of common stock at the public offering price of $20.00 per share. The gross proceeds of the offering were $368 million, before underwriting discounts and commissions and other offering expenses payable by Instil. The Company’s common stock now trades on the Nasdaq Global Select Market under the symbol "TIL."
Clinical and Regulatory:

Orphan Drug Designation for ITIL-168: On April 27, 2021 Instil received orphan drug designation from the U.S. Food and Drug Administration for the treatment of melanoma stages IIB to IV for its ITIL-168 TIL product candidate.
American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting: Presented late-breaking e-Poster on clinical data from a compassionate use program for the treatment of metastatic melanoma at the AACR (Free AACR Whitepaper) virtual meeting April 10 – 15, 2021.
Upcoming Phase 2 Clinical Trial: Instil expects to initiate a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma and begin enrolling patients in the second half of 2021.
Manufacturing:

Facility Readiness for Clinical Trials: Manufacturing facilities in the United Kingdom are functional and ready to support clinical manufacturing for the upcoming ITIL-168 clinical trial, with additional capacity expected to come online later this year. Instil also expects U.S. clinical manufacturing to be online in the first half of 2022.
First Quarter 2021 Financial and Operating Results

As of March 31, 2021, cash and cash equivalents totaled $609.6 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of March 31, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses for the three months ended March 31, 2021 were $14.4 million, compared to $2.0 million for the same period in 2020.

General and administrative expenses for the three months ended March 31, 2021 were $9.0 million, compared to $1.9 million for the same period in 2020.