On May 6, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that Shehnaaz Suliman, M.D., MBA, M.Phil., president and chief operating officer of Alector, will participate in a fireside chat at the BofA Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021, at 11:45 a.m. ET (Press release, Alector, MAY 6, 2021, View Source [SID1234579348]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 30 days following the event.

On May 6, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2021 (Press release, Nektar Therapeutics, MAY 6, 2021, View Source [SID1234579365]).

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Cash and investments in marketable securities at March 31, 2021 were approximately $1.1 billion as compared to $1.2 billion at December 31, 2020.

"We continue to build momentum with our clinical pipeline of novel cytokine therapeutics," said Howard W. Robin, President and CEO of Nektar. "We have a robust development program for bempegaldesleukin focused on pursuing large front-line and adjuvant tumor settings. Our five registrational studies underway in melanoma, renal cell carcinoma, and bladder cancer are progressing as planned. In February, we added a sixth registrational study for bempegaldesleukin plus pembrolizumab in head and neck cancer, which we expect to initiate later this year. In addition, we remain on track to report the first data for our PROPEL study evaluating bempegaldesleukin plus pembrolizumab in patients with metastatic non-small cell lung cancer in the second half of 2021."

"For our second cytokine program in oncology, NKTR-255, our initial efforts include two Phase 1 clinical studies in combination with ADCC antibodies, one in hematological malignancies and one in solid tumors, and we look forward to sharing data from these studies in Q4 of this year," continued Mr. Robin. "Finally, as part of the broad development program for NKTR-358, our T regulatory cell IL-2 agent, our partner Eli Lilly is conducting Phase 2 studies in both lupus and ulcerative colitis and plans to initiate additional Phase 2 studies in two different immune-mediated diseases over the next 9-12 months."

Summary of Financial Results

Revenue in the first quarter of 2021 was $23.6 million as compared to $50.6 million in the first quarter of 2020. The decrease was due primarily to the recognition of the $25.0 million milestone payment from Bristol-Myers Squibb related to the initiation of the registrational trial of bempegaldesleukin plus Opdivo in muscle-invasive bladder cancer in the first quarter of 2020.

Total operating costs and expenses in the first quarter of 2021 were $133.0 million as compared to $184.2 million in the first quarter of 2020. Operating costs and expenses decreased primarily as a result of $45.2 million in impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program and a decrease in R&D expense.

R&D expense in the first quarter of 2021 was $95.6 million as compared to $109.0 million for the first quarter of 2020. R&D expense decreased primarily due to a decrease in manufacturing costs for bempegaldesleukin.

G&A expense was $31.7 million in the first quarter of 2021 and $26.2 million in the first quarter of 2020. G&A expense increased primarily due to an increase in pre-commercial costs for bempegaldesleukin.

Net loss for the first quarter of 2021 was $123.0 million or $0.68 basic and diluted loss per share as compared to a net loss of $138.7 million or $0.78 basic and diluted loss per share in the first quarter of 2020.

First Quarter 2021 and Recent Business Highlights:

●In February 2021, Nektar announced a clinical trial collaboration and supply agreement with Merck for a Phase 2/3 study of bempegaldesleukin, Nektar’s investigational IL-2 pathway agent, in combination with Merck’s KEYTRUDA (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1. The study is planned to start in the second half of 2021.

●In February 2021, Nektar announced a financing and co-development collaboration with SFJ Pharmaceuticals for the development of bempegaldesleukin plus pembrolizumab in SCCHN. SFJ has agreed to fund up to $150 million to support the planned Phase 2/3 study and manage clinical trial operations for the study. In return, Nektar agrees to pay SFJ success-based annual milestone payments over a period of seven to eight years which are contingent upon receipt of certain U.S. regulatory approvals for specified indications for bempegaldesleukin, and will begin following completion of the SCCHN study, which is projected to be completed in 2024

Conference Call to Discuss First Quarter 2021 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, May 6, 2021.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 6, 2021.

To access the conference call, follow these instructions:

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call

On May 6, 2021 XOMA Corporation (Nasdaq: XOMA) reported its first quarter 2021 financial results and provided a recent operations update (Press release, Xoma, MAY 6, 2021, View Source [SID1234579382]).

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"Our team continues to identify exciting assets to add to our milestone and royalty portfolio. Their efforts resulted in our acquisition of two economic licenses from Viracta during the first quarter. We were delighted to add Day One Biopharmaceuticals’ DAY101 (pan-RAF kinase inhibitor) and Denovo Biopharma’s vosaroxin (topoisomerase II inhibitor) to our growing list of partner-funded assets," stated Jim Neal, Chief Executive Officer of XOMA. "I am proud that our team continues to be productive in this COVID-impacted environment.

"In addition, since the close of the first quarter, we added three clinical-stage assets to our portfolio, AFM13, AFM24, and an undisclosed asset, each of which resulted from a research and discovery license agreement we established with Affimed fifteen years ago. These are three interesting oncology assets as they are designed to activate the body’s innate immune system to kill cancer cells. We believe the initial data from the AFM13 Phase 1 study in patients with relapsed/refractory CD30+ lymphomas, recently presented at the AACR (Free AACR Whitepaper) Virtual Annual Meeting, are encouraging. This week, we received notification from Janssen that the first patient has been dosed in the inaugural cetrelimab Phase 3 clinical study, making it the second molecule in our portfolio to advance to the final stage of clinical development.

"To continue to support our strategy to expand our potential milestone and royalty portfolio via acquisition transactions, in April we completed a $40 million offering of Series B Perpetual Preferred Stock, which pays an 8.375% dividend, bringing our cash and restricted cash to over $100 million. And finally, we paid our first dividend on the Series A Perpetual Preferred Stock. Today, we have one of the strongest financial positions in our recent history, particularly when coupled with our very lean expense structure."

Financial Results

XOMA recorded total revenues of $0.4 million for the first quarter of 2021, compared to $0.8 million for the first quarter of 2020. The decrease for the three months ended March 31, 2021, as compared to the same period in 2020, was primarily due to $0.5 million in revenue recognized in the first quarter of 2020 related to a milestone event under XOMA’s license agreement with Compugen.

Research and development expenses were $0.1 million for the first quarter of 2021, compared to $0.1 million for the first quarter of 2020.

General and administrative ("G&A") expenses were $6.7 million for the first quarter of 2021, compared to $6.4 million for the first quarter of 2020. The increase of $0.3 million for the three months ended March 31, 2021, as compared to the same period of 2020, was primarily due to a $1.4 million increase in salary and related expenses (including an increase of $1.1 million in non-cash stock compensation expense) and $0.3 million increase in consulting and deal costs, partially offset by a $1.4 million decrease in bad debt expense.

In the first quarter of 2021, G&A expenses included $2.9 million in stock-based compensation expense compared with $1.8 million in the corresponding quarter of 2020. The increase in expense was primarily due to an increase in the fair value of options granted driven by an increase in our stock price. In the first quarter of 2020, non-cash G&A expenses also included $1.4 million in bad debt expense. The Company’s net cash used in operations in the first quarter of 2021 was $0.9 million, as compared with $2.3 million during the first quarter of 2020.

In the first quarter of 2021, XOMA recorded $0.3 million in total interest expense, as compared to $0.5 million in the corresponding period of 2020, both of which reflect the Company’s outstanding loan balances with Silicon Valley Bank and Novartis.

For the quarter ended March 31, 2021, XOMA recorded total other expense of $0.7 million, which included a $0.7 million change in the fair value of equity securities. For the quarter ended March 31, 2020, XOMA reported total other expense of $0.1 million, which included a $0.3 million change in the fair value of equity securities offset by $0.1 million in investment income.

In the first quarter of 2020, XOMA recorded an income tax benefit of $1.5 million as a result of a provision regarding net operating loss carrybacks within the CARES Act.

Net loss for the first quarter of 2021 was $7.4 million, compared to net loss of $4.8 million for the first quarter of 2020.

On March 31, 2021, XOMA had cash of $67.8 million. The Company ended December 31, 2020, with cash of $84.2 million. On April 12, 2021, XOMA announced the closing of its Depositary Shares Offering and the exercise of the underwriters’ option, which resulted in approximately $38.0 million after deducting underwriting discounts and commissions, but before expenses. On April 15, 2021, the Company paid its first dividend on Series A Cumulative Perpetual Preferred (Nasdaq: XOMAP) in the amount of $0.71875 per share. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

On May 6, 2021 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) ("IntelGenx") reported that it will release its first quarter 2021 financial results after market close on Thursday, May 13, 2021 (Press release, IntelGenx, MAY 6, 2021, View Source [SID1234579400]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

First Quarter 20210 Results Conference Call Details:

The call will also be broadcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On May 6, 2021 ESSA Pharma Inc. ("ESSA" or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal second quarter ended March 31, 2021 (Press release, ESSA, MAY 6, 2021, View Source [SID1234579416]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"This quarter was a very productive period for ESSA. We continue to advance our lead product candidate, EPI-7386, in an ongoing Phase 1 trial in patients with metastatic castration-resistant prostate cancer who are resistant to standard-of-care treatments. We recently reported promising preliminary pharmacokinetic and clinical data from the study and expect to provide a clinical update in the fourth quarter of this calendar year," said Dr. David R. Parkinson, M.D., President and Chief Executive Officer of ESSA Pharma. "During the quarter, we also announced clinical collaborations with Janssen and Astellas, and recently on April 28th entered into a partnership with Bayer, all focused on evaluating EPI-7386 in Phase 1/2 clinical studies in combination with their respective anti-androgen therapies."

Dr. David R. Parkinson added, "With the completion of a successful public offering in which we raised approximately $150 million, we are well-positioned to fund our monotherapy and collaboration studies of EPI-7386 in prostate cancer. In addition, the funding will expand and accelerate our discovery and preclinical research and development efforts to continue to build value across our overall pipeline."

Recent Clinical and Corporate Highlights

On April 28, 2021, the Company announced a clinical collaboration with Bayer to evaluate EPI-7386 in combination with Bayer’s androgen receptor inhibitor, darolutamide, in patients with metastatic castration-resistant prostate cancer ("mCRPC"). Under the terms of the agreement, Bayer may sponsor and conduct a Phase 1/2 study to evaluate the safety, pharmacokinetics and efficacy of the combination of EPI-7386 and darolutamide in mCRPC patients. ESSA will supply EPI-7386 for the trial and will retain all rights to EPI-7386. The clinical study is expected to start in the second half of calendar 2021.

On April 10, 2021, the Company reported updated preclinical data on EPI-7386 at the 2021 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that the product candidate can inhibit in vitro androgen receptor ("AR") splice variants including AR-v567es. The results also suggest that EPI-7386 can inhibit AR related transcription and EPI-7386 in combination with enzalutamide may result in broader and deeper inhibition of the AR pathway.

On February 25, 2021, the Company announced a clinical collaboration with Astellas Pharma Inc. ("Astellas") to evaluate the combination of EPI-7386 and Astellas/Pfizer’s androgen receptor inhibitor, enzalutamide, for patients with mCRPC. Under the terms of the agreement, ESSA will sponsor and conduct a Phase 1/2 study to evaluate the safety, tolerability and preliminary efficacy of the combination of EPI-7386 and enzalutamide in mCRPC patients who have not yet been treated with second-generation antiandrogen therapies. Astellas will supply enzalutamide for the trial. ESSA will retain all rights to EPI-7386. The clinical study remains on track to start in the second half of calendar 2021.

On February 22, 2021, the Company completed an underwritten public offering for aggregate gross proceeds of $149,999,985. The Company issued a total of 5,555,555 common shares of the Company at a public offering price of $27.00 per share, including the underwriters’ fully exercised option to purchase an additional 724,637 shares.

On January 13, 2021, the Company announced a clinical collaboration with Janssen Research & Development, LLC ("Janssen") to evaluate EPI-7386 in combination with abiraterone acetate/prednisone or apalutamide for patients with mCRPC. Under the terms of the agreement, Janssen may sponsor and conduct up to two Phase 1/2 studies evaluating the safety, tolerability and preliminary efficacy of the combination of EPI-7386 and apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with mCRPC who have failed a second-generation antiandrogen therapy. Janssen will assume all costs associated with these studies other than the manufacturing costs associated with the clinical drug supply of EPI-7386. The parties will form a joint oversight committee for the clinical studies, which are planned to start in 2021. ESSA will retain all rights to EPI-7386.
Summary Financial Results

Net Loss. ESSA recorded a net loss of $13.0 million ($0.36 loss per common share based on 36,484,041 weighted average common shares outstanding) for the quarter ended March 31, 2021, compared to a net loss of $9.4 million ($0.45 loss per common share based on 20,821,956 weighted average common shares outstanding) for the quarter ended March 31, 2020. For the period ended March 31, 2021, this included non-cash share-based payments of $2.7 million compared to $3.6 million for the prior year, recognized for stock options granted and vesting.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended March 31, 2021 were $7.3 million compared to $4.6 million for the quarter ended March 31, 2020 and includes non-cash costs related to share-based payments ($791,969 for period ended March 31, 2021 compared to $1.0 million for period ended March 31, 2020). The increase in R&D expenditures for the second quarter were primarily related to the increased expenditure on chemistry and manufacturing of the drug product, and clinical costs related to the Phase 1 clinical trial of EPI-7386, which commenced with the dosing of the first patient in July 2020.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended March 31, 2021 were $4.6 million compared to $4.9 million for the quarter ended March 31, 2020 and include non-cash costs related to share-based payments of $1.9 million for the period ended March 31, 2021 compared to $2.6 million for the period ended March 31, 2020. The increase in the second quarter is the result of increased share-based payments related the expense recognized in relation to the grant and vesting of these equity instruments.
Liquidity and Outstanding Share Capital
At March 31, 2021, the Company had available cash reserves and short-term investments of $208,597,224 reflecting the gross proceeds of the February 2021 financing of $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period.

As of March 31, 2021, the Company had 40,417,857 common shares issued and outstanding.

In addition, as of March 31, 2021 there were 6,728,398 common shares issuable upon the exercise of warrants and broker warrants. This includes 6,370,000 prefunded warrants at an exercise price of $0.0001, and 358,398 warrants at a weighted average exercise price of $44.13. There are 6,726,642 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.53 per common share.

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with mCRPC whose tumors have progressed on current standard-of-care therapies. The Phase I clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of our Investigational New Drug application and Health Canada acceptance. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.