On May 6, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel, small molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the first quarter ended March 31, 2021 (Press release, Calithera Biosciences, MAY 6, 2021, View Source [SID1234579349]).

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"In the first quarter, we continued to enroll patients in each of our two key clinical development programs. These include the randomized KEAPSAKE trial evaluating telaglenastat in combination with standard-of-care chemoimmunotherapy for non-small cell lung cancer patients with KEAP1/NRF2 genetic mutations and the Phase 1b clinical trial evaluating CB-280 for the treatment of cystic fibrosis," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We look forward to maintaining our focus on these key programs and plan to release interim data from CB-280 in cystic fibrosis in the second half, and from KEAPSAKE in the fourth quarter of this year".

First Quarter 2021 and Recent Highlights

Continued enrollment of the Phase 2 randomized KEAPSAKE trial in non-small cell lung cancer (NSCLC) patients with genetic mutation KEAP1/NRF2. The double-blind KEAPSAKE trial will enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have the KEAP1 or NRF2 mutation. Patients will be randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study will evaluate the safety and investigator-assessed progression-free survival (PFS) of telaglenastat plus this standard-of-care chemoimmunotherapy regimen. Calithera anticipates releasing interim data from the KEAPSAKE trial in the fourth quarter of 2021.
Ongoing enrollment of the Phase 1b clinical trial of CB-280 in patients with cystic fibrosis (CF). CB-280 is an oral inhibitor of arginase, an enzyme that depletes the amino acid arginine. The randomized, double blind, placebo-controlled, dose escalation trial is evaluating multiple ascending doses of CB-280, dosed orally twice daily for 14 days, compared to placebo in up to 32 adult CF patients to determine a safe dose range for CB-280. In October 2020, Calithera was awarded up to $2.4 million from the Cystic Fibrosis Foundation to support clinical development of CB-280. Enrollment in the Phase 1b study is ongoing and Calithera expects to announce data from this study in the second half of 2021.
Final results of the CANTATA trial to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. The Phase 2 CANTATA trial is a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. On January 4, 2021, Calithera announced topline results from the CANTATA clinical study and reported the trial did not meet the primary endpoint of improving PFS in the study population. Data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 7, 2021.
Selected First Quarter 2021 Financial Results

Cash, cash equivalents and investments totaled $102.9 million at March 31, 2021.

Research and development expenses for the first quarter 2021 were $15.3 million, compared to $20.1 million in the same period prior year. The decrease of $4.8 million was primarily due to a $3.3 million decrease in expenses associated with the telaglenastat program, a $1.6 million decrease in the INCB001158 program and a $0.2 million decrease in our early stage research programs, partially offset by an increase of $0.3 million in the CB-280 program.

General and administrative expenses for the first quarter 2021 were $5.4 million, compared to $4.9 million in the same period prior year. The increase of $0.5 million was primarily related to a $0.9 million increase in personnel-related costs, partially offset by a $0.4 million decrease in professional services costs.

Interest and other income, net for the first quarter 2021 was $0.4 million, compared to $0.6 million in the same period prior year.

Net loss for the three months ended March 31, 2021 was $20.4 million.

Conference Call Information

Calithera will host an update conference call today, Thursday, May 6, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 6250035. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On May 6, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported its financial results for the first quarter of fiscal year 2021 (Press release, Certara, MAY 6, 2021, View Source [SID1234579366]).

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Highlights:
Revenue was $66.7 million, representing growth of 16% over the first quarter of 2020.
Net income was $1.1 million, compared to a net income of $1.0 million in the first quarter of 2020.
Adjusted EBITDA was $23.9 million, representing growth of 20% over the first quarter of 2020.
2021 guidance range was updated to $277 million – $285 million of revenue, $100 million – $102 million of adjusted EBITDA, and effective annual tax rate was lowered to 40% – 45%.
"Certara realized a successful start to the year, which reflects increased adoption of our proprietary end-to-end platform globally. As the COVID-19 pandemic continues to impact lives worldwide, I want to thank our Certara team for their dedication and tireless efforts to advance the use of biosimulation and for delivering another record quarter of revenue – which is our first full quarter as a public company. With a broad and diverse customer base and robust demand for our innovative offerings, we continue to be well-positioned for sustained growth," said William F. Feehery, chief executive officer.

First Quarter 2021 Results
"In the first quarter, we delivered double-digit growth in revenue and profitability by executing on our customer commitments. With first quarter bookings growth of 34% year-over-year, we have solid momentum towards achieving our business and financial goals for the year," said Andrew Schemick, chief financial officer.

Total revenue for the first quarter of 2021 was $66.7 million, representing year-over-year growth of 16%. The revenue growth was driven primarily by technology enabled services and software licenses and subscriptions.

Total cost of revenue for the first quarter of 2021 was $26.0 million, an increase from $22.2 million in the first quarter of 2020, primarily due to a $2.3 million increase in employee related costs and a $0.8 million increase in stock-based compensation costs, partially offset by decreases in travel related cost and retention expenses.

Total operating expenses for the first quarter of 2021 were $35.1 million, an increase from $27.3 million in the first quarter of 2020, primarily due to a $3.8 million increase in stock-based compensation expense, and a $1.4 million increase in employee related costs. The remaining increases were due to increases in secondary offering costs, acquisition related costs and D&O insurance.

Net income for the first quarter of 2021 was $1.1 million, compared to a net income of $1.0 million in the first quarter of 2020. Income from operations decreased $2.4 million due to higher stock-based compensation expenses and acquisition and transaction related expenses. The decrease in income from operations was offset by lower interest expense. Diluted Earnings Per Share for the first quarter 2021 and 2020 were $0.01.

Adjusted EBITDA for the first quarter of 2021 was $23.9 million compared to $19.9 million for the first quarter of 2020, representing 20% growth. See note (1) in the section A Note on Non-GAAP Financial Measures, below, for more information on Adjusted EBITDA.

Adjusted Net Income for the first quarter of 2021 was $9.4 million compared to $2.1 million for the first quarter of 2020. Adjusted Diluted Earnings Per Share for the first quarter 2021 was $0.06 compared to $0.02 for the first quarter of 2020. See note (2) in the section A Note on Non-GAAP Financial Measures, below, for more information on Adjusted Net Income and Adjusted Diluted Earnings Per Share.

2021 Financial Outlook
Certara is updating its previously reported guidance for full year 2021 by raising the low end the range for revenue and Adjusted EBITDA and lowering the range of its effective annual tax rate. We expect the following:

Full year 2021 revenue to be in the range of $277 million to $285 million;

Full year 2021 Adjusted EBITDA to be in the range of $100 million to $102 million;

Full year 2021 Adjusted Diluted Earnings Per Share is expected to be in the range of $0.20 to $0.24;

Fully diluted shares for 2021 will be 153 million to 155 million; and

Effective annual tax rate for 2021 will be in the range of 40% to 45%.

Webcast and Conference Call Details
Certara will host a conference call today, May 6, 2021, at 5:00 p.m. ET to discuss its first quarter 2021 financial results. The dial-in numbers are (833) 360-0946 for domestic callers or (914) 987-7661 for international callers, followed by Conference ID: 9802129. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for approximately one year.

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.