On May 4, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the first quarter of 2022 (Press release, Pacira Pharmaceuticals, MAY 4, 2022, View Source [SID1234613553]).

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First Quarter 2022 Financial Highlights

Total revenues of $158.0 million
Net product sales of $129.2 million for EXPAREL, $23.6 million for ZILRETTA, and $3.0 million for iovera°
Net income of $6.8 million, or $0.15 per share (basic and diluted)
Adjusted EBITDA of $53.8 million, or $1.20 per share (basic) and $1.16 per share (diluted)
"We were delighted to end the first quarter of 2022 with record high EXPAREL sales for the month of March, which underscores the significant progress we continue to make despite operational headwinds in the elective surgery market due to COVID and labor-related disruptions," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The successful integration of the Flexion acquisition was evidenced by strong ZILRETTA sales in the first quarter, which we expect to be an important near- and long-term contributor to earnings."

"We look forward to completing our two Phase 3 studies of EXPAREL for lower extremity nerve block and to launching new high-potential registration programs evaluating EXPAREL as a stellate ganglion block for cardiac dysrhythmia. Additionally, as the market moves rapidly toward ultrasound-guided iovera° blocks delivered by pain management specialists, we plan to use our IGOR registry to publish real-world evidence to better support our commercial initiatives," continued Mr. Stack.

Recent Business Highlights

Daryl Gaugler Appointed Chief Operating Officer. Today the company is announcing the appointment of Daryl Gaugler to the position of Chief Operating Officer effective May 4, 2022. Mr. Gaugler has served as the company’s Senior Vice President of Commercial Operations since June 2019. Mr. Gaugler is a seasoned life sciences executive with 30 years of experience in commercial leadership that includes building and directing over 400 commercial teams and designing go-to-market strategies for more than 20 companies. Prior to Pacira, Mr. Gaugler spent over 20 years with the Quintiles Transnational organization (now IQVIA). In his most recent role at Quintiles, President of North America Commercial Solutions, Mr. Gaugler delivered significant revenue and profit growth while leading customer satisfaction and employee engagement within the organization.

New EXPAREL Patents. In March and April 2022, the U.S. Patent and Trademark Office (U.S. PTO) issued Patent Numbers 11,278,494, 11,304,904 and 11,311,486. The ‘494 and ‘486 patents cover composition of EXPAREL while the ‘904 is a product by process patent, each having an expiration date of January 22, 2041. All three patents are now listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalents Evaluations (Orange-Book).

Second Innovation and Training Facility. The company recently launched development plans for its second training facility in Houston, Texas. This 19,000 square-feet state-of-the-art facility will feature an adaptive lecture hall, broadcast studio, and lab space for cadaver and other interactive workshops. Together with the company’s Tampa facility, this second training center will play a core role in developing physician champions and community-based clinicians who want to stay on the forefront of opioid-sparing pain management. The company expects to open the Houston facility before the end of 2022 to host programs for EXPAREL, ZILRETTA and iovera°.
First Quarter 2022 Financial Results

Total revenues were $158.0 million in the first quarter of 2022, versus the $119.0 million reported for the first quarter of 2021.
EXPAREL net product sales were $129.2 million in the first quarter of 2022, versus the $114.7 million reported for the first quarter of 2021.
ZILRETTA net product sales were $23.6 million in the first quarter of 2022. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion Therapeutics, Inc. in November 2021.
First quarter 2022 iovera° net product sales were $3.0 million, versus the $3.3 million reported for the first quarter of 2021.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.6 million in the first quarter of 2022, versus the $0.8 million reported for the first quarter of 2021.
First quarter 2022 royalty and collaborative licensing and milestone revenues were $0.6 million, versus the $0.3 million reported for the first quarter of 2021.
Total operating expenses were $140.6 million in the first quarter of 2022, versus the $99.6 million reported for the first quarter of 2021.
Research and development (R&D) expenses were $21.6 million in the first quarter of 2022, compared to $15.9 million in the first quarter of 2021. R&D expenses included $5.0 million and $4.7 million of product development and manufacturing capacity expansion costs in the first quarters of 2022 and 2021, respectively.
Selling, general and administrative (SG&A) expenses were $64.3 million in the first quarter of 2022, compared to $48.5 million in the first quarter of 2021.
GAAP net income was $6.8 million, or $0.15 per share (basic and diluted), in the first quarter of 2022, compared to $10.4 million, or $0.24 per share (basic) and $0.23 per share (diluted), in the first quarter of 2021.
Non-GAAP net income was $29.9 million, or $0.67 per share (basic) and $0.64 per share (diluted), in the first quarter of 2022, compared to $24.5 million, or $0.56 per share (basic) and $0.53 per share (diluted), in the first quarter of 2021.
Adjusted EBITDA was $53.8 million, or $1.20 per share (basic) and $1.16 per share (diluted) in the first quarter of 2022, compared to $36.2 million, or $0.83 per share (basic) and $0.79 per share (diluted) in the first quarter of 2021.
Pacira ended the first quarter of 2022 with cash, cash equivalents and short-term available-for-sale investments ("cash") of $452.2 million. Cash provided by operations was $30.8 million in the first quarter of 2022, compared to $12.1 million in the first quarter of 2021.
Pacira had 44.9 million basic and 46.4 million diluted weighted average shares of common stock outstanding in the first quarter of 2022.
See "Non-GAAP Financial Information" below.

Financial Guidance

The company’s product sales continue to be impacted by COVID-19, which has caused significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market, the company is currently not providing revenue or gross margin guidance. To provide greater transparency, Pacira is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° until it has gained enough visibility around the impacts of COVID-19. Pacira is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter.

Today the company is reiterating its full-year 2022 operating expense guidance as follows:

Non-GAAP R&D expense of $75 million to $85 million;
Non-GAAP SG&A expense of $220 million to $230 million; and
Stock-based compensation of $40 million to $45 million.
See "Non-GAAP Financial Information" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, May 4, 2022, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 4063578. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 4063578. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per common share, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, adjusted EBITDA (as defined below) and adjusted EBITDA per share, because these non-GAAP financial measures exclude the impact of items that management believes affect comparability or underlying business trends.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2022 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures.

On May 4, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the first quarter ended March 31, 2022 (Press release, Personalis, MAY 4, 2022, View Source [SID1234613571]).

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First Quarter and Recent Highlights

Reported quarterly revenue of $15.2 million in the first quarter of 2022 compared with $20.9 million in the first quarter of 2021
Revenue from biopharma and other customers, excluding the VA MVP (as defined below), of $11.7 million in the first quarter of 2022 compared with $7.7 million in the first quarter of 2021, a 53% increase; revenue from biopharma and other customers includes revenue of $4.1 million from Natera in the first quarter of 2022; revenue from biopharma customers excluding Natera of $7.6 million for the first quarter of 2022
Revenue from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $3.5 million in the first quarter of 2022 compared with $13.2 million in the first quarter of 2021
Engaged with a large global pharmaceutical customer for NeXT Personal, and processed samples for initial order
Announced hiring of seasoned commercial executive James Azzaro to be Vice President, Diagnostics Sales
Received a new US patent for NeXT Personal, signifying its unique place among MRD assays as it combines a highly sensitive measurement of tumor burden with simultaneous tracking of thousands of tumor variants, both tumor-informed and prespecified, in a single panel
Cash, cash equivalents, and short-term investments were $266.5 million as of March 31, 2022
"We continue to be confident about our oncology revenue growth in the future due to the differentiation and strength of our offerings for both biopharma and diagnostic customers," said John West, Chief Executive Officer of Personalis. "We are making significant progress on our strategic priorities as we continue to build our clinical diagnostic team and work with world-class medical institutions. In particular, over the last several months we have announced collaborations with the Mayo Clinic and UCSD Moores Cancer Center. Our goal is to revolutionize the detection and treatment of cancer and contribute to more successful outcomes for all patients."

First Quarter 2022 Financial Results

Revenue was $15.2 million in the three months ended March 31, 2022
Gross margin was 28.1% in the three months ended March 31, 2022
Operating expenses were $32.6 million in the three months ended March 31, 2022
Net loss was $28.2 million in the three months ended March 31, 2022 and net loss per share was $0.63 based on a weighted-average basic and diluted share count of 45.0 million
Cash, cash equivalents, and short-term investments were $266.5 million as of March 31, 2022
Full Year 2022 Outlook

Personalis expects the following for the full year of 2022:

Total company revenue is expected to be in the range of $62.0 million to $67.0 million
Revenue from biopharma and all other customers, excluding the VA MVP, is expected to be in the range of $55.0 million to $60.0 million
Net loss is expected to be in the range of $110.0 million to $115.0 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter 2022 financial results after market close on Wednesday, May 4, 2022 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 3187833. The live webinar can be accessed at View Source

On May 4, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, Deciphera Pharmaceuticals, MAY 4, 2022, View Source [SID1234613471]).

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"We have made significant progress on our 2022 goals so far this year, demonstrating our commercial success with QINLOCK, strengthening our balance sheet, and rapidly advancing our potential best-in-class and first-in-class clinical-stage pipeline," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "The strong commercial launch of QINLOCK in Germany underscores the long-term potential for this medicine to benefit patients with GIST around the world. The pivotal Phase 3 MOTION study of vimseltinib, which we are developing for the treatment of tenosynovial giant cell tumor, or TGCT, is now enrolling patients and we expect to present updated results from the Phase 1/2 study in patients with TGCT in the second half of this year."

Mr. Hoerter continued, "We are very excited about our potential first-in-class autophagy pathway inhibitor, DCC-3116. At this year’s AACR (Free AACR Whitepaper) Annual Meeting, we presented encouraging preclinical data for DCC-3116 in combination with KRASG12C inhibitors highlighting the broad potential of this product candidate to benefit patients. We expect to present initial data from the single agent dose escalation portion of the Phase 1 study later this year."

First Quarter 2022 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $28.8 million in QINLOCK net product revenue in the first quarter of 2022, including $23.4 million in U.S. net product revenue and $5.4 million in international net product revenue.
Launched in Germany and received authorization for the post-approval paid access program in France.
Received a favorable ASMR III rating for QINLOCK from the Transparency Commission of the French National Authority for Health.
Vimseltinib

Continued enrollment and site activation in the pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT. MOTION is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with TGCT who are not amenable to surgery. The primary endpoint of the study is objective response rate at week 25 as measured by RECIST v1.1 by blinded independent central review.
Expects to present updated results from the ongoing Phase 1/2 study in TGCT patients in the second half of 2022.
DCC-3116

Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022.
The results showed that treatment of mutant KRASG12C NSCLC cell lines with KRASG12C inhibitors sotorasib and adagrasib induced autophagy via activation of ULK1/2 kinases as measured by an increase in ULK-mediated phosphorylation of the key ULK autophagy substrate ATG13 and resulting increase in autophagic flux.
DCC-3116 in combination with KRASG12C inhibitors translated to deeper and longer tumor regressions in mutant KRASG12C NSCLC models in vivo than with KRASG12C inhibitors alone.
Expects to present data in the second half of 2022 from the single agent dose escalation portion of the Phase 1 study of DCC-3116 in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.
Expects to initiate three Phase 1b study combination dose escalation cohorts in the second half of 2022:
In combination with trametinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations.
In combination with binimetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations, subject to feedback from regulatory authorities.
In combination with sotorasib, an FDA- approved KRASG12C inhibitor, in patients with advanced or metastatic solid tumors with KRASG12C mutations, subject to feedback from regulatory authorities.
Expects to present additional preclinical data for DCC-3116 in the second half of 2022 and continue to explore preclinical combinations with multiple additional anti-cancer agents with diverse mechanisms of action.
Proprietary Drug Discovery Platform

Expects to nominate a development candidate in 2022 from the pan-RAF inhibitor research program discovered using the Company’s novel switch-control inhibitor platform.
Corporate Updates

Announced the closing in April 2022 of an underwritten public offering of 7,501,239 shares of the Company’s common stock at a public offering price of $10.00 per share and, in lieu of common stock to certain investors, the Company issued pre-funded warrants to purchase 9,748,761 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant. The shares of common stock sold include 2,250,000 shares pursuant to the option granted by the Company to the underwriters, which option was exercised in full. This offering resulted in net proceeds of $163.4 million after deducting underwriting discounts and commissions and other offering expenses.
First Quarter 2022 Financial Results

Revenue: Total revenue for the first quarter was $29.2 million, which includes $28.8 million of net product revenue of QINLOCK and $0.4 million of collaboration revenue compared to $25.2 million of total revenue, including $20.0 million of net product revenue of QINLOCK and $5.2 million of collaboration revenue, for the same period in 2021.
Cost of Sales: Cost of sales were $0.4 million in the first quarter ended March 31, 2022 compared to $0.2 million in the same period in 2021. Cost of sales for newly launched products will not include the full cost of manufacturing until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. Deciphera does not expect the cost of sales as a percentage of net sales of QINLOCK to increase significantly after the Company has sold all zero cost inventories and commenced the sales of inventories that will reflect the full cost of manufacturing. The Company expects to continue to sell zero cost inventories of QINLOCK in the U.S. during 2022.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $47.4 million, compared to $55.7 million for the same period in 2021. The decrease was primarily due to lower clinical trial costs related to QINLOCK, including INTRIGUE, our Phase 3 study for the treatment of second-line GIST for which top-line results were announced in November 2021, and the discontinuation of our rebastinib program following the corporate restructuring implemented in the fourth quarter of 2021, partially offset by an increase in clinical trial costs related to our Phase 1 study of DCC-3116, preclinical costs, and personnel costs. Non-cash, stock-based compensation was $6.3 million and $5.0 million for the first quarters of 2022 and 2021, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2022 were $28.3 million, compared to $30.7 million for the same period in 2021. The decrease was primarily due to a decrease in professional and consultant fees. Non-cash, stock-based compensation was $8.0 million and $6.2 million for the first quarters of 2022 and 2021, respectively.
Net Loss: For the first quarter of 2022, Deciphera reported a net loss of $46.9 million, or $0.80 per share, compared with a net loss of $61.3 million, or $1.06 per share, for the same period in 2021.
Cash Position: As of March 31, 2022, cash, cash equivalents, and marketable securities were $275.4 million, compared to $327.6 million as of December 31, 2021. In April 2022, the Company completed an underwritten public offering that resulted in aggregate net proceeds of $163.4 million. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2025.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 4, 2022 at 8:00 AM ET. The conference call may be accessed by dialing (877) 270-2148 (domestic) or (412) 902-6510 (international). A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On May 4, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported financial results for the quarter ended March 31, 2022 (Press release, Allogene, MAY 4, 2022, View Source [SID1234613519]).

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"This month marks the fourth anniversary of Allogene. I am immensely proud of all that we have accomplished in such a short period of time, including our ability to treat more patients with our pipeline of AlloCAR T candidates than anyone else in the field," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Every advance we make in manufacturing, clinical development, and research brings us one step closer to achieving our vision of making CAR T therapy accessible to all eligible patients."

Corporate Highlights
Cell Forge 1 (CF1), Allogene’s commercial scale manufacturing facility located in Newark, California is now operational and producing GMP material with the intent of supplying ALLO-501A for the planned pivotal study as well as other clinical trials. CF1 is projected to have the ability to manufacture approximately 20,000 ALLO-501A AlloCAR T doses annually at scale.

In March, the Company published its inaugural ESG report. The report details Allogene’s commitment to corporate integrity and sustainable business operations and highlights its priorities: employees, the environment, and patients, including increasing their access to potential life-saving products.

Pipeline Updates
Hematologic Malignancies
Enrollment in the Phase 1 ALLO-501A ALPHA2 trial in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) has re-opened with the goal of offering AlloCAR T to patients while the Company prepares to launch the pivotal Phase 2 ALPHA2 trial. The single-arm pivotal ALPHA2 trial of ALLO-501A in r/r LBCL is planned to initiate mid-2022. The single-arm ALPHA2 trial is on track to begin mid-year 2022 with FDA discussions directed at finalizing clinical trial design and Chemistry Manufacturing and Controls (CMC) requirements.

The EXPAND trial, planned to support registration of the lymphodepleting agent ALLO-647, is intended to demonstrate the contribution of ALLO-647 to the lymphodepletion regimen and benefit to patient outcomes.

Enrollment has also resumed in trials targeting BCMA for the treatment of patients with r/r multiple myeloma (MM), including the UNIVERSAL trial with ALLO-715 and the IGNITE trial with TurboCAR candidate, ALLO-605. During the quarter, preclinical data was published demonstrating the superior long-term in vitro myeloma-killing activity of allogeneic anti-BCMA
CAR T cells from healthy donors compared with anti-BCMA CAR T cells from patients with MM. The findings were published in Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

In May 2022, the Company was granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for ALLO-605 for the treatment of MM.

The Company intends to provide an update on its CD19 and BCMA programs by the end of the year.

Solid Tumors
ALLO-316 is the Company’s first AlloCAR T candidate for solid tumors. The Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (RCC). The trial, now in its second dose level cohort, continues to accrue patients.

In April, the Company presented preclinical data at the 2022 AACR (Free AACR Whitepaper) Annual Meeting which support the ongoing clinical evaluation of ALLO-316 for the treatment of patients with RCC and other CD70 expressing cancers. The findings were simultaneously published in AACR (Free AACR Whitepaper)’s Cancer Research.

In March, the FDA granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies. Metastatic solid tumors have historically been a challenge regardless of treatment modality, and the five-year survival rate for patients with advanced kidney cancer is less than 15%, highlighting the need for innovation.

First Quarter Financial Results
•Research and development expenses were $60.2 million for the first quarter of 2022, which includes $11.1 million of non-cash stock-based compensation expense.
•General and administrative expenses were $19.9 million for the first quarter of 2022, which includes $11.2 million of non-cash stock-based compensation expense.
•Net loss for the first quarter of 2022 was $79.9 million, or $0.56 per share, including non-cash stock-based compensation expense of $22.3 million.
•The Company had $733.1 million in cash, cash equivalents, and investments as of March 31, 2022.

2022 Financial Guidance
•Allogene continues to expect full year GAAP Operating Expenses to be between $360 million and $390 million including estimated non-cash stock-based compensation expense of $90 million to $100 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 6579454. The webcast will be made
available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On May 4, 2022 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 that it will host a first quarter 2022 investor call on Wednesday, May 11, 2022 at 8:00 AM EDT to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, MAY 4, 2022, View Source [SID1234613536]).

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To access the call, participants may dial (888) 428-7458 (Toll Free US & Canada) or (862) 298-0702 (International) at least five minutes prior to the start of the call. Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.