On February 23, 2022 Integra LifeSciences Holdings Corporation (NASDAQ: IART) reported financial results for the fourth quarter and full year ended December 31, 2021, consistent with its preliminary revenue results announced on January 11, 2022 (Press release, Integra LifeSciences, FEB 23, 2022, View Source [SID1234608893]).

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Fourth Quarter 2021

Reported revenues were $405.5 million, representing an increase of 4.3% on a reported basis and an increase of 8.3% on an organic basis compared to the fourth quarter 2020.
GAAP earnings per diluted share were $0.53, compared to $1.09 in the fourth quarter 2020.
Adjusted earnings per diluted share were $0.84, flat compared to the fourth quarter of 2020.
Full-Year 2021

Reported revenues were $1,542.4 million representing an increase of 12.4% on a reported basis and an increase of 14.2% on an organic basis compared to full-year 2020.
GAAP earnings per diluted share were $1.98, compared to $1.57 in 2020.
Adjusted earnings per diluted share were $3.18, compared to $2.45 in 2020.
Key Accomplishments in 2021

Divested the Extremity Orthopedics business and acquired ACell to expand the regenerative tissue portfolio.
Completed the substantive manufacturing transfer of all Codman neurosurgical products.
Launched CereLink ICP Monitor​ in Europe and the U.S.
Initiated phased clinical launch for the Aurora Surgiscope for minimally invasive neurosurgery and MIRROR registry for intracerebral brain hemorrhage.
Filed SurgiMend PMA and completed panel meeting with FDA Advisory Committee and are currently working with FDA on the path forward for a specific indication for post-mastectomy breast reconstruction.
Published results of PriMatrix multicenter study in diabetic foot ulcers demonstrating statistically and clinically significant results against standard of care.
Marked the 25th anniversary of the U.S. approval of the Integra Dermal Regeneration Template (IDRT) for the treatment of life-threatening burns.
Recognized for the company’s leadership in ‘2021 Best Company for Diversity’ and ‘Top 100 Healthcare Technology Company’ lists.
Successfully executed CEO transition with the appointment of Jan De Witte.
"Our 2021 financial performance and business achievements are a testament to our broad and differentiated product portfolio, and the resilience and commitment of our team members around the world, despite the ongoing effects of the global pandemic," said Jan De Witte, president and chief executive officer. "I look forward to working with my Integra colleagues to continue to execute our growth priorities and accelerate our product pipeline and global opportunities in 2022 and the years to come."

Fourth Quarter 2021 Financial Summary

Total reported revenues for the fourth quarter were $405.5 million, an increase of 4.3% from the fourth quarter of 2020. Fourth quarter organic revenues increased 8.3% over the prior year. Total reported revenues include $16.9 million from the acquisition of ACell, which was completed on January 20, 2021. Reported revenue for the fourth quarter 2020 included Extremity Orthopedics.

The Company reported GAAP net income of $45.4 million, or $0.53 per diluted share, in the fourth quarter of 2021, compared to GAAP net income of $92.7 million, or $1.09 per diluted share, in the prior year. The decrease in GAAP net income was driven primarily by a one-time net tax benefit in the fourth quarter of 2020, attributable to an intra-entity transfer of certain intellectual property resulting in the recognition of a $59.2 million deferred tax benefit.

Adjusted EBITDA for the fourth quarter of 2021 was $105.4 million, compared to $102.7 million in the fourth quarter of the prior year. As a percentage of revenue, adjusted EBITDA was 26.0%, a decrease of 40 basis points from the prior year period.

Adjusted net income for the fourth quarter of 2021 was $72.2 million, or $0.84 per diluted share, compared to adjusted net income of $71.3 million, or $0.84 per diluted share, in the fourth quarter of 2020. The contribution of higher revenues in 2021 was offset by the gradual return of spending, which was below normal levels in the prior year in response to the global pandemic.

Cash flows from operations totaled $69.3 million in the fourth quarter and capital expenditures were $27.4 million.

Fourth Quarter 2021 Segment Performance

Codman Specialty Surgical (67% of Revenues)
Total revenues were $270.7 million, representing reported growth of 6.4% and organic growth of 9.0% compared to the fourth quarter of 2020. Sales in Instruments benefited from a strong recovery in order demand, while the strength in Neurosurgery was broad-based and included sales from our new CereLink ICP monitoring and continued recovery in sales of capital equipment.
Tissue Technologies (33% of Revenue)
Total revenues were $134.9 million, representing growth of 0.4% on a reported basis and organic growth of 6.7% compared to the fourth quarter of 2020. Organic growth in this segment was led by sales in Private Label and sales in Wound Reconstruction and Care, with strength in Integra Dermal Matrices and SurgiMend.
Full-Year 2021 Financial Summary

Total reported revenues for the full-year 2021 were $1,542.4 million, an increase of 12.4%, from the prior year. Organic sales for the full-year 2021 increased 14.2% compared to 2020. Total reported revenues include $65.4 million from the acquisition of ACell. Reported revenue for the full-year 2020 included Extremity Orthopedics.

The Company reported GAAP net income of $169.1 million, or $1.98 per diluted share, for the full-year 2021, compared to GAAP net income of $133.9 million, or $1.57 per diluted share in 2020. The increase in GAAP net income was primarily driven by increased revenues from procedure recovery from the COVID-19 impact in 2020 and the gain on sale of $41.8 million from the Extremity Orthopedics business, partially offset by a one-time net tax benefit in the fourth quarter of 2020.

Adjusted EBITDA for the full-year 2021 was $400.7 million, an increase of $66.2 million over the prior year. Full year EBITDA margins were 26.0% an increase of 160 basis points from the prior year.

Adjusted net income for the full-year 2021 was $271.7 million, or $3.18 per diluted share, compared to $208.7 million, or $2.45 per diluted share in 2020. The increase was primarily attributable to increased sales in 2021 after the COVID-19 impact of 2020.

2021 Balance Sheet, Cash Flow and Capital Allocation

The Company generated record cash flow from operations of $312.4 million for the full-year 2021. Full-year capital expenditures were $48.0 million. Net debt at the end of the year was $1.05 billion, and the consolidated total leverage ratio was 2.3x. As of year-end, the Company had total liquidity of approximately $1.78 billion, including approximately $513 million in cash and the remainder available under its revolving credit facility.

2022 Revenue and Adjusted Earnings Per Share Guidance

The Company’s guidance for 2022 revenue and adjusted earnings per share reflects the continuing uncertainty around the scope and duration of the pandemic, and its related impacts on our business in the first half of the year. For the first quarter 2022, the Company expects reported revenues in the range of $357 million to $365 million, representing reported growth of approximately -1% to 1.5% and organic growth of approximately 0% to 2.5%. Adjusted earnings per diluted share are expected to be in a range of $0.67 to $0.71.

For the full-year 2022, the Company expects revenues to be in a range of $1,580 million to $1,600 million, representing reported growth of approximately 2.5% to 3.5% and organic growth of approximately 3.5% to 5%. Adjusted earnings per diluted share are expected to be in a range of $3.27 to $3.35.

Organic sales growth excludes acquisitions and divestitures as well as the effects of foreign currency and the year-over-year change in revenue from discontinued products. Organic growth includes ACell as of January 20, 2022.

The Company is providing forward-looking guidance regarding adjusted earnings per diluted share but is not providing a reconciliation to GAAP earnings per share, because certain GAAP expense items are highly variable, and management is unable to predict them with reasonable certainty and without unreasonable effort. Specifically, the financial impact and timing of divestitures, acquisitions, integrations, structural optimization and efforts to comply with the EU Medical Device Regulation are uncertain, depend on various dynamic factors and are not reasonably ascertainable at this time. These expense items could have a material impact on GAAP results. Adjusted earnings per diluted share also excludes the impact of intangible asset amortization associated with prior business acquisitions, which we expect to be approximately $0.77 per diluted share for the full-year 2022.

2022 Share Repurchase

On January 12, 2022, the Company entered into an accelerated share repurchase agreement with Citibank, N.A. to repurchase $125 million in the aggregate of the Company’s outstanding shares of common stock, par value $0.01 per share. The repurchase transactions are expected to be completed in the first half of 2022. The impact of the share repurchase is reflected in the 2022 adjusted earnings per diluted share guidance range provided.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, February 23, 2022, to discuss fourth quarter and full-year 2021 financial results, and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra’s management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.

Access to the live call is available by dialing (888) 394-8218 and using the passcode 701830. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com. A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available until March 5, 2022 by dialing (888) 203-1112 and using the passcode 701830.

On February 23, 2022 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator drug, mocravimod, reported that it has entered a Loan Agreement of €17.5 million with the European Investment Bank (EIB) (Press release, Priothera, FEB 23, 2022, View Source [SID1234608892]). This loan will further support a European, US and Asian registration-enabling clinical trial with mocravimod in Acute Myeloid Leukemia (AML) patients receiving hematopoietic stem cell transplant (HSCT).

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The loan facility of €17.5 million is divided into two tranches, the first of which is €10 million and unconditional. Priothera will request payment of the first tranche in 2022 to expand the clinical development of mocravimod and prepare for its commercial drug supply. The second tranche of €7.5 million is available upon achievement of specific manufacturing, clinical and regulatory milestones and will be used to finance clinical validation in CAR-T cancer indications.

Florent Gros, Co-Founder and CEO of Priothera, comments: "We are very grateful for EIB’s support, a major and high quality European financial institution, as the Company is at an inflection point of its clinical development and potential commercialization path. This financing allows Priothera to extend its financial visibility to 2024, allowing us to complete a global registration-enabling clinical trial, as well as exploring other blood cancer indications for mocravimod. This new funding tool will help reinforce Priothera’s global lead in developing S1P receptor modulators in oncology."

Christian Kettel Thomsen, Vice-President of the EIB, said: "The European Investment Bank Group supports development of innovative and pioneering treatments and medicine by leading biotech and medtech companies in Ireland and across Europe. Priothera’s new drugs offer an opportunity to revolutionise treatment of leukaemia and other cancers and the EIB is pleased to agree to €17.5 million of new financing to accelerate the clinical development and commercialization of mocravimod."

About mocravimod
Mocravimod (also known as KRP203), a propane-1,3-diol derivative, is a novel, synthetic, sphingosine 1-phosphate receptor (S1PR) agonist with long duration in the body. Phase 1 and Phase 2 trials successfully assessed mocravimod for safety and tolerability in several autoimmune indications. Promising data from a Ph1b/Ph2a clinical study with patients with haematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving HSCT. Allogenic HSCT is the only potentially curative approach for AML patients but remains having unacceptably high mortality and morbidity rates with current treatments.

Priothera leverages S1PRs unique mode of action to maintain anti-leukaemia activity while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of HSCT. This novel treatment approach – the only S1PR modulator treating blood cancers – tackles a high unmet medical need that intends to add quality life to patients.

On February 23, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Mark Enyedy, President and CEO, will participate in the ovarian cancer panel discussion at the upcoming Cowen 42nd Annual Health Care Conference (Press release, ImmunoGen, FEB 23, 2022, View Source [SID1234608891]). The panel is scheduled for March 9, 2022 from 12:50 – 1:50pm ET.

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A webcast of the panel will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

On February 23, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported financial results for the quarter and year ended December 31, 2021 (Press release, Guardant Health, FEB 23, 2022, View Source [SID1234608890]).

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Recent Highlights
•Revenue of $108 million for the fourth quarter of 2021 and $374 million for the full year 2021, an increase of 38% and 30% over the corresponding period of 2020
•Reported 25,600 tests to clinical customers and 6,600 tests to biopharmaceutical customers in the fourth quarter of 2021, representing an increase of 48% and 36%, respectively, over the fourth quarter of 2020
•Reached enrollment of 12,750 patients in ECLIPSE pivotal study for its Guardant Shield blood test to detect colorectal cancer
•Enrolled first patient in SHIELD study to validate the performance of blood-based assay in lung cancer screening
•Successfully finalized a $25 million settlement plus royalty-bearing licensing agreement with Foundation Medicine
"2021 was a transformative year for Guardant and our team continued to push the boundaries to deliver a new paradigm of cancer care," said Helmy Eltoukhy, co-founder and co-CEO. "Our commercial team continued to deliver strong growth during the fourth quarter with clinical volumes increasing 48% year over year. This growth was particularly strong in the community setting where Guardant360 CDx grew twice as fast as in the academic centers. Looking ahead to 2022, we are bringing to fruition our vision for providing clinically differentiated offerings that will span the entire continuum of cancer care, including treatment selection, response monitoring, MRD and screening."

"We believe the promise of blood-based cancer screening is quickly becoming a reality and Guardant is well-positioned to fill this critical need," said AmirAli Talasaz, co-founder and co-CEO. "A successful readout of ECLIPSE will open up a $20 billion screening opportunity in colorectal cancer by bringing high-performance life-saving tests to millions of people, and SHIELD Lung, along with other future studies, will open up opportunities in lung and additional cancer types, paving the way towards a total addressable screening market of more than $50 billion."

Fourth Quarter 2021 Financial Results
Revenue was $108.1 million for the three months ended December 31, 2021, a 38% increase from $78.3 million for the three months ended December 31, 2020. Precision oncology revenue grew 37% driven predominantly by an increase in clinical testing revenue which grew 40% over the prior year period. There were 25,600 clinical tests and 6,600 biopharmaceutical tests performed during the fourth quarter of 2021. Development services and other revenue increased 43% primarily due to royalty revenues earned pursuant to a settlement and license agreement entered into in December 2021, and the progression of collaboration projects with biopharmaceutical customers for companion diagnostic development services during the three months ended December 31, 2021.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $74.7 million for the fourth quarter of 2021, an increase of $24.8 million from $49.9 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 69%, as compared to 64% for the corresponding prior year period.
Operating expenses were $172.9 million for the fourth quarter of 2021, as compared to $141.1 million for the corresponding prior year period, an increase of 23%. Non-GAAP operating expenses were $146.2 million for the fourth quarter of 2021, as compared to $84.7 million for the corresponding prior year period.
Other income (expense) net increased to $25.9 million for the fourth quarter of 2021, from $1.2 million for the corresponding prior year period, primarily due to $25.0 million income pursuant to a settlement and license agreement entered into in December 2021.
Net loss attributable to Guardant Health, Inc. common stockholders was $90.9 million for the fourth quarter of 2021, as compared to $93.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.89 for the fourth quarter of 2021, as compared to $0.94 for the corresponding prior year period. Non-GAAP net loss was $70.4 million for the fourth quarter of 2021, as compared to $36.7 million for the corresponding prior year period. Non-GAAP net loss per share was $0.69 for the fourth quarter of 2021, as compared to $0.37 for the corresponding prior year period.
Adjusted EBITDA loss was $64.6 million for the fourth quarter of 2021, as compared to a $29.7 million loss for the corresponding prior year period.
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Full Year 2021 Financial Results
Revenue was $373.7 million for the year ended December 31, 2021, a 30% increase from $286.7 million for the year ended December 31, 2020. Precision oncology revenue grew 29% driven predominantly by an increase in clinical testing revenue which grew 38% over the prior year period. There were 87,600 clinical tests and 18,600 biopharmaceutical tests performed during 2021. Development services and other revenue increased 38%.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $250.7 million for 2021, an increase of $56.5 million from $194.2 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 67%, as compared to 68% for the corresponding prior year period.
Operating expenses were $661.7 million for 2021, as compared to $449.1 million for the corresponding prior year period, an increase of 47%. Non-GAAP operating expenses were $506.8 million for 2021, as compared to $295.2 million for the corresponding prior year period.
Other income (expense) net increased to $25.2 million for the year ended December 31, 2021, from $3.6 million for the year ended December 31, 2020, primarily due to $25.0 million income pursuant to a settlement and license agreement entered into in December 2021.
Net loss attributable to Guardant Health, Inc. common stockholders was $405.7 million for 2021, as compared to $253.8 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $4.00 for 2021, as compared to $2.60 for the corresponding prior year period. Non-GAAP net loss was $251.7 million for 2021, as compared to $91.0 million for the corresponding prior year period. Non-GAAP net loss per share was $2.48 for 2021, as compared to $0.93 for the corresponding prior year period.
Adjusted EBITDA loss was $231.5 million for 2021, as compared to a $84.4 million loss for the corresponding prior year period.
Cash, cash equivalents and marketable securities were $1.6 billion as of December 31, 2021.
2022 Guidance
Guardant Health expects full year 2022 revenue to be in the range of $460 million to $470 million, representing 23% to 26% growth over full year 2021.
Webcast Information
Guardant Health will host a conference call to discuss the fourth quarter 2021 financial results after market close on Wednesday, February 23, 2022 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.
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Non-GAAP Measures
Guardant Health has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of precision oncology testing, non-GAAP research and development expense, non-GAAP sales and marketing expense, non-GAAP general and administrative expense, non-GAAP loss from operations, non-GAAP net loss, non-GAAP net loss attributable to Guardant Health, Inc., common stockholders, non-GAAP net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted, and Adjusted EBITDA.
We define our non-GAAP measures as the applicable GAAP measure adjusted for the impacts of stock-based compensation and related employer payroll tax payments; changes in estimated fair value redeemable noncontrolling interest; contingent consideration; acquisition related expenses, amortization of intangible assets, and other non-recurring items.
Adjusted EBITDA is defined as net loss attributable to Guardant Health, Inc. common stockholders adjusted for interest income; interest expense; other income (expense), net, provision for (benefit from) income taxes; depreciation; and amortization expense; stock-based compensation expense and related employer payroll tax payments; adjustments relating to redeemable non-controlling interest and contingent consideration and, if applicable in a reporting period, acquisition-related expenses and other non-recurring items.
We believe that the exclusion of certain income and expenses in calculating these non-GAAP financial measures can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. We use these non-GAAP financial measures to evaluate ongoing operations, for internal planning and forecasting purposes, and to manage our business.
These non-GAAP financial measures are not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.

On February 23, 2022  Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported a corporate update and reported financial results for the quarter and year ended December 31, 2021 (Press release, Allogene, FEB 23, 2022, View Source [SID1234608889]).

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"The FDA hold placed upon our clinical programs presented us with an unexpected challenge during the fourth quarter. In responding to and resolving this challenge, our team continued to demonstrate the qualities of leadership, collaboration, innovation, and focus that are required to be a pioneer in the field of allogeneic T cell therapy. I am incredibly proud of our employees’ commitment and relentless belief in the potential for our products to improve the lives of patients," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Our mission has been, and continues to be, the first to bring allogeneic CAR T products to the market in blood cancers and solid tumors. We believe we are on track and have what it takes to execute on this vision and look forward to advancing our broad portfolio of product candidates."

Corporate Highlights
On January 10, 2022, Allogene announced that the U.S. Food and Drug Administration (FDA) had removed the clinical hold on all AlloCAR T clinical trials which was announced on October 7, 2021. After extensive investigation by Allogene, it was determined that the chromosomal abnormality detected in a single patient treated with ALLO-501A was unrelated to TALEN gene editing or Allogene’s manufacturing process and had no clinical significance. The abnormality was not detected in any manufactured AlloCAR T product or in any other patient treated with the same ALLO-501A lot. The abnormality occurred after the cell product was administered and involved regions of the T cell receptor and immunoglobulin genes known to undergo rearrangement as part of the T cell or B cell maturation process.

Allogene has resumed clinical study activities on ALLO-715 and ALLO-605 for relapsed/refractory (R/R) multiple myeloma (MM), and ALLO-316 for advanced or metastatic clear cell renal cell carcinoma (RCC), and began enrolling patients earlier this month. Enrollment in the Phase 1 ALLO-501 ALPHA trial in R/R non-Hodgkin lymphoma (NHL) has completed accrual. The focus remains on preparing for the pivotal Phase 2 ALPHA2 trial of ALLO-501A in R/R Large B Cell Lymphoma (LBCL). Prior to the start of Phase 2, Allogene plans to resume enrollment in the Phase 1 study in order to offer AlloCAR T to patients in need.

Cell Forge 1 (CF1)
CF1, Allogene’s state-of-the-art manufacturing facility located in Newark, California is now fully operational and producing GMP material with the intent of supplying ALLO-501A for the planned pivotal study.

Pipeline Updates

Anti-CD19 Program
Phase 1 data from the ALPHA trial with ALLO-501 and ALPHA2 trial with ALLO-501A for the treatment of R/R NHL was presented at the 2021 Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Data from these trials continue to support the promise of Allogene’s platform to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T naïve patients.

Highlights from the ASH (Free ASH Whitepaper) 2021 presentation include:

AlloCAR T was associated with consistent and manageable safety with no dose limiting toxicities (DLTs) or graft-vs-host disease (GvHD) and minimal Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), or Grade 3 cytokine release syndrome (CRS).
There were no relapses observed in LBCL CAR T naïve patients across trials who had achieved a complete response (CR) at six months with the longest ongoing CRs with ALLO-501 at 18+ months and ALLO-501A at 15+ months.
One of the most critical advantages of AlloCAR T was further established with more than 97% of enrolled patients able to receive therapy with the median time from enrollment to initiation of treatment of five days in ALPHA and two days in ALPHA2.
Phase 2 Preparation:
The single-arm ALPHA2 trial is on track to begin mid-year 2022 with FDA discussions directed at finalizing clinical trial design and proactively accelerating activities that address Chemistry Manufacturing and Controls (CMC) requirements.

Allogene is developing ALLO-647, its proprietary anti-CD52 monoclonal antibody intended to enable expansion and persistence of AlloCAR T product candidates, including ALLO-501A. Allogene intends to launch a separate registrational trial for ALLO-647 at the time of the pivotal Phase 2 trial for ALLO-501A as part of the concurrent development plan. This trial is intended to demonstrate the safety of ALLO-647 along with its contribution to the overall benefit of the lymphodepletion regimen.

Anti-BCMA AlloCAR T Program
Allogene’s anti-BCMA strategy includes the Phase 1 UNIVERSAL trial, which has cohorts evaluating ALLO-715 as a monotherapy, consolidated dosing of ALLO-715 using ALLO-647 to selectively extend the window of lymphodepletion, and ALLO-715 in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat. The Phase 1 IGNITE trial is evaluating ALLO-605, Allogene’s first TurboCAR candidate. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells and has shown the ability to improve the potency and persistence of allogeneic cells in preclinical models. Activity in these trials has resumed and Allogene intends to provide a BCMA program clinical update by the end of 2022.

ALLO-715 UNIVERSAL Trial
Data from the UNIVERSAL trial with ALLO-715 as a monotherapy for the treatment of R/R MM was also presented at ASH (Free ASH Whitepaper) 2021. The UNIVERSAL trial is the first allogeneic anti-BCMA CAR T to demonstrate safety and substantial efficacy in MM with response rates that are similar to the approved autologous CAR T therapy.

The data presented at ASH (Free ASH Whitepaper) demonstrated that ALLO-715 was well tolerated with no GvHD and a manageable safety profile.
There was a 71% Overall Response Rate (ORR) at dose level 3 (320 million AlloCAR T+ cells) with lymphodepletion consisting of fludarabine/cyclophosphamide and ALLO-647
46% of patients achieved a Very Good Partial Response or better (VGPR+) including 25% Complete Response or Stringent Complete Response (CR/sCR).
92% of patients with VGPR+ were minimal residual disease (MRD) negative.
Median duration of response (DoR) was 8.3 months at the time of data cut-off.
Importantly, the study highlighted the ability to initiate treatment within five days of enrollment and eliminate the need for bridging therapy.
Solid Tumor AlloCAR T Program

ALLO-316 (anti-CD70) – TRAVERSE Trial

The Phase 1 trial for Allogene’s first AlloCAR T candidate for solid tumors, ALLO-316, is designed to evaluate the safety, tolerability, anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with advanced or metastatic clear cell RCC. Clinical trial activities have resumed.
Fourth Quarter and Year-End Financial Results

Research and development expenses were $54.0 million for the fourth quarter of 2021, which includes $11.1 million of non-cash stock-based compensation expense. For the full year of 2021, research and development expenses were $220.2 million. Research and development expense for the year includes $39.6 million of non-cash stock-based compensation expense.
General and administrative expenses were $20.0 million for the fourth quarter of 2021, which includes $10.9 million of non-cash stock-based compensation expense. For the full year of 2021, general and administrative expenses were $74.1 million, which includes $41.2 million of non-cash stock-based compensation expense.
Net loss for the fourth quarter of 2021 was $74.9 million, or $0.54 per share, including non-cash stock-based compensation expense of $22.0 million. For the full year of 2021, net loss was $257.0 million, or $1.89 per share, including non-cash stock-based compensation expense of $80.8 million.
The Company had $810 million in cash, cash equivalents, and investments as of December 31, 2021.
2022 Financial Guidance

Allogene expects 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 4973864. 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.