Personalis Reports First Quarter 2022 Financial Results

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

Zymeworks Provides Corporate Update and Reports First Quarter 2022 Financial Results

On May 4, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the first quarter ended March 31, 2022 (Press release, Zymeworks, MAY 4, 2022, View Source [SID1234613570]).

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"We are incredibly excited to celebrate the milestone of the last patient enrolled for our pivotal study in second-line biliary tract cancers, as well as the continued progression of multiple zanidatamab clinical studies that we will be presenting over the course of the year starting at ASCO (Free ASCO Whitepaper) in June," said Kenneth Galbraith, Chair & CEO. "The completion of enrollment in HERIZON-BTC-01 is an important step forward in our efforts to provide patients with a new HER2-targeted therapy for BTC with the potential to improve on the current standard of care. We completed this clinical milestone ahead of our previously guided timeline set out in January, and hope to continue delivering on our corporate goals and exceeding expectations as we move forward."

First Quarter 2022 Business Highlights and Recent Developments

Completed Enrollment in HERIZON-BTC-01 Pivotal Trial in 2L Biliary Tract Cancers (BTC)
Enrollment was completed ahead of schedule for the global, pivotal trial
(HERIZON-BTC-01) evaluating zanidatamab monotherapy in patients with previously-treated advanced HER2-amplified BTC. The primary endpoint of this pivotal trial is confirmed objective response rate as determined by independent central review and we expect to finalize and present top-line data by early 2023. We expect that full details of the study will be presented at a major medical meeting in 2023.
Unveiled Next-Generation TOPO1i ADC Platform Presentation
The presentation shown in March at World ADC London highlighted the development of our next-generation TOPO1i ADC payload technology. We anticipate sharing more information on potential therapeutic candidates leveraging this TOPO1i platform at our R&D day in the fourth quarter of this year as we advance towards our goal of submitting two new Investigational New Drug applications by the end of 2024.
Completed Licensing Agreement with Atreca Utilizing Auristatin-Based ADC Platform
The technology licensing agreement with Atreca provides further validation of our auristatin-based ADC and technology platforms and showcases our ability to generate continued non-dilutive funding opportunities.
ZW49 Enrollment Continues to Advance Toward Anticipated Data Readout in 2H22
Zymeworks’ second clinical-stage asset and first biparatopic HER2-targeting antibody-drug conjugate, ZW49, has completed enrollment of 30 patients in the expansion cohorts targeting 2.5 mg/kg every three weeks. Additionally, the weekly dosing regimen recently expanded enrollment in the 1.5 mg/kg cohort and, in parallel, is now enrolling patients in the 1.75 mg/kg escalation cohort. Enrollment continues to progress well and we remain on target to submit data for presentation at a major medical meeting expected to occur in the second half of this year.
Zanidatamab Update at 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Zymeworks’ Asia-Pacific partner BeiGene will present data at the upcoming ASCO (Free ASCO Whitepaper) meeting in June on the first-line treatment of patients with HER2+ metastatic breast cancer using zanidatamab plus chemotherapy and on the first-line treatment of patients with HER2+ metastatic GEA using zanidatamab in combination with chemotherapy and tislelizumab. The outcomes of these treatments will be released in abstract form on May 26th, and more detailed information will be discussed at poster presentations on June 4th for first-line GEA and on June 6th for first-line breast cancer. Both presentations will provide further validation of zanidatamab’s clinical efficacy and stand to strengthen its position as a leading biparatopic HER2-targeting antibody. We plan to host a conference call to present the clinical results and clinical development strategy for zanidatamab after the ASCO (Free ASCO Whitepaper) Annual Meeting.

"We look forward to discussing these two important datasets at the ASCO (Free ASCO Whitepaper) meeting, and how the results will help shape our future development plans for zanidatamab," said Neil Josephson, M.D., Chief Medical Officer. "This will be the first presentation of clinical data with zanidatamab in the first-line treatment of advanced or metastatic HER2-positive breast cancer. The GEA presentation will contain new data from patients treated with standard of care first-line chemotherapy combined with zanidatamab, and the PD-1 inhibitor tislelizumab; a regimen that is being evaluated in the ongoing phase 3 HERIZON-GEA-01 study. We also look forward to additional opportunities available throughout 2022 to provide progress updates and present additional clinical data to support our global development program for zanidatamab."

Financial Results for the Quarter Ended March 31, 2022

Zymeworks’ revenue relates primarily to non-recurring upfront fees, expansion payments or milestone payments from collaboration and license agreements, which can vary in timing and amount from period to period, as well as payments for research and development support. Revenue for the three months ended March 31, 2022 was $1.9 million compared to $0.6 million for the same period of 2021. Revenue for 2022 related to research support and other payments from our partners including cost sharing arrangements. Revenue for the same period in 2021 was also related to research support and other payments from our partners.

Research and development expense increased by $18.2 million in the three months ended March 31, 2022 compared to the same period in 2021. Research and development expense in 2022 included non-cash stock-based compensation recovery of $3.2 million, comprised of a $2.7 million recovery from equity classified awards and a $0.5 million recovery related to the non-cash mark-to-market revaluation of certain historical liability classified awards, as well as $5.5 million from restructuring expenses. Excluding stock-based compensation expense and restructuring expenses, research and development expense increased on a Non-GAAP basis by $17.7 million in 2022 compared to 2021. The increase related primarily to higher clinical trial expenses for zanidatamab, increased drug manufacturing expenses, severance and other expenses incurred due to the Company’s restructuring program, partly offset by lower clinical trial expense for ZW49.

We expect research and development expenditures to fluctuate over time in line with the advancement, expansion and completion of the clinical development of our product candidates, as well as our ongoing preclinical research activities.

Excluding the impact of stock-based compensation and restructuring expenses, general and administrative expense increased on a Non-GAAP basis by $3.2 million in 2022 compared to 2021. This increase was primarily due to severance and other expenses incurred due to the Company’s restructuring program in 2022 as well as a non-recurring sales tax refund recognized in 2021, which offset expenses in the prior year.

Net loss for the three months ended March 31, 2022 was $72.6 million compared to $44.6 million for the same period of 2021. This was primarily due to increase in research and development expenses and general and administrative expenses referred to above.

"We continue to make progress upon our goal of improving our financial position and have successfully completed the first steps with the reduction in anticipated spending through prioritization of R&D programs and the previously announced new equity issuance closed in January," said Chris Astle, Ph.D., SVP and Chief Financial Officer. "We remain committed to further improving our cash position through non-dilutive capital and executing on the framework laid out in January, and we look forward to reporting on these initiatives in the coming months."

As of March 31, 2022, Zymeworks had $300.5 million in cash resources consisting of cash, cash equivalents and short-term investments. Based on our current operating plan, we believe that our current cash resources, and proceeds from certain existing collaboration payments we anticipate receiving, will enable us to fund our planned operations into the second half of 2023 and potentially beyond. Further, we continue to make good progress towards our previously announced goal of executing on new partnerships and collaborations in order to provide additional non-dilutive sources of funding for our operations beyond 2023.

NANOBIOTIX to Announce First Quarter 2022 Financial Results on May 18, 2022

On May 4, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will report its financial results for the first quarter of 2022 ending March 31, 2022, on Wednesday, May 18, 2022, after the close of the US market (Press release, Nanobiotix, MAY 4, 2022, View Source [SID1234613569]).

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The announcement will be followed by a conference call and live audio webcast on Thursday, May 19, 2022, at 8:00 AM EDT / 2:00 CET, prior to the opening of the US market. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial officer, will briefly review the Company’s first quarter results and provide an update on operational activities before taking questions from analysts and investors. Investors are invited to email their questions in advance to [email protected].

Details for the call are as follows:

Participants:

In the 10 minutes prior to call start time, call the appropriate Dial-In number listed below.
Enter the Event Plus Passcode stated below and leavy any information requested after the tone. You will join automatically to the conference.
Dial-In Information:

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product, composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering an adaptive immune response and long-term anti-cancer memory. Given the MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly, with immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study, evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and for patients with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy, either naïve or resistant to prior PD-1 (either primary or secondary as per SITC (Free SITC Whitepaper) criteria).

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies.

Microba Accelerates Cancer Program With New Leads

On May 4, 2022 Microba Life Sciences Limited (ASX: MAP) ("Microba" or the "Company") reported it has identified three therapeutic leads for the Company’s Immuno-Oncology program significantly earlier than expected (Press release, Microba Life Sciences , MAY 4, 2022, View Source [SID1234613568]). This will enable preclinical animal studies to be brought forward to the end of calendar year 2022 which is approximately 12 months ahead of schedule.

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Microba’s Cancer Immuno-Oncology program is targeting the discovery and development of a microbiome therapy to improve response rates in cancer patients receiving immune checkpoint inhibitor (ICI) therapy, with a specific focus on Melanoma and Lung cancer patients. The new therapeutic leads that will be trialled in pre-clinical models later this year have been discovered through a recently completed, comprehensive meta-analysis of newly available data with Microba’s proprietary MCP microbiome profiling technology.

Further supporting Microba’s Immuno-Oncology program is the Company’s partnership and awarded grant together with the Garvan Institute of Medical Research (Garvan), targeting the collection of data on thousands of cancer patients over the coming years to establish a leading cancer microbiome dataset. This is expected to broaden the number of cancers for which Microba can identify a clear microbiome signature.

The combination of the new leads and the partnership with Garvan will enable Microba to save over US$1m of expenditure on discovery activities which were scheduled to take place over the next 18 months under the ORBIT-m study.

The leading existing ICI therapies from Merck and BMS generate in excess of $20bn1 in sales per year despite 42-80%2 of patients not responding to therapy. Development of an adjuvant therapy that can improve response rates to ICI therapies could have a significant impact on cancer treatment globally and represents a substantial commercial opportunity.

Commenting on the accelerated oncology strategy, CEO Dr Luke Reid said:

"This acceleration of our oncology program is really pleasing. The discovery of these leads enables us to advance our timelines for this program. Developing an effective adjuvant therapy for cancer patients receiving immune checkpoint inhibitors has the potential to impact outcomes for millions of patients globally."

Chief Scientific Officer Associate Professor, Lutz Krause said:

"Through applying Microba’s proprietary technology, we have uncovered therapeutic leads sooner than we had anticipated. We are excited to progress these into pre-clinical models and ultimately into human clinical trials pending the results. This exemplifies the power of Microba’s data-driven Therapeutic Platform, which enables the rapid discovery and development of these novel monoclonal microbial therapies."

This announcement has been authorised for release by the Board.

Ligand Reports First Quarter 2022 Financial Results

On May 4, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three months ended March 31, 2022 and provided an operating forecast and program updates (Press release, Ligand, MAY 4, 2022, View Source [SID1234613567]). Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

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"2022 is off to a strong start with solid financial performance from our growing roster of royalty-bearing products and great execution from all our core technology platforms," said John Higgins, CEO of Ligand. "We are excited about the potential growth of our business in the years to come as several recently approved products are launched and our portfolio of late-stage programs continue to advance. In addition to our financial performance, the announced separation of our OmniAb antibody discovery business is well underway with the merger with the Avista SPAC expected to close this year."

First Quarter 2022 Financial Results

Revenue for the first quarter of 2022 was $45.7 million, compared with $55.2 million in the prior period. First quarter revenue grew across all categories with the exception of COVID-19 related Captisol sales. Core Captisol sales in the first quarter 2022 were $6.2 million compared to $1.3 million in the prior year. The difference in sales is due to timing of customer orders. Captisol sales related to COVID-19 were $5.9 million for the first quarter of 2022, compared with $30.0 million for the same period in 2021. The lower sales are due to reduced demand for the pandemic-related treatment. Royalty revenue grew 93% to $13.7 million due primarily to contribution of sales from products using the Pelican platform. Contract revenue grew 19% to $19.9 million. Revenue attributable to the OmniAb business for the first quarter of 2022 was $9.2 million, compared with $8.6 million for the prior year period.

Cost of Captisol was $4.7 million for the first quarter of 2022, compared with $8.2 million for the same period in 2021, with the decrease primarily due to lower total sales of Captisol. Amortization of intangibles was $11.8 million for the first quarter of both 2022 and 2021. Research and development expense was $20.3 million for the first quarter of 2022, compared with $17.9 million for the same period of 2021. General and administrative expense was $18.2 million for the first quarter of 2022, compared with $12.6 million for the same period in 2021, with the increase primarily due to $4.8 million in transaction costs incurred during the first quarter of 2022 in connection with the planned spin-off of OmniAb.

Net loss for the first quarter of 2022 was $(15.4) million, or $(0.91) per share, compared with net income of $18.1 million, or $1.05 per diluted share, for the same period in 2021. Net loss for the first quarter of 2022 included a $(12.6) million net non-cash loss from the value of Ligand’s short-term investments, while net income for the first quarter of 2021 included a $9.1 million net non-cash gain from the value of Ligand’s short-term investments. Adjusted net income for the first quarter of 2022 was $13.1 million, or $0.76 per diluted share, compared with $24.3 million, or $1.41 per diluted share, for the same period in 2021. Excluding the impact of gross profit, net of tax, for Captisol sales related to COVID-19, adjusted net income for the first quarter of 2022 was $10.0 million, or $0.58 per diluted share, compared with $2.9 million, or $0.14 per diluted share, for the same period in 2021. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.

Ligand repurchased $165.8 million in principal of its 2023 Notes for $163.7 million in cash. As of March 31, 2022, Ligand had cash, cash equivalents and short-term investments of $204.0 million.

2022 Financial Guidance

Ligand is reaffirming 2022 revenue guidance for the combined business and providing revenue estimated to be attributable to the OmniAb business anticipating the spin-off later this year. Ligand expects 2022 royalties of $55 million to $60 million, Captisol sales of $40 million to $50 million and contract revenue of $52 million to $62 million. These revenue components result in total revenue of $147 million to $172 million for the combined business. Ligand expects that $35 million to $45 million of revenue will be attributable to OmniAb, principally in the contract revenue line.

Ligand is introducing full-year 2022 earnings guidance and a breakout of revenue and earnings guidance for the Ligand business excluding OmniAb and COVID-related Captisol. Of the $40 million to $50 million of expected Captisol sales, Ligand expects approximately $17 million to $19 million to be attributable to core Captisol sales, and the balance to be attributable to treatments for COVID-19. Excluding OmniAb and COVID-related Captisol, Ligand expects revenue to be $90 million to $100 million and adjusted earnings per diluted share to be $1.50 to $1.80. Ligand expects the contribution from COVID-related Captisol and the OmniAb business to be between $0.20 and $0.40 per diluted share, resulting in adjusted earnings per diluted share for the full company of $1.70 to $2.20.

Update on the OmniAb Separation Process

On March 23, 2022, Ligand announced the signing of a definitive merger agreement with Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA), a publicly traded special purpose acquisition company (SPAC), providing for the spin-off and merger of OmniAb. The combination of OmniAb and APAC is structured to provide a minimum of $130 million in gross cash to the combined company at the time of closing, and up to $266 million in the event of no redemptions by APAC shareholders.

OmniAb will have an initial pre-money equity valuation of $850 million. Ligand intends to distribute 100% of its ownership in OmniAb to Ligand shareholders immediately prior to the business combination with APAC. The transaction is expected to be tax-free to Ligand and its shareholders for U.S. federal income tax purposes. This transaction is expected to close in the second half of 2022.

See "Important Information and Where to Find It" and "Participants in the Solicitation" below for additional information regarding the transaction.

First Quarter 2022 and Recent Business Highlights

OmniAb Platform and Partner Updates

The OmniAb discovery platform provides Ligand’s pharmaceutical industry partners with access to diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. Over 55 partners have access to OmniAb-derived antibodies and more than 250 programs are being actively developed or commercialized. As of March 31, 2022, there were 25 active clinical- or commercial- stage OmniAb-derived antibodies.

In March, Immunovant held an R&D day, where they highlighted Batoclimab (IMVT-1401), an OmniAb-derived monoclonal antibody targeting the neonatal Fc receptor. Immunovant announced plans to initiate a Phase 3 trial in myasthenia gravis in the first half of 2022 with top-line results expected in 2024. Immunovant further outlined plans to initiate clinical trials in four additional indications in 2022, with two of the indications expected to enter directly into pivotal trials. Batoclimab is also being developed by Harbour BioMed in China and is currently in an ongoing pivotal Phase 3 trial in patients with myasthenia gravis.

Aptevo Therapeutics announced that a patient with relapsed/refractory acute myeloid leukemia in an on-going Phase 1b trial received an allogeneic stem cell transplant after receiving APVO436 and experiencing significant reduction in bone marrow blasts. This follows Aptevo’s previous announcement that a patient receiving combination therapy is also moving to transplant after one cycle of therapy.

In Q1 and recently, OmniAb entered into new platform licensing agreements with LTZ Therapeutics, Seismic Therapeutics, LifeArc and an undisclosed venture-backed Bay Area immuno-oncology company.

Other Portfolio Updates

In March, Travere Therapeutics announced the submission of an NDA to the FDA for accelerated approval of sparsentan for IgA nephropathy (IgAN). Travere announced that plans are underway to submit an NDA for accelerated approval to the FDA for focal segmental glomerulosclerosis (FSGS) and a combined IgAN and FSGS Marketing Authorisation Application in Europe in mid-2022.

In April, Merck announced the FDA granted Breakthrough Designation for V116, a 21-valent pneumococcal vaccine utilizing Ligand’s CRM197 vaccine carrier protein produced using the Pelican Expression Technology platform. Merck plans to initiate Phase 3 clinical trials for V116 in 2022.

On February 2, 2022 Jazz Pharmaceuticals announced the submission of a supplemental BLA to the FDA seeking approval for a M/W/F intramuscular dosing schedule for Rylaze as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia. Jazz announced on their Q4 earnings call plans to submit regulatory filings for Rylaze in Europe in mid-2022 with potential approval in 2023.

In February, BeiGene, Ltd. announced the launch of KYPROLIS (carfilzomib) for injection in China for patients with relapsed/refractory (R/R) multiple myeloma. KYPROLIS is licensed to BeiGene in China under a strategic collaboration with Amgen, and was approved in July 2021 by the China National Medical Products Administration (NMPA) in combination with dexamethasone for the treatment of adult patients with R/R multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent.

Outlook Therapeutics announced it submitted a BLA to the FDA for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration that, if approved, will be branded as LYTENAVA (bevacizumab-vikg).

Ligand provides regular updates on partner events through its Twitter account, @Ligand_LGND.

Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include share-based compensation expense, non-cash interest expense, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, gross profit for Captisol sales related to COVID-19, net of tax, transaction costs, and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, the Company does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (866) 518-6930 from the U.S. or (203) 518-9797 from outside the U.S. and use conference ID LP1Q22. To participate via live or replay webcast, a link is available at www.ligand.com.

About OmniAb

The OmniAb discovery platform provides Ligand’s pharmaceutical industry partners access to the diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. We believe OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through computational antigen design and immunization methods, paired with high-throughput single B cell screening and deep computational analysis of next-generation sequencing datasets to identify fully human antibodies with superior performance and developability characteristics. An established core competency focused on ion channels and transporters further differentiates our technology and creates opportunities to further leverage across modalities, including antibody-drug conjugates and others. The OmniAb suite of technologies and differentiating computational capabilities and BI features are combined to offer a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.