On May 9, 2022 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, reported financial results for the first quarter ended March 31, 2022 and increased full year 2022 revenue guidance (Press release, MaxCyte, MAY 9, 2022, View Source [SID1234613928]).

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First Quarter Highlights

Total revenue of $11.6 million in the first quarter of 2022, an increase of 78% over the first quarter of 2021 driven by strong growth in the core business; core business revenues grew 48% consisting of revenue from cell therapy customers increasing by 57% and drug discovery customers by 23%.
Generated a total of $2.0 million in Strategic Platform License (SPL) Program-related revenue in the first quarter of 2022, compared to immaterial SPL Program-related revenue in the first quarter of 2021.
2022 revenue guidance includes expectations for core business revenue growth to be at least 25% and expected SPL Program-related revenue of approximately $4 million.
With the addition of Intima Bioscience in February 2022, the total number of SPLs now stands at 16.
"We are pleased with this positive start to 2022 at MaxCyte, with very strong first quarter results, including 48% year-over-year core business revenue growth driven by ongoing significant growth in sales to cell therapy customers. We are encouraged by the continued expansion of our portfolio of SPLs with the addition of Intima Bioscience, our sixteenth SPL, as well as the exciting clinical progress of our existing SPL partners. The milestone revenue recorded over the period reflects the progress being made by our partners in early and mid-stage clinical development programs," said Doug Doerfler, President and CEO of MaxCyte.

"I am proud of our continued support for the clinical progress of our partners and the success of our growing global commercial team.

"In addition to the progress made by SPL programs that have entered the clinic, our SPL partners are using MaxCyte’s technology to work on a broad range of new cell types, approaches and indications including solid tumors and autoimmune disease, which also demonstrates the depth and breadth of our ExPERT platform. Ongoing investments in our field and lab science teams and the progress of our in-house manufacturing initiative leaves us well-positioned to support growing adoption of the ExPERT platform technology for cellular-based research and next-generation therapeutic development."

The following table provides details regarding the sources of our revenue for the periods presented.

Total revenue for the first quarter of 2022 was $11.6 million, compared to $6.5 million in the first quarter of 2021, representing growth of 78%.

Core business revenue was $9.6 million, including revenue growth from cell therapy customers of 57% and from drug discovery customers of 23%, compared to core business revenue of $6.5 million in the same period last year.

Our SPL Program-related revenue was $2.0 million, compared to immaterial SPL Program-related revenue in the first quarter of 2021.

Gross profit for the first quarter of 2022 was $10.5 million (91% gross margin), compared to $5.8 million (89% gross margin) in the same period of the prior year. The increase in gross margin was driven by the higher SPL Program-related revenues; excluding SPL Program-related revenues, gross margin was relatively unchanged.

Operating expenses for the first quarter of 2022 were $14.7 million, compared to operating expenses of $12.2 million in the first quarter of 2021. The prior year operating expenses included $3.9 million of CARMA-related expenses that did not recur in 2022, as we have ceased developing the CARMA platform. The overall increase in operating expenses was primarily driven by increased headcount to support growth in field sales and science, manufacturing and lab teams. Growth in public company-related and stock-based compensation expense also contributed to the higher level of expenses compared with the same period a year ago.

First quarter 2022 net loss was $4.1 million compared to net loss of $7.1 million for the same period in 2021; EBITDA, a non-GAAP measure, was a loss of $3.7 million for the first quarter of 2022, compared to a loss of $6.4 million for the first quarter of the prior year; stock-based compensation expense was $2.5 million versus $1.3 million for the same period in the prior year.

Total cash, cash equivalents and short-term investments were $246.3 million as of March 31, 2022.

2022 Revenue Guidance

Management is increasing 2022 revenue guidance based on our expectations for the core business.

We expect core business revenue (instruments and disposables to cell therapy and drug discovery customers and excluding program-related revenue) to grow at least 25% compared to 2021 core business revenue. We also continue to expect SPL Program-related revenue to be approximately $4 million in 2022.

Webcast and Conference Call Details

MaxCyte will host a conference call today, May 9, 2022, at 4:30 p.m. Eastern Time. Interested parties may access the live teleconference by dialing (844) 679-0933 for domestic callers, (918) 922-6914 for international callers, for 0203 1070 289 U.K domestic callers, or for 0800 0288 438 U.K. international callers followed by Conference ID: 1953037. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

Non-GAAP Financial Measures

This press release contains EBITDA, which is a non-GAAP measure defined as earnings, before interest, tax, depreciation and amortization. MaxCyte believes that EBITDA provides useful information to management and investors relating to its results of operations. The company’s management uses this non-GAAP measure to compare the company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The company believes that the use of EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.

Management does not consider EBITDA in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of EBITDA is that it excludes significant expenses that are required by GAAP to be recorded in the company’s financial statements. In order to compensate for these limitations, management presents EBITDA together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of net loss, the most comparable GAAP financial measure, to EBITDA is included at the end of this release. MaxCyte urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business.

On MAY 9, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Precigen, MAY 9, 2022, View Source [SID1234613927]).

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"We continue to focus on execution and build on the utility of ARCUS as a premier genome editing platform to develop novel treatments for cancer and genetic diseases. We believe the differentiated attributes of ARCUS enable a high degree of specificity, minimal levels of off-target editing and maximum versatility, including gene insertion. These qualities underpin our organic strategy and attract accomplished partners that extend our reach to more patients with serious diseases while also providing capital to advance our core development priorities," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "As our programs continue to mature, we will remain nimble and follow the data to prudently manage our portfolio. This will allow us to hone in on the most impactful approaches to develop potential allogeneic CAR T product candidates and pursue optimal strategies for delivery to various tissues for gene editing in vivo."

"As we look ahead, we plan to provide an update across our allogeneic CAR T programs in June 2022 as data matures. On the research front, we have initiated IND-enabling studies for PBGENE-PH1 delivered by LNP as we target advancing three wholly owned in vivo gene editing programs towards IND or CTA applications over the next three years," Mr. Amoroso continued.

Recent Developments and Upcoming Milestones:

Ex Vivo Allogeneic CAR T Portfolio:

PBCAR0191: PBCAR0191 is the Company’s lead investigational anti-CD19 allogeneic CAR T candidate being evaluated in a Phase 1/2a clinical trial of adult subjects with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). In December 2021, Precision announced a Phase 1 data update, in which a 100% overall response rate (6/6) and a 66% complete response rate (4/6) was observed among patients that previously received an autologous CAR T therapy and progressed. Precision prioritized enrollment of this high unmet need patient population as a potential path for PBCAR0191, and the Company plans to provide a program update on PBCAR0191 in June 2022.
PBCAR19B: PBCAR19B is a novel, immune-evading stealth cell candidate employing a single-gene edit to knock-down beta-2 microglobulin and insert an HLA-E transgene. We believe PBCAR19B is the first CAR T cell candidate in the clinic designed to evade rejection by host T cells and natural killer (NK) cells. Precision initiated a clinical trial of PBCAR19B in patients with NHL in mid-2021 and plans to commence dosing in the third quarter of 2022 at the next dose level with clinical trial material from an optimized manufacturing process. The Company plans to provide a program update on PBCAR19B in June 2022.
PBCAR269A: PBCAR269A is an investigational allogeneic CAR T cell candidate targeting B-cell maturation antigen (BCMA) for R/R multiple myeloma. Precision is evaluating PBCAR269A in a Phase 1/2a study in combination with nirogacestat, a gamma secretase inhibitor developed by SpringWorks Therapeutics. The first patient was dosed in the combination arm in June 2021, and Precision expects to provide a program update on PBCAR269A in June 2022.
In Vivo Gene Editing Portfolio:

Over the next three years, Precision expects that three of its wholly owned preclinical in vivo programs will advance to IND or CTA. This includes:

PBGENE-PCSK9: In 2021, Precision initiated a collaboration with iECURE, pursuant to which Precision’s PBGENE-PCSK9 candidate is expected to advance through preclinical activities as well as a Phase 1 study in familial hypercholesterolemia. A CTA filing is expected as early as the end of 2022.
PBGENE-PH1: Precision has initiated IND-enabling activities for its PBGENE-PH1 candidate designed to knock out the well-validated HAO1 gene as a potential one-time treatment for primary hyperoxaluria type 1 (PH1). In the first quarter of 2022, the Company initiated a non-human primate study for PBGENE-PH1 delivered by LNP and expects to submit an IND or CTA in 2023.
PBGENE-HBV: Precision’s gene editing program for chronic Hepatitis B applies ARCUS to knock out persistent covalently closed circular DNA (cccDNA) and inactivate integrated hepatitis B genomes, potentially achieving durable HBV S-antigen (HBsAg) loss and viral persistence. Precision plans to pursue clinical development of its PBGENE-HBV candidate using LNP delivery and expects to submit an IND/CTA in 2024.
Precision continues its in vivo gene editing collaboration with Lilly and is applying ARCUS nucleases for three initial targets, including Duchenne muscular dystrophy in muscle, a central nervous system directed target and a liver directed target. In addition, Precision continues to engage discussions with potential biotech collaborators to leverage the unique attributes of ARCUS, such as gene insertion, for a variety of disease targets.

As announced on May 2, 2022, preclinical data on Precision’s wholly owned PH1 and HBV programs will be presented at the upcoming American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) meeting, May 16-19, 2022.

Abstract #239, Optimization of Hydroxyacid Oxidase 1 (HAO1) Targeting ARCUS Nucleases for the Treatment of Primary Hyperoxaluria Type 1
Abstract #447, Targeting the Hepatitis B cccDNA with a Sequence-Specific ARCUS Nuclease to Eliminate Hepatitis B Virus In Vivo
Other Research:

Additional abstracts on ARCUS in vivo gene editing have been accepted for presentation at the upcoming ASGCT (Free ASGCT Whitepaper) meeting, including one abstract on Precision’s mitochondrial DNA preclinical research and one abstract from a research and license collaboration with iECURE and the company’s ornithine transcarbamylase (OTC) deficiency program.

Abstract #561, ARCUS Gene Editing to Eliminate MELAS-associated m.3243A>G Mutant Mitochondrial DNA
Abstract #811, AAV-meganuclease-mediated Gene Targeting Achieves Efficient and Sustained Transduction in Newborn and Infant Macaque Liver
Preclinical research led by the Department of Ophthalmology and Visual Sciences at the University of Louisville using ARCUS genome editing platform for autosomal dominant Retinitis Pigmentosa (adRP) was presented at the recent Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

Abstract #3710318, Successful Late-stage Disease Treatment of P23H Human RHO (hRHO) Using ARCUS Nuclease Gene Editing in a Pig Model of Autosomal Dominant Retinitis Pigmentosa (adRP)
Abstract #3712152, Characterization of a Humanized Mouse Model of P23H Rhodopsin Autosomal Dominant Retinitis Pigmentosa (adRP)
Corporate:

Intellectual Property (IP) Update: In March 2022, the U.S. Patent and Trademark Office issued Precision five new U.S. patents further adding to the Company’s IP portfolio that cover the ARCUS platform and its use developing novel ex vivo and in vivo gene editing therapies. The five new patents included: patents relating to methods of using ARCUS nucleases to target sequences in the Hepatitis B virus (U.S. Patent No. 11,274,285); methods for modifying the Factor VIII gene in hemophilia A (U.S. Patent No. 11,278,632); methods for novel co-stimulatory domain used for allogeneic CAR T expansion (U.S. Patent No. 11,286,291); and methods of making allogeneic CAR T cells and T cell receptor alpha chain (TRAC)-targeting ARCUS nucleases useful in such methods (U.S. Patent Nos. 11,268,065 and 11,266,693).
Quarter Ended March 31, 2022 Financial Results:

Cash and Cash Equivalents: As of March 31, 2022, Precision had approximately $116.2 million in cash and cash equivalents. The Company expects that existing cash and cash equivalents, expected operational receipts and available credit will be sufficient to fund its operating expenses and capital expenditure requirements into mid-2023.

Revenues: Total revenues for the quarter ended March 31, 2022 were $3.3 million, as compared to $16.3 million for the same period in 2021. The decrease of $13.0 million in revenue during the quarter ended March 31, 2022 was primarily the result of a $10.3 million decrease in revenue recognized under the Servier Agreement subsequent to full satisfaction of the performance obligation under the execution of the Program Purchase Agreement in April 2021, a $2.1 million decrease in revenue recognized under the Lilly Agreement, and a $0.6 million decrease in revenue recognized from an agriculture partnering collaboration.

Research and Development Expenses: Research and development expenses were $20.0 million for the quarter ended March 31, 2022, as compared to $25.6 million for the same period in 2021. The decrease of $5.6 million was primarily due to decreases of $2.7 million in external development costs, including clinical research organization and clinical manufacturing organization costs, associated with our PBCAR0191, PBCAR269A, PBCAR20A and PBCAR19B clinical trials, as well as decreases of $1.1 million in sublicensing royalty payable to Duke on the Lilly upfront payment that was received in 2021 and $1.4 million in employee-related costs due to reduced headcount driven by the separation of Elo in 2021.

General and Administrative Expenses: General and administrative expenses were $10.7 million for the quarter ended March 31, 2022, as compared to $9.5 million for the same period in 2021. The increase of $1.2 million was primarily due to costs required to meet our growing infrastructure needs, including an increase of $1.3 million in general and administrative employee-related costs associated with increased wages, share-based compensation, relocation and recruiting costs for key management personnel.

Net Loss: Net loss was $28.2 million, or $(0.46) per share (basic and diluted), for the quarter ended March 31, 2022, as compared to a net loss of $18.7 million, or $(0.33) per share (basic and diluted), for the same period in 2021.

On May 9, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the first quarter ended March 31, 2022 and provided business updates (Press release, Akebia, MAY 9, 2022, View Source [SID1234613926]).

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"While we were surprised and disappointed by the vadadustat Complete Response Letter we received from the FDA in March, our team has responded aggressively by working to strengthen and secure the company financially, with an aim of allowing us to continue to deliver on our purpose to better the lives of people impacted by kidney disease. We plan to focus on Auryxia commercial success while exploring our earlier stage assets and pursuing other value creating business opportunities," said John Butler, Chief Executive Officer of Akebia. "The past six months of Auryxia net sales have been the strongest ever. This is a testament to the strength of our commercial team, which has delivered, even as COVID-19 disproportionately impacted the patients we serve. As we emerge from the pandemic, we believe Auryxia revenue is positioned to continue to grow and provide a solid basis for ongoing financial support for the company."

Akebia has outlined three pillars of its refined strategic focus:

Drive Auryxia revenue and identify cash management opportunities with the objective to enable Akebia to manage the company with existing cash resources and ongoing cash from operations;
Support our partners selling and seeking regulatory approval for vadadustat globally, including potential EMA approval and European launch; and evaluate options for potential U.S. approval; and,
Thoughtfully invest in our pipeline of internal assets and assess other strategic growth opportunities.
Akebia refined its strategic focus following receipt on March 29, 2022 of a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) for Akebia’s New Drug Application for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia due to chronic kidney disease. Akebia plans to request an end of review meeting with the FDA within ninety days of receipt of the CRL. Akebia plans to evaluate and determine potential next steps for vadadustat in the U.S. following the end of review meeting with the FDA. In the meantime, the company is focused on its path forward without a U.S. approval for vadadustat.

Financial Results

Revenues: Total revenue was $61.7 million for the first quarter of 2022 compared to $52.3 million for the first quarter of 2021.
Net product revenue was $41.4 million for the first quarter of 2022 compared with $30.4 million for the first quarter of 2021, an increase of 36%.
Collaboration revenue was $20.3 million for the first quarter of 2022 compared to $21.9 million for the first quarter of 2021. The decrease in the period compared to the same period in 2021 was primarily due to lower collaboration revenue from Otsuka Pharmaceuticals Co. Ltd (Otsuka) driven by lower development costs incurred subject to cost share provisions under both the Otsuka collaboration agreement for the U.S. and the Otsuka collaboration agreement for certain territories outside the U.S.
Revenue Guidance: Akebia is providing net product revenue guidance for Auryxia of $165 – $170 million for fiscal year 2022. Guidance assumes, among other things, continued stabilization of the phosphate binder market and continued improvement of net realized price per tablet.
COGS: Cost of goods sold was $31.3 million for the first quarter of 2022 compared to $34.6 million in the first quarter 2021. In 2022, cost of goods sold consisted of costs associated with the manufacturing of Auryxia and supply of Vafseo to MTPC for commercial sale in Japan. Additionally, $5.3 million was related to excess and obsolescence reserves associated with Auryxia partially offset by a $0.8 million reduction to the liability for excess purchase commitments, and $9.0 million related to amortization of intangibles.

R&D Expenses: Research and development expenses were $43.8 million for the first quarter of 2022 compared to $40.6 million for the first quarter of 2021. The increase compared to the prior year period was primarily due to increased headcount compared to the first quarter 2021.

SG&A Expenses: Selling, general and administrative expenses were $44.3 million for the first quarter of 2022 compared to $41.3 million for the first quarter of 2021 due to higher marketing expenses in anticipation of the potential approval of vadadustat.

Net Loss: Net loss was $62.4 million for the first quarter of 2022 compared to $69.6 million for the first quarter of 2021.

Cash Position: Cash and cash equivalents as of March 31, 2022, were $174.6 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan through at least the next twelve months. Akebia’s operating plan includes assumptions pertaining to cost avoidance measures and the reduction of overhead costs resulting from the planned amendment of certain contractual arrangements, including with certain supply and collaboration partners, and the reduction of certain infrastructure costs. The outcome of these measures, such as the potential amendment of certain contractual arrangements with supply and collaboration partners, are outside of Akebia’s control.

Restructuring: On April 4, 2022, the Board of Directors of Akebia approved a reduction in workforce of approximately 42% across all areas of Akebia (47% inclusive of the majority of open positions) following the receipt of the CRL. On May 5, 2022, Akebia implemented a further reduction in workforce consisting of several members of management. In connection with the restructuring, the company estimates that it will incur restructuring charges of approximately $16.5 million in the aggregate, primarily related to one-time termination benefits and contractual termination benefits including severance, non-cash stock-based compensation expense, healthcare and related benefits primarily in the second quarter of 2022. Akebia expects that the reduction in force will result in an approximate range of $60-65 million reduction in cash required for operating activities through the end of 2023.
"There has been significant effort made since our CRL in March to streamline our operations with a goal of funding operations from the cash flows of Auryxia as well as funds from our collaboration partners," said David A. Spellman, Chief Financial Officer of Akebia. "There is still work to do, and we are focused on delivering increased revenue and greater cost savings. If we are successful in implementing cost avoidance measures, we believe we will have cash flows to support the business through at least the next twelve months and do not anticipate a near-term requirement to further finance the company to execute our operating plan."

Conference Call
Akebia will host a conference call on Monday, May 9, 2022 at 4:30 p.m. Eastern Time to discuss its first quarter financial results and provide business updates. To listen to the conference call on May 9, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 1273066. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through May 15, 2022. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 1273066. An online archive of the conference call can be accessed via the Investors section of Akebia’s website at View Source

On May 9, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended March 31, 2022 (Press release, ORIC Pharmaceuticals, MAY 9, 2022, View Source [SID1234613925]).

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"We continue to make steady progress in advancing our pipeline of novel oncology candidates," said Jacob M. Chacko, MD, chief executive officer, "We expect to report initial data from our three ongoing studies in the first half of 2023, which includes our Phase 1b single agent trials for ORIC-533, our orally bioavailable CD73 inhibitor, ORIC-114, our brain penetrant EGFR/HER2 inhibitor, and ORIC-944, our embryonic ectoderm development (EED) inhibitor."

First Quarter 2022 and Other Recent Highlights

Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2022, ORIC disclosed new preclinical data in three poster presentations and one oral presentation at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

ORIC-533: Oral Small Molecule CD73 Inhibitor

ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73 that has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule inhibitors of the adenosine pathway. In preclinical studies, ORIC-533 overcame immune suppression and triggered significant lysis and cell death of multiple myeloma cells in an assay comprised of autologous bone marrow microenvironment. A Phase 1b trial with ORIC-533 as a single agent in multiple myeloma is enrolling patients, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-114: EGFR/HER2 Inhibitor

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. In preclinical studies, ORIC-114 achieved tumor regressions in an EGFR exon 20 NSCLC model with superior efficacy relative to CLN-081 and demonstrated greater anti-tumor activity compared to mobocertinib (TAK-788) in an intracranial NSCLC model. A Phase 1b trial with ORIC-114 as a

single agent is enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows for patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-944: PRC2 Inhibitor

ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. A Phase 1b trial with ORIC-944 as a single agent is enrolling patients with metastatic prostate cancer, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

PLK4 Inhibitor Program

In March, the company announced a small molecule therapeutic program intended to address a mechanism of innate resistance found in a subset of breast cancers, specifically a synthetic lethal interaction of polo-like kinase 4 (PLK4) inhibition in tumors bearing a TRIM37 DNA amplification. ORIC discovered novel, potent, orally bioavailable small molecule inhibitors of PLK4 that are highly selective and achieved strong anti-tumor activity of TRIM37 high xenograft tumors, with corresponding pharmacodynamic effects and no body weight loss. The PLK4 inhibitor program is currently in lead optimization.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

•ORIC-533: Initial Phase 1b data in 1H 2023
•ORIC-114: Initial Phase 1b data in 1H 2023
•ORIC-944: Initial Phase 1b data in 1H 2023

First Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256.2 million as of March 31, 2022, which the company expects will fund its current operating plan into the second half of 2024.

R&D Expenses: Research and development (R&D) expenses were $16.8 million for the three months ended March 31, 2022, compared to $11.7 million for the same period in 2021, an increase of $5.1 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and our other product candidates of $4.6 million, offset by a decrease in ORIC-101 costs of $0.7 million due to the discontinuation of the program in the first quarter of 2022. Higher internal expenses related to higher personnel costs, including additional non-cash stock-based compensation of $0.5 million, also contributed to the increase in research and development expenses.

G&A Expenses: General and administrative (G&A) expenses were $6.4 million for the three months ended March 31, 2022, compared to $4.9 million for the same period in 2021, an increase of $1.6 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.7 million.

On May 9, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported financial results for the first quarter of 2022 and provided an update on recent corporate highlights (Press release, Inhibrx, MAY 9, 2022, View Source [SID1234613924]).

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Recent Corporate Highlights

On February 22, 2022, Inhibrx announced that it had entered into an amendment to its Loan and Security Agreement with Oxford Finance LLC. The amendment provides for the funding of an additional $130.0 million in gross proceeds, $40.0 million of which was funded upon execution of the amendment on February 18, 2022, with the remaining $90.0 million to be funded in three separate tranches upon future milestone events.
On March 3, 2022, Inhibrx announced that the FDA granted orphan-drug designation for INBRX-101 for the treatment of alpha-1 antitrypsin deficiency, or AATD.
On April 5, 2022, Inhibrx announced that it will be presenting late-breaking data from INBRX-101 at the American Thoracic Society 2022 Conference taking place May 13-18, 2022.
On April 25, 2022, Inhibrx announced the formation of a Scientific Advisory Board, comprised of the top global experts in AATD, for INBRX-101.
Financial Results

Cash and Cash Equivalents. As of March 31, 2022, Inhibrx had cash and cash equivalents of $143.5 million, compared to $131.3 million as of December 31, 2021.
R&D Expense. Research and development expenses were $24.9 million during the first quarter of 2022, compared to $16.4 million during the first quarter of 2021. This overall increase was primarily due to an increase in work performed by Inhibrx’s contract development and manufacturing organization partners for the formulation and manufacturing of certain of its therapeutic candidates, as well as an increase in clinical trial expenses based on the initiation of a potentially registration-enabling Phase 2 trial in conventional chondrosarcoma and the progression of ongoing Phase 1 trials. Additionally, personnel-related costs increased during the first quarter of 2022 as compared to the same period in the prior year as a result of the continued expansion of Inhibrx.
G&A Expense. General and administrative expenses were $5.1 million during the first quarter of 2022, compared to $3.0 million during the first quarter of 2021. This overall increase was primarily driven by an increase of approximately $1.4 million in additional personnel-related costs, as well as marketing research expenses related to the initiation of our potential commercialization efforts for INBRX-101 and INBRX-109.
Net Loss. Net loss was $31.3 million during the first quarter of 2022, or $0.80 per share, compared to $19.3 million during the first quarter of 2021, or $0.51 per share.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.