On March 6, 2023 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported financial results for the fourth quarter and twelve months ended December 31, 2022 (Press release, Quanterix, MAR 6, 2023, View Source [SID1234628194]).

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"Our Simoa technology continues to be on the forefront of research, testing, therapeutic trials and has been an integral part of recent advances in Alzheimer’s disease. In order to best capture and lead in this area, two quarters ago we began a corporate transformation and we’re pleased announce the program is on track, with good progress quarter over quarter, "said Masoud Toloue, President and Chief Executive Officer of Quanterix.

Sequential Progress with Strategic Business Realignment

In August 2022, the Company initiated a strategic business realignment to maximize its full potential to enable access to current and future Simoa technology. As part of the realignment, the Company established an assay redevelopment program with the goal of improving its capability to manufacture high-quality assays at scale.

Quanterix’s fourth quarter and full year revenue results were in line with expectations set forth with this plan. Gross margin, a key success indicator of the Company’s strategic realignment, saw strong quarter over quarter improvement. Q4 GAAP Gross Margin was 48.8% versus Q3 GAAP gross margin of 41.1%. Q4 Non-GAAP gross margin was 41.3% versus Q3 non-GAAP gross margin of 34.9%.

GAAP Operating loss of $22.3 million for the fourth quarter of 2022 included approximately $10 million of restructuring and impairment related charges. As a result of the restructuring, SG&A costs were $19.3M for the quarter, down $9.1M from last year Q4

Year over Year Financial Highlights

Fourth Quarter 2022

· Q4 GAAP revenue was $25.8 million versus prior year Q4 of $30.3 million, a decrease of 14.7%. Prior year Q4 revenue included $1.0M of RADx revenue.
· Q4 GAAP gross margin was 48.8% versus prior year Q4 of 53.7%; Q4 non-GAAP gross margin was 41.3% versus prior year Q4 of 47.2%.
· Cash burn for Q4 was $5 million, ended 2022 with $338.7 million of unrestricted cash.

Full Year 2022

· FY GAAP total revenue was $105.5 million versus prior year FY of $110.6 million, which included RADx revenue of $5.2 million.
· FY GAAP gross margin was 44.4% versus prior year FY of 55.8%; and FY non-GAAP gross margin was 37.5% versus prior year FY of 49.6%

For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below.

Fourth Quarter and Full Year Business Highlights

· In Q1 2022, Quanterix announced new agreements with Lilly to advance Alzheimer’s disease diagnosis and treatment; the agreements provide Quanterix access to Lilly’s P-tau217 antibody technology to create pathways for plasma-based biomarkers for use in Alzheimer’s disease and establish a framework for future collaboration and supports development of Quanterix tests to advance diagnosing and treating life-threatening diseases.

· In Q2 2022, the Company received funding from the Alzheimer’s Drug Discovery Foundation to accelerate Alzheimer’s disease diagnostic plasma test development. The Company is collaborating with Amsterdam University Medical Centers on four phases of clinical trials to validate Quanterix’s multi-analyte test. Phase 1 training cohort was completed in Q4 with 1,200 samples and Phase 1b (independent retrospective cohort) and Phase 2 (prospective trial) are expected to start by the end of Q1 2023.

· The Company is participating in the BioHermes trial with the Global Alzheimer’s Platform Foundation. The 17 US site and 1,000 early Alzheimer’s patient trial closed in November of 2022 and is expected to complete data analysis in Q2 of this year. This prospective validation trial is expected to support a regulatory filing for FDA clearance for Quanterix’s pTau-181 test.

· In Q4 2022, the Company presented findings at the 15th Clinical Trials on Alzheimer’s Disease conference, revealing that Quanterix’s Simoa technology has powered critical advances in ongoing clinical trials for the treatment of Alzheimer’s disease.

· The Company expanded its LDT menu with the launch of a neurofilament light chain (NfL) LDT, which can be used as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage. Quanterix’s Simoa NfL is the most widely published NfL test with hundreds of research papers, demonstrating its validity for assessing neuronal damage, and Simoa NfL has become widely adopted in therapeutic clinical trial designs

Published discoveries enabled through Quanterix’s Simoa technology continue to illustrate industry reliance on the Company’s ultra-sensitive technology for breakthrough discovery in research and clinical applications. The technology was highlighted in 137 new publications in the fourth quarter 2022, bringing total Simoa-specific inclusions to over 2,100 as of the end of 2022.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on March 6, 2023 at 8:30 a.m. Eastern Time. Individuals interested in listening to the conference call may do so by pre-registering here and obtaining a dial-in number and passcode.

A live webcast will also be available at: View Source . You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

Financial Highlights

Quanterix Corporation

Condensed Consolidated Statements of Operations

(Unaudited and in thousands, except share and per share data)

Three Months Ended December 31, Year Ended December 31,
2022 2021 2022 2021
Product revenue $ 16,674 $ 23,476 $ 69,808 $ 81,062
Service and other revenue 8,767 5,674 34,495 23,629
Collaboration revenue 170 162 649 648
Grant revenue 213 975 570 5,217
Total revenue 25,824 30,287 105,522 110,556
Costs of goods sold:
Cost of product revenue 9,631 9,916 40,809 34,149
Cost of service and other revenue 3,601 4,110 17,907 14,679
Total costs of goods sold and services 13,232 14,026 58,716 48,828
Gross profit 12,592 16,261 46,806 61,728
Gross margin 48.8 % 53.7 % 44.4 % 55.8 %
Operating expenses:
Research and development 5,600 7,734 25,890 27,978
Selling, general and administrative 19,272 28,423 91,995 92,336
Other lease costs 669 — 1,278 —
Restructuring 329 — 3,755 —
Goodwill impairment — — 8,220 —
Impairment expense 8,677 — 17,372 —
Total operating expenses 34,547 36,157 148,510 120,314
Loss from operations (21,955 ) (19,896 ) (101,704 ) (58,586 )
Interest income (expense), net 2,815 15 5,131 (403 )
Other income (expense), net 614 (213 ) (62 ) 1,265
Loss before income taxes (18,526 ) (20,094 ) (96,635 ) (57,724 )
Income tax (expense) benefit (75 ) 4 (65 ) 36
Net loss $ (18,601 ) $ (20,098 ) $ (96,700 ) $ (57,760 )
Net loss per share, basic and diluted $ (0.50 ) $ (0.55 ) $ (2.61 ) $ (1.60 )
Weighted-average common shares outstanding, basic and diluted 37,160,472 36,659,254 36,990,965 35,997,473

Quanterix Corporation

Condensed Consolidated Balance Sheets

(Unaudited and in thousands)

December 31, 2022 December 31, 2021
Assets
Current assets:
Cash and cash equivalents $ 338,740 $ 396,465
Accounts receivable, net 19,017 23,786
Inventory 16,786 22,190
Prepaid expenses and other current assets 6,860 6,514
Total current assets 381,403 448,955
Restricted cash 2,597 2,577
Property and equipment, net 20,162 17,960
Intangible assets, net 7,516 10,534
Goodwill — 9,632
Right-of-use assets 21,223 11,491
Other non-current assets 1,298 378
Total assets $ 434,199 $ 501,527
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 3,836 $ 9,209
Accrued compensation and benefits 10,658 13,252
Other accrued expenses 4,747 6,486
Deferred revenue 8,644 6,361
Short-term lease liabilities 2,687 1,428
Other current liabilities 386 241
Total current liabilities 30,958 36,977
Deferred revenue, net of current portion 1,415 1,099
Long-term lease liabilities 41,417 20,464
Other non-current liabilities 1,469 2,035
Total liabilities 75,259 60,575
Total stockholders’ equity 358,940 440,952
Total liabilities and stockholders’ equity $ 434,199 $ 501,527

Use of Non-GAAP Financial Measures

To supplement its financial statements presented on a GAAP basis, the Company presents non-GAAP gross profit and non-GAAP gross margin, which are calculated by including shipping and handling costs for product sales within cost of goods sold instead of within selling, general and administrative expenses. Management uses these non-GAAP measures to evaluate the Company’s operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends between the Company’s business and its competitors. Management believes that presentation of non-GAAP gross margin provides useful information to investors in assessing the Company’s operating performance within its industry and in order to allow comparability to the presentation of other companies in its industry where shipping and handling costs are included in cost of goods sold for products. Management also uses non-GAAP gross margin as a factor in assessing the Company’s progress against the strategic business realignment plan. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these pro-forma measures to their most directly comparable GAAP financial measures set forth below.

Reconciliation of GAAP to Non-GAAP Financial Measures

Quanterix Corporation

Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures

(Unaudited and in thousands, except percentages)

Three Months Ended December 31, Three Months Ended
September 30, Three Months Ended
June 30, Year Ended December 31,
2022 2021 2022 2022 2022 2021
GAAP gross profit $ 12,592 $ 16,261 $ 10,944 $ 8,711 $ 46,806 $ 61,728
Shipping and handling costs (1) (1,926 ) (1,976 ) (1,636 ) (1,868 ) (7,206 ) (6,892 )
Non-GAAP gross profit $ 10,666 $ 14,285 $ 9,308 $ 6,843 $ 39,600 $ 54,836

GAAP Revenue 25,824 30,287 26,646 23,500 105,522 110,556
GAAP Gross margin (GAAP gross profit as % of revenue) 48.8 % 53.7 % 41.1 % 37.1 % 44.4 % 55.8 %
Non-GAAP gross margin (non-GAAP gross profit as % of revenue) 41.3 % 47.2 % 34.9 % 29.1 % 37.5 % 49.6 %

GAAP total operating expenses $ 34,547 $ 36,157 $ 47,547 $ 33,670 $ 148,510 $ 120,314
Shipping and handling costs (1) (1,926 ) (1,976 ) (1,636 ) (1,868 ) (7,206 ) (6,892 )
Non-GAAP total operating costs $ 32,621 $ 34,181 $ 45,911 $ 31,802 $ 141,304 $ 113,422

GAAP loss from operations $ (21,955 ) $ (19,896 ) $ (36,603 ) $ (24,959 ) $ (101,704 ) $ (58,586 )
Non-GAAP loss from operations $ (21,955 ) $ (19,896 ) $ (36,603 ) $ (24,959 ) $ (101,704 ) $ (58,586 )

(1) Shipping and handling costs, which include freight and other activities costs associated with product shipments, net of charges passed on to the customer, are captured within operating expenses in our consolidated statements of operations. During the three months and year ended December 31, 2022, we incurred $1.9 million and $7.2 million, respectively, of shipping and handling costs recorded within operating expenses. During the three months and year ended December 31, 2021, we incurred $2.0 million and $6.9 million, respectively, of shipping and handling costs recorded within operating expenses. During the three months ended September 30, 2022, we incurred $1.6 million of shipping and handling costs within operating expenses. During the three months ended June 30, 2022, we incurred $2.1 million of shipping and handling costs within operating expenses.

On March 6, 2023 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported fourth quarter and full year 2022 financial results (Press release, Precigen, MAR 6, 2023, View Source [SID1234628193]).

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"2022 was a successful year with respect to clinical advancements for Precigen’s UltraCAR-T and AdenoVerse programs. We showcased highly encouraging safety and efficacy results from Phase 1 dose escalation of PRGN-3006 UltraCAR-T in AML at ASH (Free ASH Whitepaper) and Phase 1 dose escalation and expansion cohort data of our PRGN-2012 AdenoVerse immunotherapy in RRP at our Company’s R&D Day," said Helen Sabzevari, PhD, President and CEO of Precigen. "These data set us up for a strong 2023 as we continue our focus on rapidly advancing clinical programs and pursuing the most promising regulatory paths to licensure."

"Through the actions that we have taken over the past year, we have significantly strengthened our financial position. These actions included the divesture of Trans Ova Genetics, from which the non-dilutive proceeds were used to early retire over 85% of our outstanding $200 million of convertible notes due in July, and our public offering of common stock in January 2023. We also continue to focus on cost containment," said Harry Thomasian Jr., CFO of Precigen. "Based on present expectations, these actions provide a healthy cash runway to advance our clinical priorities into late 2024."

Key Program Highlights

· PRGN-2012 AdenoVerse Immunotherapy in RRP
o PRGN-2012 is an investigational off-the-shelf (OTS) AdenoVerse immunotherapy designed to elicit immune responses directed against cells infected with HPV 6 or HPV 11 for the treatment of RRP. The US Food and Drug Administration (FDA) granted orphan drug designation for PRGN-2012 for patients with RRP.
o The Company completed a Phase 1 dose escalation and dose expansion trial of PRGN-2012 in adult patients with severe, aggressive RRP (≥3 surgeries in prior year).
o The Company announced positive Phase 1 dose escalation and expansion cohort data (N=15) at the most recent R&D Day.
o The Company initiated the Phase 2 study and enrollment is ongoing with 22 patients enrolled to date, bringing the total number of enrolled patients to 34 at Dose Level 2.
o The Company plans to outline the regulatory strategy in RRP as FDA discussions advance.
· PRGN 2009 AdenoVerse Immunotherapy in HPV-associated Cancers
o PRGN-2009 is an OTS investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV-positive (HPV+) solid tumors.
o The Company completed enrollment in the Phase 1 monotherapy (N=6) and combination therapy (N=11) arms in patients with recurrent or metastatic HPV-associated cancers. A Phase 1 monotherapy and combination therapy safety and efficacy data presentation is expected in the first half of 2023.
o Enrollment was completed in the Phase 2 monotherapy arm with 20 evaluable patients in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients. An interim clinical data presentation from the Phase 2 monotherapy arm is expected in the second half of 2023.

· PRGN-3006 UltraCAR-T in AML
o PRGN-3006 is an investigational multigenic, autologous chimeric antigen receptor T cell (CAR-T) therapy engineered to simultaneously express a CAR specifically targeting CD33, membrane bound IL-15 (mbIL15), and a kill switch. The FDA granted orphan drug designation and fast track designation for PRGN-3006 UltraCAR-T for patients with relapsed or refractory (r/r) AML.
o The Company completed the Phase 1 dose escalation trial of PRGN-3006 in relapsed or r/r AML or higher-risk myelodysplastic syndromes (MDS).
o The Company announced positive Phase 1 dose escalation data (N=10 non-lymphodepletion; N=16 with lymphodepletion) at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
o The Company initiated a Phase 1b dose expansion trial of PRGN-3006 and expanded the trial to Mayo Clinic in Rochester, Minnesota, further validating the decentralized manufacturing model. The Company received FDA clearance to incorporate repeat dosing in the Phase 1b expansion trial. A Phase 1b clinical trial data presentation is expected in 2024.
· PRGN-3005 UltraCAR-T in Ovarian Cancer
o PRGN-3005 UltraCAR-T is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR specifically targeting the unshed portion of MUC16, mbIL15, and a kill switch.
o The Company completed enrollment in the Phase 1 dose escalation cohorts of the intraperitoneal (IP) and intravenous (IV) arms without lymphodepletion as well as in the lymphodepletion cohort in the IV arm. A Phase 1 dose escalation data presentation is expected in the first half of 2023.
o The Company initiated a Phase 1b dose expansion trial of PRGN-3005. The Company received FDA clearance to incorporate repeat dosing in the trial. A Phase 1b clinical trial data presentation is expected in 2024.
· PRGN-3007 UltraCAR-T in Advanced ROR1+ Hematological and Solid Tumors
o PRGN-3007, based on the next generation of the UltraCAR-T platform, is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), mbIL15, a kill switch, and a novel mechanism for the intrinsic blockade of PD-1 gene expression.
o Manufacturing technology transfer was completed for initiation of the Phase 1 umbrella trial in ROR1+ hematological cancers (chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL)) and solid tumors (triple negative breast cancer (TNBC)). The Phase 1 trial is open for enrollment and the Company expects to dose the first patient in the first quarter of 2023.
o The Company presented an abstract titled, "A Phase1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients with Advanced Hematologic and Solid Tumor Malignancies," at ASH (Free ASH Whitepaper).

Financial Highlights

· In January 2023, Precigen completed an underwritten public offering of approximately 44 million shares of common stock, including a partial exercise of the underwriters’ option to purchase additional shares, at a price to the public of $1.75 per share, which resulted in net proceeds to Precigen of approximately $73 million (after deducting underwriting discounts, fees and other underwriting expenses).
· During the year ended December 31, 2022, Precigen completed the sale of its wholly owned subsidiary, Trans Ova Genetics, resulting in the receipt of $162.3 million in proceeds from the sale, net of certain transaction related expenses. The Company recorded a gain on sale of discontinued operations of $94.7 million.
· As of December 31, 2022, the Company had successfully retired, through open market purchases, $156.7 million of outstanding convertible notes due in July 2023 at a discount to par. Subsequent to year end, the Company retired an additional $15.4 million of outstanding convertible notes, bringing the total face value of retired notes to $172.1 million. The early retirement of these convertible notes has resulted in savings to the Company of $6.2 million due to the discounted amount paid for these bonds and reduced future interest costs.
· Cash, cash equivalents, short-term investments and restricted cash totaled $99.7 million as of December 31, 2022.
· Selling, general and administrative (SG&A) costs decreased for both the three and twelve months ended December 31, 2022 compared to the prior year periods.

Fourth Quarter 2022 Financial Results Compared to Prior Year Period

Total revenues decreased $1.9 million, or 52%, from the three months ended December 31, 2021. Product and service revenues generated by Exemplar decreased $1.8 million from the three months ended December 31, 2021. Gross margin on product and services decreased comparable to the prior year due to the reduction in revenues and increased costs for supplies, drugs, and personnel at Exemplar.

Research and development expenses decreased $1.4 million, or 11%, from the three months ended December 31, 2021. This decrease was primarily driven by a reduction in contract research organization costs of $0.9 million, primarily due to timing differences, the completion of the 1b/2a clinical trial of AG019 in the fourth quarter of the prior year, as well as a continued prioritization of clinical product candidates, with less expense incurred related preclinical research programs for the comparable period.

SG&A expenses decreased $0.3 million, or 2%, from the three months ended December 31, 2021. Salaries, benefits, and other personnel costs decreased $1.4 million primarily due to reduced headcount as the Company scaled down corporate functions to support the more streamlined organization, offset by other costs which were primarily due to timing and not individually significant.

Loss from continuing operations was $22.2 million, or $(0.11) per basic and diluted share, compared to loss from continuing operations of $26.7 million, or $(0.13) per basic and diluted share, in 2021.

Full Year 2022 Financial Results Compared to Prior Year Period

Total revenues increased $12.6 million, or 89%, from the twelve months ended December 31, 2021. Collaboration and licensing revenues increased $14.2 million from the twelve months ended December 31, 2021, primarily due to the recognition of revenue related to agreements for which revenue was previously deferred, as it became probable that additional performance under the agreements would not be required. Product and service revenues generated by Exemplar decreased $1.3 million from the twelve months ended December 30, 2021. Gross margin on product and services decreased comparable to the prior year due to the reduction in revenues and increased costs for supplies, drugs, and personnel costs.

Research and development expenses decreased $0.8 million, or 2%, over the twelve months ended December 31, 2021. Salaries, benefits, and other personnel costs increased $1.8 million due to an increase in the hiring of employees to support the growth in the Company’s development activities as well as general salary increases. This increase was partially offset by a decrease in contract research organization costs and lab supplies of $2.4 million, primarily due to timing differences, the completion of the 1b/2a clinical trial of AG019 in the fourth quarter of the prior year, as well as a continued prioritization of clinical product candidates, with less expense incurred related preclinical research programs for the comparable period.

SG&A expenses decreased $4.0 million, or 8%, from the twelve months ended December 31, 2021. Salaries, benefits, and other personnel costs decreased $4.9 million primarily due to (i) a reduced headcount as the Company scaled down corporate functions to support the more streamlined organization and (ii) reduced stock compensation costs. This increase was partially offset by an increase of $0.9 million in legal and professional fees, primarily related to ongoing litigation

Loss from continuing operations was $79.8 million, or $(0.40) per basic and diluted share, compared to loss from continuing operations of $110.8 million, or $(0.56) per basic and diluted share, in 2021

Precigen: Advancing Medicine with Precision

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen, LinkedIn or YouTube

About AdenoVerse Immunotherapy

Precigen’s AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens designed to modulate the immune system. Precigen’s gorilla adenovectors, part of the AdenoVerse library, have potentially superior performance characteristics as compared to current competition. AdenoVerse immunotherapies have been shown to generate high-level and durable antigen-specific neutralizing antibodies and effector T cell immune responses as well as an ability to boost these antibody and T cell responses via repeat administration. Superior performance characteristics and high yield manufacturing of AdenoVerse vectors combined with UltraVector technology allows Precigen to engineer cutting-edge investigational gene therapies to treat complex diseases

About UltraCAR-T

UltraCAR-T is a multigenic autologous CAR-T platform that utilizes Precigen’s advanced non-viral Sleeping Beauty system to simultaneously express an antigen-specific CAR to specifically target tumor cells, mbIL15 for enhanced in vivo expansion and persistence, and a kill switch to conditionally eliminate CAR-T cells for a potentially improved safety profile. Precigen has advanced the UltraCAR-T platform to address the inhibitory tumor microenvironment by incorporating a novel mechanism for intrinsic checkpoint blockade without the need for complex and

expensive gene editing techniques. UltraCAR-T investigational therapies are manufactured via Precigen’s overnight manufacturing process using the proprietary UltraPorator electroporation system at the medical center and administered to patients only one day following gene transfer. The overnight UltraCAR-T manufacturing process does not use viral vectors and does not require ex vivo activation and expansion of T cells, potentially addressing major limitations of current T cell therapies.

Trademarks

Precigen, UltraCAR-T, UltraPorator, AdenoVerse, UltraVector and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Cautionary Statement Regarding Forward-Looking Statements

Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company’s business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company’s portfolio of therapies, and in particular its CAR-T and AdenoVerse therapies and its cash runway. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company’s clinical trials might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

Investor Contact:

Steven M. Harasym

Vice President, Investor Relations

Tel: +1 (301) 556-9850

[email protected]

Media Contacts:

Donelle M. Gregory

[email protected]

Glenn Silver

Lazar-FINN Partners

[email protected]

Precigen, Inc. and Subsidiaries

Consolidated Balance Sheets

(Amounts in thousands) December 31, 2022 December 31, 2021
Assets
Current assets
Cash and cash equivalents $ 4,858 $ 36,423
Restricted cash 43,339 —
Short-term investments 51,092 72,240
Receivables
Trade, net 959 1,341
Related parties, net 19 73
Other 12,826 566
Inventory 287 326
Prepaid expenses and other 4,779 5,471
Current assets held for sale — 40,188
Total current assets 118,159 156,628
Long-term investments — 48,562
Property, plant and equipment, net 7,329 8,599
Intangible assets, net 44,455 52,291
Goodwill 36,923 37,554
Right-of-use assets 8,086 9,990
Other assets 1,025 936
Noncurrent assets held for sale — 45,296
Total assets $ 215,977 $ 359,856

Liabilities and Shareholders’ Equity
Current liabilities
Accounts payable $ 4,068 $ 3,112
Accrued compensation and benefits 6,377 7,856
Other accrued liabilities 23,747 7,817
Deferred revenue 25 1,490
Current portion of long-term debt 43,219 52
Current portion of lease liabilities 1,209 1,393
Related party payables — 74
Current liabilities held for sale — 12,851
Total current liabilities 78,645 34,645
Long-term debt, net of current portion — 179,882
Deferred revenue, net of current portion 1,818 23,023
Lease liabilities, net of current portion 6,992 8,747
Deferred tax liabilities 2,263 2,539
Long-term liabilities held for sale — 3,672
Total liabilities 89,718 252,508
Commitments and contingencies
Shareholders’ equity
Common stock — —
Additional paid-in capital 1,998,314 2,022,701
Accumulated deficit (1,868,567 ) (1,915,556 )
Accumulated other comprehensive income (3,488 ) 203
Total shareholders’ equity 126,259 107,348
Total liabilities and shareholders’ equity
$ 215,977 $ 359,856

Precigen, Inc. and Subsidiaries

Consolidated Statements of Operations

(Amounts in thousands, except share and per share data) December 31, 2022 December 31, 2021
Revenues
Collaboration and licensing revenues $ 14,661 $ 506
Product revenues 1,903 2,164
Service revenues 10,094 11,095
Other revenues 251 502
Total revenues 26,909 14,267
Operating Expenses
Cost of products and services 6,339 5,745
Research and development 47,170 47,933
Selling, general and administrative 48,006 51,994
Impairment of goodwill 482 —
Impairment of other noncurrent assets 638 543
Total operating expenses 102,635 106,215
Operating loss (75,726 ) (91,948 )
Other Expense, Net
Interest expense (6,774 ) (18,755 )
Interest and dividend income 133 171
Other income (expense), net 1,539 (432 )
Total other expense, net (5,102 ) (19,016 )
Equity in net income (loss) of affiliates 862 (3 )
Loss from continuing operations before income taxes (79,966 ) (110,967 )
Income tax benefit 189 160
Loss from continuing operations (79,777 ) (110,807 )
Income (loss) from discontinued operations, net of income tax benefit 108,094 18,641
Net Income (loss) $ 28,317 $ (92,166 )
Net Income (loss) per Share
Net loss from continuing operations per share, basic and diluted $ (0.40 ) $ (0.56 )
Net income (loss) from discontinued operations per share, basic and diluted 0.54 0.09
Net Income (loss) per share, basic and diluted $ 0.14 $ (0.47 )
Weighted average shares outstanding, basic and diluted 200,360,821 197,759,900

On March 6, 2023 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy reported that it will present at the Supply Chain and Logistics for Cell Therapy Summit, March 7-9 in Boston, MA (Press release, Immunomic Therapeutics, MAR 6, 2023, View Source [SID1234628192]). Senior Director of External Manufacturing and Supply Chain, Shah Ahmed, will present a talk entitled, "Seamless Cell Therapy Supply: Addressing Bottlenecks, Building Contingencies & the Lessons Learned from Global Launches," at 4:55PM EDT on March 8, 2023.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Presentation details are as follows:

Presenter: Shah Ahmed
Title: Seamless Cell Therapy Supply: Addressing Bottlenecks, Building Contingencies & the Lessons Learned from Global Launches
Date and Time: Wednesday, March 8, 2023, 4:55PM EDT
Where: Hilton Boston Back Bay

About UNITE

ITI’s investigational UNITE platform, UNiversal Intracellular Targeted Expression, leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and used to create immune responses in tumor types that otherwise do not provoke an immune response.

On March 6, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, and its subsidiary Nexcella, Inc. ("Nexcella"), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that Ilya Rachman, M.D., Ph.D., ImmixBio Chief Executive Officer, and Gabriel Morris, Nexcella President, will discuss recent positive NXC-201 clinical data in AL Amyloidosis and Multiple Myeloma in a fireside chat at the 35th Annual Roth Conference on Tuesday, March 14, 2023 at 10:30 a.m. PT (Press release, Immix Biopharma, MAR 6, 2023, View Source [SID1234628191]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available at View Source and on the Events & Presentations page located within the Investor Relations section of the ImmixBio website at View Source for at least 30 days following the presentation.

On March 6, 2023 TransCure bioServices reported that it has developed cell line-derived xenograft (CDX) mouse models that will change how researchers tackle the preclinical studies of cancer therapies to treat acute myeloid leukemia (AML) (Press release, TransCure bioServices, MAR 6, 2023, View Source [SID1234628190]). These models enable deeper insights into the efficacy and toxicity of AML therapies, leading to the development of better treatments and bringing hope to the thousands of patients that receive an AML diagnosis each year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AML starts in bone marrow and quickly spreads through the blood, affecting platelets and both red and white blood cells. Preclinical studies typically use standard mouse models to investigate AML therapies, but they are unable to recapitulate human immune responses to the condition (a significant factor that influences the disease) and thereby lack human-relevant efficacy once they reach clinical trials. Due to the fast progression and acute nature of the disease, inadequate mouse models struggle to effectively reflect AML development. Additionally, monitoring of preclinical treatment efficacy is hampered by the cancer cells spreading throughout the body.

The new AML mouse model is generated by injecting mice with AML luciferase tumor cell lines, enabling disease progression monitoring by bioluminescence imaging. Using this model, researchers will be able to more efficiently see how their AML therapies behave in vivo, while gaining an understanding of the functional characterization of AML pathogenesis.

"AML is the most common type of leukemia in adults, yet the challenging nature of the disease means the 5-year survival rate is still under 30 percent," says Dr Sébastien Tabruyn, General Manager and Chief Scientific Officer (CSO), TransCure bioServices. "Our new mouse model represents a significant advance for those trying to develop new AML therapies by providing a greater understanding of what AML looks like, and how treatments affect it. In combination with our other research tools, including flow cytometry and immune profiling, we can support researchers to run more human-relevant preclinical studies and develop truly efficacious therapies for this aggressive cancer."

For further information on TransCure bioServices’ new CDX models for AML, please visit View Source