On August 8, 2022 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported second quarter and first half 2022 financial results (Press release, Precigen, AUG 8, 2022, View Source [SID1234617786]).
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"Precigen is laser focused on maximizing the value of our highest priority assets and prioritizing our capital allocation to enable us to reach critical inflection points in our clinical trials. We have been able to expedite our prioritized programs, rapidly progressing from Phase 1 dose escalations to 1b expansions and have already initiated Phase 2 studies for several programs," said Helen Sabzevari, PhD, President and CEO of Precigen. "We continue to demonstrate the potential of these assets and their associated therapeutic platforms, and are actively pursuing rapid regulatory strategies for licensure to bring these potential investigational therapies to patients as quickly as possible. We expect additional data this year and early next for our prioritized programs, and are particularly excited for the Phase 1 data presentation for the PRGN-2012 AdenoVerse study in Q4 2022."
"The transaction to sell Trans Ova Genetics, which is expected to close in Q3 2022, will provide Precigen with $170 million in cash up-front and up to a $10 million earn-out over the next two years. The proceeds from this sale will fortify our balance sheet and provide non-dilutive funds to pay our convertible notes, which we intend to do when due," said Harry Thomasian Jr., CFO of Precigen. "We believe that our cash on hand and cost reduction initiatives, taking into account our plan for our convertible notes, give us enough runway to advance our clinical priorities into Q4 2023."
Key Business Highlights
Agreement to Divest Non-Healthcare Subsidiary Trans Ova Genetics
Precigen entered into an agreement to sell its wholly-owned subsidiary Trans Ova Genetics to URUS for $170 million in upfront cash and up to a $10 million earn-out based on the performance of Trans Ova Genetics in 2022 and 2023. The close, subject to customary closing conditions including clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, is expected in Q3 2022.
Transaction will solidify the Company’s balance sheet and provide the ability to pay off the outstanding convertible notes utilizing a non-dilutive funding source.
PRGN-3006 UltraCAR-T in AML
The US Food and Drug Administration (FDA) Fast Track designation for PRGN-3006 UltraCAR-T, received in the first half of 2022, is important for patients with relapsed or refractory (r/r) AML, a serious condition with high unmet medical need, as it may facilitate development and expedite the review process for this promising investigational therapy.
Enrollment is ongoing in the Phase 1b expansion study of PRGN-3006 UltraCAR-T at Dose Level 3 with lymphodepletion (clinical trial identifier: NCT03927261).
The Phase 1b study of PRGN-3006 UltraCAR-T has been expanded to Mayo Clinic in Rochester, Minnesota as the first of several new sites expected as part of the multicenter expansion of the study. Additionally, technology transfer was successfully completed and FDA clearance was received to initiate PRGN-3006 UltraCAR-T manufacturing and patient treatment at Mayo Clinic.
Multicenter expansion demonstrates proof of concept for the technology transfer and scale-up for decentralized manufacturing of UltraCAR-T using UltraPorator at multiple medical centers. Technology transfer and site activation activities are in progress at several major cancer centers across the US and additional expansion sites are anticipated to be activated in 2022 and 2023.
The Company received FDA clearance to incorporate repeat dosing in the Phase 1b expansion phase of the study and plans to initiate in 2022.
Additional data for the Phase 1/1b study is expected at a major scientific conference in Q4 2022.
PRGN-3005 UltraCAR-T in Ovarian Cancer
Enrollment was completed in the dose escalation phase of both the intraperitoneal (IP) and intravenous (IV) arms of the Phase 1 study without lymphodepletion (clinical trial identifier: NCT03907527). The FDA cleared moving directly to Dose Level 3 after dosing one patient at Dose Level 1 in the IV arm, enabling rapid progression in the IV arm. Patient follow up is ongoing and the Company expects Phase 1 data to be presented in the first half of 2023.
FDA approval was received to incorporate lymphodepletion in the IV arm and enrollment (N=3) was completed at Dose Level 3 with lymphodepletion. Patient follow up is ongoing.
The Company initiated the Phase 1b expansion study of PRGN-3005 UltraCAR-T at Dose Level 3 with lymphodepletion prior to IV infusion.
The Company plans multicenter expansion of the Phase 1b study and site activation activities are in progress at major cancer centers in the US.
The Company received FDA clearance to incorporate repeat dosing in the Phase 1b expansion study and plans to initiate in 2022.
PRGN-3007 UltraCAR-T in Advanced ROR1+ Hematological and Solid Tumors
PRGN-3007, based on the next generation UltraCAR-T, incorporates intrinsic PD-1 checkpoint inhibition in addition to the three effector genes (chimeric antigen receptor (CAR), membrane-bound interleukin 15 (mbIL15) and kill switch), is being readied for the clinic.
The Phase 1/1b umbrella study of PRGN-3007 in advanced receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) hematological tumors, including chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL) and solid tumors, including triple negative breast cancer (TNBC) is on track to initiate dosing in the second half of 2022.
PRGN-2012 AdenoVerse Immunotherapy in RRP
Enrollment was completed in the Phase 1 study (N=15) and patient follow up is ongoing. The Company is planning an investigator-led Phase 1 data presentation to be held in Q4 2022.
The Company initiated a Phase 2 study of PRGN-2012 in adult patients with RRP (clinical trial identifier: NCT04724980). Enrollment is ongoing in the Phase 2 study with 11 patients enrolled to date.
Discussions with the FDA are ongoing to evaluate various regulatory paths given the high unmet medical need for this patient population.
PRGN 2009 AdenoVerse Immunotherapy in HPV-associated Cancers
Enrollment was completed in the Phase 1 monotherapy (N=6) and combination therapy (N=11) arms in patients with recurrent or metastatic HPV-associated cancers (clinical trial identifier: NCT04432597). Patient follow up is ongoing. The Company expects Phase 1 data to be presented in the first half of 2023.
Enrollment is ongoing in the Phase 2 monotherapy arm in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients with 17 patients enrolled to date.
Second Quarter and First Half 2022 Financial Highlights
Net cash used in operating activities of $25.8 million during the six months ended June 30, 2022 compared to $24.2 million during the six months ended June 30, 2021;
Cash, cash equivalents, short-term and long-term investments totaled $132.8 million as of June 30, 2022;
Selling, general and administrative (SG&A) costs decreased for both the three and six months ended June 30, 2022 compared to the prior year periods; and
As a result of the anticipated Trans Ova Genetics sale, the Trans Ova Genetics business is now classified as a discontinued operation with its assets, liabilities and operations in prior periods reclassified to conform to the current presentation.
Second Quarter 2022 Financial Results Compared to Prior Year Period
Total revenues decreased $0.9 million, or 24%, from the quarter ended June 30, 2021. Product and service revenues generated by Exemplar decreased $0.5 million and collaboration and license revenue decreased $0.3 million from the quarter ended June 30, 2021. Gross margin on products and services declined as a result of the decreased revenues, and increased costs for supplies, drugs, and personnel costs.
Research and development expenses decreased by $1.2 million, or 9%, from the quarter ended June 30, 2021. Contract research organization costs and lab supplies decreased $1.9 million due to timing differences, the completion of the Phase 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 to preclinical research programs for the comparable period. This decrease was partially offset with an increase in salaries, benefits, and other personnel costs of $0.7 million primarily due to an increase in the hiring of employees to support the growth in the Company’s development activities.
SG&A expenses decreased $2.3 million, or 15%, from the quarter ended June 30, 2021. Salaries, benefits, and other personnel costs decreased $1.5 million primarily due to reduced stock compensation in 2022 and reduced head count. Professional fees decreased $0.4 million, primarily due to decreased legal fees associated with certain matters.
Loss from continuing operations was $26.1 million, or $(0.13) per basic and diluted share, compared to loss from continuing operations of $30.9 million, or $(0.16) per basic and diluted share, in 2021.
First Half 2022 Financial Results Compared to Prior Year Period
Total revenues increased $1.2 million, or 16%, from six months ended June 30, 2021. Product and service revenues generated by Exemplar increased $1.6 million, which was offset by a $0.3 million reduction in collaboration and license revenue from the six months ended June 30, 2021. Gross margin on services remained comparable to the prior year as increased revenues were offset by increased costs for supplies, drugs, and personnel costs.
Research and development expenses increased $0.4 million, or 2%, from the six months ended June 30, 2022. Salaries, benefits, and other personnel costs increased $1.2 million due to an increase in the hiring of employees to support the growth in the Company’s development activities. This increase was partially offset with a decrease of contract research organization costs and lab supplies of $0.9 million, primarily due to timing differences, the completion of the Phase 1b/2a clinical trial of AG019 in the fourth quarter of the prior year, and a continued prioritization of clinical product candidates with less expense incurred related preclinical research programs for the comparable period.
SG&A expenses decreased $2.9 million, or 10%, from the six months ended June 30, 2021. Salaries, benefits, and other personnel costs decreased $3.5 million primarily due to reduced stock compensation in 2022 and reduced head count. This decrease was partially offset with an increase in legal and professional fees of $1.1 million, primarily due to increased consulting fees and legal fees associated with certain matters.
Loss from continuing operations was $50.0 million, or $(0.25) per basic and diluted share, compared to loss from continuing operations of $57.8 million, or $(0.29) per basic and diluted share, in 2021.