On November 14, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the third quarter ended September 30, 2024, and recent corporate updates (Press release, Abeona Therapeutics, NOV 14, 2024, View Source [SID1234648417]).

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"With the acceptance of our Biologics License Application (BLA) resubmission for pz-cel, we are ramping up our commercial readiness efforts, especially with respect to onboarding potential pz-cel treatment sites and continuing discussions with payors," said Vish Seshadri, Chief Executive Officer of Abeona.

Third Quarter and Recent Progress

Pz-cel for RDEB

Abeona completed a Type A meeting in August 2024 where it aligned with the FDA on the content for the resubmission of the Company’s BLA for pz-cel, its investigational first-in-class, autologous cell-based gene therapy currently in development for RDEB, including additional information to satisfy all Chemistry Manufacturing and Controls (CMC) requirements noted in the Complete Response Letter (CRL) issued in April 2024. The CRL required that certain CMC issues be addressed in the BLA resubmission, and did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA. The FDA did not request any new clinical trials or clinical data to support the approval of pz-cel.
Also in August 2024, the Centers for Medicare and Medicaid Services (CMS) granted a product-specific procedure code ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) for pz-cel. Also, as part of the Inpatient Prospective Payment System (IPPS) Final Rule for fiscal year 2025, CMS assigned Medicare reimbursement of pz-cel to Pre-Major Diagnostic Category, Medicare Severity Diagnosis Related Group 018 (Pre-MDC MS-DRG 018), which is among the highest available inpatient hospital reimbursement levels for cell and gene therapies. The favorable Medicare decisions support efficient hospital billing, reimbursement and patient access.
In October 2024, Abeona resubmitted its BLA for pz-cel to the FDA, seeking approval of pz-cel as a potential new treatment for patients with RDEB.
Also in October 2024, Abeona entered into a lease agreement for additional facility space in Cleveland, Ohio to enable manufacturing capacity expansion beyond the current planned manufacturing footprint.
Also in October 2024, the United States Patent and Trademark Office issued a new patent (U.S. Patent No. 12,110,504) ("the ’504 Patent") and allowed the claims of a second patent (based on U.S. Patent Application No. 16/066,253) that is expected to issue in the coming weeks. Both patents are entitled "Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa Using Genetically Corrected Autologous Keratinocytes," and include claims that cover the use of pz-cel for the treatment of RDEB. The ’504 Patent has an expiration date of January 3, 2037, subject to any applicable patent term extension.
In November 2024, the FDA accepted for review the resubmission of Abeona’s pz-cel BLA and set a PDUFA target action date of April 29, 2025.
In preparation for potential commercialization, Abeona continues to make progress on several key initiatives, including onboarding high-volume epidermolysis bullosa treatment centers in the U.S. for pz-cel treatment, engaging payers to ensure patient access, and educating key stakeholders.
In preparation for potential pz-cel launch, Abeona has hired and trained personnel to support commercialization, manufacturing, supply chain and quality.
Pipeline and partnered programs

In July 2024, Abeona announced a non-exclusive agreement with Beacon Therapeutics, under which Beacon Therapeutics will evaluate Abeona’s patented AAV204 capsid for its potential use in AAV gene therapies for select ophthalmology indications.
In October 2024, Ultragenyx participated in a successful pre-BLA meeting with the FDA during which Ultragenyx aligned on the details of its BLA for partnered program UX111 AAV gene therapy for Sanfilippo syndrome type A (MPS IIIA) that is expected to be filed around the end of 2024.
Third Quarter Financial Results and Cash Runway Guidance

Cash, cash equivalents, short-term investments and restricted cash totaled $110.0 million as of September 30, 2024. As of June 30, 2024, cash, cash equivalents, short-term investments and restricted cash totaled $123.0 million.

Abeona estimates that its current cash and cash equivalents, short-term investments and restricted cash, as well as its credit facility, are sufficient resources to fund operations into 2026, before accounting for any potential revenue from commercial sales of pz-cel, if approved, or proceeds from the sale of a Priority Review Voucher (PRV), if awarded by the FDA.

Research and development expenses for the three months ended September 30, 2024 were $8.9 million, compared to $7.1 million for the same period of 2023. General and administrative expenses were $6.4 million for the three months ended September 30, 2024, compared to $4.2 million for the same period of 2023. The increase in general and administrative expenses is primarily due to commercial and launch preparation costs. Net loss for the third quarter of 2024 was $30.3 million, including a $15.2 million loss resulting from the quarterly remeasurement of the fair value of warrant and derivative liabilities. In the third quarter of 2023, net loss was $11.8 million, including a $1.1 million loss resulting from the quarterly remeasurement of the fair value of warrant liabilities.

Conference Call Details

The Company will host a conference call and webcast on Thursday, November 14, 2024, at 8:30 a.m. ET, to discuss the quarter results. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 500590 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

On November 14, 2024 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ARTs), and 3B Pharmaceuticals GmbH (3BP), a private biotechnology company developing targeted radiopharmaceutical drugs and diagnostics for oncology indications, reported a worldwide, exclusive license and research agreement to develop an advanced preclinical stage first-in-class peptide ART for the treatment of solid tumors (Press release, 3B Pharmaceuticals, NOV 14, 2024, View Source [SID1234648416]).

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This partnership extends ARTBIO’s pipeline with the addition of a highly differentiated program focused on a novel, first-in-class target that is optimal for 212Pb-based alpha radioligand therapy. 212Pb has an ideal clinical profile well suited to this program due to a short half-life and single alpha emission that delivers maximal energy into tumors.

"In-licensing this first-in-class program from 3BP speaks to our mission to expand beyond prostate cancer and create a whole new class of therapies that can improve outcomes for patients with many types of cancer," said Emanuele Ostuni, Ph.D., CEO of ARTBIO. "We can achieve this goal by addressing targets novel to radioligand therapies. By partnering 3BP’s proven track record in peptide discovery with our leadership in 212Pb ART development, we believe we can unlock an important new target and deliver much-needed patient benefit."

The program has promise across a range of solid tumor indications where patients have a high need for alternatives and for which radioligand therapies are not currently in clinical use or advanced development. ARTBIO will advance the licensed program through clinical development, starting in 2025, with both companies contributing their respective expertise to optimize the therapy’s profile.

"By combining our unique and innovative discovery platforms, we’re redefining treatment paradigms for solid tumors," said Dr. Ulrich Reineke, Managing Director of 3BP. "Our shared vision and complementary contributions will accelerate the development of this potentially transformative treatment for patients with solid tumors."

On November 14, 2024 Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with cancer and chronic immune-related diseases, reported financial results for the quarter ended September 30, 2024 and provided recent business highlights (Press release, Shattuck Labs, NOV 14, 2024, View Source [SID1234648414]).

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"Last month we announced a strategic shift to focus on the development of SL-325, a first-in-class DR3 blocking antibody designed to achieve a more complete blockade of the clinically validated TL1A/DR3 signaling pathway. We are underway with IND-enabling, non-human primate studies to evaluate the safety, pharmacokinetic and pharmacodynamic profile of SL-325," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "As of this month, we have substantively completed our restructuring plans to focus on the development of SL-325 and are well-positioned to fund our planned operations into 2027."

Upcoming Events

•Shattuck plans to attend the following investor conferences. Details will be included on the Events & Presentations section of the Company’s website.
◦Piper Sandler & Co. 36th Annual Healthcare Conference (New York City, NY), December 3–5, 2024. Taylor Schreiber, M.D., Ph.D., CEO of Shattuck Labs will participate in a presentation on December 3, 2024.
◦Evercore ISI 7th Annual HealthCONx Conference (Miami, FL), December 3–5, 2024. The Company’s management will participate in a fireside chat on December 4, 2024.

Third Quarter 2024 Financial Results

•Cash and Cash Equivalents and Investments: As of September 30, 2024, cash and cash equivalents and investments were approximately $90.1 million, as compared to $101.1 million as of September 30, 2023.
•Research and Development (R&D) Expenses: R&D expenses were $16.3 million for the quarter ended September 30, 2024, as compared to $24.2 million for the quarter ended September 30, 2023.
•General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the quarter ended September 30, 2024, as compared to $5.1 million for the quarter ended September 30, 2023.
•Net Loss: Net loss was $16.7 million for the quarter ended September 30, 2024, or $0.33 per basic and diluted share, as compared to a net loss of $27.5 million for the quarter ended September 30, 2023, or $0.65 per basic and diluted share.

Financial Guidance

Shattuck has effectuated its restructuring plan to prioritize the development of the DR3 program and align the Company’s cost and workforce structure with the its current goals and clinical development strategy. The Company has substantially completed the reduction in force associated with the discontinuation of SL-172154.

Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its planned operations into 2027, beyond results from its Phase 1 clinical trial of SL-325. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from potential business development transactions, and/or additional costs associated with additional development activities that may be undertaken.

About SL-325

SL-325 is a first-in-class Death Receptor 3 (DR3) antagonist antibody designed to achieve a more complete blockade of the clinically validated TL1A/DR3 pathway. Shattuck’s preclinical studies demonstrate high affinity binding, superior efficacy over TL1A antibodies, and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 is currently being evaluated in a GLP toxicology study in non-human primates, with an IND filing expected in the third quarter of 2025.

On November 14, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the third quarter ended September 30, 2024, and provided corporate updates (Press release, Sensei Biotherapeutics, NOV 14, 2024, View Source [SID1234648413]).

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"The third quarter of 2024 saw significant progress in advancing patient enrollment in the dose expansion portion of the Phase 1 study for SNS-101 across dose levels and patients with primary and acquired resistance to PD-1 inhibitors. Looking ahead, management has focused its attention on preparing for Phase 2 studies," said John Celebi, President and Chief Executive Officer. "We believe SNS-101 has disruptive potential for the treatment of a multitude of cancer indications and for this reason we are making the difficult decision to reduce our headcount to focus our resources on advancing the clinical development of SNS-101. We anticipate that these changes will extend our cash runway into the second quarter of 2026. We look forward to sharing a clinical update focused primarily on the activity profile of SNS-101 and additional details about the design of Phase 2 studies. I want to express my gratitude to all our affected employees for the contributions they have made to the Company."

Clinical Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors.

Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study, with approximately half of the dose expansion study enrolled. To further the Company’s objective of generating clinical data that informs both the optimal dose and patient population for Phase 2 studies, including comprehensive data from patients with both primary and acquired resistance to PD-1 inhibitors, the Company expects to report clinical data across two dose levels in multiple tumor types in the first half of 2025.
Sensei received preliminary guidance from the FDA on the dose optimization strategy for SNS-101. The Company plans to re-engage with the agency following additional data from the dose expansion portion of the Phase 1/2 clinical trial.
SNS-101 continues to be well tolerated with a best-in-class pharmacological profile among anti-VISTA antibodies.
In November, Sensei presented an overview of SNS-101 at PEGS Europe: Protein and Antibody Engineering Summit.
In November, the Company presented data on spatial proteomic profiling of VISTA and PSGL-1 interactions across cancer indications in a poster presentation at the Society of Immunotherapy Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting.
Corporate Updates

Sensei is announcing an organizational restructuring to streamline operations and focus resources on advancing the clinical development of SNS-101. The Company will close its research site in Rockville, Maryland and reduce its workforce by approximately 46 percent, with most of the headcount reductions in the Company’s preclinical research and development group. These changes are anticipated to extend cash runway into the second quarter of 2026.
In July, the Company announced the appointment of Josiah Craver as Senior Vice President, Finance. In September, Josiah was appointed as the Company’s principal financial officer and principal accounting officer.
Third Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $47.0 million as of September 30, 2024. Sensei expects its current cash balance to fund operations into the second quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were $4.6 million for the quarter ended September 30, 2024, compared to $3.8 million for the quarter ended September 30, 2023. The increase in R&D expenses was primarily attributable to higher expense associated with clinical trials, personnel costs and manufacturing related expense partially offset by lower costs for preclinical research and lower consulting fees.

General and Administrative (G&A) Expenses: G&A expenses were $3.2 million for the quarter ended September 30, 2024, compared to $3.9 million for the quarter ended September 30, 2023. The decrease in G&A expense was primarily attributable to decreased costs associated with insurance premiums as well as lower outside services expense, personnel costs and license fees.

Net Loss: Net loss was $7.3 million for the quarter ended September 30, 2024, compared to $7.1 million for the quarter ended September 30, 2023.

On November 14, 2024 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported third quarter 2024 financial results and business updates (Press release, Precigen, NOV 14, 2024, View Source [SID1234648412]).

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"The strategic reprioritization of our portfolio announced last quarter has enabled us to focus our team and allocate resources to advance PRGN-2012 as rapidly as possible. We are excited about our imminent submission of a BLA for PRGN-2012 in RRP as we have finalized our pre-BLA meetings and are aligned with the FDA on the content for all modules and plan for submission in the fourth quarter. Our commercial and manufacturing readiness campaigns for PRGN-2012 are well underway to support a potential 2025 launch," said Helen Sabzevari, PhD, President and CEO of Precigen. "Although our primary focus is on PRGN-2012, we continue to demonstrate the many advantages of the UltraCAR-T platform over conventional CAR-Ts. Our recent data presentation at SITC (Free SITC Whitepaper) for our next generation UltraCAR-T targeting CD19 reinforces the potential to be the best-in-class CD19-targeting medicine in oncology and autoimmune diseases, such as lupus nephritis. We are excited about the potential of this platform and the strategic partnership discussions that currently are underway."

"Following our reprioritization and public equity offering announced in August, we remain focused on fiscal management while appropriately investing in activities necessary for the potential launch of PRGN-2012. We are making good progress on a number of potential financing options, including strategic partnerships and other transactions. We will update our investors on this progress in the coming months," said Harry Thomasian Jr., CFO of Precigen.

Key Program Highlights

PRGN-2012 AdenoVerse Gene Therapy in RRP

· PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of recurrent respiratory papillomatosis (RRP). PRGN-2012 received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). PRGN-2012 also received Orphan Drug Designation from the FDA and Orphan Drug Designation from the European Commission.

· Results from the pivotal clinical study of PRGN-2012 for the treatment of RRP were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in a late-breaking oral presentation titled, "PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients."

· Pivotal study met primary safety and efficacy endpoints.

· 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; Complete Responses have been durable beyond 12 months with median duration of follow up of 20 months as of the May 20, 2024 data cutoff.

· 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 (range: 3-10) pre-treatment to 0 (range: 0-7) post-treatment.

· PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.

· PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders.

· PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders.

· The Company has completed the pre-biologics license application (BLA) meeting with the FDA and is in full alignment on the content of the BLA, including the clinical and chemistry, manufacturing and controls (CMC) module, and the path for a fourth quarter 2024 rolling BLA submission under an accelerated approval pathway.

· The Company continues to rapidly advance its commercial and manufacturing readiness campaign in anticipation of a potential 2025 launch.

· Patient enrollment continues to advance in the confirmatory clinical trial of PRGN-2012 in accordance with the guidance from the FDA to initiate the study prior to submission of the BLA.

PRGN-2009 AdenoVerse Gene Therapy in HPV-associated cancers

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer are ongoing. As part of the strategic reprioritization announced earlier, the Company has paused enrollment in the cervical cancer Phase 2 clinical trial at non-NCI sites.

PRGN-3006 UltraCAR-T in AML and MDS

· The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia (AML), which received Fast Track designation from the FDA, and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps.

PRGN-3008 UltraCAR-T Targeting CD19 in Oncology and Autoimmune Diseases

· PRGN-3008 is an autologous CD19-directed UltraCAR-T, based on Precigen’s next generation UltraCAR-T platform, which is engineered to express a CD19 chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) for enhanced persistence and maintenance of stem cell memory/naïve (Tscm) phenotype, an intrinsic PD-1 blockade without complex and expensive gene editing techniques to avoid exhaustion, and a safety/kill switch, all from a single non-viral transposon to ensure a homogenous cell product.

· Next generation UltraCAR-T aims to improve on conventional CAR-T through overnight manufacturing, incorporation of a safety/kill switch, built-in PD1 downregulation that avoids the need for checkpoint inhibitor combination, and the ability for repeat dosing. These advantages give Precigen’s CD19 UltraCAR-T the potential to be the best-in-class treatment for B-cell malignancies and autoimmune indications for the proven CD19 target.

· Preclinical data for PRGN-3008 were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting in a poster presentation titled, "Non-viral engineered next generation CD19 UltraCAR-T with membrane bound IL-15 (mbIL15) and PD-1 blockade preserves stem cell memory/naïve phenotype and enhances anti-tumor efficacy."

o Preclinical data showed that in in vivo tumor models, a single administration of PRGN-3008 enhanced expansion and persistence, produced robust antitumor efficacy with complete tumor clearance, and demonstrated significantly longer survival compared to conventional CD19 CAR-T cells.

o In a simulation of tumor relapse in the in vivo model, PRGN-3008 demonstrated persistence and long-term antitumor immunity extending overall survival without additional PRGN-3008 treatment.

· In a humanized mouse model of lupus nephritis, additional preclinical data for PRGN-3008 in an autoimmune setting presented at the 2024 Cell and Gene Meeting on the Mesa showed complete elimination of B-cells as well as a decrease in antibodies to double-stranded DNA (dsDNA), a specific marker of lupus.

Financial Highlights

· The Company closed a public offering of its common stock in August 2024, resulting in net proceeds of approximately $30.9 million (after deducting underwriting discounts, fees and other underwriting expenses).

· In August 2024, the Company began a strategic prioritization of its clinical portfolio and streamlining of its resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of PRGN-2012.

Third Quarter 2024 Financial Results Compared to Prior Year Period

SG&A expenses increased by $0.6 million, or 7%, compared to the three months ended September 30, 2023. As a result of the Company’s increased focus on PRGN-2012, commercial readiness costs increased in the current quarter versus the prior year period. In addition, the third quarter of 2024 included severance costs incurred related to the Precigen workforce reduction. These increases were partially offset by a reduction in insurance expenses due to decreasing rates and professional fees incurred related to general corporate matters compared to the same period in 2023.

Research and development expenses decreased by $0.2 million, or 2%, compared to the three months ended September 30, 2023. The decrease was primarily the result of the Company’s portfolio reprioritization, which included a $2.0 million decrease in costs associated with ActoBio resulting from the shutdown of operations during the second quarter of 2024 as well as lower costs of $0.7 million incurred at contract research organizations for other programs compared to the same period in 2023. These decreases were offset by increased costs of approximately $2.5 million associated with PRGN-2012 in advance of the Company’s planned BLA submission and the Company’s ongoing confirmatory trial, as well as severance costs incurred related to the Precigen workforce reduction in the third quarter of 2024.

Other income (expense), net, decreased by $3.8 million compared to the three months ended September 30, 2023. This decrease was primarily due to the reclassification of cumulative translation losses of $2.9 million as a result of the final closing of the ActoBio facilities in the third quarter of 2024, as well as a reduction in interest income compared to the same period in 2023.

Total revenues decreased $0.4 million, or 31%, compared to the three months ended September 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.

Net loss was $24.0 million, or $(0.09) per basic and diluted share, compared to net loss of $19.8 million, or $(0.08) per basic and diluted share, in the three months ended September 30, 2023.

First Nine months 2024 Financial Results Compared to Prior Year Period

SG&A expenses increased by $0.1 million, or 1%, compared to the nine months ended September 30, 2023. As a result of the Company’s increased focus on PRGN-2012, commercial readiness costs increased versus the prior year period. In addition, the second and third quarter of 2024 included higher severance costs associated with the suspension of ActoBio’s operations and the 2024 Precigen workforce reduction. These increases were partially offset by a decrease in stock compensation and insurance expenses due to decreasing rates in 2024 compared to the same period in 2023.

Research and development expenses increased $5.7 million, or 16%, compared to the nine months ended September 30, 2023, primarily as a result of the Company’s increased focus on PRGN-2012. There were $4.4 million of increased costs associated with PRGN-2012 in advance of the Company’s planned BLA submission, including the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012 pivotal clinical trial activities and professional fees incurred related to the Company’s manufacturing facility. Additionally, personnel costs increased by $3.0 million due to an increase in the hiring of employees related to the advancement of PRGN-2012 in the third and fourth quarters of 2023 and severance charges incurred related to the Precigen workforce reduction in the third quarter of 2024. These increases were offset by lower costs incurred at contract research organizations for other programs compared to the prior year period as well as a reduction in total ActoBio operating expenses compared to the nine months ended September 30, 2023.

Other income (expense), net, decreased $4.3 million, or 166%, compared to the nine months ended September 30, 2023. This decrease was primarily due to the reclassification of cumulative translation losses of $2.9 million resulting from the final closing of the ActoBio facilities in the third quarter of 2024, as well as a reduction in net interest income compared to the same period in 2023.

In conjunction with the suspension of ActoBio’s operations, the Company recorded $34.5 million of impairment charges related to goodwill and long-lived assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million.

Total revenues decreased $2.3 million, or 45%, compared to the nine months ended September 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.

Net loss was $106.5 million, or $(0.41) per basic and diluted share, compared to net loss of $62.8 million, or $(0.26) per basic and diluted share, in the nine months ended September 30, 2023.