On May 14, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the first quarter ended March 31, 2025 and other recent business developments (Press release, Celcuity, MAY 14, 2025, View Source [SID1234653056]).

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"We continue to make steady progress across our pipeline with several critical data catalysts anticipated this year," said Brian Sullivan, CEO and co-founder of Celcuity. "We now expect to report topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 trial in the third quarter of this year and to report topline data for the PIK3CA mutant cohort in the fourth quarter of 2025. If our topline data from the WT cohort is positive, we expect the data will support the filing of our first new drug application and, if approved, our transition to a commercial stage company."

First Quarter 2025 Business Highlights and Other Recent Developments

● Based on evaluation of blinded event rates in the ongoing VIKTORIA-1 Phase 3 clinical trial, the primary completion date for the PIK3CA wild-type patient cohort is projected to occur in June 2025 with topline data now anticipated to be available in the third quarter of 2025.

○ Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial and remains on track to report topline data in the fourth quarter of 2025.
○ VIKTORIA-1 is a global Phase 3 study evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.

● Site activation activities are underway globally for the VIKTORIA-2 Phase 3 clinical trial and dosing of the first patient is anticipated to occur in the second quarter of 2025.

○ VIKTORIA-2 is a global, Phase 3 open-label randomized study evaluating the efficacy and safety of gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant.
○ Prior to initiating the Phase 3 portion of the study, a safety run-in will be conducted in 12-36 participants to assess the safety of gedatolisib in combination with ribociclib and fulvestrant.

● The CELC-G-201 study is on track to report topline data for the Phase 1b portion of the trial late in the second quarter of 2025.

○ CELC-G-201 is a Phase 1b/2 evaluating gedatolisib in combination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) whose disease progressed while on or after treatment with an androgen receptor signaling inhibitor.
○ The Phase 1b portion of the trial will assess the safety and tolerability of gedatolisib in combination with darolutamide and is expected to identify the recommended phase 2 dose regimen.

● Initiating a clinical trial collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer

○ In a prior Phase 2 study, gedatolisib was evaluated as a monotherapy in patients with endometrial cancer.

First Quarter 2025 Financial Results

Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2025, compared to the first quarter ended March 31, 2024.

Total operating expenses were $36.1 million for the first quarter of 2025, compared to $22.5 million for the first quarter of 2024.

Research and development ("R&D") expenses were $32.2 million for the first quarter of 2025, compared to $20.6 million for the prior-year period. Of the approximately $11.6 million increase in R&D expenses, $5.9 million primarily related to increased employee and consulting expenses. The remaining $5.7 million primarily related to activities supporting our ongoing clinical trials.

General and administrative ("G&A") expenses were $3.9 million for the first quarter of 2025, compared to $1.8 million for the prior-year period. Increased employee and consulting expenses accounted for $1.6 million of the increase. Professional fees, expanding infrastructure and other administrative expenses accounted for the remaining increase of approximately $0.5 million.

Net loss for the first quarter of 2025 was $37.0 million, or $0.86 loss per share, compared to a net loss of $21.6 million, or $0.64 loss per share, for the first quarter of 2024. Non-GAAP adjusted net loss for the first quarter of 2025 was $34.7 million, or $0.81 loss per share, compared to non-GAAP adjusted net loss of $19.9 million, or $0.59 loss per share, for the first quarter of 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the first quarter of 2025 was $35.9 million, compared to $17.1 million for the first quarter of 2024.

At March 31, 2025, Celcuity reported cash, cash equivalents and short-term investments of $205.7 million. We expect cash, cash equivalents, investments and drawdowns on our debt facility to fund current clinical development program activities through 2026.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the first quarter 2025 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=61a8c66165. A replay of the webcast will be available on the Celcuity website following the live event.

On May 14, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported a clinical and corporate update and announced financial results for the first quarter ended March 31, 2025 (Press release, PDS Biotechnology, MAY 14, 2025, View Source [SID1234653072]).

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"The first quarter of 2025 and recent weeks have been productive for PDS Biotech, highlighted by the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating Versamune HPV in recurrent/metastatic ("R/M") HPV16-positive head and neck squamous carcinoma ("HNSCC")," said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. "We are pleased to announce that site activation is progressing, and that Mayo Clinic sites have recently been added to the trial. HPV16-positive HNSCC represents a large, rapidly growing patient population in need of targeted therapies to treat the underlying cause of the cancer, and our Versamune HPV investigational therapy is currently the only targeted therapy in a Phase 3 trial specifically for HPV-16 positive tumors."

Clinical and Corporate Update

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On April 23, 2025, the Company announced that three abstracts on Versamune HPV (PDS0101) were selected for presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 30-June 3, 2025, in Chicago, IL.

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On May 8, 2025, the Company announced that preclinical efficacy and immune response data with a novel investigational Infectimune based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral symposium at the American Association of Immunologists’ IMMUNOLOGY2025 Annual Meeting, held May 3-7, 2025, in Honolulu, Hawaii.

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On March 13, 2025, the Company announced U.S. Food and Drug Administration ("FDA") clearance of an Investigational New Drug ("IND") application for the combination of Versamune MUC1 and PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma in patients who failed previous treatment. The National Cancer Institute ("NCI"), under its Cooperative Research and Development Agreement ("CRADA"), will lead the Phase 1/2 clinical trial evaluating the combination of Versamune MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer.

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On March 7, 2025, the Company announced the initiation of its VERSATILE-003 Phase 3 trial in HPV16-positive first-line recurrent and/or metastatic HNSCC.

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Trial is designed to include approximately 350 patients

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PDS Biotech is aligned with the FDA on the design of the registrational trial and clinical endpoints.

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Two-arm controlled trial with 2:1 randomization

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Median overall survival is the primary endpoint

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Interim readouts included in the study design

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The Company received FDA Fast Track designation for the combination of Versamune HPV and pembrolizumab in R/M HNSCC.

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For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

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On February 27, 2025, the Company announced that it had entered into securities purchase agreements with new and existing healthcare-focused institutional investors, as well as participation from certain directors of the Company, for the purchase and sale of 7,330,121 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,330,121 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules at a combined purchase price of $1.50 for the institutional investors and $1.66 for certain directors of the Company. Approximately $11 million was funded upon the closing of the offering, and up to an additional $11 million may be funded upon full cash exercise of the warrants.

First Quarter 2025 Financial Results

Reported net loss was approximately $8.5 million, or $0.21 per basic and diluted share, for the three months ended March 31, 2025, compared to $10.6 million, or $0.30 per basic share and diluted share, for the three months ended March 31, 2024. The decrease was due to increased benefit from income taxes and lower operating expenses.

Research and development expenses were $5.8 million for the three months ended March 31, 2025, compared to $6.7 million for the three months ended March 31, 2024. The decrease was primarily due to lower clinical trial expenses.

General and administrative expenses were $3.3 million for the quarter ended March 31, 2025, compared to $3.4 million for the three months ended March 31, 2024.

Total operating expenses were $9.1 million for the quarter ended March 31, 2025, compared to approximately $10.1 million for the three months ended March 31, 2024.

Net interest expenses were $0.6 million compared to approximately $0.5 million for the three months ended March 31, 2024.

The Company’s cash balance as of March 31, 2025 was $40 million, compared to $41.7 million as of December 31, 2024.

Conference Call Details

Date: May 14, 2025
Time: 8:00 a.m. Eastern Time
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
Webcast Registration: Click Here
Call MeTM Registration: Click Here (Available 15 minutes prior to call)

On May 14, 2025 AbbVie (NYSE: ABBV) and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, reported a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology (Press release, AbbVie, MAY 14, 2025, View Source [SID1234653095]).

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siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates the expression of genes. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.

The strategic collaboration will leverage ADARx’s RNA discovery expertise and proprietary siRNA technology, which has the potential to enable sustained and precise mRNA silencing. AbbVie will contribute its expertise in antibody engineering, antibody drug conjugates (ADCs) and tissue delivery approaches as appropriate, to augment ADARx’s discovery efforts.

"siRNA is a promising genetic medicine approach for silencing disease-causing genes, but challenges still remain in targeting and delivering siRNA effectively," said Jonathon Sedgwick, Ph.D., senior vice president and global head, discovery research, AbbVie. "We are very pleased to collaborate with ADARx, leveraging their proprietary RNA technology alongside our antibody, ADC, and therapeutic area research and development expertise to bring siRNA forward as a potential novel therapeutic modality alongside our other established approaches. Together, we’re committed to developing innovative solutions for difficult-to-treat diseases across neuroscience, immunology and oncology."

"This collaboration with AbbVie further validates the differentiated RNA technology that we have developed at ADARx and has the potential to unlock tremendous clinical and commercial potential across multiple disease areas. AbbVie’s research and development expertise combined with its global commercial reach make them the ideal strategic collaborator to accelerate these programs for the potential benefit of patients worldwide," said Zhen Li, Ph.D., co-founder, president and chief executive officer of ADARx. "In addition to this strategic collaboration with AbbVie, ADARx continues to advance a deep pipeline of wholly-owned clinical-stage programs that span complement-mediated, cardiovascular and thrombotic diseases and various preclinical discovery programs including in obesity and neurodegeneration."

Under the terms of the agreement, ADARx will receive a $335 million upfront payment and will be eligible to receive several billion dollars in additional contingent payments including option-related fees and milestone payments, as well as tiered royalties.

On May 14, 2025 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal quarter ended March 31, 2025 (Press release, Citius Pharmaceuticals, MAY 14, 2025, View Source [SID1234653057]).

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"As we continue to focus on the planned launch of our first FDA-approved product, LYMPHIR, through Citius Oncology, we are actively engaged in securing the necessary financing to advance our launch strategy in the coming months, as well as exploring strategic partners for Citius Oncology," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals and Citius Oncology.

"We are also in the process of preparing a submission to the FDA that reflects the valuable feedback we received from the agency concerning clinical efficacy, safety data, and in-vitro data. This submission is a key step toward supporting a future New Drug Application (NDA) for our Mino-Lok program. As a reminder, our Phase 3 Trial, which was completed last year, met its primary endpoints," added Mazur.

"During the quarter, we took deliberate steps to strengthen our financial position, including completing a registered direct offering and leveraging our existing at-the-market sales agreement to ensure capital flexibility. We also amended our license agreement with Eisai to align our payment obligations with our commercialization timeline. With these efforts underway, we believe we are positioned to deliver long-term value to patients and shareholders alike," concluded Mazur.

FISCAL SECOND QUARTER 2025 Financial Results:

Liquidity

During the six months ended March 31, 2025, the Company received net proceeds of $6 million from the issuance of equity. On April 2, 2025, the Company closed on a registered direct offering to an institutional investor of our common stock and pre-funded warrants to purchase common stock. The net proceeds to the Company from the offering were approximately $1.735 million, after deducting placement agent fees and other offering expenses payable by the Company.

As of March 31, 2025, the Company had $26,410 in cash and cash equivalents and 8,760,649 common shares outstanding excluding the April 2, 2025 financing. Citius Pharma will need to secure additional capital to support operations beyond May 2025.

Until Citius Oncology raises adequate capital through equity financings from outside investors and/or generates revenue from the future sales of LYMPHIR, Citius Pharma plans to continue to fund Citius Oncology. Citius Oncology has also retained Jefferies LLC as its exclusive financial advisor to evaluate strategic alternatives aimed at maximizing stockholder value.

Research and Development (R&D) Expenses

R&D expenses were $3.8 million for the quarter ended March 31, 2025, as compared to $3.6 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, R&D expenses were $5.9 million, as compared to $6.3 million during the six months ended March 31, 2024. R&D expenses primarily reflect LYMPHIR-related costs.

Research and development costs for LYMPHIR were $5.3 during the six months ended March 31, 2025, as compared to $3.2 million for the six months ended March 31, 2024. The $2.1 million increase in expenses was primarily due to costs associated with the expense of a drug substance batch needed for the pre license inspection of the manufacturer.

R&D expenses related to Mino-Lok decreased due to completion of the Phase 3 trial. There were no Halo Lido R&D expenses during the quarter, and $11 thousand was recorded for the six months ended March 31, 2025.

We expect that research and development expenses will continue to decrease in fiscal 2025 as we continue to focus on the commercialization of LYMPHIR and because we have completed the Phase 3 trial for Mino-Lok.

General and Administrative (G&A) Expenses

G&A expenses were $4.8 million for the quarter ended March 31, 2025, as compared to $4.3 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, G&A expenses were $10.2 million, as compared to $7.9 million for the six months ended March 31, 2024. The increase was primarily due to higher costs for pre-launch commercial activities associated with LYMPHIR. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the quarter ended March 31, 2025, stock-based compensation expense was $2.7 million, as compared to $3.1 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, stock-based compensation expense was $5.2 million, as compared to $6.1 million for the six months ended March 31, 2024. Stock-based compensation expense is primarily related to the Citius Oncology stock plans. The decrease compared to the prior year is due to lower costs associated with the Citius Pharma stock plans.

Net loss

Net loss was $11.5 million, or ($1.27) per share, for the quarter ended March 31, 2025, as compared to a net loss of $8.5 million, or ($1.34) per share, for the quarter ended March 31, 2024, as adjusted for the reverse stock split. The increase in net loss was due to a $2.6 million decrease in other income, offset by the increase in general and administrative expenses and research and development expenses.

For the six months ended March 31, 2025, we incurred a net loss of $21.8 million, as compared to a net loss of $17.8 million for the six months ended March 31, 2024. The $4.0 million increase in the net loss was primarily due to the increase of $2.2 million in general and administrative expenses and the decrease in other income of $2.9 million, partially offset by lower research and development expense and lower stock-based compensation expense.

On May 14, 2025 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported first quarter 2025 financial results and business updates (Press release, Precigen, MAY 14, 2025, View Source [SID1234653073]).

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"We are extremely pleased with the progress of our PRGN-2012 program and its immense potential for RRP patients. We remain laser-focused on advancing the program toward the rapidly approaching PDUFA target action date in August. If approved, PRGN-2012 has the potential to be the first and only FDA-approved therapeutic for the treatment of RRP," said Helen Sabzevari, PhD, President and CEO of Precigen. "We encourage anyone interested in learning more about RRP and hearing directly from RRP patients, caregivers, and the healthcare community supporting them to join Precigen and the Recurrent Respiratory Papillomatosis Foundation for the 2025 International RRP Awareness Day on June 11. Panelists will discuss the patient and caregiver experience with RRP, the significant burden of living with a rare and chronic disease such as RRP, and the challenges of repeated surgeries."

"We completed the first quarter with continued financial discipline while appropriately investing in activities related to the potential launch of PRGN-2012. We ended the quarter with cash, cash equivalents, and investments of $81 million, and we reiterate that our cash runway is expected to take us into 2026, without consideration of product-related revenue from the potential commercial launch of PRGN-2012 later this year," said Harry Thomasian Jr., CFO of Precigen.

Key Program and Company Highlights

2025 International RRP Awareness Day

The Company and the Recurrent Respiratory Papillomatosis Foundation (RRPF) will host the 2025 International RRP Awareness Day on June 11. RRP Awareness Day brings together patients with recurrent respiratory papillomatosis (RRP), their caregivers, and the healthcare community supporting them to encourage dialogue and build community among those affected by this rare, debilitating chronic disease. To stay up-to-date with RRP Awareness Day activities and to register for the June 11 webcast, please visit www.RRPAwareness.org.

PRGN-2012 (nonproprietary name: zopapogene imadenovec†) 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 adults with RRP. PRGN-2012 received Breakthrough Therapy Designation, Orphan Drug Designation, and an accelerated approval pathway from the US Food and Drug Administration (FDA), and Orphan Drug Designation from the European Commission.

· In February 2025, the FDA accepted the Company’s biologics license application (BLA) for PRGN-2012, and granted priority review of the BLA with a Prescription Drug User Fee Act (PDUFA) target action date set for August 27, 2025. The FDA has indicated that they are not currently planning to hold an advisory committee meeting to discuss the BLA.
· 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 and published in The Lancet Respiratory Medicine.
· Pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints.
· PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.
· 51% (18 out of 35) of study 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 30 months, with some complete responders surgery-free for three years as of the March 20, 2025 data cutoff.

· 86% (30 out of 35) of study patients 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 treatment induced HPV 6/11-specific T cell responses in RRP study 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 anatomical Derkay scores and VHI-10 scores in complete responders.
· 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.
· The Company continues to rapidly advance its commercial and manufacturing readiness campaign in anticipation of a potential launch in 2025.
· The Company selected EVERSANA, a leading provider of commercialization services to the global life sciences industry, to support launch strategy and commercialization of PRGN-2012 in adults with RRP in the United States. The Company and EVERSANA are developing a targeted go-to-market strategy for PRGN-2012 in preparation for potential approval in August. As part of this strategy, the Company is deploying the first wave of field teams in support of launch readiness preparation.
· Based on an internal analysis derived from review of claims data, the market opportunity for PRGN-2012 in RRP is estimated to be approximately 27,000 adult patients in the United States. More than 125,000 patients are estimated outside of the United States.

PRGN-2009 AdenoVerse Gene Therapy in HPV-associated Cancers

PRGN-2009 is an investigational off-the-shelf AdenoVerse gene therapy designed to activate the immune system to recognize and target 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.

PRGN-3006 UltraCAR-T in AML and MDS

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 safety/kill switch. PRGN-3006 has been granted Orphan Drug Designation in patients with acute myeloid leukemia (AML) and Fast Track Designation in patients with relapsed/refractory (r/r) AML by the FDA.

· The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in AML.

Financial Highlights

· Cash, cash equivalents, and investments totaled $81.0 million as of March 31, 2025
· Cash burn for the quarter ended March 31, 2025 was $16.9 million

First Quarter 2025 Financial Results Compared to Prior Year Period

Total revenues increased $0.3 million, or 26%, compared to the three months ended March 31, 2024. This increase was primarily related to increased volume of products sold and services rendered at Exemplar.

Research and development expenses decreased by $3.8 million, or 27%, compared to the three months ended March 31, 2024. The decrease was primarily due to a $1.8 million decrease in costs associated with ActoBio, including depreciation, amortization, personnel, and other operating costs after the Company closed ActoBio’s operations in late 2024. Additionally, there was a decrease of $1.2 million incurred at contract research organizations and an $0.8 million decrease due to a reduction in the number of Research and Development employees as a result of the Company’s asset prioritization announced in the third quarter of 2024.

SG&A expenses increased by $2.2 million, or 22%, compared to the three months ended March 31, 2024. This increase was primarily associated with PRGN-2012 commercial readiness. This increase was partially offset by a reduction in insurance rates and license and patent fees compared to the three months ended March 31, 2024.

Total other income (expense), net, changed from income of $0.6 million in the three months ended March 31, 2024, to expense of $31.6 million in the three months ended March 31, 2025. This change was primarily driven by the recording of a $32.5 million increase in the fair value of warrant liabilities, which was influenced by an increase in the stock price of Precigen and to a lesser extent, an increase in the liability to account for the additional warrants that will be issued as part of the paid-in-kind dividends related to the Company’s Series A Preferred Stock. This decrease was partially offset by a $0.3 million increase in interest income resulting from increased investment balances.

Net loss was $54.2 million, or $(0.18) per basic and diluted share, compared to net loss of $23.7 million, or $(0.10) per basic and diluted share, in the three months ended March 31, 2024. The non-cash change in the fair value of warrant liabilities of $32.5 million recorded in the three months ended March 31, 2025 reduced basic and diluted earnings per share in that period by $0.11.