On May 15, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported its financial results and business updates for the first quarter ended March 31, 2025 (Press release, Renovorx, MAY 15, 2025, View Source [SID1234653182]). RenovoCath powers RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform.

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"I am pleased to report a milestone event for RenovoRx: Q1 was our first full quarter of RenovoCath commercial sales, generating approximately $200,000 in revenue. Moreover, this revenue exceeded our internal expectations, and we anticipate this positive trend to continue as we expect sequential quarterly growth for the foreseeable future," said Shaun Bagai, CEO of RenovoRx. "Additionally, we believe that the approximately twenty cancer centers that have used RenovoCath as part of our ongoing Phase III TIGeR-PaC trial could also become potential customers after the planned completion of trial enrollment later this year. Our enthusiasm about the value proposition of our company has never been higher as we dual track the growth of our commercial efforts and progress our clinical trial towards important milestones later this year."

RenovoCath Commercialization Update

The first quarter of 2025 represented RenovoRx’s first full quarter of generating revenue from commercial sales. This is the result of the important strategic decision in 2024 to focus on implementing a commercial strategy for RenovoCath in tandem with the ongoing Phase III TIGeR-PaC trial.

RenovoRx planned to launch its commercial efforts for RenovoCath during the first quarter of this year in response to anticipated strong demand for the patented RenovoCath device. However, the Company received purchase orders ahead of schedule, generating $43,000 in revenue in December alone. RenovoCath is gaining strong traction, with over ten non-TIGeR-PaC medical institutions including several esteemed, high-volume, academic and community, and National Cancer Institute-designated centers who have initiated purchase orders. RenovoRx believes that many of the twenty cancer centers that have used RenovoCath as part of the TIGeR-PaC trial could also be potential customers for RenovoCath after completion of TIGeR-PaC enrollment, anticipated for later this year. Additionally, early utilization of RenovoCath devices by initial customers has led to repeat purchase orders.

RenovoRx believes that the initial total addressable market for RenovoCath (TAM) represents an estimated $400 million peak annual U.S. sales opportunity. In calculating this sales opportunity, the Company is assuming an average of 8 procedures per patient and 7,000 initial target patients at peak market penetration in patient populations where RenovoRx already has clinical usage, with catheter pricing between $6,500-$8,500 per device.

Looking ahead, RenovoRx sees expansion opportunities across other cancer indications that could create the potential for a several-billion-dollar U.S. TAM for RenovoCath over time. The prospect of penetrating even a small portion of this market combined with the potential to help patients is driving the Company’s excitement about this opportunity.

Ongoing Pivotal Phase III TIGeR-PaC Trial Update

During the first quarter of 2025, RenovoRx announced that Johns Hopkins Medicine has now initiated enrollment in the ongoing Phase III TIGeR-PaC trial. This is a valuable addition to the distinguished network of clinical cancer sites across the U.S. participating in this important trial as RenovoRx works towards full enrollment. RenovoRx is continuing to evaluate additional sites and expects that Phase III TIGeR-PaC trial will achieve full enrollment during 2025.

The current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events, or deaths, necessary to complete the final analysis. As of May 2, 2025, 91 patients have been randomized and 56 events have occurred, triggering the second interim analysis. RenovoRx anticipates the Phase III TIGeR-PaC Data Monitoring Committee will review trial data in the third quarter of 2025 and looks forward to receiving their recommendations and feedback.

First Quarter 2025 and Subsequent Key Highlights

During and subsequent to the first quarter, RenovoRx presented abstracts at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium 2025, the Society of Interventional Oncology 2025, and the Society of Surgical Oncology 2025 supporting the TAMP therapy platform via additional human pharmacokinetic (PK) data and pre-clinical data. Additionally, a publication supporting TAMP for targeted locoregional drug delivery was recognized in the Journal of Vascular and Interventional Radiology Award-Winning Paper Scientific Session during the Society of Interventional Radiology 2025 conference.

Subsequent to the first quarter of 2025, RenovoRx announced the issuance of a new U.S. patent for the Company’s TAMP therapy platform, further enhancing the Company’s intellectual property protection. RenovoRx now holds a robust portfolio of 19 patents in multiple countries across the globe, including 9 U.S. patents as well as 7 U.S. patents pending. RenovoRx’s strong and growing intellectual property portfolio provides key support to the Company’s continuing commercialization of RenovoCath. The issuance of this new patent highlights the innovation behind the TAMP therapy platform and strengthens the Company’s competitive position.

Finally, during the first quarter 2025, RenovoRx announced that in the most recent open trading window, members of the management team and Board purchased an aggregate of approximately 143,000 shares of the Company’s stock in multiple open market purchases.

Financial Highlights for the First Quarter Ended March 31, 2025:

● Revenue: RenovoRx reported revenues of approximately $200 thousand from commercial sales of the RenovoCath device.
● Cash Position: As of March 31, 2025, the Company had $14.6 million in cash and cash equivalents. The Company anticipates that the growing revenues from RenovoCath will reduce its burn rate, and that cash as of March 31, 2025, will fully fund both the RenovoCath scale-up and the continued progress towards completion in the Phase III TIGeR-PaC trial.
● R&D Expenses: Research and development expenses were $1.7 million, compared to $1.3 million in Q1 2024. The $0.4 million increase was due to an increase in employee compensation due to cost-of-living adjustments, an increase in manufacturing and non-recurring engineering costs to support commercial scale-up, an increase in conference and trade show activity, and an increase in other R&D activity.
● SG&A Expenses: Selling, general, and administrative expenses were approximately $1.6 million, up from $1.2 million for Q1 2024. The $0.4 million increase was due to an increase in personnel and benefits, an increase in professional and consulting fees to support commercialization, and an increase in other G&A activity.
● Net Loss: Net loss was $2.4 million, compared to $1.1 million in Q1 2024. The $1.3 million increase was due to an increase in loss from operations of $0.6 million and a $0.8 million decrease in the fair value of the common warrant liability.
● Shares Outstanding: As of May 9, 2025, shares of common stock outstanding totaled 36,572,232.

Conference Call Details

Event: RenovoRx First Quarter 2025 Financial Results Conference Call
Date: Thursday, May 15, 2025
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until May 29, 2025, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number: 13753595.

A question-and-answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

On May 15, 2025 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO) ("Rakovina" or the "Company"), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, reported a strategic financing of approximately $4 million (the "Offering") consisting of concurrent private placements of (i) convertible debenture units ("Debenture Units") for aggregate gross proceeds of approximately $1.1 million, and (ii) equity units ("Units" and, together with the Debenture Units, the "Offered Units") for aggregate gross proceeds of approximately $2.9 million (Press release, Rakovina Therapeutics, MAY 15, 2025, https://www.rakovinatherapeutics.com/rakovina-therapeutics-announces-strategic-private-placement-convertible-debt-financing-and-share-consolidation-to-accelerate-us-focused-growth-and-ai-powered-oncology-innovation-2/?utm_source=rss&utm_medium=rss&utm_campaign=rakovina-therapeutics-announces-strategic-private-placement-convertible-debt-financing-and-share-consolidation-to-accelerate-us-focused-growth-and-ai-powered-oncology-innovation-2 [SID1234653181]). The Offering is anchored by a $3 million indication of interest from strategic investors for $1.1 million of Debenture Units and $1.9 million of Units.

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The Company also announces that it will seek TSX Venture Exchange (the "TSXV") approval to implement a 10-for-1 share consolidation (the "Consolidation") to enhance its capital structure and position Rakovina for accelerated growth in U.S. capital markets, to be completed following closing of the Offering.

Offering

Pursuant to the Offering, Rakovina will issue approximately 58 million Units at an offering price of $0.05 per Unit, with each Unit consisting of one Pre-Consolidation Share (as defined herein) and one share purchase warrant (a "Warrant"). Each Warrant will entitle the holder to purchase one additional Pre-Consolidation Share at a price of $0.10 per Pre-Consolidation Share (or $1.00 per Post-Consolidation Share, following completion of the Consolidation), exercisable for a period of 24 months from issuance, subject to customary adjustments, including adjustment upon completion of the proposed Consolidation. If the closing price for the Company’s common shares on the TSXV is $0.25 or greater per Pre-Consolidation Share (or $2.50 per Post-Consolidation Share, following completion of the Consolidation) for five consecutive trading days, the expiry of the Warrants shall be accelerated to the date that is 30 days following the last day of the 5-day trading period.

Rakovina will also issue approximately 22 Debenture Units to a select group of investors at an offering price of $50,000 per Debenture Unit, for aggregate gross proceeds of approximately $1.1 million. Each Debenture Unit will be comprised of one unsecured convertible debenture (a "Debenture") in the principal amount of $50,000 and 100,000 share purchase warrants ("Debenture Warrants"). Each Debenture Warrant will entitle the holder to purchase one additional Pre-Consolidation Share at a price of $0.15 per Pre-Consolidation Share (or $1.50 per Post-Consolidation Share, following completion of the Consolidation), exercisable for a period of 24 months from issuance, subject to customary adjustments, including adjustment upon completion of the proposed Consolidation.

The principal amount of each Debenture shall be repayable in 36 months (unless earlier converted or redeemed) and will accrue interest at a rate of 12% per annum. Until the principal amount is repaid, a Debenture holder shall have the option to convert the principal amount of the Debenture into common shares of the Company at a conversion price of $0.10 per Pre-Consolidation Share (or $1.00 per Post-Consolidation Share, following completion of the Consolidation), subject to customary adjustments, including adjustment upon completion of the proposed Consolidation. Rakovina shall be entitled to redeem all or a portion of the principal amount of each Debenture at any time commencing 12 months after issuance of such Debenture, in cash and without premium.

The Offering may include one or more subscriptions by directors or other insiders of the Company. Subscriptions completed by insiders in the Offering may constitute a "related party transaction" as defined in Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") and Policy 5.9 of the TSXV. The Company is relying on exemptions from the formal valuation and minority shareholder approval requirements under MI 61-101 on the basis that neither the fair market value of the Offered Units issued to interested parties (as defined in MI 61-101), nor the consideration received for those Offered Units, will exceed 25% of the Company’s market capitalization.

Closing of the Offering is subject to the Company obtaining all necessary corporate and regulatory approvals, including approval of the TSXV. Pursuant to applicable Canadian securities laws, all securities issued in connection with the Offering will be subject to a statutory hold period of four months plus a day from the date of issuance. The Company may pay finders’ fees in connection with the Offering and in accordance with the policies of the TSXV.

Share Consolidation

Subject to the approval of the TSXV, Rakovina will consolidate all of its issued and outstanding common shares on the basis of 10:1, with each 10 Pre-Consolidation Shares (as defined below) being consolidated into one Post-Consolidation Share (as defined below). In accordance with the Company’s articles, shareholder approval of the proposed Consolidation will not be required.

The 140,042,575 common shares currently issued and outstanding (the "Pre-Consolidation Shares") will be reduced to approximately 14,004,257 common shares on a post-Consolidation basis (the "Post-Consolidation Shares"), assuming no additional Pre-Consolidation Shares are issued prior to completion of the Consolidation. Assuming 58,000,000 Pre-Consolidation Shares are issued pursuant to the Offering, there will be approximately 19,804,257 Post-Consolidation Shares issued and outstanding upon completion of the Consolidation. No fractional shares will be issued as a result of the Consolidation. Any fractional interest in shares that would otherwise result from the Consolidation will be rounded down to the nearest whole share, if the fractional interest is less than one-half of a share, and rounded up to the nearest whole share, if the fractional interest is equal to or greater than one-half of a share. No cash consideration will be paid in respect of fractional shares. The Company will not be changing its name in connection with the Consolidation and the Post-Consolidation Shares will continue to trade on the TSXV under the existing trading symbol.

The exercise or conversion price, and the number of Post-Consolidation Shares issuable under any of the Company’s outstanding convertible securities, will be proportionately adjusted upon the effective date of the Consolidation.

The effective date of the Consolidation, and new CUSIP and ISIN numbers for the Post-Consolidation Shares, if applicable, will be disclosed in a subsequent news release.

"This is more than a financing, it’s a pivotal inflection point," said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "We’re not just adding capital, we’re building capacity. The share consolidation strengthens our market position, while the continued integration of an advanced AI platform accelerates our ability to monetize our pipeline through high-value collaborations."

Rakovina’s proprietary DNA Damage Response (DDR) platform continues to show promise in targeting tumors with impaired DNA repair pathways—a hallmark of many treatment-resistant cancers. With a stronger capital structure, strategic investment, and embedded AI expertise, the Company is well-positioned to deliver lasting value to patients, partners, and shareholders alike.

On May 15, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation ADC therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended March 31, 2025, and provided a business update (Press release, Pyxis Oncology, MAY 15, 2025, View Source [SID1234653180]).

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"We are enthusiastic about the progress we are making with micvotabart pelidotin, particularly our recent preclinical data that validate its unique three-pronged mechanism of action and indicate that MICVO monotherapy may be eliciting immune responses in previously unresponsive tumors," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "Our focus remains on delivering durable and efficacious therapies for patients with recurrent or metastatic head and neck squamous cell carcinoma and other advanced solid tumors, building on the tremendous potential of our next generation ADC. We look forward to reporting data from our ongoing Phase 1 trials evaluating MICVO as a monotherapy and in combination with pembrolizumab later this year."

Pipeline Updates

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Pyxis Oncology presented promising preclinical data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supporting the unique three-pronged mechanism of action of MICVO driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death. These data further reinforce the potential patient benefit of MICVO as a monotherapy and in combination with an anti-PD-1 therapy.
o
MICVO demonstrated broad anti-tumor activity across ten solid tumor indications in PDX models, attributed to EDB+FN target expression, proteolytic activity for MICVO linker cleavage and tumor responsiveness to the cytotoxic Auristatin0101 payload.
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Differential gene expression analysis enabled identification of gene signatures associated with anti-tumor activity.
o
Upregulation of certain proteases may contribute to increased linker cleavage and subsequent increased MICVO activity, supporting hypothesis for extracellular mechanism.

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Combining a mouse analog of MICVO with anti-PD-1 therapy inhibited EMT6 tumor growth and improved survival.

•
The Company expects to report preliminary data from the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial evaluating MICVO in 2L and 3L R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy in the second half of 2025 and 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy in the first half of 2026. R/M HNSCC continues to be an area of high medical need despite improvements in treatment options.

•
Pyxis Oncology anticipates selecting a dose of MICVO in the ongoing Phase 1/2 combination study of micvotabart pelidotin and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors by mid-year 2025 and reporting preliminary data from the trial in the second half of 2025.

First Quarter 2025 Financial Results

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As of March 31, 2025, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $106.9 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the second half of 2026.

•
Research and development expenses were $17.0 million for the quarter ended March 31, 2025, compared to $13.0 million for the quarter ended March 31, 2024. The increase was primarily due to increased clinical trial-related expenses related to monotherapy and combination therapy of micvotabart pelidotin, increase in preclinical and translation work to support clinical development of micvotabart pelidotin and increased manufacturing of drug product and drug substance.

•
General and administrative expenses were $5.9 million for the quarter ended March 31, 2025, compared to $8.2 million for the quarter ended March 31, 2024. The decrease was primarily due to lower stock-based compensation costs, lower corporate insurance costs and decrease in legal, professional and consulting fees.

•
Net loss was $21.2 million, or ($0.35) per common share, for the quarter ended March 31, 2025, compared to $3.3 million, or ($0.06) per common share, for the quarter ended March 31, 2024. Net loss for the quarter ended March 31, 2024 included total revenues of $16.1 million related to the settlement agreement with Novartis for sale of royalty rights of Beovu for a one-time amount of $8.0 million and Novartis agreed to forgo its right to reclaim royalties previously paid of $8.1 million to us and Apexigen. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended March 31, 2025 was $17.5 million, compared to net income of $1.1 million for the quarter ended March 31, 2024.

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As of May 14, 2025, the outstanding number of shares of Common Stock of Pyxis Oncology was 61,947,665.

On May 15, 2025 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics that use its INTASYL siRNA gene silencing technology designed to make the body’s immune cells more effective in killing cancer cells, reported its financial results for the quarter ended March 31, 2025 and provided a business update (Press release, Phio Pharmaceuticals, MAY 15, 2025, View Source [SID1234653179]).

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Recent Corporate Updates

PH-762 Clinical Progress

Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma.

To date, a total of 10 patients with cutaneous carcinomas have been treated in Cohorts 1, 2 and 3. These cohorts included 9 patients with cSCC and 1 patient with metastatic melanoma. At Day 36 (planned tumor excision), of the 9 patients with cSCC, 4 patients had a pathologic complete response (100% tumor clearance). One patient had a near complete response (>90% clearance) and 1 patient had a partial response (>50% clearance). The other 3 cSCC and one metastatic melanoma patient had a pathologic non-response (< 50% clearance). Patients with a pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection. No patients, however, exhibited clinical progression of disease.

To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort.

The fourth cohort is currently enrolling and treating patients; Phio expects to complete enrollment in the trial in the third quarter of 2025.

Scientific News

During the three months ended March 31, 2025, Phio was awarded podium presentations for its INTASYL self-delivering siRNA technology at the American Academy of Dermatology (AAD) and at the Society of Investigative Dermatology (SID). The Company presented its phase 1b clinical trial results to date. The Company also presented data on INTASYL compounds PH-762 and PH-894 at the 11th Annual Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ITOC 11) conference in Munich, Germany.

The Company’s INTASYL compound RXI-231 was highlighted in the peer reviewed journal, Clinical, Cosmetic and Investigational Dermatology. The article presented proof-of-concept data for RXI-231, an INTASYL compound designed to target and reduce tyrosinase (TYR) gene expression. While further characterization and clinical testing is needed, RXI-231 shows promise in treating hyperpigmentation disorders.

Capital Sourcing

In December 2024 and January 2025, Phio raised an aggregate of approximately $9.2 million in registered direct offerings and concurrent private placements, before deduction of commissions and other expenses. Additional gross proceeds of approximately $2.9 million were raised from the exercise of warrants previously issued on July 12, 2024. With these proceeds, the Company now believes it has sufficient capital to complete the treatment phase of the Phase 1b trial.

Cost Rationalization

From April 2014 to March 2024, the Company leased space that was utilized as its corporate headquarters and primary laboratory. The lease expired on March 31, 2024. On March 1, 2024, the Company commenced a lease for a laboratory facility located at 17 Briden Street, Worcester, Massachusetts. The lease had an original expiration date of August 31, 2024, and was subsequently extended through February 28, 2025. The Company continues to lease the space on a month-to-month basis. Monthly rent is approximately $2,500. In March 2025, the Company contracted with LifeSciences PA located at 411 Swedeland Road, King of Prussia, PA 19406 for access to full working space for normal hours of operations at a fee of $300 per month, which can be cancelled at any time.

In May 2024, the Company terminated the Clinical Co-Development Agreement with AgonOx, Inc. (AgonOx) effective immediately. The Company paid AgonOx all payment obligations that accrued prior to the termination of the Clinical Co-Development Agreement. The Company made the remaining payment of $34,320, which primarily related to accrued obligations for patient fees and other miscellaneous costs as of the date of termination to AgonOx on March 21, 2025. This settled all future obligations to AgonOx.

Financial Results

Cash Position

At March 31, 2025, the Company had cash of approximately $13.3 million as compared with approximately $5.4 million at December 31, 2024.

Net cash provided by financing activities for the three months ended March 31, 2025 was approximately $9.2 million as compared to the three months ended March 31, 2024 where net cash used in financing activities was approximately $4,000. The increase in net cash provided by financing activities was primarily due to the issuance of common stock and warrants, and the exercise of warrants.

Research and Development Expenses

Research and development expenses were $0.886 million for the three months ended March 31, 2025 as compared with $1.148 million for the three months ended March 31, 2024, a decrease of 23%. The decrease in research and development expenses was primarily driven by decreases in salary-related costs and in consulting expense.

General and Administrative Expenses

General and administrative expenses were approximately $0.986 million for the three month period ended March 31, 2025 as compared with approximately $1.061 million for the three months ended March 31, 2024, a decrease of 7%. The Company considers this to be an immaterial fluctuation.

Net Loss

Net loss was $1.8 million for the three months ended March 31, 2025 as compared with $2.2 million for the three months ended March 31, 2024. The decrease in net loss was due to the reductions in research and development and general and administrative expenses cited above.

On May 15, 2025 Orna Therapeutics, a leading biotechnology company developing a proprietary pipeline of in vivo therapies across a broad range of autoimmune and oncology indications, reported the presentation of new preclinical data supporting its in vivo CAR therapy approach in autoimmune diseases during an oral session at the 28th American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting being held May 13-17, 2025, in New Orleans, Louisiana (Press release, Orna Therapeutics, MAY 15, 2025, View Source [SID1234653178]).

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"The preclinical data presented today at ASGCT (Free ASGCT Whitepaper) highlight our potential to deliver on the promise of in vivo CAR T therapy," said Joseph Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics. "Our CD19 panCAR program has demonstrated not only successful delivery of our lead panCAR LNP to disease-relevant immune cell types, but also robust and sustained B cell depletion at low doses in both peripheral blood and lymphoid tissues in non-human primates (NHPs). These compelling results continue to reinforce our commitment to translating our promising science into meaningful therapies for patients and we look forward to advancing our CD19 panCAR program towards the clinic in 2026."

Presentation Details:

Title: In Vivo panCAR Therapy Using Circular RNA for the Treatment of Autoimmune Disease

Speaker: Megan Hoban, Ph.D., panCAR Program Lead, Orna Therapeutics

Date/Time: Thursday, May 15, 2025, 8:00 AM – 9:45 AM CDT

Session Name: Cellular and Gene Therapies for Autoimmune Disease

Location: Room 388-390

In today’s presentation, Orna will showcase preclinical data demonstrating the potential of its in vivo panCAR therapy, enabled by its proprietary circular (oRNA) technology and best-in-class lipid nanoparticle (LNP) delivery system to achieve robust and sustained B cell depletion in both humanized mouse models and non-human primates across multiple doses.

Key findings from the study include:

Validated extra-hepatic delivery to disease-relevant immune cell types, including T cells, in mice and NHPs without requiring targeting ligands.
Lead panCAR LNP achieved over 60% delivery to peripheral blood and splenic T cells in NHPs.
CD19 panCAR doses as low as 0.03mpk led robust B cell depletion, with multi-dosing achieving increased B cell depletion in humanized mice.
In a humanized lupus mouse model, CD19 panCAR showed strong B cell depletion and a meaningful and differentiated reduction in dsDNA titers compared to rituximab.
CD19 panCAR induced full depletion of B cells across peripheral blood, spleen, lymph nodes, and bone marrow in NHPs, with peripheral B cells beginning to reconstitute after three weeks.