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.
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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.
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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.

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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.

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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.

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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.

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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.

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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.

On May 15, 2025 Omeros Corporation (Nasdaq: OMER) reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2025, which include (Press release, Omeros, MAY 15, 2025, View Source [SID1234653177]):

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● Net loss for the first quarter of 2025 was $33.5 million, or $0.58 per share, compared to a net loss of $37.2 million, or $0.63 per share for the first quarter of 2024.

● At March 31, 2025, we had $52.4 million of cash and short-term investments available for operations and debt servicing, a decrease of $37.7 million from December 31, 2024.

● In March 2025, we resubmitted to the U.S. Food and Drug Administration ("FDA") our Biologics License Application ("BLA") seeking regulatory approval for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy ("TA-TMA"). FDA accepted the resubmission for review as a class 2 resubmission and, pursuant to the Prescription Drug User Fee Act ("PDUFA"), assigned a target date for FDA action of September 25, 2025.

● We are also preparing a European marketing authorization application ("MAA") for narsoplimab in TA-TMA, which we expect to submit in the second quarter of 2025.

● On May 12, 2025, we entered into exchange agreements with holders of our 5.25% Convertible Senior Notes due 2026 (the "2026 Convertible Notes"). We exchanged $70.8 million in aggregate principal amount of our 2026 Convertible Notes for newly issued 9.50% Convertible Senior Notes due in June 2029, on a one-for-one basis. In addition, we reached an agreement with two affiliated holders to convert $10.0 million in aggregate principal amount of the 2026 Convertible Notes into shares of our common stock in three separate tranches, with the conversion of the entire principal to be completed no later than September 15, 2025. Following these transactions, the outstanding principal balance of the 2026 Convertible Notes will be reduced to approximately $17.1 million. Significantly, the reduction in the principal amount of our 2026 Convertible Notes eliminated the need to avoid an accelerated maturity of the entire balance of our term loan by making a $20.0 million prepayment and paying a $1.0 million prepayment premium on or prior to November 2025.

● During the first quarter we elected to temporarily suspend or pause certain activities and programs to prioritize the allocation of our currently available capital to the development of commercial infrastructure and capacities needed to ensure the successful launch of narsoplimab, assuming approval by FDA of our BLA, and to the completion of our ongoing clinical trials with enrolled patients.

● Last quarter we began initiating clinical trial sites for our Phase 3 program evaluating zaltenibart (formerly known as OMS906) for the treatment of paroxysmal nocturnal hemoglobinuria ("PNH"); however, based on the anticipated ramp up in spending on those trials and the need to prioritize the use of currently available capital, we determined to pause our Phase 3 PNH program temporarily. We are working with our vendors and investigators to ensure that the program is ready to be restarted with as little disruption to the timeline as possible after securing capital. We expect to complete remaining activities in our ongoing clinical trial evaluating zaltenibart for the treatment of PNH in treatment-naïve patients and to continue the long-term extension study, which enrolls zaltenibart-treated PNH patients who have completed any of our prior zaltenibart studies.

● Although preparations for the anticipated commercial launch of narsoplimab will continue, we have determined to suspend our expanded access program ("EAP") for narsoplimab, also known as compassionate use, to eliminate direct costs associated with drug supply and external management of the EAP program. We remain committed to supporting patients who are currently being treated under the EAP and discontinuation of the EAP will not affect these patients. Additionally, our ongoing study of narsoplimab in pediatric patients with TA-TMA will continue.

● Development spending on our long-acting, next generation MASP-2 inhibitor, OMS1029 has already been limited. That asset is Phase 2 ready, with drug product needed to support Phase 2 trials having been manufactured and stored, pending the selection of the first indication and the availability and allocation of resources to initiate Phase 2 studies.

● Spending in other areas of our complement programs, including our small-molecule MASP-2 and MASP-3 programs, is also being reduced or halted as part of our effort to focus resources on core development priorities.

"We are pleased that our BLA for narsoplimab in TA-TMA has been accepted by FDA, which is a significant milestone for our narsoplimab program and for Omeros," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "We have already received and are responding to FDA’s information requests, and our highest priority as an organization is to obtain approval for narsoplimab. For this reason, we have taken action to reduce expenses and prioritize spending on the narsoplimab launch and other key priorities. In parallel, through the recently completed exchange of the large majority of our 2026 convertible notes for convertible notes maturing in 2029 and converting a small portion to equity, our total debt will be reduced by approximately $10.0 million and our near-term debt maturities will be lowered by over $100 million, reducing our short-term debt repayment obligations from approximately $118 million to approximately $17 million. This should position us well to raise additional capital for our operations."

First Quarter and Recent Clinical Developments

● Recent developments regarding OMS527, our phosphodiesterase 7 ("PDE7") inhibitor program focused on addictions and compulsive disorders as well as movement disorders, include:

● Work on the planned randomized, double-blind, parallel-group, inpatient Phase 1b clinical trial comparing the safety and efficacy of OMS527 to placebo in the treatment of adults with cocaine use disorder ("CUD") is ongoing with committed funding from the National Institute on Drug Abuse, a part of the National Institutes of Health, in the amount of $4.02 million for the year commencing April 1, 2025. Enrollment in the study is expected to begin later this year and a readout of data from the study is anticipated late this year or in early 2026.

● Recent developments regarding our oncology platform comprising signaling-driven immunomodulators, oncotoxins, and an adoptive T-cell technology combined with an immunostimulator, include:

● In April 2025, we established the Omeros Oncology Clinical Steering Committee to advance Omeros’ OncotoX biologics program focused on acute myeloid leukemia ("AML"). The clinical steering committee is composed of leaders in AML treatment and research at the premier cancer centers across the United States. These experts in the treatment of AML are expected to help guide clinical development of our potential AML therapeutic.

● We continue on a limited basis to progress pre-clinical studies within our novel oncology program, including IND-enabling studies in our OncotoX-AML program. In both in vivo and in vitro models with human cell lines, our OncotoX-AML therapeutic has consistently demonstrated superior efficacy to current AML standard of care treatments. OncotoX-AML shows broad application across AML regardless of genetic mutation including TP53, NPM1, KMT2a, and FLT3. IND-enabling work is ongoing with an estimated timeline to clinical entry of 18-24 months.

Financial Results

Net loss for the first quarter of 2025 was $33.5 million, or $0.58 per share, compared to a net loss of $37.2 million, or $0.63 per share for the first quarter of 2024.

At March 31, 2025, we had $52.4 million of cash and short-term investments available for operations and debt service, a decrease of $37.7 million from December 31, 2024.

For the first quarter of 2025, we earned OMIDRIA royalties of $6.7 million on Rayner’s U.S. net sales of $22.3 million. This compares to earned OMIDRIA royalties of $9.4 million during the first quarter of 2024 on U.S. net sales of $31.2 million. Per the terms of our original 2022 and amended 2024 agreements with DRI Health Acquisition LP, ("DRI"), all U.S. based royalties through 2031 are remitted from Rayner to DRI through an escrow agent.

Total operating expenses for the first quarter of 2025 were $35.0 million compared to $39.0 million for the first quarter of 2024. The $4.1 million decrease was primarily due to the wind down of our clinical program developing narsoplimab for IgA nephropathy offset by increased clinical development costs with Phase 2 of our zaltenibart program.

Interest expense during the first quarter of 2025 was $3.7 million compared to $8.2 million during the prior year quarter. The decrease was due to repurchasing and retiring $118.1 million of par on our 2026 Notes in June 2024 and recording a non-cash remeasurement adjustment in the prior year to increase the OMIDRIA royalty obligation to reflect the sale of expanded royalties to DRI.

During the first quarter of 2025, we earned $1.1 million in interest and other income compared to $3.4 million in the first quarter of 2024. The difference is primarily due to lower cash and investments available to invest in the current quarter.

Net income from discontinued operations, net of tax, was $4.1 million, or $0.07 per share, in the first quarter of 2025 compared to $6.7 million, or $0.11 per share, in the first quarter of 2024. The decrease was primarily attributable to a decrease in OMIDRIA royalties earned in the current quarter.

Conference Call Details

Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time.

For online access to the live webcast of the conference call, go to Omeros’ website at View Source

To access the live conference call via phone, participants must register at the following URL View Source to receive a unique PIN. Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the "Call Me" option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN.

A replay of the call will be made accessible online at View Source