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Coherus Oncology, Inc. Announces Proposed Public Offering of Common Stock

On February 12, 2026 Coherus Oncology, Inc. ("Coherus" or the "Company") (NASDAQ: CHRS), reported a proposed underwritten public offering of its common stock (the "Offering"). In addition, Coherus intends to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the shares offered in the Offering, at the public offering price per share less underwriting discounts and commissions. All of the shares in the Offering are being offered by Coherus.

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Coherus intends to use the net proceeds from the proposed Offering to support the ongoing commercialization of LOQTORZI (toripalimab-tpzi), to continue clinical development of its product candidates, and for working capital and other general corporate purposes.

TD Cowen, Guggenheim Securities, and Oppenheimer & Co. are acting as joint bookrunners for the proposed Offering.

The proposed Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

The securities described above are being offered by Coherus pursuant to an effective shelf registration statement on Form S-3 (File No. 333-291520) that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on November 13, 2025. The Offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the Offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by request from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or Oppenheimer & Co. Inc. Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Coherus Oncology, FEB 12, 2026, View Source [SID1234662649])

Calidi Biotherapeutics To Present on its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform in a Late-Breaking Abstract at the 2026 AACR-IO Conference

On February 12, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that it will present data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) conference being held in Los Angeles, California, from February 18-21, 2026.

RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high‑level expression of therapeutic genetic payloads directly within the tumor. CLD‑401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL‑15 superagonist, a known T-cell activator, in the TME.

BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show efficacy in solid tumors where the TME inhibits T-cell activity. In immunocompetent models of metastatic disease, the RedTail platform has demonstrated that it can alter the TME and induce T-cell activation through its ability to convert tumors into local producers of IL-15 superagonist. Given the high capacity for genetic payloads with RedTail, it is possible to have simultaneous high levels of expression of multiple tumor‑localized payloads, such as an IL-15 superagonist, along with a tumor-specific BiTE.

"RedTail is a major leap forward in the delivery of genetic medicine via an engineered virus," said Eric Poma, PhD, Chief Executive Officer of Calidi. "It is able to avoid immune clearance allowing for systemic delivery but can only replicate and express payload in tumor cells."

"Our work with RedTail continues to highlight the flexibility of the platform to deliver complex biologics directly within the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "We believe simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to enable for T-cell engagement precisely where it is needed."

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The company anticipates submitting an Investigational New Drug

(IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, FEB 12, 2026, View Source [SID1234662648])

Ultragenyx Reports Fourth Quarter and Full Year 2025 Financial Results and Corporate Update

On February 12, 2026 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported its financial results for the quarter and year ended December 31, 2025.

"The year ahead marks an important turning point for the company, as we approach two potential product launches and a pivotal data readout that, together, could significantly accelerate our commercial revenue trajectory," said Emil D. Kakkis, M.D., Ph.D., chief executive officer and president of Ultragenyx. "We are implementing a strategic restructuring plan to reduce our operating expenses and ensure our resources are squarely aligned with our highest-impact opportunities, while leading the future of rare disease with multiple first ever treatments."

Fourth Quarter 2025 Selected Financial Data Tables and Financial Results

Revenues (dollars in millions), (unaudited)

Three Months Ended December 31, Year Ended December 31,
2025 2024 2025 2024
Crysvita
Product sales – Latin America and Türkiye $ 40 $ 22 $ 177 $ 135
Royalty revenue – U.S. and Canada 97 87 275 249
Royalty revenue – Europe 8 7 29 26
Total Crysvita Revenue 145 116 481 410
Dojolvi 32 31 96 88
Evkeeza 17 10 59 32
Mepsevii 13 8 37 30
Total revenues $ 207 $ 165 $ 673 $ 560

Revenues
Ultragenyx reported $207 million in total revenue for the fourth quarter 2025, which represents 25% growth compared to the same period in 2024. Crysvita revenue in the fourth quarter 2025 was $145 million, which includes product sales of $40 million from Latin America and Türkiye. Dojolvi revenue in the fourth quarter 2025 was $32 million. Evkeeza revenue in the fourth quarter 2025 was $17 million.

Total revenue for the year ended December 31, 2025 was $673 million, which represents 20% growth compared to the prior year. Full year 2025 Crysvita revenue was $481 million, which represents 17% growth compared to the prior year. This includes product sales of $177 million from Latin America and Türkiye, which represents 31% growth compared to the prior year. Dojolvi revenue in 2025 was $96 million, which represents 9% growth compared to the prior year. Evkeeza revenue in 2025 was $59 million, which represents 84% growth compared to the prior year, as demand continues to build following launches in the company’s territories outside of the United States.

Selected Financial Data (dollars in millions, except per share amounts), (unaudited)

Three Months Ended December 31, Year Ended December 31,
2025 2024 2025 2024
Total revenues $ 207 $ 165 $ 673 $ 560
Operating expenses:
Cost of sales 29 17 109 77
Research and development 203 188 750 698
Selling, general and administrative 89 82 349 321
Total operating expenses 321 287 1,208 1,096
Net loss $ (129 ) $ (133 ) $ (575 ) $ (569 )
Net loss per share, basic and diluted $ (1.29 ) $ (1.39 ) $ (5.83 ) $ (6.29 )

Operating Expenses

Total operating expenses for the fourth quarter 2025 were $321 million. Total operating expenses for the year ended December 31, 2025 were $1.2 billion, including $153 million of non-cash stock-based compensation.

Net Loss

Net loss for the fourth quarter 2025 was $129 million, or $1.29 per share basic and diluted, compared with a net loss for the fourth quarter 2024 of $133 million, or $1.39 per share basic and diluted. Net loss for the year ended December 31, 2025 was $575 million, or $5.83 per share basic and diluted, compared with a net loss the prior year of $569 million, or $6.29 per share, basic and diluted.

Cash Balance and Net Cash Used in Operations

Cash, cash equivalents, and marketable securities were $737 million as of December 31, 2025. For the three months ended December 31, 2025, net cash used in operations was $100 million and for the year ended December 31, 2025 was $466 million.

Financial Guidance and Strategic Restructuring Plan

2026 revenue guidance

Total revenues, excluding potential revenue from new product launches, in the range of $730 million to $760 million, an increase of 8% to 13% compared to 2025
Crysvita revenue in the range of $500 million to $520 million, reflecting growing underlying global demand partially offset by expected timing of ordering patterns in Brazil
Dojolvi revenue in the range of $100 million to $110 million

Strategic restructuring plan and path to profitability in 2027

Ultragenyx has initiated a strategic restructuring plan designed to reduce its headcount and expenses and focus resources on its largest value drivers. The significant reduction and partial reinvestment of expenses, and the planned growth in revenue from current and new product launches, are designed to keep the company on its path to profitability in 2027.

Today, in connection with the restructuring plan, the company announced a 10% workforce reduction, impacting approximately 130 employees.

Based on the progression of the business and the reductions from the restructuring plan:

In 2026, combined R&D and SG&A expenses are expected to be flat to down low-single digits versus 2025. This includes the impact of spend reductions and approximately $50 million for severance, manufacturing, and other non-recurring restructuring charges.
In 2027, R&D expenses are expected to decrease from 2025 levels by 38%, or approximately $280 million, driven by the completion of multiple phase 3 studies and reduction of early-stage research efforts. SG&A expenses are expected to increase in support of new product launches and existing approved products. On a combined basis, 2027 R&D and SG&A expenses are expected to decrease at least 15% versus 2025.

2026 Clinical and Regulatory Catalysts

DTX401 (pariglasgene brecaparvovec) AAV8 gene therapy for glycogen storage disease type Ia (GSDIa): Biologics License Application (BLA) rolling submission completed in December 2025, with an anticipated Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2026.

UX111 (rebisufligene etisparvovec) AAV9 gene therapy for Sanfilippo syndrome type A (MPS IIIA): The BLA was resubmitted in January 2026 and included substantial longer-term data, that were recently presented at the 2026 WORLDSymposium, on multiple measures of neurologic benefit to support an intermediate clinical endpoint for accelerated approval supported further by CSF heparan sulfate and other biomarker data, as agreed with the FDA during the last clinical review.
Earlier today the company received an Incomplete Response Letter (IRL) regarding its resubmitted BLA. The IRL requests additional supportive documentation related to its CRL CMC responses, which the company will provide in a resubmission.
GTX-102 (apazunersen) antisense oligonucleotide (ASO) for the treatment of Angelman syndrome (AS): Data from the fully enrolled, pivotal, Phase 3 Aspire study in patients with a genetically confirmed diagnosis of UBE3A deletion is expected in the second half of 2026. Enrollment in the Phase 2/3 Aurora study is also underway in other genotypes and ages, with the first patient dosed in October 2025.

UX701 (rivunatpagene miziparvovec) AAV9 gene therapy for Wilson disease: Enrollment is complete for the fourth cohort in the ongoing, dose-finding stage of the pivotal Cyprus2+ study. Data from this stage are expected in 2026.

Conference Call and Webcast Information

Ultragenyx will host a conference call today, Thursday, February 12, 2026, at 2 p.m. PT/5 p.m. ET to discuss the fourth quarter and full year 2025 financial results and provide a corporate update. The live and replayed webcast of the call will be available through the company’s website at View Source The replay of the call will be available for three months.

(Press release, Ultragenyx Pharmaceutical, FEB 12, 2026, View Source [SID1234662646])

Soligenix Details Recent Progress and Upcoming Milestones

On February 12, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.

Dear Friends and Shareholders,

I would like to start by thanking you for your continued support, and by wishing you and your families a Happy New Year. With 2026 being an important year for us, we remain energized by the promise of our late-stage rare disease pipeline as we continue to evaluate potential strategic options, including, but not limited to, partnership and merger and acquisition opportunities. The previously publicly disclosed upcoming key clinical events and milestones are summarized below.

Top-line results from the actively enrolling 80 patient confirmatory Phase 3 FLASH2 (Fluorescent Light And Synthetic Hypericin 2) clinical trial for HyBryte (SGX301 or synthetic hypericin) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL) are expected in the second half of 2026, with an interim analysis fast approaching in 2Q. Patient enrollment continues to progress nicely with 66 patients enrolled in the study as of February 10th. Importantly, the overall blinded aggregate response rate remains consistent with what was reported in November and higher than the estimated overall response rate used to design the study, increasing our confidence in the interim analysis and final study results. Just to remind you, this second Phase 3 trial (FLASH2) essentially replicates the first successful Phase 3 (FLASH) study, with the exception of shifting the primary endpoint assessment from 6 weeks in FLASH to 18 weeks in FLASH2, in keeping with findings in both the FLASH study and other recent supportive studies that have all shown that the longer we treat with HyBryte, the better it works.

A clinical update was provided for the ongoing open-label, investigator-initiated study (IIS) sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH study and is the Principal Investigator for the confirmatory Phase 3 FLASH2 study for the treatment of early-stage CTCL. The IIS evaluated extended HyBryte (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage CTCL, with a similar design to that of the active HyBryte arm in FLASH2. Following 18 weeks of continuous "real world" treatment, 75% of patients achieved "Treatment Success," with three of the eight evaluable patients achieving a complete response over the course of the study. These results reinforce HyBryte’s potential as a safe and fast-acting therapy for this chronic and underserved cancer and may explain, in part, the higher aggregate blinded response rate seen in FLASH2.

We continue to work with our lead investigators in CTCL, including pursuing publications to enhance both medical and scientific awareness of HyBryte. We anticipate additional publications around HyBryte in the first half of the year.

Top-line results from the Phase 2a proof of concept clinical trial in Behçet’s Disease (BD) with SGX945 (dusquetide) were reported in July and achieved the study objective of demonstrating biological efficacy. The Phase 2a study was an open-label study designed to be highly comparable (e.g., study endpoints, inclusion-exclusion criteria) to the published Phase 3 study of apremilast (Otezla) used to support marketing approval for oral ulcers in BD. SGX945 outcomes were compared to both the apremilast and placebo arms in this Phase 3 study. Over 4 weeks of treatment, the area under the curve (AUC; a composite measurement of both peak number of oral ulcers and the time to resolution of the oral ulcers), average number of oral ulcers, and improvements in oral pain for SGX945 were similar to outcomes obtained in the apremilast study. Notably, outcomes in weeks 5 through 8 continued to show similar outcomes to the apremilast study, even though apremilast treatment was continued through this period whereas SGX945 treatment was stopped at Week 4, per study design. These results were published in Rheumatology (Oxford) in December. With these results, we intend to embark on a reformulation of SGX945 to enable home-based treatment and look forward to interacting with the health authorities in designing a follow-on placebo-controlled Phase 2b study in 2026.

Top-line results were reported in December for the last cohort of four patients in the Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin), where SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. On average over the three evaluable patients (one patient discontinued for personal reasons), there were improvements in the Investigator Global Assessment (IGA), the Psoriasis Activity and Severity Index (PASI), the simplified psoriasis index, the dermatology life quality index and the Skindex-29 questionnaire. One patient achieved a disease status of "Almost Clear" using the IGA, which is considered a standard clinical measure for treatment success in psoriasis, with a substantial improvement in their PASI score, exceeding 50%. In totality, the initial exploratory phase of the study has confirmed that SGX302 improves psoriasis lesions, consistent with the general success of photodynamic therapies in psoriasis, and is well tolerated, potentially providing a non-carcinogenic, non-mutagenic treatment for the thicker lesions found in psoriasis. With the completion of this pilot study, the table has been set for a more detailed evaluation in this large underserved market.
Additionally, we continue to follow through on our financing strategies, and have sufficient capital and cash runway to meet our goals through 2026. We expect peak annual net sales of HyBryte in the U.S. to exceed $90 million, with the total addressable worldwide CTCL market estimated at greater than $250 million annually. Preliminary analysis of the total addressable worldwide psoriasis market opportunity with SGX302, which uses the same active ingredient as HyBryte, is significant and estimated to exceed $1 billion annually. SGX945 in BD is another meaningful worldwide market opportunity estimated at approximately $200 million annually. Overall, we are excited about our near-term and future upcoming catalytic milestones across our rare disease pipeline, with the potential for significant commercial returns of ~$2B in global annual sales.

With approximately $10.5 million in cash reported in our Form 10-Q for the quarter ended September 30, 2025, not including approximately $500 thousand in non-dilutive funding received through New Jersey’s net operating loss (NOL) sales program, we remain focused on advancing our development programs in our Specialized BioTherapeutics rare disease business segment, most notably, completion of our confirmatory Phase 3 HyBryte clinical trial, where we currently anticipate achieving multiple important and potentially transformational milestones through 2026. We also continue to evaluate strategic options before us to better position the company for growth and success.

We remain steadfast in our plans for partnership in the ex-U.S. markets and continue to pursue discussions with potential partners with similar reputation and expertise in this therapeutic area, as we advance towards successful completion of the FLASH2 confirmatory trial in order to aggressively pursue HyBryte marketing authorizations worldwide. Given HyBryte’s clinical success in CTCL, we also are evaluating other potential cutaneous indications that might similarly benefit from the use of our first-in-class synthetic hypericin.

In closing, thank you again for your interest and your ongoing support of Soligenix. Looking ahead, 2026 has the potential to be an exciting time for the Company, as we further advance our development programs towards commercialization.

(Press release, Soligenix, FEB 12, 2026, View Source [SID1234662645])

Rezolute Reports Second Quarter Fiscal 2026 Financial Results and Provides Business Update

On February 12, 2026 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), reported financial results and provided a business update for the three months ended December 31, 2025.

Congenital Hyperinsulinism (HI)

· In December 2025, Rezolute reported topline results from sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI. The study did not meet its primary or key secondary endpoints.

· The study demonstrated reductions from baseline in hypoglycemia events by self-monitored blood glucose at both ersodetug dose levels, but reductions were not statistically significant compared to placebo, due to a pronounced study effect.

· A reduction in hypoglycemia time by continuous glucose monitoring (CGM) was also demonstrated with both dose levels of ersodetug, which was statistically significant compared to placebo at the Week 16 timepoint, but did not meet significance at the Week 24 end of pivotal timepoint.

· In sunRIZE, pharmacologic activity was observed, with target therapeutic drug concentrations achieved in both treatment groups, along with highly sensitive biomarker responses of decreased insulin cell signaling in the active treatment groups, indicating drug activity.

· Notably, all 59 participants who completed the study continued into the ongoing open-label extension portion, including the roll-over of placebo participants onto ersodetug, and the vast majority remain on therapy. Some of the children have been able to stop taking their standard congenital HI therapies and are now receiving ersodetug as monotherapy.

· Subsequent to the announcement of the topline results of the primary and key secondary endpoints, the Company is undertaking extensive analysis of the results and other endpoints, in preparation for its upcoming FDA meeting.

· The Company will be meeting with FDA prior to the end of the first quarter under Breakthrough Therapy Designation to determine next steps for the program.

Tumor HI

· upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.

§ Enrollment is underway and topline results are expected in the second half of 2026.

· In January 2026, the Company shared aggregate data from the initial 9 tumor HI patients treated under the historical Expanded Access Program (EAP).

§ The data show that 75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN, providing additional evidence of the activity and potential efficacy of ersodetug across various forms of HI.

§ This cohort was the basis for FDA to grant Breakthrough Designation and agree to a single-arm, open-label registrational study design.

§ The glucose infusion rate (GIR) assessment in the EAP is the primary endpoint in upLIFT, which measures the number of participants (out of approximately 16) who achieve at least a 50% reduction in GIR.

§ The full EAP data table, filed on Form 8-K with the U.S. Securities and Exchange Commission, can be found here.

Corporate Updates

· In November 2025, the Company hosted a virtual Investor Event during which Rezolute Chief Commercial Officer, Sunil Karnawat, discussed the anticipated commercial opportunities for ersodetug as a potential treatment for congenital and tumor HI. The event also featured presentations from two leading physician experts who provided perspectives on disease background and the significant unmet clinical need in HI.

§ A replay of the virtual event is available on the Investor Relations section of the Company’s website here.

Second Quarter Fiscal 2026 Financial Results

Cash, cash equivalents and investments in marketable securities were $132.9 million as of December 31, 2025, compared with $167.9 million as of June 30, 2025.

Research and development (R&D) expenses were $14.3 million for the second quarter of fiscal 2026, compared with $12.6 million for the same period a year ago. The increase from fiscal year 2025 to fiscal year 2026 was primarily due to (i) increased expenditures in clinical trial activities and (ii) higher employee-related expenses, which included one-time severance benefits related to the December 2025 reduction in force, partially offset by a decrease in manufacturing costs for ersodetug.

General and administrative (G&A) expenses were $9.9 million for the second quarter of fiscal 2026, compared with $4.5 million for the same period a year ago. The increase was primarily attributable to increased professional fees and employee-related expenses, which included one-time severance benefits related to the December 2025 reduction in force.

Net loss was $22.8 million for the second quarter of fiscal 2026 compared with a net loss of $15.7 million for the same period a year ago.

About Ersodetug

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.

(Press release, Rezolute, FEB 12, 2026, View Source [SID1234662644])