On March 2, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported full year 2025 financial results for the period ended December 31, 2025.

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"2026 looks to bring more significant milestones for the company, as we plan to initiate the first clinical trial with GTB-5550," said Michael Breen, Executive Chairman and Chief Executive Officer. "Advancing our third TriKE candidate into the clinic underscores the continued momentum of our pipeline. GTB-3650 has shown an excellent safety profile thus far, and the higher dose cohorts will be more reflective of surpassing a potential efficacy threshold. With sufficient cash runway through Q4 2026, we look forward to providing the next update in the third quarter of 2026."

GTB-3650 TriKE for CD33 positive leukemias

The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. Enrollment in Cohort 4 (10 µg/kg/day) is ongoing, and the Company expects to initiate dosing in Cohort 5 (25 µg/kg/day) in Q2 2026. The Company anticipates providing the next update in the third quarter of 2026, which would include longer term follow-up on the six patients in Cohort 1 through 3 as well as initial observations from patients in Cohort 4 and Cohort 5. Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort). GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.

GTB-5550 TriKE for B7H3 positive solid tumor cancers

The Phase 1 basket trial with GTB-5550 will be the first dual nanobody TriKE tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial will test up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 2 expansion component of the trial will then confirm the MTD identified in the Phase 1a trial in up to seven different possible metastatic disease cohorts (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity. The Company remains well on track to initiate the trial in mid-2026.

GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS).

Year Ended December 31, 2025 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $7 million as of December 31, 2025, and an unaudited proforma cash balance as of January 31, 2026 of approximately $9 million, which is anticipated to be sufficient to fund the Company’s operations through the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2025 were approximately $3.5 million compared to $5.8 million for the prior year. The $2.3 million decrease was primarily due to a reduction in production and material costs. R&D expenses primarily relate to the Company’s continued licensing, development and production of its most advanced TriKE product candidates GTB-3650 and GTB-5550 along with the progression on other promising product candidates. In late June 2024, the Company received clearance from the Food and Drug Administration with respect to its Investigational New Drug ("IND") application in relation to its next generation GTB-3650 camelid nanobody product. Study enrollment began in early 2025 and the Company has advanced into the clinic, enrolling patients, and performing tests for data collection throughout the year. In late January 2026, the Company received clearance from the FDA with respect to its IND Application in relation to GTB-5550, with a Phase 1 dose escalation basket trial expected to initiate mid-2026.

Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the year ended December 31, 2025 were relatively flat compared to the prior year, amounting to approximately $8.5 million compared to $8.3 million, respectively.

Loss from Operations: The Company reported a loss from operations of approximately $12.4 million for the year ended December 31, 2025, compared to $14.4 million for the prior year. The $2 million decrease consisted primarily of significant decreases in R&D expenses (as described above).

Net Loss: The Company reported a net loss of approximately $28.4 million for the year ended December 31, 2025, compared to $13.2 million for the prior year. The $15.2 million increase consisted almost entirely of a non-cash expense resulting from the change in fair value of additional investment rights connected to the Company’s Series L Preferred Stock during the year.

(Press release, GT Biopharma, MAR 2, 2026, View Source [SID1234663200])

On March 2, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), reported a targeted realignment of its R&D portfolio to reinforce execution of its previously announced 2026-2028 strategic plan. The Company will pause development of OSE‑230, allowing OSE to focus its resources on late‑stage, high‑potential assets lusvertikimab (OSE‑127) and Tedopi. These two assets are expected to generate multiple clinical catalysts over the next three years.

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At the same time, Boehringer Ingelheim has decided to discontinue BI 770371 in MASH following completion of an exploratory Phase 2 study that did not demonstrate efficacy in this indication. The treatment was well tolerated with a manageable safety profile, and this indication‑specific decision does not affect the molecule’s ongoing oncology development, where multiple Phase 1 studies continue as planned.

Marc Le Bozec, Chief Executive Officer of OSE Immunotherapeutics, commented: "These decisions mark a disciplined evolution of our portfolio. By stepping away from selected early‑stage programs which were not expected to generate meaningful value inflection points over our three-year strategic program, we are concentrating our resources where OSE can create the greatest value in the near term. This strengthened focus enhances our ability to deliver late‑stage clinical progress, secure meaningful partnerships, and accelerate Tedopi and lusvertikimab, the cornerstone assets of our 2026–2028 roadmap. In parallel, the Company continues to actively assess financing options to fully support the progression of its late‑stage clinical portfolio."

OSE‑230: Strategic Focus on Near‑Term Value

OSE Immunotherapeutics has decided to pause OSE‑230 as part of its ongoing portfolio prioritization and disciplined capital allocation strategy. This decision, following an amendment to the collaboration agreement with the development partner in December 2025, reflects the Company’s focus on advancing its most mature clinical programs and near‑term value drivers. OSE Immunotherapeutics will continue to assess opportunities to maximize value across its broader pipeline.

BI 770371: Partner‑Led Realignment, Focus on Oncology

Although BI 770371 was well tolerated with a manageable safety profile, Boehringer Ingelheim has decided to discontinue development of BI 770371 for people with liver cirrhosis caused by MASH after an exploratory Phase 2 study (NCT06675929) did not demonstrate efficacy to support further development in this indication.

This MASH decision does not impact BI 770371’s ongoing oncology development, which was the initial and lead program of the OSE and Boehringer Ingelheim collaboration, where the mechanism of action is distinct and multiple Phase 1 programs remain active and progressing as planned.

Additional Pipeline Prioritization

As part of the Company’s ongoing portfolio streamlining, OSE will also discontinue exploratory research activities related to the CLEC‑1 programme in oncology, an early myeloid checkpoint target still at preclinical stage. While scientifically promising, CLEC‑1 in oncology does not fall within the Company’s immediate clinical or partnership priorities. This decision further aligns OSE’s portfolio with its late‑stage value creation strategy.

Expected Value Inflection Points over OSE’s three-year strategic plan (2026-2028)

On January 29, 20261, OSE announced the selection of chronic pouchitis and hidradenitis suppurativa (HS) as the next potential targeted indications for lusvertikimab (OSE‑127), based on strong IL‑7R‑driven biological rationale. In parallel, the Company is developing a subcutaneous formulation to advance lusvertikimab in ulcerative colitis (UC) and completing the Tedopi Phase 3 in NSCLC.

This 2026-2028 strategic plan comes with significant expected value inflection points, including2:

Q2 2026: Tedopi Ovarian Cancer Investigator Sponsored Trial Phase 2 read-out
Q3 2026: Tedopi NSCLC Pivotal Phase 3 interim futility analysis
H2 2026: Tedopi 2L NSCLC combo Investigator Sponsored Trial Phase 2 read-out
H1 2027: Lusvertikimab sub-cutaneous formulation readiness
H2 2027: Possible start of Ulcerative Colitis Phase 2b/3
Q1 2028: Tedopi NSCLC Pivotal Phase 3 read-out
2028: Lusvertikimab 1st Phase 2 read-out in pouchitis or hidradenitis suppurativa.

(Press release, OSE Immunotherapeutics, MAR 2, 2026, View Source [SID1234663199])

On March 2, 2026 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the pricing of its underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $1.50 per share for aggregate gross proceeds of $30 million, prior to deducting underwriting discounts and other offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 3,000,000 shares of common stock at the public offering price per share, less the underwriting discounts to cover over-allotments, if any. The offering is expected to close on March 4, 2026, subject to satisfaction of customary closing conditions.

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The offering was structured as a straightforward common stock only investment with no warrant coverage and was led by healthcare-dedicated investors alongside existing shareholders.

Konik Capital Partners, LLC, a division of T.R. Winston & Company is acting as the sole book-running manager for the offering.

MAIA intends to use the net proceeds from the offering to conduct clinical trials and for working capital and general corporate purposes.

The securities described above are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-273984), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2023, and declared effective on August 23, 2023.

The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement.. A prospectus supplement describing the terms of the public offering will be filed with the SEC and will form a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at View Source or by contacting Konik Capital Partners LLC, a division of T.R. Winston & Company, at 7 World Trade Center, 46th Floor, New York, NY 10007, Attention: Capital Markets Team, Email: [email protected].

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

(Press release, MAIA Biotechnology, MAR 2, 2026, View Source [SID1234663198])

On March 2, 2026 Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. ("Protagonist") (NASDAQ:PTGX) reported that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. In addition to Priority Review, rusfertide has received Breakthrough Therapy designation, Orphan Drug designation and Fast Track designation from the U.S. FDA.

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PV is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms.

"There is an urgent need for innovative treatment options in polycythemia vera, where patients currently face limited therapeutic choices to control their hematocrit and significant symptom burden," said Andy Plump, M.D., Ph.D., president of R&D at Takeda. "The FDA’s acceptance of our NDA brings us closer to potentially offering a first-in-class therapy that could meaningfully improve clinical outcomes and quality of life. This milestone is a reflection of our successful partnership with Protagonist and Takeda’s unwavering commitment to advancing innovative treatments in hematologic cancers where significant unmet needs persist."

The NDA for rusfertide was primarily based on the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized VERIFY study (NCT05210790), as well as four-year efficacy and safety data from the Phase 2 REVIVE study (NCT04057040) and long-term extension THRIVE study (NCT06033586). In the VERIFY study, rusfertide met the primary endpoint and all four key secondary endpoints. Patients receiving rusfertide plus current standard of care demonstrated a higher response rate compared to current standard of care. This included hematocrit control, a reduction in phlebotomy requirements and improvement in pre-specified patient reported outcomes of fatigue and symptom burden. Rusfertide was generally well-tolerated through 52 weeks of treatment. The most common treatment-emergent adverse events (AEs) in rusfertide-treated patients were injection site reactions (47.4%), anemia (25.6%) and fatigue (19.6%), which were mainly grade 1 or 2. Serious AEs occurred in 8.1% of overall rusfertide-treated patients.

"Rusfertide exemplifies Protagonist’s end-to-end expertise, from exploring a novel hepcidin mimetic mechanism to address unmet needs in polycythemia vera to discovering the peptide and driving its clinical development through NDA filing. We are very pleased with the FDA granting rusfertide Priority Review and look forward to its potential approval in 2026," said Dinesh V. Patel, Ph.D., Protagonist President and CEO. "We have identified a great partner in Takeda as rusfertide progresses toward this milestone, thereby bringing a successful closure to our more than decade-long journey from concept-to-commercialization."

In January 2024, Protagonist and Takeda entered into a worldwide license and collaboration agreement for rusfertide. Protagonist discovered rusfertide and led its development through Phase 3 studies, with Takeda responsible for implementing the regulatory strategy for the U.S. NDA filing and for leading any future global regulatory filings. Protagonist holds an option to co-commercialize in the U.S. through a 50/50 profit and loss share structure or to opt-out of this structure, providing Takeda with a worldwide license pursuant to the license and collaboration agreement.

About Rusfertide
Rusfertide is a first-in-class investigational subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and red blood cell production. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, rusfertide aims to reduce excess red blood cell production and help patients achieve sustained hematocrit control. Rusfertide is administered once weekly via subcutaneous self-injection and has been generally well-tolerated in clinical trials to date.

About VERIFY
The Phase 3 VERIFY study (NCT05210790) is an ongoing, three-part, global, randomized, placebo-controlled study evaluating rusfertide in 293 patients with polycythemia vera over a 156-week period, with treatment extension for participants who are continuing to derive benefit from rusfertide beyond the 156-week treatment period. The study is evaluating the efficacy and safety of once-weekly, subcutaneously self-administered rusfertide in patients with uncontrolled hematocrit who are phlebotomy-dependent despite current standard of care treatment, which could include phlebotomy, hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study was the proportion of patients achieving a response during Weeks 20-32, which was defined as the absence of "phlebotomy eligibility." To meet phlebotomy eligibility, patients in the study were required to have: confirmed hematocrit ≥45% that was ≥3% higher than their baseline hematocrit value, or hematocrit ≥48%.

All patients have completed their participation in the randomized, placebo-controlled portion of the study evaluating the efficacy and safety of rusfertide plus current standard of care versus placebo plus current standard of care and are now in the open-label portions of the study.

About REVIVE and THRIVE
The Phase 2 REVIVE study (NCT04057040) evaluated rusfertide in adult patients with polycythemia vera and consisted of three parts, including 70 patients in the dose-finding Part 1 (28 weeks), 59 patients in the blinded, placebo-controlled, randomized withdrawal Part 2 (13 weeks) and 58 patients in the Part 3 open-label expansion (52 weeks). The THRIVE study (NCT06033586) is an ongoing, open-label extension study evaluating the long-term durability of response and safety profile of rusfertide in patients with polycythemia vera. The study includes 46 patients who previously participated in REVIVE. Patients eligible to transition to the THRIVE study completed the open-label extension portion of REVIVE, ≥12 months of rusfertide therapy and had an end-of-treatment visit. THRIVE is designed to further assess the maintenance of hematocrit control, reduction in the need for therapeutic phlebotomy and overall safety of once-weekly, subcutaneous rusfertide over an additional two-year treatment period.

About Polycythemia Vera (PV)
Polycythemia vera (PV) is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, difficulty in concentrating, night sweats and pruritus.

(Press release, Takeda, MAR 2, 2026, View Source [SID1234663197])

On March 2, 2026 Rallybio Corporation (Nasdaq: RLYB) ("Rallybio") and Candid Therapeutics, Inc. ("Candid"), a global clinical-stage biotechnology company advancing a leading portfolio of T-cell engager ("TCE") therapeutics for autoimmune diseases, reported that they have entered into a definitive agreement pursuant to which Rallybio will acquire Candid through a merger transaction (the "Merger"). Upon completion of the Merger, the combined company expects to operate under the name Candid Therapeutics, Inc. and trade on Nasdaq under the ticker symbol "CDRX".

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In connection with the Merger, Candid entered into subscription agreements for a concurrent oversubscribed and upsized private financing of over $505 million in gross proceeds (the "Financing" and, together with the Merger, the "Transaction") with a syndicate of leading healthcare institutional investors and mutual funds, including Venrock Healthcare Capital Partners, RA Capital Management, Janus Henderson Investors, accounts advised by T. Rowe Price Associates, Inc., venBio Partners, Viking Global Investors, Cormorant Asset Management, Foresite Capital, Soleus Capital, TCGX, Vivo Capital, a life sciences focused institutional investor, several additional mutual funds and other institutional investors. The combined company’s cash balance at closing is expected to fund operations through 2030, supporting the advancement of Candid’s diversified pipeline of TCE programs through multiple clinical milestones, including the initiation and clinical readouts of Phase 2 studies for cizutamig, a B-cell maturation antigen ("BCMA") targeting TCE, in myasthenia gravis and interstitial lung disease ("ILD") secondary to rheumatological diseases.

The Transaction has been unanimously approved by the boards of directors of both companies and is expected to close in mid-2026, subject to certain closing conditions, including the approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the Securities and Exchange Commission (the "SEC") to register the shares of Rallybio common stock to be issued in connection with the Transaction, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the satisfaction of other customary closing conditions. Following closing, pre-Transaction Rallybio equityholders are expected to own approximately 3.65% of the combined company, and pre-Transaction Candid equityholders (inclusive of investors participating in the Financing) are expected to own approximately 96.35% of the combined company, calculated on a treasury stock method basis and assuming Rallybio has net cash at closing of $37.5 million. In addition, pre-closing Rallybio stockholders will receive contingent value rights ("CVRs") entitling them to a portion of certain cash proceeds received by the combined company from its previously announced sale of interests in REV102 and potential disposition of Rallybio’s other legacy assets.

Transaction Highlights

One of the most advanced and diversified TCE pipelines in autoimmune disease, providing significant optionality: Candid has built a leading portfolio of TCE therapeutics for autoimmune disease spanning a wide spectrum of B-cell and plasma cell targets with ongoing clinical studies in over 10 indications:
Cizutamig, a BCMA TCE: Cizutamig has the potential to be the first- and best-in-class BCMA TCE for autoimmune disease, with 87 total patients dosed including 47 autoimmune patients across multiple indications. Cizutamig has demonstrated favorable tolerability with low rates of mild cytokine release syndrome ("CRS"). Emerging clinical data suggest deeper therapeutic activity with less frequent dosing than the anti-FcRn drug class. Global Phase 2 studies in myasthenia gravis and ILD are planned to initiate in 2026.
Potentially best-in-class profile TCEs against CD19 and/or CD20: CND261, a CD20 TCE, has been dosed in over 100 patients across oncology and autoimmune indications, with low rates of CRS and early evidence of deep tissue B-cell depletion. CND319, a dual targeting CD19 and CD20 TCE, has demonstrated a promising therapeutic index profile in non-human primate studies, with first-in-human studies planned for mid-2026.
Additional preclinical programs, including a dual targeting BCMA and CD19 TCE, are also part of the pipeline.
Well-capitalized to execute: Pro-forma cash of approximately $700 million at closing is expected to provide the combined company with a strong financial foundation to advance its pipeline through multiple value-creating milestones.
Experienced leadership team: The combined company will be led by Dr. Ken Song, Chairman, President and CEO of Candid, with a management team that brings deep expertise in autoimmune drug development, TCE biology, and global clinical operations.
Dr. Ken Song, M.D., Chairman, President and Chief Executive Officer of Candid Therapeutics, said: "This transaction marks an exciting moment for Candid as we lead the development of TCEs for patients with autoimmune diseases. By combining with Rallybio and securing over $505 million in new financing from a distinguished group of healthcare investors, we have the resources to advance what we view as a transformative therapeutic modality. With Phase 2 studies planned for cizutamig in 2026 and a rich pipeline of next-generation TCE programs, we will continue to push forward this new drug class."

Dr. Stephen Uden, M.D., Co-Founder and Chief Executive Officer of Rallybio, said: "We are pleased to announce this transaction, which we believe represents a compelling opportunity for Rallybio stockholders to participate in the future value creation of a well-capitalized, clinical-stage company with a differentiated and broad portfolio of TCE drug candidates. Candid’s clinical data in myasthenia gravis and across its autoimmune pipeline, combined with the strong endorsement of leading healthcare investors further substantiates the merit of this transaction."

About the Proposed Transactions

Under the terms of the merger agreement, Rallybio will acquire Candid pursuant to the Merger. At closing, Candid stockholders will receive newly issued shares of Rallybio common stock, with the exchange ratio to be determined based on the relative valuations of the two companies at closing. Immediately following closing, the combined company will change its name to Candid Therapeutics, Inc. and trade on Nasdaq under the ticker symbol "CDRX".

In connection with the Transaction, a syndicate of leading healthcare institutional investors and mutual funds has committed to invest over $505 million in a concurrent private financing in Candid. The Financing is expected to close immediately prior to the Merger. In connection with the Transaction certain stockholders of Candid and Rallybio have executed support agreements, pursuant to which they have agreed to vote all their shares of capital stock in favor of the Transaction.

Wedbush Securities Inc. is serving as financial advisor and Cooley LLP is serving as legal counsel to Candid. Evercore is serving as lead financial advisor, Citizens Capital Markets & Advisory is serving as co-financial advisor, and Ropes & Gray LLP is serving as legal counsel to Rallybio. Jefferies, BofA Securities, TD Cowen and Cantor Fitzgerald are serving as placement agents for the concurrent private financing. Latham & Watkins LLP is serving as legal counsel to the placement agents.

Conference Call Information

Rallybio and Candid will host a joint conference call and webcast on March 2, 2026 at 8:30 AM ET. Please access the presentation by clicking on the following link: View Source

(Press release, Candid Therapeutics, MAR 2, 2026, View Source [SID1234663196])