Clinical Development - The company is advancing RLYB116, a C5 inhibitor, which has completed two Phase 1 clinical trials demonstrating significant tolerability improvements and sustained inhibition of terminal complement[27][28] - RLYB332, a long-acting MTP-2 antibody for treating iron overload diseases, is in preclinical development and aims to address significant unmet needs in patients with severe anemia[31] - RLYB116 has shown significant improvement in tolerability and complete inhibition of terminal complement in Phase 1 clinical trials[50] - RLYB116 levels exceed C5 by a ratio greater than 2:1 within 12 hours of a 300mg dose, administered once weekly[56] - Non-clinical studies of RLYB332 demonstrated favorable tolerability and sustained pharmacodynamic effects, supporting its development[61] Strategic Alliances and Collaborations - The company has entered into a strategic alliance with AbCellera to co-develop up to five rare disease therapeutic targets, focusing on unmet needs in rare metabolic diseases[33] - A strategic alliance with AbCellera aims to discover and commercialize novel antibody-based therapeutics for rare diseases[62] - The company has entered into a Product License Agreement (PLA) with Affibody, granting non-exclusive and exclusive rights for the use of Affibody ligands for human therapeutic use[78] - The company has a collaboration agreement with Johnson & Johnson, which includes an upfront payment of $0.5 million and potential additional payments based on study triggers[98] Financial Aspects and Market Opportunities - Concurrent financing related to the merger includes a commitment of approximately $505.5 million from investors for shares of Candid common stock[19] - The company received $20.0 million from the sale of its interest in the ENPP1 program, including $7.5 million upfront and $12.5 million from a milestone payment[32] - The company estimates over 25,000 cases of immune platelet transfusion refractoriness (PTR) annually in the U.S. and major markets, highlighting a substantial market opportunity[39] - Current treatments for PTR are expensive and challenging, indicating a need for more accessible and effective solutions[40] Merger and Acquisition Details - The merger with Candid is expected to result in pre-Merger equityholders of Candid owning approximately 57.55% of the combined company, while Rallybio's pre-Merger equityholders will own about 3.65%[21] - The proposed merger with Candid could result in a termination fee of $1.425 million and expense reimbursement of up to $500,000 if not completed[210] - Following the merger, existing securityholders of the company are expected to own approximately 3.65% of the combined company, while former Candid securityholders are expected to own approximately 96.35%[213] - The merger is contingent on satisfying specific conditions, and failure to meet these could adversely affect the company's operations and stock price[209] - The company is subject to significant transaction costs related to the merger, regardless of its completion[215] Regulatory Compliance and Approval Processes - Regulatory compliance is critical, as failure to meet FDA requirements may result in delays or refusal of product approvals[105] - The FDA application fee for submitting an NDA or BLA for fiscal year 2025 is approximately $4.3 million, with an annual program fee exceeding $403,000 per program[117] - The FDA conducts a preliminary review of all NDAs and BLAs within 60 days of receipt and informs the sponsor by the 74th day whether the application is sufficiently complete for substantive review[118] - The FDA has ten months to complete its initial review of a standard application and six months for priority review applications, with possible extensions of three additional months[119] - The approval process for an NDA or BLA can result in either an approval letter or a Complete Response Letter (CRL), with the latter outlining deficiencies that must be addressed for reconsideration[123] Market and Pricing Dynamics - The downward pressure on healthcare costs has led to increased barriers for new product entry, with significant scrutiny on pricing and reimbursement levels[193] - Third-party payors in the U.S. are increasingly challenging the price and cost-effectiveness of biopharmaceutical products, leading to uncertainty in coverage and reimbursement[189] - In some foreign countries, drug pricing must be approved before marketing, with requirements varying widely and potentially impacting demand[190] Manufacturing and Production - The company relies on third-party contract manufacturers for the production of product candidates, with no current plans to establish internal manufacturing facilities[100] - The company has enhanced the manufacturing process of RLYB116 to improve tolerability and increase dosage[46] - The FDA requires compliance with cGMP regulations for manufacturing, which includes quality control and assurance measures[137] Employment and Operational Structure - As of December 31, 2025, the company employed 14 full-time employees, with 7 engaged in new product sourcing and 7 in administrative functions[204] - The company is winding down general and administrative operations not needed post-merger while continuing limited R&D to maximize the potential value of contingent value rights (CVRs)[34] Risks and Challenges - The company is at risk of losing key personnel during the merger process, which could impact its operations[212] - The completion of the merger is uncertain, and any material adverse changes could negatively impact the stock price of the combined entity[216] - The company may face fines, product recalls, and operational restrictions if it fails to comply with foreign regulatory requirements[187]

Core Viewpoint - Kahn Swick & Foti, LLC is investigating the proposed merger of Rallybio Corporation and Candid Therapeutics, focusing on the fairness and adequacy of the merger process for Rallybio shareholders [1] Company Overview - Rallybio Corporation (NasdaqCM: RLYB) is set to merge with Candid Therapeutics, Inc. [1] - Upon completion of the merger, Rallybio shareholders are expected to own approximately 3.65% of the combined entity [1] Legal Investigation - Kahn Swick & Foti, LLC, led by former Louisiana Attorney General Charles C. Foti, Jr., is assessing whether the merger process and terms are fair to Rallybio shareholders [1] - The firm is open to discussions regarding legal rights related to the proposed transaction, providing contact information for inquiries [1]

PresentationGood morning, and welcome to the Rallybio Corporation conference call to discuss the merger of Rallybio and Candid Therapeutics. It is now my pleasure to turn the call over to Dr. Stephen Uden, Co-Founder and CEO of Rallybio.Steve UdenCo-Founder, President, CEO & Director Thank you, and good morning. Before we begin, I'd like to remind you that this discussion will contain forward-looking statements based upon the current expectations of Rallybio and Candid, which include, but are not limited to ...

Core Viewpoint - Rallybio Corporation is experiencing a significant increase in share price following the announcement of a merger agreement with Candid Therapeutics Inc, which is expected to enhance its portfolio of T-cell engager therapeutics for autoimmune diseases [1][4] Merger Details - The merger will involve Rallybio acquiring Candid, which has raised over $505 million in financing from prominent healthcare institutional investors [2] - The combined company is projected to have pro-forma cash of approximately $700 million, providing a robust financial foundation to support operations through 2030 and advance multiple clinical milestones, including Phase 2 studies for T-cell engager programs [2] - The transaction is expected to close in mid-2026, subject to stockholder approval and regulatory conditions [3] - Post-merger, Rallybio equityholders will own about 3.65% of the combined entity, while Candid equityholders will hold approximately 96.35% [3] - The new entity will operate under the name Candid Therapeutics and trade on Nasdaq with the ticker symbol "CDRX" [3] Market Context - The broader market saw declines, with the Nasdaq down 1.40% and the S&P 500 falling 1.07%, indicating that Rallybio's stock gains are driven by company-specific news rather than overall market trends [4] - Rallybio shares rose by 29.05% to $9.73, reaching a new 52-week high according to Benzinga Pro data [4]

NEW YORK--(BUSINESS WIRE)--Halper Sadeh LLC, an investor rights law firm, is investigating the merger of Rallybio Corporation (NASDAQ: RLYB) and Candid Therapeutics, Inc. Upon completion of the proposed transaction, Rallybio shareholders are expected to own approximately 3.65% of the combined company. Halper Sadeh encourages Rallybio shareholders to click here to learn more about their rights and options or contact Daniel Sadeh or Zachary Halper free of charge at (212) 763-0060 or sadeh@halpers. ...

Rallybio (NasdaqGS:RLYB) M&A announcement March 02, 2026 08:03 AM ET Company ParticipantsKen Song - Chairman, President, and CEOStephen Uden - Co-Founder and CEOOperatorGood morning, welcome to the Rallybio Corporation Conference Call to discuss the merger of Rallybio and Candid Therapeutics. It is now my pleasure to turn the call over to Dr. Stephen Uden, Co-Founder and CEO of Rallybio.Stephen UdenThank you, and good morning. Before we begin, I'd like to remind you that this discussion will contain forward ...

Core Insights - The biotech industry experienced significant developments this week, including FDA approvals, clinical trial results, and licensing agreements, indicating a dynamic landscape for investment opportunities and advancements in healthcare [1]. FDA Approvals & Rejections - NRx Pharmaceuticals is on track for FDA approval of NRX-100, with existing clinical data and real-world evidence from over 65,000 patients potentially supporting a New Drug Application (NDA) under Fast Track Designation [2][3]. - Kane Biotech received FDA clearance for its Revyve Antimicrobial Skin and Wound Cleanser, which targets wound bacteria and biofilms, with plans for manufacturing scale-up in 2026 [4][5]. - Johnson & Johnson's RYBREVANT FASPRO received FDA approval for a simplified monthly dosing schedule, enhancing treatment options for patients with advanced non-small cell lung cancer [6][7]. - Spruce Biosciences reported positive feedback from FDA Type B meetings for its enzyme replacement therapy for Sanfilippo syndrome type B, with a targeted BLA filing in Q4 2026 [8][9]. - Moderna's seasonal influenza vaccine submission (mRNA-1010) is under FDA review, with a PDUFA date set for August 5, 2026, aiming for availability in the 2026/2027 flu season [10][11]. - Disc Medicine received a Complete Response Letter (CRL) for its NDA for Biopertin in erythropoietic protoporphyria, citing insufficient correlation with sunlight exposure endpoints [13][14]. - AbbVie and Genentech's combination regimen of VENCLEXTA and Acalabrutinib for chronic lymphocytic leukemia (CLL) received FDA approval, showing a 35% reduction in disease progression risk compared to standard treatment [15][16]. Deals - Theriva Biologics entered an exclusive licensing agreement with Rasayana Therapeutics for SYN-020, receiving a $3 million upfront payment and potential milestone payments totaling up to $38 million [17][18]. - Sensei Biotherapeutics acquired Faeth Therapeutics, expanding its oncology portfolio with the investigational asset PIKTOR, and announced a concurrent private placement of $200 million to advance clinical milestones [19][20]. Clinical Trials - Breakthroughs - Eli Lilly's Taltz and Zepbound combination therapy showed positive results in a Phase 3 trial for plaque psoriasis and obesity, achieving superior outcomes compared to Taltz alone [21][22]. - Zealand Pharma reported positive Phase 1a results for ZP9830, a Kv1.3 channel blocker, demonstrating safety and tolerability in healthy volunteers [23][24]. - Novartis' Remibrutinib met primary endpoints in a Phase 3 trial for chronic inducible urticaria, showing significant response rates compared to placebo [26][27]. - Ocular Therapeutix's AXPAXLI demonstrated superiority over aflibercept in a Phase 3 trial for wet age-related macular degeneration, although stock prices fell due to investor disappointment [28][29]. - Rallybio's RLYB116 Phase 1 study showed promising results for immune platelet transfusion refractoriness, with plans for a Phase 2 trial in 2026 [31][32]. - Teva and Sanofi's Duvakitug Phase 2b trial demonstrated durable efficacy in ulcerative colitis and Crohn's disease, reinforcing the rationale for ongoing Phase 3 programs [35][36]. - Genentech's Gazyva met primary endpoints in a Phase III study for primary membranous nephropathy, showing significant remission rates compared to tacrolimus [38][39].

Group 1: Clinical Trial Results - The Phase 1 study results for RLYB116 demonstrated complete and sustained inhibition of terminal complement at a 300 mg dose, with a safety profile consistent with other subcutaneous biologics [2] - RLYB116 showed promising pharmacokinetic and pharmacodynamic results, indicating clinically effective blockade of terminal complement [2] - RLYB116 administered at 150 mg and 300 mg once a week was well tolerated, with no gastrointestinal side effects reported among participants [3] Group 2: Future Plans - Rallybio plans to initiate a Phase 2 clinical trial for immune platelet transfusion refractoriness in the second half of 2026, with topline data expected in 2027 [4] Group 3: Technical Analysis - Rallybio is currently trading 4.5% below its 20-day simple moving average (SMA) and 8.2% below its 100-day SMA, indicating bearish momentum in the short to medium term [5] - Shares have decreased 17.97% over the past 12 months and are positioned closer to their 52-week lows than highs [5] - The combination of neutral RSI and bearish MACD indicates mixed momentum for Rallybio, reflecting uncertainty in the stock's near-term direction [6] Group 4: Sector Performance - Rallybio is part of the healthcare sector, which is currently ranked 5 out of 11 sectors, reflecting mid-tier performance [7] - The healthcare sector has seen a modest increase of 1.46% over the past 30 days and a rise of 3.51% over the last 90 days, highlighting that Rallybio's recent performance has not mirrored this trend [7] Group 5: Market Position - According to Benzinga Edge, Rallybio's momentum is weak, with a score of 17.09, indicating underperformance compared to the broader market [8] - Rallybio shares were down 6.64% at $4.50 at the time of publication [8] - Key resistance for the stock is at $5.50, while key support is at $4.50 [9]

Summary of Rallybio Corporation 2026 Special Meeting of Stockholders Company Overview - **Company**: Rallybio Corporation - **Ticker**: NasdaqGS:RLYB - **Meeting Date**: January 26, 2026 Key Points Meeting Structure and Attendance - The special meeting was hosted virtually for stockholders, with rules of procedure accessible via a web portal [2] - Only stockholders of record as of December 30, 2025, were allowed to ask questions and vote [3] - A total of **42,243,777 shares** of common stock were outstanding and entitled to vote [4] - **34,983,474 votes** were represented at the meeting, equating to approximately **82.81%** of the voting power, confirming a quorum [5] Proposals Presented - **Proposal One**: Approval of an amendment to the Amended and Restated Certificate of Incorporation for a Reverse Stock Split at a ratio ranging from **1-for-5** to **1-for-20**, to be selected by the Board of Directors [6] - **Proposal Two**: Consideration of any other business that may properly come before the meeting [6] Voting Process - Stockholders had the opportunity to vote via a web portal, with instructions provided for those wishing to change their votes [7] - Preliminary results indicated a majority of shares voted in favor of Proposal One, with final results to be reported in a Form 8-K within four business days [7] Conclusion of Meeting - The meeting was adjourned with appreciation expressed to stockholders for their attendance [9] - The meeting concluded without further business [10] Additional Insights - The focus on a reverse stock split suggests a strategic move by Rallybio to potentially enhance its stock price and market perception, which may be critical for future financing or investment opportunities [6]

Financial Performance - Total revenue for Q3 2025 was $212,000, a decrease of 29.1% compared to $299,000 in Q3 2024[18] - Net income for Q3 2025 was $16,016,000, compared to a net loss of $11,466,000 in Q3 2024[18] - The company reported a comprehensive gain of $16,023,000 for Q3 2025, compared to a comprehensive loss of $11,226,000 in Q3 2024[18] - For the three months ended September 30, 2025, the company reported a net income of $16,016,000 compared to a net loss of $11,466,000 for the same period in 2024, resulting in a basic net income per share of $0.36 versus a loss of $0.26[62] - Total revenue for the three months ended September 30, 2025, was $212,000, a decrease from $299,000 in the same period of 2024, while total revenue for the nine months ended September 30, 2025, increased to $636,000 from $598,000 in 2024[65] - For the nine months ended September 30, 2025, total revenue was $0.6 million, slightly up from $0.6 million in 2024, indicating a marginal increase of 6.3%[125] Expenses and Cost Management - Research and development expenses for the nine months ended September 30, 2025, were $15,942,000, down 53.2% from $34,122,000 in the same period of 2024[18] - Cash flows used in operating activities for the nine months ended September 30, 2025, were $25,134,000, compared to $39,420,000 in the same period of 2024[23] - Total operating expenses for the three months ended September 30, 2025, were $7.1 million, a decrease of $5.2 million or 42.3% compared to $12.4 million in 2024[117] - Research and development expenses for the three months ended September 30, 2025, totaled $4,143,000, down from $8,240,000 in the same period of 2024[65] - General and administrative expenses decreased to $3.0 million for the three months ended September 30, 2025, compared to $4.1 million in 2024, a reduction of $1.1 million or 26.8%[121] - Research and development expenses for the nine months ended September 30, 2025, were $15.9 million, down from $34.1 million in 2024, a decrease of $18.2 million or 53.4%[126] - General and administrative expenses for the nine months ended September 30, 2025, were $11.3 million, compared to $15.4 million in 2024, a decrease of $4.0 million or 26.0%[128] Cash and Liquidity - Cash and cash equivalents increased to $32,122,000 as of September 30, 2025, from $13,903,000 at the end of 2024[15] - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $59.3 million, expected to fund operations for over 12 months[26] - The company had a net cash increase of $18,219,000 in cash and cash equivalents for the nine months ended September 30, 2025[23] - The company reported a net increase in cash and cash equivalents of $18.2 million for the nine months ended September 30, 2025[144] - The company expects its existing cash and marketable securities to be sufficient to fund operating expenses and capital expenditures through 2027[138] - The company has no ongoing material financing commitments that are expected to affect liquidity over the next five years[137] Shareholder Information - The weighted-average common shares outstanding for Q3 2025 were 45,058,591, compared to 44,593,221 in Q3 2024[18] - The company had 200 million shares of common stock authorized, with 41,935,841 shares issued and outstanding as of September 30, 2025[41] - As of September 30, 2025, the total number of shares available for future issuance under the 2021 Equity Incentive Plan was 10,367,965, with 4,108,985 shares remaining available[47] - The total number of shares available for future issuance under the 2021 Employee Stock Purchase Plan as of September 30, 2025 was 777,012 shares[53] Development Programs and Clinical Trials - The company discontinued the RLYB212 program in April 2025 due to insufficient pharmacokinetic data from the Phase 2 clinical trial[25] - RLYB116 Phase 1 clinical study demonstrated a reduction in free C5 greater than 99% within 24 hours at a 100 mg dose[85] - In the MAD portion of the study, a 100 mg weekly dose achieved sustained mean reductions in free C5 of greater than 93%[87] - RLYB116 showed a significantly cleaner safety profile in the confirmatory clinical PK/PD trial, with improved tolerability attributed to manufacturing enhancements[89] - The company is currently evaluating the impact of new accounting standards on its financial statements, including ASU 2023-09 and ASU 2024-03[34][35] - The company discontinued the development of RLYB212 due to Phase 2 clinical trial data indicating it could not achieve the required target concentrations for efficacy[188] Revenue Generation and Future Outlook - The company has not generated any revenue from product sales and relies on equity financings for funding[94][95] - The company anticipates significant additional operating losses as it advances its programs through clinical development[100] - The company expects to incur significant additional operating losses in the foreseeable future as it advances its programs[167] - The company has incurred significant operating losses since inception and may never achieve or sustain profitability[166] - The company has a limited operating history and has not yet commercialized any pharmaceutical products, making future viability difficult to evaluate[177] Risks and Challenges - The company may experience significant delays or inability to commercialize product candidates due to various factors, including regulatory requirements and clinical trial challenges[193] - The marketing approval process for product candidates is lengthy and unpredictable, with no guarantee of success[209] - Regulatory authorities may require additional testing or impose restrictions that could hinder the marketing of product candidates[213] - The company faces risks related to competition and the need to differentiate its product candidates from existing therapies[191] - Patient enrollment in rare disease clinical trials is challenging, potentially leading to increased costs and delays in product development[200]