As filed with the U.S. Securities and Exchange Commission on January 7, 2026. THE SECURITIES ACT OF 1933 Crescent Biopharma, Inc. (Exact name of registrant as specified in its charter) Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Cayman Islands 2834 06-1686563 (I.R.S. Employer Identification No.) 300 Fif ...

CR-001 IND cleared by U.S. FDA; Phase 1/2 ASCEND global clinical trial to evaluate CR-001 in first-line and previously treated patients on track to initiate in first quarter of 2026, with proof-of-concept data anticipated in first quarter of 2027 Crescent partner Kelun-Biotech receives IND approval for CR-003 (SKB105) by NMPA of China Four clinical trials across portfolio expected to initiate in 2026 WALTHAM, Mass., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (N ...

SEIZE THE MOMENT for a brighter future CRESCENT BIOPHARMA STRATEGIC PARTNERSHIP & PIPELINE UPDATE DECEMBER 4, 2025 NASDAQ: CBIO Disclaimers 2 Program Forward-Looking Statements Certain statements in this presentation, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, ...

Core Insights - Crescent Biopharma has announced a strategic partnership with Kelun-Biotech to enhance its oncology pipeline, focusing on CR-001, a PD-1 x VEGF bispecific antibody, and several antibody-drug conjugates (ADCs) [1][3][4] - The company plans to initiate clinical trials for CR-001, CR-002, and CR-003 (SKB105) in 2026, with significant data readouts expected by the end of 2027 [1][2][10] - A private placement of $185 million is set to support clinical developments and provide a cash runway into 2028 [1][16][19] Partnership Details - The partnership grants Kelun-Biotech exclusive rights to develop and commercialize CR-001 in Greater China, while Crescent retains rights for SKB105 in the U.S., Europe, and other markets [4] - Both companies can independently develop CR-001 in additional combinations, including with proprietary ADC assets [4] Pipeline Updates - CR-001 is designed to target solid tumors by blocking PD-1 and VEGF, with a Phase 1/2 trial expected to start in Q1 2026 [11][12] - CR-002 targets PD-L1 and is on track for an IND submission in mid-2026, with proof-of-concept data anticipated in late 2027 [11][19] - CR-003 (SKB105) targets integrin beta-6 and is expected to enter clinical trials in Greater China in Q1 2026, with initial data expected in Q1 2027 [11][19] Financial Overview - The private placement involves the sale of approximately 13.8 million ordinary shares at $13.41 per share, expected to close around December 8, 2025 [17][19] - The net proceeds will be used for advancing clinical development and general corporate purposes, ensuring operations are funded into 2028 [19][20] Anticipated Milestones - Key milestones include the initiation of Phase 1/2 trials for CR-001 and CR-003 in 2026, with initial combination data from CR-001 and CR-003 expected by the end of 2027 [10][14][15]

Companies to advance CR-001, a PD-1 x VEGF bispecific antibody, and SKB105, an integrin beta-6-directed antibody-drug conjugate (ADC), in global markets and China Collaboration designed to accelerate and expand the development of synergistic combinations with CR-001 and ADCs, including SKB105 CR-001 and SKB105 on track to enter Phase 1/2 monotherapy clinical trials in Q1 2026 with combination studies to follow CHENGDU, China and WALTHAM, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Sichuan Kelun-Biotech Biophar ...

Core Points - Crescent Biopharma, Inc. has granted options to purchase a total of 451,448 shares to eight non-executive employees as part of its 2025 Employment Inducement Incentive Award Plan [1] - The options have a 10-year term with an exercise price of $13.02, which is the closing price on November 14, 2025 [2] - The vesting schedule for the options includes one-fourth vesting on the first anniversary of the employee's start date, followed by monthly vesting of one-forty-eighth thereafter [2] Company Overview - Crescent Biopharma aims to become a leading oncology company focused on developing innovative therapies for cancer patients [3] - The company's pipeline features a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates (ADCs) [3] - Crescent Biopharma intends to leverage multiple modalities and established targets to advance transformative therapies for various solid tumors [3]

Product Development and Commercialization - Gyre Pharmaceuticals successfully advanced pirfenidone to commercialization in the PRC for the treatment of idiopathic pulmonary fibrosis (IPF) and is conducting an additional Phase 3 trial for pneumoconiosis, with patient enrollment completed in Q3 2025 [125]. - The company received approval for a clinical trial application for pirfenidone to treat radiation-induced lung injury, with an adaptive Phase 2/3 trial expected to initiate in Q4 2025 [125]. - Gyre Pharmaceuticals launched Etorel® in the PRC in Q2 2025, targeting systemic sclerosis-associated interstitial lung disease and progressive fibrosing interstitial lung disease, aiming to enhance market penetration and brand recognition [126]. - Contiva® was commercialized in the PRC in March 2025 for treating thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, expanding the company's product offerings [127]. - Hydronidone, a lead candidate for liver fibrosis, completed a pivotal Phase 3 trial with 248 patients, achieving a statistically significant ≥1-stage regression in liver fibrosis compared to placebo (P=0.0002) [129]. - The company plans to file a New Drug Application with the NMPA for Hydronidone and is preparing to submit a U.S. IND for a Phase 2 trial in 2026 for metabolic dysfunction-associated steatohepatitis-related liver fibrosis [130]. - Gyre Pharmaceuticals is currently enrolling patients in a Phase 2 trial for F573, a caspase inhibitor for acute liver failure, and has initiated a Phase 1 trial for F230, a selective endothelin receptor agonist for pulmonary arterial hypertension [131]. Financial Performance - For the three months ended September 30, 2025, the company reported revenues of $30.6 million, a 20% increase from $25.5 million in the same period of 2024, driven by sales growth in ETUARY®, Contiva®, and Etorel® [160]. - The net income for the three months ended September 30, 2025, was $5.9 million, representing a 108% increase compared to $2.9 million in the same period of 2024 [159]. - The cost of revenues increased by 70% to $1.6 million for the three months ended September 30, 2025, up from $1.0 million in 2024, primarily due to higher production costs and increased sales [161]. - Selling and marketing expenses rose by 12% to $15.3 million for the three months ended September 30, 2025, compared to $13.7 million in 2024, attributed to higher payroll and promotional costs [162]. - Research and development expenses decreased by 15% to $2.4 million for the three months ended September 30, 2025, down from $2.8 million in 2024, mainly due to reduced clinical trial costs [164]. - The company had an accumulated deficit of $66.7 million as of September 30, 2025, compared to $73.5 million as of December 31, 2024 [144]. - Revenues for the nine months ended September 30, 2025, were $79.4 million, a 2% increase from $77.9 million in 2024, driven by new product sales of Contiva® and Etorel® [171]. - Cost of revenues increased by $1.0 million, or 36%, to $3.7 million for the nine months ended September 30, 2025, primarily due to higher costs associated with Etorel® and Contiva® [173]. - Research and development expenses rose by $0.6 million, or 7%, to $8.9 million, mainly due to a $1.0 million increase in clinical trial costs [175]. - General and administrative expenses increased by $3.5 million, or 32%, to $14.1 million, driven by higher personnel and stock compensation costs [176]. - Net income attributable to common stockholders decreased by $5.4 million, or 45%, to $6.8 million for the nine months ended September 30, 2025 [170]. - Cash provided by operating activities was $6.6 million for the nine months ended September 30, 2025, compared to cash used of $0.9 million in 2024 [186]. - Cash provided by financing activities was $24.1 million, primarily from the issuance of common stock, for the nine months ended September 30, 2025 [191]. - The company expects continued revenue growth driven by the commercialization of Etorel® and Contiva® in 2025, alongside the growth of ETUARY® sales [160]. - The provision for income taxes increased to $1.7 million for the three months ended September 30, 2025, from $1.1 million in 2024, reflecting higher profits from operations [168]. - Other income for the three months ended September 30, 2025, was $0.7 million, compared to an expense of $0.1 million in 2024, primarily due to increased government grants [167]. Investments and Financing - On October 30, 2023, Catalyst Biosciences acquired an indirect controlling interest in Gyre Pharmaceuticals, increasing Gyre's indirect interest from 56.0% to 65.2% [133]. - BJC increased its capital contribution in Gyre Pharmaceuticals by $1.28 million in Q3 2025, raising Gyre's indirect interest to 69.7% [142]. - Gyre Pharmaceuticals entered into a private placement agreement with GNI USA for $5.0 million, involving the purchase of Series X Convertible Preferred Stock and warrants [140]. Future Commitments and Plans - The company expects revenue growth driven by the continued expansion of new product franchises [172]. - As of September 30, 2025, the company had cash and cash equivalents of $40.4 million, with an accumulated deficit of $66.7 million [181]. - The company anticipates initiating a Phase 2 trial for Hydronidone in 2026, pending approval of an IND submission [182]. - The company has committed to allocate $37.6 million toward future research and development activities, including the Hydronidone program [196]. - Commitments related to the purchase of property and equipment were $4.6 million as of September 30, 2025, expected to be incurred within one year [197]. - The company is committed to annual payments for the Etorel® IP Rights transferor over eight years following the commencement of commercial sales [198]. Regulatory and Reporting Status - There have been no significant changes to critical accounting policies and estimates compared to the previous Annual Report [199]. - The company qualifies as a "smaller reporting company" and can take advantage of scaled disclosures as long as certain market value and revenue thresholds are met [200]. - As of June 30, 2025, the company remains a smaller reporting company and continues to qualify as an "accelerated filer" under the Sarbanes-Oxley Act [201]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company [203].

Financial Performance - Net income for Q3 2025 was $5.9 million, doubling from $2.9 million in Q3 2024[20] - Basic EPS improved to $0.04 in Q3 2025, compared to $0.01 in Q3 2024[4] - Net income for the nine months ended September 30, 2025, was $11.2 million, a decrease from $17.3 million in 2024, primarily due to a $5.6 million increase in operating expenses[6] - Non-GAAP adjusted net income for the nine months ended September 30, 2025, was $14.6 million, down from $15.7 million in 2024, mainly due to a $3.3 million increase in operating expenses[6] - Non-GAAP adjusted net income for the nine months ended September 30, 2025, was $14,618 million, slightly down from $15,737 million in the same period of 2024, reflecting a decrease of 7.1%[39] Revenue and Sales - Quarterly revenue reached $30.6 million, a 20% increase year-over-year, driven by growth in ETUARY® and contributions from Etorel® and Contiva®[4] - Sales of ETUARY® for Q3 2025 were $27.7 million, compared to $25.3 million in Q3 2024[7] - Etorel® generated $1.5 million in sales during its first full quarter of launch[7] - Contiva® sales amounted to $1.2 million for Q3 2025[8] - Revenues for the nine months ended September 30, 2025, were $79.4 million, compared to $77.9 million in 2024, reflecting a $1.5 million increase[34] - Gyre Pharmaceuticals' flagship product, ETUARY®, achieved net sales of $105.8 million in 2024, maintaining a prominent market share[28] Expenses and Costs - For the nine months ended September 30, 2025, research and development expenses increased to $8.9 million from $8.3 million in 2024, primarily due to a $1.0 million rise in clinical trial costs[6] - General and administrative expenses rose to $14.1 million for the nine months ended September 30, 2025, compared to $10.6 million in 2024, driven by a $2.8 million increase in personnel and stock compensation costs[6] - Income from operations decreased to $11.4 million for the nine months ended September 30, 2025, down from $15.5 million in 2024, attributed to a $5.6 million increase in total operating expenses[6] - Stock-based compensation expenses increased to $1,147 million in Q3 2025 from $237 million in Q3 2024, marking a rise of 384%[39] Cash and Assets - Cash and cash equivalents totaled $80.3 million as of September 30, 2025, up 57% year-to-date[15] - Cash and cash equivalents increased significantly to $40.4 million as of September 30, 2025, from $11.8 million at the end of 2024[36] - Total assets grew to $159.4 million as of September 30, 2025, compared to $125.4 million at the end of 2024[36] Corporate Developments - The company completed patient enrollment in a 52-week Phase 3 trial for pirfenidone pneumoconiosis with 272 patients across 18 sites[6] - The anticipated U.S. IND filing for Hydronidone is expected in 2026, following the completion of ongoing regulatory interactions[10] - Gyre Therapeutics increased its indirect majority interest in Gyre Pharmaceuticals from 65.2% to 69.7% in Q3 2025 through additional capital contributions[28] Tax and Liabilities - Provision for income taxes for Q3 2025 was $1,693 million, compared to $1,074 million in Q3 2024, indicating an increase of 57.7%[39] - The loss from the change in fair value of warrant liability was $23 million in Q3 2025, a decrease from a gain of $228 million in Q3 2024[39]

Core Insights - Crescent Biopharma is advancing its pipeline of next-generation therapeutics for solid tumors, with significant progress expected in the coming years [2][3] Pipeline Developments - CR-001, a PD-1 x VEGF bispecific antibody, is on track for an IND submission in the fourth quarter of 2025, with a global Phase 1 trial planned to start in early 2026 [1][6] - Preclinical data for CR-001 shows cooperative pharmacology and in vivo anti-tumor activity, with initial clinical data anticipated in the second half of 2026 [2][6] - CR-002 and CR-003, novel antibody-drug conjugates (ADCs), are expected to have an IND submission in mid-2026 [4][2] Financial Performance - As of September 30, 2025, Crescent Biopharma reported a cash position of $133.3 million, which is projected to fund operations through 2027 [5][13] - Research and development expenses for Q3 2025 were $20.3 million, while general and administrative expenses were $5.5 million [5][11] - The net loss for the third quarter of 2025 was $24.6 million, equating to a loss of $1.27 per share [7][11]

Core Insights - Crescent Biopharma is focused on advancing innovative therapies for cancer patients, with a vision to become a leading oncology company [2] Company Overview - Crescent Biopharma's pipeline includes a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates (ADCs) aimed at treating various solid tumors [2] - The company utilizes multiple modalities and established targets to develop transformative therapies, either as standalone treatments or in combination regimens [2] Upcoming Events - Crescent Biopharma will present at several investor conferences in November 2025, including: - Guggenheim 2 Annual Healthcare Innovation Conference on November 11, 2025, at 8:00 a.m. ET in Boston [3] - Stifel 2025 Healthcare Conference on November 12, 2025, at 1:20 p.m. ET in New York [3] - Jefferies Global Healthcare Conference on November 19, 2025, at 9:30 a.m. GMT (4:30 a.m. ET) in London [3]