Plus Therapeutics Showcases Leptomeningeal Metastases Programs at the 2024 SNO Annual Meeting in Houston, Texas

On October 29, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that it will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24, 2024 in Houston, Texas (Press release, Plus Therapeutics, OCT 29, 2024, View Source [SID1234647492]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data presentations and symposium include:

Presentations:

Title Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the Phase 1 dose escalation study and Phase 2 administered dose selection (CTNI-63)

Presenter
Andrew Brenner, M.D., Ph.D.

Date/Time Friday, 22 November 2024, 7:30-9:30 p.m. CST

Location Hall B3

Title CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment helps in clinical management of breast cancer and Non-Small Cell Lung cancer patients having Leptomeningeal Disease (BIOM-70), (FORESEE Study, NCT05414123)

Presenter
Priya Kumthekar, M.D.

Date/Time Sunday, 24 November 2024, 10:15-11:45 a.m. CST

Location Grand Assembly B; Abstract Session – Clinical Trials – Non-Immunologic

Title The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor (BIOM-69)

Presenter
Arushi Tripathy, M.D., University of Michigan Medical School (Neurosurgery PGY-4)

Date/Time Friday, 22 November 2024, 7:30-9:30 p.m. CST

Location Hall B3

LM Educational Symposium:

The Company will be hosting an educational symposium titled, "Novel Targeted Radiotherapies to Manage Leptomeningeal Metastases" on Saturday, November 23, 2024, at 12:45pm-1:45 p.m. CST at the George R. Brown Convention Center, Room 351. Speakers include:

Priya Kumthekar, M.D., Associate Professor of Neurology and Hematology/Oncology, Northwestern University Medical School (Moderator)
Jonathan Yang, M.D., Ph.D., Associate Vice Chair for Clinical Research and Developmental Therapeutics, Department of Radiation Oncology, Director of Clinical Research, NYU Langone Health’s Perlmutter Cancer Center
Andrew Brenner, M.D., Ph.D., Professor and Kolitz / Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, Science Center at San Antonio
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe and convenient manner. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

PharmaMar Group presents its financial results as of September 30th, 2024

On October 29, 2024 PharmaMar Group reported total revenue of €126.5 million for the nine months ending September 30th, 2024, representing an 8% increase over revenue reported in the same period of the previous fiscal year (Press release, PharmaMar, OCT 29, 2024, View Source [SID1234647487]). Recurring revenue, which includes net sales plus royalties received from our partners, were €99.2 million, compared to €98.3 million as of September 30th, 2023.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oncology sales amounted to €57.0 million, compared to €59.1 million in the previous year. Total Zepzelca (lurbinectedin) sales during this period (€29.3 million) include commercial sales in Europe totalling €5.5 million, plus revenues under the compassionate use program, mainly in France, totalling €17.9 million, and sales of raw materials totalling €5.9 million. As of September 30th, 2023, total lurbinectedin revenues amounted to €32.8 million, due to the reversal of a provision for discounts that were not applied, amounting to €10.4 million. Without this accounting adjustment, lurbinectedin’s total sales in the first nine months of 2024 would have grown by approximately 30%.

Yondelis (trabectedin) sales increased in the period to €27.8 million with commercial sales in Europe of €15.7 million, along with sales of raw materials to our partners totalling €12.1 million. As of September 30th, 2023, total trabectedin sales amounted to €26.4 million. Higher sales of raw materials to our partners have offset the price impact of the entry of generics.

Meanwhile, as of September 30th, 2024, royalty revenue reached €42.2 million, representing a 10% increase compared to the same period in the previous fiscal year. This growth is driven by royalties received from our partner Jazz Pharmaceuticals for lurbinectedin sales in the U.S., which have increased by 8% to €38.4 million.

The royalties corresponding to the third quarter of 2024 are an estimate, as information on Jazz Pharmaceuticals’ sales is not available at the time of this financial report publication. Any discrepancies will be adjusted in the following quarter.

In addition to the royalties received from Jazz Pharmaceuticals up to September 30th, royalties from trabectedin sales by our partners in the U.S. and Japan totalled €3.5 million. This figure represents a 25% increase over the total royalties received in the same period of the previous year.

Regarding non-recurring income from licensing agreements, as of September 30, 2024, a total of €26.9 million was recorded, representing a 42% increase compared to the same period of the previous year. Of this total, €17.2 million corresponds to the deferred income from the 2019 agreement with Jazz Pharmaceuticals related to lurbinectedin, and €8,7 million corresponding to a payment received under the license agreement with Janssen regarding trabectedin.

R&D investment reached €76.0 million during the first nine months of 2024, an increase of 8% compared to the same period of the previous year.

Of the total R&D allocation as of September 30th, 2024, the oncology segment saw an 17% increase to €70.0 million. This increase is primarily due to progress in ongoing clinical trials, mainly the SaLuDo trial (Phase IIb/III clinical development for Leiomyosarcoma) and the LAGOON trial (Phase III clinical development for second-line treatment of Small Cell Lung Cancer). The latter trial is expected to complete recruitment by the end of 2024.

Additionally, the Company continues to invest in the clinical development of other molecules in earlier stages. In this regard, there are two ongoing Phase II clinical trials with ecubectedin in solid tumors, as well as Phase I trials with PM534 and PM54 for the treatment of solid tumors.

Thanks to increased revenue, as of September 30th, 2024, PharmaMar Group achieved an EBITDA of €6.2 million, representing a 14% growth compared to the same period of the previous year.

As a result, the Company’s net profit reached €7.4 million as of September 30th, 2024.

At the end of the quarter, PharmaMar Group reported cash and equivalents of €148.2 million and increased its debt position by €11.0 million due to a long-term bank loan of €15.0 million. Thus, following the completion in September of the share buyback program totalling €5.0 million and the dividend payment in June amounting to €11.4 million, the net cash position stands at €97.3 million.

Lastly, it is worth noting that on October 15th, 2024, PharmaMar and its partner Jazz Pharmaceuticals announced positive preliminary results from the Phase III IMforte trial, evaluating lurbinectedin in combination with atezolizumab (Tecentriq), compared to atezolizumab monotherapy as a first-line maintenance treatment for adults with Small Cell Lung Cancer. The combination of lurbinectedin and atezolizumab demonstrated a statistically significant and clinically meaningful improvement in the primary objectives of overall survival (OS) and progression-free survival (PFS) compared to atezolizumab monotherapy.

PharmaMar will submit a marketing authorization application (MAA) to the EMA in the first half of 2025 to seek approval in Europe.

Pfizer Reports Strong Third-Quarter 2024 Results And Raises 2024 Guidance

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Incyte Reports 2024 Third Quarter Financial Results and Provides Updates
on Key Clinical Programs

On October 29, 2024 Incyte (Nasdaq:INCY) reported 2024 third quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, OCT 29, 2024, View Source [SID1234647483]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the third quarter of 2024, we delivered significant achievements, including strong revenue growth for both Jakafi (ruxolitinib) and Opzelura (ruxolitinib) cream, and the advancement of our clinical pipeline highlighted by the submission to the FDA of the supplemental New Drug Application (sNDA) for ruxolitinib cream in pediatric atopic dermatitis and several key data readouts including CDK2i, retifanlimab, tafasitamab, povorcitinib and ruxolitinib cream, which all hold near to mid-term launch potential. Additionally, in August, the FDA approved Niktimvo (axatilimab-csfr) for patients with chronic graft-versus-host disease, after failure of two prior lines of therapy, making it the first anti-CSF-1R antibody approved to target the inflammation and fibrosis associated with chronic GVHD," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We are on track to achieve over ten impactful launches by 2030."

Key Recent Company Updates

•In October, the sNDA submission for ruxolitinib cream in pediatric atopic dermatitis was filed with the FDA with approval anticipated in the second half of 2025.

•In October, Opzelura was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate atopic dermatitis and nonsegmental vitiligo in patients 12 years of age and older.

•In September, Incyte presented late-breaking Phase 3 results for retifanlimab (Zynyz) and initial data from the Phase 1 CDK2 inhibitor program at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

1

◦Featured during the Presidential Symposium, the Phase 3 POD1UM-303/InterAACT2 trial for retifanlimab met the primary endpoint of progression free survival (PFS) and demonstrated improvement across secondary endpoints in patients with squamous cell anal carcinoma (SCAC) receiving retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel). Incyte plans to file a supplemental Biologics License Application (sBLA) for retifanlimab in SCAC by the end of 2024. A potential approval in 2025 could represent the first PD-(L)1 antibody for patients with SCAC.

◦Phase 1 data of INCB123667, a highly selective and potentially first-in-class CDK2 inhibitor, were presented demonstrating single-agent antitumor activity across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1. The Phase 1 trial of INCB123667 in combination with other agents is ongoing. Incyte plans to initiate a pivotal trial in ovarian cancer in 2025.

•In August, Incyte and its partner Syndax announced the U.S. Food and Drug Administration (FDA) approval of Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients. Niktimvo is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD. In September, Incyte and Syndax announced the New England Journal of Medicine publication of data from the pivotal AGAVE-201 trial of Niktimvo in chronic GVHD and the addition of Niktimvo to the NCCN Clinical Practice Guidelines in Oncology for the treatment of chronic GVHD.

•In August, Incyte announced positive topline results from the Phase 3 clinical study evaluating tafasitamab (Monjuvi) in relapsed or refractory follicular lymphoma (FL). The pivotal Phase 3 inMIND trial met the primary endpoint of PFS by investigator assessment in FL. The trial also met key secondary endpoints. No new safety signals with tafasitamab were observed. The full dataset is anticipated to be presented at an upcoming medical meeting in 2024 and Incyte expects to file an sBLA for tafasitamab in combination with lenalidomide and rituximab in FL by the end of 2024.
Jakafi:
Net product revenues for the third quarter 2024 of $741 million (+16% Y/Y):
▪Net product revenues were primarily driven by patient demand, which increased 10% in the third quarter of 2024 versus the same quarter in the prior year, with growth across all indications.
Opzelura:
Net product revenues for the third quarter 2024 of $139 million (+52% Y/Y):
▪Net product revenues of $119 million in the third quarter of 2024 in the U.S. were primarily driven by patient demand and refills in both atopic dermatitis (AD) and vitiligo.
▪Net product revenues of $20 million in the third quarter of 2024 ex-U.S. were primarily driven by sales in Germany and France.
Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
▪A bioequivalence study of ruxolitinib extended-release (XR) is enrolling. The data are anticipated in the first half of 2025.
▪A Phase 2 trial evaluating the safety and efficacy of axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD is enrolling.
▪Trials of ruxolitinib twice daily (BID) with BETi and zilurgisertib are ongoing. Additional data for BETi and zilurgisertib are anticipated in the fourth quarter of 2024.

▪The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025.
MPN and GVHD Programs Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD
Ruxolitinib + zilurgisertib
(JAK1/JAK2 + ALK2i) Myelofibrosis: Phase 2
Ruxolitinib + INCB57643
(JAK1/JAK2 + BETi) Myelofibrosis: Phase 2
Ruxolitinib + axatilimab1
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2
Steroids + axatilimab1
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3 in preparation
INCA33989
(mCALR) Myelofibrosis, essential thrombocythemia: Phase 1
INCB160058
(JAK2V617Fi) Myelofibrosis: Phase 1

1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
▪Following the announcement of the positive topline results from the Phase 3 study evaluating retifanlimab, a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in non-small cell lung cancer (NSCLC), Incyte anticipates sharing the full dataset at an upcoming medical meeting in the fourth quarter of 2024.
▪The Phase 3 study evaluating tafasitamab in first-line diffuse large B-cell lymphoma (DLBCL) is ongoing. The Phase 3 data are anticipated in the first half of 2025.
▪The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025.
Heme/Oncology Programs Indication and status
Tafasitamab (Monjuvi/Minjuvi)
(CD19)
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory follicular lymphoma (FL): Phase 3 (inMIND)
Retifanlimab (Zynyz)1
(PD-1)
Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303)
Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)
INCB123667
(CDK2i) Solid tumors with Amplification/ Overexpression of CCNE1: Phase 1
INCB161734
(KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation: Phase 1
INCA33890
(TGFßR2×PD-1)2
Advanced or metastatic solid tumors: Phase 1

1 Retifanlimab licensed from MacroGenics.
2 Development in collaboration with Merus.
3

Inflammation and Autoimmunity (IAI) – key highlights
Ruxolitinib Cream
▪In September 2024, Incyte presented multiple datasets for ruxolitinib cream at the 2024 European Academy of Dermatology and Venereology (EADV) Congress including late-breaking oral presentations for vitiligo, atopic dermatitis, hidradenitis suppurativa (HS) and lichen planus.
▪Two Phase 3 trials (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in prurigo nodularis (PN) are ongoing. The Phase 3 data are anticipated in the first half of 2025.
▪The Phase 3 trial for ruxolitinib cream in mild to moderate HS is on track to initiate in the first half of 2025 following achieving alignment on the study design with FDA. Ruxolitinib cream has the potential to provide a new therapeutic option for the approximately 150,000 mild to moderate HS patients in the U.S.
Povorcitinib (INCB54707)
▪In September 2024, Incyte presented long-term extension data at the 2024 EADV Congress from the Phase 2 randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of povorcitinib in patients with PN. In October 2024, two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib versus placebo were initiated and are enrolling.
▪The Phase 3 studies of povorcitinib in patients with hidradenitis suppurativa (STOP-HS1 and STOP-HS2) are enrolling well with data anticipated in the first quarter of 2025.
▪Two Phase 2 trials evaluating povorcitinib in asthma and chronic spontaneous urticaria (CSU) are enrolling. Data for CSU are anticipated in the first half of 2025 and data in asthma are anticipated in the second half of 2025.
INCB000262 (MRGPRX2)
▪Three clinical studies evaluating INCB000262 in CSU (Phase 2), chronic inducible urticaria (CIndu) (Phase 1b) and atopic dermatitis (AD) (Phase 2a) are ongoing. Data for all three studies are anticipated in the first quarter of 2025.
INCB000547 (MRGPRX4)
•The phase 2 clinical study evaluating MRGPRX4 in cholestatic pruritus is ongoing with data expected in the first quarter of 2025.
4

IAI and Dermatology Programs Indication and status
Ruxolitinib cream (Opzelura)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3)
Hidradenitis suppurativa: Phase 2; Phase 3 expected to initiate in 2025
Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2)
Povorcitinib
(JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 (STOP-PN1, STOP-PN2)
Asthma: Phase 2
Chronic spontaneous urticaria: Phase 2
INCB000262
(MRGPRX2) Chronic spontaneous urticaria: Phase 2
Chronic inducible urticaria: Phase 1b
Atopic dermatitis: Phase 2a
INCB000547
(MRGPRX4) Cholestatic pruritus: Phase 2a
INCA034460
(anti-CD122) Vitiligo: Phase 1

1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.
Other
Other Program Indication and Phase
Zilurgisertib
(ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2

2024 Third Quarter Financial Results

The financial measures presented in this press release for the three and nine months ended September 30, 2024 and 2023 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.

GlycoMimetics Enters Into Acquisition Agreement With Crescent Biopharma

On October 29, 2024 GlycoMimetics, Inc. (NASDAQ: GLYC) reported it has entered into an acquisition agreement with Crescent Biopharma, Inc. ("Crescent"), a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors (Press release, GlycoMimetics, OCT 29, 2024, View Source [SID1234647482]). Upon completion of the transaction, the Company plans to operate under the name Crescent Biopharma, Inc.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In support of the acquisition, a syndicate of investors led by Fairmount, Venrock Healthcare Capital Partners, BVF Partners, and a large investment management firm, with participation from Paradigm BioCapital, RTW Investments, Blackstone Multi-Asset Investing, Frazier Life Sciences, Commodore Capital, Perceptive Advisers, Deep Track Capital, Boxer Capital Management, Soleus, Logos Capital, Driehaus Capital Management, Braidwell LP, and Wellington Management, has committed $200 million to purchase GlycoMimetics common stock and GlycoMimetics pre-funded warrants to purchase its common stock. The transaction is expected to close in the second quarter of 2025. The financing is expected to close immediately following the completion of the transaction. The Company’s cash balance at closing is anticipated to fund operations through 2027, including advancement of the Company’s lead program CR-001, a tetravalent PD-1 x VEGF bispecific antibody, through preliminary proof of concept clinical data in solid tumor patients expected in the second half of 2026.

"Crescent was founded to harness recent breakthroughs in immuno-oncology and antibody-drug conjugates that pave the way for a next generation of therapies for patients with solid tumors," said Jonathan Violin, interim CEO at Crescent and Venture Partner at Fairmount. "Our lead program CR-001 was precision engineered to impart a cooperative binding pharmacology for VEGF x PD-1 bispecific blockade; this mechanism recently demonstrated superior efficacy to the anti-PD1 antibody pembrolizumab in a third party head-to-head Phase 3 clinical trial. The specific level of cooperativity engineered into CR-001 reflects a delicate mechanistic balance, which is essential to our confidence in this program. This transaction and financing enable a potentially rapid development path for CR-001, and for the antibody drug conjugate programs CR-002 and CR-003."

Crescent is the fifth company to launch with assets discovered and developed by Paragon Therapeutics. CR-001, a tetravalent PD-1 x VEGF bispecific antibody, matches the format and pharmacology of ivonescimab, which delivered superior efficacy compared to the current market leader pembrolizumab in a large third party Phase 3 trial. In addition to CR-001, Crescent is developing CR-002 and CR-003, antibody-drug conjugates (ADCs) against undisclosed targets using topoisomerase inhibitor payloads; ADCs with topoisomerase inhibitor payloads have shown improved efficacy and safety compared to ADCs with alternative payloads.

The Company anticipates that the IND for CR-001 will be filed in 4Q25 or 1Q26, and interim Phase 1 data from patients is expected in 2H26. CR-002, Crescent’s first ADC program, is designed to be best-in-class and is expected to initiate Phase 1 in 2026; the Company plans to disclose the target for CR-002 as the program approaches the clinic.

The Company intends to determine potential paths forward for its late stage clinical candidate, Uproleselan, including by supporting continued data analyses of Uproleselan from NCI, its corporate partner for China, Apollomics, and investigator initiated studies.

"We are confident that our transaction with Crescent represents a significant opportunity for GlycoMimetics and its stockholders," said Harout Semerjian, CEO of GlycoMimetics. "This transaction is the result of a comprehensive strategic review, and with additional funding for Crescent’s portfolio of novel biologics, we believe the company is well-positioned to carry forward the mission of seeking to improve the lives of patients."

About the Proposed Transactions

Under the terms of the acquisition agreement, the pre-acquisition GlycoMimetics stockholders are expected to own approximately 3.1% of the combined Company and the pre-acquisition Crescent stockholders (inclusive of those investors participating in the pre-closing financing) are expected to own approximately 96.9% of the company. The percentage of the company that GlycoMimetics’s stockholders will own as of the closing of the acquisition is subject to adjustment based on the amount of GlycoMimetics’s net cash at the closing date.

The transaction has received approval by the Board of Directors of both companies and is expected to close in the second quarter of 2025, subject to certain closing conditions, including, among other things, approval by the stockholders of each company and the satisfaction of customary closing conditions.

The company will be named Crescent Biopharma, Inc. and be led by Jonathan Violin, Ph.D., Crescent’s interim Chief Executive Officer, who will be joined on Crescent’s Board of Directors by Peter Harwin, Managing Member of Fairmount. Wedbush PacGrow is serving as strategic advisor and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Crescent. Jefferies, TD Cowen, Stifel, and LifeSci Capital are serving as the placement agents to Crescent. Covington is serving as legal counsel to the placement agents. Lucid Capital Markets is serving as financial advisor and Sidley Austin is serving as legal counsel to GlycoMimetics.

Conference Call Details

The companies plan to hold a joint conference call on October 29, 2024 at 8:00 AM EDT to discuss the merger details.

To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.