IND

Enliven Therapeutics Announces $90 Million Private Placement Financing and Provides Pipeline Updates

Retrieved on: 
Tuesday, March 19, 2024
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BOULDER, Colo., March 19, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced that it has entered into a securities purchase agreement for a private investment in public equity (PIPE) financing that is expected to result in gross proceeds of approximately $90 million, before deducting offering expenses. The financing includes participation from new and existing investors, including Commodore Capital, Fairmount, Venrock Healthcare Capital Partners, a biotech investor, a large mutual fund, Rock Springs Capital, Logos Capital, Woodline Partners LP and Acuta Capital Partners.

Key Points: 
  • “The additional funding further strengthens our balance sheet and enables us to achieve critical, longer-term clinical milestones as we advance our parallel lead programs, ELVN-001 and ELVN-002.
  • Enliven anticipates the gross proceeds from the private placement to be approximately $90 million, before deducting offering expenses.
  • The PIPE financing is expected to close on or about March 21, 2024, subject to satisfaction of customary closing conditions.
  • Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Tourmaline Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Tuesday, March 19, 2024
Research, Moyamoya disease, Quarter, Cardiovascular disease, Spirited, Growth, Exercise, Entrepreneurship, IL-6, Inflammation, Patient, SVP, Business development, Commercial, NASDAQ Biotechnology Index, MD, IND, Investment, Clinical trial, NBI, Investigational New Drug, Therapy, TRML, Medical research, Graves' ophthalmopathy, FDA, Food, Pharmaceutical industry

In October 2023, Tourmaline become a publicly-traded company via reverse merger with Talaris Therapeutics, including a concurrent private placement of $75.0 million.

Key Points: 
  • In October 2023, Tourmaline become a publicly-traded company via reverse merger with Talaris Therapeutics, including a concurrent private placement of $75.0 million.
  • Fourth Quarter and Full Year 2023 Financial Results:
    Cash, cash equivalents and investments were $203.0 million as of December 31, 2023, as compared to $8.3 million as of December 31, 2022.
  • Research and development expenses were $8.0 million for the fourth quarter of 2023, as compared to $3.8 million for the fourth quarter of 2022.
  • General and administrative expenses were $6.9 million for the fourth quarter of 2023, as compared to $1.1 million for the fourth quarter of 2022.

Cocrystal Pharma Receives Pre-IND Responses from the FDA on Oral CC-42344 for Treating Influenza A

Retrieved on: 
Tuesday, March 19, 2024
COCP, Drug discovery, Patient, Lung, IND, Influenza A virus, Safety, FDA, Feedback, Food, Vaccine

BOTHELL, Wash., March 19, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA) regarding CC-42344 as a potential oral treatment for pandemic and seasonal influenza A. A Pre-IND review provides the opportunity to obtain FDA guidance and clarification on critical steps such as the proposed clinical trial design, as well as clinical drug manufacturing and nonclinical studies deemed necessary before filing the trial design. The feedback was provided in a written response to a Pre-IND package and questions submitted by the Company in January 2024.

Key Points: 
  • The feedback was provided in a written response to a Pre-IND package and questions submitted by the Company in January 2024.
  • The Company expects to report topline results from this study in the second half of this year.
  • In addition, oral CC-42344 demonstrated favorable safety and tolerability results in a Phase 1 study in Australia.
  • This antiviral candidate was discovered using the Company’s proprietary structure-based drug discovery platform technology.

CytomX Therapeutics Announces Milestone Achievement in PROBODY® T-Cell Engaging Bispecific (TCB) Collaboration with Astellas

Retrieved on: 
Monday, March 18, 2024
Toxicology, IND, SAN, GLP, Tumor microenvironment, Therapy

SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced that the first clinical candidate in its TCB agreement with Astellas has entered into GLP toxicology studies which triggers a $5 million payment to CytomX. The clinical candidate is the first PROBODY® TCB molecule under this alliance to progress into a GLP toxicology study. CytomX and Astellas are also collaborating on additional conditionally activated TCB programs with CytomX eligible to receive future preclinical, clinical and commercial milestones. CytomX retains a cost share and co-commercialization option on a select number of targets.

Key Points: 
  • The clinical candidate is the first PROBODY® TCB molecule under this alliance to progress into a GLP toxicology study.
  • CytomX and Astellas are also collaborating on additional conditionally activated TCB programs with CytomX eligible to receive future preclinical, clinical and commercial milestones.
  • CytomX retains a cost share and co-commercialization option on a select number of targets.
  • “We are excited by the continued momentum towards a potential future IND for the first PROBODY® TCB clinical candidate in our collaboration with Astellas, and we continue to partner with Astellas on multiple preclinical programs.

Tenaya Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 18, 2024
PKP2, Biopsy, ARV, Administration, Fast track (FDA), Gene editing, Patient, SAN, CGMP, BlackRock, HDAC6, Column, G&A, IND, Research and development, Clinical trial, HCM, Investment, Therapy, Antibody, MYBPC3, Safety, FDA, ARVC, Heart failure, LP, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • “Tenaya had a successful year of sustained execution in 2023 that meaningfully advanced our portfolio of genetic medicines for heart disease.
  • Research & Development (R&D) Expenses: R&D expenses were $22.9 million for the fourth quarter and $98.0 million for the full year ended December 31, 2023.
  • General & Administrative (G&A) Expenses: G&A expenses were $8.6 million for the fourth quarter and $33.2 million for the full year ended December 31, 2023.
  • Net Loss: Net loss was $29.9 million, or $0.40 per share for the fourth quarter ended December 31, 2023.

Oculis Reports Q4 and Full Year 2023 Financial Results and Update on Company Progress

Retrieved on: 
Monday, March 18, 2024
Research, TNF, AON, Dexamethasone, Congress, International, International Financial Reporting Standards, Telecanthus, Inflammation, DME, Patient, SNP, NDA, American Academy, G&A, POC, Business analyst, IND, Abstract, DED, Bank statement, Genotype, Investment, Retina, Diabetic retinopathy, OCS, Safety, CHF, Pain, Stage 2, Pharmaceutical industry

Riad Sherif M.D., Chief Executive Officer of Oculis: “2023 was a remarkable milestone-rich year for Oculis.

Key Points: 
  • Riad Sherif M.D., Chief Executive Officer of Oculis: “2023 was a remarkable milestone-rich year for Oculis.
  • These non-IFRS financial measures exclude the impact of items that the Company’s management believes affect comparability or underlying business trends.
  • The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook.
  • The resulting non-cash foreign exchange impact of such reclassification amounted to CHF 5.0 million or $5.7 million for the year ended December 31, 2023.

IN8bio Reports Fourth Quarter and Full-Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, March 14, 2024
MGMT, Research, Survival, ASH, CD33, Environment, Patient, GBM, Neoplasm, Temozolomide, D&O, IND, AACR, Glioblastoma, Exposition, Research and development, Society, CD123, PFS, Cell, DRI, Cranial cavity, Pharmaceutical industry

(Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2023.
  • “IN8bio entered 2024 with significant momentum behind the company,” said William Ho, CEO and co-founder of IN8bio.
  • “Despite the difficult environment in 2023, the IN8bio team executed operationally and successfully advanced our programs.
  • Cash position: As of December 31, 2023, the Company had cash of $21.3 million, compared to $18.2 million as of December 31, 2022.

ABVC BioPharma Reports Annual 2023 Financials and Provides Fiscal Year 2024 First Quarter Business Update

Retrieved on: 
Thursday, March 14, 2024
SIV, Data, Combination, EGFR, Property, SPI, Patient, Sale, Attention deficit hyperactivity disorder, Syndrome, Lung cancer, IND, Myelodysplastic syndrome, Bank statement, Investment, Note, European, TNBC, ADHD, GAP, BioLite, DSM-IV codes, GMP, Investigational New Drug, MDS, Common stock, UCSF, NSCLC, Dietary supplement, Research, Good manufacturing practice, Cancer, University, Security (finance), Pancreatic cancer, Drug development, TGA, FDA, Map, Consultant, Variable, Toxicity, Metastasis, Patent, MDD, Triple-negative breast cancer, License, Long-term care, Net, US FDA, Pharmaceutical industry

As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share).

Key Points: 
  • As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share).
  • The Company entered a cooperation agreement on August 14, 2023, with Zhong Hui Lian He Ji Tuan, Ltd. (“Zhonghui”).
  • On February 06, 2024, ABVC acquired an additional real estate asset via an equity transfer of 703,495 shares at $3.50 per share to develop plant factories for ABVC’s botanical pipeline.
  • ABVC hopes the property will ultimately be used as an integrated platform for the global development of the Asian healthcare business and the medical, pharmaceutical, and biotechnology industries.

Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024
Research, EGFR, NSCLC, Disease, AML, Cullinan, Patient, Tissue, Sale, Multiple myeloma, G&A, CMC, Enrollment, IND, Lymph, Investment, MDS, FDA, Lymphoma, Spleen, CD19, CGEM, Pharmaceutical industry

CAMBRIDGE, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2023. The company also announced that Chief Financial Officer Jeff Trigilio will depart the company effective March 29. Following his departure, Jeff has agreed to support the company through a transition period.

Key Points: 
  • R&D Expenses: Research and development (R&D) expenses were $34.8 million for the fourth quarter of 2023, compared to $33.8 million for the third quarter of 2023.
  • R&D expenses for the fourth and third quarters of 2023 included $2.7 million and $3.2 million of equity-based compensation expenses, respectively.
  • G&A Expenses: General and administrative (G&A) expenses were $10.6 million for the fourth quarter of 2023, compared to $11.0 million for the third quarter of 2023.
  • Net Loss: Net loss (before items attributable to noncontrolling interest) for the fourth quarter of 2023 was $25.6 million, compared with net loss of $39.2 million for the third quarter of 2023.

Century Therapeutics Reports Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, March 14, 2024
EGFR, Gene editing, Cell, Immunotherapy, Patient, BMS, SLE, Bristol Myers Squibb, Protein engineering, IND, Investment, Therapy, CRS, Lymphoma, Research, Computational biology, ASH, Pharming, Investigational New Drug, IPSC, Cancer, Safety, Inflammation, Food, Cetuximab, AACR, Research and development, GAAP, NK, FDA, Administration, Ink, MBA, Abstract, Society, Rejection, Century, Autoimmunity, Pharmaceutical industry

PHILADELPHIA, March 14, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today reported financial results and business highlights for the full year ended December 31, 2023.

Key Points: 
  • In December 2023, Century presented initial clinical data from the Phase 1 ELiPSE-1 Trial of CNTY-101 in relapsed/refractory (r/r) B-cell lymphomas.
  • Data showed that CNTY-101 was well-tolerated at Dose Level 1 (100 million cells) in high-risk, heavily pretreated R/R B-cell lymphoma patients.
  • Net Loss: Net loss was $136.7 million for the year ended December 31, 2023, compared to $131.0 million for the year ended December 31, 2022.
  • The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $135 million and $145 million.