Welcome to our dedicated page for enGene Holdings news (Ticker: ENGN), a resource for investors and traders seeking the latest updates and insights on enGene Holdings stock.
enGene Holdings Inc. (NASDAQ: ENGN) is a clinical-stage biotechnology company pioneering the development of gene therapies aimed at enhancing patient lives. Utilizing a proprietary non-viral Dually Derivatized Oligochitosan (DDX) gene delivery platform, enGene focuses on localized delivery of therapeutics directly to mucosal tissues and other organs. This unique platform is designed to offer a safer alternative to viral vectors, enabling the delivery of DNA and various forms of RNA without triggering systemic immune responses.
The company's flagship program, EG-70 (detalimogene voraplasmid), is in pivotal Phase 2 clinical trials for treating non-muscle invasive bladder cancer (NMIBC) in patients unresponsive or naïve to Bacillus Calmette-Guérin (BCG). EG-70 is intended to stimulate both the innate and adaptive immune systems, creating a robust local immune response to target and eradicate tumors while minimizing systemic toxicity. Encouraging interim results are expected in mid-2024, with a goal to file a Biologics License Application (BLA) by early 2026.
enGene's recent business combination with Forbion European Acquisition Corp. brought approximately $138 million in gross proceeds, significantly bolstering its financial position. The company is leveraging these funds to advance EG-70 and other promising pipeline programs targeting gynecological/genitourinary (GYN/GU) malignancies and respiratory diseases. In addition, enGene has secured a $50 million loan agreement with Hercules Capital to further support its endeavors.
The appointment of Dr. Raj Pruthi as SVP of Urologic Oncology and Clinical Development underscores enGene's commitment to advancing its EG-70 program. Dr. Pruthi, with extensive experience in bladder cancer from his tenure at Johnson & Johnson Innovative Medicine, will play a pivotal role in engaging the urological community and driving clinical development.
As enGene continues to progress, it remains dedicated to mainstreaming genetic medicines and expanding its innovative DDX platform across various therapeutic areas. For more information, visit engene.com.
enGene Holdings (Nasdaq: ENGN) reported its financial results for FY2024 and provided business updates. The company's lead product, detalimogene voraplasmid, showed a 71% complete response rate in preliminary data from the LEGEND study's pivotal cohort for BCG-unresponsive NMIBC patients. The study is now recruiting across all four cohorts with protocol amendments including maintenance dosing.
Financial highlights include $297.9 million in cash and equivalents, providing runway into 2027. Total operating expenses were $62.3 million, up from $26.1 million in 2023. Net loss was $55.1 million ($1.46 per share) compared to $104.7 million ($151.22 per share) in 2023.
enGene Holdings (Nasdaq: ENGN) announced its participation in two upcoming investor conferences. The company's Chief Strategy and Operations Officer, Alex Nichols, Ph.D., will present at the Virtual Citizens JMP Hematology & Oncology Summit on December 2, 2024, at 10:00 a.m. ET, and the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, at 3:00 p.m. ET.
enGene is developing detalimogene voraplasmid, a non-viral investigational product for high-risk, BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. The presentations will be available via webcast on the company's website for 90 days.
enGene Holdings (Nasdaq: ENGN) announced its participation in Guggenheim's Inaugural Healthcare Innovation Conference. CEO Ron Cooper and CMO Dr. Raj Pruthi will engage in a fireside chat on November 12, 2024, at 10:30 a.m. ET. The company's lead investigational product, detalimogene voraplasmid, is currently in a pivotal study targeting high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. The event will be webcast live on enGene's website and remain accessible for 90 days.
enGene Holdings has announced a $60 million private placement financing through the sale of 6,758,311 common shares at $8.90 per share. The financing, expected to close on October 29, 2024, includes participation from notable investors like Deep Track Capital, Cormorant Asset Management, and OrbiMed. The proceeds will fund the development of detalimogene voraplasmid, their lead investigational product for bladder cancer treatment, pre-commercial activities, and platform expansion. Combined with current cash reserves, this funding is expected to sustain operations into 2027.
enGene Holdings Inc. (Nasdaq: ENGN) has granted an inducement equity award to Joan Connolly, the company's new Chief Technology Officer. The award, granted on October 21, 2024, consists of a non-qualified stock option to purchase 210,000 common shares at an exercise price of $9.83 per share, equal to the closing price on the grant date.
The stock option has a 10-year term and will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following three years. This grant was made outside of enGene's 2023 Incentive Equity Plan but will have consistent terms and conditions. The award was approved by the independent Compensation Committee in accordance with NASDAQ Listing Rule 5635(c)(4).
enGene Holdings Inc. (Nasdaq: ENGN) has announced key leadership changes to strengthen its executive team. Joan Connolly has been appointed as Chief Technology Officer (CTO), bringing over 30 years of experience in CMC development, manufacturing management, and regulatory filings. Anthony Cheung, Ph.D., co-founder and former CTO, will transition to the role of Chief Scientific Officer.
These appointments come as enGene advances its lead investigational product, detalimogene voraplasmid, through a pivotal study for high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis). The company anticipates filing a Biologics License Application (BLA) in mid-2026.
Ms. Connolly's expertise is expected to be important in driving the late-stage clinical asset towards commercialization. Dr. Cheung, instrumental in developing enGene's DDX platform, will focus on expanding the technology's applications.
enGene Holdings Inc. (Nasdaq: ENGN) has reported the grant of inducement equity awards to seven newly-hired employees on September 30, 2024. The awards consist of non-qualified stock options to purchase a total of 183,000 common shares at an exercise price of $6.60 per share, equal to the closing price on the grant date. Each option has a 10-year term and will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following three years. The grants were made by the Company's independent Compensation Committee as an inducement for employment, in accordance with NASDAQ Listing Rule 5635(c)(4).
enGene Holdings Inc. (Nasdaq: ENGN) announced preliminary data from the pivotal cohort of the LEGEND study for detalimogene voraplasmid, their lead investigational product for high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis). The data showed:
- 71% Complete Response (CR) rate at any time
- 67% CR rate at three months
- 47% CR rate at six months
- Favorable tolerability with no drug-related discontinuations
The results are consistent with Phase 1 findings, supporting detalimogene's potential as a foundational therapy for NMIBC. The company plans protocol refinements to potentially enhance clinical benefits. Detalimogene's profile, including ease of handling and administration, minimal storage requirements, and lack of post-procedural patient restrictions, positions it as a promising treatment option, especially for community practice settings where over 70% of urologists practice.
enGene Holdings Inc. (Nasdaq: ENGN) reported its Q3 2024 financial results and provided a business update. The company, focused on developing detalimogene voraplasmid for high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), remains on track to release preliminary LEGEND study data in September 2024. Key financial highlights include:
- Cash and cash equivalents of $257.7 million, providing runway into 2027
- Total operating expenses of $16.8 million for Q3 2024
- Net loss of $14.1 million, or $0.32 per share
The company also announced leadership changes, including Ron Cooper joining as CEO and the promotion of Dr. Raj Pruthi to Chief Medical Officer.
enGene Holdings Inc. (Nasdaq: ENGN), a clinical-stage genetic medicines company, announced its participation in three upcoming investor conferences in September 2024. The company's lead program, detalimogene voraplasmid, is currently in a pivotal study for high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis).
The conferences include:
- Morgan Stanley 22nd Annual Healthcare Conference on September 5
- Wells Fargo Healthcare Conference on September 6
- H.C. Wainwright 26th Annual Global Investment Conference on September 11
Presentations will be given by Ron Cooper (CEO), Raj Pruthi (CMO), and Alex Nichols (COO). Live webcasts will be available on the enGene website for 90 days after each event.
FAQ
What is the current stock price of enGene Holdings (ENGN)?
What is the market cap of enGene Holdings (ENGN)?
What is enGene Holdings Inc.'s primary focus?
What is the lead program of enGene?
How does EG-70 work?
What recent financial milestones has enGene achieved?
Who is leading enGene?
What are the anticipated milestones for EG-70?
How is enGene expanding its clinical programs?
What are the advantages of enGene's DDX platform?
What can investors expect from enGene in the near future?
Where can more information about enGene be found?
