GlobeNewswire by notified

Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the First Quarter of 2024

Share
  • Hemophilia Program: Ongoing registrational PRESent-2 and PRESent-3 studies of SerpinPC for the treatment of hemophilia B; PRESent-2 interim analysis planned in 2024
  • Orexin Agonist Program: Cleared IND and initiated Phase 1 first-in-human clinical trial of ORX750, a highly potent and selective OX2R agonist for the treatment of narcolepsy; Clinical proof-of-concept data in acutely sleep-deprived healthy volunteers planned in 2H of 2024
  • LockBody® Technology Platform: Ongoing Phase 1/2a study of LB101 (PD-L1xCD47)for the treatment of solid tumors
  • Cash runway, extended by recent public offering, supports clinical plans through multiple data readouts

BOSTON and LONDON, May 13, 2024 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today reported financial results and business highlights for the first quarter ended March 31, 2024.

“2024 is off to a strong start for Centessa. Following clearance of our IND, we recently initiated the Phase 1 first-in-human, clinical trial of ORX750, a highly potent and selective orexin receptor 2 (OX2R) agonist for the treatment of narcolepsy, and remain on track with our goal to share proof-of-concept data in acutely sleep-deprived healthy volunteers in the second half of this year,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “We believe this study has the potential to deliver robust translational results that could lay the foundation for an orexin agonist clinical development program targeting narcolepsy Type 1 and Type 2 with the potential to expand into other sleep-wake disorders including idiopathic hypersomnia, as well as broader neurological indications. Additionally, the PRESent registrational studies for SerpinPC for the treatment of hemophilia B are progressing, and we plan to conduct an interim analysis of the PRESent-2 study later this year.”

Dr. Saha continued, “We are thrilled to now be progressing all three of our most advanced pipeline programs in clinical studies focused on areas with significant unmet need, including hemophilia B, sleep-wake disorders, and solid tumors. With our recently strengthened balance sheet, we believe we are well positioned to execute on our clinical plans through multiple clinical readouts.”

Recent Highlights

  • In April and May, the Company completed an underwritten public offering of 12,390,254 American Depositary Shares (ADSs”) in the aggregate, at a price to the public of $9.25 per ADS, resulting in net proceeds of approximately $107.2 million, which included the underwriters’ over-allotment option to purchase additional shares.
  • In April, the Company announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human (FIH), clinical trial of ORX750 for the treatment of narcolepsy.
  • In February, the Company presented data from the third year (Part 5) of the ongoing Phase 2a study of SerpinPC, an investigational subcutaneously administered novel inhibitor of activated protein C (APC) for the treatment of hemophilia, during an oral presentation at the European Association for Haemophilia and Allied Disorders (EAHAD). Part 5 data from the Phase 2a study showed a continued favorable safety and tolerability profile for SerpinPC, as well as sustained long-term efficacy results, as measured by a 96% reduction in the median all-bleed annualized bleeding rate (ABR) from the prospective baseline measured during the pre-exposure observation period. To date, there have been no thromboembolic events and no treatment-related sustained elevations of D-dimer observed throughout the Phase 2a study.

Anticipated Upcoming Program Milestones

  • Hemophilia Program - The registrational PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with or without inhibitors) and PRESent-3 (hemophilia B with inhibitors) studies of SerpinPC are ongoing. For PRESent-2, the Company plans to review Part 1 data in 2024 (interim analysis) with the goal of confirming a dose and advancing to Part 2 of the study. The primary endpoint of the PRESent-2 study is the rate of treated bleeds (expressed as ABR) during the first 24 weeks of treatment with SerpinPC (Part 2) compared to the observation period. The Company plans to share Part 1 data at a medical conference in late 2024 or early 2025.
  • Orexin Agonist Program - The Phase 1 FIH clinical study of ORX750, which is being progressed for the treatment of narcolepsy, has been initiated. The Company expects to share clinical proof-of-concept data in acutely sleep-deprived healthy volunteers in 2H of 2024.
  • LockBody Technology Platform - The Phase 1/2a FIH clinical study of LB101 (PD-L1xCD47 LockBody) for the treatment of solid tumors is ongoing.

Where applicable, the Company plans to provide updates on preclinical assets including follow-up orexin agonists and LB206, a PD-L1xCD3 LockBody, when they advance toward clinical studies.

First Quarter 2024 Financial Results

  • Cash, Cash Equivalents and Short-term Investments: $230.2 million as of March 31, 2024. The Company expects its cash, cash equivalents and short-term investments as of March 31, 2024, in combination with approximately $107.2 million in aggregate net proceeds from our offering of ADSs completed in April and May 2024, will fund operations into mid-2026, without drawing on the remaining available tranches under the Oberland credit facility.
  • Research & Development Expenses: $22.7 million for the first quarter ended March 31, 2024, compared to $32.8 million for the first quarter ended March 31, 2023.
  • General & Administrative Expenses: $13.4 million for the first quarter ended March 31, 2024, compared to $16.1 million for the first quarter ended March 31, 2023.
  • Net Loss Attributable to Ordinary Shareholders: $38.0 million for the first quarter ended March 31, 2024, compared to $50.7 million for the first quarter ended March 31, 2023.

About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients. Our most advanced programs include a hemophilia program, an orexin agonist program for the treatment of narcolepsy and other sleep-wake disorders, and an immuno-oncology program focused on our LockBody® technology platform. We operate with the conviction that each of our programs has the potential to change the current treatment paradigm and establish a new standard of care. For more information, visit www.centessa.com, which does not form part of this release.

About SerpinPC
SerpinPC is an investigational, subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status, and which may also be developed to prevent bleeding associated with other bleeding disorders. The registrational program for SerpinPC in hemophilia B includes a set of clinical studies with multiple components. PRESent-5 is an observational feeder study to collect prospective observational data for minimum defined periods before switching to dosing subjects in the interventional studies. The interventional studies include PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with or without inhibitors) and PRESent-3 (hemophilia B with inhibitors). Additional information on the trials can be accessed at www.clinicaltrials.gov (NCT05605678, NCT05789524, NCT05789537). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC for the treatment of hemophilia B, with or without inhibitors. SerpinPC has not been approved by the FDA or any other regulatory authority for any use.

About ORX750
Centessa’s first orexin development candidate is ORX750, an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1), with potential applicability to narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other sleep-wake disorders with normal orexin levels. ORX750 has been shown in preclinical studies to potently activate the OX2R with an in vitro EC50 of 0.11 nM and 9,800-fold selectivity over the human orexin receptor (hOX1R). ORX750 is in a Phase 1 clinical study for the treatment of narcolepsy. ORX750 has not been approved by the FDA or any other regulatory authority.

About the LockBody Technology Platform and LB101
Centessa’s proprietary LockBody technology platform aims to redefine immuno-oncology treatment for patients with cancer. LockBody drug candidates are designed to selectively drive potent effector function activity, such as CD47 or CD3, to the tumor micro-environment (TME) while avoiding systemic toxicity. Centessa’s first LockBody candidate is LB101, a conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody which has two anti-CD47 domains blocked by two anti-PD-L1 domains, with proprietary human IgG-derived hinges linking the anti-CD47 and anti-PD-L1 domains. The cell-killing mechanism of action, CD47, is designed to be blocked by the PD-L1 tumor targeting domain until the IgG-derived hinges are naturally degraded in the TME, thus unlocking and activating the CD47 effector function activity in the tumor. LB101 is in a Phase 1/2a clinical trial. Additional information on the trial can be accessed at www.clinicaltrials.gov (NCT05821777). LB101 is an investigational agent that has not been approved by the FDA or any other regulatory authority.

Forward Looking Statements
This press release contains forward-looking statements. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” “aim,” “seek,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company’s ability to discover and develop transformational medicines for patients; its expectations for executing on the Company's pipeline; its expectations on its anticipated cash runway; the timing of commencement of new studies or clinical trials or clinical and preclinical data related to SerpinPC, LB101, other LockBody candidates, the LockBody technology platform, ORX750 and other orexin agonist molecules; its ability to identify, screen, recruit and maintain a sufficient number of or any subjects in its existing and anticipated studies or clinical trials including PRESent-5, the observational feeder study, PRESent-2 and PRESent-3 and studies or trials of LB101 and any other LockBody candidates, ORX750 and other orexin agonist molecules and its expectations on executing its research and clinical development plans and the timing thereof; the Company’s ability to differentiate SerpinPC, LB101, other LockBody candidates, ORX750 and other orexin agonist molecules from other treatment options; the development, design and therapeutic potential of SerpinPC, LB101, other LockBody candidates, the LockBody technology platform, ORX750 and other orexin agonist molecules; and regulatory matters, including the timing and likelihood of success of obtaining regulatory clearance, obtaining authorizations to initiate or continue clinical trials. Any forward-looking statements in this press release are based on our current expectations, estimates, assumptions and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the safety and tolerability profile of our product candidates; our ability to identify, screen and recruit a sufficient number of or any subjects in our existing and anticipated new studies or clinical trials including PRESent-2, PRESent-3, PRESent-5, and studies or trials of LB101 and ORX750 or within anticipated timelines; our expectations relating to the Phase 1 first-in-human, clinical trial of ORX750, including the predicted timing of enrollment, the predicted efficacious doses of ORX750 and our ability to successfully conduct our clinical development of ORX750, our ability to protect and maintain our intellectual property position; business (including commercial viability), regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing product candidates and technologies; future results from our ongoing and planned clinical trials; our ability to obtain adequate financing, including through our financing facility with Oberland, to fund our planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; our operating costs and use of cash, including cash runway, cost of development activities and conducting clinical trials, future expenditures risks; the risk that any one or more of our product candidates will not be successfully developed and/or commercialized; the risk that the historical results of preclinical studies or clinical studies will not be predictive of future results in ongoing or future studies; economic risks to the United States and United Kingdom banking systems; and geo-political risks such as the Russia-Ukraine war or the Middle East conflicts. These and other risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on file with the U.S. Securities and Exchange Commission (SEC). We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Kristen K. Sheppard, Esq.
SVP of Investor Relations
investors@centessa.com

Centessa Pharmaceuticals plc
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(amounts in thousands except share and per share data)
Three Months Ended
March 31, 2024
Three Months Ended
March 31, 2023
Operating expenses:
Research and development$22,652$32,826
General and administrative13,43816,051
Loss from operations(36,090)(48,877)
Interest income2,5912,531
Interest expense(2,529)(2,345)
Other expense, net(1,537)(1,346)
Loss before income taxes(37,565)(50,037)
Income tax expense481677
Net loss(38,046)(50,714)
Other comprehensive income (loss):
Foreign currency translation adjustment(25)898
Unrealized gain on available for sale securities, net of tax155
Other comprehensive income130898
Total comprehensive loss$(37,916)$(49,816)
Net loss per ordinary share - basic and diluted$(0.38)$(0.53)
Weighted average ordinary shares outstanding - basic and diluted99,887,72094,937,904


Centessa Pharmaceuticals plc
Condensed Consolidated Balance Sheets
(unaudited)
(amounts in thousands)
March 31, 2024December 31, 2023
Total assets:
Cash and cash equivalents$118,218$128,030
Short-term investments111,959128,519
Other assets97,994103,697
Total assets$328,171$360,246
Total liabilities
Other liabilities$36,208$48,302
Long term debt76,80075,700
Total liabilities113,008124,002
Total shareholders’ equity215,163236,244
Total liabilities and shareholders' equity$328,171$360,246
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Hexagon Purus and Hino Trucks Introduce Tern: A Pioneering Electric Heavy-Duty Truck20.5.2024 07:00:00 CEST | Press release

Las Vegas, NV, May 20, 2024 – Today at the Advanced Clean Transportation (ACT) Expo, Hexagon Purus in partnership with Hino Trucks, proudly announces the launch of Tern, a dedicated zero-emission truck brand along with their inaugural vehicle model, the RC8, a groundbreaking battery electric Class 8 tractor tailored for the U.S. market. This innovative semi-tractor leverages Hexagon Purus' years of development of zero-emission drivetrains for heavy-duty trucks and represents a driver-preferred option for fleets that are electrifying practical routes. A product of the new long-term agreement between Hexagon Purus and Hino Trucks, valued at up to approximately $2 billion, Tern is designed to deliver a seamless transition to electrification for the U.S. commercial vehicle sector. Manufactured in Hexagon Purus' new facility in Dallas, Texas, the Tern RC8 is scheduled for serial production in late 2024. Built on Hino's proven XL Series 4x2 chassis and equipped with Hexagon Purus' cutting-ed

Udstedelse af RSU program18.5.2024 11:34:18 CEST | pressemeddelelse

I overensstemmelse med bemyndigelsen fra generalforsamlingen den 18. april 2024 har bestyrelsen i dag indført et incitamentsprogram for selskabets bestyrelse. Incitamentetprogrammet er designet og struktureret omkring konceptet med at fastholde medlemmer af bestyrelsen samtidig med at der skabes incitament til en positiv aktiekursudvikling og virksomhedens resultater til gavn for selskabets aktionærer. Incitamentsprogrammet inkluderer Restricted Share Units ("RSU'er"), som giver ret til at deltagerne tildeles et antal aktier svarende til antallet af optjente RSU'er mod betaling af udnyttelseskursen. Programmet er underlagt en række betingelser som deltagerne skal overholde og som betyder at selskabet maksimalt vil skulle udstede 2.025 aktier til kurs 1.056 DKK forudsat at alle betingelser overholdes samt at den enkelte vælger at udnytte sine RSUér. Den beregnede værdi af programmet til den samlede bestyrelse ved brug af Black & Scholes er opgjort til DKK 350.146. Vestingkursen er bereg

Constellation Brands Announces Updated Time of Presentation at the Bernstein 40th Annual Strategic Decisions Conference on Wednesday, May 29, 202418.5.2024 01:05:50 CEST | Press release

VICTOR, N.Y., May 17, 2024 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE: STZ), a leading beverage alcohol company, announces an updated time that Bill Newlands, President and Chief Executive Officer, and Garth Hankinson, Executive Vice President and Chief Financial Officer, will participate in a previously announced fireside chat at the Bernstein 40th Annual Strategic Decisions Conference on Wednesday, May 29, 2024 in New York, NY. The presentation is scheduled to begin at 4:30 p.m. EDT and is expected to cover the company’s strategic business initiatives, financial metrics, and operating performance, as well as outlook for the future. A live, listen-only webcast of the presentation will be available on the company’s investor relations website at ir.cbrands.com under the News&Events section. When the presentation begins, financial information discussed in the presentation, and a reconciliation of reported GAAP financial measures with comparable and other non- GAAP financial mea

DBV Technologies Announces Plan to Implement ADS Ratio Change17.5.2024 22:30:00 CEST | Press release

Châtillon, France, May 17, 2024 DBV Technologies Announces Plan to Implement ADS Ratio Change DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT—CUSIP: 23306J101), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today announced plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value €0.10 (ten cents) per share, from the current ADS Ratio of one (1) ADS to one-half (1/2) of one (1) ordinary share to a new ADS Ratio of one (1) ADS to one (1) ordinary share (the “ADS Ratio Change”). The Company anticipates that the ADS Ratio Change will be effective on or about June 3rd, 2024 (the “Effective Date”). For the Company’s ADS holders, the change in the ADS Ratio will have the same effect as a one-for-two reverse ADS split and is intended to enable the Company to regain compliance with

Oculis updates share capital for its existing at-the-market offering program17.5.2024 22:30:00 CEST | Press release

ZUG, May 17, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company, has issued registered ordinary shares of the Company, each with a nominal value of CHF 0.01, issued out of existing capital band (Kapitalband), for an aggregate of 1,000,000 ordinary shares of the Company (the "New Shares"), recorded as treasury shares. The number of registered shares issued by the Company as per its Articles of Association is 46,443,700, of which 41.7 million shares are outstanding. The New Shares were issued following the Company and Leerink Partners LLC (”Leerink Partners”) entering into a sales agreement (the "Sales Agreement") with respect to an at-the-market offering program on May 8, 2024 under which the Company may offer and sell, from time to time at its sole discretion, ordinary shares of the Company having an aggregate offering price of up to $100 million through Leerink Partners as its sales agent. The Company is

HiddenA line styled icon from Orion Icon Library.Eye