Continued Strong Progress and Momentum Across Multiple Programs with Key Upcoming Data Milestones Beginning Q2 2023
STARS Phase 3 Program of Apraglutide in Short Bowel Syndrome with Intestinal Failure (SBS-IF) to Complete Enrollment this Quarter
Interim Results of STARGAZE Phase 2 Program of Apraglutide in Acute Graft Versus Host Disease (aGvHD) on track to read out by end of Q2 2023
Cash Runway Extends More than 12 Months Beyond Anticipated Release of Topline STARS Phase 3 Data
Management to Host Call Today at 8.00 a.m. ET
BASEL, Switzerland, April 19, 2023 (GLOBE NEWSWIRE) — VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, today reported financial results and provided a business update for the full year ended December 31, 2022.
“2022 was a very good year for VectivBio as we made significant progress against our R&D and corporate objectives, despite the challenging biotech environment. With respect to R&D activities, we advanced our pivotal program for apraglutide in patients with short bowel syndrome with intestinal failure (SBS-IF). This includes the Phase 3 STARS study, where we completed enrollment of the colon-in-continuity (CIC) cohort. We also made significant progress with the Phase 2 STARS Nutrition study, the first-ever dedicated clinical study in the subset of SBS-IF patients with CIC where we reported positive interim data,” said Luca Santarelli, M.D., Ph.D., Founder and Chief Executive Officer of VectivBio. “We’ve also advanced our STARGAZE proof-of-concept study in acute Graft-versus-Disease (aGvHD) achieving 50% of the enrollment target, enabling us to perform our pre-planned interim analysis by end of Q2,” said Luca Santarelli.
Dr. Santarelli went on to say, “Regarding our key corporate activities, last year we strengthened our financial position through a combination of two equity raises, the establishment of a loan facility and an important Japan licensing deal with Asahi Kasei Pharma. In total we gained access to up to $284 million in new funds and extended our cash runway to more than 12 months after our anticipated Phase 3 results.”
Dr. Santarelli continued, “Looking ahead, we see tremendous momentum in 2023, with important upcoming data readouts expected throughout the year. These include six-month data from our Phase 2 STARS Nutrition in early May, interim data from our STARGAZE study by the end of Q2 2023, as well as the completion of enrollment of the Phase 3 STARS study in Q2, which we expect will enable us to have topline data by the end of 2023. These data will position us for a filing in SBS in 2024 and further establish the broad potential of apraglutide in treating additional severe, rare gastrointestinal diseases beyond SBS. Also in 2023, we continue to execute our comprehensive launch readiness plan, with the aim of realizing the full market potential of apraglutide in SBS-IF.”
Business Update
Apraglutide: Next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal (GI) diseases where GLP-2 can play a central role in addressing disease pathophysiology, including SBS-IF and aGvHD.
Apraglutide for SBS-IF:
Apraglutide for aGvHD:
Comet Platform: Modular, small molecule platform applying innovative chemistry to address severe Inherited Metabolic Diseases (IMDs) in pediatric populations with a deficit of energy metabolism caused by the depletion of functional Coenzyme A (“CoA”).
Corporate Updates:
Full Year 2022 Financial Results
Announcement of the Annual General Meeting of Shareholders of VectivBio
The board of directors of the Company has resolved to hold the annual general meeting of shareholders of VectivBio Holding AG (the AGM) on June 1, 2023, at 03:00 p.m. CEST / 09:00 a.m. EDT, at Memox, Elisabethenstrasse 15, 4051 Basel, Switzerland .
The invitation, together with the proposal and further details on the AGM, will be published in due course.
Conference Call Details
The Company will discuss these results on a call today, April 19, 2023, at 8:00 a.m. ET.
The call will be accessible under Events and Presentations in the Investors & Media section of VectivBio’s website at ir.vectivbio.com. An archived replay of the call will be available on VectivBio’s website approximately two hours after the conference call and will be available for 30 days following the call.
About VectivBio AG
VectivBio (Nasdaq: VECT) is a global clinical-stage biotechnology company focused on transforming the lives of patients with severe rare conditions. Our lead product candidate is apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including short bowel syndrome with intestinal failure (SBS-IF) and acute Graft-versus-Host Disease (aGVHD).
VectivBio is also advancing its modular, small molecule CoMET platform to address a broad range of previously undruggable Inherited Metabolic Diseases (IMDs). Candidates from the CoMET platform are initially being evaluated in methylmalonic acidemia (MMA), propionic acidemia (PA), and other organic acidemias.
Forward Looking Statements:
Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements concerning the Company’s expected financial runway, the prospects of apraglutide and the Comet platform, as well as potential initiation and progress of, and timing of upcoming data readouts from, the Company’s clinical trials. All of such statements are subject to risks and uncertainties, many of which are difficult to predict and generally beyond VectivBio’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. Such risks and uncertainties include, but are not limited to those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics; and those risks and uncertainties identified in the “Risk Factors” section of VectivBio’s Annual Report for the year ending December 31, 2021 on Form 20-F filed with the Securities and Exchange Commission on April 7, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, VectivBio undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
VectivBio Contact:
Patrick Malloy
VectivBio SVP, Investor Relations
Patrick.malloy@vectivbio.com
VectivBio Holding AG | |||||||||
Consolidated statements of operations and other comprehensive loss | |||||||||
For the year ended December 31, |
|||||||||
In thousands of United States dollars (“USD”) | 2022 | 2021 | 2020 | ||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
Revenue from contracts with customers | 27.341 | — | — | ||||||
Research and development expenses | (73.953 | ) | (50.180 | ) | (43.035 | ) | |||
General and administrative expenses | (33.912 | ) | (36.536 | ) | (14.226 | ) | |||
Operating loss | (80.524 | ) | (86.716 | ) | (57.261 | ) | |||
Financial income | 676 | — | 1 | ||||||
Financial expense | (3.164 | ) | (36 | ) | (1.118 | ) | |||
Foreign exchange differences, net | (10.616 | ) | (193 | ) | (1.565 | ) | |||
Loss before income taxes | (93.628 | ) | (86.945 | ) | (59.943 | ) | |||
Income taxes | (107 | ) | (64 | ) | — | ||||
Net loss | (93.735 | ) | (87.009 | ) | (59.943 | ) | |||
OTHER CONSOLIDATED COMPREHENSIVE INCOME OR LOSS, NET OF INCOME TAX | |||||||||
Remeasurement of net pension liabilities | 1.439 | 457 | (858 | ) | |||||
Total items that will not be reclassified subsequently to profit or loss | 1.439 | 457 | (858 | ) | |||||
Exchange differences arising on translation of foreign operations | 7.268 | 853 | 801 | ||||||
Total items that may be reclassified subsequently to profit or loss | 7.268 | 853 | 801 | ||||||
Total other comprehensive loss, net of income tax | 8.707 | 1.310 | (57 | ) | |||||
Total comprehensive loss | (85.028 | ) | (85.699 | ) | (60.000 | ) | |||
LOSS PER SHARE | |||||||||
Basic and diluted loss per share (in USD) | (2,12 | ) | (3,23 | ) | (6,24 | ) |
VectivBio Holding AG | |||||||||
Consolidated statements of financial position | |||||||||
As of December 31, | |||||||||
In thousands of USD | 2022 | 2021 | 2020 | ||||||
ASSETS | |||||||||
NON-CURRENT ASSETS | |||||||||
Property, plant and equipment | 19 | 51 | 173 | ||||||
Goodwill | 923 | 925 | 901 | ||||||
Intangible assets | 25.230 | 25.122 | 21.758 | ||||||
Right-of-use assets | 159 | 291 | 114 | ||||||
Financial assets | 61 | 61 | 64 | ||||||
Total non-current assets | 26.392 | 26.450 | 23.010 | ||||||
CURRENT ASSETS | |||||||||
Other current receivables | 1.430 | 777 | 963 | ||||||
Other current assets | 3.361 | 6.597 | 6.417 | ||||||
Cash and cash equivalents | 221.416 | 102.707 | 40.172 | ||||||
Total current assets | 226.207 | 110.081 | 47.552 | ||||||
Total assets | 252.599 | 136.531 | 70.562 | ||||||
EQUITY AND LIABILITIES | |||||||||
EQUITY | |||||||||
Share capital | 3.499 | 1.935 | 1.408 | ||||||
Treasury shares | (805 | ) | (35 | ) | (38 | ) | |||
Reserves | 418.439 | 246.815 | 101.933 | ||||||
Accumulated losses | (207.765 | ) | (132.716 | ) | (71.065 | ) | |||
Total equity | 213.368 | 115.999 | 32.238 | ||||||
NON-CURRENT LIABILITIES | |||||||||
Borrowings | 10.302 | — | — | ||||||
Warrant liability | 2.055 | — | — | ||||||
Lease liabilities | 23 | 158 | 4 | ||||||
Net pension liabilities | 2.110 | 3.190 | 3.557 | ||||||
Total non-current liabilities | 14.490 | 3.348 | 3.561 | ||||||
CURRENT LIABILITIES | |||||||||
Contingent consideration liabilities | — | — | 19.140 | ||||||
Trade payables | 1.803 | 8.595 | 9.490 | ||||||
Accrued expenses | 20.037 | 8.339 | 5.247 | ||||||
Deferred revenue | 2.114 | — | — | ||||||
Other current liabilities | 650 | 116 | 774 | ||||||
Lease liabilities | 137 | 134 | 112 | ||||||
Total current liabilities | 24.741 | 17.184 | 34.763 | ||||||
Total liabilities | 39.231 | 20.532 | 38.324 | ||||||
Total equity and liabilities | 252.599 | 136.531 | 70.562 |
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