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xbrli:shares iso4217:CHF xbrli:pure utr:Year iso4217:JPY utr:Day iso4217:USD xbrli:shares vect:segment iso4217:CHF xbrli:shares vect:facility vect:plan vect:tranche utr:Y
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 6-K
 
 
Report of Foreign Private Issuer
Pursuant to Rule
13a-16
or
15d-16
Under the Securities Exchange Act of 1934
For the month of October 2022
Commission File Number
001-40316
 
 
VECTIVBIO HOLDING AG
(Exact name of registrant as specified in its charter)
 
 
 
Aeschenvorstadt 36
4051 Basel
Switzerland
(Address of principal executive offices)
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover Form
20-F
or Form
40-F.
Form
20-F  ☒            
Form
40-F  ☐
Indicate by check mark if the registrant is submitting the Form
6-K
in paper as permitted by Regulation
S-T
Rule 101(b)(1):  ☐
Indicate by check mark if the registrant is submitting the Form
6-K
in paper as permitted by Regulation
S-T
Rule 101(b)(7):  ☐
 
 
 

Table of Contents
Announcement of Interim Clinical Data from STARS Nutrition
On October 13, 2022, VectivBio Holding AG, or the Company, issued a press release announcing interim data from the first five of nine patients in the Company’s ongoing Phase 2 STARS Nutrition clinical trial. A copy of the press release announcing the interim data is furnished as Exhibit 99.1 to this Report on Form 6-K, and the Company hereby files as Exhibit 99.2 to this Report on
Form 6-K
the Company’s presentation with respect to the interim data from the STARS Nutrition clinical trial. The Company expects to share top-line six-month data for all nine patients in the coming months.
Amendment to Note Financing Agreement with Kreos Capital VI (UK) Limited
On October 12, 2022, the Company entered into an amendment to the note financing agreement dated March 26, 2022, with Kreos Capital VI (UK) Limited, or Kreos. The original note financing agreement is referred to as the Original Loan, and the
as-amended
note financing agreement is referred to herein as the Amended Loan.
The total amount of borrowings available under the Amended Loan remains unchanged from the EUR equivalent of up to USD 75.0 million in borrowing capacity that was provided under the master loan line in the Original Loan. The master loan line is comprised of two loan facilities, of which the EUR equivalent of USD 18.75 million is a convertible loan line, or the Convertible Loan, and the EUR equivalent of USD 56.25 million is a term loan line, or the Term Loan, each of which may be drawn down in tranches as follows:
 
 
(i)
Loan A: Convertible Loan – EUR equivalent of USD 12.5 million; Term Loan – EUR equivalent of USD 37.5 million; and
 
 
(ii)
Loan B: Convertible Loan – EUR equivalent of USD 6.25 million; Term Loan – EUR equivalent of USD 18.75 million.
Subject to certain conditions, Loan A will be available for drawdown until May 31, 2024, and Loan B will be available for drawdown until June 30, 2024. Contemporaneously with execution of the Amended Loan, the Company delivered to Kreos drawdown requests under Loan A for an aggregate amount equal to the EUR equivalent of USD 10 million, or the First Compulsory Drawdown. The Company must deliver to Kreos further drawdown requests under Loan A for an aggregate amount equal to the EUR equivalent of USD 10 million by September 30, 2023, or the Second Compulsory Drawdown.
The Amended Loan has an interest-only repayment period through June 30, 2024. Payments will then be comprised of both interest and principal until the Amended Loan is paid off, with an end date ranging from March 31, 2025 to June 30, 2026, if the interest-only period has been extended to June 30, 2024. Convertible Loan borrowings will bear interest at an implied fixed rate of 7.45% per annum and Term Loan borrowings will bear interest at a fixed rate of 8.95% per annum. The Convertible Loan amount of the First Compulsory Drawdown is convertible into up to 356,961 of the Company’s ordinary shares at a conversion price of USD 7.0036 per share. The Convertible Loan amount of the remaining Amended Loan is convertible into a number of ordinary shares to be determined based on a price per ordinary share that is equal to a 120% premium to the volume weighted average price of the Company’s shares traded during the
30-day
period ending three days prior to either (i) the earlier of the date of first drawdown of such portion or March 31, 2023, with respect to the Second Compulsory Drawdown, or (ii) the date of each subsequent drawdown, with respect to the remaining EUR equivalent of USD 55.0 million available under the Amended Loan beyond the First and Second Compulsory Drawdowns.
Under the terms of the Amended Loan, the Company may prepay all, but not part, of the Term Loan and the Convertible Loan amounts at any time, by notifying the lender at least fifteen days in advance of a date ending on a repayment date;
provided
, however, that Kreos may at its option convert the Convertible Loan into ordinary shares prior to receipt of any such prepayment notification pursuant to the conversion mechanism described in the preceding paragraph. If the Company prepays the Amended Loan, the Company shall in respect of such payment pay to Kreos an early repayment fee as follows:
 
 
(i)
if prepayment occurs within 12 months of drawdown of the Amended Loan, a prepayment fee equal to all interest that would have been payable on the amount prepaid from the date of prepayment to the termination date discounted by 4.00% for each year or part year remaining to the termination date (interest for a part year being calculated on a daily basis) and;
 
 
(ii)
if prepayment occurs within 13 to 24 months of drawdown of the Amended Loan, a prepayment fee equal to 5.00% of principal amount of the Amended Loan outstanding;
 
 
(iii)
if prepayment occurs within 25 to 36 months of drawdown of the Amended Loan, a prepayment fee equal to 3.00% of principal amount of the Amended Loan outstanding; and
 
 
(iv)
if prepayment occurs after 36 months of drawdown of the Amended Loan, a prepayment fee equal to 1.00% of principal amount of the Amended Loan outstanding,

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plus, in each case, an
end-of-loan
payment of 3.00% of the amount drawn down under each loan tranche. The 3.00% end of loan payment is payable whenever the Amended Loan is terminated (whether that be by way of prepayment or by repayment on the termination date).
In addition, if on or before September 30, 2023, (i) prepayment of the Amended Loan occurs or (ii) the Company fails to draw down the Second Compulsory Drawdown, the Company must pay to Kreos a prepayment fee equal to the aggregate of: (a) all interest that would have been payable on the Second Compulsory Drawdown amount, and (b) the 3.00%
end-of-loan
payment that would have been payable on the Second Compulsory Drawdown amount, both discounted by 4.00% for each year or part year remaining to the termination date of the Amended Loan.
In connection with the Original Loan, Kreos received a warrant to purchase 324,190 of the Company’s ordinary shares at an exercise price of USD 5.5243 per share and certain rights to receive additional warrants as set forth in the warrant instrument. In connection with the Amended Loan, Kreos will additionally have the right to receive warrants to purchase, on any prepayment of the Amended Loan, a number of the Company’s ordinary shares equal to the amount of such prepaid Amended Loan and accrued interest at a price per ordinary share equal to the volume weighted average price per share for the
30-day
period ending three days prior to (i) for the Second Compulsory Drawdown, the earlier of the drawdown date and March 31, 2023 and (ii) for all other drawdown amounts, the relevant drawdown date of each such amount. On any exercise of these additional warrants, no warrants will be issued in respect of loaned amounts that have (i) been repaid in the ordinary course or (ii) been converted by Kreos into ordinary shares pursuant to the terms of the Amended Loan prior to the date of prepayment. The warrants are exercisable until the earlier of (i) the end date of the Amended Loan or (ii) the completion of a change of control of the Company.
Announcement of an Extraordinary General Meeting of Shareholders
On October 12, 2022, the Company issued a press release announcing that it has nominated Wouter Joustra for election as an independent,
Non-Executive
Director to its Board of Directors. An Extraordinary General Meeting, or EGM, of shareholders will be held on December 9, 2022. The sole agenda item of the EGM will be the election of Mr. Joustra to the Company’s Board of Directors. The invitation to the EGM, together with the proposals and further details on the EGM, will be published in due course. On October 11, 2022, the Company published an announcement regarding the nomination of Mr. Joustra and the EGM in the Swiss Official Gazette of Commerce, or the SOGC. A copy of the Company’s press release and the announcement in the SOGC are furnished as Exhibit 99.3 and 99.4 to this Report on Form
6-K.
Other Events
The Company hereby files as Exhibits 99.5 and 99.6 to this Report on Form
6-K
the Company’s financial results for the
six-month
period ended June 30, 2022.
Incorporation by Reference
The Company hereby incorporates by reference the information contained in the body of this Report on Form
6-K,
as well Exhibits 99.2, 99.5 and 99.6, into the Company’s registration statements on Form
S-8
(File
No. 333-255524)
and Form
F-3
(File
No. 333-264653)
(including any prospectuses forming a part of such registration statements) and deems them to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

Table of Contents
Forward-Looking Statements
Any statements contained in this Report on Form
6-K
that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “will,” “shall,” “intends” and similar expressions, and are based on the Company’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from our expectations include the success of development and commercialization efforts with respect to the Company’s lead product candidate; and other risks and uncertainties that are described in the Risk Factors section of VectivBio Holding AG’s Registration Statement on Form
20-F
filed with the Securities and Exchange Commission on April 7, 2022 and its other subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this Report on Form
6-K
speak only as of the date on which they were made. Except to the extent required by law, VectivBio Holding AG undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
 
Exhibits
  
 
99.1
  
99.2
  
99.3
  
99.4    Announcement of the Extraordinary General Meeting of Shareholders
99.5
  
99.6
  
101.INS
  
XBRL Instance Document
101.SCH
  
XBRL Taxonomy Extension Schema Document
101.CAL
  
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
  
XBRL Taxonomy Extension Definition Linkbase Document
101.IAB
  
XBRL Taxonomy Extension Labels Linkbase Document
101.PRE
  
XBRL Taxonomy Extension Presentation Linkbase Document
104
  
Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
 
VECTIVBIO HOLDING AG
October 1
3
, 2022
 
 
By:
 
/s/ Claudia D’Augusta
 
 
 
Claudia D’Augusta
 
 
 
Chief Financial Officer
EX-99.1

Exhibit 99.1

LOGO

VectivBio Reports Positive Interim Clinical Data from

STARS Nutrition, a Phase 2 Study Investigating Apraglutide in

Short Bowel Syndrome with Intestinal Failure Patients (SBS-IF)

with Colon-In-Continuity (CIC)

•    Treatment with apraglutide resulted in an average 50% reduction in

Parenteral Support (PS) volume at six months

•    80% of patients were clinical responders (defined as a reduction in volume of PS of at

least 20%) and achieved at least one day off PS at six months

•    First study to prospectively show evidence of clinical benefit in SBS-IF Patients with

Colon-in-Continuity after treatment with a GLP-2 Agonist

•    CIC patients represent largest unmet need in SBS-IF

BASEL, Switzerland, October 13, 2022 – VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, today announced positive interim data from the company’s ongoing Phase 2 STARS Nutrition study evaluating the safety, pharmacokinetics and efficacy of apraglutide, an investigational new drug that is a next-generation, long-acting synthetic GLP-2 agonist, in adult patients with Short Bowel Syndrome with Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC). The STARS Nutrition clinical program is the first-ever study prospectively evaluating the clinical benefit of a GLP-2 agonist specifically in a CIC patient population. Patients with CIC anatomy represent over half of the total SBS-IF patient population and are underserved by current treatment options.

As of the cutoff date of October 7, 2022, five of nine patients had completed at least six months of treatment. Interim data showed that six-month treatment with weekly apraglutide resulted in an average 50% reduction in PS volume and a 47% reduction in parenteral energy content. Eighty percent (four/five patients) were clinical responders (defined as a reduction in volume of PS of at least 20%) and achieved at least one day off PS at 6 months. In the nine patients who reached at least three months of treatment, the average PS reduction was 31% after three months of treatment.

“The interim data from the open-label Phase 2 STARS Nutrition study are very encouraging and demonstrate potentially clinically meaningful evidence that apraglutide can improve intestinal absorption and reduce PS dependency in CIC patients,” said Tim Vanuytsel, M.D., Ph.D., gastroenterologist, Co-Chair of the Leuven Intestinal Failure and Transplantation Center and lead investigator. “Patients with CIC anatomy represent the largest group of patients with SBS-IF. They have very complex and burdensome health needs and require routine PS, the intravenous delivery of essential nutrients and fluids, to survive.”


LOGO

 

“We are very pleased with the interim clinical data and the potential promise of apraglutide to help improve the lives of patients with SBS-IF and colon-in-continuity who are in desperate need of new, effective medicines,” said Omar Khwaja, M.D., Ph.D., CMO of VectivBio. “These interim data further corroborate our belief in apraglutide as a potentially best-in-class GLP-2 analog for the treatment of SBS-IF addressing an area of high unmet need. We expect to share top-line six-month data for all nine patients in the coming months.”

Initiated in June 2021, STARS Nutrition is a multicenter, open-label Phase 2 metabolic balance study of apraglutide designed to evaluate the effects of once-weekly apraglutide on intestinal absorption and PS requirement in SBS-IF patients with CIC. The study enrolled nine adult patients with a mean age of 46.8 years.

CIC patients represent over 55% of the SBS-IF population and have a preserved colon in continuity with the remnant small intestine. The presence of a functional colon allows CIC patients to absorb sufficient levels of water through oral ingestion and, therefore, require PS primarily for energy and nutrients. Historically, prospective clinical trials evaluating the efficacy of GLP-2 analogs in SBS-IF have not demonstrated a significant benefit in patients with CIC anatomy.

About Apraglutide

Apraglutide is an investigational new drug that is 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).

About VectivBio AG

VectivBio is a global clinical-stage biotechnology company focused on transforming and improving the lives of patients with severe rare conditions. Lead product candidate apraglutide is 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). CoMET leverages innovative chemistry, based on a proprietary stabilized pantetheine backbone, to restore fundamental cellular metabolism in pediatric populations with IMDs characterized by a deficit of energy metabolism caused by the depletion of functional Coenzyme A (“CoA”). Candidates from the CoMET platform are initially being evaluated in methylmalonic acidemia (MMA), propionic acidemia (PA), and other organic acidimias.


LOGO

 

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 clinical development of apraglutide, as well as interim data and potential upcoming data readouts from VectivBio’s STARS Nutrition clinical trial, and statements regarding VectivBio’s CoMET platform. 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: the impacts of the Russian/Ukrainian war and the ongoing COVID-19 pandemic, including interruptions or other adverse effects on clinical trials and delays in regulatory review; delay in or failure to obtain regulatory approval of VectivBio’s product candidates and successful compliance with FDA and other governmental regulations applicable to product approvals; the risks inherent in drug development and in conducting clinical trials; 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 Contacts:

Patrick Malloy

VectivBio SVP, Investor Relations and Strategic Communications

Patrick.malloy@vectivbio.com

EX-99.2

Exhibit 99.2

 

LOGO

STARS Interim Data Nutrition Summary —October 2022 CONFIDENTIAL – DO NOT COPY and DO NOT DISTRIBUTE


LOGO

Disclaimer and Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current beliefs, expectations and assumptions of VectivBio Holding AG (the “Company,” “we” or “our”) regarding the future of its business, its future plans and strategies, clinical results, future financial condition and other future conditions. All statements other than statements of historical facts contained in this presentation, including statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. The words “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the ability of our clinical trials to demonstrate acceptable safety and efficacy of our lead product candidate and our development programs; the timing, progress and results of clinical trials for our lead product candidate, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, any initial or interim results from our clinical trials, the period during which the results of the trials will become available, and our research and development programs; the timing, scope and likelihood of regulatory filings and approvals; our ability to obtain marketing approvals of our lead product candidate and to meet existing or future regulatory standards or comply with post-approval requirements; our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash and cash equivalents; future milestone or royalty payments to or from our licensing partners or other third-parties, and the expected timing of such payments; the use and repayment of cash from our debt facility with Kreos Capital; our expectations regarding the potential market size and the size of the patient populations for our lead product candidate, if approved for commercial use; our expectations regarding the potential advantages of our lead product candidate over existing therapies for SBS-IF and our expectations regarding potential uses of our lead product candidate to treat other indications; the success of development and commercialization of the Comet platform; our ability to develop new product candidates using the Comet platform; developments and projections relating to our competitors and our industry, including competing therapies; the impact of COVID-19 on our business, operations and prospects and on our clinical trials; our potential to enter into new collaborations; our expectations with regard to our ability to develop additional product candidates or leverage our current product candidate for other indications, and our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives; our ability to develop, acquire and advance additional product candidates into, and successfully complete, clinical trials; the commercialization and market acceptance of our lead product candidate; our marketing and manufacturing capabilities or those of third parties with which we contract; our ability to operate our businesses without infringing the intellectual property rights and proprietary technology of third parties; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates; estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital; regulatory development in the United States, Europe and other jurisdictions; and other risks described in the “Risk Factors” section of our Annual Report filed with the Securities and Exchange Commission (SEC) on Form 20-F on April 7, 2022, and other subsequent filings. The forward-looking statements in this presentation represent our views as of the date of this presentation. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. We file Current Reports on Form 6-K, Annual Reports on Form 20-F, and other documents with the SEC. You should read these documents for more complete information about us. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. This presentation concerns products that are under clinical investigation and which have not yet been approved for marketing by any regulatory authorities. They are currently limited by applicable laws to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. 2 CONFIDENTIAL


LOGO

STARS Nutrition is the First Dedicated Phase 2 in CIC patients Supplemental study to demonstrate and quantify absorption benefits in CIC STUDY OBJECTIVES Safety tolerability, PK, and absorption parameters AT 4 & 48 WEEKS 9 SBS-IF Changes in absorption parameters AT 6 & 12 Months • wet weight absorption Changes in PS needs patients with CIC • urine output • PS volume reduction • energy absorption • % patients achieving Changes in stool output ≥1 day off PS Open label, baseline controlled Month 0 Month 6 Month 12 Weekly apraglutide -1 0 4 Apraglutide 48 52 MB MB MB Intestinal Intestinal Absorption PS reduction and wean off Absorption CIC, colon-in-continuity; SBS-IF, short bowel syndrome with intestinal failure; PK, pharmacokinetics; PS parenteral support; MB, metabolic balance assessment 3 CONFIDENTIAL    


LOGO

Baseline Characteristics Mean (SD) Median Min—Max Inclusion criteria Demographics Adult males and females with SBS-IF Sex 2 M / 7 F Less than 200 cm small bowel Age (n=9) 46.8 (17.46) 51 22—70 At least 28 cm colon and no colostomy Weight (kg) (n=9) 58.2 (4.78) 60.2 49.3—63.1 At least 12 months from last intestinal resection Height (cm) (n=9) 164.7 (8.96) 164 155—182.5 At least 3 days per week PS Subject considered stable with regard to PS (volume BMI (kg/m2) (n=9) 21.6 (2.87) 21.39 17.47—25.48 and energy) and bodyweight 3 months prior to SBS History screening Small bowel (cm) (n=9) 18.7 (17.67) 20 0—50 Colon (%) (n=9) 79.2 (19.12) 71 43—100 4 CONFIDENTIAL    


LOGO

Percentage Change from Baseline in Weekly PS volume Patients achieved a mean reduction in PS volume of 50% at 6 months 5 CONFIDENTIAL    


LOGO

Proportion of Clinical Responders (PS reduction greater than 20%) 6 CONFIDENTIAL    


LOGO

Summary of results Interim results demonstrate that once weekly apraglutide has the potential to be a best-in-class GLP2 • Average 50% reduction in PS volume and 47% reduction in energy content by 6 months in the first 5 patients • Greater than 30% average PS reduction in all 9 patients by 3 months • 80% (4 out of 5 patients) were clinical responders (defined as 20% PS reduction) at 6 months • 80% (4 out of 5 patients) achieved at least one day off PS at 6 months • No reduction in average bodyweight despite 50% reductions in PS and 47% reduction in PS energy content. Interim data as of 7 October 2022 7 CONFIDENTIAL    


LOGO

Appendix    


LOGO

Summary Table of Gattex and Glepaglutide Phase 3 Results STEPS EASE 1 STARS Nutrition Gattex1 Glepaglutide2 Apraglutide5 Number of patients N= 86 (1:1 Gattex/PBO) N= 106 (1:1:1 weekly, 2x weekly, PBO) N= 9 (open label, all CIC) Baseline volume (liters/week) 13 ± 7.8 Gattex; 13.2 ± 7.4 PBO ~14 liters across all arms 9.5 CIC: Gattex 10.6 PBO 10.53 CIC baseline volumes undisclosed Anatomy split: CIC/stoma 55% / 45% ”balanced” (~50/50) in each arm 100% CIC % Volume reduction @ wk 24 Gattex 32% rel to baseline 2x weekly 37% rel to baseline4 50% relative to baseline PBO 21% rel to baseline 1x weekly 22% rel to baseline) (CIC: 23.3% Gattex 23.8% PBO) PBO—20% rel to baseline 11% relative improvement over placebo 16% relative improvement over placebo 0% improvement over placebo in CIC (2x weekly) group No data presented on different anatomies Clinical response (% of pts 63% Gattex 65.7% 2x weekly 80% with >20% reduction) 30% PBO 45.7% 1x weekly 33% increase over placebo 38.9% PBO 26.8% increase over placebo (2x weekly) * Non-significant even excluding the outlier in 1 weekly dose arm with significant increase in PN due to duplicate entries in case report form 1 Jeppesen, et al. Gastroenterology 2012 2 Zealand Press release and investor call 4 Jeppesen, et al. Gastroenterology 2018 4 Data extrapolated from absolute volume reductions presented in Zealand Press release and investor call 5 The above data shown from separate trials are not intended to demonstrate comparative efficacy 9 CONFIDENTIAL                

EX-99.3

Exhibit 99.3

 

LOGO

VectivBio Publishes Invitation to the Extraordinary General Meeting

BASEL, Switzerland, October 12, 2022 (GLOBE NEWSWIRE) — VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, today published the date of the Extraordinary General Meeting, which will be held on Friday, December 9, 2022, at 10:00 a.m. CEST / 4:00 a.m. EDT at the offices of VectivBio Holding AG at Aeschenvorstadt 36, 4051 Basel, Switzerland.

The sole agenda item of the Extraordinary General Meeting will be the election of Wouter Joustra as a new member of the Board of Directors.

In view of the ongoing COVID-19 pandemic, and in accordance with the Ordinance 3 of the Swiss Federal Council regarding measures on combatting the coronavirus (COVID-19), the Extraordinary General Meeting will take place without the personal attendance of shareholders. Shareholders shall be represented at the Extraordinary General Meeting exclusively by the independent proxy. For information on how to exercise rights and issue voting instructions to the independent proxy, shareholders can access the invitation to the Extraordinary General Meeting at www.edocumentview.com/VECT.

About VectivBio AG

VectivBio is a global clinical-stage biotechnology company focused on transforming and improving the lives of patients with severe rare conditions. Lead product candidate apraglutide is 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). CoMET leverages innovative chemistry, based on a proprietary stabilized pantetheine backbone, to restore fundamental cellular metabolism in pediatric populations with IMDs characterized by a deficit of energy metabolism caused by the depletion of functional Coenzyme A (“CoA”). Candidates from the CoMET platform are initially being evaluated in methylmalonic acidemia (MMA), propionic acidemia (PA), and other organic acidemias.

Learn more at www.vectivbio.com, and follow us on LinkedIn and Twitter.

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 timing of the Extraordinary General Meeting. 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: the impacts of the ongoing COVID-19


pandemic and those risks and uncertainties identified in the “Risk Factors” section of VectivBio’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2022 and its other subsequent filings with the Securities and Exchange Commission. 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.

Contact:

Patrick Malloy

VectivBio SVP, Investor Relations and Strategic Communications

Patrick.Malloy@vectivbio.com

EX-99.4

Exhibit 99.4

Category: Notifications issued to company members

Sub-category: Other notification issued to company members

Publication date: SHAB 11.10.2022

Expected expiry date: 11.10.2023

Publication number: UP06-0000000903

Publishing entity

Homburger AG, Hardstrasse 201, 8005 Zürich

Announcement of the Extraordinary General Meeting of Shareholders of VectivBio Holding AG

Organisation concerned:

VectivBio Holding

AG CHE-289.024.902

Aeschenvorstadt 36

4051 Basel

Notification details:

The Board of Directors of VectivBio Holding AG (the Company) has resolved to hold an extraordinary general meeting of shareholders of the Company (the EGM) on December 9, 2022, at 10:00 a.m. CEST / 4:00 a.m. EDT at the registered office of the Company (Aeschenvorstadt 36, 4051 Basel, Switzerland). The sole agenda item of the EGM will be the election of Wouter Joustra as new member of the Board of Directors.

The invitation, together with the proposal and further details on the EGM, will be published in due course.

The Board of Directors of VectivBio Holding AG

EX-99.5
16270744352

Table of Contents
VectivBio Holding AG
Unaudited interim condensed consolidated statements of operations and other comprehensive loss
 
           
For the six-months ended

June 30,
 
In thousands of United States dollars (“USD”)
  
Notes
    
2022
   
2021
 
CONSOLIDATED STATEMENTS OF OPERATIONS
       
Revenue from contracts with customers
     8        25,879       —    
Research and development expenses
     9        (37,511     (26,494
General and administrative expenses
     10        (19,290     (19,097
     
 
 
   
 
 
 
Operating loss
     
 
(30,922
 
 
(45,591
Financial income
     11        18       —    
Financial expense
     11        (622     (23
Foreign exchange differences, net
     11        1,126       496  
     
 
 
   
 
 
 
Loss before income taxes
     
 
(30,400
 
 
(45,118
Income taxes
     12        (26     —    
     
 
 
   
 
 
 
Net loss
     
 
(30,426
 
 
(45,118
OTHER CONSOLIDATED COMPREHENSIVE INCOME OR LOSS, NET OF INCOME TAX
       
Remeasurement of net pension liabilities
     17        830       508  
     
 
 
   
 
 
 
Total items that will not be reclassified subsequently to profit or loss
     
 
830
 
 
 
508
 
Exchange differences arising on translation of foreign operations
        (3,448     (113
     
 
 
   
 
 
 
Total items that may be reclassified subsequently to profit or loss
     
 
(3,448
 
 
(113
     
 
 
   
 
 
 
Total other comprehensive gain /(loss), net of income tax
     
 
(2,618
 
 
395
 
     
 
 
   
 
 
 
Total comprehensive loss
     
 
(33,044
 
 
(44,723
     
 
 
   
 
 
 
LOSS PER SHARE
       
Basic and diluted net loss per share (in USD)
     14     
 
(0.86
 
 
(2.26
     
 
 
   
 
 
 
The accompanying notes are an integral part of these unaudited interim condensed
consolidated financial statements.
 
2

Table of Contents
VectivBio Holding AG
Unaudited interim condensed consolidated statements of financial position
 
           
As of
 
In thousands of USD
  
Notes
    
June 30, 2022
   
December 31, 2021
 
ASSETS
                         
NON-CURRENT
ASSETS
                         
Property, plant and equipment
              16       51  
Goodwill
     15        894       925  
Intangible assets
     15        24,371       25,122  
Right-of-use
assets
              220       291  
Financial assets
              59       61  
             
 
 
   
 
 
 
Total
non-current
assets
           
 
25,560
 
 
 
26,450
 
             
 
 
   
 
 
 
CURRENT ASSETS
                         
Other current receivables
              1,206       777  
Other current assets
              9,101       6,597  
Cash and cash equivalents
              142,144       102,707  
             
 
 
   
 
 
 
Total current assets
           
 
152,451
 
 
 
110,081
 
             
 
 
   
 
 
 
Total assets
           
 
178,011
 
 
 
136,531
 
             
 
 
   
 
 
 
EQUITY AND LIABILITIES
                         
EQUITY
                         
Share capital
     16        2,661       1,935  
Treasury shares
     16        (581     (35
Reserves
              292,315       246,815  
Accumulated losses
              (152,569     (132,716
             
 
 
   
 
 
 
Total equity
           
 
141,826
 
 
 
115,999
 
             
 
 
   
 
 
 
NON-CURRENT
LIABILITIES
                         
Lease liabilities
              89       158  
Net pension liabilities
     17        2,436       3,190  
Warrant liability
     18        1,124           
             
 
 
   
 
 
 
Total
non-current
liabilities
           
 
3,649
 
 
 
3,348
 
             
 
 
   
 
 
 
CURRENT LIABILITIES
                         
Trade payables
              12,527       8,595  
Accrued expenses
              14,944       8,339  
Deferred revenue
     21        3,488           
Other current liabilities
              1,445       116  
Lease liabilities
              132       134  
             
 
 
   
 
 
 
Total current liabilities
           
 
32,536
 
 
 
17,184
 
             
 
 
   
 
 
 
Total liabilities
           
 
36,185
 
 
 
20,532
 
             
 
 
   
 
 
 
Total equity and liabilities
           
 
178,011
 
 
 
136,531
 
             
 
 
   
 
 
 
The accompanying notes are an integral part of these unaudited interim condensed
consolidated financial statements.
 
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VectivBio Holding AG
Unaudited interim condensed consolidated statements of changes in equity
 
In thousands of USD
  
Share

Capital

(Note 16.1)
    
Treasury
Shares

(Note 16.2)
   
Capital
Reserves
(Reserves)
   
Foreign
exchange
(FX)
translation
(Reserves)
   
Accumulated
losses
   
Total
 
Balance as of January 1, 2021
  
 
1,409
 
  
 
(39
 
 
100,904
 
 
 
1,029
 
 
 
(71,065
 
 
32,238
 
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
     —          —         —         —         (45,118     (45,118
Other comprehensive income/(loss)
     —          —         —         (113     508       395  
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total comprehensive income/(loss)
  
 
—  
 
  
 
—  
 
 
 
—  
 
 
 
(113
 
 
(44,610
 
 
(44,723
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Share capital increase
     486        —         153,639       —         —         154,125  
Share-based payments
     —          —         —         —         11,801       11,801  
Transaction costs due to capital increase
     —          —         (13,039     —         —         (13,039
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2021
  
 
1,895
 
  
 
(39
 
 
241,503
 
 
 
916
 
 
 
(103,874
 
 
140,402
 
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance as of January 1, 2022
  
 
1,935
 
  
 
(35
 
 
244,933
 
 
 
1,882
 
 
 
(132,716
 
 
115,999
 
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
     —          —         —         —         (30,426     (30,426
Other comprehensive income/(loss)
     —          —         —         (3,448     830       (2,618
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total comprehensive loss
  
 
—  
 
  
 
—  
 
 
 
—  
 
 
 
(3,448
 
 
(29,596
 
 
(33,044
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Share capital increase (Note 16)
     511        —         53,444       —         —         53,955  
Share-based payments (Note 13)
     —          —         —         —         9,412       9,412  
Allocation of treasury shares to employees (Note 16)
     —          (331     —         —         331       —    
Issue of treasury shares (Note 16)
     215        (215     —         —         —         —    
Transaction costs due to capital increase (Note 16)
     —          —         (4,496     —         —         (4,496
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2022
  
 
2,661
 
  
 
(581
 
 
293,881
 
 
 
(1,566
 
 
(152,569
 
 
141,826
 
  
 
 
    
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The accompanying notes are an integral part of these unaudited interim condensed
consolidated financial statements.
 
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VectivBio Holding AG
Unaudited interim condensed consolidated statements of cash flows
 
           
For the six-months ended

June 30,
 
In thousands of USD
  
Notes
    
2022
   
2021
 
Net loss
        (30,426     (45,118
Adjustments for:
     
Financial income
     11        (18         
Financial expense
     11        618       23  
Change in fair value of warrants
     18        4           
Revaluation of contingent consideration liabilities
                 860  
Depreciation and amortization expenses
        121       152  
Share-based payments
     13        9,412       11,801  
Group’s pension expense
     17        175       92  
Net foreign exchange differences
        (2,993     (945
Changes in working capital:
       
- (Increase)/Decrease in other current receivables
        (449     365  
- (Increase) in other current assets
        (2,061     (1,033
- Increase/(Decrease) in trade payables
        4,210       (6,051
- Increase in accrued expenses
        6,865       2,856  
- Increase in deferred revenue
     21        3,488           
- Increase in other current liabilities
        1,333       39  
Interest received
        18           
Interest paid
        (61     (24
     
 
 
   
 
 
 
Cash flow used in operating activities
     
 
(9,764
 
 
(36,983
     
 
 
   
 
 
 
Payments for property, plant and equipment
        (17     (33
Payments to security deposit
        (2     (1
     
 
 
   
 
 
 
Cash flow used in investing activities
     
 
(19
 
 
(34
     
 
 
   
 
 
 
Share capital increase
     16        53,955       154,125  
Transaction costs due to capital increase
     16        (4,496     (12,566
Transaction costs due to Kreos Loan agreement
     18        (100         
Lease principal payment
        (67     (68
     
 
 
   
 
 
 
Cash flow provided by financing activities
     
 
49,292
 
 
 
141,491
 
     
 
 
   
 
 
 
Net increase in cash and cash equivalents
        39,509       104,474  
Cash and cash equivalents at beginning of the period
        102,707       40,172  
Net effect of exchange rate changes on cash and cash equivalents
        (72     (36
     
 
 
   
 
 
 
Cash and cash equivalents at end of the period
     
 
142,144
 
 
 
144,610
 
     
 
 
   
 
 
 
The accompanying notes are an integral part of these unaudited interim condensed
consolidated financial statements.
 
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Notes to the unaudited interim condensed consolidated financial statements
 
1.
Organization and business
VectivBio Holding AG (the “Company”) is a Swiss stock corporation whose registered office is at Aeschenvorstadt 36, Basel, Switzerland. The Company was incorporated on May 22, 2019, in Switzerland. It is subject to provisions of the articles of incorporation and to article 620 et seq. of the Swiss Code of Obligations, which describes the legal requirements for corporations (“Aktiengesellschaften”).
The Company, and its five wholly owned subsidiaries, VectivBio AG, Basel (Switzerland), VectivBio Comet AG, Basel (Switzerland), GlyPharma Therapeutic Inc., Montreal (Canada), Comet Therapeutics Inc and VectivBio Inc. (USA) (collectively, the “Group”), is a global biotechnology group committed to making a difference in the lives of patients living with serious rare conditions. The Group’s mission is to use scientific innovation to target the biological root causes of serious rare conditions to achieve disease modification. The Group’s lead program, Apraglutide, is a next-generation glucagon-like
peptide-2
(“GLP-2”)
analog for the treatment of short bowel syndrome (“SBS”) and for the treatment of patients with gastrointestinal acute versus host disease (“aGvHD”).
On April 9, 2021, VectivBio Holding AG closed its initial public offering of 8,625,000 ordinary shares, at a public offering price of USD 17.00 per share. The gross proceeds from the offering were USD 146.6 million. The Company’s ordinary shares began trading on the Nasdaq Global Market under the ticker symbol “VECT”.
These unaudited interim condensed consolidated financial statements were authorized for issuance by the Board of Directors of the Company on October 1
2
, 2022.
 
2.
Significant changes in the current reporting period
The financial position and performance of the Group was particularly affected by the following events
and transactions during the
six-months
ended June 30, 2022:
 
   
On March 30, 2022, the Company entered into a partnering agreement (the “Agreement”) with Asahi Kasei Pharma Corporation (“AKP”).
Under the Agreement, the Company has granted an exclusive license to AKP, with the right to sublicense in multiple tiers, to develop, commercialize and exploit products derived from the Company’s lead product candidate, Apraglutide, within the territory of Japan. The Company and AKP will form a joint steering committee to handle development and regulatory plans, and AKP’s activities under the agreement will be conducted in partnership with the Company. The Company retains all rights to Apraglutide not granted to AKP.
 
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On March 26, 2022, the Company entered into a note financing agreement (the “Loan”) with Kreos Capital VI (UK) Limited (“Kreos”).
The Loan is structured to provide the EUR equivalent of up to USD 75.0 million in borrowing capacity, the master loan line (“MLL”) comprising two loan facilities of which EUR equivalent of USD 18.75 million is to be a convertible loan line, (the “Convertible Loan”). The remainder of the MLL, is a term loan of EUR equivalent of USD 56.25 million which is to be drawn down at the same time as the convertible loan line in three tranches. As additional consideration for the Loan, Kreos received a fee of USD 750 thousand, as well as a warrant to purchase 324,190 of the Company’s ordinary shares at a price per ordinary share equal to the volume weighted average price per share for the
30-day
period ending three days prior to the signing of the Loan. The Company will grant to Kreos an additional warrant to purchase ordinary shares with an aggregate value of up to a maximum of USD 1.0 million, with an exercise price per share equal to the volume weighted average price per share for the
30-day
period ending three days prior to the date of the first drawdown of Loan B (Note 18). The warrants are exercisable for a period of seven years from the date of issuance.
The Loan contains customary affirmative and negative covenants. The affirmative covenants include, among others, administrative and reporting requirements subject to certain exceptions and materiality thresholds. The negative covenants include, among others, limitations on the Company’s ability to, subject to certain exceptions, incur additional debt. Additional information about this financing arrangement is disclosed in Note 18.
 
   
On June 14, 2022, the Company entered into an Underwriting Agreement with SVB Securities LLC and Piper Sandler & Co., as representatives of the several underwriters named therein, pursuant to which the Company agreed to issue and sell, in an underwritten public offering, an aggregate of 5,715,000 ordinary shares with a nominal value of CHF 0.05 per share at a public offering price of USD 5.25 per share. In addition, the Company granted the Underwriters an option for 30 days to purchase up to an additional 857,250 ordinary shares with a nominal value of CHF 0.05 per share at a public offering price of USD 5.25 per share.
 
   
On June 17, 2022, the Company issued from authorized share capital and sold 5,715,000 ordinary shares with a nominal value of CHF 0.05 per share to the underwriters. On June 23, 2022, the Company issued from authorized share capital and sold additional 752,688 ordinary shares with a nominal value of CHF 0.05 per share to the underwriters pursuant to the partial exercise of the underwriters’ previously granted option to purchase additional ordinary shares. The aggregate gross proceeds of the public offering amounted to USD 34 million, before deducting underwriting discounts and commissions and other offering expenses.
 
   
On June 14, 2022, the Company entered into a Subscription and Share Purchase Agreement (“Purchase Agreement”) with Forbion Growth Opportunities Fund II Coöperatief U.A., represented by Forbion Growth II Management B.V. (“Forbion”), pursuant to which Forbion agreed to purchase, and the Company agreed to sell an aggregate of 3,478,260 ordinary shares with a nominal value of CHF 0.05 per share at a price of USD 5.75 per share, for gross proceeds of USD 20 million, in a private placement. The 3,478,260 ordinary shares consisted of 425,252 ordinary shares issued from authorized share capital on June 23, 2022 and 3,053,008 treasury shares sold to Forbion on June 27, 2022.
 
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3.
Basis of preparation of half-year condensed consolidated financial statements
These unaudited interim condensed
consolidated financial statements as of and for the
six-months
ended June 30, 2022, have been prepared in accordance with International Accounting Standard (“IAS”) 34
Interim Financial Reporting
.
They do not include all of the information required in annual financial statements in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and should be read in conjunction with the consolidated and
carve-out
financial statements for the year ended 31 December 2021, 2020 and 2019 approved on April 6, 2022.
The accounting policies adopted are consistent with those of the previous financial year and with the corresponding interim reporting period, except for the estimation of income tax and the adoption of new and amended standards as set out below.
 
4.
Summary of selected significant accounting policies
The Group’s significant accounting policies are set out in Note 2 to the consolidated and
carve-out
financial statements as of and for each of the years ended December 31, 2021, 2020 and 2019 and conform with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”), except for the following new standards and amendments to standards published by the IASB, which are effective for annual periods beginning on or after January 1, 2022.
New and amended Standards and Interpretations that are mandatorily effective for the current year
The following standards and interpretations apply for the first time to financial reporting periods commencing on or after January 1, 2022:
 
Title
  
Effective Date
Amendments to IAS 16 – Property, Plant and Equipment: Proceeds before intended use
   January 1, 2022
Amendments to IFRS 3 – Reference to the Conceptual Framework
   January 1, 2022
Amendments to IAS 37 – Onerous Contracts – Cost of Fulfilling a Contract
   January 1, 2022
Annual Improvements to IFRS 9 Financial Instruments – clarifies which fees should be included in the 10% test for derecognition of financial liabilities.
   January 1, 2022
Annual Improvements to IFRS 16 Leases – amendment to remove any confusion about the treatment of lease incentives.
   January 1, 2022
The adoption of such standards did not have a significant impact on the unaudited interim condensed consolidated statements of financial position or statements of operations and other comprehensive loss of the Group.
 
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New accounting policies applied in the preparation of the unaudited interim condensed consolidated financial statements as of and for the
six-months
ended June 30, 2022​​​​​​​
Revenue recognition
Our revenue is derived from contracts with customers in accordance with IFRS 15, mainly from the Agreement with AKP (Note 2 and 8).
Based on IFRS 15, we have performed the following steps in determining the appropriate amount of revenue to be recognized as we fulfill our obligations under this agreement:
 
  1.
Identification of the promised goods or services in the contract;
 
  2.
Determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract;
 
  3.
Measurement of the transaction price, including the constraint on variable consideration;
 
  4.
Allocation of the transaction price to the performance obligations; and
 
  5.
Recognition of revenue when each performance obligation is satisfied.
For the licensing agreement we have considered a variety of factors in determining the appropriate estimates and assumptions, such as whether the elements within the agreement are distinct performance obligations, whether there are observable standalone selling prices, and whether the customer has right to use or a right to access a license. We have evaluated each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time.
With respect to our assessment of the Agreement with AKP (Note 2 and 8), we identified three performance obligations under the agreement (Note 8), (i) the grant of a right to use of Apraglutide intellectual property license in Japan, (ii) to conduct development services, and (iii) to provide manufacturing and supply of Apraglutide for commercial purposes.
Non-refundable
up-front
license fee and payments for development activities are considered fixed, while milestone payments and royalty payments are identified as variable consideration which must be further evaluated as to when the recognition criteria are met, and, therefore, may initially be excluded from the transaction price.
We estimate the amount of variable consideration using the most likely amount, as milestone payments typically only have two possible outcomes. We recognize revenue for sales-based royalty promised in exchange for the license of intellectual property only when the subsequent sale occurs.
We allocate transaction price by estimating standalone selling price of performance obligations and using the residual approach when the standalone selling price of the license is highly variable or uncertain.
Accordingly, we will recognize revenue for the grant of a right to use of Apraglutide intellectual property license in Japan at a point in time, as it relates to the upfront payment, when the right is granted. The regulatory milestones, sales milestones and royalties are all contingent on commercial sales of Apraglutide, and therefore, will be recognized based on the exception for sales and usage-based royalties received in exchange for licenses of intellectual property.
 
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As it relates to the development milestone payments, these will be recognized when the payments are considered certain or highly probable, since they are considered variable consideration. This will be reassessed at each reporting period and incremental payments in the form of additional milestones would be recognized if considered certain or highly probable.
In relation to the performance obligation to conduct development services, revenue would be recognized over time, considering that the research and development services are satisfied over time. The customer has access to the activities over time as development occurs, therefore, we will recognize revenue based on the costs incurred as this method depicts the transfer of services.
As it relates to the performance obligation of manufacturing and supply of Apraglutide for commercial purposes revenue will be recognized at a point in time when the transfer of control happens.
Financial liabilities and derivatives
Financial liabilities containing embedded derivatives
On March 26, 2022, the Company entered into a Loan with Kreos (Note 2 and 18) structured to provide the EUR equivalent of up to USD 75.0 million in borrowing capacity and comprising two loan facilities of which EUR equivalent of USD 18.75 million is to be a convertible loan line and the remainder of the MLL, being a term loan of EUR equivalent of USD 56.25 million. Both loans contain various embedded derivatives related with extension clauses and early repayment clauses. In addition, the convertible loan contains an embedded derivative related to the conversion option. The Company has elected to designate both financial liabilities at fair value through profit and loss.
As of June 30, 2022, no amounts have been drawn down from these loans. Refer to Note 2 and 18 for further information on these loans.
Warrants
In connection with the term loan and convertible loan agreements with Kreos, the Company issued warrants to Kreos to purchase 324,190 ordinary shares of the Company at a determined subscription price.
The warrants are considered derivatives because there is no initial investment required, their value will vary based on future foreign currency exchange rates applied to a fixed USD price per share for the Company’s shares, and they will be settled in the future (seven years from the issue date). Although issued in connection with the Loan, the warrants have been considered standalone derivative, as described above because they are contractually transferable independently of the loans. They do not meet the criteria required for equity classification because their price is fixed in a foreign currency. Therefore, they will be recognized initially at fair value, classified as a financial liability, and measured at each reporting date at fair value with changes through profit and loss. Refer to Note 2 and 18 for further information on the warrants.
 
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5.
Critical accounting judgments
Going concern
The Group has a limited operating history and has experienced net losses and significant cash used in operating activities since the inception of the Group. For the
six-months
ended June 30, 2022, the Group had a net loss of USD 30,426 thousand (June 30, 2021: USD 45,118 thousand) and net cash used in operating activities of USD 9,764 thousand (June 30, 2021: USD 36,983 thousand). Management expects the Group to continue to incur net losses and have significant cash outflows for at least the next 12 months.
The board of directors of the Company is of the opinion that, the cash position as of June 30, 2022 of USD 142,144 thousand (December 31, 2021: USD 102,707 thousand) is sufficient to continue operating through the next 12 months from this date and meet the Group’s ongoing operating requirements, recurring expenses and required capital expenditures as they arise. In addition, the Company has borrowing capacity from Kreos Loan tranches A1 and A2 of EUR equivalent of up to USD 50 million and tranche B of EUR equivalent of up to USD 25 million subject to certain conditions. Refer to Note 2 and 18 for further information.
 
6.
Use of estimates in financial statement presentation
The preparation of financial statements requires management to make certain estimates and assumptions, either at the balance sheet date or during the year, which affect the reported amounts of assets and liabilities, as well as of revenues and expenses. Actual outcomes and results could differ from those estimates and assumptions.
Net pension liabilities
The retirement benefit obligation is calculated based on various financial and actuarial assumptions. The key assumptions for assessing these obligations are the discount rate, interest credit rate, mortality rate, future salary and pension increases, average retirement age and expected life expectation at regular retirement age. The calculations of the defined benefit obligations are performed by external actuaries and the principal assumptions used are summarized in Note 17. As of June 30, 2022, the underfunding amounted to USD 2,436 thousand (December 31, 2021: USD 3,190 thousand). Refer to Note 17 for further information.
Share-based payments
The 2021 Equity Incentive Plan, 2020 Equity Incentive Plan, the 2020 RSPA, the 2019 Equity Incentive Plan and the 2019 RSPA instruments described in our annual consolidated and
carve-out
financial statements are measured at fair value at their respective grant dates. The Company used two valuation methodologies, which depend on the instrument being valued. For the restricted shares and RSUs, the Company used the share price as the fair value of the underlying equity instrument on the grant date based on the fair value of Company’s ordinary share at the forward value and estimated discount factor. For the share options, the Company used a variation of the Black-Scholes option pricing model (Black model), which takes into consideration the following variables to calculate the fair value of the options: fair value per Company’s ordinary share at the forward value, exercise price, volatility and duration. Refer to Note 13 for further information.
 
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Valuation of warrant derivative
Since the fair values of warrant derivatives recorded in the statement of financial position cannot be measured based on quoted prices in active markets, their fair value is measured using valuation techniques including a variation of the Black-Scholes option pricing model (Black model). The inputs to these models are taken from observable markets where possible, but where this is not feasible, a degree of judgement is required in establishing fair values. Judgements include considerations of inputs such as liquidity risk, credit risk and volatility. Changes in assumptions relating to these factors could affect the reported fair value of financial instruments. Refer to Note 18 for further information.
Revenue from contracts with customers
The Group has applied the following judgements that significantly affect the determination of the performance obligations under the contract with AKP:
A good or service that is promised to a customer is distinct if both of the following criteria are met: (a) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer; and (b) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. The Group determined that the performance obligations identified - (i) the grant of a right to use of Apraglutide intellectual property license in Japan, (ii) to conduct development services, and (iii) to provide manufacturing and supply of Apraglutide for commercial purposes - are each capable of being distinct.
In assessing whether each item has standalone value to the customer, the Group considers factors such as the development, manufacturing, and commercialization capabilities of the partner and the availability of the associated expertise in the general marketplace, which indicates that the customer can benefit from each of the license, the development services, and the manufacturing and supply of Apraglutide on their own. The Group also determined that the promises to transfer the license, to provide development services, and to manufacture and supply Apraglutide are distinct within the context of the contract. The license is separately identifiable in the contract and will be granted at contract inception. The license is not an input that will be integrated with the development services or manufacturing and supply of Apraglutide. The preparation and attendance of the various steering committees is to assist in conducting clinical trials and obtaining regulatory approval of the technology but does not modify the technology itself. In addition, the license, development services, and manufacturing and supply of Apraglutide are not highly interdependent or highly interrelated, because the delivery of license is not dependent on the services or deliveries of Apraglutide to be provided in the future, and accordingly, these promises are not interdependent or interrelated with each other.
In determining whether the license transfers to a customer either at a point in time or over time, the Group considers whether the nature of the Group’s promise in granting the license to a customer is to provide a right to access or a right to use the Group’s intellectual property. The Group assessed that it provides a right to use the license as the license exists (in terms of form and functionality) at a point in time at which it is granted.
The Group has allocated the transaction price to each performance obligation based on relative standalone selling prices.
 
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7.
Segment information
The Group’s
non-current
assets not classified as financial assets are located in Switzerland and in the United States amounted to USD 22,713 thousand (December 31, 2021: USD 23,601 thousand) and USD 2,788 thousand (December 31, 2021: USD 2,788 thousand), respectively.
 
8.
Revenue from contracts with customers
On March 30, 2022, the Company entered into the Agreement with AKP. Under the Agreement, the Company has granted an exclusive license to AKP, with the right to sublicense in multiple tiers, to develop, conduct medical affairs, conduct
non-clinical,
preclinical and clinical studies and trials, commercialize and exploit products derived from Apraglutide within the territory of Japan. The Company and AKP will form a joint steering committee to handle development and regulatory plans, and AKP’s activities under the agreement will be conducted in partnership with the Company. The Company retains all rights to Apraglutide not granted to AKP.
The Agreement will terminate at the later of: (a) the earlier of: (i) the date on which the product (including, the use, sale, offer for sale, importation, development, manufacturing or commercialization thereof) is no longer covered by any Group patent in Japan, and (ii) the date upon which a generic or biosimilar product is made available for commercial purchase in Japan; and (b) the date on which the last regulatory exclusivity for the product expires in Japan.
Pursuant to the terms of the Agreement, the Company received an upfront payment of JPY 3,000 million (USD 24.61 million at date of agreement) and a payment of JPY 600 million related to development activities (USD 4.92 million at date of agreement).
The Company is further eligible to receive payments of JPY 1,000 million related to development activities (USD 8.20 million at date of agreement) and to receive up to a possible total of JPY 20,000 million (USD 164.06 million at date of agreement) for various milestones as shown below:
 
   
Development milestones - JPY 1,000 million (USD 8.20 million at date of agreement);
 
   
Regulatory milestones - JPY 3,000 million (USD 24.61 million at date of agreement); and
 
   
Commercialization milestones - JPY 16,000 million (USD 131.25 million at date of agreement).
The Company will also receive a cost-plus manufacturing
mark-up
and tiered royalties of up to a
mid-double-digit
percentage on product sales continuing through the term of the Agreement.
With respect to our assessment of the Agreement with AKP (Note 2 and 4), we identified three performance obligations under the agreement, (i) the grant of a right to use of Apraglutide intellectual property license in Japan, (ii) to conduct development services, and (iii) to provide manufacturing and supply of Apraglutide products for commercial purposes.
 
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The transaction price for the performance obligations related to the grant of intellectual property license in Japan and conducting development services has been determined to be JPY 23,000 million (USD 188.67 million at date of agreement) and JPY 1,600 million (USD 13.13 million at date of agreement), respectively, of which JPY 4,600 million (USD 37.74 million at date of agreement) are certain or highly probable, representing the upfront payment of JPY 3,000 million (USD 24.61 million at date of agreement) and the payments of JPY 1,600 million related to development activities (USD 13.13 million at date of agreement).
We recognized an amount of revenue for the right to use of Apraglutide intellectual property license in Japan of USD 24.61 million and for conducting development services of USD 1.27 million for the
six-months
ended June 30, 2022. See Note 21 for related contract balances.
 
9.
Research and development expenses
 
    
For the six-months ended

June 30,
 
In thousands of USD
  
2022
    
2021
 
Employee expenses
     (8,233      (6,177
Services expenses
(i)
     (17,826      (15,838
Material expenses
(i)
     (7,906      (2,237
License and IP expenses
(ii)
     (79      (146
Consulting expenses
(iii)
     (3,394      (1,143
Change in contingent consideration liabilities
               (860
Depreciation and amortization expenses
     (73      (93
  
 
 
    
 
 
 
Total
  
 
(37,511
  
 
(26,494
  
 
 
    
 
 
 
 
(i)
Services and material expenses include services from third parties.
(ii)
License and intellectual property (“IP”) expenses mainly include legal cost in relation to IP.
(iii)
Consulting expenses include services of the scientific advisory and consultants who are not directly employed by the Group.
 
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10.
General and administrative expenses
 
    
For the six-months ended

June 30,
 
In thousands of USD
  
2022
    
2021
 
Employee expenses
     (9,318      (11,654
Professional services expenses
(i)
     (7,956      (4,615
Travel and meeting expenses
     (304      (17
Facility expenses
     (31      (14
Insurance and other charges expenses
     (27      (1
Employee recruitment expenses
     (160      (1,071
IT maintenance and support expenses
     (835      (448
Capital tax and other
non-income
tax expenses
     (78      (826
Depreciation and amortization expenses
     (48      (58
Office and other administrative expenses
     (533      (393
  
 
 
    
 
 
 
Total
  
 
(19,290
  
 
(19,097
  
 
 
    
 
 
 
 
(i)
Professional services expenses mainly include legal, accounting and other consulting expenses.
 
11.
Financial income and expense
 
    
For the six-months ended

June 30,
 
In thousands of USD
  
2022
    
2021
 
Interest income
     18        —    
Financial income
  
 
18
 
  
 
—  
 
Interest expense on lease liabilities
     (1      (1
Kreos Loan facility fee expense (Note 18)
     (556      —    
Other interest expenses and bank charges
     (61      (22
Changes in fair value of warrant liabilities
     (4   
 
—  
 
  
 
 
    
 
 
 
Financial expense
  
 
(622
  
 
(23
  
 
 
    
 
 
 
Foreign exchange differences, net
  
 
1,126
 
  
 
496
 
  
 
 
    
 
 
 
 
12.
Income taxes
Income tax expense is recognized based on management’s estimate of the weighted average effective annual income tax rate expected for the full financial year.
 
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13.
Share-based payments
The Company offered to certain directors, executive officers, employees, and external consultants, providing services similar to those rendered by employees, to participate in one of the three different share-based payment plans to receive restricted shares, share options, or RSUs.
A total expense of USD 9,412 thousand for all share-based payment plans was recognized during the
six-months
ended June 30, 2022 (June 30, 2021: USD 11,801 thousand), of which USD 3,714 thousand was recognized within research and development expense (June 30, 2021: USD 3,208 thousand) and USD 5,698 thousand within general and administrative expenses (June 30, 2021: USD 8,593 thousand), with a corresponding credit to equity (accumulated losses).
 
13.1
Restricted shares
No restricted shares were granted during the
six-months
ended June 30, 2022 or 2021.
 
13.2
Share options
For the
six-months
ended June 30, 2022, a total of 2,154,900 share options were granted (June 30, 2021: 2,358,400 share options).
The assessed fair value at grant date of share options granted is determined using an adjusted form of the Black-Scholes model that takes into account the exercise price and expected price volatility of the underlying share. The expected volatility reflects the assumption that the historical volatility over a period similar to the life of the share option is indicative of future trends, which may not necessarily be the actual outcome.
The following tables list the inputs to the model used for the plans. The weighted-average assumptions used in estimating the fair value of share options with service conditions granted in 2022 and 2021 were as follows:
 
    
As of June 30, 2022
   
As of June 30, 2021
 
Fair value per share
     3.89       12.38  
Exercise price
     5.52       4.70  
Volatility
     64.65     58.10
Duration
     10 years       10 years  
 
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A summary of share option activity, is presented below.
 
    
June 30, 2022
 
    
Average

exercise

price (USD) per

share option
    
Number of

Options
 
Outstanding as of January 1, 2022
  
 
3.32
 
  
 
3,847,800
 
  
 
 
    
 
 
 
Granted during the period
     5.52        2,154,900  
Forfeited during the period
     5.39        (191,441
  
 
 
    
 
 
 
Outstanding as of June 30, 2022
  
 
4.07
 
  
 
5,811,259
 
  
 
 
    
 
 
 
Vested as of June 30, 2022
     3.57        1,219,631  
  
 
 
    
 
 
 
Exercisable as of June 30, 2022
  
 
3.57
 
  
 
1,219,631
 
  
 
 
    
 
 
 
 
    
June 30, 2021
 
    
Average

exercise

price (USD) per

share option
    
Number of
options
 
Outstanding as of January 1, 2021
  
 
0.05
 
  
 
1,252,900
 
  
 
 
    
 
 
 
Granted during the period
     4.70        2,358,400  
Forfeited during the period
     0.05        (3,500
  
 
 
    
 
 
 
Outstanding as of June 30, 2021
  
 
3.09
 
  
 
3,607,800
 
  
 
 
    
 
 
 
Vested as of June 30, 2021
     2.91        182,677  
  
 
 
    
 
 
 
Exercisable as of June 30, 2021
  
 
2.91
 
  
 
182,677
 
  
 
 
    
 
 
 
 
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Share options outstanding at the end of the period have the following expiry dates and exercise prices:
 
Grant date
  
Expiry date
  
Exercise price
(USD)
    
Share options at
June 30, 2022
 
August 31, 2019
   August 31, 2029      0.05        46,000  
October 1, 2019
   October 1, 2029      0.05        10,000  
February 29, 2020
   February 29, 2030      0.05        6,000  
September 30, 2020
   September 30, 2030      0.05        1,187,400  
January 31, 2021
   January 31, 2031      0.05        5,000  
February 28, 2021
   February 28, 2031      0.05        40,000  
March 31, 2021
   March 31, 2031      0.05        60,000  
April 30, 2021
   April 30, 2031      4.80        1,726,176  
May 31, 2021
   May 31, 2031      4.80        428,600  
June 30, 2021
   June 30, 2031      11.66        40,000  
September 30, 2021
   September 30, 2031      7.73        160,000  
September 30, 2021
   September 30, 2031      4.80        40,000  
December 31, 2021
   December 31, 2031      4.91        40,000  
January 31, 2022
   January 31, 2032      4.83        130,000  
February 28, 2022
   February 28, 2032      5.65        1,610,483  
March 31, 2022
   March 31, 2032      4.71        15,000  
April 30, 2022
   April 30, 2032      4.50        110,000  
May 31, 2022
   May 31,2032      5.84        10,000  
June 30, 2022
   June 30,2032      5.40        146,600  
Total
        
 
5,881,259
 
Weighted average fair value of options granted during the period (in USD)
 
     3.89  
Weighted average remaining contractual life of options outstanding at end of period (in years)
 
     9.03  
 
13.3
Restricted share units
For the
six-months
ended June 30, 2022, no RSUs were granted (June 30, 2021: 446,000 RSUs were granted) and 30,000 RSUs were forfeited (June 30, 2021: no RSUs were forfeited).
 
    
June 30, 2022
 
    
Restricted share
units
    
Weighted-

average

grant-date

fair value
 
Outstanding as of January 1, 2022
  
 
548,969
 
  
 
11.86
 
  
 
 
    
 
 
 
Granted during the period
                   
Vested
     (141,212      12.45  
Forfeited during the period
     (30,000      15.55  
  
 
 
    
 
 
 
Non-vested
as of June 30, 2022
  
 
377,757
 
  
 
11.35
 
  
 
 
    
 
 
 
 
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June 30, 2021
 
    
Restricted share
units
    
Weighted-

average

grant-date

fair value
 
Outstanding as of January 1, 2021
  
 
234,500
 
  
 
4.60
 
  
 
 
    
 
 
 
Granted during the period
     446,000        15.55  
Vested
     (25,761      5.18  
Forfeited during the period
                   
  
 
 
    
 
 
 
Non-vested
as of June 30, 2021
  
 
654.739
 
  
 
12.04
 
  
 
 
    
 
 
 
The RSUs include a net settlement feature under which the Company withholds shares in order to settle the employee’s s tax obligations.
The Company equity-settles the RSUs on a net basis by withholding the number of shares with a fair value equal to the monetary value of the employee’s tax obligation and only issuing the remaining shares on completion of the vesting period. For the
six-months
ended June 30, 2022, 118,355 RSUs were equity-settled and an amount of USD 250 thousand was withheld and paid to the taxation authority (June 30, 2021 no RSUs were settled).
 
14.
Loss per share
The following summarizes basic and diluted loss per share for the period:
 
In thousands of USD, except per share data
  
For the six-months ended June 30,
 
  
2022
    
2021
 
Net loss attributable to ordinary shareholders
     (30,426      (45,118
Weighted average number of ordinary shares issued and outstanding
     35,555,929        19,977,608  
  
 
 
    
 
 
 
Basic and diluted loss per share (in USD)
  
 
(0.86
  
 
(2.26
  
 
 
    
 
 
 
For the
six-months
ended June 30, 2022, and 2021, basic loss per share was calculated based on the weighted average number of ordinary shares issued and outstanding and excluded
non-vested
shares granted in connection with the share-based payments (Note 13). Such shares are included in the weighted average number of ordinary shares as entitlement to them vests (conditional on continued employment and in the case of the RSUs, the occurrence of a liquidity event). As of June 30, 2022, the Group had 805,106 granted but not vested ordinary shares granted in connection with share-based payments (June 30, 2021: 1,957,032 granted but not vested ordinary shares). As of June 30, 2022, the Group had 9,989 RSUs not issued but vested in connection with share-based payments (June 30, 2021: 23,261 RSUs not issued but vested in connection with share-based payments), these RSUs have been included in the determination of basic and diluted loss per share.
Contingently issuable shares per terms of the anti-dilution protection granted to the Company’s issued warrants, were not evaluated for their dilutive effect, as the conditions for their conversion were not met as of June 30, 2022, and thus, were not included in diluted earnings per share.
 
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As the Group did not generate any profits for the
six-months
ended June 30, 2022, and 2021 the effect of
non-vested
shares (Note 13.1),
non-vested
share options (Note 13.2), and
non-vested
RSUs (Note 13.3) and warrants (Note 18) is anti-dilutive.
​​​​​​​
 
15.
Goodwill and intangible assets
 
    
Goodwill and intangible assets
 
In thousands of USD
  
Goodwill
    
Apraglutide
    
Comet Platform
    
Total
 
COST
           
Balance as of January 1, 2022
  
 
925
 
  
 
22,334
 
  
 
2,788
 
  
 
26,047
 
  
 
 
    
 
 
    
 
 
    
 
 
 
Additions
                                       
Retirements
                                       
Foreign exchange difference
     (31      (751                (782
  
 
 
    
 
 
    
 
 
    
 
 
 
Balance as of June 30, 2022
  
 
894
 
  
 
21,583
 
  
 
2,788
 
  
 
25,265
 
  
 
 
    
 
 
    
 
 
    
 
 
 
As of June 30, 2022, there were no indicators of impairment of any of the CGUs.
 
16.
Share capital
 
    
June 30, 2022
 
    
Number of
issued shares
    
Nominal value of
shares
 
    
Ordinary shares
    
(in thousands of
USD)
 
Balance as of January 1, 2022
     36,635,713        1,935  
Issuance of ordinary shares
     14,056,077        726  
  
 
 
    
 
 
 
Balance as of June 30, 2022
  
 
50,691,790
 
  
 
2,661
 
  
 
 
    
 
 
 
 
    
June 30, 2021
 
    
Number of
issued shares
    
Nominal value
of shares
 
    
Ordinary shares
    
(in thousands of
USD)
 
Balance as of January 1, 2021
     13,042,080        1,409  
Issuance of ordinary shares
     22,819,788        486  
  
 
 
    
 
 
 
Balance as of June 30, 2021
  
 
35,861,868
 
  
 
1,895
 
  
 
 
    
 
 
 
 
16.1
Issued share capital
As of June 30, 2022, the issued share capital amounted to CHF 2,534,589.50 (USD 2,661 thousand) (December 31, 2021: CHF 1,831,785.65 (USD 1,935 thousand)), consisting of 46,037,642 issued and outstanding ordinary shares with a nominal value of CHF 0.05 (USD 0.05) per share (December 31, 2021: 35,973,339 issued and outstanding ordinary shares) and 4,654,148 ordinary shares held in treasury (December 31, 2021: 662,374 ordinary shares) (Note 16.2). Except for the treasury shares, all of these shares have the same voting rights.
 
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Since January 1, 2022, the issued share capital increased as follows:
On May 6, 2022, the Company issued 3,053,008 ordinary shares with a nominal value of CHF 0.05 per share from authorized share capital to be held in treasury for purposes of one or several placements with investors or acquisitions.
On June 17, 2022, the Company issued from authorized share capital and sold 5,715,000 ordinary shares with a nominal value of CHF 0.05 per share to the underwriters. On June 23, 2022, the Company issued from authorized share capital and sold additional 752,688 ordinary shares with a nominal value of CHF 0.05 per share to the underwriters pursuant to the partial exercise of the underwriters’ previously granted option to purchase additional ordinary shares. The aggregate gross proceeds of the public offering amounted to USD 34 million, before deducting underwriting discounts and commissions and other offering expenses.
Also, during June 2022, Forbion purchased an aggregate of 3,478,260 ordinary shares with a nominal value of CHF 0.05 per share at a price of USD 5.75 per share, for gross proceeds of USD 20 million, in a private placement. The 3,478,260 ordinary shares consisted of 425,252 ordinary shares issued from authorized share capital on June 23, 2022 and 3,053,008 treasury shares sold to Forbion on June 27, 2022.
On June 30, 2022, the board of directors of the Company resolved to issue 4,110,129 ordinary shares with a nominal value of CHF 0.05 per share from authorized share capital to be held in treasury for purposes of one or several placements with investors or acquisitions. The capital increase was entered in the commercial register on July 4, 2022.
As a result of these transactions, the Company has incurred transaction costs amounting to a total of USD 4,496 thousand during the period until June 30, 2022. The transaction costs arising from recent share issuances as well as those incurred in previous periods have been accounted for as a reduction of equity, net of any related income tax benefit.
 
16.2
Treasury shares
Treasury shares are shares of the Company that are held by the Group mainly for the purpose of issuing shares under the Group’s equity-settled share-based payment plans for its employees and placements with investors or acquisitions. For the
six-months
ended June 30, 2022, 162’707 RSUs were settled by issuing treasury shares out of which 44’352 treasury shares were withheld in the amount which was paid to the taxation authority (June 30, 2021: no RSUs were settled) (see Note 13 for further information). Refer to the table below for the reconciliation of treasury shares for the
six-months
ended June 30, 2022.
 
    
June 30, 2022
 
    
Number of
shares
    
(in thousands of
USD)
 
Balance as of January 1, 2022
     (662,374      (35
Shares allocated for RSUs net settlement (Note 13)
     118,355        (331
Shares issued
     (4,110,129      (215
  
 
 
    
 
 
 
Balance as of June 30, 2022
  
 
(4,654,148
  
 
(581
  
 
 
    
 
 
 
 
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16.3
Authorized share capital
As of June 30, 2022, the authorized share capital amounted to CHF 90,896.15 (USD 95 thousand) (December 31, 2021: CHF 793,700 (USD 860 thousand)), consisting of 1,817,923 ordinary shares (December 31, 2021: 15,874,000 ordinary shares), with a nominal value of CHF 0.05 (USD 0.05) per share.
On June 30, 2022, the annual general meeting of shareholders of the Company resolved the increase and renewal of the authorized share capital to CHF 992,218.00 (USD 1,038 thousand), consisting of 19,844,360 ordinary shares with a nominal value of CHF 0.05 (USD 0.05) per share until June 30, 2024. The resolutions of the annual general meeting of shareholders were entered in the commercial register on July 4, 2022.
 
16.4
Conditional share capital
As of June 30, 2022, the conditional share capital amounted to CHF 832,392.25 (USD 871 thousand) (December 31, 2021: CHF 832,392.25 (USD 973 thousand)), consisting of 16,647,845 ordinary shares (December 31, 2021: 16,647,845 ordinary shares) with a nominal value of CHF 0.05 (USD 0.05) per share.
On June 30, 2022, the annual general meeting of shareholders of the Company resolved to increase the conditional share capital for participation programs to CHF 541,332.00 (USD 567 thousand), consisting of 10,826,640 ordinary shares with a nominal value of CHF 0.05 (USD 0.05) per share. The resolution of the annual general meeting of shareholders was entered in the commercial register on July 4, 2022, resulting in an aggregate conditional share capital of CHF 992,218.00 (USD 1,038 thousand), consisting of 19,844,360 ordinary shares with a nominal value of CHF 0.05 (USD 0.05) per share.
 
17.
Defined benefit plan
No curtailment or settlement occurred during the
six-months
ended June 30, 2022, in any of the defined benefit pension plans offered.
The most recent actuarial valuations of plan assets and the present value of the defined benefit obligation were carried out as of June 30, 2022, by an independent third party. The present value of the defined benefit obligation, and the related current service cost and past service cost, were measured using the Projected Unit Credit method.
 
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The amounts recognized through profit or loss as employee benefits expense either within research and development expenses or within general and administrative expenses, depending on their function with respect to the defined benefit plans, are as follows:
 
    
For the six-months ended June 30,
 
In thousands of USD
  
2022
    
2021
 
Current service cost
     718        370  
Interest cost
     22        8  
Expected return on plan assets
     (18      (7
Administration costs
     2        3  
  
 
 
    
 
 
 
Expense recognized in profit or loss
  
 
724
 
  
 
374