UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K/A
(Amendment No. 1)
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO
RULE 13a-16
OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT
OF 1934
For the month of November 2022
Commission File Number: 001-36582
Altamira Therapeutics Ltd.
(Exact name of registrant as specified in its
charter)
Clarendon House,
2 Church Street
Hamilton HM11, Bermuda
(Address of principal executive office)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F ☒ Form 40-F ☐
Explanatory Note
This Amendment No. 1 (this “Amendment No. 1”) to the Report
of Foreign Private Issuer on Form 6-K originally filed on November 30, 2022 (the “Original Form 6-K”) is being furnished solely
to correct an identified misstatement. In the Unaudited Condensed Consolidated Interim Financial Statements of Altamira Therapeutics Ltd.
(the “Company”) as of June 30, 2022 and for the six months ended June 30, 2022, furnished with the Securities and Exchange
Commission (the “SEC”) on November 30, 2022 with the Original Form 6-K, an upfront payment of $1 million (CHF 0.9 million)
related to the exclusive licensing and distribution agreement with Nuance Pharma for Bentrio® was incorrectly recorded as revenue.
In the audited financial statements as of December 31, 2022 included in the Company’s Annual Report on Form 20-F filed with the
SEC on May 16, 2023, the upfront payment is recorded as deferred income, following the correction of the identified misstatement. Adjustments
for this correction are reflected in the restated financial statements as of and for the six months ended June 30, 2022 furnished with
this Amendment No. 1 in Exhibit 99.1 and the related management’s discussion and analysis in Exhibit 99.2. This Amendment No. 1
makes no other changes to the Original 6-K, and no attempt has been made in this Amendment No. 1 to modify or update the other disclosures
presented in the Original Form 6-K. This Amendment No. 1 does not reflect subsequent events occurring after the initial furnishing of
the Original Form 6-K (i.e., those events occurring after November 30, 2022) or modify or update in any way those disclosures that may
be affected by subsequent events. Accordingly, this Amendment No. 1 should be read in conjunction with the Reports on Form 6-K furnished,
and our other filings made, with the SEC.
INCORPORATION BY REFERENCE
Exhibits 99.1 and
99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration
Numbers 333-228121,
333-249347,
333-261127,
333-264298
and 333-272338) and Form S-8 (Registration Numbers 333-232735
and 333-252141)
of Altamira Therapeutics Ltd. (formerly Auris Medical Holding Ltd.) and 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.
SIGNATURE
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.
|
Altamira Therapeutics Ltd. |
|
|
|
|
By: |
/s/ Marcel Gremaud |
|
|
Name: |
Marcel Gremaud |
|
|
Title: |
Chief Financial Officer |
Date: August 21, 2023
EXHIBIT INDEX
3
Exhibit 99.1
Unaudited Condensed Consolidated Interim Financial
Statements as of June 30, 2022 and December 31, 2021 and for the Six Months Ended June 30, 2022 and 2021
Condensed Consolidated Interim Statement of
Profit or Loss and Other Comprehensive Income or Loss (unaudited)
For the Six Months Ended June 30, 2022 and 2021
(in CHF)
| |
| |
Six Months Ended | |
| |
| |
June 30, | |
| |
Note | |
2022
(restated) | | |
2021 | |
| |
| |
| | |
| |
Revenue | |
| |
| 290,798 | | |
| - | |
Cost of Sales | |
| |
| (1,192,232 | ) | |
| - | |
Gross profit | |
| |
| (901,434 | ) | |
| - | |
Other operating income | |
| |
| 255,820 | | |
| - | |
Research and development | |
| |
| (3,563,883 | ) | |
| (3,393,710 | ) |
Sales and marketing | |
| |
| (2,129,881 | ) | |
| - | |
General and administrative | |
| |
| (2,076,383 | ) | |
| (3,062,199 | ) |
Operating loss | |
| |
| (8,415,761 | ) | |
| (6,455,909 | ) |
Interest expense | |
2 | |
| (376,848 | ) | |
| (172,462 | ) |
Foreign currency exchange gain (loss), net | |
| |
| 58,296 | | |
| 291,892 | |
Revaluation (loss) gain from derivative financial instruments | |
4, 5 | |
| 450,847 | | |
| (428,742 | ) |
Transaction costs | |
| |
| (1,137 | ) | |
| - | |
Loss before tax | |
| |
| (8,284,603 | ) | |
| (6,765,221 | ) |
Income tax gain | |
3 | |
| 46,085 | | |
| 10,642 | |
Net loss attributable to owners of the Company | |
| |
| (8,238,518 | ) | |
| (6,754,579 | ) |
Other comprehensive income: | |
| |
| | | |
| | |
Items that will never be reclassified to profit or loss | |
| |
| | | |
| | |
Remeasurement of defined benefit liability, net of taxes of CHF 0.00 | |
| |
| 209,526 | | |
| 448,946 | |
Items that are or may be reclassified
to Profit or loss | |
| |
| | | |
| | |
Foreign currency translation differences, net of taxes of CHF 0.00 | |
| |
| (63,477 | ) | |
| (41,922 | ) |
Other comprehensive income, net of taxes of CHF 0 | |
| |
| 146,049 | | |
| 407,024 | |
Total comprehensive loss attributable to owners of the Company | |
| |
| (8,092,469 | ) | |
| (6,347,555 | ) |
| |
| |
| | | |
| | |
Basic and diluted loss per share | |
9 | |
| (10.63 | ) | |
| (10.85 | ) |
The figures for the period ended June 30, 2022 have been restated to
correct an identified misstatement. Please see note 2.
The accompanying notes form an integral part
of these condensed consolidated interim financial statements
Condensed Consolidated Interim Statement of
Financial Position (unaudited)
As of June 30, 2022 and December 31, 2021 (in CHF)
| |
Note | |
June 30,
2022
(restated) | | |
December 31,
2021 | |
ASSETS | |
| |
| | |
| |
Non-current assets | |
| |
| | |
| |
Property and equipment | |
| |
| 1 | | |
| 1 | |
Right-of-use assets | |
| |
| 505,270 | | |
| 564,714 | |
Intangible assets | |
2 | |
| 15,851,501 | | |
| 14,314,877 | |
Other non-current financial assets | |
| |
| 195,421 | | |
| 199,105 | |
Total non-current assets | |
| |
| 16,552,193 | | |
| 15,078,697 | |
| |
| |
| | | |
| | |
Current assets | |
| |
| | | |
| | |
Inventories | |
| |
| 146,366 | | |
| 839,221 | |
Trade receivables | |
| |
| 182,167 | | |
| 21,746 | |
Other receivables | |
| |
| 444,034 | | |
| 671,340 | |
Prepayments | |
| |
| 782,469 | | |
| 1,575,126 | |
Cash and cash equivalents | |
| |
| 372,647 | | |
| 984,191 | |
Total current assets | |
| |
| 1,927,683 | | |
| 4,091,624 | |
| |
| |
| | | |
| | |
Total assets | |
| |
| 18,479,876 | | |
| 19,170,321 | |
| |
| |
| | | |
| | |
EQUITY AND LIABILITIES | |
| |
| | | |
| | |
Equity | |
| |
| | | |
| | |
Share capital | |
4 | |
| 170,643 | | |
| 149,643 | |
Share premium | |
| |
| 190,108,850 | | |
| 188,511,476 | |
Foreign currency translation reserve | |
| |
| (1,408 | ) | |
| 62,069 | |
Accumulated deficit | |
| |
| (183,535,121 | ) | |
| (175,686,937 | ) |
Total shareholders’ equity attributable to owners of the Company | |
| |
| 6,742,964 | | |
| 13,036,251 | |
| |
| |
| | | |
| | |
Non-current liabilities | |
| |
| | | |
| | |
Derivative financial instruments | |
4 | |
| - | | |
| 1,233 | |
Non-current lease liabilities | |
| |
| 403,015 | | |
| 461,485 | |
Employee benefits | |
| |
| 515,174 | | |
| 668,319 | |
Deferred income | |
| |
| 932,200 | | |
| - | |
Deferred tax liabilities | |
3 | |
| 95,999 | | |
| 142,484 | |
Total non-current liabilities | |
| |
| 1,946,388 | | |
| 1,273,521 | |
| |
| |
| | | |
| | |
Current liabilities | |
| |
| | | |
| | |
Loan | |
2, 5 | |
| 4,701,906 | | |
| - | |
Derivative financial instruments | |
2, 5 | |
| 284 | | |
| - | |
Current lease liabilities | |
| |
| 116,040 | | |
| 114,251 | |
Trade and other payables | |
| |
| 3,164,754 | | |
| 3,697,723 | |
Accrued expenses | |
| |
| 1,807,540 | | |
| 1,048,575 | |
Total current liabilities | |
| |
| 9,790,524 | | |
| 4,860,549 | |
Total liabilities | |
| |
| 11,736,912 | | |
| 6,134,070 | |
Total equity and liabilities | |
| |
| 18,479,876 | | |
| 19,170,321 | |
The figures as of June 30, 2022 have been restated to correct an identified
misstatement. Please see note 2.
The accompanying notes form an integral part
of these condensed consolidated interim financial statements
Condensed Consolidated Interim Statement of
Changes in Equity (unaudited)
As of June 30, 2022 and 2021 (in CHF)
| |
| |
Attributable to Owners of the Company | |
| |
| |
| | |
| | |
FX | | |
Accumulated | | |
Total | |
| |
| |
Share | | |
Share | | |
Translation | | |
Deficit | | |
Equity | |
| |
Note | |
Capital | | |
Premium | | |
Reserve | | |
(restated) | | |
(restated) | |
As of January 1, 2021 | |
| |
| 114,172 | | |
| 177,230,300 | | |
| 61,297 | | |
| (160,635,879 | ) | |
| 16,769,890 | |
Total comprehensive loss | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| |
| — | | |
| — | | |
| — | | |
| (6,754,579 | ) | |
| (6,754,579 | ) |
Other comprehensive (loss)/income | |
| |
| — | | |
| — | | |
| (41,922 | ) | |
| 448,946 | | |
| 407,024 | |
Total comprehensive loss | |
| |
| — | | |
| — | | |
| (41,922 | ) | |
| (6,305,633 | ) | |
| (6,347,555 | ) |
Transactions with owners of the Company | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Capital increase /Exercise of warrants | |
| |
| 8,974 | | |
| 3,885,764 | | |
| — | | |
| — | | |
| 3,894,738 | |
Conversion of loan | |
| |
| 5,168 | | |
| 1,366,087 | | |
| — | | |
| — | | |
| 1,371,255 | |
Share based/Asset purchase | |
| |
| 7,735 | | |
| 2,266,735 | | |
| — | | |
| 1,078,800 | | |
| 3,353,270 | |
Share based payments | |
6 | |
| 382 | | |
| 92,181 | | |
| — | | |
| 952,349 | | |
| 1,044,912 | |
Balance at June 30, 2021 | |
4 | |
| 136,431 | | |
| 184,841,067 | | |
| 19,375 | | |
| (164,910,363 | ) | |
| 20,086,510 | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | |
As of January 1, 2022 | |
| |
| 149,643 | | |
| 188,511,476 | | |
| 62,069 | | |
| (175,686,937 | ) | |
| 13,036,251 | |
Total comprehensive loss | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| |
| — | | |
| — | | |
| — | | |
| (8,238,518 | ) | |
| (8,238,518 | ) |
Other comprehensive income/(loss) | |
| |
| — | | |
| — | | |
| (63,477 | ) | |
| 209,526 | | |
| 146,049 | |
Total comprehensive loss | |
| |
| — | | |
| — | | |
| (63,477 | ) | |
| (8,028,992 | ) | |
| (8,092,469 | ) |
Transactions with owners of the Company | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Capital increase | |
4 | |
| 21,000 | | |
| 1,597,374 | | |
| — | | |
| — | | |
| 1,618,374 | |
Share based payments | |
6 | |
| — | | |
| — | | |
| — | | |
| 180,808 | | |
| 180,808 | |
Balance at June 30, 2022 | |
4 | |
| 170,643 | | |
| 190,108,850 | | |
| (1,408 | ) | |
| (183,535,121 | ) | |
| 6,742,964 | |
The figures as of June 30, 2022 have been restated to correct an identified
misstatement. Please see note 2.
The accompanying notes form an integral part
of these condensed consolidated interim financial statements
Condensed Consolidated Interim Statement of
Cash Flows (unaudited)
For the Six Months Ended June 30, 2022 and 2021
(in CHF)
| |
| |
Six | | |
| |
| |
| |
Months | | |
Six | |
| |
| |
Ended | | |
Months | |
| |
| |
June, | | |
Ended | |
| |
Note | |
2022
(restated) | | |
June,
2021 | |
| |
| |
| | |
| |
Cash flows from operating activities | |
| |
| | |
| |
Net loss | |
| |
| (8,238,518 | ) | |
| (6,754,579 | ) |
Adjustments for: | |
| |
| | | |
| | |
Depreciation | |
| |
| 59,444 | | |
| 23,636 | |
Deferred income | |
| |
| 932,200 | | |
| - | |
Unrealized foreign currency exchange (gain)/loss, net | |
| |
| (33,129 | ) | |
| (318,319 | ) |
Net interest expense | |
| |
| 366,343 | | |
| 170,906 | |
Share based payments | |
6 | |
| 180,808 | | |
| 1,044,912 | |
Employee benefits | |
| |
| 56,381 | | |
| 26,101 | |
Transaction costs | |
| |
| 1,138 | | |
| - | |
Fair value derivative financial instruments | |
| |
| (450,847 | ) | |
| 428,742 | |
Deferred tax (gain)/loss | |
3 | |
| (47,316 | ) | |
| (10,642 | ) |
| |
| |
| (7,173,496 | ) | |
| (5,389,243 | ) |
| |
| |
| | | |
| | |
Changes in: | |
| |
| | | |
| | |
Inventories | |
| |
| 692,855 | | |
| (196,415 | ) |
Other receivables | |
| |
| 23,346 | | |
| (59,446 | ) |
Prepayments | |
| |
| 785,834 | | |
| (66,403 | ) |
Trade and other payables | |
| |
| (419,075 | ) | |
| 714,292 | |
Accrued expenses | |
| |
| 506,806 | | |
| 78,646 | |
Net cash used in operating activities | |
| |
| (5,583,730 | ) | |
| (4,918,569 | ) |
| |
| |
| | | |
| | |
Cash flows from investing activities | |
| |
| | | |
| | |
Purchase of intangibles | |
| |
| (1,533,568 | ) | |
| (1,988,907 | ) |
Net cash used in investing activities | |
| |
| (1,533,568 | ) | |
| (1,988,907 | ) |
| |
| |
| | | |
| | |
Cash flows from financing activities | |
| |
| | | |
| | |
Proceeds from equity issuance and public offering | |
4 | |
| 1,618,374 | | |
| 3,894,739 | |
Proceeds from loan | |
5 | |
| 4,988,626 | | |
| - | |
Repayment of loan | |
5 | |
| - | | |
| (50,000 | ) |
Repayment of lease liability | |
| |
| (56,682 | ) | |
| - | |
Interest paid | |
| |
| (8,413 | ) | |
| (13 | ) |
Net cash from financing activities | |
| |
| 6,541,905 | | |
| 3,844,726 | |
| |
| |
| | | |
| | |
Net increase/(decrease) in cash and cash equivalents | |
| |
| (575,393 | ) | |
| (3,062,750 | ) |
Cash and cash equivalents at beginning of the period | |
| |
| 984,191 | | |
| 11,258,870 | |
Net effect of currency translation on cash | |
| |
| (36,151 | ) | |
| 270,878 | |
Cash and cash equivalents at end of the period | |
| |
| | | |
| | |
| |
| |
| 372,647 | | |
| 8,466,998 | |
The figures for the period ended June 30, 2022 have been restated to
correct an identified misstatement. Please see note 2.
Non-cash transactions
Changes in inventories for the six months ended June 30, 2022, include
a write-down of inventories of CHF 0.8 million (June 30, 2021: zero).
The accompanying notes form an integral part
of these condensed consolidated interim financial statements
Altamira Therapeutics Ltd.
Notes to the Condensed Consolidated Interim
Financial Statements
As of June 30, 2022 and December 31, 2021 and for the Six Months Ended
June 30, 2022 and 2021 (in CHF)
Altamira Therapeutics Ltd. (the “Company”)
is an exempted company incorporated under the laws of Bermuda. The Company began its operations as a corporation organized in accordance
with Swiss law and domiciled in Switzerland under the name Auris Medical Holding AG (“Auris Medical (Switzerland)”). Following
shareholder approval at an extraordinary general meeting of shareholders held on March 8, 2019 and upon the issuance of a certificate
of continuance by the Registrar of Companies in Bermuda on March 18, 2019, the Company discontinued as a Swiss company and, pursuant to
Article 163 of the Swiss Federal Act on Private International Law and pursuant to Section 132C of the Companies Act 1981 of Bermuda (the
“Companies Act”), continued existence under the Companies Act as a Bermuda company with the name “Auris Medical Holding
Ltd.” (the “Redomestication”). On March 18, 2019, the common shares of the Company began trading on the Nasdaq Capital
Market under the trading symbol “EARS”. The Company’s registered office is located at Clarendon House, 2 Church Street,
Hamilton HM 11, Bermuda. On July 21, 2021, the Company changed its name to Altamira Therapeutics Ltd. Since July 26, 2021, the Company’s
common shares are traded under the trading symbol “CYTO”. On October 25, 2022, the Company effected a one-for-twenty reverse
share split (the “2022 Reverse Share Split”) of the Company’s issued and outstanding common shares. Unless indicated
or the context otherwise requires, all per share amounts and numbers of common shares in this report have been retrospectively adjusted
for the 2022 Reverse Share Split, as if such 2022 Reverse Share Split occurred on the first day of the periods presented.
These condensed consolidated interim financial
statements comprise the Company and its subsidiaries (together referred to as the “Group” and individually as “Group
entities”). The Company is the ultimate parent of the following Group entities:
| ● | Auris Medical AG, Basel, Switzerland (100%) with a nominal
share capital of CHF 2,500,000 |
| ● | Otolanum AG, Zug, Switzerland (100%) with a nominal share
capital of CHF 100,000 |
| ● | Altamira Therapeutics, Inc., Dover, Delaware, United States
(100%) with a nominal share capital of USD 100 |
| ● | Auris Medical Ltd., Dublin, Ireland (100%) with a nominal
share capital of EUR 100 |
| ● | Zilentin AG, Zug, Switzerland (100%) with a nominal share
capital of CHF 100,000 |
| ● | Auris Medical Pty Ltd, Collingwood, Australia (100%) with
a nominal share capital of AUD 100 |
| ● | Altamira Medica AG, Zug, Switzerland (100%) with a nominal
share capital of CHF 3,000,000 |
The Group is primarily involved in the development
of novel products that address important unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner
ear therapeutics. The Group is focusing on the development of RNA therapeutics for extrahepatic therapeutic targets (AM-401 and AM-411),
nasal sprays for protection against airborne viruses and allergens (AM-301; Bentrio™) or the treatment of vertigo (AM-125), and
the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (AM-101; Keyzilen® and AM-111; Sonsuvi®).
| 2. | Basis of preparation Statement of compliance |
These condensed consolidated interim financial
statements as of June 30, 2022 and for the six months ended June 30, 2022 have been prepared in accordance with International Accounting
Standard 34 Interim Financial Reporting (“IAS 34”) and should be read in conjunction with the audited consolidated
financial statements as of and for the year ended December 31, 2021.
These condensed consolidated interim financial
statements include all adjustments that are necessary to fairly state the results of the interim period. The Group believes that the disclosures
are adequate to make the information presented not misleading. Interim results are not necessarily indicative of results to be expected
for the full year. Management does not consider the business to be seasonal or cyclical.
Certain information and footnote disclosures normally
included in consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”),
as issued by the International Accounting Standards Board, have been condensed or omitted as permitted by IAS 34. The condensed consolidated
statement of financial position as of December 31, 2021 was derived from the audited consolidated financial statements.
The interim condensed
consolidated financial statements were authorized for issuance by the Company’s Audit Committee on November 28, 2022
Functional and reporting currency
These interim condensed consolidated financial
statements are presented in Swiss Francs (“CHF”), which is the Company’s functional currency (“functional currency”)
and the Group’s reporting currency.
Significant accounting policies
The accounting policies applied by the Group in
these condensed consolidated interim financial statements are the same as those applied by the Group in its audited consolidated financial
statements as of and for the year ended December 31, 2021 and have been applied consistently to all periods presented in these condensed
consolidated interim financial statements, unless otherwise indicated.
New standards, amendments and interpretations adopted by the Group
Amendments to IAS 16 |
|
Property, Plant and Equipment: Proceeds before Intended Use |
Amendments to IAS 37 |
|
Provisions, Contingent Liabilities and Contingent Assets - Onerous contracts – Costs of fulfilling a Contract |
Amendments to IFRS 3 |
|
Business Combinations - Reference to the Conceptual Framework |
Annual Improvements to IFRS Standards 2018-2020 – Amendments
to IFRS 1, IFRS 9, IFRS 16, IAS 41
The application of these new standards, amendments
to standards and interpretations does not have material impact on the financial statements of the Group.
Convertible loan
The convertible loan obtained from FiveT Investment
Management Ltd. (see Note 5) is classified as a hybrid contract containing a host that is a financial liability and embedded derivatives
separated from the host and measured at fair value with all changes in fair value recognized in profit or loss. The embedded financial
derivatives are valued by an independent consultant initially and at period end at fair value, applying a simulation-based valuation approach.
The carrying amount of the host contract at initial
recognition is the difference between the carrying amount of the hybrid contract and the fair value of the embedded derivatives. The host
is then subsequently measured at amortized cost, using the effective interest rate method.
Intangible assets
As of June 30, 2022, Intangible assets amounted
to CHF 15,851,501, compared to CHF 14,314,877 as of December 31, 2021. The increase is due to the capitalization of development costs
related to the AM-125 program.
Going concern
The Company has incurred recurring losses and
negative cash flows from operations since inception and it expects to generate losses from operations for the foreseeable future primarily
due to research and development costs for its potential product candidates. The Company believes its cash of CHF 372,647 at June 30, 2022,
together with revenues from Bentrio product sales, the receipt of grants, proceeds from the issuance of Common Shares under the A.G.P.
Sales Agreement and the 2020 Commitment Purchase Agreement of USD 2.2 million up to the reporting date as well as from further issuances
under the A.G.P. Sales Agreement and the 2022 Commitment Purchase Agreement, and the USD 2.2 million upfront payment it expects to receive
under the Share Purchase Agreement and Option Agreement, dated October 19, 2022 and amended on November 23, 2022 (as discussed below),
will fund the Company’s projected operations through the fourth quarter of 2022. We expect that our funding requirements for operations
and financial obligations until the end of 2023 will amount to CHF 22.0 to 25.0 million and to CHF 17.0 to 20 million if the convertible
loan provided by FiveT will be converted into Common Shares. To the extent that we will be unable to generate sufficient cash proceeds
from the planned divestiture or spin-off of our legacy assets or other partnering activities, we will need substantial additional financing
to meet these funding requirements both through the fourth quarter of 2022 and thereafter. These factors raise substantial doubt about
the Company’s ability to continue as a going concern. The financial statements have been prepared on a going concern basis, which
contemplates the continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business.
The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
As is often the case with drug development companies,
the ability of the consolidated entity to continue its development activities as a going concern is dependent upon it deriving sufficient
cash from investors, from licensing and partnering activities, in particular the intended divestiture or spin-off of the Company’s
legacy assets in the fields of inner ear therapeutics and OTC consumer health products, and from other sources of revenue such as grant
funding.
On October 21, 2022, the Company announced the
sale of (i) 90% of the share capital of its subsidiary Zilentin AG and (ii) an option to purchase the subsidiaries Auris Medical AG, Otolanum
AG, Auris Medical Ltd. and Auris Medical Pty Ltd (the “Additional Subsidiaries”) – representing the Company’s
inner ear therapeutic assets – to a European family office (the “Buyer”) for a cash consideration of USD 1 million each,
for a total of USD 2 million (the “Zilentin Transaction”). Under the terms of the option agreement (the “Option”)
Zilentin will be entitled to purchase the Additional Subsidiaries for an upfront payment of USD 25. million plus potential milestone royalty
payments. The Option may be exercised for 30 days from October 19, 2022 (the “Closing Date”); beyond that period, Zilentin
will have a right of first refusal to acquire these companies until year end with the upfront payment increasing by USD 1 million per
month. There is no assurance that Buyer will exercise its option, triggering the additional upfront payment of USD 25 million. Due to
a delay in the closing of the Zilentin Transaction, the Company and the Buyer agreed on November 23, 2022 to amend their agreement, extending
the Closing Date to December 15, 2022 at the latest, increasing the share capital of Zilentin AG to be sold under the transaction from
90 to 100% and raising the amount of the initial payment for the purchase of Zilentin and for the option to purchase the Additional Subsidiaries
from USD 2 million to USD 2.2 million.
The directors have considered the cash flow forecasts
and the funding requirements of the business and continue to explore grant funding, licensing opportunities and equity investment opportunities
in the Company. Apart from the inner ear therapeutic assets, the Company intends to spin off or divest also its OTC consumer health products
business, in order to focus on the development of its OligoPhore/SemaPhore RNA delivery platform. At the date of issuing these financial
statements, such plans have not yet been realized.
Accordingly, the directors have prepared the financial
statements on a going concern basis. Should the above assumptions not prove to be appropriate, there is material uncertainty whether the
consolidated entity will continue as a going concern and therefore whether it will realize its assets and extinguish its liabilities in
the normal course of business and at the amounts stated in these financial statements.
The Company plans to secure additional capital
in the future through equity or debt financings, partnerships, collaborations, or other sources to carry out the Company’s planned
development activities. If additional capital is not available when required, the Company may need to delay or curtail its operations
until such funding is received. Various internal and external factors will affect whether and when the Company’s product candidates
become approved for marketing and successful commercialization. The regulatory approval and market acceptance of the Company’s product
candidates, length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of
the approval process will materially affect the Company’s financial condition and future operations. Such matters are not within
the control of the Company and thus all associated outcomes are uncertain.
Accounting for divestiture
From the date of entering into the agreement for
the disposal of Zilentin and the sale of the purchase option for the Additional Subsidiaries, the respective assets and liabilities are
classified as held for sale and measured at the lower of carrying amount and fair value less costs to sell. As the agreement was entered
into after June 30, 2022, and consequently the criteria for held for sale were met only after the reporting period, the disposal group
is presented in the subsequent events and not yet as held for sale in the financial statements. The assets held for sale mainly comprise
capitalized development costs related to the AM-125 program, which amounted to CHF 12.0 million as of June 30, 2022.
Adjustment of June 30, 2022 Revenue
In the Company's Unaudited Condensed Consolidated
Interim Financial Statements as of June 30, 2022 and for the six months ended June 30, 2022, furnished with the SEC on November 30, 2022
with a Report of Foreign Private Issuer on Form 6-K (the “Original Form 6-K”), an upfront payment of $1 million (CHF 0.9 million)
related to the exclusive licensing and distribution agreement with Nuance Pharma for Bentrio® was incorrectly recorded as revenue.
In the audited financial statements as of December 31, 2022 included in the Company’s Annual Report on Form 20-F filed with the
SEC on May 16, 2023, the upfront payment was recorded as deferred income, following the correction of the identified misstatement. Adjustments
for this correction are reflected in these restated condensed consolidated interim financial statements as of June 30, 2022 and for the
six months ended June 30, 2022. The table below reflects the impact of the adjustments on key income statement and balance sheet line
items.
Six months ended June 30, 2022
Adjusted consolidated Balance Sheet
| |
As of June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Deferred income | |
| - | | |
| 932,200 | | |
| 932,200 | |
Total non-current liabilities | |
| 1,014,188 | | |
| 932,200 | | |
| 1,946,388 | |
Total liabilities | |
| 10,804,712 | | |
| 932,200 | | |
| 11,736,912 | |
Accumulated deficit | |
| (182,602,921 | ) | |
| (932,200 | ) | |
| (183,535,121 | ) |
Total shareholders’ equity attributable to owners of the company | |
| 7,675,164 | | |
| (932,200 | ) | |
| 6,742,964 | |
Adjusted consolidated Statement of Profit or Loss and Other Comprehensive
Loss
| |
Half-Year ended June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Revenue | |
| 1,222,998 | | |
| (932,200 | ) | |
| 290,798 | |
Gross profit | |
| 30,766 | | |
| (932,200 | ) | |
| (901,434 | ) |
Operating loss | |
| (7,483,561 | ) | |
| (932,200 | ) | |
| (8,415,761 | ) |
Loss before tax | |
| (7,352,403 | ) | |
| (932,200 | ) | |
| (8,284,603 | ) |
Net loss attributable of owners of the Company | |
| (7,306,318 | ) | |
| (932,200 | ) | |
| (8,238,518 | ) |
Total comprehensive loss attributable to owners of the Company | |
| (7,160,269 | ) | |
| (932,200 | ) | |
| (8,092,469 | ) |
Basic and diluted loss per share | |
| (9.43 | ) | |
| (1.20 | ) | |
| (10.63 | ) |
The Group’s income tax expense recognized in the condensed interim
consolidated statement of profit or loss is presented as follows:
| |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2022 | | |
2021 | |
Current income tax expense | |
| (1,231 | ) | |
| — | |
Deferred income tax gain | |
| 47,316 | | |
| 10,642 | |
Total income tax (expense)/gain | |
| 46,085 | | |
| 10,642 | |
The tax effect of taxable temporary differences that give rise to deferred
income tax liabilities or to deferred income tax assets as of June 30, 2022 and 2021 is presented as follows:
| |
June 30, | | |
December 31, | |
| |
2022 | | |
2021 | |
Deferred Tax liabilities | |
| | |
| |
Intangible assets | |
| (47,590 | ) | |
| (51,914 | ) |
Other receivables | |
| (81,184 | ) | |
| (122,449 | ) |
Total | |
| (128,774 | ) | |
| (174,363 | ) |
Deferred Tax assets | |
| | | |
| | |
Net operation loss (NOL) | |
| 32,775 | | |
| 31,879 | |
Total | |
| 32,775 | | |
| 31,879 | |
Deferred Tax, net | |
| (95,999 | ) | |
| (142,484 | ) |
Share capital
The issued share capital of the Company consisted of:
| |
Common Shares | |
| |
Number | |
| |
2022 | | |
2021 | |
As of January 1 | |
| 748,213 | | |
| 570,858 | |
Common shares issued | |
| 105,000 | | |
| 111,299 | |
Total, as of June 30 | |
| 853,213 | | |
| 682,157 | |
As of June 30, 2022, the par value of the 853,213
issued shares amounted to CHF 170,643 with a par value of CHF 0.20 for each common share (as of June 30, 2021, the par value of 682,157
issued shares amounted to CHF 136,431 with a par value of CHF 0.20 for each common share).
Equity Offerings
On June 1, 2021, the company completed the acquisition
of Trasir Therapeutics Inc. The upfront acquisition price of USD 2.5 million was paid with 38,218 non-registered common shares at the
Reference Price of USD 65.40 to the selling shareholders. In addition, 459 non-registered common shares were issued based on the Reference
Price to reimburse USD 30,000 in expenses incurred by certain selling Trasir shareholders.
On March 4, 2021, the remaining convertible loan
by FiveT in the amount of CHF 604,545 plus accumulated interests of CHF 40,268 was converted into 25,841 common shares at a conversion
price of USD 27.00.
On April 23, 2020, the Company entered into a
purchase agreement and a Registration Rights Agreement with Lincoln Park Capital Fund, LLC (the “2020 Commitment Purchase Agreement”).
Pursuant to the 2020 Commitment Purchase Agreement, LPC agreed to subscribe for up to USD 10,000,000 of our common shares over the 30-month
term of the 2020 Commitment Purchase Agreement. Through June 30, 2022, we issued a total of 165,000 of our common shares to LPC for an
aggregate amount of USD 2,806,605 under the 2020 Commitment Purchase Agreement. During the six months ended June 30, 2022, we issued 105,000
of our common shares to LPC for an aggregate amount of USD 1,698,450 under the 2020 Commitment Purchase Agreement, and as of the date
of this report, we have issued a total of 325,000 of our common shares to LPC for an aggregate amount of USD 4,003,820 under the 2020
Commitment Purchase Agreement.
The remaining 44,872 warrants of the May 2019 Registered Offering were
exercised in March 2021.
On November 30, 2018, as amended on April 5, 2019
the Company entered into a sales agreement, as amended (the “A.G.P. Sales Agreement”) with A.G.P./Alliance Global Partners
(“A.G.P.”). Pursuant to the terms of the A.G.P. Sales Agreement, the Company may offer and sell its common shares, from time
to time through A.G.P. by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) promulgated under
the Securities Act. Pursuant to the A.G.P. Sales Agreement, the Company may sell common shares up to a maximum aggregate offering price
of USD 25.0 million. As of June 30, 2022, the Company has sold a total of 147,166 common shares for an aggregate offering price of USD
6.7 million pursuant to the A.G.P. Sales Agreement (June 30, 2021: 87,931 common shares for an aggregate offering price of USD 2.9 million),
and as of the date of this report, the Company has sold a total of 228,666 common shares for an aggregate offering price of USD 7.8 million
pursuant to the A.G.P. Sales Agreement.
As of June 30, 2022 the fair value of the warrants
issued in the January 2018 Registered Offering amounted to zero. Therefore, the fair value decreased by the total amount of CHF 1,233
in the first six months of 2022 (fair value as of December 31, 2021: CHF 1,233).
The warrants issued in the February 2017 public offering expired on
February 22, 2022, without any warrants having been exercised.
Issue of common shares upon exercise of options
During the six months ended June 30, 2022, no options were exercised.
On
February 4, 2022, the Company entered into a convertible loan agreement (the “Loan Agreement”) with FiveT Investment Management
Ltd. (the “Lender”), pursuant to which the Lender has agreed to loan to the Company CHF 5,000,000 (the “Loan”),
which Loan bears interest at the rate of 10% per annum and matures 12 months from the date (the “Disbursement Date”) the
Loan proceeds were disbursed to the Company, which occurred on February 8, 2022. The Company may prepay all or part of the Loan after
six months after the Disbursement Date; provided that the Company will pay an amount equal to 130% of the desired prepayment amount.
The Lender has the right to convert all or part of the Loan, including accrued and unpaid interest, at its option, into common shares,
subject to the limitation that the Lender own no more than 9.99% of the common shares at any time. The conversion price of the Loan into
common shares is USD 38.916, which corresponds to 150% of USD 25.944 (the trading volume weighted average price, the “VWAP”,
per common share on the NASDAQ stock exchange on the Disbursement Date), converted into Swiss Francs at the midpoint of the interbank
exchange rate shown by UBS on the day of receipt of the conversion notice at 4:00 pm Central European Time. The conversion price shall
be lowered in the event that the Company raises equity before the maturity date of the Loan through a public or private offering of common
shares at an issue price that is at least 10 (ten) % below the VWAP (the “New Issue”), according to the formula set forth
in the Loan Agreement (the “Adjustment”). Sales of common shares through equity line or at-the-market programs are not considered
New Issues triggering the Adjustment.
As
of June 30, 2022, the carrying amount of the host for the unconverted outstanding loan amounted to CHF 4,701,906 and is included in the
balance sheet under current liabilities. The fair value of the embedded derivatives amounted to CHF 284 (at initial recognition February
8, 2022: CHF 449,898) included in current derivative financial instruments. A revaluation gain related to fair value measurement of embedded
derivatives of CHF 449,614 as well as effective interest expenses and transaction costs of CHF 359,068 in total were recorded in profit
or loss.
Due
to the COVID-19 pandemic, Swiss banks granted special COVID-19 loans under certain conditions with a guarantee by the Swiss Government.
Our Company was eligible for a loan of CHF 50,000, which was granted on March 26, 2020. The loan is interest-free and may be repaid at
any time with a maximum term of five years. We repaid the entire loan as of June 16, 2021.
| |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2022 | | |
2021 | |
Salaries | |
| 1,439,578 | | |
| 812,158 | |
Pension costs | |
| 132,784 | | |
| 66,002 | |
Share based compensation expense | |
| 180,808 | | |
| 969,739 | |
Other employee costs and social benefits | |
| 157,358 | | |
| 257,108 | |
Total employee benefits | |
| 1,910,528 | | |
| 2,105,007 | |
Expenditures
for employee benefits increased in the first six months ended June 30, 2022 primarily due to increased headcount compared to the first
six months ended June 30, 2021. Share based compensation included expense related to employee stock options of CHF 180,808 in the first
six months ended June 30, 2022 compared to CHF 159,487 in the first six months ended June 30, 2021. In 2021, share based compensation
expense included CHF 810,252 for a share bonus grant related to the strategic repositioning of the Company, including CHF 360,112 for
a future share grant contingent on achieving certain results related to the Trasir transaction.
A
total of 27,861 options were granted in the six months ended June 30, 2022 (6,862 options in the corresponding six-month period in 2021).
The exercise price of the options granted as share based compensation under the Equity Incentive Plan was USD 20.80 (for the six months
ended June 30, 2021 USD 70.20). The methodology for computation of share based compensation expense for the period is consistent with
the methodology used in 2021.
| 7. | Write-down
of inventories |
The
Company’s inventory consists of the product Bentrio, a drug-free nasal spray for protection against airborne viruses and allergens.
Bentrio has a limited shelf life, which may affect the salability of the product, and is packaged in various configurations (stock keeping
units, “SKUs”) for different markets. During the six months ended June 30, 2022, the Company wrote down finished goods inventories
by CHF 764,844, based on a management review for any obsolete or slow-moving items. The write-down is included in Cost of Sales in the
condensed consolidated statement of profit or loss and other comprehensive income. There were no inventory write-downs recognized during
the six months ended June 30, 2021.
| 8. | Revision
of Prior Period Financial Statements |
In
connection with the preparation of our consolidated financial statements, we identified an immaterial error with regard to advance payments
for research and development costs and related tax credits for the annual period ended December 31, 2021. The error was mainly related
to investigator float payments to a contract research organization. Due to COVID and other reasons, the scheduled services had not been
provided by the end of the year and therefore the payments should have been recognized as advance payments and not as R&D expenses.
We evaluated the error and determined that the related impact was not material to our financial statements for any prior periods, but
that correction of the impact of the error would be significant to our results of operations for the six months ended June 30, 2022.
Accordingly, we have revised previously reported financial information for such immaterial error, as previously disclosed in our Annual
Report on Form 20-F for the year ended December 31, 2021. A summary of revisions to our previously reported financial statements presented
herein for comparative purposes is included below.
Revised consolidated Balance Sheet
| |
As of December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Other receivables | |
| 917,833 | | |
| (246,493 | ) | |
| 671,340 | |
Prepayments | |
| 996,910 | | |
| 578,216 | | |
| 1,575,126 | |
Total current assets | |
| 3,759,901 | | |
| 331,723 | | |
| 4,091,624 | |
Total assets | |
| 18,838,598 | | |
| 331,723 | | |
| 19,170,321 | |
Accumulated deficit | |
| (176,018,660 | ) | |
| 331,723 | | |
| (175,686,937 | ) |
Total shareholders’ equity attributable to owners of the company | |
| 12,704,528 | | |
| 331,723 | | |
| 13,036,251 | |
Total equity and liabilities | |
| 18,838,598 | | |
| 331,723 | | |
| 19,170,321 | |
Revised consolidated Statement of Profit or Loss and Other Comprehensive Loss
| |
Year ended December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Other income | |
| 460,710 | | |
| (246,493 | ) | |
| 214,217 | |
Research and development | |
| (8,939,037 | ) | |
| 578,216 | | |
| (8,360,821 | ) |
Total operating expenses | |
| (15,137,338 | ) | |
| 331,723 | | |
| (14,805,615 | ) |
Operating loss | |
| (17,099,793 | ) | |
| 331,723 | | |
| (16,768,070 | ) |
Loss before tax | |
| (17,368,546 | ) | |
| 331,723 | | |
| (17,036,823 | ) |
Net loss attributable of owners of the Company | |
| (17,390,166 | ) | |
| 331,723 | | |
| (17,058,443 | ) |
Total comprehensive loss attributable to owners of the Company | |
| (17,124,410 | ) | |
| 331,723 | | |
| (16,792,687 | ) |
Basic and diluted loss per share | |
| (26.26 | ) | |
| 0.50 | | |
| (25.76 | ) |
Basic
and diluted loss per share as presented in the financial statements as of December 31, 2021, prior to the one-for-twenty reverse share
split on October 25, 2022 was CHF 1.31, and the revised number would have been CHF 1.29.
Revised
consolidated Statement of Cash Flows
We
revised our consolidated statement of cash flows for the year ended December 31, 2021. There was no impact on net cash used in operating
activities.
| |
Year ended December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Net loss | |
| (17,390,166 | ) | |
| 331,723 | | |
| (17,058,443 | ) |
Changes in: | |
| | | |
| | | |
| | |
Trade and other receivables | |
| (586,612 | ) | |
| 246,493 | | |
| (340,119 | ) |
Prepayments | |
| (719,321 | ) | |
| (578,216 | ) | |
| (1,297,537 | ) |
Cash used in operating activities | |
| (13,627,738 | ) | |
| — | | |
| (13,672,738 | ) |
| |
Six Months Ended | |
| |
June 30, | | |
| |
| |
2022 | | |
June 30, | |
| |
(restated) | | |
2021 | |
Loss attributable to owners of the Company | |
| (8,238,518 | ) | |
| (6,754,579 | ) |
Weighted average number of shares outstanding | |
| 774,898 | | |
| 622,741 | |
Basic and diluted loss per share | |
| (10.63 | ) | |
| (10.85 | ) |
For
the six months ended June 30, 2022 and June 30, 2021 basic and diluted loss per share are calculated based on the weighted average number
of shares issued and outstanding and excludes shares to be issued under the stock option plans or for warrants, as they would be anti-dilutive.
As of June 30, 2022, the Company had 94,337 options outstanding under its stock option plan. The average number of options outstanding
between January 1, 2022 and June 30, 2022 was 74,996 (54,025 for the period between January 1, 2021 and June 30, 2021).
10.
Events after the Reporting Period
Loan
Agreement
On
September 9, 2022 the Company entered into a loan agreement with FiveT Investment Management Ltd., Dominik Lysek and Thomas Meyer (the
“Lenders”), pursuant to which the Lenders have agreed to loan to the Company an aggregate of CHF 600,000.00, which loan bears
interest at the rate of 5% per annum and matures as of March 31, 2023. The Company agreed to grant to the Lenders warrants (the “Warrants”)
to purchase an aggregate 41,667 common shares. The Warrants will be exercisable at an exercise price of CHF 7.20 per share for up to
five years from October 1, 2022.
Divestiture
of inner ear therapeutic assets
On
October 21, 2022, the Company announced the sale of 90% of the share capital of its subsidiary Zilentin AG and of an option to purchase
the subsidiaries Auris Medical AG, Otolanum AG, Auris Medical Ltd. and Auris Medical Pty Ltd (the “Additional Subsidiaries”)
– representing the Company’s inner ear therapeutic assets – to a European family office (the “Buyer”) for
a cash consideration of USD 1 million each. Under the terms of the option agreement (the “Option”) Zilentin will be entitled
to purchase the Additional Subsidiaries for an upfront payment of USD 25 million plus up to USD 55 million upon reaching certain clinical
and regulatory milestones as well as royalties on revenues generated with products based on Altamira’s RNA delivery technology
for certain inner ear targets at a mid-single digit percentage. The Option may be exercised for 30 days from October 19, 2022 (the “Closing
Date”); beyond that period, Zilentin will have a right of first refusal to acquire these companies until year end with the upfront
payment increasing by USD 1 million per month. Due to a delay in the closing of the Zilentin Transaction, the Company and the Buyer agreed
on November 23, 2022 to amend their agreement, extending the Closing Date to December 15, 2022 at the latest, increasing the share capital
of Zilentin AG to be sold under the transaction from 90 to 100% and raising the amount of the initial payment for the purchase of Zilentin
and for the option to purchase the Additional Subsidiaries from USD 2 million to USD 2.2 million.
Subsequent
to June 30, 2022, and after completion of the disposal of Zilentin and the sale of the purchase option for the Additional Subsidiaries,
the respective assets and liabilities associated with the purchase option will be classified as held for sale and measured at the lower
of carrying amount and fair value less costs to sell. The assets held for sale mainly comprise capitalized development costs related
to the AM-125 program, which amounted to CHF 12.0 million as of June 30, 2022.
Reverse
share split
On
October 25, 2022, the Company effected a one-for-twenty reverse stock split. Following the share split, the Company had 1,074,713 common
shares at a par value of CHF 0.20 each outstanding. No fractional common shares were issued as fractional common shares were settled
in cash.
Commitment
purchase agreement
On
November 14, 2022, we entered into a term sheet with LPC for the conclusion of a purchase agreement under which LPC would commit to subscribe
for up to USD 10,000,000 of our common shares over the 24-month term of the purchase agreement. The Company and LPC endeavor to enter
into a mutually acceptable purchase agreement (the “2022 Commitment Purchase Agreement”) and related documentation within
ten business days from the date of the term sheet. The Company shall pay to LPC upon signing of the 2022 Commitment Purchase Agreement
a commitment fee at its sole discretion of either (i) USD 250,000 in cash or (ii) issue 50,000 Common Shares and prepare and file as
soon as practicable a resale registration statement registering the shares issuable under the 2022 Commitment Purchase Agreement.
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25.76
26.26
0.50
10.63
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Exhibit
99.2
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This
management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results
of operations. We recommend that you read this in conjunction with our Unaudited Condensed Consolidated Interim Financial Statements
as of and for the six months ended June 30, 2022 and 2021 included as Exhibit 99.1 to this Report on Form 6-K, which have been prepared
in accordance with International Accounting Standard (“IAS”) 34, Interim Financial Reporting. We also recommend that
you read our management’s discussion and analysis and our audited consolidated financial statements and the notes thereto, which
appear in our Annual Report on Form 20-F for the year ended December 31, 2021 (the “Annual Report”) filed with the U.S. Securities
and Exchange Commission (the “SEC”) pursuant to the U.S. Securities and Exchange Act of 1934, as amended.
Unless
otherwise indicated or the context otherwise requires, all references in this report to “Altamira Therapeutics Ltd.” or “Altamira,”
the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to (i) Auris
Medical Holding Ltd. (formerly Auris Medical Holding AG), or Auris Medical (Switzerland), together with its subsidiaries, prior to our
corporate reorganization by way of the Merger (as defined below) on March 13, 2018 (i.e. to the transferring entity), (ii) to Auris Medical
Holding AG (formerly Auris Medical NewCo Holding AG), together with its subsidiaries after the Merger (i.e. to the surviving entity)
and prior to the Redomestication (as defined below) and (iii) to Auris Medical Holding Ltd., a Bermuda company, or Auris Medical (Bermuda),
the successor issuer to Auris Medical (Switzerland) under Rule 12g-3(a) of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), after the effective time of the Redomestication, which occurred on March 18, 2019. The trademarks, trade names and service
marks appearing in this report are property of their respective owners.
Altamira
Therapeutics Ltd. is an exempted company incorporated under the laws of Bermuda. We began our operations as a corporation organized in
accordance with Swiss law and domiciled in Switzerland under the name Auris Medical Holding AG (“Auris Medical (Switzerland)”).
Following shareholder approval at an extraordinary general meeting of shareholders held on March 8, 2019 and upon the issuance of a certificate
of continuance by the Registrar of Companies in Bermuda on March 18, 2019, we discontinued as a Swiss company and, pursuant to Article
163 of the Swiss Federal Act on Private International Law and pursuant to Section 132C of the Companies Act 1981 of Bermuda (the “Companies
Act”), continued existence under the Companies Act as a Bermuda company with the name “Auris Medical Holding Ltd.”
(the “Redomestication”). On March 18, 2019, the common shares of Auris Medical Holding Ltd. began trading on the Nasdaq Capital
Market under the trading symbol “EARS”. Our registered office is located at Clarendon House, 2 Church Street, Hamilton HM
11, Bermuda. On May 1, 2019, we effected a one-for-twenty reverse share split (the “2019 Reverse Share Split”) of our issued
and outstanding common shares. Following shareholders’ approval at an extraordinary general meeting of shareholders held on July
21, 2021 we changed our name to Altamira Therapeutics Ltd. On October 25, 2022, the Company effected a one-for-twenty reverse share split
(the “2022 Reverse Share Split”) of the Company’s issued and outstanding common shares. All per share amounts and numbers
of common shares in this report reflect the 2019 Reverse Share Split and the 2022 Reverse Share Split.
Unless
indicated or the context otherwise requires, (i) all references in this report to our common shares as of any date prior to March 13,
2018 refer to the common shares of Auris Medical (Switzerland) (having a par value of CHF 0.40 per share (pre-2019 Reverse Share Split
and 2022 Reverse Share Split)) prior to the 10:1 “reverse share split” effected through the Merger, (ii) all references to
the our common shares as of, and after, March 13, 2018 and prior to the Redomestication refer to the common shares of Auris Medical (Switzerland)
(having a par value of CHF 0.02 per share (pre-2019 Reverse Share Split and 2022 Reverse Share Split)) after the 10:1 “reverse
share split” effected through the Merger (iii) all references to our common shares as of, and after, the Redomestication on March
18, 2019 refer to the common shares of the Company (having a par value of CHF 0.02 per share pre-2019 Reverse Share Split and 2022 Reverse
Share Split)), (iv) the Company’s common shares after May 1, 2019, the date of the 2019 Reverse Share Split have a par value of
CHF 0.40 each (pre-2022 Reverse Share Split) and (v) the Company’s common shares after October 25, 2022, the date of the 2022 Reverse
Share Split have a par value of CHF 0.20 each. As of June 30, 2020, we reduced the par value of our shares to CHF 0.01 each (pre-2022
Reverse Share Split).
We
prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting
Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our financial
statements were prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”).
We maintain our books and records in Swiss Francs. We have made rounding adjustments to some of the figures included in this management’s
discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures
that precede them. Unless otherwise indicated, all references to currency amounts in this discussion and analysis are in Swiss Francs.
This
discussion and analysis is dated as of November 28, 2022.
Overview
We
are a clinical-and commercial-stage biopharmaceutical company developing therapeutics that address important unmet medical needs. We
are currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™
platforms; preclinical), nasal sprays for protection against airborne allergens, and where approved, viruses (Bentrio™; commercial)
or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing
loss (Keyzilen® and Sonsuvi®, Phase 3). We have announced our intention to reposition the Company around
RNA therapeutics while exploring strategic options to either divest our traditional businesses or spin them off as a separate entity
to shareholders.
Recent
Developments
Development
and commercial launch of Bentrio™ nasal spray
In
June 2021 we announced the market launch of Bentrio™, our drug-free nasal spray for protection against airborne viruses and allergens,
in Germany, and our intention to expand market coverage progressively through additional distribution channels and in further countries.
Bentrio™ is marketed as an “over-the-counter” medical device. Bentrio™ is based on a gel emulsion which works
by forming a protective layer on the nasal mucosa that acts as a physical barrier. In its natural state, Bentrio™ is viscous; for
application via spray it must be briefly shaken, rendering it liquid. Upon contacting the nasal mucosa, the formulation reverts to its
normal viscous state, which supports an extended nasal residence time. Development of the product had been initiated under code name
AM-301 in summer 2020. For the project, we set up a new subsidiary, Altamira Medica Ltd. (“Altamira”), based in Zug, Switzerland.
On
March 4, 2022 we announced that we had entered into an exclusive licensing and distribution agreement for Bentrio™ with Nuance
Pharma Ltd. (“Nuance”) in Chinese Mainland, Hong Kong, Macau and South Korea (the “Territory”). Under the terms
of the agreement, we will initially supply Bentrio™ to Nuance. Nuance made an upfront payment of USD 1 million and may pay to Altamira
development and commercial milestones of up to USD 3 million and up to USD 19.5 million, respectively. In a second stage, Nuance will
assume local production of the product for the Territory upon certain milestones. Once Nuance assumes local production of Bentrio™,
it will pay to us a staggered royalty on net sales in the Territory at a high-single to low-double-digit percentage.
On
May 20, 2022 we announced the results from a clinical trial with Bentrio™ in house dust mite (HDM) allergic rhinitis. The trial
enrolled a total of 37 patients with a history of perennial allergic rhinitis (“PAR”) caused by HDM exposure. Study participants
were randomized under an open label, three-period crossover design to receive either Bentrio™ in a single or double dose, or no
treatment, prior to controlled allergen exposure in an environmental exposure chamber for three hours. Bentrio™ treatment reduced
the increase in mean total nasal symptoms score (TNSS) by 1.1 points (-1.87 to -0.28 in the 95% confidence interval; p<0.01) vs. no
treatment. The protective effect was observed both with a single or double puff per nostril with no meaningful difference between the
two treatment approaches. Bentrio™ treatment was safe and well tolerated.
On
June 25, 2022 we received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Bentrio™ (“Bentrio
Allergy Blocker”) for the treatment of allergic rhinitis (hay fever) in the US. Clearance was obtained for the following
indication for use:
| ● | Bentrio
is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic
symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages)
triggered by the inhalation of various airborne allergens including indoor and outdoor environmental
pollens, house dust, animal hair and dust mites. |
| ● | Application
of Bentrio produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled
allergens within the nasal cavity and helps with their clearance. |
We
intend to market and distribute Bentrio™ Allergy Blocker in the US, and going forward also in Europe, through well-established
OTC consumer health companies.
AM-125
Phase 2 trial in acute vertigo (“TRAVERS”)
On
June 13. 2022 we announced positive top-line data from our Phase 2 TRAVERS trial with AM-125 (intranasal betahistine) in acute vertigo.
The randomized, double-blind, placebo-controlled TRAVERS trial enrolled at more than ten study sites across Europe a total of 124 patients
who suffered from acute vertigo following surgery for the removal of a tumor. Patients were randomized to receive either AM-125 at up
to 20 mg or a placebo three times daily for four weeks, which was followed by a two-week treatment-free observation period. In addition,
all trial participants followed a standardized course of vestibular rehabilitation therapy. Improvement in the “Tandem Romberg”
test, which measures how long patients are able to maintain balance with their two feet aligned one after the other while they have their
eyes closed, served as the primary efficacy outcome. For reference, the trial also included 16 patients who received ‘open label’
oral betahistine at 16 mg three times daily (the approved dose in most countries worldwide).
The
TRAVERS trial demonstrated good safety and tolerability of AM-125. Further, administration of AM-125 resulted in a dose- and time-dependent
improvement in balance and vestibular compensation. At treatment period end, mean Tandem Romberg improvement was 10.9 sec. for the 20
mg group vs. 7.4 sec. for the placebo group (mixed model repeated measures, p=0.08, significant at α = 0.05, one-sided). This was
corroborated by higher frequency of complete spontaneous nystagmus resolution (34.5 vs. 20.0% of patients). Based on the outcomes, we
are planning to file an investigational new drug application with the US Food and Drug Administration (FDA) in the fourth quarter of
2022.
Acquisition
of Trasir Therapeutics and strategic repositioning around RNA therapeutics
On
June 1, 2021, we acquired 100% of the share capital of privately held Trasir Therapeutics Inc. (“Trasir”) through the merger
of our subsidiary Auris Medical Inc. with and into Trasir (the “Merger”), with Trasir surviving the merger as the surviving
entity. Trasir was subsequently renamed Altamira Therapeutics, Inc. and redomiciled in Dover, Delaware. Founded in 2014, Trasir has been
a pioneer in the development of nanoparticles for extrahepatic oligonucleotide delivery.
The
transaction has been the starting point for a strategic repositioning under which the Company intends to focus on the development of
RNA therapeutics while in the medium term aiming to spin off or divest our non-RNA assets, which are our assets in neurotology, rhinology
and allergology, including Bentrio™, AM-125, Keyzilen®, Sonsuvi® and certain early-stage drug product candidates. Dr. Samuel
Wickline, Trasir’s founder and Professor of Medicine, was appointed Chief Scientific Officer and joined the Company’s leadership
team. In addition, to reflect the Company’s strategic repositioning, the shareholders convened for a Special General Meeting on
July 21, 2021 to approve the change of its corporate name to Altamira Therapeutics Ltd. and elected Margrit Schwarz, PhD, MBA, as an
additional Board member. Further, on July 26, 2021, the Company’s common shares started trading under the ticker symbol “CYTO”
instead of “EARS”.
Trasir’s
core technology is the proprietary peptide polyplex platform OligoPhore™ and its equivalent SemaPhore™ that can engage any
type of short interfering RNA (siRNA) or messenger RNA (mRNA), respectively, in rapid self-assembly. The technology allows for safe and
effective systemic delivery of RNA payloads with efficient cellular uptake and full endosomal release. Importantly, it enables delivery
to target tissues outside the liver, creating the potential for developing RNA-based therapies for a range of indications with substantial
unmet need.
In
various murine models of disease, OligoPhore™ and SemaPhore™ have been shown to protect the RNA payload (siRNA and/or mRNA)
from degradation in the circulation, while enabling pH-dependent nucleotide endosomal escape and cytoplasmic delivery. Proof-of-concept
for efficient delivery and target knockdown has been demonstrated for targets in the NF-kB family, various members of the ETS transcription
factor family, and targets in the JNK and TAM pathways, enabling a preclinical development pathway for several oncology indications,
rare diseases, as well as rheumatoid and osteoarthritis and inflammatory pathologies such as atherosclerosis.
In
July 2021, we announced the selection of mutant KRAS-driven colorectal cancer as the first therapeutic indication for our OligoPhore™
oligonucleotide delivery platform and the launch of a development program under product development code AM-401. In July 2022 we announced
the initiation of a second development program, AM-411, which is intended for the treatment of rheumatoid arthritis.
Russian
invasion of Ukraine
In
the context of Russia’s recent invasion of the Ukraine, oil and gas prices, which are key input factors for plastic parts such
as those used for the primary packaging of Bentrio™, as well as other components such as cardboard for packaging have increased
significantly and shown high volatility. Continued escalation of political tensions, economic instability, military activity or civil
hostilities in Ukraine could result in significant price increases for such components or difficulties of our component suppliers to
supply such components on a timely basis. If we are unable to pass on such price increases, or if component supplies are interrupted,
our business, financial condition and results of operation could be adversely affected.
COVID-19
Pandemic
In
December 2019, a novel strain of coronavirus COVID-19 was reported to have surfaced in Wuhan, China. The extent to which COVID-19 may
impact our preclinical and clinical trial operations will depend on future developments, which are highly uncertain and cannot be predicted
with confidence, such as the duration and geographic reach of the outbreak, the severity of COVID-19, and the effectiveness of actions
to contain and treat COVID-19. For example, the COVID-19 outbreak delayed enrollment of patients into our “TRAVERS” phase
2 trial with AM-125. Candidates for participation in this trial undergo certain types of neurosurgery, which are classified as elective
procedures. Due to the COVID-19 outbreak, many sites participating in the “TRAVERS” trial postponed elective procedures and
temporarily reduced or suspended clinical research activities. The effect was particularly felt in spring 2020 and then again in early
2021.
The
continued spread of COVID-19 globally could otherwise adversely impact our clinical trial operations, including our ability to recruit
and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19
if an outbreak occurs in their geography. Disruptions or restrictions on our ability to travel to monitor data from our clinical trials,
or to conduct clinical trials, or the ability of patients enrolled in our studies to travel, or the ability of staff at study sites to
travel, as well as temporary closures of our facilities or the facilities of our clinical trials partners and their contract manufacturers,
would negatively impact our clinical trial activities. In addition, we rely on independent clinical investigators, contract research
organizations and other third-party service providers to assist us in managing, monitoring and otherwise carrying out our preclinical
studies and clinical trials, including the collection of data from our clinical trials, and the outbreak may affect their ability to
devote sufficient time and resources to our programs or to travel to sites to perform work for us. Similarly, our preclinical trials
could be delayed and/or disrupted by the outbreak. As a result, the expected timeline for data readouts of our preclinical studies and
clinical trials and certain regulatory filings may be negatively impacted, which would adversely affect our ability to obtain regulatory
approval for and to commercialize our product candidates, increase our operating expenses and have a material adverse effect on our financial
results. Finally, the COVID-19 outbreak and its impact on the global financial markets may limit our ability to raise additional funds
to continuously fund our operations and complete the research and development of all our product candidates.
2022
Reverse Share Split
On
October 25, 2022, we effected a reverse share split (the “2022 Reverse Share Split”) of our common shares at a ratio of one-for-twenty.
When the reverse share split became effective, every 20 of our pre-split issued and outstanding common shares, par value 0.01 per share,
were combined into one common share, par value CHF 0.20 per share. Effecting the 2022 Reverse Share Split reduced the number of our issued
and outstanding common shares from 21,494,261 common shares to 1,074,713 common shares. It also simultaneously adjusted outstanding options
issued under our equity incentive plan and outstanding warrants to purchase common shares. All per share amounts and numbers of common
shares in this management’s discussion and analysis reflect the 2022 Reverse Share Split.
Collaboration
and License Agreements
On
December 11, 2020, Trasir entered into an Exclusive License Agreement with Washington University located in St. Louis, Missouri (“WU”),
which Exclusive License Agreement was subsequently amended and restated in June 2021 (as so amended and restated, the “Agreement”),
with effect as of December 11, 2020. Pursuant to the Agreement, WU granted Trasir an exclusive, worldwide, royalty-bearing license (with
the right to sublicense) during the term of the Agreement under certain patent rights owned or controlled by WU to research, develop,
make, have made, sell, offer for sale, use and import pharmaceutical products covered under such patent rights for all fields of use.
Such licensed products may include “silencing RNA” (siRNAs) pharmaceutical preparations formulated in combination with Trasir’s
proprietary delivery technologies. In consideration for such worldwide, exclusive license, the Company (through its acquisition of Trasir,
described above) will be obligated to pay WU: annual license maintenance fees in the low five figures through first commercial sale;
pre-clinical and clinical regulatory milestones; sales milestones; and a low single digit royalty based on annual net sales of licensed
products worldwide for at least the applicable patent term or period of marketing exclusivity, whichever is longer, but in no case less
than a minimum royalty term of 12 years; and a percentage share (in the double digits) of sublicensing revenues received by the Company
in connection with licensed products. Such regulatory and sales milestones may total up to an aggregate of USD 4,375,000. In the event
the Company fails to meet certain regulatory diligence milestones, WU will have the right to terminate the license. The Agreement also
contains customary representations, warranties and covenants by both parties, as well as customary provisions relating to indemnification,
confidentiality and other matters.
Research
and Development Expense
Our
research and development expense is highly dependent on the development phases of our research projects and therefore may fluctuate substantially
from period to period. Our research and development expense mainly relates to the following key programs:
| ● | AM-301
for protection against airborne viruses and allergens. Since the initiation of the development
program in September 2020, we have conducted a variety of in vitro and in vivo studies as
well as clinical investigations to determine the tolerability, safety and efficacy of Bentrio™
and to meet various regulatory requirements for marketing the nasal spray as a medical device
in various countries and regions. . While these assessments for obtaining market clearance
and related expenditures were essentially completed in the third quarter of 2022, we have
various other studies either ongoing or planned to further expand the body of evidence for
current or additional uses of the product. |
| ● | AM-401
for the treatment of mutant KRAS-driven colorectal cancer. Since the acquisition of Trasir
became effective only on June 1, 2021, we have initiated additional pharmacology studies
and the development and scale-up of the peptide carrier and siRNA payloads as well as analytical
development. Expenditure levels are expected to increase further as we plan to conduct various
IND-enabling studies, including toxicology in non-human primates, and move into larger-scale
production of the peptide, siRNA payloads and nanoparticles. |
| ● | AM-411
for the treatment of rheumatoid arthritis. We initiated in July 2022 a second development
program based on our OligoPhore™ delivery platform, using siRNA targeting NF-kB (p65)
for the treatment of rheumatoid arthritis. The program will benefit from substantial synergies
with program AM-401. |
| ● | AM-125
for the treatment of acute vestibular syndrome. We evaluated intranasal betahistine for
the treatment of acute vestibular syndrome in the Phase 2 TRAVERS clinical trial. In June
2022 we reported positive results from the TRAVERS trial, which showed a time- and dose-dependent
improvement in balance and vestibular compensation. In parallel, we have been conducting
several IND-enabling preclinical studies which we completed during the second half of 2021
and the first half of 2022. We intend to file an IND with the FDA in the fourth quarter of
2022 and subsequently to initiate a Phase 3 clinical program. |
| ● | AM-201
for Antipsychotic-Induced Weight Gain. We evaluated intranasal betahistine in a Phase
1b clinical trial in the prevention of antipsychotic-induced weight gain and somnolence.
The study was initiated in March 2019 at a single site in Europe and completed in 2020. While
the trial showed a dose dependent reduction in antipsychotic-induced weight gain, in the
context of our strategic repositioning, we have decided to deprioritize project AM-201 and
suspended all development work. |
Other
research and development expenses mainly relate to our pre-clinical studies of AM-102 (second generation tinnitus treatment). The expenses
mainly consist of costs for synthesis of the pre-clinical compounds and costs paid to academic and other research institutions in conjunction
with pre-clinical testing.
For
a discussion of our other key financial statement line items, please see “Item 5—Operating and Financial Review and Prospects–Operating
results — Financial Operations Overview” in the Annual Report.
Results
of Operations
The
numbers below have been derived from our Unaudited Condensed Consolidated Interim Financial Statements as of and for the six months ended
June 30, 2022 and 2021. The discussion below should be read along with this financial information, and it is qualified in its entirety
by reference to them.
Adjustment
of June 30, 2022 Revenue
In
the Company's Unaudited Condensed Consolidated Interim Financial Statements as of June 30, 2022 and for the six months ended June 30,
2022, furnished with the SEC on November 30, 2022 with a Report of Foreign Private Issuer on Form 6-K (the “Original Form 6-K”),,
an upfront payment of $1 million (CHF 0.9 million) related to the exclusive licensing and distribution agreement with Nuance Pharma for
Bentrio® was incorrectly recorded as revenue. In the audited financial statements as of December 31, 2022 included in the Company’s
Annual Report on Form 20-F filed with the SEC on May 16, 2023, the upfront payment was recorded as deferred income, following the correction
of the identified misstatement. Adjustments for this correction are reflected in the restated condensed consolidated interim financial
statements as of June 30, 2022 and for the six months ended June 30, 2022 included in this report. The table below reflects the impact
of the adjustments on key income statement and balance sheet line items.
Six
months ended June 30, 2022
Adjusted
consolidated Balance Sheet
| |
As of June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Deferred income | |
| - | | |
| 932,200 | | |
| 932,200 | |
Total non-current liabilities | |
| 1,014,188 | | |
| 932,200 | | |
| 1,946,388 | |
Total liabilities | |
| 10,804,712 | | |
| 932,200 | | |
| 11,736,912 | |
Accumulated deficit | |
| (182,602,921 | ) | |
| (932,200 | ) | |
| (183,535,121 | ) |
Total shareholders’ equity attributable to owners of the company | |
| 7,675,164 | | |
| (932,200 | ) | |
| 6,742,964 | |
Adjusted
consolidated Statement of Profit or Loss and Other Comprehensive Loss
| |
Half-Year ended June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Revenue | |
| 1,222,998 | | |
| (932,200 | ) | |
| 290,798 | |
Gross profit | |
| 30,766 | | |
| (932,200 | ) | |
| (901,434 | ) |
Operating loss | |
| (7,483,561 | ) | |
| (932,200 | ) | |
| (8,415,761 | ) |
Loss before tax | |
| (7,352,403 | ) | |
| (932,200 | ) | |
| (8,284,603 | ) |
Net loss attributable of owners of the Company | |
| (7,306,318 | ) | |
| (932,200 | ) | |
| (8,238,518 | ) |
Total comprehensive loss attributable to owners of the Company | |
| (7,160,269 | ) | |
| (932,200 | ) | |
| (8,092,469 | ) |
Basic and diluted loss per share | |
| (9.43 | ) | |
| (1.20 | ) | |
| (10.63 | ) |
Comparison of the six months ended June 30, 2022 and 2021:
| |
Six months ended | | |
| |
| |
June 30, | | |
| |
| |
2022 | | |
| | |
| |
| |
(restated) | | |
2021 | | |
Change | |
| |
(in thousands of CHF) | | |
% | |
| |
| | |
| | |
| |
Revenue | |
| 291 | | |
| - | | |
| n/a | |
Cost of sales | |
| (1,192 | ) | |
| - | | |
| n/a | |
Gross profit | |
| (901 | ) | |
| - | | |
| n/a | |
Other operating income | |
| 256 | | |
| - | | |
| n/a | |
Research and development | |
| (3,564 | ) | |
| (3,394 | ) | |
| 5 | % |
Sales and marketing | |
| (2,130 | ) | |
| - | | |
| n/a | |
General and administrative | |
| (2,076 | ) | |
| (3,062 | ) | |
| (32 | )% |
Operating loss | |
| (8,415 | ) | |
| (6,456 | ) | |
| 30 | % |
Interest expense | |
| (377 | ) | |
| (172 | ) | |
| 119 | % |
Foreign currency exchange gain (loss), net | |
| 58 | | |
| 292 | | |
| (80 | )% |
Revaluation (loss)/gain from derivative financial instruments | |
| 451 | | |
| (429 | ) | |
| (205 | )% |
Transaction costs | |
| (1 | ) | |
| - | | |
| n/a | |
Loss before tax | |
| (8,284 | ) | |
| (6,765 | ) | |
| 22 | % |
Income tax gain | |
| 46 | | |
| 10 | | |
| 360 | % |
Net loss attributable to owners of the Company | |
| (8,238 | ) | |
| (6,755 | ) | |
| 22 | % |
Other comprehensive income: | |
| | | |
| | | |
| | |
Items that will never be reclassified to profit or loss | |
| | | |
| | | |
| | |
Remeasurements of defined benefit liability | |
| 210 | | |
| 449 | | |
| (53 | )% |
Items that are or may be reclassified to profit and loss | |
| | | |
| | | |
| | |
Foreign currency translation differences | |
| (64 | ) | |
| (42 | ) | |
| 52 | % |
Other comprehensive loss | |
| 146 | | |
| 407 | | |
| (64 | )% |
Total comprehensive loss attributable to owners of the company | |
| (8,092 | ) | |
| (6,348 | ) | |
| 27 | % |
Revenue
The
revenue for the first half-year of 2022 includes product sales of Bentrio™.
Cost of Sales
| |
Six months ended | | |
| |
| |
June 30, | | |
| |
| |
2022 | | |
2021 | | |
Change | |
| |
(in thousands of CHF) | | |
% | |
Product purchases, packaging and logistics | |
| (348 | ) | |
| - | | |
| n/a | |
Employee benefits and expenses | |
| (79 | ) | |
| - | | |
| n/a | |
Inventory write-down | |
| (765 | ) | |
| - | | |
| n/a | |
Total | |
| (1,192 | ) | |
| - | | |
| n/a | |
As
of June 30, 2022, the Company’s inventory consisted of the product Bentrio, a drug-free nasal spray for protection against airborne
viruses and allergens. Bentrio has a limited shelf life, which may affect the salability of the product, and is packaged in various configurations
(stock keeping units, “SKUs”) for different markets and in different languages to address specific requirements under national
rules and regulations or by trade channels. Based on a management review of the inventory as at June 30, 2022 for any obsolete or slow-moving
items, the Company wrote down finished good inventories in the amount of CHF 0.8 million. The amount of the write down was expensed to
the income statement under Cost of Sales.
Research and development expense
| |
Six months ended | | |
| |
| |
June 30, | | |
| |
| |
2022 | | |
2021 | | |
Change | |
| |
(in thousands of CHF) | | |
% | |
Clinical projects | |
| (1,375 | ) | |
| (1,181 | ) | |
| 16 | % |
Pre-clinical projects | |
| (274 | ) | |
| (231 | ) | |
| 19 | % |
Drug manufacturing and substance | |
| (348 | ) | |
| (765 | ) | |
| (55 | )% |
Employee benefits | |
| (1,324 | ) | |
| (743 | ) | |
| 78 | % |
Other research and development expenses | |
| (243 | ) | |
| (474 | ) | |
| (49 | )% |
Total | |
| (3,564 | ) | |
| (3,394 | ) | |
| 5 | % |
Research
and development expenses amounted to CHF 3.6 million in the six months ended June 30, 2022. This represents an increase of CHF 0.2 million
compared to the six months ended June 30, 2021. Research and development expenses reflected the following:
| ● | Capitalization
of internal costs for AM-125. In the six months ended June 30, 2022, we capitalized direct
costs related to our AM-125 program for a total amount of CHF 1.5 million compared to CHF
1.7 million for the six months ended June 30, 2021. |
| ● | Clinical
projects. In the six months ended June 30, 2022 clinical expenses were higher than in
the six months ended June 30, 2021 by CHF 0.2 million due to higher trial activity levels. |
| ● | Pre-clinical
projects. In the six months ended June 30, 2022, pre-clinical expenses were essentially
unchanged compared to the six months ended June 30, 2021. |
| ● | Drug
manufacture and substance. In the six months ended June 30, 2022, drug manufacture and
substance related costs decreased by CHF 0.4 million compared to the six months ended June
30, 2021 due to lower levels of project work related to our AM-301 program. |
| ● | Employee
benefits. Employee expenses increased by CHF 0.6 million in the six months ended June
30, 2022 compared to the same period in 2021 due to a higher headcount and recruiting costs. |
| ● | Other
research and development expenses. Other research and development expenses decreased
by CHF 0.2 million in the six months ended June 30, 2022 compared to the same period in 2021
as we incurred lower expenditures for intellectual property and regulatory consulting services
to our AM-301 program. |
Sales and marketing expense
| |
Six months ended | | |
| |
| |
June 30, | | |
| |
| |
2022 | | |
2021 | | |
Change | |
| |
(in thousands of CHF) | | |
% | |
Marketing and sales expenses | |
| (2,028 | ) | |
| - | | |
| n/a | |
Employee benefits and expenses | |
| (102 | ) | |
| - | | |
| n/a | |
Total | |
| (2,130 | ) | |
| - | | |
| n/a | |
Marketing
and sales expenses are related to the commercial launch of Bentrio™ in selected European countries.
General and administrative expense
| |
Six months ended | | |
| |
| |
June 30, | | |
| |
| |
2022 | | |
2021 | | |
Change | |
| |
(in thousands of CHF) | | |
% | |
Employee benefits | |
| (405 | ) | |
| (1,362 | ) | |
| (70 | )% |
Lease expenses | |
| (7 | ) | |
| (26 | ) | |
| (73 | )% |
Business development | |
| (7 | ) | |
| (521 | ) | |
| (99 | )% |
Travel and representation | |
| (33 | ) | |
| (45 | ) | |
| (27 | )% |
Administration costs | |
| (1,565 | ) | |
| (1,108 | ) | |
| 41 | % |
Depreciation Right-of-use assets | |
| (59 | ) | |
| - | | |
| n/a | |
Total | |
| (2,076 | ) | |
| (3,062 | ) | |
| (32 | )% |
General
and administrative expense decreased to CHF 2.1 million in the six months ended June 30, 2022 compared to CHF 3.1 million in the same
period in the previous year, primarily due to lower employee benefits as there were lower shared-based bonus payments, which was partly
offset by an increase in general administration costs.
Interest
expense
Interest
expense in the six months ended June 30, 2022 amounted to CHF 376,848 (June 30, 2021: CHF 172,462) included CHF 357,930 related to the
FiveT convertible loan, as well as interest related to lease liabilities and bank charges.
Foreign
currency exchange gain / (loss), net
For
the six months ended June 30, 2022, fluctuations in foreign currency exchange rates resulted in a gain of CHF 0.06 million, compared
to a gain of CHF 0.3 million during the same period in the previous year.
Revaluation
gain / (loss) from derivative financial instruments
For
the six months ended June 30, 2022, CHF 449,614 of the revaluation gain from derivative financial instruments is related to the revaluation
of the financial derivatives embedded in the FiveT convertible loan. In the six months ended June 30, 2021, there was a revaluation loss
from derivative financial instruments of CHF 428,742.
On
January 30, 2018 we issued 1,875 warrants in connection with a direct offering of 3,125common shares, each warrant entitling its holder
to purchase one common share at an exercise price of USD 2,000.00 per common share. As of March 13, 2018, following the consummation
of the Merger, the warrants became exercisable for an aggregate of 1,875 of our common shares (assuming we decide to round up fractional
common shares to the next whole common share), at an exercise price of USD 2,000.00 per common share. As of June 30, 2022 the fair value
of the warrants amounted CHF 0. The revaluation gain of the derivative for the six months ended June 30, 2022 amounted to CHF 1,233,
compared to a revaluation loss of CHF 12,740 in the same period in 2021.
On
May 15, 2019, we issued 86,064 pre-funded warrants and 108,064 warrants in connection with the May 2019 Registered Offering of 22,000
common shares, with each pre-funded warrant entitling its holder to purchase one common share at an exercise price of CHF 0.20 and each
warrant entitling its holder to purchase one common share at an exercise price of CHF 86.80. All warrants were exercised between December
2020 and March 2021.
Cash
flows
Comparison of the six months ended June 30, 2022 and 2021
The
table below summarizes our cash flows for the six months ended June 30, 2022 and 2021:
| |
Six months ended | |
| |
June 30, | |
| |
2022 | | |
2021 | |
| |
(in thousands of CHF) | |
Net cash used in operating activities | |
| (5,584 | ) | |
| (4,919 | ) |
Net cash used in investing activities | |
| (1,533 | ) | |
| (1,989 | ) |
Net cash from financing activities | |
| 6,542 | | |
| 3,845 | |
Net effect of currency translation on cash | |
| (36 | ) | |
| 271 | |
Cash and cash equivalents at beginning of the period | |
| 984 | | |
| 11,259 | |
Cash and cash equivalents at end of the period | |
| 373 | | |
| 8,467 | |
Cash
and funding sources
On
February 4, 2022, the Company entered into a convertible loan agreement with FiveT Investment Management Ltd. The cash inflow from financing
activities for the six months ended June 30, 2022, includes CHF 5.0 million from the Five T convertible loan as well as proceeds from
equity issues.
On
December 1, 2020, a tranche of the convertible loan provided by FiveT in the amount of CHF 895,455 was converted into 36,850 common shares
at a conversion price of USD 27.00. The remaining amount of CHF 604,545 plus accumulated interest was converted into 25,841 common shares
at a conversion price of USD 27.00 on March 4, 2021.
On
December 3, 2020, the Company entered into securities purchase agreements with several institutional investors for the purchase and sale
of 100,000 common shares at an offering price of USD 80.00 per share, pursuant to a registered direct offering. The net proceeds of the
offering were approximately USD 7.3 million.
On
May 15, 2019, the Company completed a public offering of (i) 22,000 common shares, together with warrants to purchase 22,000 common shares,
and (ii) 86,064 pre-funded warrants, with each pre-funded warrant exercisable for one common share, together with warrants to purchase
86,064 common shares, including 5,500 common shares and warrants to purchase 5,500 common shares sold pursuant to a partial exercise
by the underwriters of the underwriters’ over-allotment option (the “May 2019 Registered Offering”). The exercise price
for the pre-funded warrants is CHF 0.20 per common share and for the warrants is CHF 86.80. The net proceeds to us from the May 2019
Registered Offering were approximately USD 7.6 million, after deducting underwriting discounts and other offering expenses payable by
us. In December 2020, 63,192 warrants were exercised, leaving 44,872 warrants outstanding as of December 31, 2020. These remaining warrants
were exercised in March 2021.
On
November 30, 2018, the Company entered into a sales agreement, as amended (the “A.G.P. Sales Agreement”) with A.G.P./Alliance
Global Partners (“A.G.P.”). Pursuant to the terms of the A.G.P. Sales Agreement, the Company may offer and sell its common
shares, from time to time through A.G.P. by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4)
promulgated under the Securities Act. Pursuant to the A.G.P. Sales Agreement, the Company may sell common shares up to a maximum aggregate
offering price of USD 25.0 million. As of June 30, 2022, the Company has sold 147,166 of its common shares for an aggregate offering
price of USD 6.7 million pursuant to the A.G.P. Sales Agreement, and as of the date of this report, the Company has sold a total of 228,666
common shares for an aggregate offering price of USD 7.8 million pursuant to the A.G.P. Sales Agreement.
On
July 17, 2018 the Company completed a public offering of 44,872 common shares, Series A warrants each entitling its holder to purchase
0.35 of a common share for an aggregate of 15,705 common shares, and Series B warrants entitling its holder to purchase 0.25 of a common
share for an aggregate of 11,218 common shares (the “July 2018 Registered Offering”). The exercise price for both series
Warrants at the time of the July 2018 Registered Offering was CHF 156.00 per common share. In accordance with the terms of certain Series
B warrants, the exercise price for certain Series B warrants was reduced in two steps to ultimately CHF 29.40. The net proceeds to us
from the July 2018 Registered Offering were approximately CHF 6.2 million, after deducting underwriting discounts and other offering
expenses payable by us.
On
April 23, 2020, the Company entered into a purchase agreement and a Registration Rights Agreement with Lincoln Park Capital Fund, LLC
(the “2020 Commitment Purchase Agreement”). Pursuant to the purchase agreement, LPC agreed to subscribe for up to USD 10,000,000
of our common shares over the 30-month term of the purchase agreement. Through June 30, 2022, we issued a total of 165,000 of our common
shares to LPC for an aggregate amount of USD 2,806,605 under the 2020 Commitment Purchase Agreement. During the six months ended June
30, 2022, we issued 105,000 of our common shares to LPC for an aggregate amount of USD 1,698,450 under the 2020 Commitment Purchase Agreement,
and as of the date of this report, we have issued a total of 325,000 of our common shares to LPC for an aggregate amount of USD 4,003,820
under the 2020 Commitment Purchase Agreement.
On
January 30, 2018, the Company completed a public offering of 3,125 common shares and concurrent offering of 1,875 warrants, each warrant
entitling its holder to purchase one common share (the “January 2018 Registered Offering”). The net proceeds to the Company
from the January 2018 Registered Offering were approximately CHF 4.5 million, after deducting placement agent fees and other estimated
offering expenses payable by the Company. As of March 13, 2018, following the consummation of the Merger, the outstanding warrants issued
in the January 2018 Registered Offering were exercisable for up to 1,875 common shares (assuming the Company rounds up fractional common
shares to the next whole common share) at an exercise price of USD 2000.00 per common share.
Due
to the COVID pandemic, Swiss banks granted special COVID-19 loans under certain conditions with a guarantee by the Swiss Government.
Our Company was eligible for a loan of CHF 50,000, which was granted on March 26th, 2020. The loan is interest-free and may
be repaid at any time with a maximum term of five years. We repaid the loan on June 16, 2021.
We
have no other ongoing material financial commitments, such as lines of credit or guarantees that are expected to affect our liquidity
over the next five years, other than leases.
Funding
requirements
We
have incurred recurring losses and negative cash flows from operations since inception and we expect to generate losses from operations
for the foreseeable future primarily due to research and development costs for our potential product candidates. We expect our total
cash need for funding operations in 2022 to be in the range of CHF 12.0 to 13.0 million. We believe that our cash position of CHF 372,647
at June 30, 2022, together with revenues from Bentrio product sales, the receipt of grants, proceeds from the issuance of Common Shares
under the A.G.P. Sales Agreement and the 2020 Commitment Purchase Agreement of USD 2.2 million up to the reporting date as well as from
further issuances under the A.G.P. Sales Agreement and the 2022 Commitment Purchase Agreement, and the $2.2 million upfront payment we
expect to receive under the Share Purchase Agreement and Option Agreement, dated October 19, 2022 and amended on November 23, 2022 (as
discussed below), will fund our projected operations through the fourth quarter of 2022. We expect that our funding requirements for
operations and financial obligations until the end of 2023 will amount to CHF 22.0 to 25.0 million and to CHF 17.0 to 20 million if the
convertible loan provided by FiveT will be converted into Common Shares. To the extent that we will be unable to generate sufficient
cash proceeds from the planned divestiture or spin-off of our legacy assets or other partnering activities, we will need substantial
additional financing to meet these funding requirements.
We
have based the above estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently
expect. Our future funding requirements will depend on many factors, including but not limited to:
| ● | the
ability to monetize our legacy assets, including the ability to close agreed divestiture
transactions, and the terms and timing of future divestiture transactions with third parties; |
| ● | the
scope, rate of progress, results and cost of our clinical trials, nonclinical testing, and
other related activities; |
| ● | the
cost of manufacturing clinical supplies, and establishing commercial supplies, of our product
candidates and any products that we may develop; |
| ● | the
number and characteristics of product candidates that we pursue; |
| ● | the
cost, timing, and outcomes of regulatory approvals; |
| ● | the
cost and timing of establishing sales, marketing, and distribution capabilities; and |
| ● | the
terms and timing of any collaborative, licensing, and other arrangements that we may establish,
including any required milestone and royalty payments thereunder. |
On
October 21, 2022, we announced the sale of (i) 90% of the share capital of its subsidiary Zilentin AG and (ii) an option to purchase
the subsidiaries Auris Medical AG, Otolanum AG, Auris Medical Ltd. and Auris Medical Pty Ltd (the “Additional Subsidiaries”)
– representing our inner ear therapeutic assets – to a European family office (the “Buyer”) for a cash consideration
of USD 1 million each, for a total of USD 2 million. Under the terms of the option agreement (the “Option”) Zilentin will
be entitled to purchase the Additional Subsidiaries for an upfront payment of USD 25 million plus potential milestone royalty payments.
The Option may be exercised for 30 days from October 19, 2022 (the “Closing Date”); beyond that period, Zilentin will have
a right of first refusal to acquire these companies until year end with the upfront payment increasing by USD 1 million per month. There
is no assurance that Buyer will exercise its option, triggering the additional upfront payment of USD 25 million. Due to a delay in the
closing of the Zilentin Transaction, the Company and the Buyer agreed on November 23, 2022 to amend their agreement, extending the Closing
Date to December 15, 2022 at the latest, increasing the share capital of Zilentin AG to be sold under the transaction from 90 to 100%
and raising the amount of the initial payment for the purchase of Zilentin and for the option to purchase the Additional Subsidiaries
from USD 2 million to USD 2.2 million.
Apart
from the inner ear therapeutic assets, we intend to spin off or divest also our OTC consumer health products business, in order to focus
on the development of our OligoPhore/SemaPhore RNA delivery platform.
We
expect that we will require additional funding, including under the 2020 Commitment Purchase Agreement and A.G.P. Sales Agreement to
continue our ongoing clinical development activities and seek to obtain regulatory approval for, and commercialize, our product candidates.
If we receive regulatory approval for any of our product candidates, and if we choose not to grant any licenses to partners, we expect
to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where
we choose to commercialize. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if
raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital
when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
On
June 3, 2021, in connection with the acquisition of Trasir, we announced our intention to reposition the Compound around RNA therapeutics
and to prepare for the separation of the Company’s legacy assets either through a divestiture or a spin-off to shareholders within
the next 12-18 months. At this point, there can be no assurance that the Buyer and Zilentin will exercise the Option or purchase the
Additional Subsidiaries under its right of first refusal or that the Company will be successful in its efforts to divest the Bentrio™
asset in the near term and/or at reasonable and attractive terms and conditions. Should the Company be unable to execute on the divestiture
of both the Additional Subsidiaries and Bentrio™, it may have to reduce or stop certain activities and will have to raise additional
capital through the sale of equity or convertible debt securities. In such an event, the ownership interest of the Company’s current
shareholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect
their rights as a holder of our common shares.
For
more information as to the risks associated with our future funding needs, see “Item 3—Key Information-D. Risk factors”
in the Annual Report.
Contractual Obligations and Commitments
The following table presents information relating to our contractual obligations as of June 30, 2022:
| |
Payments Due by Period | |
| |
Less Than | | |
Between | | |
Between | | |
| |
| |
1 Year | | |
1 and 3 Years | | |
3 and 5 | | |
Years Total | |
| |
| | |
(in thousands of CHF) | | |
| |
Convertible loan | |
| 5,000 | | |
| — | | |
| — | | |
| 5,000 | |
Loan agreement | |
| 600 | | |
| — | | |
| — | | |
| 600 | |
Lease obligations (3) | |
| 3 | | |
| — | | |
| — | | |
| 3 | |
Total | |
| 5,603 | | |
| — | | |
| — | | |
| 5,603 | |
(1) | On
February 4, 2022, the Company entered into a convertible loan agreement with FiveT Investment
Management Ltd. The loan bears interest at the rate of 10% and matures 12 months from the
disbursement date, if not converted into common shares. |
| (2) | On
September 9, 2022 the Company entered into a loan agreement with FiveT Investment Management
Ltd., Dominik Lysek and Thomas Meyer. The loan bears interest at the rate of 5% and matures
as of March 31, 2023. |
| (3) | Lease
obligations consist of payments pursuant to a short-term lease agreement not accounted for
on the balance sheet. The lease term is indefinite and can be terminated with a six month
notice period. |
Under
the terms of our collaboration and license agreement with Xigen, we are obliged to make development milestone payments on an indication-by-indication
basis of up to CHF 1.5 million upon the successful completion of a Phase 2 clinical trial and regulatory milestone payments on a product-by-product
basis of up to CHF 2.5 million, subject to a mid-twenties percentage reduction for smaller indications, e.g., those qualifying for orphan
drug status, upon receiving marketing approval for a product. The milestones are not included in the table above as they have not met
the recognition criteria for provisions and the timing of these is not yet determinable as it is dependent upon the achievement of earlier
mentioned milestones.
Under
the terms of the asset purchase agreement with Otifex Therapeutics Pty Ltd, we made a one-time, final development milestone payment of
USD 100,000 related to AM-125.
Off-Balance
Sheet Arrangements
As
of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet
arrangements except for the short-term lease mentioned in “Item 5—Operating and Financial Review and Prospects-F. Tabular
disclosure of contractual obligations” in the Annual Report.
Significant
Accounting Policies and Use of Estimates and Judgment
There
have been no material changes to the significant accounting policies and estimates described in “Item 5—Operating and Financial
Review and Prospects–A. Operating results—Significant accounting policies and use of estimates and judgment” in the
Annual Report.
Recent
Accounting Pronouncements
See
Note 4 to our audited financial statements included in our most recent Annual Report on Form 20-F for a full description of recent accounting
pronouncements, including the expected dates of adoption and effects on the Company’s financial condition, results of operations
and cash flows.
Cautionary
Statement Regarding Forward Looking Statements
Forward-looking
statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our
intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on
information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ
materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to:
| ● | our
operation as a development-stage company with limited operating history and a history of
operating losses; |
| ● | the
COVID-19 outbreak, which continues to evolve, and which could significantly disrupt our preclinical
studies and clinical trials, and therefore our receipt of necessary regulatory approvals; |
| ● | our
need for substantial additional funding to continue the development of our product candidates
before we can expect to become profitable from sales of our products and the possibility
that we may be unable to raise additional capital when needed, particularly in light of the
global outbreak of the novel coronavirus, which continues to evolve; |
| ● | the
timing, scope, terms and conditions of a potential divestiture or spin-off of the Company’s
traditional business as well as the cash such transaction(s) may generate; |
| ● | the
market acceptance and resulting sales from Bentrio™ in international markets; |
| ● | our
dependence on the success of AM-125, AM-301, AM-401, AM-411, Keyzilen® (AM-101) and Sonsuvi®
(AM-111), which are still in clinical development, may eventually prove to be unsuccessful; |
| ● | the
chance that we may become exposed to costly and damaging liability claims resulting from
the testing of our product candidates in the clinic or in the commercial stage; |
| ● | the
chance our clinical trials may not be completed on schedule, or at all, as a result of factors
such as delayed enrollment or the identification of adverse effects, particularly in light
of the global outbreak of the novel coronavirus, which continues to evolve; |
| ● | uncertainty
surrounding whether any of our product candidates will receive regulatory approval, which
is necessary before they can be commercialized; |
| ● | if
our product candidates obtain regulatory approval, our product candidates being subject to
expensive, ongoing obligations and continued regulatory overview; |
| ● | enacted
and future legislation may increase the difficulty and cost for us to obtain marketing approval
and commercialization; |
| ● | the
chance that we do not obtain orphan drug exclusivity for Sonsuvi®, which would allow
our competitors to sell products that treat the same conditions; |
| ● | dependence
on governmental authorities and health insurers establishing adequate reimbursement levels
and pricing policies; |
| ● | our
products may not gain market acceptance, in which case we may not be able to generate product
revenues; |
| ● | our
reliance on our current strategic relationships with INSERM or Xigen and the potential success
or failure of strategic relationships, joint ventures or mergers and acquisitions transactions; |
| ● | our
reliance on third parties to conduct our nonclinical and clinical trials and on third-party,
single-source suppliers to supply or produce our product candidates; |
| ● | our
ability to obtain, maintain and protect our intellectual property rights and operate our
business without infringing or otherwise violating the intellectual property rights of others; |
| ● | our
ability to meet the continuing listing requirements of Nasdaq and remain listed on The Nasdaq
Capital Market; |
| ● | the
chance that certain intangible assets related to our product candidates will be impaired;
and |
| ● | other
risk factors set forth in our most recent Annual Report on Form 20-F. |
Our
actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating
to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire
or occur, or if any of them do so, what impact they will have on our results of operations, cash flows or financial condition. Except
as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking
statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.
v3.23.2
Document And Entity Information
|
6 Months Ended |
Jun. 30, 2022 |
Document Information Line Items |
|
Entity Registrant Name |
Altamira Therapeutics Ltd.
|
Document Type |
6-K/A
|
Current Fiscal Year End Date |
--12-31
|
Amendment Flag |
true
|
Amendment Description |
This Amendment No. 1 (this “Amendment No. 1”) to the Report
of Foreign Private Issuer on Form 6-K originally filed on November 30, 2022 (the “Original Form 6-K”) is being furnished solely
to correct an identified misstatement. In the Unaudited Condensed Consolidated Interim Financial Statements of Altamira Therapeutics Ltd.
(the “Company”) as of June 30, 2022 and for the six months ended June 30, 2022, furnished with the Securities and Exchange
Commission (the “SEC”) on November 30, 2022 with the Original Form 6-K, an upfront payment of $1 million (CHF 0.9 million)
related to the exclusive licensing and distribution agreement with Nuance Pharma for Bentrio® was incorrectly recorded as revenue.
In the audited financial statements as of December 31, 2022 included in the Company’s Annual Report on Form 20-F filed with the
SEC on May 16, 2023, the upfront payment is recorded as deferred income, following the correction of the identified misstatement. Adjustments
for this correction are reflected in the restated financial statements as of and for the six months ended June 30, 2022 furnished with
this Amendment No. 1 in Exhibit 99.1 and the related management’s discussion and analysis in Exhibit 99.2. This Amendment No. 1
makes no other changes to the Original 6-K, and no attempt has been made in this Amendment No. 1 to modify or update the other disclosures
presented in the Original Form 6-K. This Amendment No. 1 does not reflect subsequent events occurring after the initial furnishing of
the Original Form 6-K (i.e., those events occurring after November 30, 2022) or modify or update in any way those disclosures that may
be affected by subsequent events. Accordingly, this Amendment No. 1 should be read in conjunction with the Reports on Form 6-K furnished,
and our other filings made, with the SEC.
|
Entity Central Index Key |
0001601936
|
Document Period End Date |
Jun. 30, 2022
|
Document Fiscal Year Focus |
2022
|
Document Fiscal Period Focus |
Q2
|
Entity File Number |
001-36582
|
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v3.23.2
Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income or Loss (Unaudited) - CHF (SFr)
|
6 Months Ended |
Jun. 30, 2022 |
Jun. 30, 2021 |
Condensed Consolidated Interim Statement Of Profit Or Loss And Other Comprehensive Income Or Loss Unaudited Abstract |
|
|
Revenue |
SFr 290,798
|
|
Cost of Sales |
(1,192,232)
|
|
Gross profit |
(901,434)
|
|
Other operating income |
255,820
|
|
Research and development |
(3,563,883)
|
(3,393,710)
|
Sales and marketing |
(2,129,881)
|
|
General and administrative |
(2,076,383)
|
(3,062,199)
|
Operating loss |
(8,415,761)
|
(6,455,909)
|
Interest expense |
(376,848)
|
(172,462)
|
Foreign currency exchange gain (loss), net |
58,296
|
291,892
|
Revaluation (loss) gain from derivative financial instruments |
450,847
|
(428,742)
|
Transaction costs |
(1,137)
|
|
Loss before tax |
(8,284,603)
|
(6,765,221)
|
Income tax gain |
46,085
|
10,642
|
Net loss attributable to owners of the Company |
(8,238,518)
|
(6,754,579)
|
Items that will never be reclassified to profit or loss |
|
|
Remeasurement of defined benefit liability, net of taxes of CHF 0.00 |
209,526
|
448,946
|
Items that are or may be reclassified to Profit or loss |
|
|
Foreign currency translation differences, net of taxes of CHF 0.00 |
(63,477)
|
(41,922)
|
Other comprehensive income/(loss), net of taxes of CHF 0 |
146,049
|
407,024
|
Total comprehensive loss attributable to owners of the Company |
SFr (8,092,469)
|
SFr (6,347,555)
|
Basic and diluted loss per share (in Francs per share) |
SFr (10.63)
|
SFr (10.85)
|
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Condensed Consolidated Interim Statement of Financial Position (Unaudited) - CHF (SFr)
|
Jun. 30, 2022 |
Dec. 31, 2021 |
Non-current assets |
|
|
Property and equipment |
SFr 1
|
SFr 1
|
Right-of-use assets |
505,270
|
564,714
|
Intangible assets |
15,851,501
|
14,314,877
|
Other non-current financial assets |
195,421
|
199,105
|
Total non-current assets |
16,552,193
|
15,078,697
|
Current assets |
|
|
Inventories |
146,366
|
839,221
|
Trade receivables |
182,167
|
21,746
|
Other receivables |
444,034
|
671,340
|
Prepayments |
782,469
|
1,575,126
|
Cash and cash equivalents |
372,647
|
984,191
|
Total current assets |
1,927,683
|
4,091,624
|
Total assets |
18,479,876
|
19,170,321
|
Equity |
|
|
Share capital |
170,643
|
149,643
|
Share premium |
190,108,850
|
188,511,476
|
Foreign currency translation reserve |
(1,408)
|
62,069
|
Accumulated deficit |
(183,535,121)
|
(175,686,937)
|
Total shareholders’ equity attributable to owners of the Company |
6,742,964
|
13,036,251
|
Non-current liabilities |
|
|
Derivative financial instruments |
|
1,233
|
Non-current lease liabilities |
403,015
|
461,485
|
Employee benefits |
515,174
|
668,319
|
Deferred income |
932,200
|
|
Deferred tax liabilities |
95,999
|
142,484
|
Total non-current liabilities |
1,946,388
|
1,273,521
|
Current liabilities |
|
|
Loan |
4,701,906
|
|
Derivative financial instruments |
284
|
|
Current lease liabilities |
116,040
|
114,251
|
Trade and other payables |
3,164,754
|
3,697,723
|
Accrued expenses |
1,807,540
|
1,048,575
|
Total current liabilities |
9,790,524
|
4,860,549
|
Total liabilities |
11,736,912
|
6,134,070
|
Total equity and liabilities |
SFr 18,479,876
|
SFr 19,170,321
|
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v3.23.2
Condensed Consolidated Interim Statement of Changes in Equity (Unaudited) - CHF (SFr)
|
Share Capital |
Share Premium |
FX Translation Reserve |
Accumulated Deficit (restated) |
Total |
Balance at Dec. 31, 2020 |
SFr 114,172
|
SFr 177,230,300
|
SFr 61,297
|
SFr (160,635,879)
|
SFr 16,769,890
|
Total comprehensive loss |
|
|
|
|
|
Net loss |
|
|
|
(6,754,579)
|
(6,754,579)
|
Other comprehensive income/(loss) |
|
|
(41,922)
|
448,946
|
407,024
|
Total comprehensive loss |
|
|
(41,922)
|
(6,305,633)
|
(6,347,555)
|
Transactions with owners of the Company |
|
|
|
|
|
Capital increase /Exercise of warrants |
8,974
|
3,885,764
|
|
|
3,894,738
|
Conversion of loan |
5,168
|
1,366,087
|
|
|
1,371,255
|
Share based/Asset purchase |
7,735
|
2,266,735
|
|
1,078,800
|
3,353,270
|
Share based payments |
382
|
92,181
|
|
952,349
|
1,044,912
|
Balance at Jun. 30, 2021 |
136,431
|
184,841,067
|
19,375
|
(164,910,363)
|
20,086,510
|
Balance at Dec. 31, 2020 |
114,172
|
177,230,300
|
61,297
|
(160,635,879)
|
16,769,890
|
Balance at Dec. 31, 2021 |
149,643
|
188,511,476
|
62,069
|
(175,686,937)
|
13,036,251
|
Balance at Jun. 30, 2021 |
136,431
|
184,841,067
|
19,375
|
(164,910,363)
|
20,086,510
|
Balance at Jun. 30, 2022 |
170,643
|
190,108,850
|
(1,408)
|
(183,535,121)
|
6,742,964
|
Balance at Dec. 31, 2021 |
149,643
|
188,511,476
|
62,069
|
(175,686,937)
|
13,036,251
|
Total comprehensive loss |
|
|
|
|
|
Net loss |
|
|
|
(8,238,518)
|
(8,238,518)
|
Other comprehensive income/(loss) |
|
|
(63,477)
|
209,526
|
146,049
|
Total comprehensive loss |
|
|
(63,477)
|
(8,028,992)
|
(8,092,469)
|
Transactions with owners of the Company |
|
|
|
|
|
Capital increase |
21,000
|
1,597,374
|
|
|
1,618,374
|
Share based payments |
|
|
|
180,808
|
180,808
|
Balance at Jun. 30, 2022 |
SFr 170,643
|
SFr 190,108,850
|
SFr (1,408)
|
SFr (183,535,121)
|
SFr 6,742,964
|
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v3.23.2
Condensed Consolidated Interim Statement of Cash Flows (Unaudited) - CHF (SFr)
|
6 Months Ended |
Jun. 30, 2022 |
Jun. 30, 2021 |
Cash flows from operating activities |
|
|
Net loss |
SFr (8,238,518)
|
SFr (6,754,579)
|
Adjustments for: |
|
|
Depreciation |
59,444
|
23,636
|
Deferred income |
932,200
|
|
Unrealized foreign currency exchange (gain)/loss, net |
(33,129)
|
(318,319)
|
Net interest expense |
366,343
|
170,906
|
Share based payments |
180,808
|
1,044,912
|
Employee benefits |
56,381
|
26,101
|
Transaction costs |
1,138
|
|
Fair value derivative financial instruments |
(450,847)
|
428,742
|
Deferred tax (gain)/loss |
(47,316)
|
(10,642)
|
Total |
(7,173,496)
|
(5,389,243)
|
Changes in: |
|
|
Inventories |
692,855
|
(196,415)
|
Other receivables |
23,346
|
(59,446)
|
Prepayments |
785,834
|
(66,403)
|
Trade and other payables |
(419,075)
|
714,292
|
Accrued expenses |
506,806
|
78,646
|
Net cash used in operating activities |
(5,583,730)
|
(4,918,569)
|
Cash flows from investing activities |
|
|
Purchase of intangibles |
(1,533,568)
|
(1,988,907)
|
Net cash used in investing activities |
(1,533,568)
|
(1,988,907)
|
Cash flows from financing activities |
|
|
Proceeds from equity issuance and public offering |
1,618,374
|
3,894,739
|
Proceeds from loan |
4,988,626
|
|
Repayment of loan |
|
(50,000)
|
Repayment of lease liability |
(56,682)
|
|
Interest paid |
(8,413)
|
(13)
|
Net cash from financing activities |
6,541,905
|
3,844,726
|
Net increase/(decrease) in cash and cash equivalents |
(575,393)
|
(3,062,750)
|
Cash and cash equivalents at beginning of the period |
984,191
|
11,258,870
|
Net effect of currency translation on cash |
(36,151)
|
270,878
|
Cash and cash equivalents at end of the period |
|
|
Cash and cash equivalents at end of the period |
SFr 372,647
|
SFr 8,466,998
|
X |
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v3.23.2
Reporting Entity
|
6 Months Ended |
Jun. 30, 2022 |
Reporting Entity [Abstract] |
|
Reporting entity |
Altamira Therapeutics Ltd. (the “Company”)
is an exempted company incorporated under the laws of Bermuda. The Company began its operations as a corporation organized in accordance
with Swiss law and domiciled in Switzerland under the name Auris Medical Holding AG (“Auris Medical (Switzerland)”). Following
shareholder approval at an extraordinary general meeting of shareholders held on March 8, 2019 and upon the issuance of a certificate
of continuance by the Registrar of Companies in Bermuda on March 18, 2019, the Company discontinued as a Swiss company and, pursuant to
Article 163 of the Swiss Federal Act on Private International Law and pursuant to Section 132C of the Companies Act 1981 of Bermuda (the
“Companies Act”), continued existence under the Companies Act as a Bermuda company with the name “Auris Medical Holding
Ltd.” (the “Redomestication”). On March 18, 2019, the common shares of the Company began trading on the Nasdaq Capital
Market under the trading symbol “EARS”. The Company’s registered office is located at Clarendon House, 2 Church Street,
Hamilton HM 11, Bermuda. On July 21, 2021, the Company changed its name to Altamira Therapeutics Ltd. Since July 26, 2021, the Company’s
common shares are traded under the trading symbol “CYTO”. On October 25, 2022, the Company effected a one-for-twenty reverse
share split (the “2022 Reverse Share Split”) of the Company’s issued and outstanding common shares. Unless indicated
or the context otherwise requires, all per share amounts and numbers of common shares in this report have been retrospectively adjusted
for the 2022 Reverse Share Split, as if such 2022 Reverse Share Split occurred on the first day of the periods presented.
These condensed consolidated interim financial
statements comprise the Company and its subsidiaries (together referred to as the “Group” and individually as “Group
entities”). The Company is the ultimate parent of the following Group entities:
| ● | Auris Medical AG, Basel, Switzerland (100%) with a nominal
share capital of CHF 2,500,000 |
| ● | Otolanum AG, Zug, Switzerland (100%) with a nominal share
capital of CHF 100,000 |
| ● | Altamira Therapeutics, Inc., Dover, Delaware, United States
(100%) with a nominal share capital of USD 100 |
| ● | Auris Medical Ltd., Dublin, Ireland (100%) with a nominal
share capital of EUR 100 |
| ● | Zilentin AG, Zug, Switzerland (100%) with a nominal share
capital of CHF 100,000 |
| ● | Auris Medical Pty Ltd, Collingwood, Australia (100%) with
a nominal share capital of AUD 100 |
| ● | Altamira Medica AG, Zug, Switzerland (100%) with a nominal
share capital of CHF 3,000,000 |
The Group is primarily involved in the development
of novel products that address important unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner
ear therapeutics. The Group is focusing on the development of RNA therapeutics for extrahepatic therapeutic targets (AM-401 and AM-411),
nasal sprays for protection against airborne viruses and allergens (AM-301; Bentrio™) or the treatment of vertigo (AM-125), and
the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (AM-101; Keyzilen® and AM-111; Sonsuvi®).
|
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v3.23.2
Basis of Preparation Statement of Compliance
|
6 Months Ended |
Jun. 30, 2022 |
Basis of Preparation [Abstract] |
|
Basis of preparation Statement of compliance |
| 2. | Basis of preparation Statement of compliance |
These condensed consolidated interim financial
statements as of June 30, 2022 and for the six months ended June 30, 2022 have been prepared in accordance with International Accounting
Standard 34 Interim Financial Reporting (“IAS 34”) and should be read in conjunction with the audited consolidated
financial statements as of and for the year ended December 31, 2021.
These condensed consolidated interim financial
statements include all adjustments that are necessary to fairly state the results of the interim period. The Group believes that the disclosures
are adequate to make the information presented not misleading. Interim results are not necessarily indicative of results to be expected
for the full year. Management does not consider the business to be seasonal or cyclical.
Certain information and footnote disclosures normally
included in consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”),
as issued by the International Accounting Standards Board, have been condensed or omitted as permitted by IAS 34. The condensed consolidated
statement of financial position as of December 31, 2021 was derived from the audited consolidated financial statements.
The interim condensed
consolidated financial statements were authorized for issuance by the Company’s Audit Committee on November 28, 2022 Functional and reporting currency
These interim condensed consolidated financial
statements are presented in Swiss Francs (“CHF”), which is the Company’s functional currency (“functional currency”)
and the Group’s reporting currency.
Significant accounting policies
The accounting policies applied by the Group in
these condensed consolidated interim financial statements are the same as those applied by the Group in its audited consolidated financial
statements as of and for the year ended December 31, 2021 and have been applied consistently to all periods presented in these condensed
consolidated interim financial statements, unless otherwise indicated.
New standards, amendments and interpretations adopted by the Group
Amendments to IAS 16 |
|
Property, Plant and Equipment: Proceeds before Intended Use |
Amendments to IAS 37 |
|
Provisions, Contingent Liabilities and Contingent Assets - Onerous contracts – Costs of fulfilling a Contract |
Amendments to IFRS 3 |
|
Business Combinations - Reference to the Conceptual Framework |
Annual Improvements to IFRS Standards 2018-2020 – Amendments
to IFRS 1, IFRS 9, IFRS 16, IAS 41
The application of these new standards, amendments
to standards and interpretations does not have material impact on the financial statements of the Group.
Convertible loan
The convertible loan obtained from FiveT Investment
Management Ltd. (see Note 5) is classified as a hybrid contract containing a host that is a financial liability and embedded derivatives
separated from the host and measured at fair value with all changes in fair value recognized in profit or loss. The embedded financial
derivatives are valued by an independent consultant initially and at period end at fair value, applying a simulation-based valuation approach.
The carrying amount of the host contract at initial
recognition is the difference between the carrying amount of the hybrid contract and the fair value of the embedded derivatives. The host
is then subsequently measured at amortized cost, using the effective interest rate method.
Intangible assets
As of June 30, 2022, Intangible assets amounted
to CHF 15,851,501, compared to CHF 14,314,877 as of December 31, 2021. The increase is due to the capitalization of development costs
related to the AM-125 program.
Going concern
The Company has incurred recurring losses and
negative cash flows from operations since inception and it expects to generate losses from operations for the foreseeable future primarily
due to research and development costs for its potential product candidates. The Company believes its cash of CHF 372,647 at June 30, 2022,
together with revenues from Bentrio product sales, the receipt of grants, proceeds from the issuance of Common Shares under the A.G.P.
Sales Agreement and the 2020 Commitment Purchase Agreement of USD 2.2 million up to the reporting date as well as from further issuances
under the A.G.P. Sales Agreement and the 2022 Commitment Purchase Agreement, and the USD 2.2 million upfront payment it expects to receive
under the Share Purchase Agreement and Option Agreement, dated October 19, 2022 and amended on November 23, 2022 (as discussed below),
will fund the Company’s projected operations through the fourth quarter of 2022. We expect that our funding requirements for operations
and financial obligations until the end of 2023 will amount to CHF 22.0 to 25.0 million and to CHF 17.0 to 20 million if the convertible
loan provided by FiveT will be converted into Common Shares. To the extent that we will be unable to generate sufficient cash proceeds
from the planned divestiture or spin-off of our legacy assets or other partnering activities, we will need substantial additional financing
to meet these funding requirements both through the fourth quarter of 2022 and thereafter. These factors raise substantial doubt about
the Company’s ability to continue as a going concern. The financial statements have been prepared on a going concern basis, which
contemplates the continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business.
The financial statements do not include any adjustments that might result from the outcome of this uncertainty. As is often the case with drug development companies,
the ability of the consolidated entity to continue its development activities as a going concern is dependent upon it deriving sufficient
cash from investors, from licensing and partnering activities, in particular the intended divestiture or spin-off of the Company’s
legacy assets in the fields of inner ear therapeutics and OTC consumer health products, and from other sources of revenue such as grant
funding.
On October 21, 2022, the Company announced the
sale of (i) 90% of the share capital of its subsidiary Zilentin AG and (ii) an option to purchase the subsidiaries Auris Medical AG, Otolanum
AG, Auris Medical Ltd. and Auris Medical Pty Ltd (the “Additional Subsidiaries”) – representing the Company’s
inner ear therapeutic assets – to a European family office (the “Buyer”) for a cash consideration of USD 1 million each,
for a total of USD 2 million (the “Zilentin Transaction”). Under the terms of the option agreement (the “Option”)
Zilentin will be entitled to purchase the Additional Subsidiaries for an upfront payment of USD 25. million plus potential milestone royalty
payments. The Option may be exercised for 30 days from October 19, 2022 (the “Closing Date”); beyond that period, Zilentin
will have a right of first refusal to acquire these companies until year end with the upfront payment increasing by USD 1 million per
month. There is no assurance that Buyer will exercise its option, triggering the additional upfront payment of USD 25 million. Due to
a delay in the closing of the Zilentin Transaction, the Company and the Buyer agreed on November 23, 2022 to amend their agreement, extending
the Closing Date to December 15, 2022 at the latest, increasing the share capital of Zilentin AG to be sold under the transaction from
90 to 100% and raising the amount of the initial payment for the purchase of Zilentin and for the option to purchase the Additional Subsidiaries
from USD 2 million to USD 2.2 million.
The directors have considered the cash flow forecasts
and the funding requirements of the business and continue to explore grant funding, licensing opportunities and equity investment opportunities
in the Company. Apart from the inner ear therapeutic assets, the Company intends to spin off or divest also its OTC consumer health products
business, in order to focus on the development of its OligoPhore/SemaPhore RNA delivery platform. At the date of issuing these financial
statements, such plans have not yet been realized.
Accordingly, the directors have prepared the financial
statements on a going concern basis. Should the above assumptions not prove to be appropriate, there is material uncertainty whether the
consolidated entity will continue as a going concern and therefore whether it will realize its assets and extinguish its liabilities in
the normal course of business and at the amounts stated in these financial statements.
The Company plans to secure additional capital
in the future through equity or debt financings, partnerships, collaborations, or other sources to carry out the Company’s planned
development activities. If additional capital is not available when required, the Company may need to delay or curtail its operations
until such funding is received. Various internal and external factors will affect whether and when the Company’s product candidates
become approved for marketing and successful commercialization. The regulatory approval and market acceptance of the Company’s product
candidates, length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of
the approval process will materially affect the Company’s financial condition and future operations. Such matters are not within
the control of the Company and thus all associated outcomes are uncertain.
Accounting for divestiture
From the date of entering into the agreement for
the disposal of Zilentin and the sale of the purchase option for the Additional Subsidiaries, the respective assets and liabilities are
classified as held for sale and measured at the lower of carrying amount and fair value less costs to sell. As the agreement was entered
into after June 30, 2022, and consequently the criteria for held for sale were met only after the reporting period, the disposal group
is presented in the subsequent events and not yet as held for sale in the financial statements. The assets held for sale mainly comprise
capitalized development costs related to the AM-125 program, which amounted to CHF 12.0 million as of June 30, 2022.
Adjustment of June 30, 2022 Revenue
In the Company's Unaudited Condensed Consolidated
Interim Financial Statements as of June 30, 2022 and for the six months ended June 30, 2022, furnished with the SEC on November 30, 2022
with a Report of Foreign Private Issuer on Form 6-K (the “Original Form 6-K”), an upfront payment of $1 million (CHF 0.9 million)
related to the exclusive licensing and distribution agreement with Nuance Pharma for Bentrio® was incorrectly recorded as revenue.
In the audited financial statements as of December 31, 2022 included in the Company’s Annual Report on Form 20-F filed with the
SEC on May 16, 2023, the upfront payment was recorded as deferred income, following the correction of the identified misstatement. Adjustments
for this correction are reflected in these restated condensed consolidated interim financial statements as of June 30, 2022 and for the
six months ended June 30, 2022. The table below reflects the impact of the adjustments on key income statement and balance sheet line
items. Six months ended June 30, 2022
Adjusted consolidated Balance Sheet
| |
As of June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Deferred income | |
| - | | |
| 932,200 | | |
| 932,200 | |
Total non-current liabilities | |
| 1,014,188 | | |
| 932,200 | | |
| 1,946,388 | |
Total liabilities | |
| 10,804,712 | | |
| 932,200 | | |
| 11,736,912 | |
Accumulated deficit | |
| (182,602,921 | ) | |
| (932,200 | ) | |
| (183,535,121 | ) |
Total shareholders’ equity attributable to owners of the company | |
| 7,675,164 | | |
| (932,200 | ) | |
| 6,742,964 | |
Adjusted consolidated Statement of Profit or Loss and Other Comprehensive
Loss
| |
Half-Year ended June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Revenue | |
| 1,222,998 | | |
| (932,200 | ) | |
| 290,798 | |
Gross profit | |
| 30,766 | | |
| (932,200 | ) | |
| (901,434 | ) |
Operating loss | |
| (7,483,561 | ) | |
| (932,200 | ) | |
| (8,415,761 | ) |
Loss before tax | |
| (7,352,403 | ) | |
| (932,200 | ) | |
| (8,284,603 | ) |
Net loss attributable of owners of the Company | |
| (7,306,318 | ) | |
| (932,200 | ) | |
| (8,238,518 | ) |
Total comprehensive loss attributable to owners of the Company | |
| (7,160,269 | ) | |
| (932,200 | ) | |
| (8,092,469 | ) |
Basic and diluted loss per share | |
| (9.43 | ) | |
| (1.20 | ) | |
| (10.63 | ) |
|
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v3.23.2
Taxation
|
6 Months Ended |
Jun. 30, 2022 |
Taxation [Abstract] |
|
Taxation |
The Group’s income tax expense recognized in the condensed interim
consolidated statement of profit or loss is presented as follows:
| |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2022 | | |
2021 | |
Current income tax expense | |
| (1,231 | ) | |
| — | |
Deferred income tax gain | |
| 47,316 | | |
| 10,642 | |
Total income tax (expense)/gain | |
| 46,085 | | |
| 10,642 | |
The tax effect of taxable temporary differences that give rise to deferred
income tax liabilities or to deferred income tax assets as of June 30, 2022 and 2021 is presented as follows:
| |
June 30, | | |
December 31, | |
| |
2022 | | |
2021 | |
Deferred Tax liabilities | |
| | |
| |
Intangible assets | |
| (47,590 | ) | |
| (51,914 | ) |
Other receivables | |
| (81,184 | ) | |
| (122,449 | ) |
Total | |
| (128,774 | ) | |
| (174,363 | ) |
Deferred Tax assets | |
| | | |
| | |
Net operation loss (NOL) | |
| 32,775 | | |
| 31,879 | |
Total | |
| 32,775 | | |
| 31,879 | |
Deferred Tax, net | |
| (95,999 | ) | |
| (142,484 | ) |
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v3.23.2
Capital and Reserves
|
6 Months Ended |
Jun. 30, 2022 |
Capital and Reserves [Abstract] |
|
Capital and reserves |
Share capital
The issued share capital of the Company consisted of:
| |
Common Shares | |
| |
Number | |
| |
2022 | | |
2021 | |
As of January 1 | |
| 748,213 | | |
| 570,858 | |
Common shares issued | |
| 105,000 | | |
| 111,299 | |
Total, as of June 30 | |
| 853,213 | | |
| 682,157 | |
As of June 30, 2022, the par value of the 853,213
issued shares amounted to CHF 170,643 with a par value of CHF 0.20 for each common share (as of June 30, 2021, the par value of 682,157
issued shares amounted to CHF 136,431 with a par value of CHF 0.20 for each common share).
Equity Offerings
On June 1, 2021, the company completed the acquisition
of Trasir Therapeutics Inc. The upfront acquisition price of USD 2.5 million was paid with 38,218 non-registered common shares at the
Reference Price of USD 65.40 to the selling shareholders. In addition, 459 non-registered common shares were issued based on the Reference
Price to reimburse USD 30,000 in expenses incurred by certain selling Trasir shareholders.
On March 4, 2021, the remaining convertible loan
by FiveT in the amount of CHF 604,545 plus accumulated interests of CHF 40,268 was converted into 25,841 common shares at a conversion
price of USD 27.00. On April 23, 2020, the Company entered into a
purchase agreement and a Registration Rights Agreement with Lincoln Park Capital Fund, LLC (the “2020 Commitment Purchase Agreement”).
Pursuant to the 2020 Commitment Purchase Agreement, LPC agreed to subscribe for up to USD 10,000,000 of our common shares over the 30-month
term of the 2020 Commitment Purchase Agreement. Through June 30, 2022, we issued a total of 165,000 of our common shares to LPC for an
aggregate amount of USD 2,806,605 under the 2020 Commitment Purchase Agreement. During the six months ended June 30, 2022, we issued 105,000
of our common shares to LPC for an aggregate amount of USD 1,698,450 under the 2020 Commitment Purchase Agreement, and as of the date
of this report, we have issued a total of 325,000 of our common shares to LPC for an aggregate amount of USD 4,003,820 under the 2020
Commitment Purchase Agreement.
The remaining 44,872 warrants of the May 2019 Registered Offering were
exercised in March 2021.
On November 30, 2018, as amended on April 5, 2019
the Company entered into a sales agreement, as amended (the “A.G.P. Sales Agreement”) with A.G.P./Alliance Global Partners
(“A.G.P.”). Pursuant to the terms of the A.G.P. Sales Agreement, the Company may offer and sell its common shares, from time
to time through A.G.P. by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) promulgated under
the Securities Act. Pursuant to the A.G.P. Sales Agreement, the Company may sell common shares up to a maximum aggregate offering price
of USD 25.0 million. As of June 30, 2022, the Company has sold a total of 147,166 common shares for an aggregate offering price of USD
6.7 million pursuant to the A.G.P. Sales Agreement (June 30, 2021: 87,931 common shares for an aggregate offering price of USD 2.9 million),
and as of the date of this report, the Company has sold a total of 228,666 common shares for an aggregate offering price of USD 7.8 million
pursuant to the A.G.P. Sales Agreement.
As of June 30, 2022 the fair value of the warrants
issued in the January 2018 Registered Offering amounted to zero. Therefore, the fair value decreased by the total amount of CHF 1,233
in the first six months of 2022 (fair value as of December 31, 2021: CHF 1,233).
The warrants issued in the February 2017 public offering expired on
February 22, 2022, without any warrants having been exercised.
Issue of common shares upon exercise of options
During the six months ended June 30, 2022, no options were exercised.
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v3.23.2
Loans
|
6 Months Ended |
Jun. 30, 2022 |
Loans [Abstract] |
|
Loans |
On
February 4, 2022, the Company entered into a convertible loan agreement (the “Loan Agreement”) with FiveT Investment Management
Ltd. (the “Lender”), pursuant to which the Lender has agreed to loan to the Company CHF 5,000,000 (the “Loan”),
which Loan bears interest at the rate of 10% per annum and matures 12 months from the date (the “Disbursement Date”) the
Loan proceeds were disbursed to the Company, which occurred on February 8, 2022. The Company may prepay all or part of the Loan after
six months after the Disbursement Date; provided that the Company will pay an amount equal to 130% of the desired prepayment amount.
The Lender has the right to convert all or part of the Loan, including accrued and unpaid interest, at its option, into common shares,
subject to the limitation that the Lender own no more than 9.99% of the common shares at any time. The conversion price of the Loan into
common shares is USD 38.916, which corresponds to 150% of USD 25.944 (the trading volume weighted average price, the “VWAP”,
per common share on the NASDAQ stock exchange on the Disbursement Date), converted into Swiss Francs at the midpoint of the interbank
exchange rate shown by UBS on the day of receipt of the conversion notice at 4:00 pm Central European Time. The conversion price shall
be lowered in the event that the Company raises equity before the maturity date of the Loan through a public or private offering of common
shares at an issue price that is at least 10 (ten) % below the VWAP (the “New Issue”), according to the formula set forth
in the Loan Agreement (the “Adjustment”). Sales of common shares through equity line or at-the-market programs are not considered
New Issues triggering the Adjustment.
As
of June 30, 2022, the carrying amount of the host for the unconverted outstanding loan amounted to CHF 4,701,906 and is included in the
balance sheet under current liabilities. The fair value of the embedded derivatives amounted to CHF 284 (at initial recognition February
8, 2022: CHF 449,898) included in current derivative financial instruments. A revaluation gain related to fair value measurement of embedded
derivatives of CHF 449,614 as well as effective interest expenses and transaction costs of CHF 359,068 in total were recorded in profit
or loss.
Due
to the COVID-19 pandemic, Swiss banks granted special COVID-19 loans under certain conditions with a guarantee by the Swiss Government.
Our Company was eligible for a loan of CHF 50,000, which was granted on March 26, 2020. The loan is interest-free and may be repaid at
any time with a maximum term of five years. We repaid the entire loan as of June 16, 2021.
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v3.23.2
Employee Benefits
|
6 Months Ended |
Jun. 30, 2022 |
Employee Benefits [Abstract] |
|
Employee Benefits |
| |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2022 | | |
2021 | |
Salaries | |
| 1,439,578 | | |
| 812,158 | |
Pension costs | |
| 132,784 | | |
| 66,002 | |
Share based compensation expense | |
| 180,808 | | |
| 969,739 | |
Other employee costs and social benefits | |
| 157,358 | | |
| 257,108 | |
Total employee benefits | |
| 1,910,528 | | |
| 2,105,007 | |
Expenditures
for employee benefits increased in the first six months ended June 30, 2022 primarily due to increased headcount compared to the first
six months ended June 30, 2021. Share based compensation included expense related to employee stock options of CHF 180,808 in the first
six months ended June 30, 2022 compared to CHF 159,487 in the first six months ended June 30, 2021. In 2021, share based compensation
expense included CHF 810,252 for a share bonus grant related to the strategic repositioning of the Company, including CHF 360,112 for
a future share grant contingent on achieving certain results related to the Trasir transaction.
A
total of 27,861 options were granted in the six months ended June 30, 2022 (6,862 options in the corresponding six-month period in 2021).
The exercise price of the options granted as share based compensation under the Equity Incentive Plan was USD 20.80 (for the six months
ended June 30, 2021 USD 70.20). The methodology for computation of share based compensation expense for the period is consistent with
the methodology used in 2021.
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v3.23.2
Write-down of Inventories
|
6 Months Ended |
Jun. 30, 2022 |
Write-down of Inventories [Abstract] |
|
Write-down of inventories |
| 7. | Write-down
of inventories |
The
Company’s inventory consists of the product Bentrio, a drug-free nasal spray for protection against airborne viruses and allergens.
Bentrio has a limited shelf life, which may affect the salability of the product, and is packaged in various configurations (stock keeping
units, “SKUs”) for different markets. During the six months ended June 30, 2022, the Company wrote down finished goods inventories
by CHF 764,844, based on a management review for any obsolete or slow-moving items. The write-down is included in Cost of Sales in the
condensed consolidated statement of profit or loss and other comprehensive income. There were no inventory write-downs recognized during
the six months ended June 30, 2021.
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v3.23.2
Revision of Prior Period Financial Statements
|
6 Months Ended |
Jun. 30, 2022 |
Disclosure Of Separate Financial Statements Text Block Abstract |
|
Revision of Prior Period Financial Statements |
| 8. | Revision
of Prior Period Financial Statements |
In
connection with the preparation of our consolidated financial statements, we identified an immaterial error with regard to advance payments
for research and development costs and related tax credits for the annual period ended December 31, 2021. The error was mainly related
to investigator float payments to a contract research organization. Due to COVID and other reasons, the scheduled services had not been
provided by the end of the year and therefore the payments should have been recognized as advance payments and not as R&D expenses.
We evaluated the error and determined that the related impact was not material to our financial statements for any prior periods, but
that correction of the impact of the error would be significant to our results of operations for the six months ended June 30, 2022.
Accordingly, we have revised previously reported financial information for such immaterial error, as previously disclosed in our Annual
Report on Form 20-F for the year ended December 31, 2021. A summary of revisions to our previously reported financial statements presented
herein for comparative purposes is included below.
Revised consolidated Balance Sheet
| |
As of December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Other receivables | |
| 917,833 | | |
| (246,493 | ) | |
| 671,340 | |
Prepayments | |
| 996,910 | | |
| 578,216 | | |
| 1,575,126 | |
Total current assets | |
| 3,759,901 | | |
| 331,723 | | |
| 4,091,624 | |
Total assets | |
| 18,838,598 | | |
| 331,723 | | |
| 19,170,321 | |
Accumulated deficit | |
| (176,018,660 | ) | |
| 331,723 | | |
| (175,686,937 | ) |
Total shareholders’ equity attributable to owners of the company | |
| 12,704,528 | | |
| 331,723 | | |
| 13,036,251 | |
Total equity and liabilities | |
| 18,838,598 | | |
| 331,723 | | |
| 19,170,321 | |
Revised consolidated Statement of Profit or Loss and Other Comprehensive Loss
| |
Year ended December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Other income | |
| 460,710 | | |
| (246,493 | ) | |
| 214,217 | |
Research and development | |
| (8,939,037 | ) | |
| 578,216 | | |
| (8,360,821 | ) |
Total operating expenses | |
| (15,137,338 | ) | |
| 331,723 | | |
| (14,805,615 | ) |
Operating loss | |
| (17,099,793 | ) | |
| 331,723 | | |
| (16,768,070 | ) |
Loss before tax | |
| (17,368,546 | ) | |
| 331,723 | | |
| (17,036,823 | ) |
Net loss attributable of owners of the Company | |
| (17,390,166 | ) | |
| 331,723 | | |
| (17,058,443 | ) |
Total comprehensive loss attributable to owners of the Company | |
| (17,124,410 | ) | |
| 331,723 | | |
| (16,792,687 | ) |
Basic and diluted loss per share | |
| (26.26 | ) | |
| 0.50 | | |
| (25.76 | ) |
Basic
and diluted loss per share as presented in the financial statements as of December 31, 2021, prior to the one-for-twenty reverse share
split on October 25, 2022 was CHF 1.31, and the revised number would have been CHF 1.29.
Revised
consolidated Statement of Cash Flows
We
revised our consolidated statement of cash flows for the year ended December 31, 2021. There was no impact on net cash used in operating
activities.
| |
Year ended December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Net loss | |
| (17,390,166 | ) | |
| 331,723 | | |
| (17,058,443 | ) |
Changes in: | |
| | | |
| | | |
| | |
Trade and other receivables | |
| (586,612 | ) | |
| 246,493 | | |
| (340,119 | ) |
Prepayments | |
| (719,321 | ) | |
| (578,216 | ) | |
| (1,297,537 | ) |
Cash used in operating activities | |
| (13,627,738 | ) | |
| — | | |
| (13,672,738 | ) |
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v3.23.2
Loss Per Share
|
6 Months Ended |
Jun. 30, 2022 |
Loss Per Share [Abstract] |
|
Loss per share |
| |
Six Months Ended | |
| |
June 30, | | |
| |
| |
2022 | | |
June 30, | |
| |
(restated) | | |
2021 | |
Loss attributable to owners of the Company | |
| (8,238,518 | ) | |
| (6,754,579 | ) |
Weighted average number of shares outstanding | |
| 774,898 | | |
| 622,741 | |
Basic and diluted loss per share | |
| (10.63 | ) | |
| (10.85 | ) |
For
the six months ended June 30, 2022 and June 30, 2021 basic and diluted loss per share are calculated based on the weighted average number
of shares issued and outstanding and excludes shares to be issued under the stock option plans or for warrants, as they would be anti-dilutive.
As of June 30, 2022, the Company had 94,337 options outstanding under its stock option plan. The average number of options outstanding
between January 1, 2022 and June 30, 2022 was 74,996 (54,025 for the period between January 1, 2021 and June 30, 2021).
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v3.23.2
Events After the Reporting Period
|
6 Months Ended |
Jun. 30, 2022 |
Events After the Reporting Period [Abstract] |
|
Events after the Reporting Period |
10.
Events after the Reporting Period
Loan
Agreement
On
September 9, 2022 the Company entered into a loan agreement with FiveT Investment Management Ltd., Dominik Lysek and Thomas Meyer (the
“Lenders”), pursuant to which the Lenders have agreed to loan to the Company an aggregate of CHF 600,000.00, which loan bears
interest at the rate of 5% per annum and matures as of March 31, 2023. The Company agreed to grant to the Lenders warrants (the “Warrants”)
to purchase an aggregate 41,667 common shares. The Warrants will be exercisable at an exercise price of CHF 7.20 per share for up to
five years from October 1, 2022.
Divestiture
of inner ear therapeutic assets
On
October 21, 2022, the Company announced the sale of 90% of the share capital of its subsidiary Zilentin AG and of an option to purchase
the subsidiaries Auris Medical AG, Otolanum AG, Auris Medical Ltd. and Auris Medical Pty Ltd (the “Additional Subsidiaries”)
– representing the Company’s inner ear therapeutic assets – to a European family office (the “Buyer”) for
a cash consideration of USD 1 million each. Under the terms of the option agreement (the “Option”) Zilentin will be entitled
to purchase the Additional Subsidiaries for an upfront payment of USD 25 million plus up to USD 55 million upon reaching certain clinical
and regulatory milestones as well as royalties on revenues generated with products based on Altamira’s RNA delivery technology
for certain inner ear targets at a mid-single digit percentage. The Option may be exercised for 30 days from October 19, 2022 (the “Closing
Date”); beyond that period, Zilentin will have a right of first refusal to acquire these companies until year end with the upfront
payment increasing by USD 1 million per month. Due to a delay in the closing of the Zilentin Transaction, the Company and the Buyer agreed
on November 23, 2022 to amend their agreement, extending the Closing Date to December 15, 2022 at the latest, increasing the share capital
of Zilentin AG to be sold under the transaction from 90 to 100% and raising the amount of the initial payment for the purchase of Zilentin
and for the option to purchase the Additional Subsidiaries from USD 2 million to USD 2.2 million.
Subsequent
to June 30, 2022, and after completion of the disposal of Zilentin and the sale of the purchase option for the Additional Subsidiaries,
the respective assets and liabilities associated with the purchase option will be classified as held for sale and measured at the lower
of carrying amount and fair value less costs to sell. The assets held for sale mainly comprise capitalized development costs related
to the AM-125 program, which amounted to CHF 12.0 million as of June 30, 2022.
Reverse
share split
On
October 25, 2022, the Company effected a one-for-twenty reverse stock split. Following the share split, the Company had 1,074,713 common
shares at a par value of CHF 0.20 each outstanding. No fractional common shares were issued as fractional common shares were settled
in cash.
Commitment
purchase agreement
On
November 14, 2022, we entered into a term sheet with LPC for the conclusion of a purchase agreement under which LPC would commit to subscribe
for up to USD 10,000,000 of our common shares over the 24-month term of the purchase agreement. The Company and LPC endeavor to enter
into a mutually acceptable purchase agreement (the “2022 Commitment Purchase Agreement”) and related documentation within
ten business days from the date of the term sheet. The Company shall pay to LPC upon signing of the 2022 Commitment Purchase Agreement
a commitment fee at its sole discretion of either (i) USD 250,000 in cash or (ii) issue 50,000 Common Shares and prepare and file as
soon as practicable a resale registration statement registering the shares issuable under the 2022 Commitment Purchase Agreement.
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v3.23.2
Accounting Policies, by Policy (Policies)
|
6 Months Ended |
Jun. 30, 2022 |
Accounting Policies [Abstract] |
|
Functional and reporting currency |
Functional and reporting currency These interim condensed consolidated financial
statements are presented in Swiss Francs (“CHF”), which is the Company’s functional currency (“functional currency”)
and the Group’s reporting currency.
|
Significant accounting policies |
Significant accounting policies The accounting policies applied by the Group in
these condensed consolidated interim financial statements are the same as those applied by the Group in its audited consolidated financial
statements as of and for the year ended December 31, 2021 and have been applied consistently to all periods presented in these condensed
consolidated interim financial statements, unless otherwise indicated.
|
New standards, amendments and interpretations adopted by the Group |
New standards, amendments and interpretations adopted by the Group
Amendments to IAS 16 |
|
Property, Plant and Equipment: Proceeds before Intended Use |
Amendments to IAS 37 |
|
Provisions, Contingent Liabilities and Contingent Assets - Onerous contracts – Costs of fulfilling a Contract |
Amendments to IFRS 3 |
|
Business Combinations - Reference to the Conceptual Framework |
Annual Improvements to IFRS Standards 2018-2020 – Amendments
to IFRS 1, IFRS 9, IFRS 16, IAS 41 The application of these new standards, amendments
to standards and interpretations does not have material impact on the financial statements of the Group.
|
Convertible loan |
Convertible loan The convertible loan obtained from FiveT Investment
Management Ltd. (see Note 5) is classified as a hybrid contract containing a host that is a financial liability and embedded derivatives
separated from the host and measured at fair value with all changes in fair value recognized in profit or loss. The embedded financial
derivatives are valued by an independent consultant initially and at period end at fair value, applying a simulation-based valuation approach. The carrying amount of the host contract at initial
recognition is the difference between the carrying amount of the hybrid contract and the fair value of the embedded derivatives. The host
is then subsequently measured at amortized cost, using the effective interest rate method.
|
Intangible assets |
Intangible assets As of June 30, 2022, Intangible assets amounted
to CHF 15,851,501, compared to CHF 14,314,877 as of December 31, 2021. The increase is due to the capitalization of development costs
related to the AM-125 program.
|
Going concern |
Going concern The Company has incurred recurring losses and
negative cash flows from operations since inception and it expects to generate losses from operations for the foreseeable future primarily
due to research and development costs for its potential product candidates. The Company believes its cash of CHF 372,647 at June 30, 2022,
together with revenues from Bentrio product sales, the receipt of grants, proceeds from the issuance of Common Shares under the A.G.P.
Sales Agreement and the 2020 Commitment Purchase Agreement of USD 2.2 million up to the reporting date as well as from further issuances
under the A.G.P. Sales Agreement and the 2022 Commitment Purchase Agreement, and the USD 2.2 million upfront payment it expects to receive
under the Share Purchase Agreement and Option Agreement, dated October 19, 2022 and amended on November 23, 2022 (as discussed below),
will fund the Company’s projected operations through the fourth quarter of 2022. We expect that our funding requirements for operations
and financial obligations until the end of 2023 will amount to CHF 22.0 to 25.0 million and to CHF 17.0 to 20 million if the convertible
loan provided by FiveT will be converted into Common Shares. To the extent that we will be unable to generate sufficient cash proceeds
from the planned divestiture or spin-off of our legacy assets or other partnering activities, we will need substantial additional financing
to meet these funding requirements both through the fourth quarter of 2022 and thereafter. These factors raise substantial doubt about
the Company’s ability to continue as a going concern. The financial statements have been prepared on a going concern basis, which
contemplates the continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business.
The financial statements do not include any adjustments that might result from the outcome of this uncertainty. As is often the case with drug development companies,
the ability of the consolidated entity to continue its development activities as a going concern is dependent upon it deriving sufficient
cash from investors, from licensing and partnering activities, in particular the intended divestiture or spin-off of the Company’s
legacy assets in the fields of inner ear therapeutics and OTC consumer health products, and from other sources of revenue such as grant
funding. On October 21, 2022, the Company announced the
sale of (i) 90% of the share capital of its subsidiary Zilentin AG and (ii) an option to purchase the subsidiaries Auris Medical AG, Otolanum
AG, Auris Medical Ltd. and Auris Medical Pty Ltd (the “Additional Subsidiaries”) – representing the Company’s
inner ear therapeutic assets – to a European family office (the “Buyer”) for a cash consideration of USD 1 million each,
for a total of USD 2 million (the “Zilentin Transaction”). Under the terms of the option agreement (the “Option”)
Zilentin will be entitled to purchase the Additional Subsidiaries for an upfront payment of USD 25. million plus potential milestone royalty
payments. The Option may be exercised for 30 days from October 19, 2022 (the “Closing Date”); beyond that period, Zilentin
will have a right of first refusal to acquire these companies until year end with the upfront payment increasing by USD 1 million per
month. There is no assurance that Buyer will exercise its option, triggering the additional upfront payment of USD 25 million. Due to
a delay in the closing of the Zilentin Transaction, the Company and the Buyer agreed on November 23, 2022 to amend their agreement, extending
the Closing Date to December 15, 2022 at the latest, increasing the share capital of Zilentin AG to be sold under the transaction from
90 to 100% and raising the amount of the initial payment for the purchase of Zilentin and for the option to purchase the Additional Subsidiaries
from USD 2 million to USD 2.2 million. The directors have considered the cash flow forecasts
and the funding requirements of the business and continue to explore grant funding, licensing opportunities and equity investment opportunities
in the Company. Apart from the inner ear therapeutic assets, the Company intends to spin off or divest also its OTC consumer health products
business, in order to focus on the development of its OligoPhore/SemaPhore RNA delivery platform. At the date of issuing these financial
statements, such plans have not yet been realized. Accordingly, the directors have prepared the financial
statements on a going concern basis. Should the above assumptions not prove to be appropriate, there is material uncertainty whether the
consolidated entity will continue as a going concern and therefore whether it will realize its assets and extinguish its liabilities in
the normal course of business and at the amounts stated in these financial statements. The Company plans to secure additional capital
in the future through equity or debt financings, partnerships, collaborations, or other sources to carry out the Company’s planned
development activities. If additional capital is not available when required, the Company may need to delay or curtail its operations
until such funding is received. Various internal and external factors will affect whether and when the Company’s product candidates
become approved for marketing and successful commercialization. The regulatory approval and market acceptance of the Company’s product
candidates, length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of
the approval process will materially affect the Company’s financial condition and future operations. Such matters are not within
the control of the Company and thus all associated outcomes are uncertain.
|
Accounting for divestiture |
Accounting for divestiture From the date of entering into the agreement for
the disposal of Zilentin and the sale of the purchase option for the Additional Subsidiaries, the respective assets and liabilities are
classified as held for sale and measured at the lower of carrying amount and fair value less costs to sell. As the agreement was entered
into after June 30, 2022, and consequently the criteria for held for sale were met only after the reporting period, the disposal group
is presented in the subsequent events and not yet as held for sale in the financial statements. The assets held for sale mainly comprise
capitalized development costs related to the AM-125 program, which amounted to CHF 12.0 million as of June 30, 2022.
|
Adjustment Revenue |
Adjustment of June 30, 2022 Revenue In the Company's Unaudited Condensed Consolidated
Interim Financial Statements as of June 30, 2022 and for the six months ended June 30, 2022, furnished with the SEC on November 30, 2022
with a Report of Foreign Private Issuer on Form 6-K (the “Original Form 6-K”), an upfront payment of $1 million (CHF 0.9 million)
related to the exclusive licensing and distribution agreement with Nuance Pharma for Bentrio® was incorrectly recorded as revenue.
In the audited financial statements as of December 31, 2022 included in the Company’s Annual Report on Form 20-F filed with the
SEC on May 16, 2023, the upfront payment was recorded as deferred income, following the correction of the identified misstatement. Adjustments
for this correction are reflected in these restated condensed consolidated interim financial statements as of June 30, 2022 and for the
six months ended June 30, 2022. The table below reflects the impact of the adjustments on key income statement and balance sheet line
items. Six months ended June 30, 2022 Adjusted consolidated Balance Sheet
| |
As of June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Deferred income | |
| - | | |
| 932,200 | | |
| 932,200 | |
Total non-current liabilities | |
| 1,014,188 | | |
| 932,200 | | |
| 1,946,388 | |
Total liabilities | |
| 10,804,712 | | |
| 932,200 | | |
| 11,736,912 | |
Accumulated deficit | |
| (182,602,921 | ) | |
| (932,200 | ) | |
| (183,535,121 | ) |
Total shareholders’ equity attributable to owners of the company | |
| 7,675,164 | | |
| (932,200 | ) | |
| 6,742,964 | |
Adjusted consolidated Statement of Profit or Loss and Other Comprehensive
Loss
| |
Half-Year ended June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Revenue | |
| 1,222,998 | | |
| (932,200 | ) | |
| 290,798 | |
Gross profit | |
| 30,766 | | |
| (932,200 | ) | |
| (901,434 | ) |
Operating loss | |
| (7,483,561 | ) | |
| (932,200 | ) | |
| (8,415,761 | ) |
Loss before tax | |
| (7,352,403 | ) | |
| (932,200 | ) | |
| (8,284,603 | ) |
Net loss attributable of owners of the Company | |
| (7,306,318 | ) | |
| (932,200 | ) | |
| (8,238,518 | ) |
Total comprehensive loss attributable to owners of the Company | |
| (7,160,269 | ) | |
| (932,200 | ) | |
| (8,092,469 | ) |
Basic and diluted loss per share | |
| (9.43 | ) | |
| (1.20 | ) | |
| (10.63 | ) |
|
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v3.23.2
Basis of Preparation Statement of Compliance (Tables)
|
6 Months Ended |
Jun. 30, 2022 |
Disclosure Of Basis Of Preparation Of Financial Statements Text Block Abstract |
|
Schedule of adjusted consolidated balance sheet |
| |
As of June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Deferred income | |
| - | | |
| 932,200 | | |
| 932,200 | |
Total non-current liabilities | |
| 1,014,188 | | |
| 932,200 | | |
| 1,946,388 | |
Total liabilities | |
| 10,804,712 | | |
| 932,200 | | |
| 11,736,912 | |
Accumulated deficit | |
| (182,602,921 | ) | |
| (932,200 | ) | |
| (183,535,121 | ) |
Total shareholders’ equity attributable to owners of the company | |
| 7,675,164 | | |
| (932,200 | ) | |
| 6,742,964 | |
|
Schedule of adjusted consolidated statement of profit or loss and other comprehensive loss |
| |
Half-Year ended June 30, 2022 | |
| |
As reported | | |
Adjustment | | |
Adjusted | |
Revenue | |
| 1,222,998 | | |
| (932,200 | ) | |
| 290,798 | |
Gross profit | |
| 30,766 | | |
| (932,200 | ) | |
| (901,434 | ) |
Operating loss | |
| (7,483,561 | ) | |
| (932,200 | ) | |
| (8,415,761 | ) |
Loss before tax | |
| (7,352,403 | ) | |
| (932,200 | ) | |
| (8,284,603 | ) |
Net loss attributable of owners of the Company | |
| (7,306,318 | ) | |
| (932,200 | ) | |
| (8,238,518 | ) |
Total comprehensive loss attributable to owners of the Company | |
| (7,160,269 | ) | |
| (932,200 | ) | |
| (8,092,469 | ) |
Basic and diluted loss per share | |
| (9.43 | ) | |
| (1.20 | ) | |
| (10.63 | ) |
|
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v3.23.2
Taxation (Tables)
|
6 Months Ended |
Jun. 30, 2022 |
Taxation [Abstract] |
|
Schedule of income tax expense |
| |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2022 | | |
2021 | |
Current income tax expense | |
| (1,231 | ) | |
| — | |
Deferred income tax gain | |
| 47,316 | | |
| 10,642 | |
Total income tax (expense)/gain | |
| 46,085 | | |
| 10,642 | |
|
Schedule of deferred income tax liabilities or to deferred income tax assets |
| |
June 30, | | |
December 31, | |
| |
2022 | | |
2021 | |
Deferred Tax liabilities | |
| | |
| |
Intangible assets | |
| (47,590 | ) | |
| (51,914 | ) |
Other receivables | |
| (81,184 | ) | |
| (122,449 | ) |
Total | |
| (128,774 | ) | |
| (174,363 | ) |
Deferred Tax assets | |
| | | |
| | |
Net operation loss (NOL) | |
| 32,775 | | |
| 31,879 | |
Total | |
| 32,775 | | |
| 31,879 | |
Deferred Tax, net | |
| (95,999 | ) | |
| (142,484 | ) |
|
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v3.23.2
Employee Benefits (Tables)
|
6 Months Ended |
Jun. 30, 2022 |
Disclosure Of Employee Benefits Text Block Abstract |
|
Schedule of Employee Benefits |
| |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2022 | | |
2021 | |
Salaries | |
| 1,439,578 | | |
| 812,158 | |
Pension costs | |
| 132,784 | | |
| 66,002 | |
Share based compensation expense | |
| 180,808 | | |
| 969,739 | |
Other employee costs and social benefits | |
| 157,358 | | |
| 257,108 | |
Total employee benefits | |
| 1,910,528 | | |
| 2,105,007 | |
|
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v3.23.2
Revision of Prior Period Financial Statements (Tables)
|
6 Months Ended |
Jun. 30, 2022 |
Disclosure Of Separate Financial Statements Text Block Abstract |
|
Schedule of Revised Consolidated Balance Sheet |
| |
As of December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Other receivables | |
| 917,833 | | |
| (246,493 | ) | |
| 671,340 | |
Prepayments | |
| 996,910 | | |
| 578,216 | | |
| 1,575,126 | |
Total current assets | |
| 3,759,901 | | |
| 331,723 | | |
| 4,091,624 | |
Total assets | |
| 18,838,598 | | |
| 331,723 | | |
| 19,170,321 | |
Accumulated deficit | |
| (176,018,660 | ) | |
| 331,723 | | |
| (175,686,937 | ) |
Total shareholders’ equity attributable to owners of the company | |
| 12,704,528 | | |
| 331,723 | | |
| 13,036,251 | |
Total equity and liabilities | |
| 18,838,598 | | |
| 331,723 | | |
| 19,170,321 | |
|
Schedule of Revised Consolidated Statement of Profit or Loss and Other Comprehensive Loss |
| |
Year ended December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Other income | |
| 460,710 | | |
| (246,493 | ) | |
| 214,217 | |
Research and development | |
| (8,939,037 | ) | |
| 578,216 | | |
| (8,360,821 | ) |
Total operating expenses | |
| (15,137,338 | ) | |
| 331,723 | | |
| (14,805,615 | ) |
Operating loss | |
| (17,099,793 | ) | |
| 331,723 | | |
| (16,768,070 | ) |
Loss before tax | |
| (17,368,546 | ) | |
| 331,723 | | |
| (17,036,823 | ) |
Net loss attributable of owners of the Company | |
| (17,390,166 | ) | |
| 331,723 | | |
| (17,058,443 | ) |
Total comprehensive loss attributable to owners of the Company | |
| (17,124,410 | ) | |
| 331,723 | | |
| (16,792,687 | ) |
Basic and diluted loss per share | |
| (26.26 | ) | |
| 0.50 | | |
| (25.76 | ) |
|
Schedule of Consolidated Statement of Cash Flows |
We
revised our consolidated statement of cash flows for the year ended December 31, 2021. There was no impact on net cash used in operating
activities.
| |
Year ended December 31, 2021 | |
| |
As reported | | |
Adjustment | | |
As revised | |
Net loss | |
| (17,390,166 | ) | |
| 331,723 | | |
| (17,058,443 | ) |
Changes in: | |
| | | |
| | | |
| | |
Trade and other receivables | |
| (586,612 | ) | |
| 246,493 | | |
| (340,119 | ) |
Prepayments | |
| (719,321 | ) | |
| (578,216 | ) | |
| (1,297,537 | ) |
Cash used in operating activities | |
| (13,627,738 | ) | |
| — | | |
| (13,672,738 | ) |
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v3.23.2
Reporting Entity (Details) - 6 months ended Jun. 30, 2022
|
CHF (SFr) |
USD ($) |
EUR (€) |
AUD ($) |
Auris Medical AG [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Name of subsidiary |
Auris Medical AG
|
|
|
|
Principal place of business |
Basel
|
|
|
|
Country of incorporation |
Switzerland
|
|
|
|
Ownership percentage in subsidiary |
100.00%
|
|
|
|
Otolanum AG [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Name of subsidiary |
Otolanum AG
|
|
|
|
Principal place of business |
Zug
|
|
|
|
Country of incorporation |
Switzerland
|
|
|
|
Ownership percentage in subsidiary |
100.00%
|
|
|
|
Altamira Therapeutics, Inc [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Name of subsidiary |
Altamira Therapeutics, Inc.
|
|
|
|
Principal place of business |
Dover, Delaware
|
|
|
|
Country of incorporation |
United States
|
|
|
|
Ownership percentage in subsidiary |
100.00%
|
|
|
|
Auris Medical Ltd. [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Name of subsidiary |
Auris Medical Ltd.
|
|
|
|
Principal place of business |
Dublin
|
|
|
|
Country of incorporation |
Ireland
|
|
|
|
Ownership percentage in subsidiary |
100.00%
|
|
|
|
Zilentin AG [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Name of subsidiary |
Zilentin AG
|
|
|
|
Principal place of business |
Zug
|
|
|
|
Country of incorporation |
Switzerland
|
|
|
|
Ownership percentage in subsidiary |
100.00%
|
|
|
|
Auris Medical Pty Ltd [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Name of subsidiary |
Auris Medical Pty Ltd
|
|
|
|
Principal place of business |
Collingwood
|
|
|
|
Country of incorporation |
Australia
|
|
|
|
Ownership percentage in subsidiary |
100.00%
|
|
|
|
Altamira Medica AG [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Name of subsidiary |
Altamira Medica AG
|
|
|
|
Principal place of business |
Zug
|
|
|
|
Country of incorporation |
Switzerland
|
|
|
|
Ownership percentage in subsidiary |
100.00%
|
|
|
|
Switzerland [Member] | Auris Medical AG [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Share capital of subsidiary |
SFr 2,500,000
|
|
|
|
Switzerland [Member] | Otolanum AG [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Share capital of subsidiary |
100,000
|
|
|
|
Switzerland [Member] | Zilentin AG [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Share capital of subsidiary |
100,000
|
|
|
|
Switzerland [Member] | Altamira Medica AG [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Share capital of subsidiary |
SFr 3,000,000
|
|
|
|
USD [member] | Altamira Therapeutics, Inc [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Share capital of subsidiary | $ |
|
$ 100
|
|
|
EUR [Member] | Auris Medical Ltd. [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Share capital of subsidiary | € |
|
|
€ 100
|
|
Australia [Member] | Auris Medical Pty Ltd [Member] |
|
|
|
|
Reporting Entity (Details) [Line Items] |
|
|
|
|
Share capital of subsidiary | $ |
|
|
|
$ 100
|
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v3.23.2
Basis of Preparation Statement of Compliance (Details) $ in Millions |
1 Months Ended |
6 Months Ended |
|
Oct. 21, 2022
USD ($)
|
Jun. 30, 2022
CHF (SFr)
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2021
CHF (SFr)
|
Basis of Preparation Statement of Compliance (Details) [Line Items] |
|
|
|
|
Intangible asset (in Francs) | SFr |
|
SFr 15,851,501
|
|
SFr 14,314,877
|
Agreement description |
|
The Company believes its cash of CHF 372,647 at June 30, 2022,
together with revenues from Bentrio product sales, the receipt of grants, proceeds from the issuance of Common Shares under the A.G.P.
Sales Agreement and the 2020 Commitment Purchase Agreement of USD 2.2 million up to the reporting date as well as from further issuances
under the A.G.P. Sales Agreement and the 2022 Commitment Purchase Agreement, and the USD 2.2 million upfront payment it expects to receive
under the Share Purchase Agreement and Option Agreement, dated October 19, 2022 and amended on November 23, 2022 (as discussed below),
will fund the Company’s projected operations through the fourth quarter of 2022. We expect that our funding requirements for operations
and financial obligations until the end of 2023 will amount to CHF 22.0 to 25.0 million and to CHF 17.0 to 20 million if the convertible
loan provided by FiveT will be converted into Common Shares.
|
The Company believes its cash of CHF 372,647 at June 30, 2022,
together with revenues from Bentrio product sales, the receipt of grants, proceeds from the issuance of Common Shares under the A.G.P.
Sales Agreement and the 2020 Commitment Purchase Agreement of USD 2.2 million up to the reporting date as well as from further issuances
under the A.G.P. Sales Agreement and the 2022 Commitment Purchase Agreement, and the USD 2.2 million upfront payment it expects to receive
under the Share Purchase Agreement and Option Agreement, dated October 19, 2022 and amended on November 23, 2022 (as discussed below),
will fund the Company’s projected operations through the fourth quarter of 2022. We expect that our funding requirements for operations
and financial obligations until the end of 2023 will amount to CHF 22.0 to 25.0 million and to CHF 17.0 to 20 million if the convertible
loan provided by FiveT will be converted into Common Shares.
|
|
Sale percentage of share capital |
90.00%
|
|
|
|
Cash consideration |
$ 1.0
|
|
|
|
Total, cash consideration |
2.0
|
|
|
|
Additional Subsidiaries upfront payment |
25.0
|
|
|
|
Upfront payment increasing per month amount |
$ 1.0
|
|
|
|
Unconverted outstanding loan amount |
|
SFr 4,701,906
|
$ 25.0
|
|
Option to purchase percentage |
|
90.00%
|
90.00%
|
|
Capitalized development costs (in Francs) | SFr |
|
SFr 12,000,000
|
|
|
Eexclusive licensing |
|
SFr 900,000
|
$ 1.0
|
|
Bottom of range [member] |
|
|
|
|
Basis of Preparation Statement of Compliance (Details) [Line Items] |
|
|
|
|
Not yet received initial amount |
|
|
2.0
|
|
Top of range [member] |
|
|
|
|
Basis of Preparation Statement of Compliance (Details) [Line Items] |
|
|
|
|
Not yet received initial amount |
|
|
$ 2.2
|
|
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v3.23.2
Basis of Preparation Statement of Compliance (Details) - Schedule of adjusted consolidated balance sheet
|
Jun. 30, 2022
USD ($)
|
As Reported [Member] |
|
Basis of Preparation Statement of Compliance (Details) - Schedule of adjusted consolidated balance sheet [Line Items] |
|
Deferred income |
|
Total non-current liabilities |
1,014,188
|
Total liabilities |
10,804,712
|
Accumulated deficit |
(182,602,921)
|
Total shareholders’ equity attributable to owners of the company |
7,675,164
|
Adjustment [Member] |
|
Basis of Preparation Statement of Compliance (Details) - Schedule of adjusted consolidated balance sheet [Line Items] |
|
Deferred income |
932,200
|
Total non-current liabilities |
932,200
|
Total liabilities |
932,200
|
Accumulated deficit |
(932,200)
|
Total shareholders’ equity attributable to owners of the company |
(932,200)
|
Adjusted [Member] |
|
Basis of Preparation Statement of Compliance (Details) - Schedule of adjusted consolidated balance sheet [Line Items] |
|
Deferred income |
932,200
|
Total non-current liabilities |
1,946,388
|
Total liabilities |
11,736,912
|
Accumulated deficit |
(183,535,121)
|
Total shareholders’ equity attributable to owners of the company |
$ 6,742,964
|
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v3.23.2
Basis of Preparation Statement of Compliance (Details) - Schedule of adjusted consolidated statement of profit or loss and other comprehensive loss - USD ($)
|
12 Months Ended |
Jun. 30, 2022 |
Dec. 31, 2021 |
As Reported [Member] |
|
|
Basis of Preparation Statement of Compliance (Details) - Schedule of adjusted consolidated statement of profit or loss and other comprehensive loss [Line Items] |
|
|
Revenue |
$ 1,222,998
|
|
Gross profit |
30,766
|
|
Operating loss |
(7,483,561)
|
$ (17,099,793)
|
Loss before tax |
(7,352,403)
|
(17,368,546)
|
Net loss attributable of owners of the Company |
(7,306,318)
|
$ (17,390,166)
|
Total comprehensive loss attributable to owners of the Company |
$ (7,160,269)
|
|
Basic loss per share (in Dollars per share) |
$ (9.43)
|
$ (26.26)
|
Adjustment [Member] |
|
|
Basis of Preparation Statement of Compliance (Details) - Schedule of adjusted consolidated statement of profit or loss and other comprehensive loss [Line Items] |
|
|
Revenue |
$ (932,200)
|
|
Gross profit |
(932,200)
|
|
Operating loss |
(932,200)
|
$ 331,723
|
Loss before tax |
(932,200)
|
331,723
|
Net loss attributable of owners of the Company |
(932,200)
|
$ 331,723
|
Total comprehensive loss attributable to owners of the Company |
$ (932,200)
|
|
Basic loss per share (in Dollars per share) |
$ (1.2)
|
$ 0.5
|
Adjusted [Member] |
|
|
Basis of Preparation Statement of Compliance (Details) - Schedule of adjusted consolidated statement of profit or loss and other comprehensive loss [Line Items] |
|
|
Revenue |
$ 290,798
|
|
Gross profit |
(901,434)
|
|
Operating loss |
(8,415,761)
|
|
Loss before tax |
(8,284,603)
|
|
Net loss attributable of owners of the Company |
(8,238,518)
|
|
Total comprehensive loss attributable to owners of the Company |
$ (8,092,469)
|
|
Basic loss per share (in Dollars per share) |
$ (10.63)
|
|
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- DefinitionThe amount of tax expense or income relating to changes in deferred tax liabilities and deferred tax assets, recognised in profit or loss. [Refer: Deferred tax assets; Deferred tax expense (income); Deferred tax liabilities]
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v3.23.2
Taxation (Details) - Schedule of deferred income tax liabilities or to deferred income tax assets - CHF (SFr)
|
Jun. 30, 2022 |
Dec. 31, 2021 |
Deferred Tax liabilities |
|
|
Total |
SFr (128,774)
|
SFr (174,363)
|
Deferred Tax assets |
|
|
Total |
32,775
|
31,879
|
Deferred Tax, net |
(95,999)
|
(142,484)
|
Net operation loss (NOL) [Member] |
|
|
Deferred Tax assets |
|
|
Total |
32,775
|
31,879
|
Intangible assets [Member] |
|
|
Deferred Tax liabilities |
|
|
Total |
(47,590)
|
(51,914)
|
Other Receivables [Member] |
|
|
Deferred Tax liabilities |
|
|
Total |
SFr (81,184)
|
SFr (122,449)
|
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v3.23.2
Capital and Reserves (Details)
|
|
|
|
1 Months Ended |
6 Months Ended |
12 Months Ended |
|
Jun. 01, 2021
USD ($)
shares
|
Dec. 01, 2020 |
May 15, 2019
shares
|
Apr. 23, 2020 |
Nov. 30, 2018
USD ($)
|
Jan. 30, 2018
shares
|
Jun. 30, 2022
CHF (SFr)
SFr / shares
shares
|
Jun. 30, 2022
USD ($)
shares
|
Jun. 30, 2021
CHF (SFr)
SFr / shares
shares
|
Dec. 31, 2021
CHF (SFr)
|
Jun. 30, 2021
USD ($)
shares
|
Capital and Reserves (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Upfront acquisition price (in Dollars) | $ |
$ 2,500,000
|
|
|
|
|
|
|
|
|
|
|
Non registered common shares |
38,218
|
|
|
|
|
|
|
|
|
|
|
Reference price (in Dollars) | $ |
$ 65.4
|
|
|
|
|
|
|
|
|
|
|
Additional non registered price |
459
|
|
|
|
|
|
|
|
|
|
|
Additional reference price (in Dollars) | $ |
$ 30,000
|
|
|
|
|
|
|
|
|
|
|
Description of public offering |
|
On March 4, 2021, the remaining convertible loan
by FiveT in the amount of CHF 604,545 plus accumulated interests of CHF 40,268 was converted into 25,841 common shares at a conversion
price of USD 27.00.
|
|
|
|
|
|
|
|
|
|
Purchase agreement, description |
|
|
|
On April 23, 2020, the Company entered into a
purchase agreement and a Registration Rights Agreement with Lincoln Park Capital Fund, LLC (the “2020 Commitment Purchase Agreement”).
Pursuant to the 2020 Commitment Purchase Agreement, LPC agreed to subscribe for up to USD 10,000,000 of our common shares over the 30-month
term of the 2020 Commitment Purchase Agreement. Through June 30, 2022, we issued a total of 165,000 of our common shares to LPC for an
aggregate amount of USD 2,806,605 under the 2020 Commitment Purchase Agreement. During the six months ended June 30, 2022, we issued 105,000
of our common shares to LPC for an aggregate amount of USD 1,698,450 under the 2020 Commitment Purchase Agreement, and as of the date
of this report, we have issued a total of 325,000 of our common shares to LPC for an aggregate amount of USD 4,003,820 under the 2020
Commitment Purchase Agreement.
|
|
|
|
|
|
|
|
Warrants |
|
|
44,872
|
|
|
|
|
|
|
|
|
Proceeds from issue of ordinary shares (in Dollars) | $ |
|
|
|
|
$ 25,000,000
|
|
|
|
|
|
|
Shares issued |
|
|
|
|
|
|
147,166
|
147,166
|
|
|
|
Aggregate offering price (in Dollars) | $ |
|
|
|
|
|
|
|
$ 6,700,000
|
|
|
|
Common shares |
|
|
|
|
|
|
|
|
|
|
87,931
|
Aggregate offering price (in Dollars) | $ |
|
|
|
|
|
|
|
|
|
|
$ 2,900,000
|
Share Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
Capital and Reserves (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Issued shares |
|
|
|
|
|
|
853,213
|
853,213
|
682,157
|
|
|
Amount of stock (in Francs) | SFr |
|
|
|
|
|
|
SFr 170,643
|
|
SFr 136,431
|
|
|
Nominal value per share (in Francs per share) | SFr / shares |
|
|
|
|
|
|
SFr 0.2
|
|
SFr 0.2
|
|
|
LPC Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Capital and Reserves (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Purchase agreement, description |
|
|
|
|
On November 30, 2018, as amended on April 5, 2019
the Company entered into a sales agreement, as amended (the “A.G.P. Sales Agreement”) with A.G.P./Alliance Global Partners
(“A.G.P.”).
|
|
|
|
|
|
|
AGP Sales Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Capital and Reserves (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares issued |
|
|
|
|
|
|
228,666
|
228,666
|
|
|
|
Aggregate offering price (in Dollars) | $ |
|
|
|
|
|
|
|
$ 7,800,000
|
|
|
|
Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Capital and Reserves (Details) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrants exercisable shares |
|
|
|
|
|
459
|
|
|
|
|
|
Changes in fair value of warrants issued (in Francs) | SFr |
|
|
|
|
|
|
SFr 1,233
|
|
|
SFr 1,233
|
|
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v3.23.2
Loans (Details) $ in Millions |
|
|
|
6 Months Ended |
|
Feb. 08, 2022
CHF (SFr)
|
Feb. 04, 2022
CHF (SFr)
|
Mar. 26, 2020
CHF (SFr)
|
Jun. 30, 2022
CHF (SFr)
|
Jun. 30, 2022
USD ($)
|
Sep. 09, 2022
CHF (SFr)
|
Description Of Accounting Policy For Loans And Receivables Text Block Abstract |
|
|
|
|
|
|
Loan amount |
|
SFr 5,000,000
|
|
|
|
SFr 600,000
|
Loan bears interest rate |
|
10.00%
|
|
|
|
|
Loan agreement, description |
|
The Company may prepay all or part of the Loan after
six months after the Disbursement Date; provided that the Company will pay an amount equal to 130% of the desired prepayment amount.
The Lender has the right to convert all or part of the Loan, including accrued and unpaid interest, at its option, into common shares,
subject to the limitation that the Lender own no more than 9.99% of the common shares at any time. The conversion price of the Loan into
common shares is USD 38.916, which corresponds to 150% of USD 25.944 (the trading volume weighted average price, the “VWAP”,
per common share on the NASDAQ stock exchange on the Disbursement Date), converted into Swiss Francs at the midpoint of the interbank
exchange rate shown by UBS on the day of receipt of the conversion notice at 4:00 pm Central European Time. The conversion price shall
be lowered in the event that the Company raises equity before the maturity date of the Loan through a public or private offering of common
shares at an issue price that is at least 10 (ten) % below the VWAP (the “New Issue”), according to the formula set forth
in the Loan Agreement (the “Adjustment”).
|
|
|
|
|
Unconverted outstanding loan amount |
|
|
|
SFr 4,701,906
|
$ 25
|
|
Fair value of the embedded derivatives amount |
|
|
|
SFr 284
|
|
|
Initial recognition |
SFr 449,898
|
|
|
|
|
|
Fair value measurement of embedded derivatives |
449,614
|
|
|
|
|
|
Effective interest expenses and transaction costs |
SFr 359,068
|
|
|
|
|
|
Loan eligible amount |
|
|
SFr 50,000
|
|
|
|
Loan interest free repaid term |
|
|
5 years
|
|
|
|
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v3.23.2
Employee Benefits (Details)
|
6 Months Ended |
Jun. 30, 2022
CHF (SFr)
shares
|
Jun. 30, 2022
$ / shares
|
Jun. 30, 2021
CHF (SFr)
shares
|
Jun. 30, 2021
$ / shares
|
Disclosure Of Employee Benefits Text Block Abstract |
|
|
|
|
Stock options |
SFr 180,808
|
|
SFr 159,487
|
|
Share based compensation expense |
|
|
810,252
|
|
Future share grant contingent |
|
|
SFr 360,112
|
|
Granted options (in Shares) | shares |
27,861
|
|
6,862
|
|
Equity incentive plans (in Dollars per share) | $ / shares |
|
$ 20.8
|
|
$ 70.2
|
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Employee Benefits (Details) - Schedule of Employee Benefits - CHF (SFr)
|
6 Months Ended |
Jun. 30, 2022 |
Jun. 30, 2021 |
Schedule Of Employee Benefits Abstract |
|
|
Salaries |
SFr 1,439,578
|
SFr 812,158
|
Pension costs |
132,784
|
66,002
|
Share based compensation expense |
180,808
|
969,739
|
Other employee costs and social benefits |
157,358
|
257,108
|
Total employee benefits |
SFr 1,910,528
|
SFr 2,105,007
|
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v3.23.2
Revision of Prior Period Financial Statements (Details) - Schedule of Revised Consolidated Balance Sheet
|
Dec. 31, 2021
USD ($)
|
As Reported [Member] |
|
Revision of Prior Period Financial Statements (Details) - Schedule of Revised Consolidated Balance Sheet [Line Items] |
|
Other receivables |
$ 917,833
|
Prepayments |
996,910
|
Total current assets |
3,759,901
|
Total assets |
18,838,598
|
Accumulated deficit |
(176,018,660)
|
Total shareholders’ equity attributable to owners of the company |
12,704,528
|
Total equity and liabilities |
18,838,598
|
Adjustment [Member] |
|
Revision of Prior Period Financial Statements (Details) - Schedule of Revised Consolidated Balance Sheet [Line Items] |
|
Other receivables |
(246,493)
|
Prepayments |
578,216
|
Total current assets |
331,723
|
Total assets |
331,723
|
Accumulated deficit |
331,723
|
Total shareholders’ equity attributable to owners of the company |
331,723
|
Total equity and liabilities |
331,723
|
As Revised [Member] |
|
Revision of Prior Period Financial Statements (Details) - Schedule of Revised Consolidated Balance Sheet [Line Items] |
|
Other receivables |
671,340
|
Prepayments |
1,575,126
|
Total current assets |
4,091,624
|
Total assets |
19,170,321
|
Accumulated deficit |
(175,686,937)
|
Total shareholders’ equity attributable to owners of the company |
13,036,251
|
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$ 19,170,321
|
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v3.23.2
Revision of Prior Period Financial Statements (Details) - Schedule of Revised Consolidated Statement of Profit or Loss and Other Comprehensive Loss - USD ($)
|
12 Months Ended |
Jun. 30, 2022 |
Dec. 31, 2021 |
As Reported [Member] |
|
|
Revision of Prior Period Financial Statements (Details) - Schedule of Revised Consolidated Statement of Profit or Loss and Other Comprehensive Loss [Line Items] |
|
|
Other income |
|
$ 460,710
|
Research and development |
|
(8,939,037)
|
Total operating expenses |
|
(15,137,338)
|
Operating loss |
$ (7,483,561)
|
(17,099,793)
|
Loss before tax |
(7,352,403)
|
(17,368,546)
|
Net loss attributable of owners of the Company |
$ (7,306,318)
|
(17,390,166)
|
Total comprehensive loss attributable to owners of the Company |
|
$ (17,124,410)
|
Basic and diluted loss per share (in Dollars per share) |
$ (9.43)
|
$ (26.26)
|
Adjustment [Member] |
|
|
Revision of Prior Period Financial Statements (Details) - Schedule of Revised Consolidated Statement of Profit or Loss and Other Comprehensive Loss [Line Items] |
|
|
Other income |
|
$ (246,493)
|
Research and development |
|
578,216
|
Total operating expenses |
|
331,723
|
Operating loss |
$ (932,200)
|
331,723
|
Loss before tax |
(932,200)
|
331,723
|
Net loss attributable of owners of the Company |
$ (932,200)
|
331,723
|
Total comprehensive loss attributable to owners of the Company |
|
$ 331,723
|
Basic and diluted loss per share (in Dollars per share) |
$ (1.2)
|
$ 0.5
|
As Revised [Member] |
|
|
Revision of Prior Period Financial Statements (Details) - Schedule of Revised Consolidated Statement of Profit or Loss and Other Comprehensive Loss [Line Items] |
|
|
Other income |
|
$ 214,217
|
Research and development |
|
(8,360,821)
|
Total operating expenses |
|
(14,805,615)
|
Operating loss |
|
(16,768,070)
|
Loss before tax |
|
(17,036,823)
|
Net loss attributable of owners of the Company |
|
(17,058,443)
|
Total comprehensive loss attributable to owners of the Company |
|
$ (16,792,687)
|
Basic and diluted loss per share (in Dollars per share) |
|
$ (25.76)
|
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v3.23.2
Revision of Prior Period Financial Statements (Details) - Schedule of Consolidated Statement of Cash Flows
|
12 Months Ended |
Dec. 31, 2021
USD ($)
|
As Reported [Member] |
|
Revision of Prior Period Financial Statements (Details) - Schedule of Consolidated Statement of Cash Flows [Line Items] |
|
Net loss |
$ (17,390,166)
|
Changes in: |
|
Trade and other receivables |
(586,612)
|
Prepayments |
(719,321)
|
Cash used in operating activities |
(13,627,738)
|
Adjustment [Member] |
|
Revision of Prior Period Financial Statements (Details) - Schedule of Consolidated Statement of Cash Flows [Line Items] |
|
Net loss |
331,723
|
Changes in: |
|
Trade and other receivables |
246,493
|
Prepayments |
(578,216)
|
Cash used in operating activities |
|
As Revised [Member] |
|
Revision of Prior Period Financial Statements (Details) - Schedule of Consolidated Statement of Cash Flows [Line Items] |
|
Net loss |
(17,058,443)
|
Changes in: |
|
Trade and other receivables |
(340,119)
|
Prepayments |
(1,297,537)
|
Cash used in operating activities |
$ (13,672,738)
|
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v3.23.2
Events After the Reporting Period (Details) SFr / shares in Units, $ in Millions |
|
|
|
1 Months Ended |
6 Months Ended |
|
Nov. 14, 2022 |
Oct. 21, 2022
USD ($)
|
Sep. 09, 2022
CHF (SFr)
SFr / shares
shares
|
Oct. 26, 2022
CHF (SFr)
|
Oct. 25, 2022
shares
|
Jun. 30, 2022
CHF (SFr)
|
Feb. 04, 2022
CHF (SFr)
|
Events After the Reporting Period [Abstract] |
|
|
|
|
|
|
|
Aggregate amount (in Francs) | SFr |
|
|
SFr 600,000
|
|
|
|
SFr 5,000,000
|
Interest rate |
|
|
5.00%
|
|
|
|
|
Maturity date |
|
|
March 31, 2023
|
|
|
|
|
Aggregate common shares (in Shares) | shares |
|
|
41,667
|
|
|
|
|
Exercise price, per share (in Francs per share) | SFr / shares |
|
|
SFr 7.2
|
|
|
|
|
Share capital percentage |
|
90.00%
|
|
|
|
|
|
Cash consideration |
|
$ 1
|
|
|
|
|
|
Additional subsidiaries |
|
25
|
|
|
|
|
|
Revenues from royalties |
|
55
|
|
|
|
|
|
Upfront payment |
|
$ 1
|
|
|
|
|
|
Divestiture of inner ear therapeutic assets description |
|
|
|
|
|
Due to a delay in the closing of the Zilentin Transaction, the Company and the Buyer agreed
on November 23, 2022 to amend their agreement, extending the Closing Date to December 15, 2022 at the latest, increasing the share capital
of Zilentin AG to be sold under the transaction from 90 to 100% and raising the amount of the initial payment for the purchase of Zilentin
and for the option to purchase the Additional Subsidiaries from USD 2 million to USD 2.2 million.
|
|
Capitalized development costs (in Francs) | SFr |
|
|
|
|
|
SFr 12,000,000
|
|
Share split of common shares (in Shares) | shares |
|
|
|
|
1,074,713
|
|
|
Nominal value (in Francs) | SFr |
|
|
|
SFr 0.2
|
|
|
|
Commitment purchase agreement description |
On
November 14, 2022, we entered into a term sheet with LPC for the conclusion of a purchase agreement under which LPC would commit to subscribe
for up to USD 10,000,000 of our common shares over the 24-month term of the purchase agreement. The Company and LPC endeavor to enter
into a mutually acceptable purchase agreement (the “2022 Commitment Purchase Agreement”) and related documentation within
ten business days from the date of the term sheet. The Company shall pay to LPC upon signing of the 2022 Commitment Purchase Agreement
a commitment fee at its sole discretion of either (i) USD 250,000 in cash or (ii) issue 50,000 Common Shares and prepare and file as
soon as practicable a resale registration statement registering the shares issuable under the 2022 Commitment Purchase Agreement.
|
|
|
|
|
|
|
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Altamira Therapeutics (NASDAQ:CYTO)
Gráfica de Acción Histórica
De Dic 2024 a Ene 2025
Altamira Therapeutics (NASDAQ:CYTO)
Gráfica de Acción Histórica
De Ene 2024 a Ene 2025