RLFFD Relief Therapeutics Holdings AG (QB)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13A-16 OR 15D-6

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of September, 2023

Commission File Number: 001-41174

RELIEF THERAPEUTICS Holding SA

(Exact name of Registrant as specified in its charter)

Not Applicable

(Translation of registrant’s name into English)

Switzerland

(Jurisdiction of incorporation or organization)

Avenue de Sécheron 15

1202 Geneva

Switzerland

Tel: +41 22 545 11 16

(Address of principal executive offices)

Indicate by check mark if the registrant files or will file annual reports under cover of Form 20-F or Form 40-F

Form 20-F  ☒ Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1)  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7)  ☐

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On September 15, 2023, RELIEF THERAPEUTICS Holding SA (the “Company”) presented to its shareholders (i) a corporate update and presentation, (ii) its Condensed Consolidated Financial Statements (unaudited) as of June 30, 2023, and (iii) its Management’s Discussion and Analysis of Financial Condition and Results of Operations for the six months ended June 30, 2023, which are attached hereto as Exhibits 99.1, 99.2, and 99.3 respectively.

On September 15, 2023, the Company issued a press release reporting on its results for the six months ended June 30, 2023 and providing a corporate update, which press release is attached hereto as Exhibit 99.4.

INDEX TO EXHIBITS

1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: September 15, 2023

2

Exhibit 99.2

RELIEF THERAPEUTICS Holding SA

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CONSOLIDATED INTERIM BALANCE SHEET

The accompanying notes form an integral part of these consolidated interim financial statements.

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CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE LOSS

The accompanying notes form an integral part of these consolidated interim financial statements.

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CONSOLIDATED INTERIM STATEMENT OF CASH FLOW

The accompanying notes form an integral part of these consolidated interim financial statements.

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CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY

The accompanying notes form an integral part of these consolidated interim financial statements.

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NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS

RELIEF THERAPEUTICS Holding SA (“Relief”, the “Company” or the “Group”) is a Swiss stock corporation domiciled at 15 Avenue de Sécheron, 1202 Geneva, Switzerland. The Company’s shares are listed on the SIX Swiss Exchange (ticker: RLF) and quoted in the U.S. on OTCQB (tickers: RLFTF, RLFTY).

The Group focuses on identification, development and commercialization of novel, patent protected products intended for the treatment of metabolic, dermatological and pulmonary rare diseases with a portfolio of clinical and marketed products that serve unmet patient needs.

In March 2021, Relief signed a collaboration and license agreement with Acer Therapeutics, Inc. (“Acer”) for the worldwide development and commercialization of ACER-001 (OLPRUVA^™) for the treatment of urea cycle disorders (“UCDs”) and maple syrup urine disease (“MSUD”). In December 2022, the FDA approved ACER-001 for the treatment of UCDs in the U.S. In August 2023, Relief and Acer terminated the March 2021 collaboration and license agreement and entered into a new exclusive license agreement for the development and commercialization of ACER-001 for the treatment of UCDs, MSUD, and other potential indications. Under the terms of the new agreement, Acer retains development and commercialization rights worldwide, excluding Europe where Relief retains these rights.

In June 2021, the Group acquired APR Applied Pharma Research SA (“APR”), a privately held Swiss pharmaceutical company specialized in formulating, developing, and commercializing known molecules designed with proprietary drug delivery systems for niche and specialty diseases. The acquisition transformed Relief into a fully integrated commercial-stage biopharmaceutical group. The acquisition further diversified Relief’s pipeline and portfolio with both commercial products and clinical-stage programs, provided a commercial infrastructure in Europe and strengthened internal research and development (“R&D”) capabilities.

In July 2021, the Group acquired AdVita Lifescience GmbH (“AdVita”). The acquisition strengthened the Group’s expertise and intellectual property rights around the inhaled formulation and delivery of aviptadil.

In 2022, Relief established a commercial unit in the U.S. to launch PKU Golike in October 2022 and market potential future products in the U.S. market.

These unaudited condensed consolidated interim financial statements were approved for publication by the Board of Directors on September 14, 2023.

There were no new standards or amendments to existing standards that have a significant impact on the Group’s accounting policies and interim financial statements.

These condensed consolidated interim financial statements were prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as issued by the International Accounting Standards Board (IASB). They do not include all disclosures that would otherwise be required in a complete set of financial statements and should therefore be read in conjunction with the Group’s annual consolidated financial statements for the year ended December 31, 2022. They have been prepared under the historical cost convention, as modified by the revaluation of financial instruments at fair value, and are presented in Swiss francs (CHF). All values are rounded to the nearest thousand (TCHF), except when otherwise indicated.

A gain of TCHF 740 on fair value remeasurement of contingent consideration in the comparative period of the consolidated interim statement of comprehensive loss has been reclassified from ‘Other gains’ to a distinct line ‘Change in fair value of contingent consideration’ to conform with the current period presentation. This reclassification had no impact on the Group’s previously reported financial position or result of operations.

The accounting policies used in the preparation and presentation of the condensed interim consolidated financial statements are consistent with those applied for the Group’s last annual consolidated financial statements for the year ended December 31, 2022.

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The business is not subject to any seasonality. Expenses largely depend on the phase of the respective projects, particularly with regard to external research and development expenditures.

Costs that incur unevenly during the financial year are anticipated or deferred in the interim report only if it would also be appropriate to anticipate or defer such costs at the end of the financial year.

The preparation of the consolidated financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the application of policies and reported amounts of assets, liabilities, income, expenses and related disclosures. The estimates and underlying assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making the judgments about carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.

Critical judgments in applying accounting policies were the same as those applied to the consolidated financial statements for the year ended December 31, 2022.

Key sources of estimation uncertainty were the same as those applied to the consolidated financial statements for the year ended December 31, 2022.

Going concern

These consolidated financial statements have been prepared assuming the Group will continue as a going concern which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business.

As of August 31, 2023, the Group had CHF 18.3 million cash in hand, which includes proceeds of USD 10 million from the renegotiation of licensing terms with Acer (refer to note 29). Based on liquidity forecasts and development plans, existing cash was expected to be sufficient to meet the Group’s cash needs for at least the next 12 months.

Since its inception, the Group has primarily relied on external financing to fund its cash needs and has experienced recurring losses. The Group may continue to generate operating losses in the foreseeable future. The Group’s long-term viability depends on its ability to raise additional capital until it generates positive cash flows to support its operations. The Group may never achieve sustainable profitability and is exposed to all the risks inherent in establishing a business. Management intends to continue to explore options to obtain additional funding, including public or private financing, or license and collaboration agreements. However, there can be no assurance that capital will be available in sufficient amounts or on acceptable terms. If Relief is unable to obtain the required funding, it will be forced to delay, reduce or eliminate some or all of its research and development programs and of its product portfolio expansion or commercialization efforts, which could adversely affect its business prospects or result in the Group’s inability to continue operations.

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The disaggregation of the Group’s revenue is presented in the following table:

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In December 2022, ACER-001 was approved in the U.S. by the Food and Drug Administration (FDA) for the treatment of Urea Cycle Disorders under the trademark OLPRUVA^™. The intangible asset associated with the ACER-001 license is amortized from January 1, 2023, on a straight-line basis over its estimated useful life of 14 years.

Impairment test

Intangible assets with finite lives are amortized over the useful economic life and assessed for impairment whenever there is an indication that the intangible asset may be impaired. Intangible assets with indefinite useful lives are not amortized but are tested for impairment either individually or at the cash-generating unit level. The Group generally tests its intangible assets for impairment at the end of the year, or more frequently if events or changes in circumstances indicate that intangible assets may be impaired. The Group considers the relationship between its market capitalization and its equity book value, among other factors, when reviewing for indication of impairment. As of June 30, 2023, Relief’s market capitalization was CHF 33.7 million, representing a significant decrease from CHF 132.2 million as of December 31, 2022, and a large discount to the carrying amount of its net assets, indicating a potential impairment of Relief’s intangible assets. Additionally, the Group identified circumstances that negatively affected the recoverable value of its in-development assets. Consequently, the Group carried out impairment tests of its intangible assets and goodwill as of June 30, 2023.

For the purpose of impairment testing, goodwill was allocated to each CGU constituting the sole operating segment of the Group. The recoverable amount of the group of CGUs is based on the cumulated value in use estimated for each CGU or group of CGUs. The Group’s material CGUs relate to on-market drugs and drug candidates referred to above. The impairment test was performed by determining the recoverable amount of each CGU as the risk-adjusted net present value of future cashflows.

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Key assumptions used in value in use calculations

The estimation of recoverable amounts involves significant management judgment. The values assigned to each assumption on an asset basis are based on historical data from external and internal sources and on management’s estimates. The key assumptions used in the valuation models were determined as follows:

Impairment test conclusion

For the six-month ended June 30, 2023, the Group recognized a non-cash impairment charge of TCHF 55’734 to write down the carrying value of intangible assets associated with RLF-100^®, RLF-TD011 and Sentinox^™. The impairment charge was recorded in the comprehensive statement of loss under the heading ‘Impairment expense’.

As part of a comprehensive strategic review conducted in the second and third quarters of 2023, the Group prioritized certain development programs to ensure resource efficiency amid constrained funding conditions and revised its development plans. Under the revised strategic plan, resource allocation to development programs related to drug candidates RLF-100, RLF-TD011 and Sentinox was scaled back. The de-prioritization of these programs is expected to postpone potential economic returns while reducing required short-term investments. The Group plans to primarily allocate available resources to the ongoing development of its metabolic disorder programs, including RLF-OD032, PKU Golike and ACER-001. It aims to resume the accelerated development of RLF-100, RLF-TD011 and Sentinox once adequate financing or strategic partnerships are secured for their completion. Clinical programs with RLF-100 and RLF-TD011 remained ongoing as of June 30, 2023.

The postponement of estimated future net cash flows from these assets, as well as an increase of the discount rate compared to December 31, 2022, resulted in impairment charges of TCHF 24’225, TCHF 22’534 and TCHF 2’958 recognized against the intangible assets associated with RLF-100, RLF-TD011 and Sentinox, respectively. In addition, goodwill allocated to these assets was entirely impaired for a total amount of TCHF 6’017.

For other intangible assets and remaining goodwill, the Group determined based on the results of the impairment test that their estimated value in use exceeded their respective carrying amounts as of the measurement date. Therefore, the Group did not record an impairment charge on these other assets for the period ended June 30, 2023.

Sensitivity to changes in assumptions

The Group performed a sensitivity analysis taking into account reasonably possible changes in the assumptions the value in use is most sensitive to, as listed in the key assumptions section above, including higher discount rate, lower projected income, increased development budget, and postponed market launch when applicable. The results of the sensitivity analysis as of June 30, 2023, are presented hereafter.

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For intangible assets associated with the ACER-001 license, the Group concluded that no reasonably possible change of key assumptions would cause the carrying amount to exceed the recoverable amount.

While management believes the assumptions used are reasonable, changes in these assumptions could result in a future material impairment. The completion of the development of IPR&D assets and the ongoing commercialization of on-market products are subject to the availability of capital, which is uncertain as discussed in note 4.2 of these interim consolidated financial statements. If the Group is unable to secure sufficient capital, it will be forced to delay or abandon certain development and commercialization activities, which could lead to a material impairment of the affected assets.

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The net carrying amount of property and equipment increased to TCHF 390 as of June 30, 2023, from TCHF 49 as of December 31, 2022, primarily in relation to the acquisition of laboratory equipment and office material.

As of June 30, 2023, the share capital consisted of 14’040’837 issued shares with a par value of CHF 4.00 each. The Company held 1’822’398 shares in treasury as of June 30, 2023.

Reverse stock split

On May 5, 2023, RELIEF THERAPEUTICS Holding SA effected a 1-for-400 reverse stock split, whereby every 400 shares of the pre-reverse split share capital were combined and reclassified into one share. A total of 5’616’334’800 pre-reverse split ordinary shares were combined and reclassified into 14’040’837 ordinary shares post-reverse stock split. The par value of each share was multiplied by 400 from CHF 0.01 to CHF 4.00. The Company paid in cash fractional shares, and accordingly, no fractional shares were issued in connection with the reverse stock split.

As a result of the reverse stock split, all references in these financial statements to units of shares or per share amounts are reflective of the reverse split for all periods presented. In addition, the exercise prices and the numbers of shares issuable upon the exercise of any outstanding options, warrants, and other securities entitling their holders to purchase or receive Relief shares were proportionally adjusted.

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Equity transactions in 2023

During the first semester of 2023, the following transactions resulted in cash gross proceeds of TCHF 5’030 before deducting transaction costs of TCHF 487.

On June 15, 2023, the Company entered into a securities purchase agreement pursuant to which the Company agreed to sell in a private placement 1’200’000 ordinary shares, pre-funded warrants to purchase up to 300’000 ordinary shares (the “Pre-Funded Warrants”) and warrants to purchase up to 1’500’000 ordinary shares (the “Warrants”). The Company received total gross proceeds of TCHF 4’995 before deducting placement agent fees and related expenses.

The Warrants are exercisable until June 21, 2028, at an exercise price of CHF 3.40 per share. The Pre-Funded Warrants were prefunded at CHF 3.329 per share and are exercisable with no expiration date at an exercise price of CHF 0.001 per share. Each of the Warrants and Pre-Funded Warrants represents the right to purchase one ordinary share of the Company. Relief committed to reserving from its treasury shares reserve the maximum number of shares to be issued upon exercise of the Warrants and Pre-Funded Warrants. As of June 30, 2023, none of the Warrants and Pre-Funded Warrants had been exercised.

The Company retired fractional shares upon completion of the reverse stock split. Fractional shares representing 3’009 shares post-reverse stock split were acquired in May 2023 for a total cost of TCHF 22.

Pursuant to changes in the Swiss Code of Obligations effective January 1, 2023, and the decision of the extraordinary general meeting held on April 28, 2023, the Company’s authorized capital was replaced by a capital band. The capital range can be used for issuance of shares for strategic acquisitions and financing transactions.

As of June 30, 2023, the Board of Directors was authorized, at any time until 30 May 2024, to increase the share capital by the issuance of up to 2’500’000 ordinary shares with a nominal value of CHF 4.00, under the terms and conditions set forth in Article 3a^ter of Relief’s Articles of Association.

The conditional share capital of the Company as of June 30, 2023, was TCHF 16’688, consisting of 4’171’924 shares with a par value of CHF 4.00 each, of which 264’424 shares to be used for stock options and 3’907’500 shares for grant of option rights in connection with bonds, notes or similar financial instruments issued by the Company.

As of June 30, 2023, there were 182’283 outstanding stock options under the Company’s stock option plans and 1’800’000 outstanding warrants as issued in the June 2023 private placement. Each option allows its holder to acquire one share at a predetermined price, subject to certain vesting conditions.

As of June 30, 2023, the company had two outstanding bank loans: a TCHF 355 loan from a German bank carrying interest at 2.7% per year until December 30, 2023, and a TCHF 19 loan that is interest-free and repayable in monthly installments until 2026.

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As of June 30, 2023, the Group recognized provisions of TCHF 7’032 for contingent payments that may become due to the former shareholders of APR and AdVita upon completion of pre-agreed milestones. As a result of changes in its development strategy (note 6), the Group reevaluated its assessment of contingent payments related to the affected programs. Consistent with assumptions underlying the impairment of the carrying value of the associated intangible assets, the expected settlement dates of the contingent payments were postponed. The resulting gain of TCHF 3’962 from fair value remeasurement was recorded in the income statement for the six months ended June 30, 2023.

Contingent consideration for the acquisition of APR

As of June 30, 2023, remaining milestone payments under the acquisition agreement were (i) the execution of a definitive agreement for the commercialization of Sentinox^™, (ii) the launch of Sentinox in the first of France, Germany, Spain, Italy, and the United Kingdom, and (iii) the launch of RLF-TD011 in the first of France, Germany, Spain, Italy and the United Kingdom. Contingent payments aggregate to a maximum amount of CHF 28 million, in a combination of cash and Relief shares.

Contingent consideration for the acquisition of AdVita

As of June 30, 2023, remaining milestone payments under the acquisition agreement were (i) the approval in the U.S. or Europe of the inhaled form of aviptadil for the treatment of sarcoidosis or berylliosis, and (ii) the conduct of a phase II clinical study for the inhaled form of aviptadil in the treatment of checkpoint inhibitor-induced pneumonitis. Contingent payments aggregate to a maximum amount of EUR 10 million (CHF 9.8 million), in cash.

Provisioned amounts are calculated at the end of each reporting period by determining the probability-weighted present value of potential payments. As of June 30, 2023, probabilities ranged from 15% to 90% based on the estimated likelihood of completion for each underlying milestone. These probabilities are consistent with those estimated for the impairment test conducted for intangible assets and goodwill (note 6). Time to completion of each milestone ranged from approximately one year to eight years. A discount rate of 5% was determined based on the estimated time value of comparable liabilities, excluding risks factored into the probabilities of success.

A provision of TCHF 136 recorded as of December 31, 2022, was released upon the conclusion of an investigation initiated in June 2021 by SIX Exchange Regulation AG. The actual cost amounted to TCHF 142.

In January 2021, the Company signed a financing agreement with its largest shareholder, GEM Global Yield LLC (“GEM”), for the implementation of a share subscription facility (the “SSF”) in the amount of up to CHF 50 million until January 20, 2024. As of June 30, 2023, the Company had not drawn on the SSF.

The Company agreed to pay GEM a commitment fee (the “Fee”) of TCHF 1’250 plus accrued interest. As of June 30, 2023, the Fee was payable on demand and bore interest at 1% above the base rate of Barclays Bank plc. As the obligation to pay the Fee arose with the execution of the agreement, the Company recorded it in full as a liability on the signature date. The corresponding expense is recognized as financial expense (note 23) over the SSF commitment period of three years ending January 20, 2024.

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Expenses incurred with third parties in relation to the purchase and manufacturing of drug products for sale, as well as laboratory supplies in connection with research and development services provided to customers, are classified in ‘raw materials and consumables expenses’. Expenses incurred with third parties in relation to advertising, marketing, sales promotion, shipping, distribution and commission on sales, are classified as ‘external selling and distribution expenses’.

The increase in ‘raw materials and consumables expenses’ correlates with the increase in revenue from product sales. A change in the product mix, with a higher proportion of sales stemming from higher-margin products, reduced the ratio of raw materials and consumables expenses over product sales. The increase in ‘external selling and distribution expenses’ is primarily due to marketing activities subsequent to the launch of PKU Golike in the U.S. in October 2022.

External research and development expenses include costs associated with outsourced clinical research organization activities, sponsored research studies, clinical trial costs, process development, and product manufacturing expenses in relation to research and development programs.

In the first six months of 2023, external research and development expenses mainly comprised the clinical and drug product development costs associated with RLF-OD032, RLF-100 and RLF-TD011, complemented by the continued development of the PKU Golike products franchise. In the comparative period, these expenses mainly related to costs incurred by Acer under the license and collaboration agreement for development and premarketing activities for ACER-001.