Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

 

  

UNITED STATES SECURITIES

AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

Date of report: September 27, 2023

 

Commission File Number: 001-38974

 

BIOPHYTIS S.A.

(Translation of registrant’s name into English)

 

Stanislas Veillet
Biophytis S.A.

Sorbonne University-BC 9, Bâtiment A 4ème étage

4 place Jussieu

75005 Paris, France

[phone]

(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:

x 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): ¨

 

 

 

 

 

 

On September 27, 2023, Biophytis S.A. (the “Company”) issued its Interim Financial Report for the first half of fiscal year 2023. A copy of the Company’s Interim Financial Report is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

EXHIBIT LIST

Exhibit			Description
99.1			Interim Financial Report issued by the registrant on September 27, 2023

 

 

 

 

SIGNATURES

 

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

 

	BIOPHYTIS S.A.
Date: September 27, 2023	By:	/s/ Stanislas Veillet
		Name: Stanislas Veillet
		Title: Chairman and Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

 

French public limited company with a Board of Directors with share capital of €4,267,706.99
Registered office: 14 Avenue de l'Opéra – 75001 PARIS
Paris Commercial Register (RCS) 492 002 225

 

HALF-YEAR FINANCIAL REPORT

 

AS OF JUNE 30, 2023

 

 

 

 

Half-year financial report as of June 30, 2023 

 

CONTENTS

 

1.		Activity report as of June 30, 2023	4
	1.1	Business trends and significant events	4
	1.2	Analysis of consolidated income	5
	1.3	Cash flow and financial position	6
	1.4	Subsequent events	6
	1.5	Developments and outlook	7
	1.6	Risk factors	8
	1.7	Transactions between related parties	8
2.		Unaudited condensed interim consolidated financial statements under IFRS for the six-month period ended June 30, 2023	9
	Statement of consolidated financial position		9
	Statement of consolidated operations		10
	Statement of consolidated comprehensive loss		10
	Statement of changes in consolidated shareholders’ equity		11
	Statement of consolidated cash flows		12
	Notes to the unaudited interim condensed consolidated financial statements		13

 

Page 2 of 28

 

 

Half-year financial report as of June 30, 2023 

 

GENERAL NOTES

Definitions

 

In this half-year financial report, and unless otherwise indicated:

 

·

The terms “Company” or “Biophytis” refer to Biophytis SA whose registered office is located at 14 Avenue de l'Opéra – 75001 PARIS, France, registered with the Paris Trade and Companies Registry under number 492 002 225 and its subsidiaries Instituto Biophytis do Brasil (Brazil) and Biophytis Inc (United States);

 

·

“Financial Report” means this half-year financial report as of June 30, 2023.

 

About Biophytis

 

Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases.

 

Sarconeos (BIO101), our lead drug candidate, is a small molecule in development for age-related neuromuscular (sarcopenia and Duchenne muscular dystrophy) and cardiorespiratory (COVID-19) diseases. Promising clinical results were obtained in the treatment of sarcopenia in an international Phase 2 study, enabling the launch of a Phase 3 study in this indication (SARA project). The safety and efficacy of Sarconeos (BIO101) in the treatment of severe COVID-19 were studied in a positive international Phase 2-3 clinical trial (COVA project), enabling the preparation of Conditional Marketing Authorization (CMA) applications in Europe and Emergency Use Authorization (EUA) applications in the United States. A pediatric formulation of Sarconeos (BIO101) is currently being developed for the treatment of Duchenne muscular dystrophy (DMD, MYODA project).

 

The Company is based in Paris, France, and Cambridge, Massachusetts. The Company’s ordinary shares are listed on Euronext Growth Paris (Ticker: ALBPS - ISIN: FR0012816825) and its ADSs (American Depositary Shares) are listed on the Nasdaq (Ticker BPTS - ISIN: US09076G1040).

 

For more information: www.biophytis.com

 

Page 3 of 28

 

 

Half-year financial report as of June 30, 2023

 

1.

Activity report as of June 30, 2023

 

1.1 Business trends and significant events

 

1.1.1

Research and development

 

In the first half of 2023, the Company continued to develop its main clinical and pre-clinical programs:

 

·

COVA program – Development of Sarconeos (BIO101) for the prevention of respiratory deterioration in COVID-19 patients

 

In early February 2023, Biophytis announced the final results of its Phase 2-3 COVA clinical study, including data from 54 patients (of the 233 patients treated) who were missing from the Top Line analysis released on September 7, 2022. The final analysis demonstrates that the COVA study met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with the positive Post-Hoc analysis released on November 3, 2022. Moreover, Sarconeos (BIO101) has a very good safety profile, with a lower proportion of patients with adverse events compared to the placebo (57% vs. 64%), in particular a lower frequency of serious, mostly respiratory, adverse events (25% vs. 31%).Detailed results of the study were presented at the European Respiratory Society Lung Science Conference in March 2023 in Estoril, Portugal and at the American Thoracic Society International Conference in Washington DC, United States in May 2023.

 

Based on the results, Biophytis has begun the regulatory process to give access to Sarconeos (BIO101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death as quickly as possible. To that end, the Company has developed a multi-pronged strategy:

 

-

Submit applications for early access programs in key countries. In France, the application was submitted in May and a response is expected in the second half of 2023. The early access program in France will be carried out in partnership with Intsel Chimos, a pharmaceutical company based in Saint-Cloud, France that is specialized in the importation, provision and exploitation of innovative medicines to treat patients with rare and/or serious diseases for whom no other therapeutic options are available. In Brazil, an early access program was approved in 2022 to treat critically ill COVID-19 patients in intensive care units (ICUs), but was suspended pending the results of the COVA study. Based on the positive results obtained, the program is being reactivated.

 

-

Submit applications for Conditional Marketing Authorization (CMA) in Europe and Emergency Use Authorization (EUA) in the United States. On August 16, 2023, the Company announced that it had received feedback from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), enabling it to plan the next regulatory steps for its COVA project dedicated to the development of Sarconeos (BIO101) for severe forms of COVID-19.

 

·

SARA program – Development of Sarconeos (BIO101) for sarcopenia

 

In May 2023, the Company submitted the application for Clinical Trial Authorization (CTA) to initiate SARA-31, the first Phase 3 study in sarcopenia, on the European portal of the European Medicines Agency (EMA). A similar application was submitted to the Food and Drug Administration (FDA) at the beginning of July to launch the study in the United States.

 

The launch of the Phase 3 program follows encouraging results from the SARA-INT Phase 2b study and interactions with the health authorities in 2022. The objective of the SARA-31 Phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of mobility disability. Approximately 900 patients over 65 years of age with severe sarcopenia (3 ≤ SPPB ≤ 7) with low walking speed (4-m Gait speed ≤ 0.8 m/s) and low grip strength (HGS < 20kg for women and < 35.5 kg for men) will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either the placebo or 350mg of Sarconeos (BIO101) twice daily. The primary endpoint will be the assessment of the risk of major mobility disability (MMD), measured by the ability to walk 400m in less than 15 minutes over time. In addition to the primary endpoint, the following secondary endpoints will be assessed: walking speed (4-m walking speed from the short physical performance battery (SPPB) test), handgrip strength (HGS) and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire developed specifically for sarcopenia).

 

Page 4 of 28

 

 

Half-year financial report as of June 30, 2023

 

On August 8, 2023, Biophytis announced that it had received a positive opinion from the Belgian authorities to conduct its SARA-31 program. On September 11, 2023, the Company announced that it had also received a positive opinion from the FDA to conduct the study in the United States.

 

·

Other programs

 

At the Clinical and Scientific Conference organized by the Muscular Distrophy Association (MDA) from March 19 to 22, 2023 in Dallas, Texas, the Company presented a poster with new information concerning its MYODA project for Duchenne muscular dystrophy (DMD), for which a clinical development plan is under preparation, and the therapeutic potential of BIO101 in rare neuromuscular diseases such as spinal muscular atrophy, for which promising pre-clinical results have been obtained.

 

1.1.2

Financing

 

On May 11, 2023, the Company announced the successful completion of a new financing round in the form of a private placement with professional investors combined with a public offering for individual investors, for a gross amount of €2.3 million. The transaction was carried out pursuant to the 2^nd and 4^th resolutions of the Combined General Meeting of April 17, 2023. A total of 103,717,811 new ordinary shares, representing 32% of the Company’s share capital prior to the transaction, were issued at a price of €0.0222 per share. The per-share price included a 25% discount on the volume-weighted average price of the Biophytis shares during the five trading days prior to the transaction. The total nominal amount of the capital increase was €1,037 thousand and the total issue premium was €1,265 thousand. The new shares were listed on Euronext Growth Paris under ISIN code FR0012816825 ALBPS at the start of trading on May 15, 2023. They rank pari passu with the Company’s existing shares and have carried dividend rights since their issuance.

 

1.1.3

Governance

 

At the Ordinary General Meeting of June 16, 2023, Jean Mariani was reappointed for a three-year term. Further to the resignation of Dmitri Batsis on April 27, 2023, the Board of Directors comprises four members as of the date of this Financial Report, three of whom are independent:

 

-

Stanislas Veillet, Chairman and Chief Executive Officer;

-

Nadine Coulm;

-

Claude Allary;

-

Jean Mariani.

 

1.2 Analysis of consolidated income

 

1.2.1            Net operating loss

 

The net operating loss came to €(6,524) thousand for first-half 2023 versus €(11,920) thousand for first-half 2022, reflecting the research and development costs and general and administrative expenses incurred during the period and detailed below. The Group did not generate any revenue during the first six months of the year.

 

(amounts in thousands of euros)		First-half 2022				First-half 2023
Personnel costs			(2,950	)			(1,443	)
Purchases and external expenses			(6,435	)			(3,099	)
Research tax credit			2,614				922
Other			(95	)			(143	)
Research and development costs			(6,867	)			(3,763	)
Personnel costs			(2,682	)			(962	)
Purchases and external expenses			(2,235	)			(1,685	)
Other			(136	)			(114	)
General and administrative expenses			(5,053	)			(2,761	)
Net operating loss			(11,920	)			(6,524	)

 

Page 5 of 28

 

 

Half-year financial report as of June 30, 2023

 

The sharp decrease in personnel costs is primarily due to the value of instruments giving access to the Company’s share capital, which decreased from €3,533 thousand in first-half 2022 to €322 thousand in first-half 2023.

 

The decline in R&D purchases and external expenses chiefly reflects the completion of clinical trials for the COVA and SARA programs in second-half 2022. Some residual clinical development costs were recognized in 2023, but most R&D costs in the first half of the year concerned pre-clinical work on the Company’s various programs and the transition of BIO101 production to a commercial stage.

 

1.2.2            Net loss

 

(amounts in thousands of euros)		First-half 2022				First-half 2023
Net operating loss			(11,920	)			(6,524	)
Net financial expense			(478	)			(1,241	)
Income tax benefit (expense)			-				-
Net loss for the period			(12,398	)			(7,764	)

 

The Company recognized a net financial expense of €(1,241) thousand in first-half 2023 versus €(478) thousand in first-half 2022. The decrease of €763 thousand mainly reflects the change in the fair value of convertible bonds.

 

1.3 Cash flow and financial position

 

Cash and cash equivalents amounted to €5.8 million as of June 30, 2023 versus €11.1 million as of December 31, 2022. The change over the period breaks down as follows:

 

(amounts in thousands of euros)		First-half 2023
Net cash flow used in operating activities			(8,162	)
Net cash flow from investing activities			(777	)
Net cash flow from financing activities			3,691

 

1.4 Subsequent events

 

1.4.1            Developments in R&D programs

 

Developments in R&D programs after June 30 are described in section 2.1.1.

 

1.4.2            Financing

 

On July 19, 2023, the Company finalized the terms and conditions of a $3.8 million financing transaction. The transaction involved the sale of 1,333,334 units, each consisting of one (1) American Depositary Share (“ADS”) or one (1) prefunded warrant giving the holder the right to one (1) ADS (the “Prefunded Warrants”) and one (1) warrant giving the holder the right to one (1) ADS (the “Ordinary Warrants”), at a purchase price of $2.85 per unit comprising an ADS and $2.84 per unit comprising a Prefunded Warrant. Each ADS represents the right to receive one hundred (100) new ordinary shares of the Company, with a nominal value €0.01 per share. The ADSs and Prefunded Warrants were purchased through a registered direct offering, while the Ordinary Warrants were purchased through a concurrent private placement. Each Prefunded Warrant, giving the holder the right to one (1) ADS, was subscribed at a price of $2.84 and will have an exercise price of $0.01 per ADS. The Prefunded Warrants will be exercisable immediately upon issuance and will expire ten years after their issuance. The Ordinary Warrants will have an exercise price of $3.00 per ADS, will become exercisable immediately upon issuance and will expire three years after their issuance.

 

Page 6 of 28

 

 

Half-year financial report as of June 30, 2023

 

The ADSs and Prefunded Warrants (and the underlying ADSs) (excluding the Ordinary Warrants offered in the concurrent private placement and the ADSs underlying the Ordinary Warrants) were offered and sold by the Company pursuant to a “shelf” registration statement using Form F-3 (File No. 333-271385) filed with the US Securities and Exchange Commission (SEC) on April 21, 2023 and declared effective by the SEC on May 1, 2023. The offering of the ADSs and Prefunded Warrants (and the underlying ADSs) was made exclusively by means of a prospectus, including a prospectus supplement, forming part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering were filed with the SEC.

 

The Ordinary Warrants described above were issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the ADSs underlying the Ordinary Warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the Ordinary Warrants and the ADSs underlying the Ordinary Warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

 

The issuance of the 50,500,000 new ordinary shares underlying the ADSs resulted in an immediate capital increase of €1.3 million, representing approximately 11% of the Company’s share capital and voting rights before the offering. The issue price of the ordinary shares underlying the ADSs represents a premium of 2% over the volume-weighted average price (VWAP) of the Company’s ordinary shares on the Euronext Growth Paris market during the 15 trading sessions preceding the determination of the issue price on July 18, 2023 and a discount of 21% on the VWAP when including 23% of the theoretical value of one warrant, which is €0.013 per warrant.

 

1.5 Developments and outlook

 

In the second half of 2023, the Company will pursue its value-creation strategy based on the development of its therapeutic innovations, in particular its drug candidate Sarconeos (BIO101), and anticipates the following main events:

 

·

COVA program – Development of Sarconeos (BIO101) for severe forms of COVID-19 patients

 

The company will be seeking Scientific Advice from the EMA and FDA (Type B meeting) in the second half of the year on the clinical and regulatory development plan for Sarconeos (BIO101) up to the submission of a marketing authorization application for the treatment of severe forms of COVID-19.The discussions will enable Biophytis to present the available data (pre-clinical, clinical, product and industrialization) and specify the additional information to be provided as part of marketing authorization applications, in particular the design of a confirmatory Phase 3 clinical study. Biophytis will also ask the agencies about the possibility of extending the scope of its indication to viral respiratory pathologies other than COVID-19, notably influenza, based on its non-specific mechanism of action. This extension would significantly increase the number of patients eligible for treatment and optimize the commercial potential of Sarconeos (BIO101).

 

In addition, the Company is awaiting HAS authorization for its early access program in France, and is preparing for its launch in the second half of 2023 with its partner, the Intsel Chimos laboratory. It will also apply to reactivate the authorization of its early access program in Brazil in the second half of 2023. These two programs should enable the drug to be prescribed as early as this year to hospitalized patients with severe forms of COVID-19 at risk of respiratory failure and death.

 

Page 7 of 28

 

 

Half-year financial report as of June 30, 2023

 

·

SARA program – Development of Sarconeos (BIO101) for sarcopenia

 

Based on the authorizations received from the Belgian and US agencies to conduct a Phase 3 study in sarcopenia, the Company will continue to actively look for partners in order to begin in 2024 the very large-scale study in a collaboration arrangement under licensing agreements with global or regional pharmaceutical companies.

 

·

MYODA program – Development of Sarconeos (BIO101) for Duchenne muscular dystrophy (DMD)

 

The Company plans to finalize the preparation of a Phase 1-2 study, with the aim of enrolling the first patient in the first half of 2024.

 

·

MACA program – Development of Macuneos (BIO201) for Age-related macular degeneration (AMD)

 

The Company will continue its pre-clinical development work on Macuneos (BIO201) and its backup BIO203, and prepare for clinical development its drug candidate for dry AMD (MACA program).

 

1.6 Risk factors

 

The risk factors are the same as those presented in the 2022 Annual Financial Report in Appendix 2 “Risks and uncertainties faced by the Company”.

 

1.7 Transactions between related parties

 

Transactions with related parties are the same as those presented in the 2022 Annual Financial Report in Note 20 “Related parties” of section 3 “Consolidated financial statements prepared in accordance with IFRS as of and for the year ended December 31, 2022” and in Note 19 “Related parties” of section 4 “Annual financial statements of Biophytis SA for the year ended December 31, 2022”.

 

Page 8 of 28

 

 

 

Half-year financial report as of June 30, 2023

 

2.	Unaudited condensed interim consolidated financial statements under IFRS for the six-month period ended June 30, 2023

 

Statement of consolidated financial position

 

						AS OF
(amounts in thousands of euros)		NOTES				DECEMBER 31, 2022				JUNE 30, 2023
ASSETS
Patents and software							2,655				2,647
Property, plant and equipment							121				101
Property, plant and equipment – Right of use			2				463				324
Other non-current financial assets							173				164
Total non-current assets							3,411				3,237
Other receivables			3				6,934				5,162
Other current financial assets							590				432
Cash and cash equivalents			4				11,053				5,782
Total current assets							18,576				11,376
TOTAL ASSETS							21,987				14,613
LIABILITIES AND SHAREHOLDERS' EQUITY
Shareholders' equity
Share capital			6				47,660				4,268
Premiums related to the share capital							(1,588	)			8,353
Treasury shares							(21	)			(19	)
Foreign currency translation adjustment							(25	)			(7	)
Retained earnings - attributable to owners of the parent							(23,689	)			(8,153	)
Net loss - attributable to owners of the parent							(24,216	)			(7,806	)
Shareholders' equity - attributable to owners of the parent							(1,879	)			(3,322	)
Non-controlling interests							(32	)			(32	)
Total shareholders' equity							(1,911	)			(3,354	)
Liabilities
Employee benefit obligations			9				183				188
Non-current financial liabilities			8				4,368				3,558
Non-current lease liability			8				190				163
Non-current derivative financial instruments			8				-				-
Total non-current liabilities							4,551				3,909
Current financial liabilities			8				9,933				8,935
Current lease liability			8				280				170
Provisions							75				-
Trade payables			5;10.1				6,940				3,711
Accrued taxes and employee benefits payable			10.2				1,780				904
Current derivative financial instruments			8				13				7
Other creditors and miscellaneous liabilities			7				328				332
Total current liabilities							19,348				14,058
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY							21,987				14,613

 

Page 9 of 28

 

 

Half-year financial report as of June 30, 2023

 

Statement of consolidated operations

 

						FOR THE SIX-MONTH PERIOD ENDED JUNE 30,
(amounts in thousands of euros, except share and per share data)		NOTES				2022				2023
Revenue							-				-
Cost of sales							-				-
Gross margin							-				-
Research and development expenses, net			11.1				(6,867	)			(3,763	)
General and administrative expenses			11.2				(5,053	)			(2,761	)
Operating loss							(11,920	)			(6,524	)
Financial expenses							(1,492	)			(795	)
Financial income							(14	)			143
Change in fair value of convertible notes							1,028				(589	)
Net financial expense			12				(478	)			(1,241	)
Loss before taxes							(12,398	)			(7,764	)
Income taxes							-				-
Net loss for the period							(12,398	)			(7,764	)
Attributable to owners of the company							(12,398	)			(7,764	)
Non-controlling interests							-				-
Basic and diluted weighted average number of shares outstanding							147,803,141				327,549,006
Basic loss per share (€/share)			13				(0.08	)			(0.02	)
Diluted loss per share (€/share)			13				(0.08	)			(0.02	)

 

Statement of consolidated comprehensive loss

 

		FOR THE SIX-MONTH PERIOD ENDED JUNE 30,
(amounts in thousands of euros)		2022				2023
Net loss for the period			(12,398	)			(7,764	)
Items that will not be reclassified to profit or loss
Remeasurements of the defined benefit liability (asset)			40				23
Items that will be reclassified to profit or loss
Foreign currency translation adjustment			46				18
Other comprehensive income			86				41
Total comprehensive loss			(12,312	)			(7,724	)
Attributable to owners of the company			(12,312	)			(7,724	)
Non-controlling interests			-				-

 

Page 10 of 28

 

 

Half-year financial report as of June 30, 2023

 

Statement of changes in consolidated shareholders’ equity

 

(amounts in thousands of euros, except share data)		Notes		Share capital – number of shares				Share capital				Premiums related to the share capital				Accumulated deficit and net loss				Foreign currency translation adjustment				Share based payment				Split accounting impact related to convertible notes and warrants attached to non-convertible bonds				Treasury Shares				Shareholders' equity - Attributable to owners of the company				Non-controlling interests				Shareholders' equity
As of January 1, 2022					135,953,657				27,191				27,781				(58,852	)			(72	)			8,942				897				(51	)			5,835				(32	)			5,803
Net loss for the period					-				-				-				(12,398	)			-				-				-				-				(12,398	)			0				(12,398	)
Other comprehensive income					-				-				-				40				46				-				-				-				86				-				86
Total comprehensive income (loss)					-				-				-				(12,358	)			46				-				-				-				(12,312	)			0				(12,312	)
Conversion of convertible notes					27,847,526				5,570				374				-				-				-				-				-				5,943				-				5,943
Share capital increase					-				-				-				-				-				-				-				-				-				-				-
Exercise of warrants					22,320				4				2				-				-				-				-				-				7				-				7
Treasury shares movements, net					-				-				-				-				-				-				-				(3	)			(3	)			-				(3	)
Allocation of premiums to retained earnings					-				-				(19,748	)			19,748				-				-				-				-				-				-				-
Gains and losses, net related to treasury shares					-				-				-				(29	)			-				-				-				-				(29	)			-				(29	)
Impact of IFRS 16					-				-				-				18				-				-				-				-				18				-				18
Equity settled share-based payments					-				-				-				-				-				3,533				-				-				3,533				-				3,533
As of June 30, 2022					163,823,503				32,765				8,409				(51,474	)			(27	)			12,477				896				(54	)			2,992				(32	)			2,960
As of January 1, 2023					238,297,642				47,660				(1,588	)			(63,312	)			(25	)			14,510				896				(21	)			(1,880	)			(32	)			(1,911	)
Net loss for the period									-				-				(7,764	)			-				-				-				-				(7,764	)			(0	)			(7,764	)
Other comprehensive income									-				-				23				18				-				-				-				41				-				41
Total comprehensive income (loss)									-				-				(7,742	)			18				-				-				-				(7,724	)			(0	)			(7,724	)
Conversion of convertible notes (1)					83,170,323				14,724				(10,717	)			-				-				-				-				-				4,007				-				4,007
Share capital increase					103,717,811				1,037				1,265				-				-				-				-				-				2,302				-				2,302
Costs incurred in relation to equity transactions					-				-				(339	)			-				-				-				-				-				(339	)			-				(339	)
Exercise of warrants					1,597,355				16				(15	)			-				-				-				-				-				1				-				1
Capital decrease (2)					-				(59,169	)			-				59,169				-				-				-				-				-				-				-
Allocation of share premium (3)					-				-				19,748				(19,748	)			-				-				-				2				2				-				2
Gains and losses, net related to treasury shares					-				-				-				(13	)			-				-				-				-				(13	)			-				(13	)
Equity settled share-based payments					-				-				-				-				-				322				-				-				322				-				322
As of June 30, 2023					426,770,699				4,268				8,354				(31,645	)			(7	)			14,833				896				(19	)			(3,322	)			(32	)			(3,354	)

 

	(1)	The negative additional paid-in capital is due to the nominal value of the shares being higher than their actual value at the time of conversion of the bonds
	(2)	On April 17, 2023, the Board of Directors decided to reduce the share capital by reducing the par value of each share form €0.20 to €0.01.
	(3)	On April 17, 2023, the Board of Directors decided to allocate additional paid-in capital to retained earnings.

 

Page 11 of 28

 

 

Half-year financial report as of June 30, 2023

 

Statement of consolidated cash flows

 

						FOR THE SIX-MONTH PERIOD ENDED JUNE 30,
(amounts in thousands of euros)		NOTES				2022				2023
Cash flows from operating activities
Net loss for the period							(12,398	)			(7,764	)
Adjustments to reconcile net loss to cash flows used in operating activities
Amortization and depreciation of intangible and tangible assets							150				256
Additions of provisions, net of reversals							43				(200	)
Expenses associated with share-based payments			7				3,533				322
Gross financial interest paid			12				1,219				549
Changes in fair value of convertible notes			12				(1,028	)			589
Unwinding of conditional advances and other financial expenses							15				12
Amortized cost of convertible notes and non-convertible bonds							169				149
Operating cash flows before change in working capital requirements							(8,296	)			(6,086	)
(+) Change in working capital requirements (net of depreciation of trade receivables and inventories)							(1,965	)			(2,075	)
(Increase) decrease in other non-current financial assets							-				9
(Increase) decrease in other receivables							(3,646	)			2,018
Increase (decrease) in trade payables							2,483				(3,230	)
Increase (decrease) in tax and social security liabilities							(711	)			(876	)
Increase (decrease) in other creditors and miscellaneous liabilities							(92	)			4
Cash flows (used in) from operating activities							(10,261	)			(8,204	)
Cash flows used in investing activities
Acquisition of intangible and tangible assets							(22	)			(90	)
Interests on investment accounts
(Increase) decrease of other current financial assets							344				(695	)
Sale of term deposit classified as other non-current financial assets							12				8
Cash flows (used in) from investing activities							333				(777	)
Cash flows from financing activities
Proceeds from share capital increase			6				-				2,303
Costs paid in relation to equity transactions			6				-				(339	)
Exercise of warrants (BSA) and founders’ warrants (BSPCE)							7				-
Proceeds of subsidies							153				-
Proceeds of the prefinanced CIR receivables, net of guarantee deposit			3				-				1,059
Proceeds from conditional advances							4				-
Repayment of conditional advances							(149	)			(165	)
Financial interest paid							(687	)			(246	)
Proceeds from the issuance of non-convertible bonds and convertible notes			8				8,000				1,890
Repayment of non-convertible bonds			8				(1,259	)			(615	)
Repayment of lease liabilities			8				-				(144	)
Cost incurred in relation to the issuance of convertible notes and non-convertible bonds							(380	)			(55	)
Cash flows (used in) from financing activities							5,689				3,691
Net effect of exchange rate changes on cash and cash equivalents							58				(24	)
Decrease in cash and cash equivalents							(4,181	)			(5,272	)
Cash and cash equivalents at the beginning of the period			4				23,926				11,053
Cash and cash equivalents at the end of the period			4				19,745				5,782

 

Page 12 of 28

 

 

 

Half-year financial report as of June 30, 2023

 

Notes to the unaudited interim condensed consolidated financial statements

 

The following information constitutes the Notes to the condensed interim financial statements for the six-month period ended June 30, 2023 with comparative information for the year ended December 31, 2022 for balance sheet items and for the six-month period ended June 30, 2022 for income statement items.

 

The unaudited condensed consolidated interim financial statements of Biophytis, or the “Financial Statements”, have been prepared under the responsibility of management of the Company and were approved and authorized for issuance by the Company’s Board of Directors on September 27, 2023.

 

Unless otherwise indicated, the unaudited condensed consolidated interim financial statements are presented in thousands of euros. Certain amounts may be rounded for the purpose of calculating the financial information contained in the unaudited condensed interim consolidated financial statements. Consequently, the totals in certain tables may not correspond exactly to the sum of the preceding figures.

 

Biophytis and its subsidiaries are referred to hereinafter as “Biophytis,” or the “Company”.

 

Note 1: Accounting principles, rules and methods

 

1.1 Statement of compliance

 

In accordance with European regulation 16/06/2002 of July 19, 2002 on international accounting standards, the Company's unaudited condensed interim consolidated financial statements for the six months ended June 30, 2023 have been prepared in accordance with current international accounting standards, as adopted by the European Union ("IFRS") and IFRS standards as published by the IASB (International Accounting Standards Board). These standards include the International Accounting Standards (IAS/IFRS), the interpretations of the Standard Interpretations Committee (SIC) and the International Financial Reporting Interpretations Committee (IFRIC) as published by the International Accounting Standards Board (IASB) as at June 30, 2023 and applicable at that date.

 

The unaudited condensed consolidated financial statements for the six months ended June 30, 2023 have been prepared in accordance with IAS 34 - Interim Financial Reporting, as adopted by the European Union, and IFRS standards as published by the IASB (International Accounting Standards Board) which allows a selection of explanatory notes to be presented. As they are condensed financial statements, they do not include all the information required by IFRS and should be read in conjunction with the Company's annual IFRS consolidated financial statements for the year ended December 31, 2022 (the "Annual Financial Statements").

 

1.2 Going concern

 

The Board of Directors approved the Financial Statements on a going concern basis despite the loss of (7,8) million euros for the six-month period ended June 30, 2023. This analysis takes into account :

 

	-	Cash and cash equivalents as of June 30, 2023 amounted to 5.8 million euros; and
	-	The potential use of a funding line of convertible notes established in June 2021 with Atlas that could generate up to 20 million euros of additional funding (8 tranches with a nominal value of 4 million euros each, the first and the second tranches have been issued in April, June and October 2022, respectively).

 

The Company believes that the level of cash and cash equivalents, supplemented by the use of existing financing facilities, is sufficient to cover the Company's cash requirements for the next 12 months from the balance sheet date.

 

Page 13 of 28

 

 

Half-year financial report as of June 30, 2023

 

1.3 Accounting methods

 

The accounting principles adopted for the Financial Statements as of and for the six-month period ended June 30, 2023 are the same as for the year ended December 31, 2022 with the exception of the specific provisions for the preparation of interim financial statement.

 

Standards, amendments and interpretations published by the IASB for mandatory application from 1 January 2023

 

The main standards and amendments in force, whose application will be compulsory from January 1, 2023 within the European Union, are as follows:

 

	·	IFRS 17 on insurance contracts;
	·	Disclosure of accounting policies - Amendment to IAS 1 and IFRS Practice Statement 2;
	·	Definition of accounting estimates - Amendment to IAS 8; and
	·	Deferred tax relating to assets and liabilities arising from the same transaction - Amendment to IAS 12.

 

These standards and amendments did not have a material impact on the Company's condensed interim consolidated financial statements. At 30 June 2023, the IASB had not published any additional amendments that could have an impact on the Company's consolidated financial statements.

 

Significant standards, amendments and interpretations published by the IASB but not yet mandatory

 

No standards, amendments or interpretations which have been published by the IASB, but not yet adopted by the European Union and which are not yet applicable at June 30, 2023 could have a significant impact on the financial statements of the company.

 

1.4 Translation of the financial statements of foreign subsidiaries

 

The financial statements of entities whose functional currency is not the euro are translated as follows:

 

	·	assets and liabilities are converted using the closing rate of the period;
	·	income statement items are translated using the average rate of the period as long as it is not called into question by significant changes in rate; and
	·	equity items are converted using the historical rate.

 

The exchange differences arising on translation are recognized in Other Comprehensive Income. They are reclassified as profit or loss upon total or partial exit with loss of control of the entity.

 

Page 14 of 28

 

 

Half-year financial report as of June 30, 2023

 

The exchange rates used for the preparation of the Financial Statements are as follows:

 

		Closing rate AS OF								Average rate for the Six-month period ended
EXCHANGE RATE		DECEMBER 31, 2022				JUNE 30, 2023				JUNE 30, 2022				JUNE 30, 2023
BRL			5.6386				5.2788				5.5565				5.4827
USD			1.0666				1.0866				1.0934				1.0807

 

1.5 Use of judgments and estimates

 

The preparation of financial statements requires management to make reasonable estimates and assumptions based on information available at the date the financial statements are finalized. These estimates and assumptions may affect the reported amounts of assets, liabilities and expenses in the financial statements, and the disclosure of contingent assets and liabilities at the date of review of the financial statements.

 

In preparing the condensed interim consolidated financial statements, the main judgements made by management and the main assumptions used are the same as those applied in preparing the annual financial statements for the year ended December 31, 2022.

 

These estimates are based on the going concern assumption and are prepared on the basis of the information available at the time.

 

The international geopolitical and economic situation has not led to the use of any significant new estimates or judgements in the first half of 2023.

 

Note 2: Leases

 

(Amounts in thousands of euros)		12/31/2022				Increase				Decrease				06/30/2023
Right of use			770				-				-				770
Amortization of right of use			(307	)			(139	)			-				(446	)
Net value of right of use			464				(139	)			0				324

 

Rights of use mainly relate to the lease of the head office and leases of laboratory equipment. These rights of use are amortized over the residual term of the contracts.

 

Note 3: Other receivables

 

(Amounts in thousands of euros)		12/31/2022				06/30/2023
Research Tax Credit (CIR)			3,904				4,144
Value added tax			956				647
Prepaid expenses			1,574				152
Trade payables – prepayments and trade debtors			488				209
Others			12				12
Total other receivables			6,934				5,162

 

The French Research Tax Credit ("CIR") at June 30, 2023 includes the CIR for the year ended December 31, 2022 (€3,364 thousand) for which repayment has been requested by the Company. The CIR is estimated on the basis of expenses incurred and eligible for the tax credit. The 2022 CIR was pre-financed to the tune of 2,414 thousand euros by the Predirec Innovation 3 common securitization fund with Neftys as arranger. Consequently, the Company recorded a liability corresponding to the amount due to NEFTYS upon collection of the CIR recognized at amortized cost in accordance with IFRS 9 (see note 8) and a financial asset for the amounts taken by NEFTYS from the assigned receivables.

 

Page 15 of 28

 

 

Half-year financial report as of June 30, 2023

 

Note 4: Cash and cash equivalents

 

Cash and cash equivalents are broken down as follows:

 

(amounts in thousands of euros)		AS OF DECEMBER 31,  2022				AS OF JUNE 30, 2023
Bank accounts			6,060				1,793
Short-term deposits			4,993				3,989
Total cash and cash equivalents			11,053				5,782

 

On June 30, 2023, the Company had a term deposit of 4 million euros maturing on July 28 2023 and bearing interest at 2.02%. As this term deposit meets the requirements of IAS 7.6 and IAS 7.7, i.e. short-term, liquid investments that can be drawn down quickly, it has been classified as cash and cash equivalents.

 

Note 5: Financial assets and liabilities and impacts on consolidated statement of profit or loss

 

The Company’s financial assets and liabilities are measured as follows as of December 31, 2022 :

 

		AS OF DECEMBER 31, 2022
										Value - Statement of financial
		Value -								position (IFRS 9)
		Statement of								Fair value
		financial								through profit				Amortized
(amounts in thousands of euros)		position				Fair value				or loss				cost
Non-current financial assets			173				173								173
Other receivables			6,934				6,934				-				6,934
Other current financial assets			590				590				-				590
Cash and cash equivalents			11,053				11,053				11,053				-
Total financial assets			18,749				18,749				11,053				7,696
Non-current financial liabilities			4,367				4,117				-				4,367
Current financial liabilities			10,177				10,308				6,660				3,552
Current derivative financial instruments			13				13				13				-
Trade payables			6,940				6,940				-				6,940
Tax and social liabilities			1,780				1,780				-				1,780
Miscellaneous liabilities			328				328				-				328
Total financial liabilities			23,640				23,485				6,673				16,967

 

Page 16 of 28

 

 

Half-year financial report as of June 30, 2023

 

The Company’s financial assets and liabilities are measured as follows as of June 30, 2023 :

 

		AS OF JUNE 30, 2023
										Value - Statement of financial
		Value -								position (IFRS 9)
		Statement of								Fair value
		financial								through profit				Amortized
(amounts in thousands of euros)		position				Fair value				or loss				cost
Non-current financial assets			164				164				-				164
Other receivables			5,152				5,152				-				5,152
Other current financial assets			432				432				-				432
Cash and cash equivalents			5,782				5,782				5,782				-
Total financial assets			11,530				11,530				5,782				5,748
Non-current financial liabilities			3,721				3,710				-				3,721
Current financial liabilities			9,105				8,947				5,054				4,052
Current derivative financial instruments			7				7				7				-
Trade payables			3,711				3,711				-				3,711
Tax and social liabilities			904				904				-				904
Miscellaneous liabilities			332				332				-				968
Total financial liabilities			17,779				17,611				5,061				13,356

 

The impact of the Company’s financial assets and liabilities on the consolidated statement of profit or loss are as follows for the six-month period ended June 30, 2022 and 2023:

 

		AS OF JUNE 30, 2022								AS OF JUNE 30, 2023
(amounts in thousands of euros)		Interest				Change in fair value				Interest				Change in fair value
Profit or loss impact of liabilities
Derivative financial instruments			-				1,262				-				6
Liabilities at amortized cost: non-convertible bonds			(1,004	)			-				(724	)			-
Liabilities at fair value: convertible notes			-				1,028				-				(589	)
Liabilities at amortized cost: advances			(15	)			-				(31	)			-

 

Note 6: Share capital

 

		AS OF DECEMBER 31,  2022				AS OF JUNE 30, 2023
Share capital (in thousands of euros)			47,660				4,268
Number of outstanding shares			238,297,642				426,770,699
Nominal value per share (in euros)			0,20	€			0,01	€

 

During the six months ended June 30, 2023 :

 

-

124 bonds held by Atlas Capital were converted into new shares generating the issue of 83,170,323 shares, representing a capital increase of €14,724 thousand and an issue premium of €(10,717) thousand (based on the fair value of the shares issued at the date of conversion).

 

-

Following the exercise of warrants during the period, the share capital was increased by €101 through the issue of 5,963 new shares, with a total issue premium of €417.

 

Page 17 of 28

 

 

Half-year financial report as of June 30, 2023

 

-

On April 17, 2023, the Board of Directors decided to reduce the Company's share capital by a total of €59.2 million, by reducing the par value of each share from €0.20 to €0.01 and by deducting this amount from retained earnings.

 

-

On May 11, 2023, the Company carried out a capital increase for a net amount of €1,963 thousand (including €339 thousand in capital increase costs) by issuing 103,717,811 new ordinary shares with a par value of €0.01. This represents a capital increase of €1,037 thousand and a share premium of €926 thousand.

 

In addition, the General Meeting of April 17, 2023 decided to increase the "share premium" account by €19,748 thousand, by offsetting the "retained earnings" account.

 

Note 7: Warrants and founders’ warrants

 

BSA warrants issued to investors

 

					Number of outstanding warrants																				Number of
Type			Grant date		As of January 1, 2023				Granted				Exercised				Lapsed				As of June 30, 2023				shares which can be subscribed
Warrants 2020			04/07/2020			2,469,969				-				(6,021	)							2,463,948				2,463,948
Total						2,469,969				-				(6,021	)							2,463,948				2,463,948

  

In April 2020, the Company decided to carry out a public offering of warrants. The main aim of the operation is to involve investors in the COVA program and in the Company's future development. At the end of the operation, 7,475,708 warrants were issued after the extension clause had been fully exercised. The subscription price was €0.06 per warrant. The warrants may be exercised over a period of 5 years from April 30, 2020, at an exercise price of 0.27 euro per new share. Each warrant entitles its holder to subscribe to one new ordinary share in the Company.

 

BSA warrants issued pursuant to equity-compensation plan

 

The following table summarizes the data related to the warrants issued pursuant to equity-compensation plans as well as the assumptions adopted for valuation in accordance with IFRS 2:

 

					Characteristics											Assumptions								IFRS2 Initial valuation (Black-
Type			Grant date		Number of warrants granted				Maturity date			Exercise price				Volatility				Risk-free rate				Scholes) in thousands of euros
BSA 2021			06/17/2022			398,476			06/17/2028			€	0.097				63	%			0.62	%			17
BSA 2022			04/14/2023			927,333			04/14/2029			€	0.054				74	%			2.79	%			12

  

On 14 April 2023, the Company allocated 927,333 BSA2022 giving entitlement to subscribe for one new ordinary share with a par value of one euro cent (€0.01). The issue price is €0.0027 and the exercise price is €0.0544. The BSA2022 exercise period is divided into 3 tranches: 1/3 of the BSAs may be exercised immediately, 1/3 of the BSAs may be exercised 1 year after the grant date and 1/3 of the BSAs may be exercised 2 years after the grant date. No condition of presence is attached to the 2022 warrants.

 

Page 18 of 28

 

 

Half-year financial report as of June 30, 2023

 

Changes in the number of warrants in circulation at 30 June 2023 can be analyzed as follows:

 

						Number of outstanding warrants														Number of
Type			Grant date		As of January 1, 2023				Granted			Exercised		Lapsed			As of June 30, 2023			shares which can be subscribed
BSA-2021			06/17/2022			398,476			-			-		-			398,476			398,476
BSA 2022			04/14/2023			-			927,223			-		-			927,233			927,223
Total						398,476			927,223			-		-			1,325,699			1,325,699

  

BSA warrants issued to Kreos Group

 

See Note 8.2.2 Issuance of convertible and non-convertible bonds to Kreos – Contract 2021.

 

Founders’ warrants (“BSPCE”)

 

The following table summarizes the data related to BSPCE founder’s warrants issued as well as the assumptions used for valuation in accordance with IFRS 2:

  

				Characteristics													Assumptions								IFRS 2 Initial
																									valuation
					Number of																				(Black-Scholes)
					warrants			Maturity		Expected			Exercise								Risk-free				in thousands of
Type		Grant date			granted			date		term			price				Volatility				rate				euros
BSPCE2019-1		04/03/2020			1,333,333			03/04/2026		2 years			0.27	€			48.36	%			-0.62	%			674
BSPCE2019-2		04/03/2020			666,667			03/04/2026		4 years			0.27	€			53.32	%			-0.56	%			356
BSPCE2020-1		12/22/2020			999,393			22/12/2026		2 years			0.47	€			57.80	%			-0.77	%			508
BSPCE2020-2		12/22/2020			499,696			22/12/2026		4 years			0.47	€			57.91	%			-0.77	%			284
BSPCE2021-1		09/15/2021			2 919 415			15/09/2027		1 year			0.73	€			79.11	%			-0.73	%			677
BSPCE2021-2		09/15/2021			1 459 707			15/09/2027		2 years			0.73	€			106.04	%			-0.75	%			595

 

Activity for BSPCE founder’s warrants that were outstanding during the six-month period ended June 30, 2023 are summarized in the table below:

 

								Number of outstanding warrants																				Number of
																												shares
								As of																As of				which can
								January 1,																June 30,				be
Type				Grant date				2023				Granted				Exercised				Lapsed				2023				subscribed
BSPCE2019-1				04/03/2020				831,298				-				-				(76,469	)			754,828				754,828
BSPCE2019-2				04/03/2020				590,542				-				-				(38,235	)			552,007				552,007
BSPCE2020-1				12/22/2020				640,803				-				-				(155,809	)			484,993				484,993
BSPCE2020-2				12/22/2020				353,643				-				-				(77,905	)			275,738				275,738
BSPCE2021-1				09/15/2021				2,581,393				-				-				(591,387	)			1,990,007				1,990,007
BSPCE2021-2				09/15/2021				1,290,697				-				-				(295,693	)			995,003				995,003
Total								6,288,073				-				-				(1,238,498	)			5,052,576				5,052,576

 

Page 19 of 28

 

 

Half-year financial report as of June 30, 2023

 

Free shares

  

IFRS 2 Initial

Characteristics

Assumptions

valuation (Black-

Number of

Scholes) in

free shares

Maturity

Exercise

Risk free -

thousands of

Type

Grant date

granted

date

price

Volatility

rate

euros

Free shares 2021-2

04/25/2021

1,591,334

N/A

N/A

N/A

N/A

271

Free shares 2022

04/14/2023

18,904,158

N/A

N/A

N/A

N/A

775

Total

20,495,492

1,046

 

Activity for the unvested free shares that were outstanding during the six-month period ended June 30, 2023 are summarized in the table below:

 

					Number of unvested free shares
					Unvested free																Unvested free
					shares as of																shares as of
Type		Grant date			January 1, 2023				Granted				Vested				Cancelled				June 30, 2023
Free shares 2021-2		04/25/2021			1,591,334				-				(1,591,334	)			-				-
Free shares 2022		04/14/2023			-				18,904,158				-				-				18,904,158
Total					1,591,334				18,904,158				-				-				18,904,158

 

On April 14, 2023, the Company granted 18,904,158 free shares allowing beneficiaries to receive one free ordinary share in the Company. Free shares 2022s are subject to a one-year presence condition and a one-year holding period.

 

Stock-based compensation expense recognized for the periods presented

 

(amounts in thousands of euros)

 

			SIX-MONTH PERIOD ENDED JUNE 30, 2022																SIX-MONTH PERIOD ENDED JUNE 30, 2023
							Cumulative																Cumulative
			Probabilistic				expenses -								Cumulative				Probabilistic				expenses -								Cumulative
			cost of the				beginning				Expense for				expense to				cost of the				beginning				Expense for				expense to
Type			plan				of period				the period				date				plan				of period				the period				date
BSA2021			17				-				17				17				17				17				-				17
BSA2022			-				-				-				-				12				-				12				12
BSPCE2019--1			646				572				74				646				646				646				-				646
BSPCE2019-2			297				111				56				166				293				209				28				237
BSPCE2020-1			433				341				50				390				438				438				-				438
BSPCE2020-2			197				43				32				75				165				101				2				104
BSPCE2021-1			639				431				145				576				640				640				-				640
BSPCE2021-2			503				77				121				198				401				328				31				359
Free shares2020			2,301				1,184				565				1,749				2,301				2,301				-				2,301
Free shares2021-1			4,907				1,447				2,425				3,872				4,907				4,907				-				4,907
Free shares2021-2			271				-				49				49				271				186				86				271
Free shares2022			-				-				-				-				775				-				163				163
Total			10,211				4,206				3,533				7,739				10,865				9,772				322				10,094

 

Page 20 of 28

 

 

 

Half-year financial report as of June 30, 2023

 

Note 8 : Borrowings and financial liabilities

 

(amounts in thousands of euros)		AS OF DECEMBER 31,  2022				AS OF JUNE 30, 2023
Conditional advances			664				559
Non-convertible bonds			1,721				1,122
Convertible bonds			1,792				1,877
Non-current lease obligations			190				163
Non-current financial liabilities			4,367				3,721
Non-current derivative financial instruments			-				-
Conditional advances			418				371
Non-convertible bonds			1,017				1,131
Convertible notes			6,462				5,054
Financial liabilities related to the prefinancing of a portion of the research tax credit receivables			2,035				2,314
Current lease obligations			280				170
Accrued interest payable			-				66
Current financial liabilities			10,213				9,104
Current derivative financial instruments			13				7

 

Breakdown of financial debt at 30 June 2023 by maturity, at balance sheet value :

 

		AS OF JUNE 30,				Current				Non-current
(amounts in thousands of euros)		2023				< 1 year				1 to 5 years				> 5 years
Conditional advances			929				371				559				-
Non-convertible bonds			2,253				1,131				1,122				-
Convertible notes			6,931				5,054				1,877				-
Lease liabilities			333				170				163				-
Financial liabilities related to the prefinancing of a portion of the research tax credit receivables			2,314				2,314				-				-
Accrued interest payable			66				66				-				-
Total financial liabilities			12,825				9,104				3,721				-
Derivative financial instruments			7				7				-				-

  

8.1 Conditional advances

 

(amounts in thousands of euros)		BPI – BIO101				AFM - Téléthon				BPI – BIO201				Total
As of January 1, 2023			324				385				373				1,083
(+) Proceeds from conditional advances			-				-				-				-
(-) Repayment			(165	)			-				-				(165	)
Subsidies			-				-				-				-
Financial expenses			6				4				3				13
Others			-				(2	)			-				(2	)
As of June 30, 2023			165				387				377				929

 

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Half-year financial report as of June 30, 2023

 

Breakdown of conditional advances by maturity in repayment value

 

(amounts in thousands of euros)		BPI – BIO 101				AFM - Téléthon				BPI – BIO 201				Total
As of June 30, 2023			165				387				377				929
<1 year			165				193				14				373
1 year to 5 year			-				193				363				566
>5 years			-				-				-				-

 

8.2 Convertible notes and non-convertible bonds

 

8.2.1 Issuance of convertible notes to ATLAS – 2021 Atlas Contract

 

(Amounts in thousands of euros)		ATLAS ORNANE - 2021
As of January 1, 2023			6 462
(+) Gross proceeds (1)			2000
(+/-) Change in fair value of financial liabilities			595
(-) Conversion			(4 003	)
As of June 30, 2023			5 054

 

⁽¹⁾ Net proceeds of €1,890 thousand (subscription price of 96% of the par value of €2,000 thousand) less expenses of €30 thousand.

 

In June 2021, the Company signed a new convertible bond financing of up to 32 million euros with Atlas Special Opportunities LLC (the “2021 Atlas Contract”) to continue the development of Sarconeos (BIO 101) through the issuance of multiple convertible notes. This three-year contract provides for the issue of a maximum of 1,280 bonds with an option to be exchanged for cash and/or converted into new or existing shares (ORNANE) in eight successive tranches of €4 million each.

 

The agreement imposes certain operational and financial restrictions. These covenants may limit the ability of the parent company and its subsidiaries, in certain circumstances, to, among other things, incur additional debt, create or incur liens, sell or transfer assets and pay dividends. These covenants were met at 30 June 2023. The agreement also contains certain customary covenants and events of default, including in the event of a change of control.

 

Main characteristics of the ORNANE ATLAS 2021

 

The ORNANE will have a par value of 25 000 euros. They will not bear interest and will have a 24-month maturity from issuance. The holder of ORNANE may request at any time to convert them into shares during their maturity period, and the Company shall have the right to redeem the ORNANE in cash. In case of cash redemption, the amount reimbursed will be limited to 110% of the principal. At the end of the maturity period, and in the case where the ORNANE would not have been redeemed either in cash or in new or existing shares, the holder will have the obligation to convert the ORNANE.

 

The holder can ask to convert the ORNANE at any time at the conversion parity determined by the following formula: N = CA / CP, where

 

·

“N” is the number of shares yielded by the conversion,

 

·

“CA” is the par value of the ORNANEs (i.e., 25,000 euros each),

 

·

“CP” is the conversion price (i.e., the lowest stock market price observed over the 10 days preceding the conversion request).

 

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Half-year financial report as of June 30, 2023

 

On the day of the conversion request, the Company may redeem the ORNANE in cash using the following formula: V = (CA/CP) * CPr, where

 

·

“V” is the amount to be redeemed to the holder.

 

·

“CPr” is the revised price.

 

The revised price is the lowest price between (i) the volume weighted average price over the 10 trading days preceding the date on which conversion is requested and (ii) P*1.10

 

Accounting treatment:

 

The Company determined that it could not reliably estimate separately the fair value of the conversion option embedded in the convertible bonds, and therefore concluded that the entire hybrid contract should be measured at fair value through profit or loss until settlement. Fair value is measured using a binomial valuation model. As the expected maturity of the bonds is short, the "Day one loss" (including the redemption premium and/or the issue premium) is immediately recognized in the income statement.

 

In the first half of 2023, the Company issued 80 ORNANE bonds (second half of the third tranche) for a total of 2 million euros. Issue premiums were paid for 80 thousand euros and transaction costs for 30 thousand euros. In addition, the whole of Tranche 1, i.e. 160 ORNANE bonds, and 136 ORNANE bonds from Tranche 2 were converted.

 

The tables below summarizes the key inputs to measure the fair value of the convertible notes:

 

		Tranche 2
ATLAS 2021		At issuance date (June 28, 2022)				June 30, 2023
Number of outstanding convertible notes			160				24
Conversion price			0.10	€			0.02	€
Volatility			70	%			85	%
Risk-free rate			1.82	%			3.78	%
Value of the convertible notes (in thousands of €)			3,840				659

 

		Tranche 3
ATLAS 2021		At issuance date (October 28, 2022)				June 30, 2023
Number of outstanding convertible notes			160				160
Conversion price			0.04	€			0.02	€
Volatility			70	%			85	%
Risk-free rate			2.81	%			3.88	%
Value of the convertible notes (in thousands of €)			3,840				4,394

 

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Half-year financial report as of June 30, 2023

 

8.2.2 Issuance of convertible and non-convertible bonds to Kreos – Contract 2021

 

(financial liabilities in thousand euros)		KREOS 2021 Non-Convert. Tranches				KREOS 2021 Convert. Tranches				KREOS 2021 Bifurcated derivatives				KREOS 2021 BSA 2018 Buyback				KREOS 2021 day one gain				Total
As of December 31, 2022 (As restated)			2,687				1,792				13				(48	)			53				4,497
(+/-) Fair value of derivative instruments (1)			-				-				(6	)			-				-				(6	)
(+/-) Amortized cost			149				85				-				-				(19	)			215
(-) Repayment			(615	)			-				-				-				-				(615	)
As of June 30, 2023			2,219				1,876				7				(48	)			33				4,089

 

(1)

Decrease in value per option from 0,00584€ on December 31, 2022, to 0,00327€ on June 30, 2023

 

On November 19, 2021, the Company entered into a "venture loan agreement" with KREOS in lieu of a framework agreement organizing the issue of a bond loan for an amount of up to €10 million through the issue of 7,75 million euros in non-convertible bonds ("Straight bonds"), the issue of 2.25 million euros in convertible bonds ("Convertible bonds"), and the issue of Biophytis share subscription warrants. The issuance of the first tranche is conditioned to the subscription of the warrants previously mentioned. The four-tranche loan agreement was partially drawn down by the Company in fiscal 2021 for a total amount of 6.2 million euros.

 

The non-convertible bonds bear interest at an annual rate of 10% and have been repaid in cash in 36 monthly installments since April 1, 2022.

 

The convertible bonds bear interest at an annual rate of 9.5%. The Company will redeem them for their principal amount no later than March 31, 2025, unless they are previously converted into shares, at the option of Kreos Capital, at a fixed conversion price of €0.648.

 

The Company has also issued to Kreos Capital 2,218,293 warrants giving the right to subscribe to new ordinary shares in the Company, on the basis of one share for one warrant. The warrants may be exercised over a period of 7 years from the date of issue. The exercise price of the warrants has been set at €0.56. If, in the event of exercise of the warrants, the market price (VWAP) of Biophytis shares on the exercise date is lower than the exercise price, Kreos will receive a cash payment from the Company based on a formula taking into account the difference between these two prices.

 

The loan agreement pledges the Company's goodwill, bank account balances and intellectual property rights to Kreos. It also imposes certain operational and financial restrictions. These covenants may limit the ability of the Company and its subsidiaries, in certain circumstances, to, among other things, incur additional debt, sell or transfer assets and pay dividends. The agreement also contains certain customary covenants and events of default, including in the event of a change of control.

 

Accounting treatment of KREOS 2021 hybrid financing

 

The analysis of the characteristics of the hybrid contract according to the IFRS9 and IAS32 criteria led to the need to recognize the conversion options, as well as the BSAs, as derivative instruments separate from the host contract (no equity component insofar as these options do not in all circumstances lead to the delivery of a fixed number of shares, for a fixed price).

 

Page 24 of 28

 

 

Half-year financial report as of June 30, 2023

 

The amount of cash of €5.5 million, received on November 19, 2021 (excluding transaction costs) corresponds to the estimated fair value of the instruments put in place on the date the funds were drawn: financial debt for tranches A and B for €(4.3) million (convertible and non-convertible), liability derivatives for premiums received on options sold for €(1.2) million (€464 thousand for conversion options and €710 thousand for BSAs issued), and financial compensation of €48 thousand for the 2018 BSAs bought back by Biophytis from KREOS. Regarding the third tranche (C) of the straight bond issued in December 2021 for €677 thousand (excluding transaction costs), as the drawdown conditions were fulfilled outside the framework of the contract, the company analyzed the drawdown of the third tranche (C) as a new loan contract, with Kreos Capital VI UK. As such, the third tranche (C) is recognized for its fair value on the balance sheet, estimated on the basis of the financing rate deducted from the Kreos VI financing. The entry value of the liabilities of the Tranche C leads to the recognition of a day one Gain of €98 thousand. Given the unobservable nature of the market rate, the day one gain is deferred on the Company’s balance sheet and recorded as financial liabilities.

 

In accordance with IAS 32, the redemption value of the 2018 BSAs was recognized for €48 thousand as a reduction in equity, consistent with the treatment applied to the BSAs issued in 2018.

 

The financial debt components are accounted for according to the principles of amortized cost, based on an average effective interest rate of 26.37% for the non-convertible tranches, and 22.85% for the convertible tranches. Derivative instruments are valued at their Fair Value on the balance sheet, with changes in fair value recorded in the income statement. Fair value is estimated using a binomial valuation model for convertible bonds, and a Black & Scholes valuation model for BSAs.

 

The table below presents the valuations of the conversion options:

 

Fair value of bifurcated conversion options of tranches A and B (maturing March 2025)		At issuance date (11/19/2021)				12/31/22				06/30/23
Number of obligations in circulation			2,250,000				2,250,000				2,250,000
Number of shares that can be subscribed			2,250,000				2,250,000				2,250,000
Share price			0.451	€			0.046	€			0.021	€
Exercise price			0.648	€			0.648	€			0.648	€
Volatility over a 12 months period			85	%			65	%			85	%
Risk-free rate			-	%			3.39	%			3.9	%
Credit spread			23.14	%			23.14	%			23.14	%
Fair value of the derivative instrument (in K€)			(464	)			-				-
Change in the fair value of the derivative instrument (in K€)							536				-

 

The table below shows the valuations of the BSA 2021 attached to the KREOS contract:

 

BSA – KREOS 2021

 

Derivative instruments		At issuance date  (19/11/2021)				12/31/2022				06/30/2023
Number of BSAs in circulation			2,218,293				2,218,293				2,218,293
Exercise price per share			0.56	€			0.56	€			0.56	€
Maturity			7 years				5.88 years				5.38 years
Volatility			85	%			65	%			85	%
Risk-free rate			-				3.24	%			3.9	%
Fair value of BSA 2021 issued in favor of KREOS (in K€)			(710	)			(13	)			(7	)
Change in the fair value of the derivative instrument (in K€)							775				6

 

(1) Refer to note 2.7 “Restatement of Previously Issued Financial Statements”

 

Page 25 of 28

 

 

Half-year financial report as of June 30, 2023

 

Note 9: Employee benefit obligation

 

Employee benefits consist of the provision for retirement indemnities. In estimating this provision, there have been no significant changes in the assumptions used compared with those presented in note 13 to the consolidated financial statements for the year ended December 31, 2022.

 

Note 10: Current liabilities

 

10.1 Trade payables

 

		AS OF
(amounts in thousands of euros)		DECEMBER 31, 2022				JUNE 30, 2023
Research and development suppliers			5,250				2,237
General and administrative suppliers			1,690				1,473
Total trade payables			6,940				3,710

 

The change in trade accounts payable is consistent with the reduction in R&D expenditure, linked in particular to the finalization of clinical studies under the COVA and SARA programs in the second half of 2022.

 

10.2 Tax and social liabilities

 

		AS OF
(amounts in thousands of euros)		DECEMBER 31, 2022				JUNE 30, 2023
Personnel expenses			855				440
Social security expenses			831				399
Other taxes			94				65
Total tax and social liabilities			1,780				904

 

The decrease in social security liabilities is due to the reduction in the provision for performance-related bonus in the period under review, and to the reduction in the employer's contribution in relation to bonus shares granted by the Company and acquired by beneficiaries.

 

Note 11: Details of expenses and products by function

 

11.1 Research and development expenses

 

		FOR THE SIX-MONTH PERIOD ENDED JUNE 30,
(amounts in thousands of euros)		2022				2023
Personnel expenses			(2,950	)			(1,443	)
Purchases and external expenses			(6,435	)			(3,099	)
Other			(99	)			(143	)
Research and development expenses			(9,485	)			(4,685	)
Research tax credit			2,614				922
Subsidies			4				-
Research tax credit and subsidies			2,618				-
Research and development expenses, net			(6,867	)			(3,763	)

 

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Half-year financial report as of June 30, 2023

 

11.2 General and administrative expenses

 

		FOR THE SIX-MONTH PERIOD ENDED JUNE 30,
(amounts in thousands of euros)		2022				2023
Personnel expenses			(2,682	)			(962	)
Purchases and external expenses			(2,235	)			(1,685	)
Other			(136	)			(114	)
General and administrative expenses			(5,053	)			(2,761	)

 

Total personnel costs amounted to 2,406 thousand euros at June 30, 2023, compared with 5,633 thousand euros at June 30, 2022. This sharp reduction stems mainly from expenses relating to share-based payments, which amounted to 322 thousand euros in 2023 compared with 3,533 thousand euros in 2022 (see Note 7). The Company's average headcount is stable at 26 in the first quarter of 2023, compared with 24 in the first quarter of 2022.

 

External expenses fell sharply, particularly in R&D activities. This change reflects the completion of clinical trials for the COVA and SARA programs in the second half of 2022. Residual costs related to clinical development were booked in 2023, but the bulk of R&D expenditure over the half-year concerned various preclinical work on the Company's different programs, and work relating to the production of BIO101

 

Note 12: Net financial income and expenses

 

		FOR THE SIX-MONTH PERIOD ENDED JUNE 30,
(amounts in thousands of euros)		2022				2023
Financial interest and amortized cost of the non-convertible bonds (1)			(1,004	)			(724	)
Changes in fair value of convertible notes (1)			1,028				(589	)
Accrual of provision in relation with Negma litigation			(75	)			-
Other financial expenses			(33	)			(36	)
Transaction costs related to the issuance of convertible notes			(380	)			-
Other financial income			(14	)			143
Foreign exchange gains (losses)			-				(34	)
Total net financial expense			(478	)			(1,241	)

 

(1) Refer to Note 12.2 Convertible notes and non-convertible bonds

 

Note 13: Earnings per share

 

		FOR THE SIX-MONTH PERIOD ENDED JUNE 30,
		2022				2023
Net income attributable to common shareholders			(12,398	)			(7,764	)
Number of shares issued			238,297,642				426,770,699
Number of treasury shares			54,310				19,129
Number of shares outstanding (excluding treasury stock)			238,243,332				426,751,570
Share warrants			3,795,678				3,789,647
Warrants for business creator shares			6,288,076				5,052,576
Shares from conversion of convertible bonds			288,472,222				198,214,189
Bonus shares			-				18,904,159
Number of shares issued and potential (excluding treasury stock)			536,799,308				653,397,309
Weighted average number of shares outstanding (excluding treasury stock)			147,803,141				327,549,006
Earnings per share in euros			-0.08				-0.02
Potential dilutive securities resulting from the exercise of warrants, conversion of bonds or acquisition of bonus shares			286,325,709				214,421,435
Weighed average number of outstanding and potential shares (excluding treasury stock)			434,128,850				541,970,441
Diluted earnings per share in euros (*)			(0.08	)			(0.02	)

 

(*) The impact of dilution is not presented for 2022 and 2023, as it is accretive due to negative earnings.

 

Page 27 of 28

 

 

Half-year financial report as of June 30, 2023

 

Note 14: Related Parties

 

No significant new transactions were entered into with the Company's related parties during the first six months of fiscal 2023.

 

Note 15: Off-balance-sheet commitments

 

The off-balance-sheet commitments have not changed significantly since December 31, 2022.

 

Note 16: Subsequent events

 

There are no events after June 30, 2023 likely to have an impact on the financial statements.

 

Page 28 of 28

 

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