Biophytis Publishes First-Half Financial Results and Provides an Update on its Business Activities

Rhea-AI Summary

Biophytis SA, a clinical-stage biotech company, has released its first-half 2024 financial results and business update. Key highlights include:

1. Launch of the OBA program targeting obesity with BIO101, with a phase 2 clinical trial set to begin in H2 2024.
2. Exclusive licensing agreement with Blanver for Latin America, potentially generating up to €108 million in revenue.
3. Extension of bond financing line with Atlas, providing €16 million over two years.
4. Operating loss reduced to €4.4 million from €6.5 million in H1 2023.
5. Net loss of €5.7 million, down from €7.8 million in H1 2023.
6. Cash position of €2.2 million as of June 30, 2024.

The company plans to advance BIO101 through proof of concept in humans for obesity and Duchenne muscular dystrophy, while seeking co-development partnerships for sarcopenia and COVID-19 programs.

Positive

• Launch of new obesity program (OBA) with BIO101, targeting a market projected to reach $100 billion by 2030
• Exclusive licensing agreement with Blanver for Latin America, potentially generating up to €108 million in revenue
• Extension of bond financing line with Atlas, providing €16 million over two years
• Reduction in operating loss from €6.5 million to €4.4 million year-over-year
• Decrease in net loss from €7.8 million to €5.7 million compared to H1 2023

Negative

• Cash position decreased from €5.6 million (Dec 31, 2023) to €2.2 million (June 30, 2024)
• Current cash resources only expected to fund operations until end of October 2024
• Financial expenses increased from €795,000 to €1,545,000 year-over-year
• Outstanding debt with Atlas Capital of €2.3 million limits ability to draw additional funds

Insights

Financial Analyst

The first half of 2024 financial results for Biophytis show mixed signals. The company has managed to reduce its operating loss to €4.4 million from €6.5 million in the previous year, primarily due to decreased R&D expenses. However, the net loss remains substantial at €5.7 million, albeit an improvement from €7.8 million in H1 2023.

The company's cash position is concerning, with only €2.2 million available as of June 30, 2024, expected to fund operations only until October 2024. This tight liquidity situation puts pressure on Biophytis to secure additional funding quickly. The potential €2 million tranche from Atlas Capital could provide some breathing room, but it's conditional on reducing the current outstanding debt.

On the positive side, the launch of the OBA program for obesity and the licensing agreement with Blanver for Latin America present significant opportunities. The obesity market's projected growth to $100 billion by 2030 and the potential €108 million in revenue from the Blanver deal could be game-changers if Biophytis can successfully navigate its near-term financial challenges and advance its clinical programs.

Medical Research Analyst

Biophytis' strategic pivot towards obesity with its BIO101 compound is a promising move. The OBA program, targeting a rapidly growing market, could position the company well if the Phase 2 trial yields positive results. The planned start of this trial in H2 2024, with results expected by end of 2025, provides a clear timeline for potential value creation.

The company's focus on Duchenne Muscular Dystrophy (DMD) with the planned Phase 1/2 MYODA study in 2025 also addresses an unmet medical need. However, the shift in strategy for the SARA (sarcopenia) and COVA (COVID-19) programs to seek co-development partnerships is notable. While this approach could reduce financial burden, it may also limit potential upside if these indications prove successful.

The emphasis on partnering in Asia for sarcopenia is strategically sound, given the large and growing patient population. With 38 million people over 65 suffering from sarcopenia in China and Japan alone and a 5% annual growth rate, this represents a significant market opportunity if Biophytis can secure the right partnerships.

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 30, 2024 / Biophytis SA (Euronext Growth Paris:ALBPS) ("Biophytis" or the "Company"), a clinical-stage biotechnology company focused on developing treatments for age-related diseases, publishes today its financial results for the first half of 2024 and provides an update on the company's key achievements.

Stanislas Veillet, CEO of Biophytis, commented:

"We are particularly pleased with the progress made in the first half of 2024. The launch of our clinical program OBA for obesity, addressing a major public health issue, and our partnership with Blanver to develop BIO101 in Latin America, are key milestones that demonstrate Biophytis' ability to innovate and capitalize on market opportunities.

We are now entering a critical phase where the results of our clinical trials, especially in the obesity field, along with our continued strategy of regional pharmaceutical partnerships, particularly in Asia, could significantly transform the company's future.

Despite the ongoing challenges in financial markets, the Company has been able to extend its bond financing line, and is actively working on recapitalization solutions to support its future growth."

Key Highlights for the First Half of 2024:

Launch of a new obesity program with BIO101 (20-hydroxyecdysone): In April 2024, Biophytis announced the launch of its OBA program targeting obesity with BIO101 (20-hydroxyecdysone). The global market for obesity treatments, valued at $6 billion in 2023, is projected to reach $100 billion by 2030, with an average annual growth rate of 42%. Biophytis is positioned to capitalize on this trend with BIO101, the first oral MAS receptor activator, already recognized for its beneficial effects on muscle mass and fat mass regulation in preclinical models. A phase 2 clinical trial for the OBA program, involving 164 patients with obesity, is set to begin in the second half of 2024. Results from this pivotal study are expected by the end of 2025 and could pave the way for new therapeutic options for millions of patients struggling with obesity.

Exclusive Licensing Agreement with Blanver for Latin America: In June 2024, Biophytis entered into an exclusive licensing agreement with Blanver, a leading pharmaceutical player in Latin America, for the registration and commercialization of BIO101 across all its current indications: sarcopenia, obesity, COVID-19, and Duchenne muscular dystrophy. This strategic partnership could generate up to €108 million in revenue for Biophytis through milestone payments and sales-based royalties. The first phase of the agreement involves regulatory submissions in several key Latin American countries at the beginning of 2025.

Expansion of Financing Capabilities: During the first half of 2024, Biophytis leveraged its bond financing line with Atlas through a new issuance of €4 million. The contract, set to expire in June 2024, was renewed for two years with a total value of €16 million, allowing the Company to draw €2 million every 40 trading days. This amendment provides the Company with a bond financing facility, complementing equity financing or non-dilutive funding options.

Financial highlights:

		06/30/2023				06/30/2024
(amounts in thousands of euros, except share data)		6 months				6 months
Research and development costs, net			(3,763	)			(2,105	)
General and administrative expenses			(2,761	)			(2,285	)
Operating income			(6,524	)			(4,390	)
Financial expenses			(795	)			(1,545	)
Financial income			143				121
Change in fair value of convertible bonds			(589	)			(3	)
Net financial income			(1,240	)			(1,427	)
Profit before tax			(7,764	)			(5,817	)
Income tax			-				-
Net income (loss)			(7,764	)			(5,817	)

Biophytis' operating result shows a loss of €4.4 million as of June 30, 2024, compared to €6.5 million a year earlier. External expenses have significantly decreased, particularly in R&D activities. This change is explained by the completion of clinical trials for the COVA and SARA programs in the first half of 2023, along with substantial internalization of regulatory and clinical work associated with the launch of the OBA obesity program initiated in April 2024, as well as a global reduction in overhead expenses.

The financial result decreased from -€1.2 million as of June 30, 2023, to -€1.4 million as of June 30, 2024, mainly driven by expenses related to convertible and non-convertible bond borrowings with Atlas Capital and Blackrock (formerly Kreos Capital).

The net loss amounts to €5.7 million as of June 30, 2024, compared to €7.8 million for the same period in 2023.

The company's available cash stood at €2.2 million as of June 30, 2024, compared to €5.6 million as of December 31, 2023. These resources, which include non-dilutive financing obtained during the summer totaling €0.8 million (including Bpifrance subsidies and partial pre-financing of the 2024 CIR), are expected to fund operations until the end of October 2024. Drawing a new €2 million tranche from the bond facility with Atlas Capital could extend the cash horizon until the end of 2024. This drawdown is conditional upon the outstanding debt with Atlas, which must not exceed €2 million at the time of the drawdown. It is noted that the current outstanding debt is €2.3 million.

Outlook and Next Steps

The Company will continue in 2024 and 2025 with its value creation strategy focused on the development of its therapeutic innovations.

Based on its financing capabilities, the Company plans to advance its drug candidate BIO101 (20-hydroxyecdysone) through proof of concept in humans, demonstrating tolerance and efficacy in a phase 2 study across two indications: obesity and Duchenne muscular dystrophy. For its sarcopenia and severe COVID-19 programs with BIO101, the Company will actively seek co-development partnerships based on the positive results already achieved in terms of efficacy and safety.

• OBA Program - Development of BIO101 for Obesity

The Company plans to initiate the Phase 2 OBA study in the second half of 2024, in the United States, with potential additional centers in Europe. Preliminary results on the efficacy of BIO101 are expected by the end of 2025.

• MYODA - Development of BIO101 for Duchenne Muscular Dystrophy (DMD)

The Company plans to start a phase 1/2 OBA study in non-ambulant DMD patients in 2025.

• SARA (development of BIO101 in sarcopenia) and COVA (development of BIO101 in severe forms of COVID-19) programs

Over the past few years, the Company has achieved significant results in terms of efficacy, particularly in patients with sarcopenia and severe forms of COVID-19, while demonstrating good tolerance in these fragile patients. The next development steps for the SARA and COVA programs will require long and costly Phase 3 studies, for which the support of a pharmaceutical partner will be necessary through co-development and licensing agreements.

Following the agreement with Blanver in June 2024 for Latin America, Biophytis is now focusing its search for potential partners in the Asia region. Sarcopenia is a widespread condition in this region, particularly in China and Japan. In these two countries, nearly 38 million people over the age of 65 suffer from sarcopenia¹, and this population is expected to grow by over 5% per year through 2030², making it an especially attractive target market.

Upcoming events:

• October 2, 2024: European Midcap Event - Paris

• December 6-8, 2024: International Conference on Sarcopenia, Cachexia, and Wasting Disorders (SCWD International Conference) - Washington DC, USA

About BIOPHYTIS

Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start, and Duchenne muscular dystrophy, Phase 1-2 to be started), respiratory diseases (COVID-19, Phase 2-3 completed), and metabolic disorders (obesity, Phase 2 to be started). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company's ordinary shares are listed on Euronext Growth Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401). For more information, visit www.biophytis.com.

Disclaimer

This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates," or the negative version of these words or comparable words. These forward-looking statements are based on assumptions that Biophytis considers reasonable. However, there is no guarantee that the forward-looking statements contained in these statements will be accurate, as they are subject to various risks and uncertainties. The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered significant by Biophytis. Therefore, there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. Please also refer to the "Risks and Uncertainties" section of the Company's 2023 annual financial report available on the BIOPHYTIS website (www.biophytis.com), and as outlined in the "Risk Factors" section of Form 20-F and other forms filed with the SEC (Securities and Exchange Commission, USA). We do not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future developments, or otherwise, unless required by law.

Biophytis Contacts

Investor Relations
Nicolas Fellmann, Chief Financial Officer
Investors@biophytis.com

Media Contacts
Antoine Denry: antoine.denry@taddeo.fr - +33 6 18 07 83 27
Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50

Consolidated financial statement

		12/31/2023				06/30/2024
(amounts in thousands of euros)
ASSETS
Patents and software			2,637				2,535
Property, plant and equipment			315				275
Property, plant and equipment - right of use			186				160
Other non-current financial assets			158				161
Total non-current assets			3,110				2,970
Other receivables			2,916				3,442
Other current financial assets			368				113
Cash and cash equivalents			5,567				2189
Total current assets			8,850				5,744
TOTAL ASSETS			11,960				8,714
LIABILITIES
Capital			2,081				4,203
Additional paid-in capital			13,483				14,062
Own shares			(12	)			(9	)
Conversion differences			(25	)			(58	)
Reserves - Group share			(2,357	)			(18,771	)
Net income - Group share			(17,026	)			(5,812	)
Shareholder equity - Group share			(3,857	)			(6,385	)
Non-controlling interests			(32	)			(33	)
Total shareholder equity			(3,889	)			(6,418	)
Staff commitments			237				224
Non-current borrowing			3,247				818
Total non-current liabilities			3,484				1,041
Current borrowings			5,023				8,838
Short-term lease liabilities							54
Provision			223				179
Trade accounts payable			5,392				3,758
Tax and social security liabilities			1,348				940
Current derivative liabilities			1
Other creditors and accrued liabilities			378				322
Total current liabilities			12,365				14,091
TOTAL LIABILITIES			11,960				8,714

Consolidated income statement

		06/30/2023				06/30/2024
(amounts in thousands of euros, except share data)		6 months				6 months
Revenues			-				-
Cost of sales			-				-
Gross margin			-				-
Research and development costs, net			(3,763	)			(2,105	)
General and administrative expenses			(2,761	)			(2,285	)
Operating income			(6,524	)			(4,390	)
Financial expenses			(795	)			(1,545	)
Financial income			143				121
Change in fair value of convertible bonds			(589	)			(3	)
Net financial income			(1,240	)			(1,427	)
Profit before tax			(7,764	)			(5,817	)
Income tax			-				-
Net income (loss)			(7,764	)			(5,817	)
Of which Group share			(7,764)				(5,812)
Of which non-controlling interests			-				(5	)
Weighted average number of shares outstanding (excluding treasury shares)			818,873				3,499,971
Basic earnings per share (€/share)			(9.48	)			(1.66	)
Diluted earnings per share (€/share)			(9.48	)			(1.66	)

Note: for comparison purposes, the number of shares used to calculate earnings per share as of 06/30/2023 retrospectively takes into account the reverse stock-split of May 3, 2024 on the basis of one new share for 400 old shares

Statement of consolidated comprehensive income

		06/30/2023				06/30/2023
		6 months				6 months
(amounts in thousands of euros)
Net income (loss)			(7,764	)			(5,817	)
Items not recyclable in the income statement
Actuarial gains and losses on post-employment benefits			23				10
Items recyclable in the income statement
Conversion difference variation			18				10
Other comprehensive income items			41				20
Comprehensive income (loss)			(7,724	)			(5,797	)
Of which Group share			(7,724)				(5,796)
Of which non-controlling interests			-				(1)

Statement of consolidated cash flows

		06/30/2023				06/30/2024
(amounts in thousands of euros)		6 months				6 months
Cash flow from operating activities
Net income (loss)			(7,764	)			(5,817	)
Elimination of depreciation on fixed assets			256				148
Provisions, net of reversals			(200	)			(64	)
Share-based payment costs			322				515
Gross interest paid			549				547
Change in fair value of convertible bonds			589				236
Discounting / undiscounting advances			12
Amortized cost of convertible and non-convertible bonds			149
Other items without cash impact							760
Cash flow from operating activities before changes in working capital			(6,086	)			(3,674	)
(+) Change in working capital (net of impairment of trade receivables and inventories)			(2,075	)			(2,278	)
(Increase) decrease in other non-current financial assets			9
(Increase) decrease in other receivables			2,018				122
			(3,230	)			(1,574	)
Increase (decrease) in tax and social security liabilities			(876	)			(735	)
			4				(91	)
Cash flow from operating activities			(8,204	)			(5,951	)
Cash flow related to investment operations
Acquisition of intangible assets and property, plant and equipment			(90	)			(9	)
Subscription of term deposits classified as other current financial assets			(695	)
Decrease (increase) in term deposits classified as other non-current financial assets			8
Cash flow related to investment operations			(177	)			(9	)
Cash flow related to financing operations
Capital increase			2,303				-
Expenses relating to capital increase			(339	)			-
Exercise of 'BSA' warrants and 'BSPCE' warrants			-				9
Receipt of grants			-				-
Payment of CIR (Research tax credit) pre-financing net of deposit			1,059				164
Payment of repayable advances			-
Repayment of repayable advances			(165	)			(110	)
Gross interest paid			(246	)			(547	)
Issue of convertible and non-convertible bonds			1,890				4,000
Repayments of convertible and non-convertible bonds			(615	)			(680	)
Repayment of lease liabilities			(144	)			(26	)
Bond issue costs			(55	)			(220	)
Other cash flows related to financing operations							(8	)
Cash flow related to financing operations			3,691				2,582
Impact of exchange rate fluctuations			(24	)
Increase (decrease) in cash flow			(5,272	)			(3,378	)
Opening cash and cash equivalents			11,053				5,567
End of year cash and cash equivalents			5,782				2,189

¹Yuan 2023, Epidemiology of Sarcopenia, Metabolism; Shafiee 2017, Prevalence of Sarcopenia in the world, Journal of diabetes & metabolic disorders; http://dx.doi.org/10.1590/1809-9823.2015.14139

²Marché du traitement de la sarcopénie - Analyse des tendances et de la croissance | Année de prévision 2030 - https://www.theinsightpartners.com/fr/reports/sarcopenia-treatment-market -

View the original press release on accesswire.com

FAQ

What is Biophytis' new obesity program and when will clinical trials begin?

Biophytis launched the OBA program targeting obesity with BIO101 (20-hydroxyecdysone) in April 2024. A phase 2 clinical trial involving 164 patients with obesity is set to begin in the second half of 2024, with results expected by the end of 2025.

How much potential revenue could Biophytis generate from its licensing agreement with Blanver?

The exclusive licensing agreement with Blanver for Latin America could generate up to €108 million in revenue for Biophytis through milestone payments and sales-based royalties.

What was Biophytis' (BPTS) net loss for the first half of 2024?

Biophytis reported a net loss of €5.7 million for the first half of 2024, compared to €7.8 million for the same period in 2023.

How long is Biophytis' current cash expected to fund operations?

Biophytis' current cash resources are expected to fund operations until the end of October 2024. Drawing a new €2 million tranche from the bond facility with Atlas Capital could extend the cash horizon until the end of 2024.