CureVac to Report Third Quarter and First Nine Months 2024 Financial Results
and Business Update on November 12, 2024
 

TÜBINGEN, Germany/BOSTON, USA – November 7, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), will report financial results, and provide business updates for the third quarter and first nine months 2024 on Tuesday, November 12, 2024. The company will host a conference call and webcast on the same day at
3 p.m. CET / 9 a.m. EST.

Dial-in numbers to participate in the conference call:

U.S. Toll-Free: +1-877-407-0989

International: +1-201-389-0921

Germany: 0800-182-0040 (landline access) / 0800-184-4713 (cell phone access)

The live webcast link can be accessed via the newsroom section of the CureVac website at https://www.curevac.com/en/newsroom/events/

Corresponding presentation slides will be posted shortly before the start of the webcast. A replay will be made available at this website after the event.

About CureVac

CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media and Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Forward-Looking Statements of CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway expectations, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (the “SEC”). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

Corporate News

Bad Neustadt a. d. Saale | 7 November 2024

RHÖN-KLINIKUM AG continues solid performance in the first nine months –
outlook confirmed  

RHÖN-KLINIKUM AG continues to report an increase in consolidated revenues and profit. In the first
nine months of financial year 2024, revenues were up by EUR 82.1 million to reach EUR 1,171.1 million
(9M 2023: EUR 1,089.0 million). Consolidated profit improved by 27.7% to EUR 30.4 million (9M 2023: EUR 23.8 million). At EUR 75.1 million, EBITDA was 2.3% above the level in prior year (9M 2023: EUR 73.4 million). From January to September 2023 a total of 688,787 patients were treated on an inpatient and outpatient basis in the hospitals and medical care centres, 3.6% more compared with the same period of the previous year (9M 2023: 664,594).

“We are taking various strategic measures enabling us to achieve a stable performance in this challenging market environment and are prepared for the hospital reform. In this regard, we are focusing on our strengths such as the specialisation of our facilities, the high level of treatment quality as well as the close collaboration within the Group’s network. Moreover, we are reinvesting our earnings in new staff and the infrastructure of our facilities to ensure our processes are effective and efficient”, said Prof. Dr. Tobias Kaltenbach, chairman of the Board of Management of RHÖN-KLINIKUM AG.

Outlook for 2024 confirmed

For the current financial year, RHÖN-KLINIKUM AG continues to expect revenues of EUR 1.6 billion within a range of plus or minus 5%. For earnings before interest, tax and depreciation/amortisation (EBITDA), a level of between EUR 110 million and EUR 120 million is expected.

The outlook is subject to considerable uncertainties in connection with the numerous global crises in the form of inflation and price increases and any regulatory measures impacting our remuneration structure in 2024.

The Quarterly Statement for Q3 2024 is published on the Internet.

RHÖN-KLINIKUM AG is one of the largest healthcare providers in Germany. The hospitals offer excellent medical care with a direct tie-in to universities and research facilities. Each year some 882,000 patients are treated at our five sites – RHÖN-KLINIKUM Campus Bad Neustadt, Klinikum Frankfurt (Oder), Universitätsklinikum Gießen and Universitätsklinikum Marburg (UKGM) as well as Zentralklinik Bad Berka. The Company employs over 18,200 persons. The innovative RHÖN Campus approach committed to cross-sector and future-oriented healthcare delivery in rural areas, the steadfast continuation of the gradual digital transformation within the Company as well as the strategic partnership with Asklepios are key elements of our corporate strategy. RHÖN-KLINIKUM AG is an independent Company operating under the umbrella of Asklepios Kliniken GmbH & Co. KGaA.   www.rhoen-klinikum-ag.com

Contact:

RHÖN-KLINIKUM AG | Head of Corporate Finance, Treasury, Investor Relations and Sustainability
Julian Schmitt | T. +49 9771 65-12250 | julian.schmitt@rhoen-klinikum-ag.com

RHÖN-KLINIKUM AG | Schlossplatz 1 | D-97616 Bad Neustadt a. d. Saale

APONTIS PHARMA reports profitable revenue growth for Single Pill combinations in 9M 2024 – revenue guidance adjusted

• Revenue growth for Single Pill combinations in 9M 2024 to EUR 26.2 million (9M 2023: EUR 17.9 million)
• Novartis collaboration (asthma products) contributes EUR 5.6 million to revenues
• EBITDA rises to EUR 2.7 million (9M 2023: EUR -7.0 million) on the back of higher revenues and a reduced cost base
• Net result profitable at EUR 0.8 million (9M 2023: net loss of EUR 6.2 million)
• Full-year revenue forecast for 2024 lowered slightly to EUR 48.7 million (previously: EUR 50.7 million), mainly due to delays in the effectiveness of the revised marketing concept – EBITDA forecast unchanged at EUR 3.3 million

Monheim am Rhein, November 7, 2024 – APONTIS PHARMA AG (Ticker APPH / ISIN DE000A3CMGM5), a leading pharmaceutical company specializing in Single Pill combinations in the German market, continued its profitable revenue growth with Single Pill combinations in the third quarter of 2024. The revised marketing concept is having an effect, albeit not yet at the planned rate. APONTIS PHARMA thus remains on a profitable growth path.

The 47% growth in the core business with Single Pill combinations to EUR 26.2 million (9M 2023: EUR 17.9 million) resulted from the improved supply capacity for Atorimib (+EUR 6.9 million) and the development of the remaining Single Pill portfolio (+EUR 1.4 million). Contrary to the original planning, sales with Tonotec only fell by EUR 1.5 million. Due to the tender situation, the company had expected a decline of EUR 2.6 million for Tonotec. Revenue in the cooperation business rose to EUR 8.5 million (9M 2023: EUR 7.8 million). The cooperation with Novartis for the products Atectura and Enerzair, which began in April 2024, already contributed EUR 5.6 million to revenue. Overall, APONTIS PHARMA generated total revenue of EUR 35.9 million, an increase of 32.4% over the same period of the previous year (9M 2023: EUR 27.1 million).

Earnings before interest, taxes, depreciation and amortization (EBITDA) improved by EUR 9.7 million to EUR 2.7 million (9M 2023: EUR -7.0 million). This development was driven in particular by the significantly reduced cost base as a result of the successfully completed restructuring, but also by higher revenues from Single Pill combinations. Cash outflow from operating activities decreased to EUR -5.0 million (H1 2023: EUR -13.4 million) and was particularly characterized by the outflow of funds in the amount of EUR 5.6 million from the restructuring provision formed in the previous year. With an equity ratio of 68.4% and a net liquidity of EUR 14.3 million (December 31, 2023: EUR 20.8 million), APONTIS PHARMA continues to have a solid financial position.

Full-year revenue forecast for 2024 slightly lowered – EBITDA forecast unchanged

Taking into account delays in the effectiveness of the revised marketing concept, the Executive Board of APONTIS PHARMA AG has decided to slightly reduce the total revenue forecast for the 2024 financial year to EUR 48.7 million (previously: EUR 50.7 million). Revenues of EUR 34.0 million (previously: EUR 36.0 million) are expected for the Single Pill combination business. EBITDA for the full year 2024 is still expected to be EUR 3.3 million.

Bruno Wohlschlegel, CEO of APONTIS PHARMA: “The first nine months of 2024 have been successful for APONTIS PHARMA. We have realigned, streamlined and strengthened the organization – we have returned to a growth path. We were able to achieve a significantly positive result again. In addition to the noticeably reduced cost base, the revenue growth of the Single Pill combinations was decisive. Here, we were able to achieve growth not only with our successful product Atorimib, but also with other Single Pill combinations. The cooperation with Novartis for the two asthma drugs Atectura and Enerzair has also got off to a promising start. At the same time, we see that our revised marketing strategy is gradually taking effect, even though there has been a slight delay in the effectiveness of the revised marketing concept. Consequently, we have slightly lowered our revenue expectations for the full year 2024. However, we are confident that our measures will increasingly materialize.”

Voluntary public purchase offer by Zentiva

After a careful and thorough review of the offer document published by the bidder on October 24, 2024, the APONTIS PHARMA Executive and Supervisory Boards recommend that APONTIS PHARMA shareholders accept the offer. The Executive Board and Supervisory Board of APONTIS PHARMA consider the offer price of EUR 10.00 per APONTIS PHARMA share to be fair, reasonable and attractive from a financial point of view and see an attractive premium of around 52.9% compared to the closing price on October 15, 2024, and a premium of 38.3% compared to the average Xetra closing price over the past three months.

The members of the Executive Board and Supervisory Board of APONTIS PHARMA intend to tender all of their APONTIS PHARMA shares. Zentiva has already secured a stake of approximately 37.5% of the APONTIS PHARMA shares through a purchase agreement with the main shareholder of the Company.

The joint reasoned statement of the Executive Board and Supervisory Board of APONTIS PHARMA AG is published in German on the Company’s website in the Investor Relations section under “voluntary public purchase offer” and is also provided in a non-binding English translation. The exact terms of the offer can be viewed at www.zentiva-offer.com.

Group figures (unaudited)

Note: The figures for the nine-month period are unaudited. Rounding differences may occur.

Webcast/Conference Call:

CEO Bruno Wohlschlegel, CPO Thomas Milz and CFO Thomas Zimmermann will explain the results for the first nine months of 2024 in a webcast presentation today, November 7, 2024, 11:30 CET. The presentation will be held in English.

Please register for participation in advance at:

APONTIS PHARMA Interim Statement 9M 2024 – Webcast/Conference Call.

The accompanying presentation will also be available on the Company’s website before it begins.

Additional information:

Information on upcoming events can be found at https://apontis-pharma.de/en/financial-calendar and the latest analyst recommendations at https://apontis-pharma.de/en/share-price.

Condensed Group Income Statement (unaudited)

Note: The figures for the nine-month period are unaudited. Rounding differences may occur.

Condensed Consolidated Statement of Financial Position (unaudited)

Note: The figures as of September 30, 2024, are unaudited. Rounding differences may occur.

Condensed Group Statement of Cash Flows (unaudited)

Note: The figures for the nine-month period are unaudited. Rounding differences may occur.

About APONTIS PHARMA:

APONTIS PHARMA AG is a leading pharmaceutical company specializing in Single Pill combinations in Germany. Single Pills combine two to three generic active ingredients in a single dosage form administered once a day. Single Pill therapies have been scientifically proven to significantly increase adherence and thus improve the treatment prognosis and quality of life of patients while reducing complications, mortality, and treatment costs. Consequently, Single Pill combinations are the preferred treatment option in numerous international treatment guidelines, including in the EU and Germany. APONTIS PHARMA has been developing, promoting, and distributing a broad portfolio of Single Pill combinations and other pharmaceutical products since 2013, with a special focus on cardiovascular diseases such as hypertension, hyperlipidemia, and secondary prevention. For additional information about APONTIS PHARMA, please visit www.apontis-pharma.de.

APONTIS PHARMA AG

Investor Relations
ir@apontis-pharma.de
T: +49 2173 89 55 4900
F: +49 2173 89 55 1521
Rolf-Schwarz-Schütte-Platz 1
40789 Monheim / Rhein
Germany
apontis-pharma.de

APONTIS PHARMA Press Contact

CROSS ALLIANCE communication GmbH
Sven Pauly
ir@apontis-pharma.de
T: +49 89 125 09 0330

Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Australia, Canada or Japan or any other jurisdiction in which such release, publication or distribution would be unlawful. The important notes at the end of this announcement need to be observed.

Strong EBITDA growth: Cantourage Group SE posts EBITDA of EUR 1.4 million in third quarter of 2024 and sets course for further profitable growth

• EBITDA in the third quarter of 2024 significantly higher year-on-year at EUR +1.4 million (Q3 2023: EUR -0.7 million)
• Sales increased to EUR 30.2 million in the period from January 1 to September 30, 2024 (prior-year period: EUR 17.0 million)
• Analyst firms NuWays and Montega confirm buy recommendation for Cantourage shares with price targets of EUR 10.00 and EUR 11.00 respectively

Berlin, November 7, 2024 – Cantourage Group SE (hereinafter “Cantourage”, ISIN: DE000A3DSV01, www.cantourage.com), Europe’s leading listed cannabis company, posted a new record quarter in terms of both sales and operating result (EBITDA) in the period from July 1 to September 30, 2024. Cantourage thus continues the strong growth trend from the first two quarters (Figures for fiscal year 2024 based on preliminary, unaudited figures for the Cantourage group):

• Q1 2024: EUR 6.1 million in sales; EBITDA of EUR -0.3 million
• Q2 2024: EUR 10.9 million in sales; EBITDA of EUR +1.0 million
• Q3 2024: EUR 13.2 million in sales; EBITDA of EUR +1.4 million

“Cantourage is on an excellent economic path. We started in 2019 with sales of around EUR 0.5 million and now expect sales of at least EUR 40 million and EBITDA of over EUR 2.0 million in 2024. From the very beginning, our goal at Cantourage was not only to continuously increase our sales, but above all to grow profitably. In fiscal year 2024, we will now achieve both for the first time on a full-year basis,” said Philip Schetter, CEO of Cantourage.

The main driver of Cantourage’s positive business development in recent months has been the expansion of processing capacities in Germany and Portugal, which was accompanied by partial legalization of Cannabis on April 1, 2024. As a result, Cantourage is increasingly able to meet the continuing strong growth in demand for cannabis products, particularly in Germany and the UK. Cantourage is also benefiting from the variety of high-quality cannabis products in its own portfolio. In the third quarter of 2024 alone, the company launched a total of 16 new cannabis flower strains on the market. Thanks to its high product diversity and flexible business model, Cantourage is not only able to respond quickly and comprehensively to a wide range of patient needs, but also to take advantage of the ongoing growth momentum in the European medical cannabis market. The product portfolio is also to be further diversified and expanded in the future. In light of this, Cantourage entered into new collaborations with a total of six cultivation partners from four different continents in the third quarter of 2024. The company is also planning to launch the new “value” brand MEDICUS in November 2024, under which patients will initially have access to five cannabis flower products with a particularly attractive price-performance ratio. Cantourage is thus also further expanding its presence in this dynamically growing market segment.

Philip Schetter is very optimistic about the future of Cantourage: “One thing is certain for us: no matter how legalization develops for the recreational market: Medical cannabis is here to stay – not only in Germany, but also in more and more European countries that are currently opening up to the topic. Thanks to our position as market leader in Germany and our flexible business model, we will continue to record strong, profitable growth in the years ahead. This is also the assumption of the two analyst firms that regularly follow our company’s development and prospects in detail. The analysts at NuWays and Montega recently confirmed their buy recommendation for Cantourage shares with a price target of EUR 10.00 and EUR 11.00 respectively. With a view to our further capital market activities, we at Cantourage are certainly looking forward to engaging in intensive discussions with investors, financial journalists and analysts about our company in the coming weeks. Special highlights in this context will certainly be our participation in the German Equity Forum in Frankfurt at the end of November and the Hamburg Investor Days at the beginning of February 2025.”

Further information on current business developments and analysts’ growth estimates for the coming years can be found in the “Investors” section of the company’s website: www.cantourage.com/investors

About Cantourage

Cantourage is a leading European producer and distributor of cannabis flowers and cannabis-based medicinal preparations and drugs. The Berlin-based company was founded in 2019 by industry pioneers Norman Ruchholtz, Dr. Florian Holzapfel and Patrick Hoffmann. With an experienced management team and its “Fast TrackAccess” platform, Cantourage enables producers from around the world to become part of the growing European medical cannabis market faster, easier and more cost-effectively by processing and distributing their cannabis raw materials and extracts. In this context, Cantourage ensures compliance with the highest European pharmaceutical quality standards at all times. The company offers pharmaceutical-grade products in all relevant market segments: dried flower, extracts, dronabinol and cannabidiol. Cantourage was listed on the Frankfurt Stock Exchange on 11 November 2022 and is listed under ticker symbol “HIGH.”

Further information: www.cantourage.com

This announcement does not constitute a public offer or an advertisement for a public offer to sell securities, in particular not within the meaning of Regulation (EU) 2017/1129 (Prospectus Regulation).

Press contact at Cantourage:

Frederick Steudemann
Tel. +49 (0)30 4701 350 – 50
steudemann@cantourage.com
 

aap Implantate AG (“aap” or “Company”) informs that as of October 31, 2024, conversion rights in the amount of 97.4% of the mandatory convertible bond issued in October 2023 were exercised in the context of elective conversions. This means that only 2.6% of the conversion rights have not yet been exercised, which corresponds to an amount of around EUR 69.5 thousand.

The exercise of these conversion rights will reduce the company’s liabilities by EUR 2.63 million as well as the associated interest burden of 6% per annum for the remaining term until October 6, 2028. The equity ratio is rising accordingly.

——————————————————————————————————————————————-

aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German Stock Exchanges –

About aap Implantate AG

 aap Implantate AG is a global medical technology company headquartered in Berlin, Germany. The company develops, manufactures and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the IP-protected portfolio includes a wide range of perforated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects, such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical and not yet adequately solved problems in traumatology.  In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics, while on an international level, it primarily uses a broad network of distributors in around 25 countries. In the USA, the company is relying  on a hybrid sales strategy with its subsidiary aap Implants Inc. Sales are carried out both through distribution agents and within the framework of partnerships with global orthopaedic companies. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

There may be technical rounding differences in the figures presented in this press release, which do not affect the overall statement.

Forward-Looking Statements

This release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of future developments and results referred to therein. Various known and unknown risks, uncertainties and other factors could cause the actual results, financial condition, development or performance of the Company to differ materially from the estimates given herein. These factors also include those  described by aap in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo; Chairman of the Board of Directors/CEO; Lorenzweg 5; 12099 Berlin

Phone: +49 (0)30 75019 – 141; Fax: +49 (0)30 75019 – 290; Email: r.digirolamo@aap.de

Nyxoah Reports Third Quarter Financial and Operating Results 

FDA approval on track for first quarter 2025, U.S. commercial team build out in progress

Company fully funded with cash until mid 2026

Mont-Saint-Guibert, Belgium – November 6, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024. 

Recent Financial and Operating Highlights

• Presented compelling DREAM data results at International Surgical Sleep Society in September.
• Raised €24.6 million through an ATM program from a single U.S. healthcare-dedicated fund providing incremental flexibility as we shift into U.S. commercialization and extending cash runway until mid 2026.
• Strengthened U.S. organization with the hiring of John Landry as Chief Financial Officer and the addition of several key commercial leaders in the U.S.
• Reported third quarter sales of €1.3 million, representing 30% growth versus third quarter 2023.
• Total cash position of €71.0 million at the end of the quarter, €95.6 million proforma including the €24.6 million raised.

“Our actions in the third quarter have further positioned us well for a successful U.S. commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our U.S. commercial team,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “I am more confident than ever that we have set Genio up for a strong commercial start in the U.S. immediately after FDA approval.”

Third Quarter 2024 Results

CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)

 (in thousands)

 CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)

(in thousands)

Revenue

Revenue was €1.3 million for the third quarter ending September 30, 2024, compared to €1.0 million for the third quarter ending September 30, 2023.

Cost of Goods Sold

Cost of goods sold was €482,000 for the three months ending September 30, 2024, representing a gross profit of €0.8 million, or gross margin of 62.0%. This compares to total cost of goods sold of €336,000 in the third quarter of 2023, for a gross profit of €0.6 million, or gross margin of 66.0%.

Research and Development

For the third quarter ending September 30, 2024, research and development expenses were €7.9 million, versus €6.6 million for the third quarter ending September 30, 2023.

Operating Loss

Total operating loss for the third quarter ending September 30, 2024, was €15.0 million versus €11.0 million in the third quarter ending September 30, 2023. This increase was primarily driven by expanded commercial activities, higher R&D investments, and ongoing clinical activities.

Cash Position

As of September 30, 2024, cash and financial assets totaled €71.0 million, compared to €57.7 million on December 31, 2023.  Total cash burn was approximately €5.6 million per month during the third quarter 2024.

Third Quarter 2024

Nyxoah’s financial report for the third quarter 2024, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation

Company management will host a conference call to discuss financial results on Wednesday, November 6, 2024, beginning at 10:30pm CET / 4:30pm ET.

A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah’s Q3 2024 earnings call webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah’s Q3 2024 earnings call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

The archived webcast will be available for replay shortly after the close of the call.

About Nyxoah

Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

FORWARD-LOOKING STATEMENTS

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and reporting data from Nyxoah’s DREAM U.S. pivotal trial; receipt of FDA approval; entrance to the U.S. market; and the anticipated closing and use of the proceeds from the offering. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Contacts:

Nyxoah
Loïc Moreau
IR@nyxoah.com

For Media

In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com

In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

In International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu

Asklepios places its first Social Schuldschein loan of EUR 500.0 million

• First transaction under the newly established Social Finance Framework
• Issuance proceeds to be used for (re-)financing social projects
• High demand for the Social Schuldschein loan enabled a doubling of the issuance volume

Hamburg, November 6, 2024. Asklepios Kliniken GmbH & Co. KGaA successfully refinanced itself through a Social Schuldschein loan issuance amounting to EUR 500.0 million. The new Schuldschein was placed with maturities of 3, 5, 7, and 10 years among both existing and new investors.

The structure as a Social Schuldschein loan, through which the issuance proceeds under the newly established Social Finance Framework can be allocated to the area of social healthcare infrastructure, met with significant investor interest. Despite challenging market conditions, the issuance volume was doubled from the initial EUR 250.0 million to a total of EUR 500.0 million.

In addition to the official Schulschein marketing, existing investors with maturities in 2025 had the opportunity to reinvest their Schuldschein holdings early in the new Social Schuldschein through an exchange offer.

“The new Social Schuldschein loan enables us to finance investments in our healthcare infrastructure, thus ensuring a clear allocation of funds to the social benefit of our daily actions as a healthcare group,” says Hafid Rifi, Chief Financial Officer of the Asklepios Group. “Moreover, establishing the Asklepios Social Finance Framework marks an important step in further integrating our sustainability ambitions into our financing strategy,” Rifi continues. “We are pleased with the strong demand from both existing and new investors, underscoring trust in our business model and corporate strategy once again.”

“With 35% of the issuance volume, the share of foreign investors was high once again,” adds Benedikt Brörmann, Group Head of Corporate Finance & Treasury at Asklepios. “We were also able to place approximately 20% of the issuance volume with new investors,” says Brörmann. “The success of this year’s transaction was due to the compelling Asklepios credit story combined with the right marketing strategy and timing.”

The placement of the Social Schuldschein loan was supported by Landesbank Hessen-Thüringen, ING Bank, Landesbank Baden-Württemberg, and UniCredit as arrangers. Linklaters LLP acted as Asklepios’ legal advisor.

About Asklepios

Asklepios Kliniken is one of the leading private operators of hospitals and healthcare facilities in Germany. The hospital group stands for highly qualified care for its patients with a clear commitment to medical quality, innovation and social responsibility. On the basis of this, Asklepios has developed dynamically since it was founded more than 35 years ago. The group currently has 164 healthcare facilities across Germany. These include acute hospitals at all levels of care, university hospitals, specialist clinics, psychiatric and forensic facilities, rehabilitation clinics, care homes and medical centres. In the financial year 2023, over 3.5 million patients were treated in Asklepios Group facilities. The company has more than 68,000 employees.

 For inquiries:

Creditor Relations contact:
Stefan Sinzel
Manager Corporate Finance
Asklepios Kliniken GmbH & Co. KGaA
Debusweg 3 – 61462 Königstein-Falkenstein
Tel: +49 6174 9011-96
E-Mail: ir@asklepios.com

Press contact:
Rune Hoffmann
Head of Corporate Communications & Marketing
Asklepios Kliniken GmbH & Co. KGaA
Rübenkamp 226 – 22307 Hamburg
Tel.: +49 40 1818-82 6630
Fax: +49 40 1818-82 6639
E-Mail: presse@asklepios.com

Visit Asklepios on the internet, Facebook, or YouTube:
www.asklepios.com
www.asklepios.com/konzern/gesundheitsmagazin
www.facebook.com/asklepioskliniken
www.youtube.com/asklepioskliniken

Subscribe to the Asklepios newsletter:
https://www.asklepios.com/konzern/newsletter-anmeldung/
Nursing Blog: „Wir sind Pflege“

PRESS RELEASE

Heidelberg Pharma: Promising New Clinical Data on Lead ADC-Candidate HDP-101 to be Presented at ASH Annual Meeting 2024

Ladenburg, Germany, 6 November 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage developer of innovative Antibody Drug Conjugates (ADCs), today announces that new clinical data on its lead Amanitin-based ADC candidate, HDP-101, will be presented at the 66^th American Society of Hematology (ASH) Annual Meeting, taking place from 7-10 December 2024 in San Diego, California, USA.

Robert Z. Orlowski, MD, PhD, (Ad Interim) Director of Myeloma and Professor of Medicine in the Departments of Lymphoma/Myeloma and Experimental Therapeutics, University of Texas, Houston, Texas, and principal investigator at MD Anderson Cancer Center, Houston, Texas, USA, will report the latest developments from the ongoing Phase I/IIa study of HDP-101 for the treatment of relapsed or refractory multiple myeloma.

Currently advancing in its sixth cohort, the study has shown encouraging results, including complete remission in one patient from the fifth cohort who had been previously treated multiple times and had received several courses of HDP-101. In addition, several patients showed promising biological activity and objective improvements, underscoring the potential of HDP-101 as a treatment option for patients with this disease.

66th American Society of Hematology (ASH) Annual Meeting

In October, Robert Z. Orlowski, MD, PhD, along with Heidelberg Pharma’s Chief Medical Officer, András Strassz, and another Key Opinion Leader (KOL) in the field of Myeloma, discussed the progress of the dose escalation study of HDP-101 during a R&D webinar.

Robert Z. Orlowski commented, “I would say that this should be considered a great drug for all relapsed or refractory myelomas.”

The recording of the R&D webinar can be found here: Virtual KOL Event on Multiple Myeloma and Updated Clinical Data from the IMS Oral Presentation of HDP-101, an Anti-BCMA ADC

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma uses several compounds and has built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. The goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors. Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology. It offers the opportunity to overcome therapy resistance and also eliminate dormant tumor cells, which could lead to significant progress in cancer therapy – even for patients who no longer respond to other treatment.

The most advanced product candidate HDP-101 is a BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

The first candidate that Heidelberg Pharma is developing with a toxin other than Amanitin is HDP-201, an Exatecan-based ADC. Exatecan is a topoisomerase I inhibitor that has proven itself in cancer therapy and is used in two already approved ADCs. It differs in its mode of action from that of Amanitin and thus expands the company’s range of compounds.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

• Guidance for 2024 confirmed with full-year 2024 revenue and adjusted EBITDA targets on track, despite challenging market conditions
• Robust growth of Just – Evotec Biologics driven by roll out of projects together with Sandoz and progress of discovery partnerships 
• Successful extensions & expansions with BMS and Novo Nordisk; new collaboration with Pfizer to advance cutting-edge therapeutic solutions
• Priority reset on track to deliver annualised adj. EBITDA improvement of over € 40 m and strategic review initiated

Hamburg, Germany, 06 November 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced its financial results and corporate updates for the third quarter of 2024, highlighting strategic progress across key partnerships and operations.

Dr Christian Wojczewski, Chief Executive Officer of Evotec, said: “We continue to deliver on the successful execution of our Priority Reset and have achieved significant progress across key initiatives. New and extended partnerships clearly underscore Evotec’s enduring leadership in R&D and precision medicine. Building on this exceptionally strong foundation, we are now laying the groundwork for an accelerated transformation program that will pave the way for long-term profitable growth. While the challenging market environment has impacted near-term results, we are seeing strong momentum across strategic priorities and look forward to reporting back on our progress in early 2025.”
 

Challenging market conditions weigh on Shared R&D, while Just – Evotec Biologics delivers strong growth

• Group revenues decreased by (1)% to € 575.7 m (9M 2023: € 580.1 m)
• Total Shared R&D revenues decreased by (12)% to € 447.1 m (9M 2023: € 506.1 m, due to a challenging market environment
• Evotec’s Just – Evotec Biologics segment saw impressive growth, with revenues rising by 74% year-over-year, contributing €128.7 m (9M 2023: € 74.1 m) to the overall topline
• Adjusted Group EBITDA totalled € (6.0) m (9M 2023: € 50.2 m) driven by a mismatch between revenues and cost base in the Shared R&D segment as well as costs related to the expansion of operations of Just – Evotec Biologics
• Core business activities in Shared R&D as well as Just – Evotec Biologics reached break-even
   

Transformation Process on track with significant savings realised

• Priority Reset is set to yield an annualised adjusted EBITDA improvement of over € 40 m, starting H2 2024
• Successful implementation of measures to improve liquidity
• One-off costs related to Priority Reset measures recognised at € 62.3 m as of Q3, lower than initial provision of € 68.5 m on 30 June 2024
• Strategic Review process initiated to examine status quo and deliver performance and productivity improvements as part of transformation for long-term profitable growth

New and expanded partnerships

• Extension and expansion of tech partnership with Sandoz for development and commercial manufacturing of biosimilars
• Extension of collaboration with Bristol Myers Squibb (“BMS”) based on targeted protein degradation into indications outside of oncology, triggering programme-based payment of US$ 50 m to fund further research
• Further progress made in strategic neuroscience collaboration with Bristol Myers Squibb, payments of US$ 25 m received
• Strong progress in strategic protein degradation partnership with Bristol Myers Squibb, resulted in reception of performance-based and programme-based payments of in total US$ 75 m
• New technology development partnership with Novo Nordisk to support next-generation cell therapies
• New multi-year master research collaboration and option and license agreement with Pfizer, initially focusing on early discovery research for metabolic and infectious diseases
• Collaboration with X-Chem to access DNA-encoded library (“DEL”) to expand hit-finding options

Operational milestone achieved

• Opening of cutting-edge biologics facility J.POD in Toulouse, France (EU) on 20 September 2024 marks significant expansion of European production capabilities and strengthens position in the biologics market.

Business Outlook for full-year 2024

• Group revenues¹⁾ expected in the range of € 790 – 820 m (2023: € 781.4 m).
• R&D expenditures are expected in a range of € 50 – 60 m (2023: € 64.8 m).
• Adjusted Group EBITDA¹⁾ is expected to reach € 15 – 35 m (2023: € 66.4 m).

¹⁾ Guidance including future non-core activities 

More detailed information and financial tables are available in the half-year report published on the Evotec website under the following link: https://www.evotec.com/en/investor-relations/financial-publications

Webcast/Conference Call

The Company plans to hold a conference call to discuss the results as well as provide an update on its performance. The conference call will be held in English.

Webcast details

Date:  Wednesday, 06 November 2024

Time:  2.00 pm CET (01.00 pm BT, 08.00 am ET)

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand version of the webcast will be available on our website: www.evotec.com/en/investor-relations/financial-publications.

Conference call details

To join via phone, please pre-register via this link.

You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available under this link.

About Evotec SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec provides high value pipeline co-creating partnerships and solutions to all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s sites in Europe and the USA offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.

Forward-looking-statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information, please contact:

Investor Relations

Volker Braun
EVP Head of Global Investor Relations & ESG
volker.braun@evotec.com

Media

Susanne Kreuter
VP Head of Strategic Marketing
susanne.kreuter@evotec.com

PharmaSGP Holding SE: Peter Gerckens succeeds Natalie Weigand as Chief Executive Officer

Gräfelfing, November 05, 2024 – Peter Gerckens, who has been a member of the Management Board of PharmaSGP Holding SE as Chief Commercial Officer (CCO) since July 1, 2024, will take over the position of Chief Executive Officer (CEO) of the company on January 1, 2025. This was decided by the Supervisory Board today. Peter Gerckens succeeds Natalie Weigand in this position. She informed the Supervisory Board today that she has decided not to extend her contract, which expires at the end of the year. However, Natalie Weigand will remain associated with the company in an advisory role after her departure.

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Contact

PharmaSGP Holding SE
Claudius Krause | Jakob Hafer (cometis AG)
Lochhamer Schlag 1
82166 Gräfelfing | Germany
Phone: +49 611 205855-0
E-Mail: ir@pharmasgp.com