CEO change at PharmaSGP Holding SE: Peter Gerckens succeeds Natalie Weigand as of January 1, 2025

Gräfelfing, November 05, 2024 – German OTC pharmaceutical company PharmaSGP Holding SE is announcing a change in the position of Chief Executive Officer (CEO). After more than seven years as CEO, Natalie Weigand informed the Supervisory Board today that, due to personal reasons, she will not be renewing her contract with PharmaSGP, which expires at the end of the year. 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 succeed Ms. Weigand as CEO on January 1, 2025. Peter Gerckens has already been able to familiarize himself extensively with PharmaSGP since July 2024 and will continue to drive PharmaSGP’s successful growth course as CEO. The internal succession plan ensures a smooth and rapid transition process. In addition, there is continuity in the PharmaSGP Management Board team with Michael Rudolf as longstanding Chief Financial Officer (CFO). Natalie Weigand will also remain active for the company in an advisory position.

Natalie Weigand, CEO of PharmaSGP, on her upcoming exit: “After careful consideration, I have decided not to extend my contract with PharmaSGP after almost ten years with the company, including more than seven years as CEO. I would like to thank all my colleagues for the successful time we shared and wish each and every one of them all the best. I will remain associated with the company in an advisory position in the future and look forward to accompanying the ongoing success story of PharmaSGP from this new perspective.”

Dr. Clemens Fischer, Chairman of the Supervisory Board: “On behalf of the entire Supervisory Board and the entire company, we would like to thank Ms. Weigand for her outstanding contribution to the successful development of PharmaSGP in recent years. Under her leadership, PharmaSGP has regularly achieved new revenue and earnings records. We wish Ms. Weigand all the best for the future and are delighted that she will continue to support the company in an advisory role. At the same time, we are very happy that we have been able to find an internal successor in Peter Gerckens. Mr. Gerckens knows the business model, the market and the growth opportunities inside out and is therefore, in our view, the ideal person to successfully lead PharmaSGP in the future.”

Peter Gerckens, CCO of PharmaSGP: “It is impressive what Natalie Weigand has built up as CEO together with Michael Rudolf and the entire PharmaSGP team in recent years. Since joining PharmaSGP in July of this year, I have been able to get to know the company very well and I am impressed by the commitment and passion of our entire team. I would like to thank them for their trust and am now looking forward to continuing PharmaSGP success story in my new role.”

CONTACT

cometis AG 
Claudius Krause | Jakob Hafer
Phone: +49-611-2058550 
Email: ir@pharmasgp.com

ABOUT PHARMASGP HOLDING SE

PharmaSGP is a leading consumer health company with a diversified portfolio of over-the-counter (OTC) pharmaceuticals and other healthcare products that are marketed with a focus on the pharmacy distribution channel. These products are mostly based on natural active pharmaceutical ingredients with documented efficacy and few known side effects. 

The Company’s core brands cover chronic indications, including rheumatic pain, nerve pain and other age-related ailments. In Germany, PharmaSGP is the market leader for systemic chemical-free pain remedies with its brand families RubaXX® for rheumatic pain and Restaxil® for neuralgic pain. Furthermore, PharmaSGP also offers leading products against sexual weakness and vertigo symptoms. Since introducing the first product from the current product portfolio in 2012, PharmaSGP has successfully established its business model in other European countries, including Austria, Italy, Belgium, Spain and France. In September 2021, the product portfolio was expanded by the brands Baldriparan®, Formigran®, Spalt® and Kamol®, thus also strengthening or developing the indications pain and sleep disorder. The sales territory was expanded to include Switzerland and Eastern Europe. In 2023, PharmaSGP generated revenues of €101.1 million at an adjusted EBITDA margin of 33.7%. 

In order to further expand its competitive position, PharmaSGP plans to increase the number of indications covered by PharmaSGP’s product offering, increase PharmaSGP’s European footprint, and accelerate its growth strategy especially by capitalizing on selected M&A opportunities. 

Hamburg, 05 November 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) has announced the sale of its chemical API manufacturing site, Evotec DS GmbH, located in Halle/Westphalia, to Monacum Partners GmbH – a Munich based Private Equity firm. This transaction forms part of Evotec’s “Priority Reset” initiative launched in April 2024, which aims to foster profitable growth by refining the company’s operational footprint and focusing on its primary growth sectors and core competencies.

Evotec DS in Halle/Westphalia is a specialized CDMO (Contract Development and Manufacturing Organization) with a strong foundation in chemical APIs, intermediates, and building blocks, which provides an end-to-end service portfolio, encompassing development to commercial-scale manufacturing.

The transaction presents an opportunity for Evotec DS to achieve its growth ambitions under new ownership. Under the agreement, all business operations and the entire workforce at Evotec DS will transition to Monacum Partners and continue business as DAPIN GmbH (Deutsche API & Intermediates). Financial terms of the transaction were not disclosed.

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.

About Monacum Partners
Monacum Partners is a Munich based private equity firm, focused on repositioning of European headquartered businesses. The core of Monacum Partners strategy, is acquiring underperforming companies with significant operational improvement potential and support them through proven turnaround playbooks, implemented by Monacum Partners’ highly experienced operational team. For additional information please go to www.monacumpartners.com.
 

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

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, 4 November 2024

Spexis expects SIX to delist shares of Spexis on the SIX exchange imminently.

Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that it expects the Swiss SIX exchange to delist the shares of Spexis imminently.

Relevant background to the above is provided as follows: 

1. As reported by the Company on 22 July 2024 and made effective by SIX on 30 July, 2024, trading in the Company’s shares on the SIX exchange were suspended due to the Company’s inability to publish audited 2023 and half-year (through June 30, 2024) financial results, for the reasons reported in the referenced 22 July 2024 report.
    
2. Furthermore, according to the SIX Listing Rules (“LR”), Art. 58 para. 1 point 4, if trading has been suspended for a continuous three-month period, and the reasons for the suspension continue to exist, the SIX Regulatory Board may cancel the listing of securities.
    
3. No annual report 2023 in accordance with Art. 49 LR and no interim (semi-annual) report 2024 in accordance with Art. 50 LR have been published yet. Additionally, as of today, 4 November 2024, trading in shares of Spexis Ltd have been suspended for a continuous three-month period and the reasons for the suspension continue to exist.
    
4. Accordingly, suspension of trading in the shares of Spexis Ltd according to Art. 57 LR will continue until the public announcement of the delisting by SER, which is expected imminently. 

Jeff Wager MD, Chair & CEO of Spexis, commented on this development as follows, “While of course delisting from SIX will be a materially negative event, it is not wholly unexpected and does not deter us from continuing to pursue options that will enable the Company to emerge from our moratorium status.  The Company has the right to appeal any forthcoming decision by SIX to delist its shares, and while the probability is low that Spexis will pursue such an appeal, we will reserve deciding upon such an option pending evolution of ongoing discussions with prospective investors.  However, in any event of permanent delisting, our plan is to nonetheless pursue solutions to its moratorium status as a private company.”

About Spexis

Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com.
 

For further information please contact:

Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of Spexis management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Spexis’ results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Spexis disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Berlin and Würzburg, Germany, November 4, 2024 – Pentixapharm, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, welcomes the recent announcement by the U.S. Centers for Medicare & Medicaid Services (CMS) to implement separate payments for specialized diagnostic radiopharmaceuticals used in the hospital outpatient setting, extending beyond the transitional pass-through payment period. This significant policy shift could have a direct impact on future reimbursement streams for Pentixapharm’s Ga68-PentixaFor, a diagnostic radiopharmaceutical for which Pentixapharm intends to start a U.S. centric phase III clinical trial next year. The pivotal clinical trial could lead to a U.S. market authorization in primary aldosteronism (PA), one of the major causes of secondary hypertension, as early as 2028.

The CMS pass-through payment period is a temporary reimbursement mechanism under the Hospital Outpatient Prospective Payment System (OPPS). Lasting up to three years, this period provides additional payments for newly introduced medical devices, drugs, and biologicals, encouraging hospitals to adopt cutting-edge technologies by covering their costs beyond standard rates. However, under previous policies, after the pass-through period ended, products would typically revert to standard OPPS payment bundles. With this new policy announcement, CMS has changed this approach, allowing for separate payments beyond the pass-through period for qualifying high-cost diagnostics.

This decision by CMS is highly significant given the size and impact of the Medicare and Medicaid systems, which together insure more than 140 million Americans. As the primary healthcare payer for older adults and individuals with disabilities, CMS’s reimbursement policies shape access to medical innovations across the country. The new rule, effective in 2025, also has the potential to set a market precedent that may influence private insurers to follow CMS’s lead in reimbursing innovative diagnostic tools, further expanding the accessibility of these advanced diagnostics. By providing consistent reimbursement for diagnostic radiopharmaceuticals that exceed a per-day cost threshold of US$630, CMS encourages other insurers to consider similar reimbursement strategies.

The separate payment rule will most likely apply to Pentixapharm’s lead diagnostic compound, Ga68-PentixaFor, following its anticipated approval and the expiration of its pass-through status. Ga68-PentixaFor is a novel tracer for positron emission tomography (PET) imaging used to detect aldosterone-hypersecreting adenomas in patients diagnosed with primary Aldosteronism (PA). With rising prevalence rates for PA, now exceeding 20% in some populations with resistant hypertension, the need for accessible and precise diagnostics is greater than ever.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

PentixaFor (Gallium (⁶⁸Ga) boclatixafortide) is an innovative PET tracer that specifically targets the chemokine-4 receptor (CXCR4), with broad applications in oncological, cardiovascular, and inflammatory diseases. Particularly in hypertension, PentixaFor has the potential to significantly improve patient management by identifying the presence of hormone-secreting adenomas through non-invasive and broadly available PET/CT imaging.

Apart from PentixaFor, the clinical pipeline also encompasses PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL). Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Recently, the EMA granted PRIME status to PentixaFor in the indication PA.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

• MEDICLIN increases consolidated sales for 9M 2024 by 2.0% to EUR 558.2 million
• Group EBIT of EUR 34.5 million higher than in the same period of the
  previous year (9M 2023: EUR 29.4 million)
• Occupancy rate up on previous year at 86.0 (9M 2023: 84,4%)
• Hospital reform expected at the turn of the year
• The Executive Board confirms the forecast for the year

Offenburg, 04 November 2024: In the first nine months of 2024, MEDICLIN Aktiengesellschaft (MEDICLIN) generated consolidated sales of EUR 558.2 million. This is EUR 11.1 million or 2.0% more than in the first nine months of 2023. The consolidated operating result improved by EUR 5.1 million to EUR 34.4 million compared to the same period of the previous year. A positive business performance in the third quarter and a stable capacity utilisation rate of 86.0% (9M 2023: 84.4%) allow the Executive Board to confirm the annual forecast. For the current financial year, a decline in sales at the upper end of the forecast of -2.0% to 0.0% is expected. The consolidated operating result is now also expected to be at the upper end of the range of EUR 33.0 million to EUR 39.0 million last specified in the first half of the year.

Sales and earnings performance of the segments

In the post-acute segment, sales increased by 7.2% to EUR 361.2 million (9M 2023: EUR 337.0 million). At EUR 38.0 million, the segment operating result was EUR 2.9 million higher than in the same period of the previous year (9M 2023: EUR 35.1 million). The cost of materials ratio rose by 0.3 percentage points to 20.4% (9M 2023: 20.1%). At EUR 73.8 million, the absolute cost of materials was 9.1% higher than in the previous year (9M 2023: EUR 67.6 million). Personnel expenses increased by EUR 8.1 million or 4.5% to EUR 187.4 million compared to the first half of the previous year. The personnel expenses ratio fell to 51.9% (9M 2023: 53.2%).

The acute segment reported a decline in segment sales of EUR 16.3 million or 8.5%. The segment operating result totalled EUR -3.8 million after EUR -5.4 million in the third quarter of 2023. The cost of materials fell by 12.8% to EUR 50.0 million (9M 2023: EUR 57.3 million). The cost of materials ratio fell slightly to 28.5 % (9M 2023: 29.9%). Personnel expenses totalled EUR 106.1 million and were therefore 8.6% lower than in the first nine months of 2023 (9M 2023: EUR 116.1 million). The personnel expenses ratio remained almost unchanged at 60.4% after 60.5% in the same period of the previous year.

Sales in the Other Activities segment totalled EUR 21.5 million was 17.5% higher than the previous year’s figure, i.e. EUR 3.2 million. The nursing care business division contributed EUR 17.5 million to this figure, which corresponds to an increase of 11.3% compared to the previous year (9M 2023: EUR 15.8 million). At EUR 0.3 million, the segment operating result was up on the previous year’s result of EUR

-0.3 million.

Outlook – positive business performance in the third quarter of 2024

“As in previous years, the third quarter is once again the strongest of the current year. Group sales increased by EUR 7.9 million year-on-year to EUR 190.2 million. Profitability for the quarter was also positive with an EBIT margin of 11.8%. We are in a good financial position and confirm the annual forecasts for sales and consolidated operating profit at the upper end in each case due to the positive business develop-ment”, reports Tino Fritz, CFO of MEDICLIN.

Hospital reform expected at the turn of the year

“The hospital reform expected at the turn of the year has not taken rehabilitation into account. We are convinced that the elimination of hospital beds in the acute sector will not lead to fewer, but to more and earlier rehabilitation services. With MEDICLIN HOME, DIRECT and CAMPUS, we set out early on to face up to the developments in the healthcare market and take advantage of the opportunities offered by the outpati-ent and digitalisation of rehabilitation,” says Dr Joachim Ramming, CEO of MEDICLIN.

Thomas Piefke, COO of MEDICLIN, adds: “On 11 October, we opened outpatient orthopaedic rehabilitation at the Staufenburg Klinik in Durbach – as part of the MEDICLIN DIRECT range of services. With the expansion of this service, we are supplementing the existing services for rehabilitation in the areas of cancer, diabetes and obesity and are thus responding to the increasing demand for outpatient orthopaedic therapies. We are thus successfully driving forward outpatientisation at MEDICLIN and consistently implementing our strategy.”

The interim report as at 30 September 2024 is available from today at www.mediclin.de in German and English.

For further information:

MEDICLIN Aktiengesellschaft
Okenstrasse 27
77652 Offenburg

Investor Relations
Ender Gülcan
Phone: 0781/488-326
ender.guelcan@mediclin.de

Public Relations
Dr Janina Lossen
Phone: 0781/488-180
janina.lossen@mediclin.de

www.mediclin.de

About MEDICLIN Aktiengesellschaft (Ticker: MED; WKN: 659 510)
MEDICLIN includes 32 clinics, six care facilities and ten medical care centers. The Group has around 8,300 beds/care places and employs around 10,000 people. In a strong network, MEDICLIN offers the patient integrative care from the first visit to the doctor through the operation and subsequent rehabilitation to outpatient aftercare. Doctors, therapists and nurses work together in a carefully coordinated manner. MEDICLIN designs the care and support of people in need of care according to their individual needs and personal needs.

MEDICLIN ─ a company of the Asklepios Group

 CureVac to Present at the 12th International mRNA Health Conference
 

TÜBINGEN, Germany/BOSTON, USA – November 4, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that new and updated data will be shared in two oral presentations and four posters at the 12^th International mRNA Health Conference, taking place in Boston, Massachusetts, November 12-14, 2024.

More detailed preliminary safety, tolerability and immunogenicity data from the dose escalation part of CureVac’s ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be shared in an oral presentation. Initial data from this study was presented last month at the European Society for Medical Oncology (ESMO) Congress demonstrating that treatment with CVGBM monotherapy successfully induced cancer antigen-specific T-cell responses in 77% of evaluable patients, of which 84% of immune responses were generated de novo by the vaccine. Expanded data from the dose escalation portion of the study will also be shared at the upcoming Society for Immunotherapy of Cancer (SITC) 39^th Annual Meeting later this week.

A second oral presentation will cover CureVac’s approach to developing optimized LNP delivery, while posters shared at the meeting will provide additional data on how CureVac optimizes its mRNA platform with different approaches as well as highlighting new targets for future development programs. The data to be shared will demonstrate the potential of CureVac’s mRNA platform in technology optimization, oncology, and infectious disease, driving future innovation in the mRNA space.

“With our recent corporate realignment and increased focus on research and innovation to develop meaningful mRNA medicines in different therapeutic areas, CureVac is more committed than ever to extending the horizons of mRNA. We are pleased to be presenting the recently announced promising clinical data from our glioblastoma mRNA vaccine program as well as results from our ongoing research in lipid nanoparticle delivery technology, oncology and infectious diseases,” said Dr. Myriam Mendila, Chief Scientific Officer at CureVac. “These presentations demonstrate the evolution of our long-standing commitment to apply mRNA technology in service to patients across a diverse spectrum of disease areas.”

Details on the two oral presentations are below: 

Title: Development of multiepitope mRNA vaccines – first results of Phase I human study in Glioblastoma patients
Session type: Oral Presentation
Date: Thursday, November 14
Time: 1:44 p.m. EST
Presenting Author: Regina Heidenreich, Ph.D., Senior Director Oncology Preclinical Development, CureVac SE

Title:  Development and optimization of lipid nanoparticles for delivery of mRNA vaccines
Session type: Oral Presentation
Date: Thursday, November 14
Time: 9:38 a.m. EST
Presenting Author: Paula Muresan, Ph.D., Research Scientist, CureVac SE

For more information on the conference and program, please visit the website: https://www.mrna-conference.com/

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.

CureVac Strengthens Leadership Team with Appointment of Seasoned Industry Executive Axel Sven Malkomes as Chief Financial Officer
 

• Experienced CFO and investment banker with 30-year track record will help drive CureVac’s transformation
   

TÜBINGEN, Germany/BOSTON, USA – November 4, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced the appointment of Axel Sven Malkomes as Chief Financial Officer, effective November 11, 2024.

Mr. Malkomes joins CureVac at a pivotal moment as the company enters a new chapter of growth and innovation, bringing over three decades of senior corporate and investment banking experience within the biotech and pharmaceutical industries.

“Axel’s appointment corresponds with a significant milestone in CureVac’s evolution,” said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. “As we embark on an exciting new phase of corporate development, his extensive expertise and proven leadership in the life sciences sector will be instrumental. Axel will play a key role in advancing our strategic initiatives, strengthening our financial foundation, and enhancing shareholder value. We are thrilled to welcome him to our leadership team.”

“I am honored to join CureVac at such a transformative time in the company’s journey,” said Axel Malkomes. “With its pioneering mRNA technology and the momentum from the recent deal with GSK, CureVac is well-positioned to make significant advancements in developing innovative medicines. I look forward to leveraging my experience in financial management and corporate growth to support CureVac’s mission and contribute to its future success.”

Mr. Malkomes most recently served as CFO at Cardior Pharmaceuticals GmbH, a private clinical-stage biopharmaceutical company pioneering the discovery and development of non-coding RNA-based therapeutics designed to address the root causes of heart disease. During his tenure, he played a crucial role in strategically and financially preparing the company for capital markets, co-leading significant financing rounds, and supported potential M&A and partnering transactions, culminating in the successful acquisition of Cardior by Novo Nordisk in 2024.

Before Cardior, Mr. Malkomes was CFO and Chief Business Officer at Medigene AG, a publicly listed cell therapy company. There, he was instrumental in strategically and financially reshaping the company, significantly extending its cash runway and expanding its portfolio of strategic collaborations.

His extensive experience also includes senior healthcare investment banking roles at Barclays and Société Générale, as well as co-heading European healthcare investments at 3i Group plc, a UK-listed private equity firm with over $20 billion in assets under management. Earlier in his career, he held senior operational and corporate leadership positions at Merck KGaA.

Mr. Malkomes began his career in investment banking with institutions such as Dresdner Bank, Donaldson Lufkin Jenrette (which later became Credit Suisse), and Lehman Brothers, focusing on corporate finance, M&A, equity capital markets, and private equity transactions in the healthcare and life sciences sectors.

Since 2022, he has been a member of the Board of Directors of Cellectis SA, a cell and gene editing company listed on NASDAQ and Euronext, where he chairs the audit committee.

Mr. Malkomes holds a degree in business administration from Otto-Friedrich University in Bamberg, Germany, and has completed executive management programs at INSEAD, Kellogg School of Management at Northwestern University, and the Hong Kong University of Science and Technology.

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.

Classification of NuWays AG to CS MEDICA A/S

Revolutionizing alternative medicine; Initiate with BUY

CS MEDICA, a Danish Med-Tech company founded in 2011, is at the forefront of developing CBD-infused medical devices that offer safe, effective alternatives for autoimmune and stress-related conditions like arthritis, psoriasis, pain and hair loss. The company utilizes CBD’s proven anti-inflammatory and antioxidative properties in >10 products, classified as medical devices or cosmetics and backed by clinical trials. With regulatory approval in major markets such as the EU, U.K. and the U.S., CS MEDICA has established itself as a key player in the rapidly growing alternative medicine space.

CS MEDICA’s capital-light business model focuses on R&D and distribution while outsourcing manufacturing to partners in Europe. This allows the company to scale efficiently while minimizing operational risks. As one of only few CBD-infused medical device company registered for sale in pharmacies, CS MEDICA occupies a unique position at the intersection of the pharmaceutical and cosmetics markets, offering clinically proven products with fewer side effects at competitive price points.

CS MEDICA’s hybrid product formulations, which combine R&D, clinical evidence, compliance, and the benefits of CBD, a natural ingredient, set the company apart from competition. Its flagship line, CANNASEN ®, includes highly effective treatments for pain, skin disorders, and hair loss, with superior bioavailability when applied topically.

Strong growth prospects: Global demand for alternative treatments is booming, with the alternative medicine market projected to grow at a 15.7% CAGR until 2031. CS MEDICA is well-positioned to benefit from this trend. Especially non-European markets such as MENA and APAC offer high growth potentials once the regulatory hurdles have been overcome and social acceptance increased. The company’s private/white-label segment (~ 2/3 of order intake), offers a steady revenue stream, while its CANNASEN® brand continues to expand, contributing to rapid top-line growth.

The market’s strong growth prospects coupled with CS MEDICA’s unique positioning should allow the company to strongly grow its top-line to DKK 108m by FY 2027/28e, implying a 61% CAGR (vs FY 2023/24e). At the same time, thanks to the resulting operating leverage, the EBITDA margin should turn positive, reaching 25%.

We initiate the coverage with a BUY rating and a EUR 2.30 PT based on a SOTP valuation.

You can download the research here: http://www.more-ir.de/d/31171.pdf

For additional information visit our website: www.nuways-ag.com/research

Contact for questions:
NuWays AG – Equity Research
Web: www.nuways-ag.com
Email: research@nuways-ag.com
LinkedIn: https://www.linkedin.com/company/nuwaysag
Adresse: Mittelweg 16-17, 20148 Hamburg, Germany
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Diese Meldung ist keine Anlageberatung oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.
Offenlegung möglicher Interessenskonflikte nach § 85 WpHG beim oben analysierten Unternehmen befinden sich in der vollständigen Analyse.
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Press Release // November 04, 2024

Formycon applies for admission to the Prime Standard of the Frankfurt Stock Exchange

• Application for admission to trading on the regulated market (Prime Standard) of the Frankfurt Stock Exchange will be submitted today
• Trading of Formycon shares on the Prime Standard segment is expected to start on November 12, 2024
• Company aims to expand its international investor base by continuously increasing share visibility, tradability, and liquidity
• Additional index listings are targeted following Formycon’s inclusion in the MSCI Germany Small Cap Index in May 2023

Planegg-Martinsried, Germany – Formycon AG (“Formycon” or “The company”) announced today that it is applying to list its shares on the regulated market (Prime Standard) of the Frankfurt Stock Exchange (“uplisting”). The Prime Standard segment maintains the highest transparency standards with above average reporting requirements, specifically aimed at companies with an international investor focus. Through this uplisting, Formycon seeks to strengthen its international market position and enhance its visibility and appeal among investors by meeting the most stringent transparency and disclosure criteria.

The company expects to receive trading approval for the Prime Standard segment of the regulated market on November 11, 2024, with trading set to commence on November 12, 2024. The prospectus required for the uplisting is anticipated to earn BaFin approval on November 8, 2024, and will be made available shortly thereafter on the Formycon website at www.formycon.com/prospectus

“Over the past years, we’ve established Formycon as an internationally recognized, independent specialist for the development of biosimilars. Following FYB201- which is now available in 20 countries and the leading Lucentis^® biosimilar in most markets – FYB202 and FYB203 will offer attractive therapeutic options for many patients and markets. This promising operational business development underlines the development potential of our company and forms the basis for the planned uplisting to a higher stock market segment, which sends a strong signal for our presence on the capital market,” says Dr. Stefan Glombitza, CEO of Formycon AG.

“We have been preparing intensely for this step over the past months, and we are thrilled to announce this important milestone for Formycon. With a market capitalization of approximately 870 million euros, the company has reached a stage of growth and maturity that has significantly increased interest from international and institutional investors. Moving to the Prime Standard was essential to provide this investor group—and our existing shareholders—with enhanced access to Formycon’s stock. Looking ahead, this transition also opens the door to potential inclusion in one of Deutsche Börse’s select indices, which would further boost the stock’s visibility and appeal,” explained Enno Spillner, CFO of Formycon AG.

Currently, the company’s shares are traded on the Frankfurt Stock Exchange’s open market (Scale segment) under ISIN DE000A1EWVY8 (WKN A1EWVY). This listing will be discontinued once trading on the regulated market begins. The ISIN and WKN will remain the same following the uplisting.

M.M.Warburg & CO (AG & Co.) is acting as the listing agent for the uplisting.

About Formycon:

Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:

Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller
Director Investor Relations & Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149

Fax: + 49 (0) 89 – 86 46 67 110

Sabrina.Mueller@formycon.com

Disclaimer:

This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

Relief Therapeutics Signs Non-Binding Letter of Intent with Renexxion for Reverse Merger
 

GENEVA (NOV. 4, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced it has signed a non-binding letter of intent (LOI) with Renexxion, Inc. (Renexxion), a privately-held U.S.-based clinical-stage biotechnology company specializing in gastrointestinal disorders therapies. The proposed reverse merger between Relief and Renexxion aims to create a combined entity with an expanded therapeutic pipeline addressing critical unmet healthcare needs worldwide.

The transaction, if entered into and completed, is expected to strengthen the combined company’s competitive position in the biotech industry while providing new growth initiatives through their complementary resources and expertise. This potential strategic merger is anticipated to enhance shareholder value, broaden access to capital, and accelerate the delivery of innovative therapies to patients.

“The contemplated merger with Renexxion represents an exceptional opportunity to build a more resilient and innovative business that stands to benefit our stakeholders, leveraging Relief’s portfolio and proven expertise in rare and specialty diseases,” said Dr. Raghuram Selvaraju, chairman of the board of directors of Relief. “After an extensive strategic review and careful consideration of multiple alternatives, Relief’s board of directors has determined that this combination with Renexxion is the most promising path to deliver sustained value for our shareholders and accelerate our impact on critical healthcare needs worldwide.”

“This prospective merger will be a transformative step forward in Renexxion’s journey,” said Dr. Peter G. Milner, chairman and CEO of Renexxion. “In partnership with Relief, we will be positioned to redefine the landscape of gastrointestinal healthcare by accelerating the clinical development of naronapride, our lead compound, to address critical unmet needs in conditions such as gastroparesis and PPI-non-responsive symptomatic GERD. The FDA IND clearance for U.S. trials in both of these indications underscores naronapride’s strong safety and efficacy profile, positioning it as a potential best-in-class prokinetic. By combining Relief’s resources and expertise with our proven development framework, we aim to accelerate the delivery of urgently needed treatments to patients and expand the therapeutic areas in which the combined company will operate. Together, we are committed to advancing GI therapeutics and becoming a global leader in this space, with a focus on innovation, patient safety, and impactful outcomes.”

Transaction Overview
Pursuant to the terms of the LOI, the transaction will be structured as an equity combination in which Relief would acquire all outstanding shares of Renexxion in exchange for newly issued shares of Relief to be allocated to the Renexxion shareholders, subject to shareholder approval and other conditions. This exchange is based on pre-determined valuations of each company’s equity interests. Relief’s fully diluted equity is valued at USD 100 million, while Renexxion’s equity is valued at USD 260 million, in each case subject to adjustment based on cash held by each company at closing. The initial merger ratio would therefore allocate approximately 72.2% ownership to Renexxion shareholders and 27.8% to Relief shareholders. Post-transaction, it is anticipated that the shares of the combined entity would continue to trade on the SIX Swiss Exchange and remain quoted in the U.S. on OTCQB.

The LOI also provides for a one-year post-closing reset mechanism to adjust the ownership ratio based on the combined entity’s market value at that time within certain parameters. This provision is intended to protect Relief’s legacy shareholders by ensuring that the ownership distribution continues to accurately reflect performance after the business combination.

Relief and Renexxion will continue negotiations to enter into a definitive merger agreement by December 31, 2024. Completion of the transaction is subject to customary conditions, including (i) the satisfactory completion of additional due diligence, (ii) the execution of a definitive merger agreement, (iii) the completion of a concurrent private financing by Renexxion, and (iv) regulatory and shareholder approvals. There can be no assurance that a definitive agreement will be reached or that the proposed transaction will be entered into or completed as proposed, or at all.

ABOUT RENEXXION
Renexxion, Inc. is a clinical-stage biopharmaceutical company pioneering therapies for gastrointestinal (GI) disorders. Renexxion’s lead compound, naronapride, is a potential best-in-class, highly selective dual-action 5-HT4 agonist/D2-antagonist prokinetic agent designed to enhance GI motility with minimal systemic absorption. Naronapride is currently being studied in a Phase 2 clinical trial for gastroparesis in collaboration with Renexxion’s strategic European partner, a leader in GI therapeutics.

The ongoing multi-center global study (ClinicalTrials.gov ID: NCT05621811) is evaluating naronapride’s efficacy, safety and tolerability in a 320-patient, placebo-controlled Phase 2b (MOVE-IT) trial for gastroparesis. Following recent FDA clearance of the Investigational New Drug (IND) application, the trial has expanded to up to 25 sites across the United States. Top-line results are anticipated in 2025.

Gastroparesis is a serious and often underdiagnosed disorder characterized by delayed gastric emptying, affecting approximately 1.7% of the population in the U.S. and 1% in Europe with gastroparesis-like symptoms. Patients experience debilitating symptoms, such as nausea, vomiting, and bloating, often due to diabetic or idiopathic causes. Existing treatments, like metoclopramide, come with significant safety concerns, including a black-box warning, underscoring the need for safer, more effective alternatives. Naronapride’s unique, topically active 5-HT4 and D2 activity has demonstrated acceleration of gastric emptying in healthy volunteers, and relief of symptoms in a range of Phase 2 studies of functional GI disorders.

Additionally, Renexxion has received FDA IND clearance for naronapride as a potential treatment for proton pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD). PPI-nrsGERD affects up to 10 million people in the U.S., with between 10–40% of patients not achieving adequate symptom control from PPIs alone. Published evidence shows that a combination of PPI treatment and GI prokinetics is more effective than PPIs alone for certain patients. As a locally acting prokinetic, naronapride addresses the GI motility issues underlying these symptoms, offering a promising adjunctive treatment. Renexxion, in conjunction with its European partner, has prioritized PPI-nrsGERD as the next focus in its global development plan.

Renexxion has a robust intellectual property portfolio which strengthens its competitive edge in the GI therapeutics sector. Through strategic partnerships, scientific advancements, and a commitment to addressing patients with high-unmet need, Renexxion aims to redefine GI healthcare and deliver transformative solutions for millions of patients worldwide.

For more information, visit Renexxion’s websites at www.renexxion.com and www.rnexltd.ie.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date. The information provided on Renexxion within this press release and on Renexxion’s website is provided by Renexxion. Relief makes no representation or warranty as to the accuracy, completeness, or reliability of such information and disclaims any obligation or liability in connection with it.

Participants in the Solicitation: Relief and Renexxion and their respective directors and officers and other members of management and employees may be deemed participants in the solicitation of proxies in connection with the proposed business combination. Relief shareholders and other interested persons may obtain more detailed information regarding directors and officers of Relief in Relief’s Report on Form 20-F for the year ended December 31, 2023, as filed with the SEC on April 30, 2024. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from Relief’s and Renexxion’s shareholders in connection with the proposed business combination will be included in the definitive proxy statement/prospectus that Relief, Renexxion or a combined company intends to file with the SEC.

No Offer or Solicitation: This press release does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Renexxion, Relief or any of their respective affiliates. There shall not be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the laws of such other jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.