Press Release: Sanofi moves forward with EUROAPI listing on Euronext Paris

On March 18 2022 Today marks a major milestone for EUROAPI, a leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients* (API), as Sanofi’s Board of Directors reported, on March 17th, to submit to its shareholders the distribution of circa 58% of the share capital of EUROAPI. In addition to the previously proposed €3.33 cash dividend per Sanofi share, this additional extraordinary dividend, exclusively in kind, is subject to shareholders approval
at Sanofi’s May 3, 2022 Ordinary and Extraordinary Shareholders’ Meeting. If approved, the distribution will take place shortly after the listing of EUROAPI’s shares on the regulated market of Euronext Paris, subject to the approval of the French Autorité des Marchés Financiers (AMF) on EUROAPI’s French prospectus, which will be made available to the public ahead of Sanofi’s Shareholders’ Meeting. Through this transaction, Sanofi is giving its shareholders the opportunity to take part in the success of a leading player in the API market with strong ambitions to become a global champion on a growing and dynamic market, and due to be listed on the regulated market of Euronext Paris.

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In connection with the proposed spin-off, French Tech Souveraineté has agreed to purchase
12% in EUROAPI shares from Sanofi for up to €150 million, with the acquisition price to be determined based upon the thirty day volume weighted average trading price ("VWAP") of EUROAPI’s shares on Euronext Paris, starting on the first day of trading. As a result, French Tech Souveraineté will become a long-term reference shareholder of EUROAPI and will be represented by two non-executive members on EUROAPI’s Board of Directors, including Benjamin Paternot and another member to be determined. French Tech Souveraineté’s investment is subject to approval of the spin-off by Sanofi’s shareholders and other customary conditions.

Post transaction, Sanofi confirms that it will hold circa 30% of the share capital and voting rights of EUROAPI and will remain a long-term strategic partner, supporting EUROAPI’s growth ambitions as an independent company over the coming years. In addition to its highly diversified customer base of approximately 530 customers, EUROAPI benefits from a strong and long-term customer relationship with Sanofi, which represented nearly half of EUROAPI’s revenues in 2021.

In line with its "Play to Win" strategy aiming at simplifying its operations, Sanofi announced in February 2020 its ambition to create a new world leader in APIs to secure significant manufacturing and supply capacities that are critical for patients in Europe and beyond, in a context of increasing shortage of medicines essential to patient care. In 2021, Sanofi announced several critical steps in this journey with the unveiling of the creation of EUROAPI and the appointment of Karl Rotthier as its CEO in January, the appointment of Viviane Monges as Chair of the Supervisory Board in July and the finalization of the carve-out in December 2021.

Despite volatile market conditions, Sanofi has decided to move forward with the listing process of EUROAPI. As an independent stand-alone company, EUROAPI will be able to fully unlock its growth potential, offering the best alignment of strategy, value creation and financial objectives for all of Sanofi’s shareholders.

With a diversified technology portfolio, EUROAPI is positioned as the world’s leading manufacturer of small molecule API (including complex chemical synthesis molecules, biochemical molecules from fermentation and highly potent molecules). It was the world’s second largest manufacturer of APIs (including both small and large molecules such as peptides and oligonucleotides) in 2021 and number seven in the global CDMO (Contract Development and Manufacturing Organization) market in 20201.

EUROAPI develops, manufactures, markets and distributes APIs and intermediates used in the formulation of medicines for human and veterinary use, both from originators and generics, through its API Solutions business and CDMO activities.

Drawing on more than 150 years of experience in the growing API market, EUROAPI has a network of six production sites, all of which are located in Europe, and delivers around 200 APIs to approximately 530 customers in over 80 countries. The company will be able to rely on the expertise of around 3,350 employees and expects to achieve consolidated sales of around EUR 1 billion in the year ending December 31, 2022.

Further details regarding the specifics of the distribution, including the parity, and the timetable of the spin-off will be set forth in EUROAPI’s French prospectus.

Following the AMF’s approval of EUROAPI’s French prospectus, Sanofi and EUROAPI’s management teams will host a dedicated Capital Markets Day on April 1, 2022 at 1:30 pm CET to present EUROAPI’s business in greater detail (event registration details are available here).

*About Active Pharmaceutical Ingredients (APIs)
Active Pharmaceutical Ingredients (APIs) are the chemical or biological substances in a medicine that have a therapeutic effect. They are the essential molecules used in the composition and manufacture of any medicine.

Nymox Announces $5 Million Registered Direct Offering

On March 18, 2022 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported it has entered into definitive agreements with institutional and accredited investors for the purchase and sale of 3,030,304 common shares at a purchase price of $1.65 per share in a registered direct offering for gross proceeds of approximately $5 million before deducting placement agent fees and expenses (Press release, Nymox, MAR 18, 2022, View Source [SID1234610339]). The Company has also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 3,030,304 common shares. The warrants are exercisable immediately at an exercise price of $2.00 per share and will expire five (5) years from the date of an effective registration statement covering the shares underlying the warrants. The closing of the offering is expected to occur on or about March 22, 2022, subject to the satisfaction of customary closing conditions.

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Nymox intends to use the proceeds for general corporate purposes, including working capital.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering of the common shares (but not the warrants or the common shares underlying the warrants) is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-261571) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Nymox has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Nymox and such offering.

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

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

Janux Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results

On March 18, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update (Press release, Janux Therapeutics, MAR 18, 2022, View Source [SID1234610337]).

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"Janux made great strides in 2021 as we transitioned to a public company and advanced our pipeline of next generation immunotherapies utilizing our novel TRACTr and TRACIr platforms. We continue to build on this momentum by nominating a development candidate for our costimulatory bispecific program, the first development candidate discovered using our TRACIr platform," said David Campbell, Ph.D., President and CEO of Janux. "In 2022, we remain on-track to execute key milestones, including IND submissions for our PSMA-TRACTr and EGFR-TRACTr candidates, and we look forward to continuing to advance our additional pipeline programs in the year ahead."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

TRACTr product candidates advancing as planned. Janux’s lead TRACTr programs of next-generation T cell engagers remain on-track, with two Investigational New Drug (IND) applications expected in 2022.

In the first half of 2022, Janux expects to submit an IND for its PSMA-TRACTr candidate, targeting prostate-specific membrane antigen (PSMA), for the treatment of metastatic castration-resistant prostate cancer (mCPRC). cGMP manufacturing of drug substance and drug product has been completed.

In the second half of 2022, Janux expects to submit an IND application for its EGFR-TRACTr candidate, targeting epidermal growth factor receptor (EGFR), for the treatment of metastatic colorectal cancer (mCRC), squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC). cGMP manufacturing of drug substance has been completed.

In 2023, Janux expects to submit an IND application for its TROP2-TRACTr, targeting trophoblast cell surface antigen 2 (TROP2).

Nominated first TRACIr development candidate, a PD-L1xCD28 costimulatory bispecific for the treatment of solid tumors. Janux has successfully applied its TRACIr platform to

develop a costimulatory bispecific product candidate against programmed death-ligand 1 (PD-L1) and Cluster of Differentiation 28 (CD28) to further enhance the anti-tumor activity of T cells, which we believe has the potential to be used as a single-agent or in combination with our current TRACTr pipeline and other modalities. This is Janux’s first program derived from its TRACIr platform. In 2023, Janux expects to submit an IND application for this program.

Strengthened management team with appointment of Byron Robinson, Ph.D., J.D., as Chief Strategy Officer. Dr. Robinson brings 30 years of industry expertise and experience from key strategy roles at large pharma companies. Prior to joining Janux, Dr. Robinson served as Senior Vice President of Clinical Development Strategy and Innovation at Merck KGaA. In this role, he was responsible for generating strategic insights for internal and external innovation for the generation of the Clinical Oncology Franchise Strategy for all Merck KGaA oncology assets. In addition, he also served as the Senior Vice President Global Program Leader for the avelumab program, where he advanced BAVENCIO through late-stage development, including eleven registrational Phase 3 trials and more than 240 clinical trials.

FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS:

Cash and cash equivalents and short-term investments: As of December 31, 2021, Janux reported cash, cash equivalents and short-term investments of $375.0 million, compared to $7.8 million at December 31, 2020.

Research and development expenses: Research and development expenses were $11.2 million for the quarter and $26.2 million for the year ended December 31, 2021, compared to $1.0 million and $3.0 million for the same quarter and year in 2020.

General and administrative expenses: General and administrative expenses were $3.9 million for the quarter and $10.3 million for the year ended December 31, 2021, compared to $0.7 million and $1.8 million for the same quarter and year in 2020.

Net loss: Net loss was $13.4 million for the quarter and $32.7 million for the year ended December 31, 2021, compared to $1.7 million and $6.8 million for the same quarter and year in 2020.

Ichnos Sciences Presents Preclinical Data Package on First-in-class Oncology Treatment, ISB 1442, at IO360 Conference

On March 18, 2022 Ichnos Sciences Inc., a global biotechnology company developing innovative biologics in oncology, reported that preclinical data on ISB 1442, a first-in-class bispecific antibody for relapsed/refractory multiple myeloma and other CD38 positive hematologic malignancies, at the Immuno-Oncology 360 (IO360) conference (Press release, Ichnos Sciences, MAR 18, 2022, View Source [SID1234610336]). President and Chief Executive Officer of Ichnos, Cyril Konto, M.D., shared the data in a presentation titled "Beyond the T cell: Co-targeting CD38 and CD47 with a 2+1 Biparatopic Multispecific Antibody" during an afternoon session of the conference.

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In addition to presenting data for ISB 1442, Dr. Konto provided a description of Ichnos’ proprietary BEAT platform1 to meeting attendees. More specifically, he shared in vivo and in vitro study results showing the potency and anti-tumor effects of ISB 1442 relative to clinical benchmarks, daratumumab and agrolimab, and highlighted the flexibility of BEAT, which utilizes advanced heavy chain pairing and a common light chain, allows for modulation of the Fc functionality, and enables the exploration of the full design space.

The IO360 Conference is an annual gathering that convenes stakeholders from across the scientific and business communities, providing a forum to share the latest innovations in immuno-oncology. Ichnos was pleased to be a part of the agenda, which also included presentations by institutions such as John’s Hopkins University and several Fortune 100 pharmaceutical companies.

"Events such as IO360 are a great opportunity to learn about the latest in immuno-oncology and to exchange ideas with colleagues across the field," said Dr. Konto. "I am pleased to have had the opportunity to present data on ISB 1442, and Ichnos’ proprietary BEAT platform at the meeting."

Apeiron is making its debut at AACR

On March 18, 2022 Dr. Fred Aswad, SVP of Biology at Apeiron reported that it will present preclinical data on GTAEXS617, a novel, orally bioavailable, selective small-molecule inhibitor of CDK7 discovered using AI-driven drug discovery (Press release, GT Apeiron Therapeutics, MAR 18, 2022, View Source [SID1234610335]). GTAEXS617 is currently in IND-enabling studies. Preclinical data demonstrates that GTAEXS617 has favorable drug like properties and exhibits potent anti-tumour activity in HGSOC and TNBC xenograft tumour-bearing mice, resulting in complete tumour regression. Furthermore, by leveraging Exscientia’s precision oncology platform, Apeiron and Exscientia are examining the impact of GTAEXS617 on primary patient cancer samples to identify predictive biomarkers that may enable patient and indication enrichment in early clinical development.

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The AACR (Free AACR Whitepaper) Conference (American Association for Cancer Research) being held in New Orleans from April 8-13, 2022, is the focal point of the cancer research community.

Stay tuned for Apeiron session:
Title: AI-driven discovery and profiling of GTAEXS-617, a selective and highly potent inhibitor of CDK7
Session Title: Emerging New Anticancer Agents
Abstract Number: #3930
Date/Time: Wednesday, April 13 / 9:00 AM – 12:30 PM CT