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ADC Therapeutics Announces Proposed Public Offering

On September 21, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients with hematological malignancies and solid tumors, reported the commencement of a proposed underwritten public offering of 5,500,000 shares of its common shares (Press release, ADC Therapeutics, SEP 21, 2020, View Source [SID1234565430]). Certain existing shareholders expect to grant the underwriters a 30-day option to purchase up to 825,000 additional common shares. ADC Therapeutics will not receive any proceeds from the sale of such shares by the selling shareholders. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

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Morgan Stanley, BofA Securities and Cowen are acting as joint book-running managers for the offering.

The offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of ADC Therapeutics SA, such as the common shares, in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and these securities will not be listed or admitted to trading on the SIX Swiss Exchange or on any other regulated trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.

NuCana Announces Closing of Public Offering of American Depositary Shares and Full Exercise of Underwriters’ Option to Purchase Additional American Depositary Shares

On September 21, 2020 NuCana plc, a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, reported the closing of its previously announced underwritten public offering of 17,888,889 American Depositary Shares ("ADSs"), at a public offering price of $4.50 per ADS, which includes 2,333,333 additional ADSs issued upon the exercise in full of the underwriters’ option to purchase additional ADSs (Press release, Nucana BioPharmaceuticals, SEP 21, 2020, View Source [SID1234565428]). The aggregate gross proceeds to NuCana from the offering, before deducting underwriting discounts and commissions and estimated offering expenses were $80.5 million. All of the ADSs in the offering were sold by NuCana.

Jefferies, Cowen, William Blair, and Truist Securities acted as joint book-running managers for the offering.

The securities were offered pursuant to a shelf registration statement on Form F-3 which has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on October 22, 2018. This offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and accompanying prospectus relating to this offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340 or by e-mail at [email protected], or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, email: [email protected], telephone: 1-833-297-2926, or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at [email protected], or Truist Securities, Inc., 3333 Peachtree Road NE, 9th Floor, Atlanta, GA 30326, Attention: Prospectus Department; email: [email protected]. For the avoidance of doubt, such prospectus does not constitute a "prospectus" for the purposes of the Prospectus Regulation (as defined below) and has not been reviewed by any competent authority in any EEA member state or the United Kingdom.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

For readers in the European Economic Area (EEA) and the United Kingdom

In any EEA Member State and the United Kingdom (a "Relevant State"), this communication is only addressed to and directed at "qualified investors" in that Relevant State within the meaning of the Prospectus Regulation (Regulation (EU) 2017/1129) (the "Prospectus Regulation").

Further notice for readers in the United Kingdom

There will be no offer of ADSs to the public in the United Kingdom. This communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000 as amended ("FSMA")) in connection with the securities which are the subject of the offering described in this press release or otherwise, is being directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) ("Investment professionals") of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) ("High net worth companies, unincorporated associations etc.") of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as "relevant persons"). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents. This communication does not contain an offer or constitute any part of an offer to the public within the meaning of ss. 85 and 102B of FSMA or otherwise.

VBL Therapeutics to Present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

On September 21, 2020 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that Prof. Dror Harats, M.D., Chief Executive Officer, will provide a corporate overview, at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit being held virtually September 21-23, 2020 (Press release, VBL Therapeutics, SEP 21, 2020, View Source [SID1234565427]).

Presentation Details:
Date: Wednesday, September 23
Time: 10AM Eastern Time.
Webcast: Webcast Link
An archive recording will be available for listening after the event, on the Investor Relations page of VBL’s corporate website, under "Events & Presentations."

FENNEC ANNOUNCES ISSUANCE OF U.S. PATENT FOR PEDMARKTM

On September 21, 2020 Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, reported that the U.S. Patent and Trademark Office will issue U.S. Patent 10,792,363 entitled "Anhydrous Sodium Thiosulfate and Formulations Thereof (Press release, Fennec Pharmaceuticals, SEP 21, 2020, View Source [SID1234565426])." As suggested by the title, the patent captures the unique anhydrous form of the active ingredient in Fennec’s PEDMARK product, as well as related methods of synthesis. This patent is eligible for listing in the U.S Food and Drug Administration (FDA) Orange Book, and reflects Fennec’s strategy to expand and diversify its intellectual property portfolio to obtain protection for the PEDMARK product.

PEDMARK was granted Orphan Drug Designation by the FDA in 2004. This designation, along with a patent portfolio that includes a previously issued method of use patent from March 2020 and this recent to-be-issued composition patent, further strengthens the position of PEDMARK as the first potential treatment for the prevention of platinum induced ototoxicity in pediatric patients.

About PEDMARK (A unique formulation of sodium thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and is particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated annually that over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this type of hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

PEDMARK received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.

The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).

21/09/2020: Theradiag publishes 2020 H1 results

On September 21, 2020 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported its results for the six months ended June 30, 2020, as approved by the Board of Directors on September 17, 2020 (Press release, Theradiag, SEP 21, 2020, View Source [SID1234565425]).

(1) Theradiag company financial statements for 2019 restated for changes in consolidation, as subsidiary Prestizia has not been consolidated since 2019.

Theradiag CEO Bertrand de Castelnau said: "Thanks to the commitment of each employee and the flexibility of our teams, Theranostic sales grew by 16.5% and now represent 50% of the company’s revenues compared to 40% over the same period in 2019. Global earnings held up well in the first half of 2020. These results confirm our position as leader in monitoring biotherapies in France and abroad. It is by accelerating our development thanks to our recognized and innovative solutions that we will make rapid progress towards financial breakeven."

Board chairman Pierre Morgon added: "I would like to thank and congratulate Theradiag’s teams for their unwavering commitment during this period impacted by unprecedented economic and health conditions. Everyone did their utmost to find solutions to organizational challenges and to preserve commercial efforts and Research and Development activities. Theradiag has once again demonstrated its capacity for innovation and agility, in particular by building a Covid test offer very quickly and preserving its growth capacity in monitoring biotherapies. Theradiag is fully focused on the future, making its fundamentals top-notch assets in a changing context that requires agility and audacity."

Strong resilience in revenue underpinned by robust momentum in theranostics

Theradiag posted first half 2020 revenue of €4.9 million, compared to €5 million in H1 2019. Achieved during the health crisis, this resilience proves the robustness and quality of the tests and solutions marketed by the Group.

Theranostics posted a further six months of strong growth (+16.5%), driven by LISA TRACKER kits for routine use, for which sales exceeded €2.4 million in the first half of 2020 (versus €2.0 million in H1 2019).

Theranostics sales in France amounted to €1.0 million, up 13.5% from H1 2019 despite the introduction of the plan blanc emergency hospital plan in mid-March. US revenue rose 45.4% to €0.4 million. The export business continued to prosper, posting an entirely satisfactory growth of 8.9%. As seen over the past few six-month periods, theranostics is Theradiag’s strategic priority and, as such, accounts for its recurring business, boosting the Company’s visibility.

Meanwhile, in vitro diagnostics (IVD) revenue fell 15.2% from €2.9 million in H1 2019 to €2.4 million, mainly due to non-recurring sales generated with former partner HOB in H1 2019. This decrease is mainly the result of a base effect related to the impact of exceptional sales with the former HOB partner in the first half of 2019. Excluding this unfavorable basis of comparison, Theradiag revenue rose 1.6% in line with its expectations and forecasts, despite the global situation.

At company level, after eliminating the adverse comparative effect arising from non-recurring sales generated in 2019 with former partner HOB, revenue increased, an impressive achievement under the circumstances.

Reduction in operating income mainly due to the business slowdown caused by lockdown measures, the plan blanc emergency plan in French hospitals and continued investment in the USA and R&D in order to drive future growth

2020 H1 operating expenses were down €18K versus H1 2019, to around €6 million, illustrating Theradiag’s ability to control costs during the first six months of 2020 despite the costs of launching the new partnership in the USA, where business is just beginning to develop, and the decrease in capitalized R&D expenses (€399K in H1 2020 versus €496K in H1 2019).

Notwithstanding, operating income fell €276K versus H1 2019 due to investments in the future designed to drive R&D development and innovation and Theradiag’s international expansion, primarily in the USA.

The loss before tax and non-recurring items amounted to €358K compared to €132K in first half 2019.

Net income before non-recurring items was down €221K compared to H1 2019.

As stated in previous press releases, the difference between non-recurring items in the two periods is due to the high volume of non-recurring instrumentation sales generated with HOB in H1 2019 and the reversal of provisions recorded to cover the dispute between HOB and Theradiag, which has now been settled.

Including the aforementioned non-recurring items, the Group posted a net loss of €229K for H1 2020 compared to net income of €727K in H1 2019.

Cash position

At June 30, 2020, net cash stood at €1.7 million, compared to €2.9 million at December 31, 2019. The Company’s present cash position is in line with its roadmap despite the Q2 slowdown and late payments. The Company continues to prepare for the future and must continue to step up development of the theranostics business by building inventories and investing in i-Track10 machines, which will be progressively brought to market.

Theradiag has obtained an agreement in principle on the grant of a PGE state-guaranteed loan, which it will use as and when required.

Lastly, a €34K compensation payment has been received in respect of the furlough scheme implemented from March until end June 2020, corresponding to 3,121 hours of downtime involving several categories of staff.

Theradiag launches antigen test in France to detect Covid-19 in less than 15 minutes

During this exceptional period, Theradiag showed its capacity for innovation and product development in the field of Covid tests. In addition to the test ranges already developed and marketed by Theradiag, the Company will also be marketing antigen tests, known as Sars-CoV-2 rapid diagnostic tests, following an order officially authorizing such tests published in the French Official Journal on Wednesday September 16, 2020. The tests can be incorporated into nationwide Covid testing campaigns.

Outlook

Theradiag has indicated a likely impact of around 10% on 2020 full-year revenue. This estimate is cautious with regard to first half performance but is still appropriate in view of the lack of visibility and contrasting situations currently observed with regard to the resumption of business, particularly overseas. At this stage of the year, the Company does not have a sufficiently clear view of upcoming changes in economic and health conditions in order to evaluate the impact on full-year earnings. Notwithstanding, Theradiag will do its utmost to stay the course, meet its financial targets and return to breakeven over a period extended until 2021 in light of developments observed to date.

2020 highlights to date

– February 2020: Theradiag publishes excellent results for the new TRACKER range i-Tracker kits at the ECCO Congress.

– February 2020: Theradiag helps establish new WHO international standard for biotherapy monitoring.

–March 2020: Theradiag announces the CE marking for the first four i-Tracker test kits in its TRACKER range.

– April 2020: Theradiag joins the fight against Covid-19.

– May 2020: Theradiag announces the validation of an initial Covid-19 test, the ‘RT-PCR’.

– June 2020: Update on Covid-19 test business and CE marking of new Theradiag-labeled tests.

– July 2020: The University of Tours and Theradiag sign two agreements: an exclusive licensing agreement for the production of Covid-19 viral proteins and a global collaboration agreement that could lead to the creation of further partnerships.

– September 2020: Launch of four new tests designed for use with the IDS-iSYS automated analyzer.

– September 2020: Launch of antigen test in France to detect Covid-19 in less than 15 minutes

Upcoming financial conference attended by Theradiag:

– October 1, 2020: Digital Portzamparc BNP Paribas Healthcare/Biotech Seminar