On March 18, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it has completed a $43.7 million private placement of common stock and warrants (Press release, Protalix, MAR 18, 2020, View Source [SID1234555676]). In connection with the offering, the Company issued 17,604,423 unregistered shares of the Company’s common stock at a purchase price per share of $2.485 and warrants to purchase an additional 17,604,423 shares of common stock at an exercise price of $2.36 per share. Net proceeds to the Company from the private placement are expected to be approximately $41 million, after deducting advisory fees and other estimated offering expenses. Rosario Capital and Houlihan Lokey Capital Inc. served as financial advisors in the private placement.

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The Company intends to use the net proceeds from the financing to advance the Company’s clinical programs of PRX-102, the Company’s product candidate under development for the treatment of Fabry disease, as well as to further develop its early stage pipeline of therapeutics, and for general corporate purposes.

"We appreciate the confidence expressed by our new and existing stockholders in Protalix’s commitment to bring important treatment options to the Fabry patient community," said Dror Bashan, Protalix’s President and Chief Executive Officer. "This funding gives us the runway and ability to complete our pivotal Phase III BALANCE clinical trial of PRX-102, as well as pursue strategic opportunities to bring additional value to the Company and its stockholders."

Neither the shares of the Company’s common stock nor the warrants sold in the private placement have been registered under the U.S. Securities Act of 1933 (the "Securities Act") or applicable state securities laws, and accordingly 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 Securities Act and such applicable state securities laws. The Company agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement, including the shares of common stock issuable upon exercise of the warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On March 18, 2020 THERADIAG (ISIN: FR0004197747, Mnémonique: ALTER), a company specializing in in vitro diagnostics and theranostics reported its annual results for the year ended December 31, 2019 and adopted by the Board of Directors on March 17, 2020 (Press release, Theradiag, MAR 18, 2020, View Source [SID1234555673]).

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2019 annual results

Notes: (1) Social accounts for 2018 of the company Theradiag restated for consolidation items, the Prestizia subsidiary not being consolidated since 2019. (2) Following a final post-publication audit of turnover of Jan. 30, 2020, turnover has been adjusted to € 9,638 thousand instead of € 9,647 thousand previously

Bertrand de Castelnau, CEO of Theradiag , comments "Theradiag’s 2019 annual results are fully in line with our expectations. Excluding exceptional items, the result for the year is even closer to breakeven, it is a first great achievement on the path to profitability. Innovation remains absolutely central to Theradiag’s growth and we are very satisfied with our continuous investment in R&D, in theranostics in particular with our new i-Track 10 automated system. We have before us important stages of development to come in 2020, particularly internationally in the United States, where we wish to accelerate our presence. We are pleased to announce today a tangible improvement in our financial indicators and look forward to the next few years. "

"The priorities for 2019 were clear and the team’s commitment to achieving them was productive. The exceptional result generated allows Theradiag to pursue its development strategy in a calm manner. The company has real growth potential to assert itself even more in 2020, in France and on its priority markets, as the leader in monitoring biotherapies, " added Pierre Morgon, Chairman of the Board of Directors.

[…]

Financial calendar:

Annual General Meeting, May 14, 2020
Sales for the first half of 2020 , Tuesday July 21, 2020
Upcoming conferences in which Theradiag participates, subject to confirmation:

May 2-5, 2020: Digestive Disease Week (DDW) Congress, Chicago, USA
May 20-24, 2020: 11th International Autoimmunity Congress, Athens, Greece
June 25 to 26, 2020: Nils-Olivier Olsson conference at GEAI, Paris
June 25 to 26, 2020: Francophone Days of Hepato-gastroenterology and Digestive Oncology 2020 (JFHOD), Paris.

On March 18, 2020 Sunesis Presented the Corporate Presentation (Presentation, Sunesis, MAR 18, 2020, View Source [SID1234555669]).

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On March 18, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported preliminary antigen-specific immune response data from a Phase 2 randomized investigator-sponsored trial (IST) of nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal (Press release, Sellas Life Sciences, MAR 18, 2020, View Source [SID1234555668]).

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"We are pleased to report preliminary results from the National Cancer Institute-sponsored Phase 2 VADIS trial, showing NPS is capable of inducing an antigen-specific antitumor immune response in DCIS patients even after a single vaccination, which is particularly encouraging," said Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Based on the immunobiological mechanism of action of NPS, we believe that NPS could be synergistic with standard therapies or novel immunotherapeutic approaches in women with DCIS. Moreover, these data correlate to previous findings of NPS in patients with invasive (non-DCIS) breast cancer. Given NPS’ low toxicity burden and high antigen-specific immune response, further clinical study of NPS as a therapeutic which could address the medical need of women with DCIS at an early stage of their therapeutic journey is likely warranted and these data further support our business development efforts to seek out-licensing opportunities to fund and conduct the future clinical development of NPS in order to maximize the potential of the program."

The study enrolled 13 patients, with nine patients receiving NPS plus GM-CSF and four patients receiving GM-CSF only. The relative frequency of NPS-specific CD8 cytotoxic T-lymphocytes as a percentage (NPS-CLT%) was twice as large in the NPS-treated patients. The NPS-CLT% was measured in the peripheral blood by a sensitive and specific assay using dextramer staining followed by flow cytometry, both at baseline (before vaccination or GM-CSF) and at 30 (+/-7) days after surgery. The mean difference in NPS-CTL% increase between the active and control groups was +0.10% vs +0.05%. The relative magnitude of change in NPS-CTL% mean values in NPS-treated patients over time was an 11-fold increase, from 0.01% at baseline to 0.11% after surgery, indicating a continued antigen-specific T-cell response post-NPS vaccination. NPS was generally well-tolerated in the study with no drug-related unexpected serious adverse reactions. The overall adverse event profile was consistent with previous safety data.

The final data is being further analyzed by the National Institute of Health, MD Anderson Cancer Center and the study principal investigator, Dr. Elizabeth Mittendorf, MD, PhD of the Dana-Farber/Brigham and Women’s Cancer Center, and will be presented at an upcoming medical conference.

"The preliminary data from the VADIS study showing a doubling of the difference in increase in antigen-specific CD8 cytotoxic T-lymphocytes in NPS-treated patients vs. controls, even with a single NPS inoculation, indicate in vivo immunogenicity of this cancer vaccine in DCIS. These data, as well as the previously reported clinical effects of NPS in the adjuvant setting after frontline therapy for invasive breast cancer, provide support for the possibility that NPS may be able to decrease the rate of recurrences in earlier-stage disease, such as DCIS, which I believe should be studied formally in future clinical studies," said Dr. Mittendorf. "While additional analyses of certain histologic and molecular markers of the patients’ immune responses against the NPS and other HER2 antigenic epitopes are currently ongoing, these initial immunobiological results from the VADIS study are encouraging."

About the Phase 2 VADIS Trial

This Phase 2 randomized trial is sponsored and operationalized by the National Cancer Institute (NCI) to study NPS’ potential clinical effects in earlier-stage disease. Patients are randomized to receive, prior to surgery, either GM-CSF followed by NPS two weeks later or GM-CSF alone. The primary endpoint of the trial is the difference in the frequency of newly induced NPS-cytotoxic T lymphocytes (CTL; CD8+ T-cell) in peripheral blood between the two arms of the study, using a dextramer assay. Secondary endpoints to be compared between the two arms include the nature and incidence of adverse events and in vivo immune response to NPS, in addition to other select histologic and molecular biomarkers.

About DCIS

DCIS is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct and have not spread outside the duct to other tissues in the breast. DCIS is the most common type of breast neoplasm with malignant potential. In some cases, DCIS may become invasive cancer and spread to other tissues and, currently, it is not possible to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. Tamoxifen is given in cases with hormone receptor positivity only. No targeted or immune therapies have shown any definitive clinical activity in DCIS to date. The current standard treatment aims at forestalling the progression of DCIS to invasive cancer. In approximately 15-25% of cases progression does occur. DCIS is diagnosed in more than 60,000 women each year in the United States, comprising 1 in 5 newly diagnosed cases of breast cancer.

On March 18, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS), reported that the Company will release its year-end 2019 financial results on Tuesday, March 24, 2020, after the market closes (Press release, Onconova, MAR 18, 2020, View Source [SID1234555667]). Management will host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs.

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Interested parties who wish to participate in the conference call may do so by dialing (855) 428-5741 for domestic and (210) 229-8823 for international callers and using conference ID 3267259. Those interested in listening to the conference call live via the internet may do so by visiting the investors’ page of the company’s website at www.onconova.com and clicking on the webcast link.

A webcast replay will be available on the Onconova website for 90 days following the call by visiting the investor page of the company’s website at www.onconova.com