On February 11, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2019 fourth quarter and full year financial results on Tuesday, February 25, 2020, after the close of the financial markets (Press release, Jazz Pharmaceuticals, FEB 11, 2020, View Source [SID1234554184]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EST/9:30 p.m. GMT to discuss fourth quarter and full year 2019 financial results and provide a business and financial update and guidance for 2020 financial results.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

On February 11, 2020 Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported the pricing of an underwritten public offering of 26,315,790 shares of common stock at a public offering price of $19.00 per share, before underwriting discounts and commissions (Press release, Moderna Therapeutics, FEB 11, 2020, View Source [SID1234554223]). In addition, Moderna has granted the underwriters a 30-day option to purchase up to an additional 3,947,368 shares of common stock at the public offering price, less underwriting discounts and commissions. All shares of common stock are being offered by Moderna. Gross proceeds from the offering will be approximately $500 million. The offering is expected to close on or about February 14, 2020, subject to the satisfaction of customary closing conditions.

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Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers for the offering. Piper Sandler & Co. and Barclays Capital Inc. are acting as book-running managers, while Needham & Company, Oddo BHF SCA, Oppenheimer & Co. Inc., Chardan and Roth Capital Partners are acting as co-managers for the offering.

A registration statement on Form S-3 (File No. 333-236348) relating to these securities has been previously filed with the Securities and Exchange Commission (SEC) and has become effective. The offering will be made only by means of a prospectus. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and forms a part of the effective registration statement. A copy of the final prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at Attn: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by fax at (212) 902-9316, or by email at [email protected], or from Morgan Stanley & Co. LLC, by mail at Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

This press release shall not constitute an offer to sell or a 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.

On February 11, 2020 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") is reported that it has closed its offering (the "Offering") of 16,317,000 units (the "Units") at a price of C$0.50 per Unit (the "Offering Price") for gross proceeds of C$8,158,500 (Press release, IntelGenx, FEB 11, 2020, View Source [SID1234554151]).

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Each Unit consists of one share of common stock (the "Offered Shares") and one warrant (a "Warrant") entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share (a "Warrant Share"). The Warrants are exercisable immediately and will expire on the third anniversary of the date of their issuance.

The Units were distributed under a short form prospectus dated January 27, 2020 filed by the Company in connection with the Offering and available on SEDAR at www.sedar.com and have been registered with the United States Securities and Exchange Commission pursuant to a Form S-1 Registration Statement that was declared effective on January 31, 2020 (the "Registration Statement"). The Offering was conducted, on a best efforts basis, by Echelon Wealth Partners Inc. (the "Agent"). In consideration for the services rendered by the Agent, the Company has paid the Agent an agency fee equal to 7% of the gross proceeds of the Offering and has issued the Agent a number of warrants (the "Agent Warrants") equal to 7% of the number of Units issued under the Offering, each Agent Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share until the third anniversary of the date of their issuance. After the payment of the Agent’s commissions and the reimbursement of certain of the Agent’s Offering expenses and the payment of other Offering expenses, the Company expects the net proceeds from the Offering to be approximately C$7.4 million.

The Company has granted the Agent an over-allotment option exercisable, in whole or in part, at the sole discretion of the Agent, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the date hereof, to offer and sell up to an additional number of Units representing 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.

The TSX Venture Exchange (the "TSXV") has conditionally approved the listing of the Warrants and the common stock that will be issued by the Company in the Offering, including the shares of common stock issuable upon the exercise of the Warrants and the Agent Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 15 days of the closing of the Offering.

The Warrants will be listed on the TSXV under the symbol "IGX.WT" and will commence trading effective at the opening of the market on Thursday, February 13, 2020.

The Company intends to use the net proceeds from the Offering for its Phase 2A Montelukast Study and general working capital requirements.

On February 11, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, and Personalis Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported a collaboration to leverage Personalis’ ImmunoID NeXT Platform in Advaxis’ ongoing Phase 1/2 ADXS-503 (HOT Lung) program evaluating ADXS-503 alone and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) (Press release, Advaxis, FEB 11, 2020, View Source [SID1234554169]). The ADXS-503 construct targets 11 public or shared, hotspot neoantigens in KRAS, EGFR and TP53 as well as 11 proprietary tumor-associated antigen targets. Under the terms of the expanded agreement, Personalis will conduct comprehensive tumor immunogenomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.

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Via the deep analysis of ~20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one; providing a multidimensional view of the tumor and the immune microenvironment from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery and CDx development.

"We are thrilled to expand our relationship with Personalis and believe the resulting analyses may lead to the establishment of predictive biomarkers and the characterization of immunological impact of treatment which will be relevant to the successful development of ADXS-503 and our other off-the-shelf neoantigen constructs," said Dr. Andres A. Gutierrez, Chief Medical Officer of Advaxis. "With the emerging clinical signals we are seeing in our ongoing ADXS-503 clinical study and the extensive capabilities of ImmunoID NeXT to interrogate a patient’s tumor and immune response at both the DNA- and RNA-level from a single FFPE tissue sample, the analysis will help guide our development plans in order to target the right patient population and to potentially increase the clinical benefit of our off-the-shelf, ADXS-HOT drug constructs."

This new agreement builds upon the prior two-year collaboration between Advaxis and Personalis for the genomic analysis of clinical tumor samples to manufacture the Company’s ADXS-NEO drug construct, its personalized, neoantigen-directed immunotherapy to treat a variety of late stage cancers. As previously published, the ADXS-NEO drug constructs were able to efficiently generate de novo CD8+ T cells versus KRAS and EGFR hotspot mutations in late stage-cancer patients, thus providing proof-of-mechanism for our ADXS-HOT program.

On February 11, 2020 Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology drug development, reported it will present clinical data in metastatic castration resistant prostate cancer (mCRPC) at the Genitourinary Cancers Symposium, demonstrating safety and biological activity of PT-112 in a heavily refractory population of late-stage prostate cancer patients from two separate Phase I studies (Press release, Phosplatin, FEB 11, 2020, View Source [SID1234554185]).

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"The unmet need in heavily pre-treated patients with mCRPC is extensive, and we believe that PT-112’s immunogenic cell death (ICD) induction and its biodistribution, including osteotropism, are responsible for the encouraging drug activity we have observed among Phase I patients," said Jose Jimeno, MD, PhD, Chief Medical Officer. "These are the first data presented publicly with PT-112 used in a single-disease sub-population. PT-112’s demonstrable activity and attractive safety profile in both the monotherapy and combination cohorts underscores the potential for future clinical development in this late-stage setting of mCRPC," said Robert Fallon, President & CEO of Phosplatin Therapeutics.

Phosplatin’s novel Immunogenic Cell Death (ICD) inducing agent, PT-112, is shown to be well-tolerated with evidence of drug activity in advanced mCRPC as both monotherapy and in combination with avelumab*, an anti-PD-L1 immune checkpoint inhibitor, in heavily pre-treated patients with prostate cancer with a median of 6 prior lines of therapy. Bone pain improvement and nearly universal observation of alkaline phosphatase reduction suggest marked therapeutic activity of PT-112 in bone metastases, likely a consequence of osteotropism conferred by the drug’s pyrophosphate moiety. Serologic and RECIST-defined responses, as well as prolonged disease control in multiple patients substantiate further development of PT-112 in mCRPC, as a monotherapy and in combination with immune checkpoint inhibition.

The poster #D7, abstract number 83, entitled, "PT-112 in advanced metastatic castrate-resistant prostate cancer (mCRPC), as monotherapy or in combination with PD-L1 inhibitor avelumab: Findings from two phase I studies," available here, will be presented by Alan H. Bryce, MD, Associate Professor of Medicine and Chair, Division of Hematology and Medical Oncology, Mayo Clinic, on Thursday, February 13, 2020 from 11:30 AM – 1:00 PM and 5:30 PM – 6:30 PM PST at the Genitourinary Cancers Symposium in San Francisco.

Phosplatin Therapeutics entered a clinical trial collaboration and supply agreement with Pfizer and Merck KGaA, Darmstadt, Germany, in 2017 to evaluate PT-112, a novel small molecule inducer of immunogenic cell death (ICD) in combination with avelumab*, a human anti-PD-L1 IgG1 monoclonal antibody.

Further information on these clinical trials that are currently open can be found at the clinicaltrials.gov registry under NCT 02266745 and NCT 03409458.

*Avelumab is under clinical investigation for treatment of solid tumors in combination with PT-112. There is no guarantee that avelumab will be approved for use in prostate cancer by any health authority.

About PT-112

PT-112 is a novel anti-cancer agent, the first cytotoxic small molecule conjugate of pyrophosphate developed in oncology therapeutics. PT-112 promotes immunogenic cell death (ICD), or the release of damage associated molecular patterns (DAMPs) that lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a potential best-in-class small molecule inducer of this immunological form of cancer cell death. The first-in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses and tumor control among heavily pre-treated patients, and was presented at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress, winning "Best Poster" among the Developmental Therapeutics category. The novelty of its pyrophosphate moiety also results in osteotropism, or the propensity of the drug to reach the mineralized bone. This property is of interest in cancer types with metastatic bone involvement, such as mCRPC.

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US, EU, Japan and other countries for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with mMCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.