On April 27, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its first quarter 2020 financial results on Tuesday, May 5, 2020 (Press release, Iovance Biotherapeutics, APR 27, 2020, View Source [SID1234556699]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EDT.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 4564469. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.

On April 27, 2020 I-SPY 2 TRIAL reported that results on April 27 at the clinical trial plenary session of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 annual meeting, which showed that adding the immune checkpoint inhibitor durvalumab and the PARP inhibitor olaparib to standard of care pre-operative (neoadjuvant) chemotherapy improved outcomes for women with stage II/III, high-risk, HER2-Negative Breast Cancer (Press release, I-SPY 2 TRIAL, APR 27, 2020, View Source [SID1234556605]). Patients who received durvalumab + olaparib + paclitaxel (DOP) followed by doxorubicin/cyclophosphamide (AC), achieved complete eradication of their cancer from the breast and axillary lymph nodes at the time of surgery (i.e pathologic complete response) at a greater rate than patients treated with chemotherapy alone (37% versus 20%). This degree of response met the threshold for graduation, meaning that there is a greater than 85% predicted probability of success if this combination was tested against standard chemotherapy in a phase 3 trial of 300 neoadjuvant patients.

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I-SPY2 is a multicenter, phase 2 trial using response-adaptive randomization within molecular subtypes defined by receptor status and MammaPrint risk to evaluate novel agents as neoadjuvant therapy for breast cancer. I-SPY 2 evaluates drugs (or combination of drugs) in parallel with the goal of determining which drugs work best in various types of breast cancer. I-SPY 2 patients are given chemotherapy before surgery so that response to treatment can be assessed. The primary endpoint of the study is pathologic complete response (pCR). Patients who participated in this study had tumors ≥ 2.5 cm, were HER2-negative, and if the cancer was hormone receptor positive (HR+) had to be classified as MammaPrint high risk status. Lead investigator of the study arm, Dr. Lajos Pusztai, Professor of Medicine and Director of Breast Cancer Translational Research at Yale Cancer Center, presented the efficacy and biomarker results which showed the predicted probability of pCR for the overall HER2-negative group, (22% vs 37%) and by subtypes, in HER2-negative/ER-positive (14% vs 28%) and triple negative (TNBC) (27% vs 47%) breast cancer subtypes.

The investigators also evaluated proposed potential markers that could identify the subgroup of patients who selectively benefited from the inclusion of immune enhancing agents such as durvalumab and DNA damage response targeting agents such as olaparib. Among the HR+/HER2- cohort, the MammaPrint ultra-high group was the primary beneficiary of the combined therapy (pCR rates 64% with the combination versus 22% with chemotherapy alone). Specific gene expression signatures thought to be associated with response were prospectively identified and the following were found to be associated with higher pCR in the experimental arm among TNBC: low CD3/CD8 ratio; high Macrophage/T cell-MHC class II ratio, and high proliferation. The safety signals were not unexpected. Adverse events were consistent with known side effects of these drugs. Overall 11% of patients in durvalumab + olaparib arm experienced immune-related grade 3 adverse events vs 1.3% in the control arm. According to Dr. Pusztai, chaperone for this arm in the I-SPY 2 TRIAL, "These results provide further evidence for the clinical value of immunotherapy in early stage breast cancer and suggest new avenues for how to exploit these drugs in HR+ breast cancers."

As noted by I-SPY 2 principal investigator, Dr. Laura Esserman of the University of California San Francisco, "There is a consistent signal of improved response from immuno-oncology and DNA damage response targeted agents in the adaptive I-SPY 2 platform trial as well as other trials, which gives us confidence that these types of agents will have a place in improving outcomes for women with highest risk early breast cancer. "

AACR has selected these findings as newsworthy and will be highlight during an AACR (Free AACR Whitepaper) webcast with the meeting program chair Dr. Antoni Ribas and AACR (Free AACR Whitepaper) President Dr. Elaine Mardis.

On April 27, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report first quarter financial results and provide a corporate update on May 4, 2020 (Press release, Corcept Therapeutics, APR 27, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-first-quarter-financial-results-5 [SID1234556625]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information
To participate, dial 1-800-458-4121 from the United States or 1-323-794-2093 internationally approximately ten minutes before the start of the call. The passcode will be 2827359.

A replay will be available through May 18, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 2827359.

On April 27, 2020 INOVIO (NASDAQ:INO) reported that first quarter 2020 financial results will be released after the market close on May 11, 2020 (Press release, Inovio, APR 27, 2020, View Source [SID1234556641]). Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update, including the company’s ongoing vaccine developments for COVID-19.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10143530.

On April 27, 2020 Biogen Inc. (Nasdaq: BIIB) reported the pricing of two series of senior unsecured notes for an aggregate principal amount of $3.0 billion (Press release, Biogen, APR 27, 2020, View Source [SID1234556700]). The notes will mature as follows:

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$1.5 billion will mature on May 1, 2030 and will bear interest at an annual rate of 2.25%

$1.5 billion will mature on May 1, 2050 and will bear interest at an annual rate of 3.15%
The offering is expected to close on April 30, 2020, subject to customary closing conditions.

Biogen intends to use the net proceeds from the sale of the notes to redeem in full $1.5 billion in aggregate principal amount of its outstanding 2.90% Senior Notes due September 15, 2020, and all accrued and unpaid interest thereon, to fund, together with cash on hand, repurchases of its common stock under its share repurchase plans and for working capital and other general corporate purposes.

Goldman Sachs & Co. LLC, BofA Securities, Inc. and J.P. Morgan Securities LLC are acting as joint book-running managers and representatives of the several underwriters. A copy of the preliminary prospectus supplement and the accompanying base prospectus, which is filed as part of Biogen’s effective shelf registration statement on Form S-3 filed on April 24, 2020 (File No. 333-237819), may be obtained from any of the representatives by calling Goldman Sachs & Co. LLC toll-free at 1 (866) 471-2526, BofA Securities, Inc. toll-free at 1 (800) 294-1322 or J.P. Morgan Securities LLC at 1 (212) 834-4533.

An electronic copy of the preliminary prospectus supplement and the accompanying base prospectus may also be obtained at no charge at the Securities and Exchange Commission’s website at www.sec.gov.

This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or other jurisdiction where such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction, where the offer, solicitation or sale of these securities would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering of the notes may be made only by means of a prospectus supplement and the accompanying base prospectus.