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Agios to Webcast Conference Call of Second Quarter 2021 Financial Results on July 29, 2021

On July 15, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, reported that the company will host a conference call and live webcast on Thursday, July 29, 2021 at 8:00 a.m. ET to report its second quarter 2021 financial results and other business highlights (Press release, Agios Pharmaceuticals, JUL 15, 2021, https://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-second-quarter-2021-financial [SID1234584872]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 2663508. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.

Advaxis Announces Initiation of Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer

On July 15, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the initiation of its Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer (Press release, Advaxis, JUL 15, 2021, View Source [SID1234584871]). The study, being conducted at Columbia University Irving Medical Center, is the first clinical evaluation of ADXS-504, Advaxis’ off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer. Mark Stein, M.D., associate professor of medicine in the Division of Hematology/Oncology at Columbia University Vagelos College of Physicians and Surgeons, is the study’s principal investigator.

"Evaluating ADXS-504 in patients with biochemically recurrent prostate cancer is the first step in testing whether Lm-based immunotherapies may have a role in the adjuvant setting in cancer patients who have undergone radical therapy and who have no detectable primary tumor or metastatic disease at enrollment," said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. "This Phase 1 study will evaluate the safety, tolerability, immunogenicity and clinical activity of ADXS-504 in men who have undergone radical prostatectomy or radiotherapy and whose prostate specific antigen (PSA) levels in the blood are rising, which we believe are ideal patients to evaluate with this approach. Moreover, we believe our multi-neoantigen vector has the potential to drive T cell responses against both hormone-sensitive and hormone-resistant cancer cells, which could result in disease control and may delay the start of androgen blockade therapy and its associated long-term complications. This study will also examine our lowest dose of an Lm-based immunotherapy to date, which could enhance the risk/benefit ratio that we have previously observed in our ADXS-HOT program."

Kenneth A. Berlin, President and Chief Executive Officer of Advaxis stated, "We are pleased to be launching the first clinical evaluation of ADXS-504, expanding the reach of our off-the-shelf neoantigen immunotherapy program to a second potential indication. Our strong foundation of clinical data generated across both prostate cancer and non-small cell lung cancer suggest Lm-based immunotherapy may bring meaningful clinical benefit to patients and we look forward to continued momentum across the ADXS-HOT program."

The Phase 1 open-label dose escalation study will evaluate the safety and tolerability of two dose levels (1e7 and 1e8 CFU) of ADXS-504 monotherapy, administered via infusion every four weeks for six total doses in 9-18 patients with biochemically recurrent prostate cancer (i.e., those with elevation of prostate-specific antigen (PSA) in the blood after radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and who are not currently receiving androgen ablation therapy). The study will also evaluate preliminary clinical and immune responses following treatment with ADXS-504 monotherapy.

ADXS-504 is a novel Lm-based immunotherapy, bioengineered to elicit T cell responses against 24 tumor antigens that include 14 peptide antigens derived from frequently occurring and commonly shared hotspot mutations in patients with prostate cancer and 10 peptide antigens derived from sequence-optimized tumor-associated antigens (TAAs) that are differentially expressed or overexpressed in prostate cancer. ADXS-504 is designed to express multiple tumor antigen targets to which patients may generate a broad set of effector T cells for tumor control. Similar to Advaxis’s other Lm-based immunotherapies, ADXS-504 is expected to induce an innate immune response followed by the adaptive response and modification of the immunosuppressive tumor microenvironment (TME) by reducing regulatory T cells (Tregs) and myeloid-derived suppressor cell (MDSC) frequencies in the TME.

PTC Therapeutics to Host Conference Call to Discuss Second Quarter 2021 Financial Results

On July 15, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the Company will host a webcast conference call to report its second quarter 2021 financial results and provide an update on the company’s business and outlook on Thursday, July 29, 2021, at 4:30 p.m. (ET) after the closing of the market (Press release, PTC Therapeutics, JUL 15, 2021, https://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-host-conference-call-discuss-second-quarter-6 [SID1234584869]).

The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 7064479. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at View Source A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

MorphoSys to Complete Transformational Acquisition of Constellation Pharmaceuticals, Bolstering Its Position in Hematology-Oncology

On July 15, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) ("MorphoSys") reported the successful completion of its previously announced cash tender offer for all outstanding shares of Constellation Pharmaceuticals, Inc. (NASDAQ: CNST) ("Constellation") for $34.00 per share, net to the seller in cash, without interest and subject to any applicable withholding of taxes (Press release, MorphoSys, JUL 15, 2021, View Source [SID1234584865]). The tender offer expired at one minute after 11:59 p.m. New York City Time, on July 14, 2021.

Approximately 42,811,957 shares of Constellation were validly tendered, and not validly withdrawn in the tender offer, representing approximately 89% of Constellation’s outstanding shares at the time of the expiration of the tender offer. In accordance with the terms of the merger agreement by and among Constellation, MorphoSys and MorphoSys Development Inc., all shares that were validly tendered and not validly withdrawn have been accepted for payment. MorphoSys will promptly complete its acquisition of Constellation through a second step merger of MorphoSys Development Inc. with and into Constellation resulting in Constellation surviving as an indirect wholly owned subsidiary of MorphoSys.

The merger is expected to close today before the start of trading on the NASDAQ market in the U.S., and Constellation shares will cease trading on The NASDAQ Global Select Market. The total equity value of the transaction is approximately $1.7 billion.

"We are pleased to welcome the Constellation team to MorphoSys. With Constellation’s high-potential product candidates, complementary R&D capabilities, and outstanding team, we can further advance our mission in the fight against cancer," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "This transformational acquisition bolsters our position in hematology-oncology and marks the beginning of an important next chapter in our company’s history."

In connection with completing its acquisition of Constellation, MorphoSys has moved forward with a long-term strategic funding partnership with Royalty Pharma plc ("Royalty Pharma"). As previously announced, Royalty Pharma has made a $1.425 billion upfront payment to MorphoSys, supporting the financing of the transaction with Constellation and development of the combined pipeline. Royalty Pharma will also provide MorphoSys with access to up to $350 million in Development Funding Bonds with the flexibility to draw over a one-year period and will make additional payments of up to $150 million to MorphoSys upon reaching clinical, regulatory and commercial milestones for otilimab, gantenerumab and pelabresib. Royalty Pharma will have the rights to receive 100% of MorphoSys’ royalties on net sales of Tremfya(R), 80% of future royalties and 100% of future milestone payments on otilimab, 60% of future royalties on gantenerumab, and 3% on future net sales of Constellation’s clinical stage assets (pelabresib and CPI-0209). With the completion of MorphoSys’ acquisition of Constellation, Royalty Pharma will invest $100 million in a cash capital increase of MorphoSys under an authorization to exclude subscription rights of existing shareholders. The new MorphoSys shares will be listed on the Frankfurt Stock Exchange.

As previously announced, MorphoSys will remain headquartered in Munich, Germany, and will maintain a significant commercial and R&D presence in Boston, Massachusetts, given the highly complementary nature of the companies’ respective R&D organizations.

MorphoSys will provide additional information regarding the combined company’s operations during the MorphoSys second quarter 2021 earnings call scheduled for July 29, 2021.

Advisors

Goldman Sachs Bank Europe SE acted as financial advisor to MorphoSys and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor. Centerview Partners LLC acted as financial advisor to Constellation and Wachtell, Lipton, Rosen & Katz as its legal advisor.

Adlai Nortye Raises $100 Million in Series D Financing, Co-led by SDIC Fund Management and Tigermed, participated by Legend Star, WuXi Biologics Healthcare Ventures

On July 15, 2021 Adlai Nortye Ltd. (hereinafter referred to as "Adlai Nortye"), a global biopharmaceutical company focused on developing innovative oncology drugs, reported the completion of $100 million Series D financing round (Press release, Adlai Nortye Biopharma, JUL 15, 2021, asiaone.com/business/adlai-nortye-raises-100-million-series-d-financing-co-led-sdic-fund-management-and?amp [SID1234584864]). Co-led by SDIC Fund Management and Tigermed, this round of financing is participated by Legend Star, Wuxi Biologicals Healthcare Ventures, Triwise Capital, Qingdao Mukui, Guolian Industrial Investment, Tian Ge Interactive, etc. Proceeds from the financing will be used to accelerate the development of ongoing clinical and preclinical programs, expand drug portfolio through in-house R&D capability, in-licensing, mergers and acquisitions and other strategic collaborations.

"We intend to develop differentiated and innovative oncology drugs globally to address the unmet medical needs and aspire to transform the deadly cancer into a chronic and eventually a curable disease," said Carsten Lu, President and CEO of Adlai Nortye. "This round of financing represents an important milestone for Adlai Nortye, and we are honored to continue gaining support from our prestigious new and existing investors as Adlai Nortye has demonstrated a proven track record of delivering what we promised to the market and investors in the previous rounds. We are well-positioned to advance the development of our robust therapeutics pipeline and looking forward to bringing in more and more innovative treatments benefiting patients globally."

"We have strong conviction in innovation and paying close attention to what is trending in the biopharmaceutical industry," said Dazhong Lv, Managing Director of SDIC Fund Managemengt. "Adlai Nortye’s strategic vision in global market, dedication to innovation in research and strong execution capability are what have been attracting us. We are pleased to have the opportunity to lead Adlai Nortye’s D round and look forward to the development of multiple first-in-class drugs from the company’s innovative pipeline globally and in China."

Yan Leng, partner of Legend Star added, "Adlai Nortye is quickly emerging as a leader in the field of oncology and we are delighted to have invested in Adlai Nortye and provided support for the R&D of the company’s promising pipeline. Combining innovative research and advanced clinical assets with proven management experience, Adlai Nortye has built an exciting portfolio filled with opportunities. We are excited to join such an experienced and proven management team, outstanding group of investors and top-tier pharmaceutical partners to advance the company’s pipeline products."