On September 4, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ONA-XR in combination with the antiestrogen anastrozole in patients with recurrent endometrial cancer (Press release, Context Therapeutics, SEP 4, 2020, View Source [SID1234564498]). Saveri Bhattacharya, DO and Russell Schilder, MD of The Kimmel Cancer Center at Jefferson Health are the study’s Co-Primary Investigators.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 2 trial will include patients who have progesterone receptor positive (PR+) recurrent endometrial. Patients will be administered the combination of onapristone extended release (ONA-XR) and anastrozole. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. To further characterize the activity of ONA-XR, secondary endpoints will include duration of response, clinical benefit rate, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of ONA-XR in these patients, as well as biomarker analyses to explore predictive factors of response to ONA-XR

"Currently, there are limited therapeutic options to treat advanced endometrial cancer. Recent preclinical findings, together with Phase 1 study results in patients with advanced PR+ ovarian and endometrial cancers, give us reason to believe that ONA-XR can help these women with PR+ gynecological cancers," said Tarek Sahmoud, MD, PhD, Chief Medical Officer of Context Therapeutics. [1],[2]. "We believe ONA-XR can make a meaningful difference for patients in the trial."

About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently the subject of an ongoing Phase 2 clinical trial in progesterone receptor positive ovarian cancer. Additional Phase 2 clinical trials in breast and endometrial cancers will initiate in 2020. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.

On September 4, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it has entered into definitive subscription agreements with a consortium of institutional investors (the "Investors") to raise approximately US$418 million through a private placement (Press release, I-Mab Biopharma, SEP 4, 2020, View Source [SID1234564497]). The consortium is led by Hillhouse Capital Group ("Hillhouse"), with significant participation by GIC, and also includes certain other leading Asian and U.S. biotech investment funds, such as Avidity Partners, OrbiMed, Octagon Capital Advisors, Invus, Lake Bleu Capital, Perceptive Advisors, Cormorant Asset Management, Sphera Healthcare and Alyeska Investment Group, L.P. Hillhouse is entitled to nominate one representative to I-Mab’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The private placement comprises (1) the sale to the Investors of approximately US$418 million of the Company’s 29,133,502 ordinary shares (the "Ordinary Shares") (equivalent to 12,666,740 American Depositary Shares ("ADSs") at a purchase price equivalent to US$33 per ADS, representing a 2.9% premium to the 30-day VWAP; and (2) warrants (the "Warrants") to subscribe for an aggregate of 5,341,267 Ordinary Shares (equivalent to 2,322,290 ADSs) at an exercise price equivalent to US$45 per ADS, representing a 40.3% premium to the 30-day VWAP, which may further increase the proceeds of approximately US$104.5 million if the Warrants are fully exercised. The Warrants will remain exercisable at the election of the Investors within 12 months after the closing of the private placement.

The Company will receive all proceeds from the private placement and intends to utilize them to fund the ongoing and planned research and clinical programs globally as well as the development of its commercialization capabilities in China.

"We are honored to have the support of such a distinguished group of globally renowned investors. This financing, which is among one of the largest PIPE deals in recent history, will strengthen our position to effectively execute our strategic priorities and advance our globally competitive pipeline to ultimately bring innovative medicines to patients in need," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "We are very pleased to welcome Hillhouse to our Board and look forward to its counsel on our journey to become a fully integrated biopharma."

Mr. Michael Yi, Co-CIO of Hillhouse, said, "Our latest investment in I-Mab is a perfect example of Hillhouse’s long-term commitment to funding pioneering innovation in life sciences. We see in I-Mab the same qualities that have propelled other biotech companies to success: clear scientific vision, unswerving focus on innovation and flawless execution. We are delighted to partner with an industry leader like I-Mab to scale new heights in its quest for truly transformative therapies."

Choo Yong Cheen, Chief Investment Officer of Private Equity, GIC, said, "Our recent investment represents the strengthening of our partnership with I-MAB, As a long-term investor, GIC invests throughout a company’s various stages of development and we have been impressed by I-MAB’s steadfast resolve on innovation and achievements since inception."

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file registration statements with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the Ordinary Shares issuable in connection with this private placement, including upon exercise of the Warrants.

Jefferies LLC is acting as lead placement agent for the private placement. China Renaissance also participated as a financial advisor.

On the same date, the Company announces that it has entered into a global partnership agreement for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of cancers. In addition, the two partners will collaborate on additional transformative CD47-based bispecific antibodies as well as combination therapies.

I-Mab Conference Call and Webcast Information

Investors and analysts are invited to join the conference call today at 8:00 a.m. ET using the following dial-in information:

United States: +1-888-346-8982
International: +1-412-902-4272
Mainland China: 400-120-1203
Hong Kong: 800-905-945
Conference ID: 10147681
A live webcast and an archived replay of the conference call can be accessed on the Company’s investor relations website at View Source

A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1-877-344-7529 (U.S.), 1-412-317-0088 (International). The conference ID number for the replay is 10147681. The replay will be available through September 11, 2020.

On September 4, 2020, Geron Corporation (the "Company") reported that it entered into an At Market Issuance Sales Agreement (the "2020 Sales Agreement") with B. Riley Securities, Inc. ("B. Riley"), pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $100 million from time to time through B. Riley as its sales agent (Filing, 8-K, Geron, SEP 4, 2020, View Source [SID1234564496]). The Company is not obligated to make any sales of common stock under the 2020 Sales Agreement. In connection with entering into the 2020 Sales Agreement, the Company and B. Riley terminated the At Market Issuance Sales Agreement previously entered into by the Company and B. Riley, dated May 18, 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The issuance and sale of common stock by the Company under the 2020 Sales Agreement is subject to the effectiveness of the Company’s shelf registration statement on Form S-3 to be filed with the United States Securities and Exchange Commission (the "SEC") on September 4, 2020 (the "Shelf Registration Statement"). The Company makes no assurances as to if or whether the Shelf Registration Statement will become effective or, if it does become effective, as to the continued effectiveness of the Shelf Registration Statement.

Sales of the Company’s common stock through B. Riley may be made by any method that is deemed an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. Subject to the terms and conditions of the 2020 Sales Agreement, B. Riley will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company imposes).

Unless earlier terminated as provided below, the 2020 Sales Agreement will automatically terminate upon the earlier of (1) the sale of all Company common stock subject to the 2020 Sales Agreement or (2) September 4, 2023. The 2020 Sales Agreement may also be terminated by the Company or B. Riley at any time upon 10 days’ notice to the other party, or by B. Riley at any time in certain circumstances, including the occurrence of a material adverse change in the Company.

The Company will pay B. Riley an aggregate commission rate equal to up to 3.0% of the gross proceeds of the sales price per share for common stock sold through B. Riley under the 2020 Sales Agreement. The Company has also provided B. Riley with customary indemnification rights.

The foregoing description of the 2020 Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the 2020 Sales Agreement, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On September 4, 2020 InxMed (Nanjing) Co., Ltd., a Nanjing, China-based clinical stage biotech company dedicated to developing innovative, individualized medicines with international impact, reported that it has completed a Series A+ financing of approx. US$19m (Press release, InxMed, SEP 4, 2020, View Source [SID1234564495]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The round was led by Ennovation Ventures and China Growth Capital and followed by InnoMed Capital and Grand Yangtze Capital.

The company intends to use the funds to accelerate its IN10018 clinical program and expand the portfolio, which include IN10018, a potent and selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor, with three indications undergoing clinical trials in the USA, Australia and China. These indications include Uveal Melanoma and NRAS mutant Metastatic Melanoma,Diffuse Gastric Cancer and Platinum-resistant Ovarian Cancer. InxMed owns the exclusive global rights for development and commercialization of IN10018. The funding will also help to strengthen the company’s translational platform and enrich differentiable pipeline.

Led by Dr. Zaiqi Wang, Chairman and CEO, InxMed is a clinical-stage biotech company focusing on developing medicines to bring novel treatment option for patients. Established in the end of 2018, the company has raised tens of millions of US dollars in financing, established an integrated research and clinical development team across Shanghai, Beijing, United States, Canada and Australia, built a differentiated pipeline, and established licensing or co-development partnership with various multinational pharmaceutical companies.

On September 4, 2020 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to participate in two upcoming virtual investor conferences (Press release, Veracyte, SEP 4, 2020, View Source [SID1234564489]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Baird’s 2020 Global Healthcare Conference
Presentation on Wednesday, September 9, 2020, at 1:25 p.m. ET
Morgan Stanley 18th Annual Global Healthcare Conference
Fireside chat on Monday, September 14, 2020; 11:15 a.m. ET
Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days following the conclusion of each live presentation broadcast.