On November 7, 2019 TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company", reported together with its subsidiaries, the "Group", stock code: 1875) was well received by the capital market and should be the eleventh 18A Biotech company listed in Hong Kong since the inception of the new listing regulation last year (Press release, Tot Biopharm, NOV 7, 2019, View Source [SID1234550717]).

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The Company’s shares will commence trading on the Main Board of The Stock Exchange of Hong Kong Limited at 9:00 a.m. HKT tomorrow (8 November 2019, Friday) under the stock code of 1875, with board lot of 400 Shares each.

The final offer price of TOT BIOPHARM was determined at HK$6.55 per Offer Share. The net proceeds to be received by the Company is estimated to be approximately HK$511.4 million from the Global Offering (assuming that the Over-allotment Option is not exercised, after deduction of the underwriting fees and commission and estimated expenses payable by the Company in connection with the Global Offering). The Hong Kong Offer Shares initially offered under the Hong Kong Public Offering have been significantly over-subscribed by approximately 11.95 times of the total number of 9,000,000 Hong Kong Offer Shares initially available for subscription under the Hong Kong Public Offering. The International Offer Shares initially offered under the International Offering have been moderately over-subscribed.

Focusing on Innovative Oncology Drugs and Therapies, Developed Diversified Product Mix

TOT BIOPHARM is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies. The Company has a comprehensive portfolio of oncology drug candidates, which include monoclonal antibodies (mAbs), antibody drug conjugates (ADCs), oncolytic virus products and specialty oncology drugs such as liposome drugs, targeting various types of cancers.

The Company focuses on achieving a diverse product mix. The Company’s comprehensive product pipeline consists of seven biological and five chemical drug candidates, 11 of which are in-house developed. Product pipeline covers a wide variety of cancer types and extended applications with sustainable launch schedule. Leveraging commercial-scale manufacturing and proven sales and marketing capabilities of TOT BIOPHARM, the Company is able to shorten time-to-market and time-to-peak sales of the products when approved.

At present, four biological drug candidates of TOT BIOPHARM are in the clinical stage. Moreover, the Company has submitted the ANDA for one chemical drug candidate, which was accepted by the NMPA in July 2019. In addition, two chemical drug candidates of the Company are undergoing CMC or BE study. The Company targets to launch the products from 2020.

Full Industry Value Chain Capabilities, Attractive to Quality Business Partner

Since inception in 2009, the Group has built and established a fully integrated in-house platform of discovery, process development, quality management, pre-clinical and clinical development, as well as commercial-scale manufacturing facilities and proven sales and marketing capabilities, which provides flexibility and scalability for its business to expand along the innovative drug industry value chain. Equipped with full industry value chain capabilities, TOT BIOPHARM adopts an open platform business model under which the Company collaborates with third party business partners at different stages of the industry value chain. Benefiting from the strong platform capabilities, the Company has great support from several reputable investors such as Vivo Capital and Advantech Capital.

Ms. Yeh-Huang Chun-Ying, Executive Director and General Manager of TOT BIOPHARM said, "Since the inception of TOT BIOPHARM, we strive to develop innovative drugs that have high viability for commercialization and clear market demands to reach a wider group and benefit the majority of patients. Currently, our product pipeline consists 12 of biological and chemical drug candidates, of which our core product TAB008 is expect to launch between late 2020 and early 2021. In the future, we target to commercialize these pipeline products in China once approved and plan to establish our presence in the overseas markets in the long term."

One of the First Mover in Bevacizumab Market

The bevacizumab market in China has significant growth potential. The bevacizumab market in China is expected to reach RMB3.2 billion in 2018 and is estimated to grow to RMB13.1 billion in 2023, representing a CAGR of 32.7%, according to Frost & Sullivan.

TAB008, the most advanced biological drug candidate and Core Product of the Company, is currently undergoing Phase III clinical trials in China, and is expected to be launched between the end of 2020 and early 2021, subject to regulatory approval. It is an anti-VEGF mAb and biosimilar drug candidate to bevacizumab, which will be sold under the trade name of Avastin. The Company adopts and develops cost-effective technologies the Company use 2,000L bioreactors to manufacture TAB008, demonstrating the readiness for cost-efficient commercial production. Leveraging commercial-scale manufacturing and proven sales and marketing capabilities of, the Company is able to shorten time-to-market and time-to-peak sales of our TAB008 when approved.

Well-Established and Advanced Technology Platforms and Manufacturing Facilities

The Company owns and operates cost-efficient commercial-scale and state-of-the-art manufacturing facilities, built to and operating at international standards, at Suzhou Production Center, of which the No. 2 campus has a designed capacity of 16,000L to accommodate high-quality commercial manufacturing. At the same time, TOT BIOPHARM has established three advanced technology platforms, including the Therapeutic Monoclonal Antibody and ADC Technology Platform, the Gene Engineering Based Therapeutics Technology Platform and the Innovative Drug Delivery Technology System, to develop different types of oncology drugs. TOT BIOPHARM owns self-developed know-how for manufacturing processes and developed a robust product pipeline, which will continue to further the clinical and pre-clinical development of drug candidates and manage pipeline development to achieve fast-to-market commercialization. Supported by three advanced technology platforms, the Company has gained five invention patents and one utility model patent in China.

Industry-leading Talent Base

TOT BIOPHARM has assembled a senior management team with extensive experience and profound knowledge in cancer treatment. The senior management team of the Company represents a full spectrum of complementary skillsets, including pre-clinical research, clinical development, manufacturing, quality control and assurance and commercialization, and broad experience in different cancer treatments including mAbs, ADCs, oncolytic virus and specialty oncology drugs, which lead the Company to achieve future success. The Company’s research and development staff are also able to progress the development efficiently, keep track of achievements in their respective fields and create innovative solutions.

Ms. Yeh-Huang Chun-Ying concluded, "Looking ahead, TOT BIOPHARM’s mission is to build a leading brand name of oncology treatments trusted by patients and their families as well as medical professionals in China. We believe, by commercializing TAB008, rapidly advancing our clinical trials for drug candidates, enriching product portfolio by focusing on immune-oncology combination therapies, strengthening our in-house sales and marketing force and commercial-scale manufacturing capacities and maximizing the value of our integrated platform, the Group has even brighter prospects."

On November 7, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported that its stockholders voted to approve the company’s proposed combination with Exact Sciences Corp (NASDAQ: EXAS) at a special meeting held earlier (Press release, Genomic Health, NOV 7, 2019, View Source [SID1234550716]).

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As previously announced on July 29, 2019, Genomic Health and Exact Sciences entered into the merger agreement by which Exact Sciences will acquire Genomic Health in a cash and stock transaction. With the receipt of the required stockholder approval, Genomic Health and Exact Sciences expect to close the transaction on Friday, November 8 subject to satisfaction of the remaining customary closing conditions.

Final vote tallies from the Genomic Health special meeting of stockholders are subject to certification by the Company’s inspector of elections and will be included in a report to be filed by the Company with the Securities and Exchange Commission (the "SEC").

On November 7, 2019 Affimed N.V. ("Affimed" or the "Company") (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that it has commenced an underwritten public offering of its common shares (Press release, Affimed, NOV 7, 2019, View Source [SID1234550715]). The Company expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of common shares sold in connection with the offering. All of the shares in the offering will be sold by Affimed. This offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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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

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Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers of the offering. A shelf registration statement relating to these securities filed with the Securities and Exchange Commission (the "SEC") was declared effective by the SEC on November 7, 2018. The offering will be made only by means of a prospectus and prospectus supplement. A preliminary prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available at the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus related to the offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388 or by email at [email protected], or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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 November 7, 2019 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies for the treatment of cancer patients, reported its financial results for the third quarter ended September 30, 2019 and provided an update on recent developments (Press release, IGM Biosciences, NOV 7, 2019, View Source [SID1234550714]).

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"During the third quarter of 2019, we continued to make progress towards our research, clinical development and financing goals, including initiating our first-in-human clinical trial of our lead IgM antibody, IGM-2323, in patients with relapsed/refractory B cell Non-Hodgkin’s lymphoma and closing both our Series C financing and our initial public offering," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "During 2020, we hope to continue our progress and report initial data from our IGM-2323 Phase 1 trial and file an IND for our second product candidate, an IgM antibody targeting DR5."

Recent Highlights

Initiated Phase 1 clinical trial of IGM-2323. In October 2019, IGM announced dosing of the first patient in its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL). This Phase 1 clinical trial represents the first-in-human application of IGM Biosciences’ engineered IgM antibody technology. The Company expects to report initial data from this Phase 1 trial in the second half of 2020.

Completed initial public offering (IPO) and Series C financing. In September 2019, IGM closed its IPO of 12,578,125 shares of its common stock at a price to the public of $16.00 per share, which included the exercise in full by the underwriters of their option to purchase up to 1,640,625 additional shares. IGM received gross proceeds of $201.3 million from the offering. Prior to the IPO, in July 2019, IGM completed a $102 million Series C financing which included conversion of $20 million in unsecured promissory notes. In aggregate, IGM raised $264.5 million in cash proceeds pursuant to these financings, net of note conversion, underwriting discounts and commissions and estimated offering expenses.

Third Quarter 2019 Financial Results

Cash and Investments: Cash and investments as of September 30, 2019 were $251.3 million.
Research and Development (R&D) Expenses: For the third quarter of 2019, R&D expenses were $8.3 million.
General and Administrative (G&A) Expenses: For the third quarter of 2019, G&A expenses were $2.4 million.
Net Loss: For the third quarter of 2019, net loss was $10.2 million, or a loss of $2.41 per share.
Shares outstanding: Shares outstanding as of September 30, 2019 were 30.5 million including both voting common stock and non-voting common stock.

Financial Guidance

Management estimates operating expenses for 2019 of approximately $42.0 – $45.0 million, including estimated stock-based compensation expense of approximately $1.0 million. Management also expects a balance of over $230 million in cash and investments and approximately 30.6 million shares outstanding, including both voting common stock and non-voting common stock, at December 31, 2019.

On November 7, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported financial results and business highlights for the third quarter ended September 30, 2019 (Press release, Stemline Therapeutics, NOV 7, 2019, View Source [SID1234550713]).

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Robert Francomano, SVP and Global Head of Commercial, stated, "We are very pleased with the sustained revenue generation and significant progress we continue to make on the ELZONRIS launch. Notably, we observed a greater than 20% increase in estimated new patient starts quarter over quarter, which is a testament to our execution and bodes very well for the future of the brand. Additionally, we implemented a number of strategies designed to increase the speed and accuracy of BPDCN diagnoses, not only in hematology and hematopathology but also within the dermatology and dermatopathology segments – where our data indicate the preponderance of misdiagnoses occurs. Our entire organization is focused on ensuring that patients with BPDCN gain access to ELZONRIS, and we look to capitalize on the positive trends we are seeing to ensure continued performance through 2020 and beyond."

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented, "We are very pleased with the continued commercial performance and our efforts to realize additional value from ELZONRIS in other indications. Based on encouraging clinical data observed in the first stages of our clinical trial in chronic myelomonocytic leukemia (CMML), combined with a strong rationale for targeting CD123 in this disease setting, we view CMML as our next key indication. We anticipate opening enrollment of the registration-directed stage of the trial in the next few months. We look forward to data and regulatory updates around this program, including in both relapsed/refractory and first-line patients, by the second half of 2020."

Third Quarter 2019 Financial Results Review
Net revenue for ELZONRIS increased to $13.3 million for the quarter ended September 30, 2019.

Stemline ended the third quarter with $174.5 million in cash, cash equivalents and short-term investments. For the third quarter, Stemline reported a net loss of $14.9 million, with net cash expenditures of $11.8 million.

Research and development expenses were $12.3 million for the third quarter of 2019, which reflects an increase of $0.5 million compared with $11.8 million for the third quarter of 2018. The higher costs were primarily due to increased investment as we continue to explore new indications for ELZONRIS.

Selling, general and administrative expenses were $15.4 million for the third quarter of 2019, which reflects an increase of $5.8 million compared with $9.6 million for the third quarter of 2018. The increase in costs were primarily attributable to ongoing commercial launch expenses for ELZONRIS.

Recent Business Highlights

Commercial

We continue to create a positive reimbursement environment for ELZONRIS that we expect will further enhance the value proposition of the brand and generate more patient starts for the foreseeable future. In particular,
Awarding by the CMS (the Centers for Medicare and Medicaid Services) of NTAP (New Technology Add-On Payment), granted to therapies that are deemed to deliver a substantial clinical improvement over existing therapies, for ELZONRIS went into effect on October 1, 2019.
Assignment of an ELZONRIS specific J-Code which makes billing for treatment easier and speeds up claims processing time, also in effect October 1st.
With regard to private payers, ELZONRIS now has favorable coverage for over 170 million lives, with policy decisions to the label for key large commercial payers.
We continue to execute on our brand and disease awareness efforts which are designed to raise the profile of BPDCN and underscore the importance of testing patients for CD123, particularly within the dermatology and dermatopathology segment.
ELZONRIS Product Line Extension Efforts

In an ongoing effort to pursue market expansion opportunities, ELZONRIS is being investigated in a variety of clinical trials and indications, with a number of others planned. By the end of 2020, we expect substantial data and regulatory updates, including in the following programs:
Chronic myelomonocytic leukemia (CMML)

We plan to open an additional single-arm cohort, Stage 3, of patients with relapsed/refractory CMML to the currently enrolling trial in the next few months. In the first part of Stage 3 (Stage 3a), enrichment strategies (e.g. high CD123 expression levels) and certain potential efficacy endpoints, including spleen size reduction, symptom score improvement, and bone marrow complete response with partial hematologic recovery will be evaluated. First-line CMML patients not expected to benefit from available therapies will also be enrolled.
Stage 3a endpoints will be assessed for potential inclusion in the confirmatory cohort (Stage 3b), that will aim to provide the primary evidence of efficacy to support potential registration.
We expect to provide data from Stage 3a, in both relapsed/refractory and first-line patients, as well as further regulatory updates by the end of 2020.
Myelofibrosis (MF)

ELZONRIS clinical data from the ongoing Phase 1/2 trial in patients with relapsed/refractory MF were selected for oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) conference.
We are encouraged by the clinical data thus far and are expanding the Stage 2 cohort of the currently enrolling Phase 2 trial of ELZONRIS in patients with relapsed/refractory MF.
We will continue to assess ELZONRIS in relapsed/refractory MF patients as a whole as well as in certain patient subsets of interest including patients with baseline thrombocytopenia (a setting where other agents in this area may require dose interruption or reduction), monocytosis (a potential poor prognostic feature), and high CD123 expression levels.
We expect to provide additional data, including in various subsets of interest, by the end of 2020, and possibly before.
Maintenance therapy post-stem cell transplant (SCT) in BPDCN

The Phase 2 investigator-sponsored clinical trial of ELZONRIS in patients with BPDCN as maintenance therapy post- SCT has been granted regulatory authorization to proceed. The trial will evaluate the safety and feasibility of ELZONRIS in the maintenance setting for patients with BPDCN after SCT.
We expect to provide updates by the end of 2020, and possibly before.
Acute myeloid leukemia (AML)

A Phase 1/2 investigator-sponsored trial is currently ongoing with ELZONRIS in combination with azacitidine and venetoclax in patients with relapsed/refractory AML, elderly AML unfit for chemotherapy, and high-risk myelodysplastic syndrome (MDS).
Phase 1/2 investigator-sponsored trials are currently planned with ELZONRIS in combination with other agents in patients with relapsed/refractory AML and elderly AML unfit for chemotherapy, with high CD123 expression levels and/or BPDCN-like features.
We expect to provide updates by the end of 2020, and possibly before.
Ex-U.S.

In January 2019, Stemline submitted a Marketing Authorization Application to the European Medicines Agency (EMA), seeking approval of ELZONRIS for the treatment of adult patients with BPDCN. We continue to interact with the EMA regarding the application and a scientific advisory group meeting is expected to occur in the first quarter of 2020. Based on this timeline, we expect an opinion or further questions from the Committee for Medicinal Products for Human Use (CHMP) in the first quarter 2020.
ELZONRIS clinical trial data in BPDCN was presented via oral presentation on October 13th at the Japanese Society of Hematology (JSH) meeting in Tokyo, Japan.
Additional Pipeline Candidates

Felezonexor (SL-801) is a reversible inhibitor of XPO1. Updated Phase 1 data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting. The trial is ongoing, and we intend to provide further updates as the Phase 1 trial continues.
Stemline is also developing its preclinical assets, SL-1001 (RET kinase inhibitor) and SL-901 (kinase inhibitor), which are both in IND-enabling studies and are expected to enter the clinic next year.
Conference Call Information
The conference call can be accessed by dialing 1-800-367-2403 (domestic) or 1-334-777-6978 (international) and referring to conference ID 9176352. The webcast can be accessed via the company’s website (www.stemline.com), at the bottom of the "Investors & Media" section in the "News & Events" page, and will be available live and for replay shortly after the event.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.