On September 9, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported further STRO-002 updated interim Phase 1 safety and preliminary efficacy data in ovarian cancer, and an upcoming presentation at the 2020 xDigital Annual Global Meeting of the International Gynecologic Cancer Society (IGCS) on Sept. 10, 2020 (Press release, Sutro Biopharma, SEP 9, 2020, View Source [SID1234564912]).

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The interim clinical data from this dose escalation study evaluating the anti-folate receptor alpha (FolRα) antibody drug-conjugate (ADC) STRO-002 included 34 patients treated at 2.9 mg/kg and higher dose levels, with an overall response rate of 24% in 33 evaluable patients with post-baseline scans, with durability of 44% of patients on treatment for 16 weeks or greater and 12% of patients on treatment for 1 year or greater. The results announced today are based on a data cut-off date of Aug. 31, 2020, with 39 patients having been enrolled in the dose escalation study.

"We are pleased to observe improved efficacy outcomes as our data mature with longer follow-up, and the observed rate of objective response, stable disease and overall disease control during this study suggest that STRO-002 is potentially superior to other targeted ADC therapies being studied currently in ovarian cancer," said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. "Taken together with the optimized design approach to ADC safety, we believe that STRO-002 will be a potent and well-tolerated treatment option for patients. Next up, we plan to initiate a dose expansion trial in patients with less heavily pretreated ovarian cancer in the fourth quarter of 2020."

The interim clinical data for STRO-002 in patients evaluable for RECIST response include eight patients with partial responses. Seven patients with partial responses and 13 patients with stable disease achieved a disease control rate of 60% at 12 weeks or greater. STRO-002 continued to be well-tolerated and 87% of all treatment-emergent adverse events (AEs) were Grade 1 or 2; prophylactic corticosteroid eye drops have not been required. The most common Grade 3 and 4 AE was reversible neutropenia, with neuropathy and arthralgia observed at higher doses.

"We continue to see an encouraging efficacy and safety profile for STRO-002 in this heavily pretreated patient population," said Wendel Naumann, M.D., gynecologic oncologist at Levine Cancer Institute and a principal investigator on the STRO-002 study. "While Sutro plans to explore further dose optimization during dose expansion in a less heavily pre-treated patient population, we anticipate that the optimized therapeutic window and the recommended Phase 2 dose will be in the 4.3 to 5.2 mg/kg range. There is a tremendous unmet need for effective treatments in patients with advanced platinum-resistant and refractory epithelial ovarian cancer and we look forward continuing this study to explore the use of STRO-002 in treating this disease."

The Phase 1, open-label, multicenter, dose escalation trial with dose expansion of STRO-002 has completed enrollment and ongoing follow-up and will continue to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian or primary peritoneal cancer, and endometrial cancer. The trial is registered with clinicaltrials.gov identifier NCT03748186. Sutro discovered, developed and manufactures STRO-002 using its proprietary XpressCF cell-free protein synthesis and XpressCF+ site-specific conjugation technologies.

Conference Call Information:
To access the conference call and live audio webcast on Wednesday, Sept. 9, at 5:30 p.m. EDT, please dial (877) 407-8974 (domestic) or (201) 389-0894 (international).

The conference call will be webcast via the Investors page on the Company’s website at ir.sutrobio.com. Approximately two hours following the live event, a webcast replay of the conference call will be available through the Company Presentation page of the Investor section of the company’s website at www.sutrobio.com for approximately 30 days.

Presentation Details:

Title:

Phase 1 Dose-Escalation Study of STRO-002, an anti-Folate Receptor alpha (FRα) Antibody Drug Conjugate (ADC), in Patients with Advanced Platinum-Resistant/Refractory Epithelial Ovarian Cancer (OC)

Abstract Number:

138 IGCS20_1113

Date/Time:

Sept. 10-13, 2020

Presenter:

Wendel Naumann, M.D.

The e-poster presentation can be found on the IGCS Meeting website and is also accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of Sutro Biopharma’s website at www.sutrobio.com on the day of the poster presentation.

On September 9, 2020 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that management will present at the following virtual investor conferences (Press release, Insmed, SEP 9, 2020, View Source [SID1234564911]):

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The H.C. Wainwright Annual Global Investment Conference on Monday, September 14, 2020 at 9:30 a.m. ET

The Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 15, 2020 at 9:30 a.m. ET

The Cantor Virtual Healthcare Conference on Thursday, September 17, 2020 at 9:20 a.m. ET
Each presentation will be webcast live and can be accessed by visiting the investor relations section of the company’s website at www.insmed.com. Each webcast will be archived for a period of 30 days following the conclusion of each live event.

On September 9, 2020 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2020 (Press release, MEI Pharma, SEP 9, 2020, View Source [SID1234564909]).

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"This past year was marked by progress on multiple fronts, particularly for zandelisib, formerly called ME-401, which is our PI3K delta inhibitor in the Phase 2 TIDAL study intended to support an accelerated approval marketing application with FDA," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "The progress on zandelisib this past year includes entering a global license, development and commercialization agreement with Kyowa Kirin Company, maturing Phase 1b study data that continues to support best-in-class potential, as well as obtaining Fast Track designation from FDA."

Dr. Gold continued: "With about $183 million in cash at the start of our fiscal year, we believe we have an operational runway at least through 2023 and are well positioned to advance our ongoing clinical programs. In particular, we look forward to completing TIDAL enrollment as we initiate additional clinical studies to fully explore zandelisib’s potential to benefit patients with B-cell malignancies while we continue our staged build-out of a commercial infrastructure to optimally capture value from the program."

Fiscal Year 2020 Zandelisib (ME-401) and Corporate Highlights

Zandelisib (formerly called ME-401), an oral, once-daily, investigational drug-candidate selective for phosphatidylinositol 3-kinase delta (PI3Kδ), for B-Cell Malignancies

The World Health Organization approved "zandelisib" as the International Nonproprietary Name, or INN, for ME-401, the Company’s investigational cancer treatment being developed as an oral, once-daily, selective PI3Kδ inhibitor for the treatment of B-cell malignancies.
In May 2020, the Company and Kyowa Kirin Co. presented updated data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program from a Phase 1b study of zandelisib (ME-401) for the treatment of B-cell malignancies. These data evaluating patients on an intermittent dosing schedule of zandelisib showed that treatment was generally well tolerated and demonstrated an 83% overall response rate in patients with relapsed or refractory follicular lymphoma (n=36). The responses were durable with no median yet reached (median follow-up of 13.2 months: range: 3.0-27.6).
In April 2020, the Company entered into a global license, development and commercialization agreement with Kyowa Kirin Co. to further develop and commercialize MEI’s zandelisib:
MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S.
MEI to book U.S. sales on 50-50 profit and cost sharing.
$100 million upfront cash payment to MEI.
$582.5 million in potential development, regulatory and commercial milestones
Kyowa Kirin obtains exclusive commercialization rights ex-U.S.
MEI to receive escalating tiered royalty payments starting in the teens on ex-U.S. sales.
In March 2020, the Company was granted Fast Track designation by the U.S. FDA for zandelisib for the treatment of adult patients with relapsed or refractory follicular lymphoma.
Corporate Highlights

In April 2020, Cheryl L. Cohen, former chief commercial officer of Medivation, Inc. and a product launch and commercialization veteran with over 25 years of service in the pharmaceutical and biotechnology industry, joined the Board of Directors.
In December 2019, the Company closed an underwritten public offering of 32,343,750 shares of its common stock for total gross proceeds of approximately $51,750,000. Additionally, during the year ended June 30, 2020, MEI sold 5,471,684 shares under the ATM Sales Agreement for net proceeds of $20.8 million.
In July 2019, Tamar Howson, M.S., MBA, a highly experienced business development executive with over 30 years of service in the pharmaceutical and biotechnology industry, joined the Board of Directors.
Fiscal Year 2020 Financial Results

As of June 30, 2020, MEI had $182.6 million in cash, cash equivalents, and short-term investments with no outstanding debt. Additionally, MEI has a receivable of $20.4 million that is expected to be received from the Japanese taxing authorities in fiscal year 2021 that was withheld from the $100 million paid by Kyowa Kirin Co. under the terms of April 2020 global license, development and commercialization agreement. The withholding was a result of the US Internal Revenue Service being closed because of the COVID pandemic, resulting in an inability to provide the necessary documentation to support an exemption from the required foreign withholding.
For the year ended June 30, 2020, cash used in operations was $45.3 million compared to $39.4 million for 2019.
Research and development expenses were $34.1 million for the year ended June 30, 2020, compared to $32.3 million for 2019. The increase was primarily related to increased development costs associated with zandelisib, as well as increased personnel costs to support our clinical trial activities.
General and administrative expenses were $16.7 million for the year ended June 30, 2020, compared to $14.6 million for 2019. The increase primarily relates to personnel costs and general corporate expenses incurred during the year ended June 30, 2020.
MEI recognized revenues of $28.9 million for the year ended June 30, 2020, compared to $4.9 million for the year ended June 30, 2019. Revenues resulted from the recognition of license revenue associated with the Kyowa Kirin license agreement as well as fees allocated to research and development activities related to the Kyowa Kirin and Helsinn license agreements.
Net loss was $46.0 million, or $0.51 per share, for the fiscal year ended June 30, 2020, compared to net loss of $16.8 million, or $0.24 per share for 2019. The Company had 111,513,689 shares of common stock outstanding as of June 30, 2020, compared with 73,544,576 shares as of June 30, 2019.
The adjusted net loss for the fiscal year ended June 30, 2020, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure), was $23.1 million.
Conference Call and Webcast

MEI Pharma will host a conference call with simultaneous webcast today, September 9, 2020, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial (866) 939-3921 (United States) or (678) 302-3550 (International), conference ID 49919899. The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.

On September 9, 2020 Haemonetics Corporation (NYSE: HAE) reported that Chris Simon, President and CEO, will present at the 18th Annual Morgan Stanley Virtual Global Healthcare Conference on Tuesday, Sept. 15, 2020, at 9:30 a.m. ET (Press release, Haemonetics, SEP 9, 2020, View Source [SID1234564908]).

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The public may access Mr. Simon’s presentation live via webcast and subsequent replay at: View Source;tp_key=8d479de3b1

On September 9, 2020 Natera, Inc. (Nasdaq: NTRA), a global leader in cell-free DNA testing, reported the launch of a proposed follow-on public offering of $250,000,000 of shares of its common stock (Press release, Natera, SEP 9, 2020, View Source [SID1234564907]). In addition, Natera expects to grant the underwriters a 30-day option to purchase up to an additional $37,500,000 of shares of its common stock from Natera at the public offering price less the underwriting discounts and commissions. The offering is subject to market and other 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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J.P. Morgan, Morgan Stanley, Cowen, and SVB Leerink are acting as joint book-running managers for the offering. Baird and Craig-Hallum Capital Group are acting as co-managers for the offering.

The securities described above are being offered pursuant to an automatically effective shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission on September 9, 2020. The offering will be made only by means of an effective registration statement, including a preliminary prospectus and, when available, final prospectus, copies of which may be obtained by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, by telephone at (866) 803-9204 or by emailing [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ex. 6132 or by email at [email protected]

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