1stOncology™: Cancer Intelligence Service – Page 10845 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Syndax Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Clinical and Business Update

On November 2, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the third quarter ended September 30, 2020. In addition, the Company provided a clinical and business update (Press release, Syndax, NOV 2, 2020, View Source [SID1234569690]).

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!

"We continue to make exciting progress in the Phase 1 portion of the AUGMENT-101 trial of SNDX-5613, our highly selective, potent, oral menin inhibitor, in adult and pediatric patients with acute leukemias that harbor MLL-r and NPM1 genetic alterations," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We are highly encouraged by initial data from this study, which demonstrated clear clinical activity in this difficult to treat population of patients with genetically defined acute leukemias. We remain on track to present Phase 1 data from AUGMENT-101 and commence the Phase 2 portion in early 2021."

Dr. Morrison added, "In addition, following recent interactions with the FDA, we are excited to take the next step of initiating a pivotal trial for axatilimab, our anti-CSF-1R monoclonal antibody, in patients with cGVHD which we expect by the end of this year. We are encouraged by the clinical activity and overall safety we’ve seen in the ongoing trial, and firmly believe axatilimab has the potential to serve as an effective intervention for patients with cGVHD. We look forward to sharing updated results from the Phase 1 trial during an oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December."

Pipeline Updates

SNDX-5613

In August 2020, the Company enacted the following enhancements to the Phase 1 portion of the AUGMENT-101 trial in patients with MLL-r and NPM1 mutant acute leukemias: focusing enrollment exclusively on patients with mixed lineage leukemia rearranged (MLL-r) and nucleophosmin (NPM1) mutant acute leukemias; backfilling any dose escalation cohort up to a total of 12 patients if efficacy has been observed at that dose level; and expansion of enrollment to include pediatric patients over 30 days old. These enhancements were supported by initial clinical data, as well as insights from emerging data in the pediatric compassionate use setting. Enrollment in the amended Phase 1 portion remains ongoing, with a data presentation expected in early 2021. In early 2021, the Company also anticipates commencing the Phase 2 portion of AUGMENT-101, which it believes could serve as the basis for registration. SNDX-5613 was previously granted Orphan Drug Designation for the treatment of adult and pediatric acute myeloid leukemia by the U.S. Food and Drug Administration (FDA).
Axatilimab

The Company reported that following its End-of-Phase 1 meeting with the FDA, it has aligned on a regulatory path for axatilimab, its anti-CSF-1R monoclonal antibody, for the treatment of chronic graft versus host disease (cGVHD). The Company plans to commence a pivotal Phase 2 trial, AGAVE-201, to assess the safety and efficacy of different doses and schedules of axatilimab for the treatment of patients with cGVHD. The primary endpoint will assess objective response rate based on the 2014 NIH consensus criteria for GVHD with key secondary endpoints including duration of response and improvement in modified Lee Symptom Scale score. The Company expects to begin enrollment by year-end, with topline data anticipated in 2023.
Enrollment remains ongoing in the Phase 2 portion of the Phase 1/2 trial evaluating axatilimab for the treatment of patients with cGVHD. In previously announced preliminary data from the Phase 1 portion of the trial, axatilimab demonstrated compelling clinical activity and a well-tolerated safety profile. The Company will present updated data from the Phase 1 portion in an oral presentation during the American Society of Hematology (ASH) (Free ASH Whitepaper) Virtual Annual Meeting in December. Abstracts for the meeting, which will be held December 5-8, 2020, will be available on Thursday, November 5, 2020 at 9:00 a.m. ET.
Financial Update and Guidance

As of September 30, 2020, Syndax had cash, cash equivalents and short-term investments of $170.2 million and 44.4 million shares and share equivalents issued and outstanding which included 38.8 million shares of common stock and pre-funded warrants to purchase 5.6 million shares of common stock.

Third quarter 2020 research and development expenses increased to $14.4 million from $9.9 million for the prior year period. The increase was primarily due to increased clinical activity for SNDX-5613 and axatilimab and a $2.0 million milestone payable to UCB upon the achievement of a certain milestone.

General and administrative expenses for the third quarter 2020 increased to $5.8 million from $3.6 million for the prior year period. This increase was primarily due to employee related expenses including a one-time non-cash stock compensation expense.

For the three months ended September 30, 2020, Syndax reported a net loss attributable to common stockholders of $20.4 million or $0.46 per share compared to $12.8 million or $0.41 per share for the prior year period.

Financial Guidance

For the fourth quarter of 2020, research and development expenses are expected to be $15 to $20 million, and total operating expenses are expected to be $20 to $25 million.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, November 2, 2020.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website, www.syndax.com.

Ascendis Pharma A/S Announces Third Quarter 2020 Financial Results and Business Update Conference Call on November 11

On November 2, 2020 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will hold a conference call and live webcast on Wednesday, November 11, 2020 at 4:30 p.m. Eastern Time (ET) to review its third quarter 2020 financial results and provide a business update (Press release, Ascendis Pharma, NOV 2, 2020, View Source [SID1234569689]).

Conference Call Details

A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

Curis to Release Third Quarter 2020 Financial Results and Hold Conference Call on November 10, 2020

On November 2, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its third quarter 2020 financial results on Tuesday, November 10, 2020, after the close of US markets (Press release, Curis, NOV 2, 2020, View Source [SID1234569688]). Management will host a conference call on the same day at 4:30 p.m. ET.

To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

Halozyme Reports Third Quarter 2020 Results And Raises Full Year 2020 Guidance

On November 2, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the third quarter ended September 30, 2020 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, NOV 2, 2020, View Source [SID1234569687]).

"I am pleased to report the first quarter of what the Company projects will be sustainable royalty revenue growth, primarily driven by the strong uptake of Janssen’s DARZALEX SC with our ENHANZE technology," said Dr. Helen Torley, president and chief executive officer. "In addition, we achieved higher milestone-related revenues in the quarter driven by partner clinical trial progress. Based on the improved outlook for royalties and greater visibility on anticipated milestone revenues, we are increasing our full year 2020 financial guidance. Recent new product launches and partner development progress position Halozyme to deliver continued strong growth. Our strong growth outlook supports our commitment to capital return, which has already resulted in $312.4 million worth of share repurchases under our three-year $550 million share repurchase program announced in November 2019."

Third Quarter 2020 and Recent Highlights Include:

On October 22, argenx announced it is advancing development of efgartigimod SC with Halozyme’s ENHANZE technology for pemphigus (vulgaris and foliaceus), a group of autoimmune skin disorders. The global Phase 3 ADDRESS trial evaluating SC efgartigimod in up to 150 pemphigus patients is expected to initiate by end of 2020, and will result in a milestone payment to Halozyme. In addition, argenx announced it had initiated a Phase 1 healthy volunteer study of intravenous ARGX-117 and subcutaneous ARGX-117 utilizing ENHANZE technology targeting complement C2. On October 6, the Company announced that argenx expanded its existing global collaboration and license agreement that was signed in February 2019. Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme’s ENHANZE drug delivery technology for three additional targets upon nomination for a total of up to six targets. To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn, which is blocked by efgartigimod, and complement component C2.
On September 17, the Company announced that Roche presented a poster with data from Part 1 of its Phase 1b study (IMscin001) evaluating atezolizumab (Tecentriq) for subcutaneous administration utilizing Halozyme’s ENHANZE technology in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020. The poster concluded that atezolizumab utilizing Halozyme’s ENHANZE technology, provided similar exposure as atezolizumab IV and that results supported further development of subcutaneous atezolizumab in IMscin001 Part 2, a confirmatory phase III study. Initiation of the Tecentriq Phase 3 study will result in a milestone payment to Halozyme.
On September 15, Takeda Pharmaceutical announced that the European Medicines Agency (EMA) approved a label update for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] broadening its use and making it the first and only facilitated subcutaneous immunoglobulin replacement therapy in adults, adolescents and children with an expanded range of secondary immunodeficiencies (SID).
On September 10, the Company announced that Janssen submitted a supplemental BLA for FDA approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) to be approved for a new indication, light chain (AL) amyloidosis. The application is based on positive data from the phase 3 ANDROMEDA trial (NCT03201960). An estimated 30,000 to 45,000 people are living with AL amyloidosis in the U.S. and Europe, and an estimated 4,500 people develop the disease each year in the U.S. alone. There are currently no approved therapies for the disease.
In August 2020, Janssen announced that Health Canada approved DARZALEX SC utilizing ENHANZE technology (daratumumab) in four regimens across five indications in patients with multiple myeloma, most notably newly diagnosed, transplant ineligible patients as well as relapsed or refractory patients.
During the third quarter, the Company repurchased approximately 2.1 million shares of common stock for $58.9 million at an average price per share of $27.57, bringing the total for year-to-date open market share repurchases to $112.4 million at an average price of $20.76.
Third Quarter 2020 Financial Highlights

Revenue for the third quarter was $65.3 million compared to $46.2 million for the third quarter of 2019. The year-over-year increase was primarily driven by $32.0 million in collaboration revenue from Roche and argenx in the current period. Revenue for the quarter included $23.9 million in royalties, an increase of 44% compared to $16.6 million in the prior year period.
Research and development expenses for the third quarter were $7.7 million, compared to $30.5 million for the third quarter of 2019. The decrease in expenses was due to a decrease in clinical trial activities-related costs as a result of the Company halting its oncology drug development efforts beginning in November 2019.
Selling, general and administrative expenses for the third quarter were $11.7 million, compared to $18.0 million for the third quarter of 2019. The decrease was due to lower compensation and commercial-related expenses related to the corporate restructuring announced in November 2019.
The Company reported its second consecutive quarter of what it expects will be sustainable profitability. Net income for the third quarter was $36.2 million, or $0.25 per share, compared to a net loss in the third quarter of 2019 of $25.0 million, or $0.17 per share.
Cash, cash equivalents and marketable securities were $346.7 million at September 30, 2020, compared to $421.3 million at December 31, 2019.
Financial Outlook for 2020

The Company continues to monitor the impact of the COVID-19 pandemic on its business and receives updates from its partners and suppliers on how their businesses are affected. Based on this information and Halozyme’s planned expenditures for the year, the Company is raising full year 2020 financial guidance and now expects:

Revenues of $250 million to $260 million, increased from prior guidance of $230 million to $245 million, representing growth of 28 to 33% over prior year revenues;
Earnings per share on a GAAP basis of $0.80 to $0.85, increased from prior guidance of $0.60 to $0.75.
Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the third quarter of 2020 today, Monday, November 2, 2020 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call.

Cancer Genetics, Inc. Announces Closing of Public Offering and Full Exercise of the Underwriter’s Option to Purchase Additional Shares

On November 2, 2020 Cancer Genetics, Inc. (Nasdaq: CGIX) ("Cancer Genetics" or "the Company"), a leader in drug discovery and preclinical oncology and immuno-oncology services, reported the closing of its previously announced underwritten public offering of 1,568,182 shares of its common stock ("Common Stock"), inclusive of the full exercise by the underwriter of its option to purchase 204,545 shares of Common Stock, at a public offering price of $2.20 per share (Press release, Cancer Genetics, NOV 2, 2020, View Source [SID1234569686]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses are approximately $3.45 million.

H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

Cancer Genetics intends to use the net proceeds from this offering to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on July 21, 2020. A prospectus supplement describing the terms of the offering was filed with the SEC on October 29, 2020, and is available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

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. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.