On November 12, 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 that Fred Schwarzer, Chief Executive Officer, will present at three upcoming investor conferences (Press release, IGM Biosciences, NOV 12, 2019, View Source [SID1234550951]):

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Stifel 2019 Healthcare Conference on Tuesday, November 19 at 4:45 p.m. ET in New York.
Jefferies 2019 London Healthcare Conference on Thursday, November 21 at 11:20 a.m. GMT in London.
Piper Jaffray 31st Annual Healthcare Conference on Wednesday, December 4 at 3:00 p.m. ET in New York.
A live webcast of the events will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 90 days following the presentation.

On November 12, 2019 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, reported its business update and financial results for the third quarter ended September 30, 2019 (Press release, Fennec Pharmaceuticals, NOV 12, 2019, View Source [SID1234550950]).

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"We are nearing completion of the NDA for PEDMARK and expect to complete the rolling submission to the FDA in early 2020" said Rosty Raykov, chief executive officer of Fennec. "With the addition of a chief commercial officer during the quarter, we are focused on building the necessary team and infrastructure to support a rapid commercial launch of PEDMARK, if approved, in the second half of 2020."

Financial Results for the Third Quarter 2019

·Cash Position – Cash and cash equivalents were $15.2 million as of September 30, 2019. The reduction in cash balance over the quarter is the result of cash used for operating activities including the manufacturing and regulatory expenses associated with the regulatory submissions of PEDMARKTM.
·R&D Expenses – Research and development (R&D) expenses were $0.8 million for the three months ended September 30, 2019, compared to $1.8 million for the same period in 2018 as the Company completed a significant part of the activities needed for regulatory approval of PEDMARKTM during the first six months of 2019.
·G&A Expenses – General and administrative (G&A) expenses were $1.1 million for the three months ended September 30, 2019, and $1.1 million for the same period in 2018.
·Net Loss – Net loss was $1.8 million and $2.7 million for the three months ended September 30, 2019 and 2018, respectively.
·Financial Guidance – The Company believes its cash and cash equivalents on hand as of September 30, 2019 will be sufficient to fund the Company’s planned commercial launch of PEDMARKTM in the second half of 2020.

Financial Update

The selected financial data presented below is derived from our audited condensed consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete interim unaudited consolidated financial statements for the period ended September 30, 2019 and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe there is estimated that over 10,000 children may receive platinum-based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

On November 12, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products, reported financial results for the third quarter and nine months ended September 30, 2019 (Press release, CASI Pharmaceuticals, NOV 12, 2019, View Source [SID1234550949]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We launched EVOMELA in China during the third quarter and completed our transition to a commercial organization. The sales revenue since the launch and the demand for the drug were greater than our initial expectations and we are now working with our partner and manufacturer to accelerate the production timeline of EVOMELA due to this demand. Our successful launch was driven by our strong commercial team which continues to gain significant insight into the hematology oncology market which we believe will be invaluable as we continue launching additional products in this space. We are excited about our momentum and will continue evaluating additional strategic assets to tactically grow our pipeline."

Third Quarter 2019 Financial Results

·Revenues consisted primarily of product sales of EVOMELA that launched in August 2019. Revenue from EVOMELA was $2.7 million for the third quarter 2019. As commercial sales began in August 2019, revenue for the third quarter 2019 only consisted of approximately 1.5 months of sales.

·Costs of goods sold were $2.6 million for the third quarter 2019. Cost of goods sold have been impacted by a transitional supply agreement that is in the process of being modified with an alternate manufacturer. Cost of goods sold also was impacted by certain non-recurring charges associated with the startup production for the commercial launch. With the alternate supply line and the passing of start-up related charges, we expect the Cost of goods sold to be considerably reduced in the future.

CASI Pharmaceuticals, Inc. / 9620 Medical Center Drive / Suite 300 / Rockville, MD 20850

Phone 240.864.2600 / Fax 301.315.2437

·Research and development expenses for the third quarter 2019 were $1.8 million, compared with $1.8 million for the same period in 2018.

·General and administrative expenses for the third quarter 2019 were $8.0 million, compared with $6.9 million for the same period in 2018. The increase is primarily due to support costs related to the launch of EVOMELA that occurred during August 2019.

·Selling and marketing expenses for the third quarter 2019 were $975,000. The increase is due to selling cost related to commercial sales of EVOMELA that began during August 2019.

·Net loss for the third quarter 2019 was $9.7 million compared to $8.8 million for the same period in 2018.

·As of September 30, 2019, CASI had cash and cash equivalents of $63.2 million compared to $84.2 million as of December 31, 2018. The decrease in cash is primarily due to the Black Belt and Juventas investments made during the second quarter 2019, along with normal operating expenses.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, can be found at www.casipharmaceuticals.com.

About EVOMELA

EVOMELA (melphalan hydrochloride for injection) is an alkaline drug that is approved and in China is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. EVOMELA was previously granted priority review by the China NMPA because multiple myeloma is classified as a rare disease in China, there is no melphalan in any formulation available in China to address this unmet medical need; and EVOMELA has clear therapeutic advantage to currently available therapeutics.

On November 12, 2019 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at two upcoming investor healthcare conferences (Press release, Coherus Biosciences, NOV 12, 2019, View Source [SID1234550948]).

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Management will deliver a company presentation at the Jefferies 2019 London Healthcare Conference on Thursday, November 21st at 9:20 a.m. GMT taking place in London, UK.
Management will deliver a company presentation at the Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3rd at 1:30 p.m. ET taking place in New York, New York.
The audio portion of the presentations will be available on the investors page of the Coherus BioSciences website at View Source

On November 12, 2019 Applied Therapeutics, Inc. (NASDAQ: APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported it has entered into a definitive securities purchase agreement, dated as of November 7 2019, for the sale of its common stock, par value $0.0001 per share (the "Shares"), in a private placement (the "Private Placement") expected to result in gross proceeds to the Company of approximately $20 million, before deducting placement agent commissions and other offering expenses (Press release, Applied Therapeutics, NOV 12, 2019, View Source [SID1234550947]).

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The Private Placement is expected to close on or about November 12, 2019, subject to the satisfaction of customary closing conditions. Additional details regarding the Private Placement will be included in a Form 8-K to be filed by the Company with the Securities and Exchange Commission ("SEC").

The Company intends to use the net proceeds to fund development of its drug candidates.

Cowen and UBS Investment Bank acted as placement agents in the transaction (the "Placement Agents"). Skadden, Arps, Slate, Meagher & Flom LLP acted as legal counsel for the Company, and Davis Polk & Wardwell LLP acted as legal counsel for the Placement Agents.

The securities being sold in the Private Placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the Shares issuable in connection with the Private Placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.