On November 12, 2019 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2019 (Press release, Soligenix, NOV 12, 2019, View Source [SID1234551033]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We are now approaching data read-out in two Phase 3 clinical programs. We anticipate completing patient enrollment before the end of the year with final top-line results in the first quarter of 2020 for our pivotal double-blind, placebo-controlled Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin). Following the recent positive recommendation received from the independent Data Monitoring Committee (DMC), we continue to enroll patients in our pivotal double-blind, placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy. The study remains on target to complete enrollment and provide topline results in the second quarter of 2020."

Dr. Schaber continued, "Additionally, we continue to advance our heat stable ricin vaccine, RiVax, with the support of a National Institute of Allergy and Infectious Disease contract award of up to $24.7 million."

Soligenix Recent Accomplishments:

On October 24, 2019, the Company announced that the United States Patent Office had allowed the divisional patent application titled "Systems and Methods for Producing Synthetic Hypericin". The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin. Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the Company’s photodynamic therapy for the treatment of CTCL. To view this press release, please click here.
On September 16, 2019, the Company announced that it had appointed Daniel P. Ring as Vice President of Business Development and Strategic Planning. Mr. Ring has over 22 years of business development and commercial experience in the biopharmaceutical industry. In this new role, Mr. Ring will oversee the Company’s global business development function, which will include balanced and disciplined management of any current or new strategic business opportunities, initiatives, mergers, acquisitions, partnerships, alliances, and/or licensing agreements. To view this press release, please click here.
On September 11, 2019, the Company announced that it had appointed Jonathan Guarino, CPA, CGMA, as its Senior Vice President and Chief Financial Officer. Mr. Guarino has over 20 years of diverse experience in the financial and strategic management of emerging growth and commercial companies, including in the life sciences industry. He has a proven track record and expertise in corporate financial operations, partnerships, as well as growth financings. To view this press release, please click here.
On August 28, 2019, the Company announced it had received a positive recommendation from the independent DMC to continue enrolling into the company’s pivotal Phase 3 "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with HNC. To view this press release, please click here.
On August 15, 2019, the Company announced that the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health (NIH), had awarded Soligenix a Phase I Small Business Innovation Research (SBIR) of approximately $150,000 to support the evaluation of SGX942 (dusquetide) in pediatric indications. This award will facilitate the assessment of SGX942 safety in juvenile animals, supporting future studies in pediatric populations, including oral mucositis indications in pediatric patients undergoing stem cell transplants and treatments for HNC. To view this press release, please click here.
Financial Results – Third Quarter Ended September 30, 2019

Soligenix’s revenues for the quarter ended September 30, 2019 were $1.3 million as compared to $1.4 million for the quarter ended September 30, 2018. Revenues included payments on a contract in support of RiVax, in addition to the grants received to support the development of SGX301 for the treatment of CTCL and SGX942 for the treatment of oral mucositis in HNC.

Soligenix’s basic net loss was $2.7 million, or ($0.14) per share, for the quarter ended September 30, 2019, as compared to $1.9 million, or ($0.11) per share, for the quarter ended September 30, 2018.

Research and development expenses were $2.3 million as compared to $1.4 million for the quarters ended September 30, 2019 and 2018, respectively. The increase in research and development spending for the three months ended September 30, 2019 was primarily attributable to higher clinical trial expenditures relating to the two pivotal Phase 3 studies for SGX301 and SGX942, compared to the same period in 2018.

General and administrative expenses were $0.8 million as compared to $0.7 million for the quarters ended September 30, 2019 and 2018, respectively.

As of September 30, 2019, the Company’s cash position was approximately $6.6 million.

On November 12, 2019 Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported positive preliminary results from recently completed animal studies in its immuno-oncology program, wherein anti-tumor activity was tested in mice following treatment with Biomica’s rationally designed bacterial consortia BMC121 & BMC127 (Press release, Biomica, NOV 12, 2019, View Source [SID1234551109]).

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It has been widely described in the scientific literature[1] that gut microbiome could affect the efficacy of cancer immunotherapy, especially immune-checkpoint inhibitors involving blockade of PD-1 or PD-L1 and CTLA-4. The study, which is part of Biomica’s immuno-oncology program, examined the effect of addition of Biomica’s rationally designed bacterial consortia BMC121 & BMC127 on the response to checkpoint inhibitor (anti-PD1) therapy in a mouse cancer model. BMC121 & BMC127 bacterial consortia were identified & designed based on data obtained from cancer patients who displayed varying degrees of response to immune-checkpoint inhibitors therapy. The specific strains selected for the consortia were designed to trigger beneficial anti-tumor immune-modulatory processes. Identification and selection of the bacteria for BMC121 & BMC127 consortia were done using PRISM, a high-resolution microbiome analysis platform and a detailed functional genomic analysis.

In the study, Biomica’s drug candidates were tested in vivo in combination with checkpoint inhibitor therapy (anti-PD1) using a mouse cancer model. BMC121 and BMC127 demonstrated improved anti-tumor activity compared to checkpoint inhibitor therapy alone also indicating validation of the computational predictions.

Improved antitumor activity following the administration of BMC121 & BMC127, compared to treatment with checkpoint inhibitor therapy alone, was manifested in a number of parameters. These parameters include higher percentage of responders, greater tumor growth inhibition (%TGI) and increased antitumor immune responses, including higher numbers of tumor-infiltrating immunocytes, higher levels of tumor infiltrating CD8 T-lymphocytes, and higher levels of intra-tumor inflammation, indicating an increased anti-tumor immune reaction. The results of these in vivo studies are the first demonstration that treatment with BMC121 & BMC127 may increase the efficacy of immune checkpoint inhibitors therapy and improve anti-tumor activity also indicating validation of the computational predictions.

Prof. Yehuda Ringel, Biomica CSO, stated: "The results of these in vivo studies are the first demonstration of the beneficial potential of BMC121 & BMC127 in cancer immunotherapy. We look forward to conducting broader studies to further validate our computational mechanism-of-action predictions at the beginning of next year."

Dr. Elran Haber, Biomica CEO, stated: "I am very pleased with these encouraging results that show early promise of improving the efficacy of immune checkpoint inhibitors therapy. Although immunotherapies hold great promise in treating cancer, only a portion of patients respond to the available immunotherapy drugs. Our drug candidates were designed to provide specific microbial functional capabilities to trigger beneficial immuno-stimulatory anti-tumor activity, ultimately leading to better patient response to immune-checkpoint inhibitors therapy."

On November 12, 2019 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol-Myers Squibb") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "Celgene Notes") issued by Celgene Corporation (NASDAQ:CELG) ("Celgene") for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb Company (the "Bristol-Myers Squibb Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Bristol-Myers Squibb on behalf of Celgene to adopt certain proposed amendments (the "Amendments") to the indentures governing the Celgene Notes (Press release, Bristol-Myers Squibb, NOV 12, 2019, View Source [SID1234550934]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on November 13, 2019, to 5:00 p.m., New York City time, on November 15, 2019 (as the same may be further extended, the "Expiration Date").

On the early participation date of May 1, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the Celgene Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal hereby, each as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019, November 5, 2019, November 7, 2019 and as amended hereby, and are conditioned upon the closing of Bristol-Myers Squibb’s acquisition of Celgene (the "Merger"), which condition may not be waived by Bristol-Myers Squibb, and certain other conditions that may be waived by Bristol-Myers Squibb.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and on or about the closing date of the Merger. The closing of the Merger is expected to occur by the end of 2019. As a result, the Expiration Date may be further extended one or more times. Bristol-Myers Squibb will provide notice of any such extension in advance of the Expiration Date.

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Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Celgene Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019, November 5, 2019, November 7, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470 3900 (U.S. toll-free) or (212) 430 3774 (banks and brokers). The eligibility form is available electronically at: View Source

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 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported financial results for the third quarter ended September 30, 2019, and provided an overview of recent developments (Press release, Atreca, NOV 12, 2019, View Source [SID1234550969]).

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"We continued to make strong progress this quarter with our Investigational New Drug (IND) application for our lead product candidate, ATRC-101 and expect to initiate a Phase 1b clinical trial in patients with solid tumors early next year," said John Orwin, Chief Executive Officer. "To highlight our progress we recently presented a poster at the annual SITC (Free SITC Whitepaper) meeting describing the discovery and preclinical evaluation of ATRC-101, underscoring both our ability to leverage the human immune response to find novel antibody-target pairs, as well as the potential of ATRC-101 to become an important treatment option for patients with a variety of solid tumor cancers."

Recent Developments and Highlights

Atreca presented a poster describing the preclinical evaluation of ATRC-101 at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019). The poster included preclinical data highlighting ATRC-101’s robust and persistent anti-tumor activity as both monotherapy and in combination with PD-1 checkpoint inhibitors.

In August 2019, Atreca appointed Lindsey Rolfe, BSc, MB ChB, MRCP, FFPM, to the company’s Board of Directors, who brings more than 20 years of drug development experience to the company.
In August 2019, the period for centralized opposition of patent rights at the European Patent Office (EPO) ended with respect to European Patent EP2702146B1, entitled "Identification of Polynucleotides Associated with a Sample", which was granted by the EPO in November 2018. This patent is part of the portfolio of patents and patent applications exclusively licensed by the Board of Trustees of the Leland Stanford Junior University to Atreca that relates to Atreca’s proprietary Immune Repertoire Capture technology.
Upcoming Milestones

Atreca anticipates completion of the IND process with the U.S. Food and Drug Administration for ATRC-101 by late 2019 and expects to initiate a Phase 1b clinical trial in patients with solid tumors in early 2020.
Third Quarter 2019 Financial Results

As of September 30, 2019, cash and cash equivalents and short-term investments totaled $201.0 million.

Research and development expenses for the three months ended September 30, 2019 were $12.8 million, including non-cash share-based compensation expense of $920,000.

General and administrative expenses for the three months ended September 30, 2019 were $4.9 million, including non-cash share-based compensation expense of $958,000.

Atreca reported a net loss of $15.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.57, for the three months ended September 30, 2019.