On November 2, 2020 Sun BioPharma, Inc. (Nasdaq:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported that it will host a conference call on November 12, 2020 at 4:30 PM Eastern Time to discuss results for its third quarter ended September 30, 2020 (Press release, Sun BioPharma, NOV 2, 2020, View Source;utm_medium=rss&utm_campaign=sbp-schedules-conference-call-on-nov-12-2020-to-report-q32020-financial-results [SID1234569682]).

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Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial.

On November 2, 2020 Immunomic Therapeutics, Inc. reported that it will present preclinical data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses when used with its investigational UNITE vaccine, ITI-3000, in mice (Press release, Immunomic Therapeutics, NOV 2, 2020, View Source [SID1234569681]). UNITE fuses a tumor-associated antigen, here a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV), with lysosomal-associated membrane protein 1 (LAMP1). This lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response, as ITI-3000 activated antigen-specific CD4+ T cells in vivo. The data will be presented at the SITC (Free SITC Whitepaper) Virtual Annual Meeting, November 9-14, 2020.

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"ITI-3000 is an innovative and novel targeted approach to a MCPγV vaccine," says Teri Heiland, Ph.D., Immunomic’s Chief Scientific Officer. "We are greatly reassured by this data and anticipate advancement to the clinic for ITI-3000."

The majority of Merkel cell carcinomas (MCC) are associated with Merkel cell polyomavirus (MCPyV) infection, making LT an attractive target for therapeutic cancer vaccines. MCPγV integrates into the host genome, resulting in expression of a truncated form of the viral LT in infected cells. While induction of tumor-reactive CD8+ T cells is a major goal of cancer therapy, CD4+ T cells provide essential support to CD8+ T cells by promoting their expression of cytotoxic effector molecules and increasing their migratory capacity. Cytokines secreted by CD4+ T cells, such as IFNγ, can also exert desirable effects on the tumor microenvironment. Although further study is needed, a cancer vaccine that promotes potent, antigen-specific CD4+ T cell responses to MCPγV-LT may drive anti-tumor immune responses.

Poster Title: LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses and prevents tumor growth

Session Type: Virtual Poster Hall

Poster Number: 857

Poster Session Date and Time: 11/11/2020 – 11/14/2020, 9:00 am – 5:00 pm EST

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On November 2, 2020 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported financial results for the third quarter of 2020 and provided a corporate update (Press release, Arca biopharma, NOV 2, 2020, View Source [SID1234569680]).

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Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, "With the resurgence of SARS-CoV-2 across the country and around the globe, the need for effective therapies to treat patients hospitalized with COVID-19 remains an urgent priority. AB201’s combination of anticoagulant, anti-inflammatory and antiviral properties, give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways. We are working rapidly towards initiating the Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID-19."

Pipeline Update

AB201 (rNAPc2) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.

Advancing development of AB201 as a potential treatment for patients hospitalized with COVID-19

U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for AB201 as a potential treatment for COVID-19

ARCA estimates initiating Phase 2b clinical testing of AB201 in fourth quarter of this year
Gencaro (bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF). The FDA has issued a Special Protocol Assessment (SPA) agreement for a single Phase 3 clinical trial (PRECISION-AF) to examine Gencaro as a genetically targeted therapy for the prevention of AF recurrence in certain heart failure patients. Initiation of the PRECISION-AF Phase 3 clinical trial is on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. Future development of Gencaro, including initiating any Phase 3 clinical trial, is dependent on obtaining additional financing.

Third Quarter 2020 Summary Financial Results

Cash and cash equivalents were $51.1 million as of September 30, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022, including the projected costs for the AB201 Phase 2b clinical trial.

Research and development (R&D) expense for the three months ended September 30, 2020 was $1.1 million compared to $0.3 million for the corresponding period of 2019, an increase of $0.7 million. R&D expense for the nine months ended September 30, 2020 was $1.8 million compared to $1.4 million for the corresponding period of 2019, an increase of approximately $0.3 million.

Clinical expense increased approximately $0.3 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. Manufacturing process development costs increased approximately $0.2 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. The increase in costs were related to initial costs for the AB201 clinical trial, which the Company plans to initiate in the fourth quarter of 2020. The remaining increase is primarily a result of higher outside services and consulting costs.

General and administrative (G&A) expenses were $0.9 million for both the three months ended September 30, 2020 and 2019. G&A expenses were $2.9 million and $3.1 million for the nine months ended September 30, 2020 and 2019, respectively. The $0.2 million decrease was primarily a result of lower personnel costs and lower outside services and consulting costs in 2020.

Total operating expenses for the three months ended September 30, 2020 were $1.9 million compared to $1.2 million for the corresponding period in 2019. Total operating expenses for the nine months ended September 30, 2020 were $4.6 million compared to $4.5 million for the corresponding period in 2019.

Net loss for the three months ended September 30, 2020 was $2.0 million, or $0.33 per basic and diluted share, compared to $1.2 million, or $0.76 per basic and diluted share, for the corresponding period in 2019. Net loss for the nine months ended September 30, 2020 was $4.6 million, or $1.46 per basic and diluted share, compared to $4.3 million, or $3.46 per basic and diluted share, for the corresponding period in 2019.

On November 2, 2020 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and nine months ended September 30, 2020 (Press release, Eagle Pharmaceuticals, NOV 2, 2020, View Source [SID1234569669]).

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Business and Recent Highlights:

Received formal notification from FDA granting Priority Review for the Company’s abbreviated new drug application ("ANDA") filed for vasopressin. A trial date of January 11, 2021 has been set;
Added four experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams as follows: Judith ("Judi") Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D., is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development;
Promoted Brian Cahill as the Company’s new Chief Financial Officer. Mr. Cahill has served as Eagle’s VP, Finance for the last four years and brings more than 20 years of public company and public accounting experience to the Company;
Received Board approval for a $25.0 million accelerated share repurchase transaction with JPMorgan as part of the Company’s existing $160.0 million share repurchase program. To date, Eagle has purchased $205.0 million, or approximately 22% of the Company’s issued shares, at approximately $55.00 per share;
Announced the publication of preclinical research on dantrolene sodium in the peer-reviewed Journal of Alzheimer’s Disease. The academic-based study, conducted by Eagle’s collaboration partner, the University of Pennsylvania, demonstrated dantrolene sodium improved memory and cognition in a mouse model of Alzheimer’s disease;
Initiating dose ranging studies in another animal model using intravenous administration of RYANODEX for the treatment of brain damage secondary to nerve agent exposure and will include an arm using an intramuscular formulation of EA-111. Eagle believes that the preliminary results will allow the Company to update its Special Protocol Assessment with the FDA; and
Despite the ongoing COVID-19 pandemic, the Company has not experienced significant disruptions to its supply chain to date, and believes it has sufficient supply chain inventory to continue manufacturing and to provide product without interruption consistent with its current business plans and projections; the Company has experienced variable financial impacts and has also experienced delays in the timing of certain of its pre-clinical programs and delays in its ongoing litigation matters due to the COVID-19 pandemic; the Company continues to monitor the ongoing pandemic and evaluate and evolve its business plans and response strategy thereto.
Oncology Highlights:

Held a positive Type C meeting with FDA on fulvestrant and is in the process of gaining agreement on the details of the formal protocol for the clinical study;
Japanese licensing partner, SymBio, received regulatory approval for TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency in Japan. The approval covers all currently approved TREAKISYM indications (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia) and triggered a $5.0 million milestone payment to Eagle. SymBio’s conversion of its current lyophilized formulation of TREAKISYM to Eagle’s RTD liquid formulation and commercial launch are expected in January 2021;
Centers for Medicare & Medicaid Services established unique Healthcare Common Procedure Coding System code, or J-code, for PEMFEXY (Pemetrexed for Injection, 10 mg), a branded alternative to ALIMTA effective October 1, 2020;
Granted a supplement approval by FDA for 500mg multiple-dose vial of PEMFEXY. The Company has initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022; and
The Company’s strategic collaboration partner, Tyme Technologies, Inc. ("Tyme"), announced that FDA granted Orphan Drug Designation for its lead product candidate, SM-88, a treatment for patients with pancreatic cancer.
Third Quarter 2020 Financial Highlights

Total revenue for Q3 2020 was $49.9 million, compared to $41.1 million in Q3 2019, primarily reflecting increased product sales of BELRAPZO and RYANODEX, as well as the $5.0 million milestone from SymBio, partially offset by lower product sales of BENDEKA.
Net income for Q3 2020 was $7.1 million, or $0.52 per basic and $0.51 per diluted share, compared to net loss for Q3 2019 of $2.4 million, or ($0.17) per basic and diluted share.
Adjusted non-GAAP net income for Q3 2020 was $16.1 million, or $1.19 per basic and $1.17 per diluted share, compared to adjusted non-GAAP net income for Q3 2019 of $3.7 million, or $0.27 per basic and $0.26 per diluted share.
Cash and cash equivalents were $89.7 million, net accounts receivable was $52.2 million, and debt was $36.0 million as of September 30, 2020.
"Our strong third-quarter results demonstrate the efficiency of our business model as we continue to reinvest in our company. This momentum is further supported by multiple near-term product opportunities we are advancing, including vasopressin, fulvestrant, RYANODEX for several indications and PEMFEXY, along with our key partnerships with SymBio for bendamustine and Tyme for pancreatic cancer and other oncology indications. We are also excited to welcome a talented group of pharmaceutical executives to the Eagle team and look forward to their contributions in support of our promising lineup of products and anticipated upcoming launches. The next 12-18 months look to be an active period for Eagle, and I am optimistic about our prospects going forward," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2020 Financial Results

Total revenue for Q3 2020 was $49.9 million, as compared to $41.1 million for Q3 2019.

Q3 2020 BELRAPZO product sales were $8.7 million, compared to $3.4 million in Q3 2019.

Q3 2020 RYANODEX product sales were $4.2 million, compared to $2.6 million in Q3 2019.

Royalty revenue was $27.6 million in the third quarter of 2020, compared to $26.5 million in the third quarter of 2019. BENDEKA royalties were $27.6 million in the third quarter of 2020, compared to $26.2 million in the third quarter of 2019. A summary of total revenue is outlined below:

Gross Margin was 76% during the third quarter of 2020, as compared to 64% in the third quarter of 2019. The expansion in gross margin in the third quarter of 2020 was driven by an increase in RYANODEX sales, lower BENDEKA product sales in the period to our marketing partner, on which Eagle earns no profit, the increase in BENDEKA royalty revenue, and the $5.0 million milestone payment from SymBio.

R&D expense was $4.8 million for the third quarter of 2020, compared to $10.2 million in the third quarter of 2019. The decrease primarily resulted from lower spending on vasopressin and RYANODEX for the treatment of exertional heat stroke, as well as lower stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2020 was $5.3 million.

SG&A expense in the third quarter of 2020 decreased to $17.7 million compared to $18.5 million in the third quarter of 2019, primarily due to decreases in travel and entertainment expenses, trade show costs, and external legal expenses. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2020 SG&A expense was $11.9 million.

Net income for the third quarter of 2020 was $7.1 million, or $0.52 per basic and $0.51 per diluted share, compared to net loss of $2.4 million, or ($0.17) per basic and diluted share, in the third quarter of 2019.

Adjusted non-GAAP net income for the third quarter of 2020 was $16.1 million, or $1.19 per basic and $1.17 per diluted share, compared to adjusted non-GAAP net income of $3.7 million or $0.27 per basic and $0.26 per diluted share in the third quarter of 2019. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2020 Expense Guidance

R&D expense in 2020, on a non-GAAP basis, is expected to be $40-$44 million, as compared to $31 million in 2019.
SG&A spend in 2020, on a non-GAAP basis, is expected to be $61-$64 million, as compared to $56 million in 2019.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of September 30, 2020, the Company had $89.7 million in cash and cash equivalents plus $52.2 million in net accounts receivable, $34.3 million of which was due from Teva. The Company had $36.0 million in outstanding debt. Therefore, as of September 30, 2020, the Company had net cash plus receivables of $105.9 million.

In the third quarter of 2020, the Company repurchased $28.0 million of its common stock as part of the Company’s $160.0 million share repurchase program. From August 2016 through September 30, 2020, the Company repurchased $205.0 million of its common stock.

Conference Call

As previously announced, Eagle management will host its Q3 2020 conference call as follows:

www.eagleus.com, under the "Investor + News" section

Participants should dial in 15 minutes prior to the start of the call to ensure timely access.

A replay of the conference call will be available for one week after the call’s completion by dialing 800-934-3336 (US) or 402-220-1148 (International) and entering conference call ID EGRXQ320. The webcast will be archived for 30 days at the aforementioned URL.

On November 2, 2020 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported a collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer (Press release, Fusion Pharmaceuticals, NOV 2, 2020, View Source [SID1234569668]).

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The collaboration leverages Fusion’s Targeted Alpha Therapies (TATs) platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of antibodies and cancer therapeutics, including DNA Damage Response Inhibitors (DDRis).

Under the terms of the agreement, the companies will discover, develop and commercialize novel TATs, which will utilize Fusion’s Fast-Clear linker technology platform with antibodies in AstraZeneca’s oncology portfolio. In addition, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s lead candidate FPI-1434) and AstraZeneca therapeutics, for the treatment of various cancers. Both companies will retain full rights to their respective assets.

"This collaboration represents a true partnership that combines the expertise and intellectual property of each collaborator," said Fusion Pharmaceuticals Chief Executive Officer John Valliant, Ph.D. "The agreement will allow us to leverage Fusion’s platform and AstraZeneca’s industry-leading antibody portfolio, creating new therapies with shared rights on new TATs, while allowing Fusion to retain full ownership of our existing programs. We are excited about AstraZeneca’s long-term commitment to our collaboration including significant support for exploring combination therapies. We believe it is evidence of the growing interest in the use of molecularly targeted radiation as a next-generation cancer therapy."

"Radiopharmaceuticals are a promising area of exploration in oncology, with the potential to deliver radiation therapy selectively to tumors. With this collaboration, we will seek to identify synergies between our pipelines to unlock the full potential of our medicines, and also to develop novel targeted radiopharmaceuticals," said Susan Galbraith, Ph.D., Senior Vice President and Head of Research and Early Development, Oncology R&D, AstraZeneca. "We believe that the Fusion team’s expertise in next-generation radiopharmaceuticals complements AstraZeneca’s extensive research and development portfolio."

Collaboration Terms

The agreement includes an upfront payment from AstraZeneca , as well as future development milestone and other payments.

Co-Development and Potential Co-Commercialization of Novel TATs

Under the terms of the agreement, Fusion and AstraZeneca will jointly discover, develop and have the option to co-commercialize novel TATs in the United States. The novel TATs will leverage Fusion’s Fast-Clear linker technology to bind the alpha-emitting isotope Actinium-225 to antibodies in AstraZeneca’s oncology portfolio. Fusion will be responsible for preclinical development through first-time-in-human studies, while AstraZeneca will be responsible for subsequent clinical development. For these novel TATs, the companies will share development costs equally through clinical development. Fusion will have co-promotion rights in the United States and AstraZeneca will have commercialization rights in the rest of the world, unless otherwise agreed. Both companies will have a 50/50 profit and loss share on a worldwide basis.

Development of Combination Therapies with Fusion and AstraZeneca Products

The companies will also evaluate potential combination strategies involving existing assets in their respective portfolios. Fusion will conduct preclinical development. AstraZeneca will conduct and fund clinical development of the combination therapies. Each company retains all rights to their respective assets.

Fusion Conference Call Information

Fusion will host a live conference call and webcast today beginning at 8:30 a.m. ET to discuss the collaboration agreement. To access the live call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) and refer to the Fusion Pharmaceuticals event. A webcast of the conference call will be available under "Events and Presentations" in the Investors & Media section of Fusion’s website at View Source The archived webcast will be available on Fusion’s website shortly after the conclusion and will be available for 90 days following the event.