On August 12, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended June 30, 2020 and provided a business update (Press release, Phio Pharmaceuticals, AUG 12, 2020, View Source [SID1234563516]).

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"The second quarter was an exciting period for our team as we presented during three major medical conferences new preclinical data from animal studies that validate the potential of our INTASYL RNAi technology as a cancer immunotherapy platform for innovative therapeutics. For example, we now have in vivo data showing the ability and safety of INTASYL technology to reprogram immune cells, such as T cells, in situ through intratumoral application, resulting in impressive anti-tumoral efficacy," said Dr. Gerrit Dispersyn, President and CEO of Phio.

"The recent data we presented from studies conducted with our lead asset, PH-762, our BRD4 targeting INTASYL compound, PH-894, as well as other pipeline products, support our advancement of these products into additional studies. We are currently planning to initiate clinical studies with PH-762 in 2021, and the required steps needed to initiate these clinical trials are underway. Due to the potential for delays related to the ongoing COVID-19 pandemic, we cannot provide more specific guidance as to exactly when the studies will be initiated."

Quarter in Review and Recent Corporate Updates

Announced detailed data that provide support for the potential of PH-804, the Company’s TIGIT targeting INTASYL compound, as an immuno-oncology therapeutic and a viable alternative to anti-TIGIT antibodies in a presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II. These data provide insight around the mechanisms of action of the tumor growth suppression with PH-804.
Presented new data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program that show how intratumoral delivery of INTASYL compounds inhibited tumor growth by overcoming the immunosuppressive tumor microenvironment as shown by changes in T cell composition and activation. Therefore, the Company believes these pipeline programs show great promise in the treatment of solid tumors.
Presented data at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2020 Annual Meeting that details how INTASYL compares favorably to other technologies for improving cells used in adoptive cell therapy (ACT) for the treatment of solid tumors, especially in cases where permanent gene modification is not required or is undesirable.
Hosted a key opinion leader (KOL) call on intratumoral therapy with self-delivering RNAi that featured a presentation by Professor Caroline Robert, M.D., Ph.D., of the Gustave Roussy Institute, on the promising new avenues to treat melanoma patients. Her presentation included scientific and clinical rationale for intratumoral neoadjuvant therapy and the role that INTASYL technology can play in such therapeutic approaches.
Announced ongoing preclinical work and planning that are underway that would support the planned initiation of clinical trials with PH-762 in 2021, assuming no additional delays due the COVID-19 pandemic.
Raised total net proceeds of $3.5 million through financing activities completed in April 2020.
Financial Results

Cash Position

At June 30, 2020, the Company had cash of $18.9 million as compared with $6.9 million at December 31, 2019. During the second quarter of 2020, the Company received net proceeds of $3.8 million from the exercise of outstanding warrants and raised $3.5 million in net proceeds through an equity offering completed in April. The Company expects its cash will be sufficient to fund currently planned operations for at least the next 12 months.

Research and Development Expenses

Research and development expenses were approximately $0.8 million for the quarter ended June 30, 2020, compared to approximately $1.1 million for the quarter ended June 30, 2019. The decrease is primarily due to a reduced use of an outside interim temporary labor consultant and a reduction in patent-related expenses as compared to the prior year period.

General and Administrative Expenses

General and administrative expenses were relatively steady at $0.9 million for the three-month periods ended June 30, 2020 and 2019.

Net Loss

Net loss was $1.7 million, or $0.34 per share, for the quarter ended June 30, 2020, compared with $2.0 million, or $4.62 per share, for the quarter ended June 30, 2019. The decrease in net loss was primarily attributable to a decrease in research and development expenses, as discussed above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of our capital raise activities as compared to the prior year period.

On August 12, 2020 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported second quarter financial results for the period ended June 30, 2020 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, AUG 12, 2020, View Source [SID1234563515]).

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"We continued to advance our six clinical programs during the second quarter of 2020, most notably completing enrollment in the Phase 3 DeFi trial of nirogacestat in patients with desmoid tumors and initiating, through our collaboration with GSK, the first Phase 1 trial evaluating nirogacestat in combination with a BCMA therapy for patients with multiple myeloma," said Saqib Islam, Chief Executive Officer of SpringWorks. "During the second half of the year, we will remain focused on executing against our objectives and believe we are well-positioned to progress our pipeline across our three distinct oncology focus areas of late-stage rare oncology, BCMA combinations in multiple myeloma and biomarker-defined metastatic solid tumors."

Recent Business Highlights

Achieved full enrollment in the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors.
Announced that the first patient was dosed in a Phase 1b trial evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), GSK’s anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, in patients with relapsed or refractory multiple myeloma.
Received a new patent (U.S. Patent No. 10,710,966 [the ‘966 patent]) with method of use claims covering the treatment of desmoid tumors with nirogacestat. Like the recently granted composition of matter patent covering the polymorphic form of nirogacestat that is currently in clinical development, this method of use patent expires in 2039 and further enhances the intellectual property position of nirogacestat. The ‘966 patent is assigned to Pfizer and SpringWorks has exclusive rights to it pursuant to an existing worldwide license with Pfizer.
Presented preclinical data from studies of mirdametinib in combination with BeiGene’s RAF dimer inhibitor, lifirafenib, at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II. Results demonstrated potent and synergistic activity in vitro and in vivo across a panel of cancer models harboring a variety of RAS mutations.
Expanded the ongoing Phase 1 trial of BGB-3245 to the United States and began dosing patients at Memorial Sloan Kettering Cancer Center. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a clinical-stage company that is jointly owned by SpringWorks and BeiGene, Ltd.
Continued to strengthen the Company’s Board of Directors with the appointment of Julie Hambleton, M.D., an experienced oncology drug developer and pharmaceutical executive.
COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and the company is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2020 and refer to the Forward-Looking Statements section in this press release.

Second Quarter and Year to Date 2020 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $12.9 million and $22.7 million for the second quarter and year-to-date periods, respectively, compared to $11.2 million and $19.6 million for the comparable periods of 2019, respectively. The increases in R&D expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of R&D personnel, and an increase in non-cash share-based compensation expense.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million and $13.3 million for the second quarter and year-to-date periods, respectively, compared to $3.6 million and $6.9 million for the comparable periods of 2019, respectively. The increases in G&A expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of G&A personnel supporting the growth of the organization, and an increase in non-cash share-based compensation expenses, as well as increases in expenses related to the expansion of business activities.
Net Loss Attributable to Common Stockholders: SpringWorks reported net losses of $19.9 million, or $0.47 loss per share, and $35.2 million, or $0.84 loss per share, for the second quarter and year-to-date periods ended June 30, 2020, respectively. This compares to net losses of $13.8 million, or $15.75 loss per share, and $17.5 million, or $22.47 loss per share, for the comparable periods of 2019, respectively.
Cash Position: Cash, cash equivalents and marketable securities were $291.2 million as of June 30, 2020.

On August 12, 2020, Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company") reported that issued and sold $1.250 billion aggregate principal amount of the Company’s 1.750% Senior Notes due 2030 (the "2030 Notes") and $750 million aggregate principal amount of the Company’s 2.800% Senior Notes due 2050 (the "2050 Notes" and, together with the 2030 Notes, the "Notes") (Filing, 8-K, Regeneron, AUG 12, 2020, View Source [SID1234563514]). The Notes were registered pursuant to an automatic shelf registration statement on Form S-3 under the Securities Act of 1933, as amended (Registration Statement No. 333-228352) (filed with the Securities and Exchange Commission on November 13, 2018) (the "Registration Statement"), and were issued pursuant to an Indenture, dated as of August 12, 2020 (the "Base Indenture"), between the Company and U.S. Bank National Association, as trustee (the "Trustee"), as supplemented by the First Supplemental Indenture thereto, dated as of August 12, 2020 (the "First Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), between the Company and the Trustee. Net proceeds to the Company from the issuance and sale of the Notes were approximately $1,977 million (after deducting underwriting discounts and the Company’s estimated offering expenses) and were used in part to repay in full the Sanofi Repurchase Bridge Facility (as defined in Item 8.01 below) and to pay accrued interest and related fees and expenses in connection therewith.

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The Notes are senior unsecured obligations of the Company and rank equal in right of payment with Regeneron’s other existing and future senior unsecured obligations that are not, by their terms, expressly subordinated in right of payment to the Notes, and senior in right of payment to any of Regeneron’s future subordinated indebtedness. The Notes are effectively subordinated to all of Regeneron’s existing and future secured indebtedness and other secured liabilities, if any, to the extent of the value of the assets securing such indebtedness and liabilities; and are structurally subordinated to all existing and future obligations of Regeneron’s subsidiaries. The 2030 Notes will accrue interest at the rate of 1.750% per year and will mature on September 15, 2030. The 2050 Notes will accrue interest at the rate of 2.800% per year and will mature on September 15, 2050. Interest on each series of Notes will be payable semi-annually in arrears on March 15 and September 15 of each year, commencing on March 15, 2021, until their respective maturity dates.

The Notes may be redeemed at the Company’s option at any time at 100% of the principal amount plus accrued and unpaid interest to, but not including, the redemption date and, until a specified period before maturity, a specified make-whole amount. The Notes contain a change-of-control provision that, under certain circumstances, may require the Company to offer to repurchase the Notes at a price equal to 101% of the principal amount plus accrued and unpaid interest to, but not including, the date of repurchase.

The Indenture also contains certain limitations on the Company’s ability to incur liens and enter into sale and leaseback transactions, as well as customary events of default.

The foregoing summary of the Indenture is not complete and is qualified in its entirety by reference to the full and complete text of the Base Indenture, a copy of which is attached hereto as Exhibit 4.1 and is incorporated by reference herein, and the First Supplemental Indenture, a copy of which is attached hereto as Exhibit 4.2 and is incorporated by reference herein

On August 12, 2020 ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that it will host a conference call and live webcast on Tuesday, August 18, 2020 at 8:30 am EDT to report financial results for the second quarter ended June 30, 2020 and provide business updates (Press release, ADC Therapeutics, AUG 12, 2020, View Source [SID1234563513]).

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To access the call, please dial 646-787-0157 (domestic) or +41-22-5017540 (international) and insert pin number 773478. A live webcast of the presentation will be available under "Events and Presentations" on the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available after the completion of the event and for 30 days following the call.

On August 12, 2020 Viela Bio (Nasdaq:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, reported financial results and provided program highlights for the second quarter ended June 30, 2020 (Press release, Viela Bio, AUG 12, 2020, View Source [SID1234563512]).

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"Viela had another productive quarter marked by the U.S. FDA approval of UPLIZNA—also known as inebilizumab—in the U.S.," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "In parallel, we continue to advance the development of inebilizumab in the U.S. in additional indications such as myasthenia gravis and IgG4-related disease."

Added Dr. Yao: "Beyond UPLIZNA, we continue to make progress throughout our entire pipeline. We recently reported positive interim Phase 1b data from our ongoing trial with VIB7734 and selected systemic lupus erythematosus as our area of focus for a Phase 2 trial. Separately, we are planning to initiate a Phase 1 trial with this product candidate in patients with COVID-19-related acute lung injury. Looking toward our objectives for the rest of the year and beyond, we are well-positioned having recently raised gross proceeds of approximately $169 million in an underwritten public offering, which will support our clinical and commercial execution and extends our cash runway into 2023."

PROGRAM HIGHLIGHTS

UPLIZNA (inebilizumab-cdon)

UPLIZNA Commercial Launch Underway
On June 11, the U.S. Food and Drug Administration (FDA) approved UPLIZNA for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. UPLIZNA is the first and only treatment designed to deplete B cells that is approved by the FDA for this patient population. Commercial launch activities are currently underway, with focus on both centers of excellence and community neurologists throughout the U.S.

Viela Preparing for Additional Clinical Trials with Inebilizumab
Phase 3 trials of inebilizumab in myasthenia gravis and IgG4-related disease are projected to initiate in Q4 2020. The Company is also conducting a Phase 2 trial for kidney transplant desensitization, which due to the COVID-19 pandemic, remains voluntarily paused.
VIB4920

Viela Resumes New Patient Enrollment in Ongoing Trial with VIB4920
Viela is currently conducting a Phase 2b trial with VIB4920 in Sjögren’s syndrome as well as a Phase 2 trial in patients with kidney transplant rejection. Due to the COVID-19 pandemic, new patient enrollment in both trials had been voluntarily paused, but has recently resumed in the kidney transplant rejection trial, with enrollment in the Sjögren’s trial anticipated to resume in Q4 2020. The Company continues to explore other potential indications associated with the CD40/CD40L co-stimulatory pathway for potential additional clinical studies.
VIB7734

Company Reports Interim Results from Phase 1b trial with VIB7734 and Selects SLE for Phase 2 Trial
In May, the Company reported positive interim data from a Phase 1b study with VIB7734, its novel anti-ILT7 therapy. Interim findings indicated safety and tolerability comparable to placebo control across all cohorts with the final data analysis expected to be completed in Q3 2020. Based on the positive interim results, as well as additional efficacy and biomarker data from cohort 3, the Company has selected systemic lupus erythematosus (SLE) as the lead indication of a planned Phase 2 trial.
Viela Prepares for New Study in COVID-19-Related Acute Lung Injury
Viela is planning to initiate a Phase 1 study in Q3 2020 with VIB7734 in patients with COVID-19-related acute lung injury. Results from this study are anticipated in Q1 2021, at which time the Company will decide whether to pursue additional clinical trials in this indication.
FINANCIAL RESULTS

For the second quarter of 2020, Viela reported a net loss of $38.9 million, compared to a net loss of $5.5 million for the second quarter of 2019. As of June 30, 2020, Viela had $448.4 million in cash, cash equivalents, and investments and no outstanding debt. In June 2020, Viela completed an underwritten public offering of its common stock and issued and sold 3,600,000 shares of common stock, at a public offering price of $47.00 per share, for aggregate gross proceeds of $169.2 million.

Research and development expenses were $25.4 million for the second quarter of 2020, which include $1.4 million of non-cash stock-based compensation expenses.

General and administrative expenses were $14.4 million for the second quarter of 2020, which include $1.7 million of non-cash stock-based compensation expenses.

Total operating expenses for the second quarter of 2020 totaled $39.8 million, compared to $6.1 million for the second quarter of 2019. Non-cash share-based compensation expenses totaled $3.1 million for the second quarter of 2020, compared to $0.6 million for the second quarter of 2019.
Conference Call and Webcast
The Company will host a live webcast and conference call to discuss financial results and program highlights for the second quarter of 2020 today at 5:00 p.m. EDT.

The webcast will be accessible on the Events & Presentations page of Viela Bio’s website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 4945969

The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.