On November 7, 2018 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the first quarter ended September 30, 2018 (Press release, Immunomedics, NOV 7, 2018, View Source [SID1234530991]). The Company also highlighted recent key progress and planned activities for its sacituzumab govitecan program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more details on the Company’s financial results.

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The Company has made significant progress in the first fiscal quarter with an ongoing focus on regulatory, clinical, manufacturing and launch preparatory efforts and will continue to work closely and collaboratively with the FDA to address outstanding review issues in connection with our Biologics License Application for sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC).

"Patients with mTNBC are in dire need of better treatment options," said Michael Pehl, President and Chief Executive Officer of Immunomedics. "Our entire team is dedicated to bringing sacituzumab govitecan, with its highly differentiated benefit/risk profile, to these patients and focused on a potential marketing approval by the PDUFA date of January 18, 2019. We are well underway with commercial launch preparations, including the official onboarding of the salesforce this week, while we continue to expand our manufacturing collaborations and clinical plans to reflect our long-term commitment to cover multiple underserved indications and expanded geographies in the future."

Highlights of Recent Progress

The Company has entered into a long-term manufacturing partnership with Samsung BioLogics Co., Ltd as our second source manufacturer of hRS7, the antibody used in sacituzumab govitecan, to further enhance our supply chain and prepare for future demand driven by additional indications and broadening of our geographic footprint.

The Company has recruited and is in the process of training fifty highly-qualified sales representatives, all of whom have experience in the breast cancer field. In addition, the commercial leadership team across marketing, sales, sales operations, and market access is now fully staffed.

The Company has broadened its ongoing clinical collaboration with AstraZeneca and its global biologics research and development arm, MedImmune, on the development of the combination of durvalumab and sacituzumab govitecan to include second-line metastatic non-small cell lung cancer (NSCLC), leveraging AstraZeneca’s existing development infrastructure.
First Quarter Fiscal 2019 Results
The Company had no revenues in the three-month period ended September 30, 2018 due primarily to the discontinued sale of LeukoScan during the third quarter of fiscal 2018 in order for the Company to focus on its ADC business. Revenues in the three-month period ended September 30, 2017 were approximately $0.7 million.

Total costs and expenses were $57.2 million for the three months ended September 30, 2018, compared to $22.3 million for the three months ended September 30, 2017, due primarily to a $20.9 million increase in research and development expenses, a $8.5 million increase in general and administrative expenses, and a $5.6 million increase in sales and marketing expenses. Most of these increases were attributable to activities related to preparations for the potential approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic TNBC in the United States.

The Company recognized $1.2 million in non-cash income for the three months ended September 30, 2018, compared to $86.4 million in non-cash expense for the three months ended September 30, 2017. The decrease in expense was due primarily to the exercise of warrants, partially offset by an increase in the fair market value of warrants outstanding. Interest expense was $10.1 million for the three months ended September 30, 2018, compared to $2.6 million for the three months ended September 30, 2017. The increase was due primarily to increased debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $64.2 million, or $0.34 per share, for the three months ended September 30, 2018, compared to $118.7 million, or $0.97 per share, for the same quarter in fiscal 2018.

As of September 30, 2018, the Company had $585.5 million in cash, cash equivalents, and marketable securities, which it believes is sufficient to support its next phase of growth; further build its clinical, medical affairs, commercial, and manufacturing infrastructure; begin its effort to commercialize sacituzumab govitecan globally; and fund its operations into 2021.

Balance Sheet
On October 5, 2018, Immunomedics completed the exchange of approximately $12.9 million in aggregate principal amount of its 4.75% Convertible Senior Notes due 2020 (Convertible Senior Notes) for newly issued shares of the Company’s common stock, pursuant to privately negotiated exchange agreements entered into between the Company and a limited number of holders of the Convertible Senior Notes. The remaining aggregate principal amount of the Convertible Senior Notes is approximately $7.1 million.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the first quarter fiscal 2019 and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 1568527. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

On November 7, 2018 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a leader in precision genetic medicine for rare diseases, reported that it is offering to sell, subject to market and other conditions, $500,000,000 in shares of its common stock in an underwritten public offering (Press release, Sarepta Therapeutics, NOV 7, 2018, View Source [SID1234531156]). Sarepta also intends to grant the underwriters a 30-day option to purchase an additional $75,000,000 in shares of its common stock offered in the public offering.

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Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Credit Suisse are acting as joint book-running managers of the proposed offering.

Sarepta intends to use the net proceeds from the offering principally for the continuation and initiation of further clinical trials, commercialization, manufacturing, business development activities including the potential licensing or acquisition of complementary products and technologies and other general corporate purposes. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares are being offered by Sarepta pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

On November 7, 2018 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and Company update as well as host investor meetings, at the following three conferences (Press release, Supernus, NOV 7, 2018, View Source [SID1234531188]):

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Stifel 2018 Healthcare Conference
Date: Tuesday, November 13, 2018
Time: 3:30 p.m. EST
Place: Lotte New York Palace Hotel, New York

Jefferies 2018 London Healthcare Conference
Date: Thursday, November 15, 2018
Time: 2:40 p.m. GMT (9:40 a.m. EST)
Place: Waldorf Hilton, London, U.K.

Piper Jaffray 30th Annual Healthcare Conference
Date: Tuesday, November 27, 2018
Time: 12:00 p.m. EST
Place: Lotte New York Palace Hotel, New York

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live webcast of the respective presentations can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of these webcasts will be available for 60 days after the respective conferences on the Company’s website.

On November 7, 2018 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for nirogacestat, an investigational, oral, small molecule, selective gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (Press release, SpringWorks Therapeutics, NOV 7, 2018, View Source [SID1234538851]).

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Desmoid tumors are rare and debilitating soft-tissue tumors that can occur in both children and adults. Depending on their size and location, desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, and limited range-of-motion. In some cases, desmoid tumors can be fatal if they impact vital organs.1 It is estimated that 900 to 1,500 new cases of desmoid tumors are diagnosed each year in the United States.2

"The Fast Track designation recognizes that desmoid tumors have a substantial impact on the lives of patients, and that nirogacestat has the potential to address the significant needs faced by this community who currently do not have an FDA-approved treatment," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We look forward to continuing to work closely with the FDA throughout our development program with the hope of ultimately bringing this important medicine to patients."

The FDA’s Fast Track program is designed to expedite the development and review of drugs with the potential to treat serious or life-threatening conditions, and with nonclinical or clinical data that demonstrate the potential to address unmet medical needs. Fast Track designation enables a company to have frequent communication with the FDA throughout the drug development and review process.3

In June 2018, the U.S. FDA granted Orphan Drug designation for nirogacestat for the treatment of desmoid tumors. SpringWorks expects to initiate the DeFi Study, a global Phase 3, double-blind, randomized, placebo-controlled, trial in patients with desmoid tumors in the first half of 2019.

About Desmoid Tumors
Desmoid tumors (also referred to as aggressive fibromatosis or desmoid-type fibromatosis) are rare, non-metastatic tumors of connective tissue cells that can arise in any part of the body, with the most common sites being the upper and lower extremities, abdominal walls, thoracic areas, and the head and neck. The severity of desmoid tumors and associated symptoms varies based on their size and location. Desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, limited range of motion, and in some cases, fatality if they impact vital organs. While they can affect children and adults, desmoid tumors are more commonly diagnosed in young adults between 20-30 years of age, with a two-to-three-fold predominance in females. 1,4 It is estimated that desmoid tumors affect 2 to 4 per million people worldwide, and that there are 900 to 1,500 new cases diagnosed per year in the United States.2 Historically, desmoid tumors were treated with surgical resection or in severe cases, amputation, but even with these interventions, high rates of tumor regrowth have been observed.5 There are currently no FDA-approved therapies for the treatment of desmoid tumors.

About Nirogacestat
Nirogacestat is an investigational, oral, small molecule, selective gamma-secretase inhibitor. Gamma secretase is an integral membrane protein that cleaves multiple different transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth. Nirogacestat has been investigated in 24 patients with desmoid tumors across Phase 1 and Phase 2 clinical trials.

On November 7, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory, cancer and other diseases, reported financial results for the third quarter of 2018 ended September 30, 2018 and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, NOV 7, 2018, View Source [SID1234530848]).

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"We are pleased to announce that PRS-060, an IL-4 receptor alpha antagonist for moderate-to-severe asthma, was safe and well-tolerated by healthy volunteers in a single ascending dose Phase I study. This is the first clinical use of an inhaled Anticalin protein and marks an important development milestone for the Company. We continue to enroll subjects with mild asthma in a multiple ascending dose Phase I study. Along with our partner AstraZeneca, we anticipate reporting the data from the Phase I studies at an upcoming medical meeting. For PRS-343, our 4-1BB/HER2 bispecific, we now intend to report initial data from a Phase I study in the first half of next year, after completing the dose escalation, to provide a more comprehensive data set," said Stephen S. Yoder, President and CEO of Pieris. "We look forward to providing updates on our progress as we head into 2019."

PRS-060: PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, was tested in 48 healthy volunteers at dose levels ranging from 0.25 mg to 400 mg in a single ascending dose Phase I study. The drug candidate was safe and well-tolerated in this study. Pieris continues to enroll subjects with mild asthma and elevated levels of fractional exhaled nitric oxide (FeNO) in a multiple ascending dose Phase I study. This study will evaluate the safety, tolerability and FeNO-reducing potential of PRS-060 versus placebo. The data from the PRS-060 Phase I studies will be presented at an upcoming medical meeting. PRS-060 is the lead candidate in Pieris’ respiratory collaboration with AstraZeneca. Pieris is sponsoring the Phase I studies and AstraZeneca is funding the costs. AstraZeneca will conduct and fund the Phase IIa study, after which Pieris will have separate options to co-develop and co-commercialize the drug candidate.

PRS-343: The Company continues to enroll and treat patients in a Phase I dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, and now intends to report initial data from the study in the first half of 2019, after completing the dose escalation, in order to provide a more comprehensive data set. Our objective for the remaining enrollment will be to favor patient selection across a range of immunotherapy-responsive tumor types. The Company is screening patients for the 11th cohort of the study, a dose level comparable to approved dose levels of trastuzumab. In August, Pieris initiated a trial with PRS-343 in combination with atezolizumab, and the Company intends to report data from this trial in 2019.

PRS-080: Pieris is planning to enroll and complete dosing of the final patient in its Phase IIa multiple ascending dose study of PRS-080, a half-life-optimized hepcidin antagonist for anemia, by year end. In the ongoing trial, PRS-080 at both doses (4mg/kg and 8mg/kg) has not generated any observed drug-related serious adverse events and has demonstrated substantial iron mobilization and transferrin saturation (TSAT) increases versus placebo. To date, there has been no conclusive change in hemoglobin at either dose versus placebo. We remain committed to completing the study and sharing the data with ASKA and other potential partners for continued development. We intend to report the full data set from the study in the first half of 2019.

PRS-344: Pieris will present preclinical data for PRS-344, a PD-L1/4-1BB antibody-Anticalin bispecific in IND-enabling studies, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 Annual Meeting in Washington, D.C. The poster, P375, will be presented on November 9–10, 2018. PRS-344 is one of five development programs in Pieris’ immuno-oncology alliance with Servier.

Board Appointments: In September 2018, Pieris appointed Peter Kiener, D.Phil. to the Company’s Board of Directors. Dr. Kiener served in several executive roles, most recently as the Chief Scientific Officer at Sucampo. In October 2018, Pieris also appointed Matthew L. Sherman, M.D. to the Company’s Board of Directors. Dr. Sherman most recently served as Executive Vice President and Chief Medical Officer at Acceleron Pharma.

Preclinical Pipeline: Pieris remains committed to advancing several early-stage programs into the clinic and is on track to file two immuno-oncology INDs, one for a proprietary drug candidate and one as part of its collaboration with Servier, in 2019. The Company has also initiated two proprietary respiratory programs.
Third Quarter Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $137.3 million as of September 30, 2018, compared to a cash, cash equivalents and investments balance of $82.6 million as of December 31, 2017. The increase was driven primarily by the $47.2 million in net proceeds from the Company’s February 2018 equity financing, the $30.0 million in upfront payments received as part of the Seattle Genetics immuno-oncology collaboration, and the $12.5 million milestone payment from AstraZeneca that was triggered during the fourth quarter of 2017 and received during the first quarter of 2018. The increase was partially offset by $35.7 million of operating cash expenditures during the year.

R&D Expense – R&D expenses were $11.4 million for the three months ended September 30, 2018, compared to $6.3 million for the three months ended September 30, 2017. R&D expenses were $28.5 million for the nine months ended September 30, 2018, compared to $17.0 million for the nine months ended September 30, 2017. The Company’s increase in R&D expenses reflects preparation for and advancement of clinical studies as well as advancement across its pipeline of preclinical programs.

G&A Expense – G&A expenses were $4.7 million for the three months ended September 30, 2018, compared to $2.9 million for the three months ended September 30, 2017. G&A expenses were $13.9 million for the nine months ended September 30, 2018, compared to $11.2 million for the nine months ended September 30, 2017. The Company’s increase in G&A expenses reflects higher personnel costs and professional services costs for audit and legal, as well as an increase in general administrative costs to support the growing business of the Company. On a nine-month basis, the increase was partially offset by lower transaction fees for license and collaboration agreements compared to amounts recorded in the first half of 2017.

Interest Income – Interest income was $0.5 million and $1.5 million for the three and nine months ended September 30, 2018, respectively, compared to no interest income earned in the comparable 2017 periods. The Company began investing cash received from the collaboration agreements signed in 2017 in the fourth quarter of 2017.

Other Income – Other income was $1.1 million and $1.5 million for the three and nine months ended September 30, 2018, respectively, compared to other expense of $1.7 million and $3.1 million for the three and nine months ended September 30, 2017, respectively. The Company began investing cash received from the collaboration agreements signed in 2017 in the fourth quarter of 2017. The increase in income for the three- and nine-month periods is a result of net foreign currency transaction gains due to the strengthening of the U.S. dollar against the euro, positively impacting the remeasurement of U.S. dollar denominated monetary assets held in Germany.

Net Loss – Net loss was $6.2 million or $(0.11) per share for the three months ended September 30, 2018, compared to a net loss of $7.1 million or $(0.16) per share for the three months ended September 30, 2017. Net loss was $15.1 million or $(0.29) per share for the nine months ended September 30, 2018, compared to a net loss of $25.1 million or $(0.58) per share for the nine months ended September 30, 2017.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Standard Time on Wednesday, November 7, 2018, to discuss the third quarter of 2018 financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.