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IntelGenx Reports Second Quarter 2019 Financial Results

On August 8, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported financial results for the second quarter ended June 30, 2019 (Press release, IntelGenx, AUG 8, 2019, View Source [SID1234538500]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2019 Second Quarter Financial Summary:

Revenue was $197,000, compared to $234,000 in the second quarter of 2018
Adjusted EBITDA was ($2.1 million), compared to ($1.9 million) in Q2-2018
Cash and short-term investments totaled $6.1 million as at June 30, 2019 compared to $3.7 million in Q2-2018
Recent Developments:

Received its first shipment of cannabis extract from Tilray, Inc. (NASDAQ:TLRY) ("Tilray"), providing sufficient quantities for ongoing R&D batch production of cannabis-infused VersaFilm.
In connection with its ongoing Montelukast clinical program, announced that a poster, entitled "The BUENA Study: A Phase 2a Clinical Trial to Test Safety and Efficacy of Montelukast VersaFilm in Alzheimer’s Patients," will be presented in collaboration with Prof. Dr. Ludwig Aigner’s group from the Paracelsus Medical University in Salzburg at the 12th edition of Clinical Trials on Alzheimer’s Disease (CTAD2019), to be held in San Diego, California, from December 4-7, 2019.
Entered into a definitive worldwide agreement with Aquestive Therapeutics, Inc. (NASDAQ:AQST) for the co-development and commercialization of Tadalafil oral films for the treatment of erectile dysfunction.
Filed a non-provisional U.S. patent application for newly-developed platform that enables the incorporation of oil-based (lipophilic) active ingredients into oral film formulations.
Received a second U.S. Patent for its topical oral film technology platform.
Company remains on track to resubmit the RIZAPORT new drug application in Q3, which will address the questions contained in the U.S. Food and Drug Administration’s Complete Response letter IntelGenx received in Q2.
Promoted its oral films CDMO services at CPhI North America and received significant interest from potential partners for the development and manufacture of novel oral film products based on its proprietary VersaFilm technology platform.
"We made progress on two key VersaFilm programs recently, with the addition of BUENA clinical trial sites in Ottawa and Peterborough, and the commencement of cannabis-infused VersaFilm R&D production as part of our worldwide partnership with Tilray," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We believe our oral cannabis-infused films offer a discrete, precise and convenient option for adult-use and medical cannabis consumers, putting IntelGenx in a strong position among the many other companies preparing to launch edible cannabis products soon after their legalization in Canada later this year. Now approaching a period of anticipated growth, we look forward to updating our stakeholders as we continue to make progress towards bringing these and other VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended June 30, 2019 amounted to $197,000, a decrease of $37,000 compared to $234,000 for the three-month period ended June 30, 2018. The decrease is mainly attributable to the $37,000 decrease in R&D revenues.

Operating costs and expenses were $2.5 million for the second quarter of 2019, versus $2.4 million for the corresponding three-month period of 2018. The increase for the three-month period ended June 30, 2019 is mainly attributable to a $325,000 increase in R&D expenses primarily related to the Montelukast clinical program.

For the second quarter of 2019, the Company had an operating loss of $2.3 million, compared to an operating loss of $2.1 million for the comparable period of 2018.

Net comprehensive loss for the three-month period ended June 30, 2019 was $2.5 million, or $0.03 on a basic and diluted per share basis, compared to $2.4 million, or $0.04 on a basic and diluted per share basis, for the comparable period of 2018.

As of June 30, 2019, the Company’s cash and short-term investments totalled $6.1 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2019 second quarter financial results today on August 8, 2019, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 5684153. A live and archived webcast of the call will be available on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.

FIBROGEN REPORTS SECOND QUARTER 2019 FINANCIAL RESULTS

On August 8, 2019 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the second quarter of 2019 and provided an update on the company’s recent developments (Press release, FibroGen, AUG 8, 2019, View Source [SID1234538498]).

"This has been a very productive quarter with the achievement of multiple regulatory and clinical milestones. We had a positive pre-NDA meeting with the FDA on roxadustat. Supported by positive efficacy and safety data, including compelling MACE and MACE+ results, we look forward to submitting our U.S. NDA in October. In IPF, the first patient was dosed in our Phase 3 pamrevlumab program," said Thomas B. Neff, Chief Executive Officer. "We are pleased to see the publication of two articles in the New England Journal of Medicine on our pivotal roxadustat Phase 3 studies in China."

Recent Developments and Upcoming Milestones

Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S. and Europe

Positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA)

Reached agreement on the content of the NDA, including cardiovascular safety analyse

On-track to submit U.S. NDA in October 2019

Astellas anticipates the submission of Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) within the second half of their 2019 fiscal year, ending March 2020

Roxadustat for Anemia in CKD in China

Two articles on the China Phase 3 studies were published in the New England Journal of Medicine (NEJM)

Commercial manufacturing plant certified; commercial product manufactured and shipped

Regulatory decision for treatment of anemia in non-dialysis-dependent CKD anticipated in the third quarter of 2019

Roxadustat for Anemia in CKD in Japan

Regulatory decision for treatment of anemia in dialysis-dependent CKD anticipated in the second half of 2019

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Initiated dosing in the ZEPHYRUS Phase 3 randomized, double-blind, placebo-controlled study

Pamrevlumab for Locally Advanced Pancreatic Cancer (LAPC)

Screening patients in the LAPIS Phase 3 randomized, double-blind, placebo-controlled study of pamrevlumab as a neoadjuvant therapy in combination with gemcitabine and nab-paclitaxel

Pamrevlumab for Duchenne Muscular Dystrophy (DMD)

Reported positive one-year Phase 2 preliminary clinical findings at the Parent Project Muscular Dystrophy (PPMD) 2019 Annual Conference in June

Relative to previously published data of DMD patients, our single-arm study of pamrevlumab showed:

Less than expected decline in pulmonary function tests

Increase in cardiac function measured by mean change of left ventricular ejection fraction from baseline

Increase in grip-strength score in both dominant and non-dominant hands

Less than expected decline in the performance of the upper limb test

Corporate and Financial

Net income for the second quarter of 2019 was $116.0 million, or $1.34 net income per basic share and $1.26 net income per diluted share, compared to a net loss of $23.4 million, or $0.28 net loss per basic and diluted share one year ago

In accordance with U.S. GAAP, in the second quarter, we are including in our revenue recognition methodology a total of $180 million, in anticipated milestone payments related to the filing of the U.S. NDA and EU MAA, of which $171.1 million was recognized in the current quarter and the remaining balance will be recognized in future periods 1

At June 30, 2019, FibroGen had $686.1 million in cash, restricted time deposits, cash equivalents, investments, and receivables

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Thursday, August 8, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (800) 708-4540 (U.S. and Canada) or 1 (847) 619-6397 (international), reference the FibroGen second quarter 2019 financial results conference call, and use confirmation number 48879852. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 4887 9852.

About Roxadustat

Roxadustat (FG-4592), discovered by FibroGen, is a first-in-class, orally administered small molecule currently approved in China for the treatment of anemia in CKD patients on dialysis. Roxadustat is a HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and has been granted Orphan Drug Designation (ODD) in these indications as well as in Duchenne muscular dystrophy (DMD). Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and for patients with locally advanced unresectable pancreatic cancer. Pamrevlumab is currently in a Phase 2 trial for DMD. Across all trials, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

Under U.S. GAAP revenue recognition guidelines, we are required to include estimated consideration from milestones in the determination of revenue recognition in the period that milestone achievement becomes probable. Receipt of milestone payments is dependent on the occurrence of the triggering event.

Dynavax Technologies Announces Pricing of $70.1 Million Public Offering of Common Stock, Non Voting Preferred Stock and Warrants to Purchase Common Stock

On August 8, 2019 Dynavax Technologies Corporation (Nasdaq: DVAX), a fully-integrated biopharmaceutical company focused on discovering, developing and commercializing novel vaccines, reported the pricing of an underwritten public offering of 18,525,000 shares of its common stock, 4,840 shares of its newly designated non-voting Series B Convertible Preferred Stock (Series B stock), and warrants to purchase an aggregate of 5,841,250 shares of its common stock (Press release, Dynavax Technologies, AUG 8, 2019, View Source [SID1234538497]). Each share of common stock is being sold together with a warrant to purchase 0.25 of a share of common stock, at a combined price to the public of $3.00 per share of common stock and accompanying warrant. Each share of Series B stock is being sold together with warrants to purchase 250 shares of common stock, at a combined price to the public of $3,000.00 per share of Series B stock and accompanying warrants. Each share of Series B stock will be convertible into 1,000 shares of common stock at the holder’s option, subject to beneficial ownership limitations. All of the warrants being sold in the offering will have an exercise price of $4.50 per share of common stock, will be immediately exercisable upon issuance and will expire on the 30-month anniversary of the date of issuance. The offering is expected to close on or about August 12, 2019, subject to customary closing conditions. The gross proceeds to Dynavax from the offering are expected to be $70.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by Dynavax.

Cowen and William Blair are acting as joint book-running managers for the offering.

Dynavax anticipates using the net proceeds from the offering to fund activities associated with ongoing commercialization of HEPLISAV-B and for general corporate purposes, including working capital.

The securities described above are being offered by Dynavax pursuant to a shelf registration statement that automatically became effective upon filing with the Securities and Exchange Commission (SEC) on August 8, 2017. A final prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting: Cowen and Company, LLC, Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 274-2806; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at [email protected].

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 state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

DiaMedica Therapeutics to Report Second Quarter 2019 Financials and Provide a Business Update August 13, 2019

On August 8, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that its second quarter 2019 financial results will be released after the markets close on Tuesday, August 13th (Press release, DiaMedica, AUG 8, 2019, View Source [SID1234538496]). DiaMedica will host a live conference call on Wednesday, August 14th at 7:00am Central Time to discuss its business update and financial results.

Conference Call details:

Date: Wednesday, August 14, 2019
Time: 7:00 AM CT / 8:00 AM ET
Web access: View Source
Dial In: (866) 962-3583 (domestic)
(630) 652-5857 (international)
Conference ID: 9274148
Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 21, 2019, by dialing (855) 859-2056 (US Toll Free), (404) 537-3406 (International), replay passcode 9274148.

Caladrius Biosciences Reports 2019 Second Quarter and First Six Months Financial Results and Provides Corporate Update

On August 8, 2019 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a late-stage therapeutics development biopharmaceutical company pioneering advancements of cell therapies in select cardiovascular and autoimmune diseases, reported financial results for the three and six months ended June 30, 2019 and provides highlights of progress within the development pipeline (Press release, Caladrius Biosciences, AUG 8, 2019, View Source [SID1234538495]).

"I am delighted to announce that, after close collaboration with the U.S. Food and Drug Administration, we have finalized the protocol design for a confirmatory Phase 3 trial of CLBS14 in no-option refractory disabling angina ("NORDA"). We now plan to initiate enrollment in this trial in early 2020," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "The protocol defines a prospective, randomized, double blind, ~400 total subject trial with a primary endpoint of total exercise time at the 6-month follow-up visit."

Dr. Mazzo continued, "We also recently announced that the European Medicines Agency granted CLBS12 the Advanced Therapy Medicinal Product classification for the treatment of critical limb ischemia ("CLI"). As a result, we now have the opportunity to work closely with the European regulators to define a path forward that would accelerate the approval of CLBS12’s registration to treat CLI in Europe. Finally, the preliminary data from our clinical programs studying our CD34+ cell therapy platform for coronary microvascular dysfunction ("CMD") in the United States and CLI in Japan, continue to trend positively and we reiterate our expectations to report top-line data by the end of 2019 and early 2020, respectively."

Second Quarter Financial Highlights

Research and development expenses for the second quarter of 2019 were $3.0 million, a 41% increase compared with $2.1 million for the second quarter of 2018. Research and development in both periods focused on the advancement of our ischemic repair platform and related to (i) expenses associated with our ongoing Phase 2 study of CLBS12 in CLI development program in Japan, (ii) expense associated with our ongoing clinical study for CLBS16 in CMD, and (iii) expenses associated with the planning and preparation for Phase 3 enrollment initiation of our CLBS14 program in NORDA.

General and administrative expenses, which focus on general corporate related activities, were $2.4 million for the second quarter of 2019, a 10% increase compared with $2.1 million for the second quarter of 2018.

The net loss for the second quarter of 2019 was $5.1 million, or $0.49 per share, compared with $4.1 million, or $0.42 per share, for the second quarter of 2018.

Six Month Financial Highlights

Research and development expenses for the first six months of 2019 were $5.0 million, a 15% increase compared with $4.4 million for the first six months of 2018. Research and development in both periods focused on the advancement of our ischemic repair platform and related to (i) expenses associated with our ongoing Phase 2 study of CLBS12 in CLI development program in Japan, (ii) expense associated with our ongoing Phase 2 clinical study

for CLBS16 in CMD, and (iii) expenses associated with the planning and preparation for Phase 3 enrollment initiation of our CLBS14 program in NORDA.

General and administrative expenses, which focus on general corporate related activities, were $4.9 million for the first six months of 2019, a 3% decrease compared with $5.0 million for the first six months of 2018.

The net loss for the first six months of 2019 was $9.5 million, or $0.93 per share, compared with $9.1 million, or $0.95 per share, for the first six months of 2018.

Balance Sheet Highlights

As of June 30, 2019, Caladrius had cash, cash equivalents and marketable securities of $33.7 million. Based on existing programs and projections, the Company remains confident that its cash balances will allow it to fund its current business plan through the second quarter of 2020.

Conference Call

Caladrius’ management will host a conference call for the investment community beginning at 4:30 p.m. ET on Thursday, August 8, 2019 to discuss the financial results, provide a company update and answer questions.

Shareholders and other interested parties may participate on the conference call by dialing (866) 595-8403 (domestic) or (706) 758-9979 (international), using the conference ID number: 4491545. The conference call will also be webcast live and can be accessed from the Company’s website at www.caladrius.com/investors/news-events.

For those unable to participate in the live conference call or webcast, an audio recording will be available for replay approximately two hours after the conclusion of the call until 11:59 p.m. ET on August 15, 2019. To access the audio replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide conference ID number: 4491545.

A webcast replay of the conference call will remain available on the Company’s website for 90 days.