On August 5, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the Canaccord Genuity 40th Annual Growth Conference on Wednesday, August 12, 2020 at 8:00 a.m. ET (Press release, Bicycle Therapeutics, AUG 5, 2020, View Source [SID1234562911]). The conference will be held in a virtual meeting format.

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A live webcast of the fireside chat will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the fireside chat date.

On August 5, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported results for the second quarter and first half of 2020 (Press release, MorphoSys, AUG 5, 2020, View Source [SID1234562910]).

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Financial Results for the First Half of 2020

Group revenue increased to €269.7 million (H1 2019: €48.2 million), mainly driven by the upfront payment from the Incyte collaboration in Q1 2020
EBIT thus reached €163.5 million (H1 2019: €-29.3 million)
Liquidity position of €1.06 billion at end of Q2 2020 (December 31, 2019: €357.4 million)
Financial guidance for 2020 (excluding Monjuvi(R) contribution) confirmed: Group revenues of €280 to €290 million, R&D expenses of €130 to €140 million, EBIT of €-15 to €5 million

Highlights Second Quarter 2020 and beyond

Proprietary Development
– Monjuvi(R) (Tafasitamab-cxix)

FDA approves Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant
Validation of European Marketing Authorization Application (MAA), seeking approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with r/r DLBCL
Long-term follow-up results from ongoing L-MIND study in r/r DLBCL confirm previously reported results
First-MIND study in newly diagnosed DLBCL patients is on track, as are plans to start a pivotal study in this patient population in early 2021
Presentation of tafasitamab data at virtual annual meetings of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper)
– Felzartamab (MOR202)

I-Mab: First phase 3 patient in mainland China treated in relapsed or refractory multiple myeloma
MorphoSys: Recruitment of patients for the M-PLACE study with felzartamab in membranous nephropathy, which has been temporarily paused due to the COVID-19 pandemic, has been resumed. The first patient was dosed on July 27, 2020
– Otilimab (MOR103/GSK3196165)

GSK started a clinical trial (OSCAR) to evaluate the efficacy and safety of otilimab in patients with severe pulmonary COVID-19-associated disease

Partnered Discovery
– Janssen: FDA approval of Tremfya(R) (guselkumab) as a treatment for adult patients living with active psoriatic arthritis (PsA)

– 15th antibody from Novartis collaboration entered clinical development

Roland Wandeler, Ph.D., appointed to MorphoSys’ Management Board, effective May 5, 2020, in his function as today’s Chief Operating Officer leading global commercial operations and overseeing the Company’s U.S. operations

Re-election of Wendy Johnson, Dr. George Golumbeski and Michael Brosnan to MorphoSys’ Supervisory Board by the Company’s Annual General Meeting on May 27, 2020

Update on the Impact of the Global COVID-19 Pandemic:

MorphoSys recognizes the impact of the global COVID-19 pandemic on healthcare systems and society worldwide, as well as the resulting potential impact on preclinical and clinical programs, especially clinical trials. In addition to the steps already communicated to mitigate the impact of the pandemic on MorphoSys’ employees, patients and the broader community, further measures may need to be implemented in the future. MorphoSys will take various factors into consideration, including potential adaptation of clinical trials due to restrictions on visits to healthcare facilities, increased demands on healthcare services and changes in the availability of study personnel. MorphoSys continuously monitors the situation and takes appropriate decisions on a case-by-case basis to ensure the safety of patients, study personnel and other stakeholders as well as to safeguard data integrity.
MorphoSys and Incyte are prepared for the successful commercial launch of Monjuvi(R) (tafasitamab-cxix), following its FDA approval on July 31, 2020. Despite the uncertainty caused by the COVID-19 pandemic in the United States, the commercial and medical teams of both companies are well-prepared for the launch of Monjuvi(R), using a combination of virtual engagement tools.
Patient enrollment for all ongoing tafasitamab studies continues as planned. However, a delay cannot be excluded due to the factors mentioned above.
Recruitment of patients for the M-PLACE study with felzartamab, which had been temporarily paused due to the COVID-19 pandemic, has been resumed.
"We are all very proud that Monjuvi(R) received FDA approval as a combination therapy with lenalidomide," commented Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "This accelerated approval is an important milestone, not only for MorphoSys, but also for patients battling relapsed or refractory diffuse large B-cell lymphoma, as Monjuvi(R) is the first FDA-approved second-line therapy for adult patients with DLBCL. The approval not only marks an important transformational step for MorphoSys into an integrated biopharmaceutical company but also provides a significant value creation opportunity for all our stakeholders."

"We are very excited with the accelerated approval of Monjuvi(R) by the FDA," added Jens Holstein, Chief Financial Officer of MorphoSys. "MorphoSys is well prepared for its next step as an integrated biopharmaceutical company given our strong financial position. We, together with our partner Incyte, will drive forward the launch of Monjuvi(R) in the United States."

Financial Review for Q2 2020 (IFRS)

Group revenues for the second quarter of 2020 amounted to €18.4 million (Q2 2019: €34.7 million). The revenues include success-based payments of €12.8 million, primarily from Janssen (Q2 2019 success-based payments: €32.4 million, including a milestone payment from GSK of €22.0 million).

In the Proprietary Development segment, MorphoSys researches and develops its own drug candidates for cancer and inflammation. In Q2 2020, this segment recorded revenues of €5.0 million (Q2 2019: €25.9 million). The decline primarily reflects the €22.0 million milestone payment from GSK which was booked in the same time period of last year.

In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies and thus participates in its partners’ development advancements through research and development (R&D) funding, licensing fees, success-based milestone payments and royalties. Revenues in the Partnered Discovery segment climbed to €13.4 million in Q2 2020 from €8.7 million in Q2 2019.

Total operating expenses increased to €-66.8 million from €-40.3 million in the same time period last year, due to the expenditure in relation to the preparations for the anticipated Monjuvi(R) U.S. commercialization as well as the further expansion of MorphoSys US Inc. Cost of sales amounted to €+7.2 million versus €-4.9 million in the same quarter of 2019, while R&D expenses rose to €-30.9 million as compared to €-24.7 million in Q2 2019. Selling expenses in Q2 2020 increased to €-29.3 million (Q2 2019: €-3.2 million) and general and administrative expenses to €-13.8 million (Q2 2019: €-7.5 million). The increase of the two latter was primarily driven by higher personnel expenses and expenses for external services in association with the preparation for the Monjuvi(R) launch. Selling expenses also comprised expenses for services rendered by Incyte in connection with the joint US activities.

Earnings before interest and taxes (EBIT) for the Group amounted to €-50.1 million in Q2 2020 versus €-5.7 million in Q2 of the previous year. The Proprietary Development segment reported an EBIT of €-51.3 million (Q2 2019: €-7.0 million), while Partnered Discovery segment delivered an EBIT of €11.1 million (Q2 2019: €6.3 million). The consolidated net loss was €-53.1 million (Q2 2019: €-5.9 million). Basic earnings per share were €-1.62 compared to €-0.19 in Q2 2019.

On June 30, 2020, the Group’s liquidity position amounted to €1,061.8 million.This liquidity position is reported on the balance sheet under the items "cash and cash equivalents", "financial assets at fair value through profit or loss", and current and non-current "other financial assets at amortized cost".

The number of shares issued totaled 32,890,046 at the end of Q2 2020 (year-end 2019: 31,957,958).

Results for the First Half 2020 (IFRS)

During the first half of 2020, Group revenues soared to €269.7 million from €48.2 million in the first half of last year. The increase was primarily driven by the collaboration and licensing agreement with Incyte in the first quarter of this year to further develop and commercialize tafasitamab globally. Research and development expenses amounted to €-52.4 million versus €-49.3 million in the same time period last year. The EBIT rose to €163.5 million, compared to €-29.3 million in H1 2019.

Financial Guidance and Operational Outlook for 2020

For the financial year 2020, MorphoSys confirmed its financial guidance. Management continues to expect Group revenues in the range of €280 to €290 million, R&D expenses of €130 to €140 million and EBIT of €-15 to €5 million. This guidance is based on constant currency exchange rates and does not include any contributions from Monjuvi(R) revenues and any effects from potential in-licensing or co-development deals for new development candidates. The operational and financial guidance might potentially be impacted by the ongoing global COVID-19 crisis on MorphoSys’ business operations including but not limited to the Company’s supply chain, clinical trial conduct, as well as timelines for regulatory and commercial execution. While MorphoSys is maintaining its previously communicated guidance on its clinical trials, these could potentially be affected in terms of patient enrollment and data collection timelines, among other factors.

Ongoing Trials and Other Highlights

Proprietary Development
– Monjuvi(R) (Tafasitamab-cxix)

Launch of Monjuvi(R) (tafasitamab-cxix) using a combination of virtual engagement tools to address customer needs and to grow connectivity with customers, following Monjuvi(R)’s FDA approval on July 31, 2020. Monjuvi(R)is expected to be available commercially shortly
Continue phase 1b study First-MIND in previously untreated DLBCL
Continue pivotal phase 3 trial evaluating tafasitamab plus bendamustine in r/r DLBCL in comparison to rituximab and bendamustine (B-MIND trial)
Continue phase 2 COSMOS trial of tafasitamab with idelalisib and venetoclax in CLL/SLL
Expansion of tafasitamab’s clinical development beyond DLBCL under the collaboration and licensing agreement with Incyte

– Felzartamab (MOR202)

I-Mab: Continue pivotal development program with felzartamab in multiple myeloma in the Chinese region
MorphoSys: Continue clinical development of felzartamab in membranous nephropathy; recruitment of patients in the M-PLACE study was resumed after having been temporarily paused due to COVID-19. The first patient was dosed on July 27, 2020
– Otilimab (MOR103/GSK3196165)

GSK to continue clinical phase 3 development program with otilimab in rheumatoid arthritis

Partnered Discovery
– Tremfya(R) (Guselkumab)

Janssen is currently conducting a series of clinical studies with Tremfya(R) (guselkumab) in various indications, some of which could generate data during 2020. In 2019, Janssen submitted marketing authorization applications to the U.S. FDA and EMA for Tremfya(R) for the treatment of psoriatic arthritis. On July 14, 2020, Janssen reported the approval of Tremfya(R) as a treatment for adult patients with active psoriatic arthritis by the U.S. FDA. A decision on the EMA application could potentially also be made in 2020.
– Other partnered programs

Publication of clinical data and achievement of regulatory milestones from other partnered programs may occur during 2020. Whether, when and to what extent news will be published following the primary completion of trials in the Partnered Discovery segment is at the full discretion of MorphoSys’ partners.
MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.

MorphoSys continues its expansion of strategic presence of MorphoSys US Inc.

Percentage point

** Tremfya(R) is still considered as a clinical program due to ongoing studies in various indications.

*** Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK.

MorphoSys will hold its conference call and webcast tomorrow, August 6, 2020, to present the second quarter and first half financial results 2020 and the further outlook for 2020.

Dial-in number for the analyst conference call (in English) at 2:00pm CEST; 1:00pm BST; 8:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
(all numbers reachable from any geography)

Participant PIN: 43014391#

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at www.morphosys.com.

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript of the prepared remarks will be available on www.morphosys.com.

On August 5, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the second quarter ended June 30, 2020 (Press release, Fate Therapeutics, AUG 5, 2020, View Source [SID1234562909]).

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"Early clinical data from our FT596 program are very encouraging, as we observed a partial response in a heavily-pretreated patient with refractory diffuse large B-cell lymphoma at the first dose level without any reported events of cytokine release syndrome, neurotoxicity or graft-versus-host disease. Additionally, the safety, tolerability, and immunogenicity data across our off-the-shelf NK cell programs continue to suggest that multiple doses of iPSC-derived NK cells can be administered to a patient without matching," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We continue to be pleased with our pace of innovation, where the recent clearances of our IND applications by the FDA for FT538, the first-ever CRISPR-edited iPSC-derived cell therapy, and for FT819, the first-ever iPSC-derived CAR T-cell therapy, continue to demonstrate our unique ability to rapidly bring multiplexed engineered, off-the-shelf NK cell and T-cell cancer immunotherapies to patients. In addition, we successfully launched our Janssen collaboration with strong momentum, bringing together Janssen’s proprietary tumor-targeting antigen binders and our industry-leading iPSC product platform to develop novel off-the-shelf CAR NK and CAR T-cell immunotherapies for hematologic malignancies and solid tumors."

Clinical Programs

Partial Response Reported with FT596 Monotherapy at First Dose Level. In June, the Company reported Day 29 protocol-defined response assessments for the first two patients treated with FT596, the Company’s off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-cancer modalities: a proprietary CD19-targeting chimeric antigen receptor (CAR), a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, and an IL-15/IL-15 receptor fusion. Each patient had previously been treated with at least four lines of therapy for diffuse large B-cell lymphoma (DLBCL), and was administered a single dose of FT596 as a monotherapy at the first dose level (30 million cells). The first patient had progressive disease, having most recently relapsed following treatment with an FDA-approved CD19-targeting CAR T-cell therapy. The second patient had a partial response, having most recently been refractory to an experimental donor-derived NK cell regimen. The FT596 response assessment in this patient showed a greater than 70% reduction in metabolic activity and a greater than 50% reduction in tumor size as assessed by PET-CT scan. No dose-limiting toxicities, no FT596-related serious adverse events (SAEs), and no events of cytokine release syndrome, neurotoxicity, or graft-versus-host disease were reported by investigators in either patient.
Enrollment Initiated with FT596 in Combination with Rituximab for B-cell Lymphoma. In addition to assessing FT596 as a monotherapy, the FT596 Phase 1 clinical trial includes the administration of FT596 in combination with rituximab, which enables dual-antigen targeting of CD19 and CD20 through the product candidate’s CAR and hnCD16 receptors, respectively. Enrollment into this dose-escalating regimen has been initiated at 30 million cells for patients with relapsed / refractory B-cell lymphoma.
Second FT516 IND Application Cleared by FDA for Advanced Solid Tumors. In April, the U.S. Food & Drug Administration (FDA) cleared an investigational new drug (IND) application for FT516, the Company’s off-the-shelf NK cell cancer immunotherapy derived from a clonal master iPSC line engineered to express hnCD16 Fc receptor. The Phase 1 study, which is sponsored by investigators from the Masonic Cancer Center, University of Minnesota, is intended to assess intraperitoneal administration of three once-weekly doses of FT516, each with IL-2 cytokine support, for women with recurrent ovarian cancer. The Company is preparing to initiate a multi-dose Phase 1 clinical trial of FT516 in combination with avelumab, a checkpoint inhibitor therapy targeting PD-L1, for patients with advanced solid tumors, and is continuing to enroll a multi-dose Phase 1 clinical trial of FT516 as a monotherapy for patients with acute myeloid leukemia (AML) and in combination with CD20-directed monoclonal antibodies for patients with advanced B-cell lymphoma.
Evidence of Clinical Activity Observed with FT500 for Advanced Solid Tumors. In May 2020, the Company announced the completion of the dose-escalation stage of the FT500 Phase 1 clinical trial for advanced solid tumors, having enrolled three patients at the second dose level of FT500 in combination with checkpoint inhibitor therapy. Each of these three patients was previously treated with at least four lines of therapy, and most recently was refractory to, or had relapsed on, checkpoint inhibitor therapy. Evidence of clinical activity was observed in two patients, with one patient having a 58% reduction in the size of target lesions prior to discontinuing treatment during the second 30-day cycle due to non-target lesion formation and one patient having stable disease following completion of the second 30-day cycle. No dose-limiting toxicities, no FT500-related SAEs or Grade ≥3 adverse events, and no events of cytokine release syndrome, neurotoxicity, or graft-versus-host disease were reported by investigators in the dose-escalation stage of the study. The Company is enrolling the dose-expansion stage of the FT500 Phase 1 clinical trial and intends to treat up to 15 patients who are refractory to, or have relapsed on, checkpoint inhibitor therapy, administering three once-weekly doses of FT500 at 300 million cells per dose, each with IL-2 cytokine support, for up to two 30-day cycles in combination with the same checkpoint inhibitor on which the patient failed or relapsed.
IND Application Cleared by FDA for FT538, the First-ever CRISPR-edited, iPSC-derived Cell Therapy. In May 2020, the FDA cleared the Company’s IND application for FT538, its off-the-shelf NK cell product candidate derived from a clonal master iPSC line engineered with three functional components to enhance innate immunity: a novel hnCD16 Fc receptor; an IL-15/IL-15 receptor fusion; and the elimination of CD38 expression. The Company is preparing to initiate a multi-center Phase 1 clinical trial of three once-weekly doses of FT538 as a monotherapy for patients with relapsed / refractory AML and in combination with daratumumab for patients with relapsed / refractory multiple myeloma.
IND Application Cleared by FDA for FT819, the First-ever iPSC-derived CAR T-cell Therapy. In June 2020, the FDA cleared the Company’s IND application for FT819, an off-the-shelf allogeneic CAR T-cell therapy targeting CD19+ malignancies. FT819 is the first-ever CAR T-cell therapy derived from a clonal master iPSC line, and is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy including: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR expression and enhanced T-cell potency; and complete bi-allelic disruption of T-cell receptor expression for the prevention of graft-versus-host disease, a potentially life-threatening complication associated with allogeneic T-cell therapy. The Company is preparing to initiate a multi-center Phase 1 clinical trial of FT819 for patients with chronic lymphocytic leukemia, acute lymphoblastic leukemia, or B-cell lymphoma. Each indication will enroll independently and evaluate three dose-escalating treatment regimens: a single dose of FT819; a single dose of FT819 with IL-2 cytokine support; and three fractionated doses of FT819.
Investigator-initiated Clinical Trial of FT516 for COVID-19 Opened to Enrollment. Investigators from the Department of Medicine, Division of Infectious Diseases and International Medicine, University of Minnesota are currently enrolling a Phase 1 clinical trial of FT516 in up to 20 patients with Coronavirus Disease 2019 (COVID-19) at high risk of developing critical life-threatening illness.
Preclinical Programs

Four Anti-Tumor Modalities of FT576 for Multiple Myeloma Highlighted at ASGCT (Free ASGCT Whitepaper). The Company presented new preclinical data for FT576, its off-the-shelf, iPSC-derived, multi-antigen targeted CAR-BCMA NK cell product candidate for multiple myeloma, at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Virtual Annual Meeting in May. In a serial re-stimulation cytotoxicity assay against an MM1.R myeloma cell line, FT576 was shown to be resistant to anti-CD38 monoclonal antibody induced fratricide and to have enhanced cytotoxicity both as a monotherapy and in combination with daratumumab as compared to daratumumab alone. The presentation "Generation of a Novel Single Cell-Derived Multi-Engineered Master Pluripotent Cell Line as a Renewable Source of Off-The-Shelf Multi-Antigen-Targeting NK Cell Immunotherapy for Multiple Myeloma" was selected by ASGCT (Free ASGCT Whitepaper) as an outstanding poster award winner.
New CAR MICA/B Solid Tumor Program Announced. At ASGCT (Free ASGCT Whitepaper) in May, the Company presented initial preclinical data from its new CAR MICA/B solid tumor program, which targets the pan-tumor associated stress antigens MICA and MICB. While these stress-inducible cell-surface proteins are selectively expressed at high levels on many solid tumors, shedding of these proteins by cancer cells is a common mechanism of immune evasion. The preclinical data demonstrated that the Company’s novel CAR MICA/B construct targets a specific epitope that uniquely prevents antigen shedding to overcome tumor escape (Science, DOI: 10.1126/science.aao0505).
Corporate Highlights

Strategic Collaboration Formed with Janssen for Novel iPSC-derived Cell-based Cancer Immunotherapies. In April, the Company entered into a global collaboration and option agreement with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop iPSC-derived CAR NK and CAR T-cell product candidates targeting up to four tumor-associated antigens. In entering into the collaboration, the Company received $100 million including $50 million in an upfront cash payment and $50 million from the purchase by Johnson & Johnson Innovation – JJDC, Inc. (JJDC) of the Company’s common stock. The Company is eligible to receive payments of up to $3.0 billion upon the achievement of certain development, regulatory and commercial milestones, plus tiered double-digit royalties on worldwide net sales of products targeting the antigens, and has the right to elect to co-commercialize each product candidate in the U.S. and share equally in profits and losses in the U.S., subject to its payment of certain clinical development costs and adjustments in milestone and royalty payments.
Completed $201 Million Common Stock Offering. In June, the Company closed an underwritten public offering of 7.1 million shares of its common stock at a public offering price of $28.31 per share. In connection with the offering, JJDC purchased an additional 1.8 million newly-issued shares of the Company’s common stock in a private placement at the offering price.
Second Quarter 2020 Financial Results

Cash & Investment Position: Cash, cash equivalents and investments as of June 30, 2020 were $533.4 million.
Total Revenue: Revenue was $5.5 million for the second quarter of 2020, which was derived from the Company’s collaborations with Janssen and Ono Pharmaceutical.
R&D Expenses: Research and development expenses were $26.7 million for the second quarter of 2020, which includes $4.4 million of non-cash stock-based compensation expense.
G&A Expenses: General and administrative expenses were $7.5 million for the second quarter of 2020, which includes $2.9 million of non-cash stock-based compensation expense.
Shares Outstanding: Common shares outstanding were 86.8 million, and preferred shares outstanding were 2.8 million, as of June 30, 2020. Each preferred share is convertible into five common shares.
Today’s Conference Call and Webcast
The Company will conduct a conference call today, Wednesday, August 5, 2020 at 5:30 p.m. ET to review financial and operating results for the quarter ended June 30, 2020. In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 8295527. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On August 5, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, reported that it intends to offer and sell its common shares in an underwritten public offering (Press release, DiaMedica, AUG 5, 2020, View Source [SID1234562908]). In addition, DiaMedica intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the common shares offered in the public offering. All of the common shares will be offered by DiaMedica. The offering is subject to market 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.

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DiaMedica intends to use the net proceeds from the offering to continue its clinical and product development activities, including the addition of a new cohort III to its REDUX study to be comprised of participants with Type II diabetes mellitus with chronic kidney disease, hypertension and albunuria, and for other working capital and general corporate purposes.

Guggenheim Securities, LLC is acting as lead book-running manager for the offering. Craig-Hallum Capital Group LLC is acting as joint book-running manager.

The securities described above are being offered by DiaMedica pursuant to a shelf registration statement on Form S-3 (File No. 333-235775) previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 registration or qualification under the securities laws of any such state or other jurisdiction.

On August 5, 2020 MannKind Corporation (NASDAQ:MNKD) reported financial results for the quarter and six months ended June 30, 2020 (Press release, Mannkind, AUG 5, 2020, View Source [SID1234562907]).

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"I am proud of how our employees pulled together during these uncertain times and innovated as a team to minimize the impact of the COVID-19 pandemic on our business during the second quarter," said Michael Castagna, Chief Executive Officer. "A small 3% reduction in Afrezza TRx compared to the first quarter, when there was a bolus of prescriptions due to patient stockpiling, reflects the successful execution of our commercial plan in a new virtual environment. We faced many challenges during this quarter, but whether it was production personnel ensuring Afrezza supply through the end of the year, the research team producing clinical supplies for our collaboration partner, United Therapeutics, the field force executing new sales tactics or home office staff adapting to a totally virtual environment, our team exceeded all expectations."

Second Quarter 2020 Results

Total revenues were $15.1 million for the second quarter of 2020, reflecting Afrezza net revenue of $7.0 million and collaboration and services revenue of $8.1 million. Afrezza net revenue increased 15% compared to $6.1 million in the second quarter of 2019, primarily driven by price, a favorable mix of cartridges and higher product demand. Collaboration and services revenue for the second quarter of 2020 decreased $0.8 million compared to the second quarter of 2019, primarily due to the substantial completion of the research agreement with United Therapeutics in the second quarter of 2019.

Afrezza gross profit for the second quarter of 2020 was $3.3 million vs. $1.7 million in the same period of 2019, a 90% increase that was driven primarily by higher Afrezza revenue combined with a reduction in cost of goods sold. Cost of goods sold decreased by $0.7 million, primarily due to $0.6 million in reduced spending. Gross margin in the second quarter of 2020 increased to 47% from 29% for the same quarter in 2019.

Selling, general and administrative expenses for the second quarter of 2020 were $13.7 million compared to $16.6 million for the second quarter of 2019. This 18% decrease was primarily due to a $1.9 million reduction in promotional and marketing activities, a $0.5 million decrease in personnel related costs as well as a $0.2 million decrease in professional costs.

Interest expense for the second quarter of 2020 was $2.4 million compared to $1.7 million for the second quarter of 2019. This $0.7 million increase was primarily attributable to a higher balance of outstanding principal.

The net loss for the second quarter of 2020 was $10.3 million, or $0.05 per share, compared to a $12.4 million net loss in the second quarter of 2019, or $0.07 per share. The lower net loss is mainly attributable to a decrease in operating expenses of $2.9 million. The reduction in the net loss per share was impacted by both lower operating expenses and a greater number of outstanding shares.

Six Months Ended June 30, 2020

Total revenues were $31.3 million for the six months ended June 30, 2020, reflecting Afrezza net revenue of $15.0 million and collaboration and services revenue of $16.4 million. Afrezza net revenue increased 35% compared to $11.1 million for the six months ended June 30, 2019, primarily driven by higher product demand, a more favorable mix of Afrezza cartridges, price and a reduction in wholesaler channel inventory in the six months ended June 30, 2019. Collaboration and services revenue for the six months ended June 30, 2020 decreased $4.9 million compared to the six months ended June 30, 2019, primarily due to a $5.5 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in the second quarter of 2019, partially offset by a $0.6 million increase in revenue from the UT License Agreement.

Afrezza gross profit for the six months ended June 30, 2020 was $7.1 million vs. $2.8 million in the same period of 2019, a 156% increase that was driven primarily by higher Afrezza revenue. Cost of goods sold decreased by $0.5 million, primarily attributable to $1.2 million of increased manufacturing activities, which resulted in a greater amount of costs capitalized to inventory and $0.6 million in reduced spending, partially offset by $0.9 million in costs associated with higher commercial product sales and $0.5 million of inventory write-offs. Gross margin for the six months ended June 30, 2020 increased to 48% from 25% for the same period in 2019, primarily due to higher Afrezza revenue.

Selling, general and administrative expenses for the six months ended June 30, 2020 were $28.0 million compared to $42.3 million for the same period in 2019. This 34% decrease was primarily due to $9.3 million spent on direct-to-consumer television advertising in 2019 (which was not repeated in 2020), a $3.1 million decrease in promotional and marketing activities, a $1.2 million decrease in personnel and employee related costs and a $0.5 million decrease in consulting costs.

Interest expense for the six months ended June 30, 2020 was $4.7 million compared to $3.3 million for the same period in 2019. This $1.4 million increase was primarily due to the borrowings under the MidCap Credit Facility in August 2019.

The net loss for the six months ended June 30, 2020 was $19.6 million, or $0.09 per share, compared to a $27.3 million net loss for the same period in 2019, or $0.15 per share. The lower net loss is mainly attributable to a decrease in operating expenses of $10.5 million. The reduction in the net loss per share was impacted by both lower operating expenses and a greater number of outstanding shares.

Cash, cash equivalents and restricted cash at June 30, 2020 was $63.5 million compared to $50.2 million at December 31, 2019, which also included short-term investments of $20.0 million. The increase was primarily due to the receipt of a $12.5 million United Therapeutics milestone payment, $12.2 million of net proceeds received from the at-the-market offering, $11.6 million received from warrant exercises and the origination of a Paycheck Protection Program loan for $4.9 million, offset by non-GAAP net cash used in operating activities of $27.4 million.

Chief Commercial Officer

As previously announced, Alejandro Galindo, M.B.A, M.S., joined the Company on August 4, 2020 as Chief Commercial Officer. Mr. Galindo has an accomplished track-record of over 25 years in the healthcare, energy, and consumer industries. He spent the past six years at Medtronic as Vice President and President of the Advanced Insulin Management Business Unit, where he led a fast-paced, double-digit growth global business within their diabetes division. Prior to Medtronic, Mr. Galindo spent nine years at General Electric (GE) Healthcare in a variety of leadership roles, leading emerging markets, strategic corporate development and global supply chain operations. Prior to joining GE’s Healthcare division, he spent eleven years in various global leadership positions for the company’s energy and appliance sectors, overseeing advanced manufacturing engineering and product development. Mr. Galindo received a B.Sc. in Industrial & Systems Engineering from Monterrey Institute of Technology, Mexico and M.B.A. and M.S. degrees from Indiana University.

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.