On February 27, 2020 Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported the closing of a registered direct offering of 10,084,034 Class A Units, each consisting of one share of its common stock and one half of a common warrant to purchase one share of its common stock, at a price of $0.595 per Class A Unit, for total gross proceeds to the Company of approximately $6 million, before deducting placement agent fees and other estimated offering expenses (Press release, Lipocine, FEB 27, 2020, View Source [SID1234554936]). The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

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Roth Capital Partners acted as sole agent for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-220942) (including a prospectus) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the offering has been filed with the SEC.

A copy of the prospectus supplement and the accompanying prospectus relating to these securities may be obtained by contacting Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147. Electronic copies of the prospectus supplement and the accompanying prospectus are also available free of charge on the website of the SEC at www.sec.gov.

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

On February 27, 2020 BioInvent reported that Financial Statement January 1 – December 31, 2019 (Press release, BioInvent, FEB 27, 2020, View Source;december-31-2019-301012311.html [SID1234554953]).

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"We are proud that we have delivered on our goals for the year and feel confident that we will continue to do so in 2020, with a number of important milestones approaching. Our cooperation with Merck & Co is our second large pharma collaboration and an excellent validation of BioInvent’s work, as we develop BI-1206 in solid tumors as well as in haematological cancers."

Martin Welschof, CEO BioInvent

Financial information

Fourth quarter 2019

Net sales SEK 25.4 (10.4) million.
Loss after tax SEK -40.9 (-32.7) million.
Loss after tax per share before and after dilution SEK -0.08 (-0.09).
Cash flow from operating activities and investment activities SEK -28.5 (-38.2) million.
January – December, 2019

Net sales SEK 93.7 (38.5) million.
Loss after tax SEK -138.6 (-123.2) million.
Loss after tax per share before and after dilution SEK -0.31 (-0.36).
Cash flow from operating activities and investment activities SEK -129.3 (-145.2) million. Liquid funds as of December 31, 2019: SEK 154.0 (68.9) million.
Events in the fourth quarter

BioInvent entered into a clinical trial collaboration and supply agreement with Merck & Co to evaluate BI-1206 in combination with KEYTRUDA in advanced solid tumors. (R)
Selection of second target and extension of the research collaboration and license agreement with Pfizer Inc. announced. (R)
BioInvent and Transgene announced compelling preclinical data for BT-001 in solid tumors.
Manufacturing agreement signed with Cancer Research UK expected to generate approximately SEK 30 million (~$3 million). (R)
BI-1206 preclinical data in mantle cell lymphoma presented at ASH (Free ASH Whitepaper) 2019.
(R)= Regulatory event
Comments from the CEO

As we look back at 2019 for BioInvent, we can be proud of the delivery on our goals for the year. It is particularly exciting to pursue our lead clinical candidate BI-1206 in solid tumors as well as in hematological cancers.

In December, we concluded an agreement with Merck & Co. to evaluate the combination of BI-1206 and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase l/lla clinical trial for the treatment of advanced solid tumors. This expands BI-1206 clinical development and builds on preclinical data that demonstrates its ability to address an important mechanism of resistance to PD-1 inhibition, in combination, with one of the most successful immune-oncology drug. The collaboration is an excellent validation of our work and scientific excellence, as Merck has carefully evaluated the pre-clinical data and mode of action that Bioinvent has generated. They have provided insightful feedback on the clinical protocol, and provided input on the strategy for the development of BI-1206 before concluding this agreement.

Our partnership with Pfizer is also progressing well, and further validates the high scientific quality of the work performed by the team at BioInvent. Pfizer has now selected the second target under our cancer immunotherapy research collaboration and license agreement, and we have extended the research term by six months.

These agreements with two of the largest and most highly-respected pharmaceutical companies in the world strongly endorse BioInvent’s proprietary F.I.R.S.T platform. The platform enables us to simultaneously identify targets and high-quality antibodies that bind to them and generates promising new drug candidates that broaden our pipeline and create licensing and partnering opportunities.

Importantly, we also presented pre-clinical data indicating a broad and clinically relevant role of FcγRIIb in mantle cell lymphoma and highlight the potential of BI-1206 to help overcome resistance to treatment in this disease. This further reinforces our belief that FcγRIIb will become a key component for the treatment of advanced hematological and solid malignancies.

We have made important strategic advances in our collaboration with Cancer Research UK (CRUK). Given the overlap with BioInvent’s own Phase I/IIa trial of BI-1206 in combination with rituximab in Non-Hodgkin Lymphoma (NHL), and the fact that standard of care for patients with chronic lymphocytic leukemia (CLL) has dramatically evolved over the last few years, recruitment in the UK study has become increasingly challenging – in particular since CRUK can only carry out trials in the UK. For these reasons we have agreed to limit the CRUK study to monotherapy, which is almost completed. This will result in a more complementary work and more efficient use of resources. BioInvent and CRUK look forward to explore the possibilities for a continued collaboration as we move forward.

We reported compelling results from extensive in vitro and in vivo preclinical studies with BT-001, an oncolytic virus expressing our proprietary anti-CTLA4 antibody and the cytokine GM-CSF. We are developing BT-001 in collaboration with Transgene and intend to submit a clinical trial application in Q1 2020. Preclinical data on BT-001 will be presented at scientific meetings in the coming months.

We anticipate several important milestones in 2020. This will include early results from the Phase I open label study with a combination of BI-1206 and rituximab in indolent NHL in the second half of the year. We will also be initiating the Phase l/lla study of BI-1206 in combination with pembrolizumab, as mentioned above, with early results from the Phase I study expected in the second half of 2021. We are expecting to advance two compounds into clinical programs in solid cancer: in 2020 the anti-TNFR2 antibody BI-1808, as single agent and in combination with an anti-PD1 antibody; and in 2021 the anti-FcγRllB antibody BI-1607 in combination with a checkpoint inhibitor.

As BioInvent continues to bring new opportunities and programs towards clinical development, financing is of course, a focus and priority for us, and we will continue to use a combination of sources for funding. Firstly, we are engaged in several business development discussions with the aim of partnering one or more of the programs in our portfolio. Secondly, the collaboration with Pfizer, which is also a model for other potential collaborations which commercialize our platform. Thirdly, our manufacturing capabilities generate revenue, with the most recent agreement with CRUK expected to generate SEK 30 million. CRUK has the potential to become a long-term strategic partner, as it works with a number of small- to mid-sized companies that need manufacturing support. And our fourth option is to use capital markets for financing. Based on the support from our large institutional investors and increased interest in our programs we feel optimistic that a combination of these four sources will continue to support BioInvent financially.

BioInvent consistently delivered on its strategy in 2019 and this is continuing into 2020. We are looking forward to keeping you updated on the exciting developments ahead.

On February 27, 2020 GlaxoSmithKline plc reported that the European Medicines Agency (EMA) has validated the company’s Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status (Press release, GlaxoSmithKline, FEB 27, 2020, View Source [SID1234554851]). Validation of the T2V confirms that the submission is accepted and begins the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP).

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The submission is based on data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically meaningful outcomes of niraparib treatment in the first-line maintenance setting.[1] Results from the PRIMA study were presented at the 2019 European Society for Medical Oncology Congress and simultaneously published in the New England Journal of Medicine. The PRIMA study enrolled women who responded to first-line treatment with platinum-based chemotherapy, including those with high risk of disease progression, a population with high unmet need and previously under-represented in first-line ovarian cancer studies.

In Europe, ovarian cancer is the sixth deadliest cancer among women and more than 65,000 women are diagnosed each year.[2] Most women are diagnosed with advanced (stage III or IV) ovarian cancer and have a five-year survival rate of ~30%.[3] Despite high response rates to platinum-based chemotherapy in the first-line, approximately 85% of women with advanced ovarian cancer will see their disease return.[4] With each recurrence, the time a woman may spend without her cancer progressing until the next recurrence gets shorter.

About PRIMA

PRIMA is a double-blind, randomised Phase III study designed to evaluate niraparib versus placebo in women being treated first-line for stage III or IV ovarian cancer. The study assessed the efficacy of niraparib as maintenance therapy, as measured by progression free survival. Patients in complete or partial response to first-line platinum-based chemotherapy were randomised 2:1 to niraparib or placebo.

About Zejula (niraparib)

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies, including a Phase III study as a first-line triplet maintenance treatment in ovarian cancer (FIRST).

Important Information for ZEJULA
Zejula approved indication:

Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum‑based chemotherapy.

Important Safety Information
Contraindications: Hypersensitivity to niraparib or to any of the excipients and breast-feeding.

Warnings and precautions: Test complete blood counts weekly for the first month of treatment, then monthly thereafter. If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued. Due to the risk of thrombocytopenia, anticoagulants and medicinal products known to reduce the thrombocyte count should be used with caution. If MDS and/or AML are confirmed while being prescribed Zejula , treatment should be discontinued, and the patient treated appropriately. Hypertension, including hypertensive crisis, has been reported with the use of Zejula. Pre‑existing hypertension should be adequately controlled before starting Zejula treatment. Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy. Patients with galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine. Tartrazine may cause allergic reactions. Paediatric safety and efficacy has not yet been established.

Undesirable effects: The most common serious adverse reactions were thrombocytopenia and anaemia.

Very common (≥1/10): urinary tract infection, thrombocytopenia, anaemia, neutropenia, decreased appetite, insomnia, headache, dizziness, dysgeusia, palpitations, hypertension, dyspnea, cough, nasopharyngitis, nausea, constipation, vomiting, abdominal pain, diarrhoea, dyspepsia, back pain, arthralgia, fatigue, asthenia.

Common (≥1/1000 to <1/10): bronchitis, conjunctivitis, leukopenia, hypokalemia, anxiety, depression, tachycardia, epistaxis, dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis, photosensitivity, rash, myalgia, oedema peripheral, Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased.

Refer to the Zejula Prescribing Information for a full list of adverse events and the complete important safety information.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On February 27, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported financial results for the fourth quarter and full year 2019 (Press release, Immunomedics, FEB 27, 2020, View Source [SID1234554902]). Please refer to the Company’s Annual Report on Form 10-K for more details on the Company’s financial results.

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"We are pleased to have submitted our Biologics License Application (BLA) in late November – our top priority for 2019," said Dr. Behzad Aghazadeh, executive chairman of Immunomedics. "While we are working closely with the FDA to facilitate their review of our BLA, we continued to execute against key initiatives across our commercial, clinical, and manufacturing operations. Our commercial team has been actively preparing for launch readiness, and, as we wait for an FDA decision, we are well positioned to commercialize sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC) on or before the June 2, 2020 PDUFA goal date. In addition, our main goals for 2020 include maximizing the global commercial potential of sacituzumab govitecan, while accelerating its development as a single agent and in combination with checkpoint inhibitors across a number of clinical settings to meet our commitment to help transform the lives of people with hard-to-treat cancers worldwide."

2019 Highlights

Resubmitted BLA seeking accelerated approval for sacituzumab govitecan in mTNBC, which was accepted for filing by the FDA with a PDUFA target action date of June 2, 2020.
Completed enrollment of the Phase 3 confirmatory ASCENT study of sacituzumab govitecan in mTNBC.

Initiated the Phase 3 registrational TROPiCS-02 study of sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HER2‒) metastatic breast cancer.

Continued to expand clinical collaborations to move sacituzumab govitecan into earlier lines of therapy in breast cancer, including the combination with Roche’s Tecentriq in frontline mTNBC and the German Breast Group’s Phase 3 study in the curative setting of HER2‒ breast cancer as a single-agent.

Corroborated the positive Phase 2 results of sacituzumab govitecan in metastatic urothelial cancer with an interim 29% overall response rate presented at ESMO (Free ESMO Whitepaper) 2019 Congress on 35 patients, while completing enrollment of the full cohort of 100 patients previously treated with platinum-based chemotherapies and immune checkpoint inhibitor.

Initiated the multi-cohort, Trop-2-enriched Phase 2 TROPiCS-03 study of sacituzumab govitecan for patients with metastatic non-small cell lung cancer (mNSCLC).

Closed the largest single-asset biologics license deal for Greater China to date, with $65 million upfront, $60 million to be received upon FDA approval, up to $710 million in additional development and sales milestone payments, and escalating royalties that begin in the mid-teens.
These accomplishments have positioned Immunomedics to have a transformative 2020. We entered the year with a robust balance sheet that will enable us to meet our goals.

The Company continued to bolster the leadership team, both at the board and the executive management level, with the nomination of Robert Azelby to the board, and the permanent appointment of Dr. Loretta Itri to the chief medical officer position.

The company has recently also broadened the development program for sacituzumab govitecan by expanding the TROPHY U-01 study to include a third cohort of checkpoint inhibitor-naïve patients to assess the combination with pembrolizumab. Furthermore, a new Phase 2 study in persistent or recurrent endometrial cancer was launched by Dr. Alessandro Santin, Professor of Obstetrics, Gynecology, and Reproductive Sciences at Yale University. Finally, to help alleviate the unmet need of mTNBC patients between now and potential approval of sacituzumab govitecan, the Company instituted its first Expanded Access Program in January 2020. Details of this program can be obtained from View Source

Anticipated Key 2020 Milestones

Besides the FDA action date in the second quarter and a potential commercial launch, we anticipate the following key milestones in 2020:

Topline data from Phase 3 confirmatory ASCENT study around mid-year
Topline data from full cohort of 100 patients with prior platinum-based and immune checkpoint inhibitor therapies from Phase 2 pivotal TROPHY U-01 study
Enrollment completion for the Phase 3 registrational TROPiCS-02 study
Enrollment completion for the 40-patient cohort of cisplatin-ineligible patients in TROPHY U-01
Evaluate preliminary results from signal-seeking Phase 2 TROPiCS-03 study in mNSCLC
Continue to expand combination development opportunities between sacituzumab govitecan and checkpoint inhibitors across indications, internally and through partnerships
Fourth Quarter and Full Year 2019 Financial Results

Total revenues were $0.3 million for both the quarter and the year ended December 31, 2019 due to service fee revenues earned related to the Janssen Promotion Agreement. The Company had no revenues in 2018 for the comparable quarter ended, and $0.9 million for the year ended December 31, 2018.

Total costs and expenses were $91.5 million for the quarter and $325.1 million for the year ended December 31, 2019, compared to $87.4 million for the comparable quarter and $235.4 million for the year ended December 31, 2018. The increases were primarily due to an increase in research and development expenses, mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for mTNBC in the United States, and CRL remediation costs, including outside manufacturers’ organizations services costs, and external consulting services to improve our manufacturing and regulatory functions.

The increases in research and development costs were partially offset by a decrease in general and administrative expenses, which was primarily due to decreased legal and advisory expenses resulted from reduced reliance on outside legal counsel, as well as a decrease in other and consulting services, partially offset by an increase in labor costs.

The Company had no non-cash warrant-related income or expense for the quarter and the year ended December 31, 2019, compared to a $0.2 million of non-cash gain for the comparable quarter and a $47.6 million warrant-related expense for the year ended December 31, 2018, due to changes in the fair value of then outstanding warrants. There were no warrants outstanding at December 31, 2019 and 2018.

Interest expense was $10.0 million for the quarter and $40.3 million for the year ended December 31, 2019, compared to $9.9 million for the comparable quarter and $40.4 million for the year ended December 31, 2018. The differences were due primarily to changes in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $99.6 million, or $0.50 per share, for the quarter ended December 31, 2019, compared to $93.5 million, or $0.50 per share, for the comparable quarter ended December 31, 2018. Net loss attributable to stockholders was $357.2 million, or $1.84 per share, for the year ended December 31, 2019, compared to $310.2 million, or $1.74 per share, for the year ended December 31, 2018.

As of December 31, 2019, the Company had $613.2 million in cash, cash equivalents, and marketable securities. The Company believes this amount is adequate to accelerate commercial launch readiness, pending FDA approval, of sacituzumab govitecan in the United States in mTNBC; continue to expand the clinical development programs for sacituzumab govitecan; invest in the broader clinical development of the ADC platform (including IMMU-130 and IMMU-140); continued scale up of manufacturing and manufacturing process improvements; and general working capital requirements.

Conference Call

The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss fourth quarter and full year 2019 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 4365097. 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 February 27, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, provided a corporate update and reported fourth quarter and full-year 2019 financial results for the periods ended December 31, 2019 (Press release, Allogene, FEB 27, 2020, View Source [SID1234554919]).

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"2019 was a very successful year for Allogene. We accomplished all of our corporate goals, which includes the establishment of world-class capabilities across multiple new functions and the initiation of our first clinical trials in patients with relapsed or refractory aggressive non-Hodgkin lymphoma and multiple myeloma," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Our momentum and focus towards making AlloCAR T therapies and their life-saving potential a reality for patients will continue at full speed in 2020. This year will be an important one as we look to demonstrate proof-of-concept data from two key programs and plan for potential pivotal studies."

Recent Highlights

ALLO-501 (anti-CD19 AlloCAR T)
•In 2019, Allogene initiated the ALLO-501 Phase 1 ALPHA trial in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). This study utilizes ALLO-647, Allogene’s anti-CD52 monoclonal antibody (mAb) as a part of the lymphodepletion regimen. Initial data is planned to be presented at a medical meeting in Q2 2020.
•The U.S. Food and Drug Administration cleared the Investigational New Drug Application (IND) for ALLO-501A, the Company’s next generation anti-CD19 AlloCAR T construct devoid of the rituximab off-switch. ALLO-501A, previously referred to as ALLO-501.1, was created to eliminate the rituximab recognition domains in ALLO-501, allowing for use in a broader patient population, including those NHL patients with recent rituximab exposure.
•The Company expects to initiate an abbreviated Phase 1 portion of the ALLO-501A trial (ALPHA2) in the second quarter of the year. The ALPHA2 trial will leverage the findings of the ALPHA trial to finalize the ALLO-501A cell dose and the ALLO-647 based lymphodepletion regimen for a potential pivotal Phase 2 trial.

ALLO-715 (anti-BCMA AlloCAR T)
•The Company has created a robust anti-BCMA strategy centered around ALLO-715 for the treatment of multiple myeloma (MM).
•In 2019, Allogene initiated the ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM, designed to assess the safety and tolerability of ALLO-715. This trial is also intended to identify the optimal dose of ALLO-647 and includes the potential to evaluate lymphodepletion regimens that do not include fludarabine and cyclophosphamide. UNIVERSAL continues to accrue as planned with initial data anticipated in Q4 2020.
•In January 2020, Allogene entered into a clinical collaboration with SpringWorks Therapeutics to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM. The Company expects to initiate this combination trial in the second half of 2020.
•The Company nominated ALLO-605 as its first TurboCARTM candidate and part of its larger MM strategy. The TurboCAR technology provides the effects of cytokine stimulation to AlloCAR T cells with the goal of enhancing

their potency, expansion and persistence. ALLO-605 is advancing in preclinical development with a potential IND in 2021.

Additional Pipeline Updates
•The Company nominated ALLO-316, an anti-CD70 AlloCAR T, as its next clinical candidate for potential development in acute myeloid leukemia, T-cell malignancies and/or renal cell carcinoma. Submission of the IND for ALLO-316 is expected by year end 2020.

Fourth Quarter Financial Results
•As of December 31, 2019, Allogene had $588.9 million in cash, cash equivalents, and investments.
•Research and development expenses were $49.4 million for the fourth quarter of 2019, which includes $6.4 million of non-cash stock-based compensation expense and $10.0 million in expenses associated with the signing of our collaboration with Notch Therapeutics. For the full year of 2019, research and development expenses were $144.5 million. Research and development expense for the year includes $19.4 million of non-cash stock-based compensation expense.
•General and administrative expenses were $15.2 million for the fourth quarter of 2019, which includes $7.5 million of non-cash stock-based compensation expense. For the full year of 2019, general and administrative expenses were $57.5 million, which includes $26.6 million of non-cash stock-based compensation expense.
•Net loss for the fourth quarter of 2019 was $61.0 million, or $0.58 per share, including non-cash stock-based compensation expense of $13.9 million. For the full year of 2019, our net loss was $184.6 million, or $1.83 per share, including non-cash stock-based compensation expense of $46.1 million.

2020 Financial Guidance
•Allogene expects full year GAAP net losses to be between $260 million and $280 million including estimated non-cash stock-based compensation expense of $70 million to $75 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss financial results and provide a business update. To access the live conference all by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 2981059. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.