On March 13, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported an update on its clinical pipeline and financial results for the first quarter ended January 31, 2020 (Press release, Advaxis, MAR 13, 2020, View Source [SID1234555547]).

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Key recent corporate and clinical pipeline updates:

●Presented updated clinical data from the ongoing Phase 1/2 ADXS-503 trial at the I/O 360° Conference. Data presented showed that the first two patients treated in the combination arm, who previously progressed on KEYTRUDA, achieved a partial response with substantial tumor shrinkage of nearly 60% and the other patient achieving stable disease with a 25% reduction in a target lesion.
●Presented updated survival data from the Phase 1/2 ADXS-PSA trial at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium. Data highlights include reported median overall survival (95% CI) of 16.4 months (4.0-NR) (n=11) for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA compared to an estimated 11 months with current standard of care. In addition, median overall survival (95% CI) was 33.7 months (15.4-33.7) in all patients treated with ADXS-PSA in combination with KEYTRUDA (n=37).
●Data presented in 2020 suggest that both ADXS-503 and ADXS-PSA may have the potential to enhance or restore sensitivity to checkpoint inhibitors such as KEYTRUDA.
●Announced FDA allowance of its Investigational New Drug Application (IND) for ADXS-504 for the treatment of prostate cancer. ADXS-504 is the Company’s second drug product candidate from its HOT off-the-shelf neoantigen clinical program targeting hotspot mutations and other tumor-associated antigens.
●Closing of a $10.5 million equity financing with two investors.
●Announced a research agreement with Personalis to deploy ImmunoID NeXT Platform in the ADXS-503 clinical program. Personalis will conduct comprehensive tumor immunogenic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.

Management Commentary

"We have started our fiscal year with encouraging positive data presented in our ADXS-PSA and ADXS-503 clinical programs," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Importantly, data from both studies suggest that Lm immunotherapies may have the ability to synergistically enhance or restore sensitivity to checkpoint inhibitors which could be a meaningful breakthrough in improving outcomes for advanced and refractory patients. We continue to execute on our HOT off-the-shelf program in NSCLC with enrollment continuing in the combination arm of the study, Part B, and a planned initiation of Part C which will move combination therapy to a first-line setting, later this year. We are also planning to move an additional HOT construct, ADXS-504, for prostate cancer, into the clinic later this year for which the IND was allowed earlier this year."

Mr. Berlin continued, "We are currently evaluating next steps for our ADXS-PSA program based on the promising increases in median overall survival observed in combination with KEYTRUDA. With an anticipated cash runway into mid-2021, we are positioned to explore the early signals of activity in our ongoing trials while advancing additional programs that leverage these important findings."

First Quarter Ended January 31, 2020 Financial Results

During the quarter ended January 31, 2019, the Company recognized $19.4 million in revenue associated with the revenue recognition requirements surrounding the termination of the collaboration agreement with Amgen in 2019; no similar situation existed during the fiscal quarter ended January 31, 2020.

Research and development expenses for the first quarter of fiscal year 2020 were $4.9 million, compared with $6.7 million for the first quarter of fiscal year 2019. The decrease is largely attributable to the winding down of our Phase 3 AIM2CERV and Phase 1 ADXS-NEO studies as announced in June 2019 and October 2019, respectively.

General and administrative expenses for the three months ended January 31, 2020 were approximately $3.0 million compared to $2.7 million in the same three-month period in 2019 as a result of higher business development and legal fees.

As of January 31, 2020, the Company had approximately $34.2 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business until at least mid-2021.

On March 13, 2020 Portage Biotech Inc. (PBT.U, OTC Markets: PTGEF) ("Portage" or the "Company") is reported that it has filed its third quarter financial statements and accompanying management and discussion (Press release, Portage Biotech, MAR 13, 2020, View Source [SID1234555546]).

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These documents are available on SEDAR and on the Company’s website: www.portagebiotech.com.

Highlights of this quarter include:

• October 2019, Intensity therapeutics announced the dosing of its first patient with a combination of its drug INT230-6 and Merck’s Ketruda. This is part of a clinical trial collaboration agreement with Merck to study this combination

• October 2019, Sentien CEO Brian Miller presented Phase 1b clinical data of SBI-101 in acute renal injury at the 2019 Cell and Gene Meeting

• November 2019, Intensity announced that its experimental product, INT230-6 induced prolonged stable disease with abscopal effects and immune responses in multiple solid tumors. This data was selected for an oral presentation at the 34th annual Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting.

• In the period, further progress on preclinical work and progress made in furthering projects from the other subsidiary’s towards the clinic. The Company also wishes to provide an update on the status of its application (the "Revocation Application") to the Ontario Securities Commission (the "OSC") to revoke an outstanding cease trade order issued on August 2, 2019 (the "CTO").

The Company has resolved almost all comments from the OSC except for one: during the review process, the Company was informed by the OSC that it would be required to file a business acquisition report (BAR) under National Instrument 51-102 Continuous Disclosure Obligations in connection with its acquisition of SalvaRx Limited. Although there is already substantial public disclosure in respect of the acquisition available on SEDAR and the Company’s website, the presentation of financial information in respect of SalvaRx Limited was not in a format in compliance with the BAR requirements. The Company is in the process of compiling the relevant financial records for the creation of a proper BAR and is hopeful it will be able to resolve this issue in the very near future.

As indicated in the Company’s news release of January 30, 2020, the relief being sought under the Revocation Application is discretionary and, as such, no firm estimate can be provided as to-2-

when a revocation order will be issued by the OSC. The Company is confident, however, that a revocation order will be issued and, upon issuance, it is expected that the Company’s common shares will resume trading on CSE almost immediately thereafter.

In the interim, shareholders and investors are reminded that, although trading in the shares of the Company may not currently be effected through CSE, trading is permitted on OTC Markets in the United States as follows:

(a) Under the terms of the CTO, Canadian shareholders may trade the shares of the Company on OTC Markets in the United States provided they use the services of a registered dealer in Canada with access to OTC Markets;

(b) US shareholders may trade through OTC markets using the services of any dealer in the United States; and

(c) Other foreign shareholders, such as those in the United Kingdom, may trade through through the services of any dealer (other than Canadian) with access to OTC Markets.

Each dealer will have their own internal rules regarding the ability of shareholders and investors to trade the Company’s shares on OTC Markets. It is the individual responsibility of each shareholder or investor to satisfy these rules before they may trade.

The common shares of the Company trade on OTC Markets under the symbol "PTGEF".

At the time the revocation order is issued, the Company will announce a date for an annual meeting of shareholders at which the Company will bring shareholders and investors up to date on the current operations of the Company and its future plans. The Company wishes to thank shareholders for their continued patience while the Revocation Application is processed.

On march 13, 2020 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial results for the fourth quarter and full-year 2019 (Press release, Progenics Pharmaceuticals, MAR 13, 2020, View Source [SID1234555538]).

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"The recent positive top line results from the Phase 3 CONDOR trial of PyL highlights the potential of our radiopharmaceutical pipeline. By merging with Lantheus, we believe we can leverage Lantheus’ long-standing expertise in complex manufacturing, supply chain and commercial excellence to deliver on the promise of PyL, AZEDRA and our complementary PSMA-targeted product portfolio," said David Mims, Interim Chief Executive Officer of Progenics.

Mr. Mims continued, "The reconstituted Progenics Board’s support for the Lantheus merger is based on the culmination of our thorough evaluation of the business prospects and operations of Progenics as a stand-alone business, as well as the value of the interest of Progenics’ shareholders in the combined company under the revised terms. The Board believes the combination with Lantheus under the newly revised negotiated terms of the merger agreement represents the best pathway forward to maximize long-term stockholder value."

Fourth Quarter and Full-Year 2019 Financial Results

Fourth quarter 2019 revenue totaled $15.1 million, up from $3.2 million in the fourth quarter of 2018. Full-year 2019 revenue totaled $35.0 million, up from $15.6 million for the full-year 2018. The increases for the full year relate primarily to a $10.0 million RELISTOR sales milestone for the achievement of U.S. net sales over $100 million, a $4.0 million upfront payment from FUJIFILM under the aBSI agreement, a $2.0 milestone under the Bayer agreement for initiation of a Phase 1 trial of PSMA TTC, an increase of $2.1 million in RELISTOR royalties and $1.6 million of AZEDRA net sales.

Research and development expenses increased by $2.7 million and $14.1 million in the fourth quarter and full-year 2019, respectively, compared to the corresponding periods in 2018, resulting primarily from higher costs associated with the transition of the AZEDRA manufacturing site, initiatives to increase production capacity and provide redundancy for iodine-based products AZEDRA and 1095, and higher costs associated with the clinical trials for 1095 and PyL. Fourth quarter and full-year selling, general and administrative expenses increased by $4.5 million and $18.4 million, respectively, compared to the corresponding periods in 2018, primarily attributable to legal and advisory fees associated with the contested election at our 2019 annual meeting of shareholders and the consent solicitation campaign, legal and advisory fees associated with the merger agreement with Lantheus in 2019, and higher PSMA-617 litigation costs.

For the three months and full-year ended December 31, 2019, Progenics recognized interest expense of $1.0 million and $4.1 million, respectively, related to the RELISTOR royalty-backed loan, compared to $1.1 million and $4.7 million recognized in the corresponding periods in 2018.

Net loss attributable to Progenics for the fourth quarter was $11.3 million or $0.13 per diluted share, compared to a net loss of $14.7 million or $0.17 per diluted share in the corresponding 2018 period. Net loss for the full-year 2019 was $68.6 million or $0.80 per diluted share, compared to net loss of $67.7 million or $0.87 per diluted share for the full-year 2018.

Progenics ended the year with cash and cash equivalents of $42.0 million, reflecting a decrease of $22.5 million in the quarter and a decrease of $95.7 million from 2018 year-end, reflecting primarily cash used for operating expenses and for the acquisition of the Somerset manufacturing site for AZEDRA, as well as for capital expenditures to increase production capacity and provide redundancy for iodine-based products.

Due to the pending merger with Lantheus, Progenics will not be hosting a conference call this quarter.

Indication
AZEDRA (iobenguane I 131) is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

Important Safety Information
Warnings and Precautions:
Risk from radiation exposure: AZEDRA contributes to a patient’s overall long-term radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of AZEDRA are greater in pediatric patients than in adults. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with AZEDRA consistent with institutional good radiation safety practices and patient management procedures.
Myelosuppression: Severe and prolonged myelosuppression occurred during treatment with AZEDRA. Among the 88 patients who received a therapeutic dose of AZEDRA, 33% experienced Grade 4 thrombocytopenia, 16% experienced Grade 4 neutropenia, and 7% experienced Grade 4 anemia. Five percent of patients experienced febrile neutropenia. Monitor blood cell counts weekly for up to 12 weeks or until levels return to baseline or the normal range. Withhold and dose reduce AZEDRA as recommended in the prescribing information based on severity of the cytopenia.
Secondary myelodysplastic syndrome, leukemia, and other malignancies: Myelodysplastic syndrome (MDS) and acute leukemias were reported in 6.8% of the 88 patients who received a therapeutic dose of AZEDRA. The time to development of MDS or acute leukemia ranged from 12 months to 7 years. Two of the 88 patients developed a non-hematological malignancy.
Hypothyroidism: Hypothyroidism was reported in 3.4% of the 88 patients who received a therapeutic dose of AZEDRA. Initiate thyroid-blocking medications starting at least 1 day before and continuing for 10 days after each AZEDRA dose to reduce the risk of hypothyroidism or thyroid neoplasia. Evaluate for clinical evidence of hypothyroidism and measure thyroid-stimulating hormone (TSH) levels prior to initiating AZEDRA and annually thereafter.
Elevations in blood pressure: Eleven percent of the 88 patients who received a therapeutic dose of AZEDRA experienced a worsening of pre-existing hypertension defined as an increase in systolic blood pressure to ≥160 mmHg with an increase of 20 mmHg or an increase in diastolic blood pressure to ≥100 mmHg with an increase of 10 mmHg. All changes in blood pressure occurred within the first 24 hours post infusion. Monitor blood pressure frequently during the first 24 hours after each therapeutic dose of AZEDRA.
Renal toxicity: Of the 88 patients who received a therapeutic dose of AZEDRA, 7% developed renal failure or acute kidney injury and 22% demonstrated a clinically significant decrease in glomerular filtration rate (GFR) measured at 6 or 12 months. Monitor renal function during and after treatment with AZEDRA. Patients with baseline renal impairment may be at greater risk of toxicity; perform more frequent assessments of renal function in patients with mild or moderate impairment. AZEDRA has not been studied in patients with severe renal impairment.
Pneumonitis: Fatal pneumonitis occurred 9 weeks after a single dose in one patient in the expanded access program. Monitor patients for signs and symptoms of pneumonitis and treat appropriately.

Progenics Announces Fourth Quarter and Full-Year2019 Financial Results

Embryo-fetal toxicity: Based on its mechanism of action, AZEDRA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating AZEDRA. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with AZEDRA and for 7 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the final dose.
Risk of infertility: Radiation exposure associated with AZEDRA may cause infertility in males and females. Radiation absorbed by testes and ovaries from the recommended cumulative dose of AZEDRA is within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

Adverse Reactions:
The most common severe (Grade 3–4) adverse reactions observed in AZEDRA clinical trials (≥10%) were lymphopenia (78%), neutropenia (59%), thrombocytopenia (50%), fatigue (26%), anemia (24%), increased international normalized ratio (18%), nausea (16%), dizziness (13%), hypertension (11%), and vomiting (10%). Twelve percent of patients discontinued treatment due to adverse reactions (thrombocytopenia, anemia, lymphopenia, nausea and vomiting, multiple hematologic adverse reactions).
Drug Interactions:
Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells and therefore interfere with dosimetry calculations or the efficacy of AZEDRA. These drugs were not permitted in clinical trials that assessed the safety and efficacy of AZEDRA. Discontinue the drugs listed in the prescribing information for at least 5 half-lives before administration of either the dosimetry dose or a therapeutic dose of AZEDRA. Do not administer these drugs until at least 7 days after each AZEDRA dose.
For important risk and use information about AZEDRA, please see Full Prescribing Information.
To report suspected adverse reactions, contact Progenics Pharmaceuticals, Inc. at 844-668-3950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference: AZEDRA prescribing information. New York, NY: Progenics Pharmaceuticals, Inc.; 08 2018.

About RELISTOR

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Bausch Health Companies, Inc. RELISTOR Tablets (450 mg once daily) are approved in the United States for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for OIC approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.

IMPORTANT SAFETY INFORMATION – RELISTOR (methylnaltrexone bromide) tablets, for oral use and RELISTOR (methylnaltrexone bromide) injection, for subcutaneous use

Progenics Announces Fourth Quarter and Full-Year2019 Financial Results

RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.

A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.
In the clinical studies, the most common adverse reactions were:
h Quarter and Full-Year2019 Financial Results

OIC in adult patients with chronic non-cancer pain

RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).

RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).

OIC in adult patients with advanced illness

RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

Please see complete Prescribing Information for RELISTOR at www.bauschhealth.com. For more information about RELISTOR, please visit www.RELISTOR.com.

On March 13, 2020 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported fourth quarter and year-end 2019 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAR 13, 2020, View Source [SID1234555537]).

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Recent Highlights

Completed meeting with the U.S. Food & Drug Administration (FDA) to finalize the Phase 3 cytisinicline clinical development program

Presented new findings from the Phase 2b ORCA-1 trial evaluating cytisinicline in U.S. smokers at the Society for Research on Nicotine & Tobacco (SRNT) Annual Conference in March 2020

Established agreement with the FreeMind Group to assist in securing non-dilutive funding to evaluate cytisinicline in vapers and e-cigarette users

Closed underwritten public offering for gross proceeds of $13.8 million, before underwriting discounts and commissions and offering expenses

"With over 34 million smokers and nearly 11 million vape and e-cigarette users in the United States alone, the nicotine addiction epidemic continues to be a major public health crisis that Achieve is exclusively focused on addressing through the development of cytisinicline," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "Our key priorities in the coming months are to initiate the ORCA-2 Phase 3 clinical trial in smokers and secure non-dilutive financing to evaluate cytisinicline specifically in the growing population of vape users."

Completed FDA Meeting

In the fourth quarter of 2019, Achieve received feedback on the Phase 3 clinical trial protocols and the cytisinicline clinical development program. Specifically, the FDA agreed with the overall Phase 3 study designs that anticipate utilizing the simplified cytisinicline dosing schedule of 3.0 mg administered three times daily and the duration of 6 and 12 weeks of treatment. Additionally, the FDA agreed that no further escalation in cytisinicline dosing beyond the 30.0 mg dose was necessary for defining a maximum tolerated dose, which is required for the New Drug Application.

Additional ORCA-1 Results at SRNT Annual Conference

An oral presentation featuring new ORCA-1 Phase 2b trial analyses was presented at the SRNT Annual Meeting in March 2020. In addition to previously reported data indicating a statistically significant improvement in quit rates, new analyses demonstrate cytisinicline biochemical efficacy via measurement of serum cotinine as well as the previous carbon monoxide efficacy. Additionally, further analyses confirm that cytisinicline benefit was observed across all clinical sites, baseline characteristics, and attributes. Thus, regardless of trial site location, patient demographics, smoking history, or prior treatments, all subjects treated with cytisinicline showed similar smoking cessation benefit.

Agreement with the FreeMind Group to secure non-dilutive financing for vaping trials

Achieve retained the FreeMind Group, an international consulting firm dedicated to assisting life science organizations secure non-dilutive funding. Achieve and FreeMind will conduct a strategic assessment of potential non-dilutive funding opportunities from various public and private sources, followed by anticipated grant production and submission, to further the clinical development of cytisinicline in vaping or e-cigarette cessation.

Closed underwritten public offering for gross proceeds of $13.8 million

In December 2019, Achieve announced the closing of an underwritten public offering that raised total gross proceeds of $13.8 million, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses.

Financial Results

As of December 31, 2019, the company’s cash, cash equivalents, and restricted cash was $16.7 million. Total operating expenses for the fourth quarter and year ended December 31, 2019 were $3.2 million and $16.5 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2019 was $3.2 million and $16.4 million, respectively.

As of March 13, 2020 Achieve had 31,352,764 shares outstanding.

Conference Call Details

Achieve will host a conference call at 8:30 a.m. Eastern time today, Friday, March 13, 2020. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6628874. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On March 13, 2020 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2019, and provided a corporate update (Press release, Lipocine, MAR 13, 2020, View Source [SID1234555536]).

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Fourth Quarter and Recent Corporate Highlights

·Resubmitted the New Drug Application ("NDA") in February 2020 for TLANDO, the Company’s oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
oThe NDA resubmission was made following a Post Action Meeting with the U.S. Food and Drug Administration ("FDA") to discuss a potential path forward for TLANDO. The NDA incorporates the reanalysis of existing data based on written feedback from the FDA to address the deficiency from the Complete Response Letter ("CRL") received from the FDA in November 2019.
oThe FDA has assigned a Prescription Drug User Fee Act ("PDUFA") goal date of August 28, 2020.
· Continued to actively enroll in the ongoing LPCN 1144 LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study, a paired-biopsy study in confirmed pre-cirrhotic non-alcoholic steatohepatitis ("NASH") patients.
oTop-line liver fat reduction data, as measured by MRI-PDFF at 12 weeks, are expected in the second half of 2020, followed by 36-week biopsy data which are expected by the first half of 2021.
·Raised $6.0 million in gross proceeds in a registered direct offering of common stock and warrants in February 2020.
·Raised $6.0 million in gross process in a public offering of common stock and warrants in November 2019.

"We are pleased that the FDA has assigned a new PDUFA date for TLANDO and are committed to working with the Agency towards the goal of achieving approval of TLANDO," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "Based on the recent Post Action Meeting and subsequent written feedback, the FDA has indicated our approach to addressing the deficiency from the most recent CRL appears to be a reasonable path forward. In parallel, we continue to develop LPCN 1144 for the treatment of NASH and look forward to announcing top line liver fat data from the ongoing LiFT clinical study in the second half of 2020."

Year Ended December 31, 2019 Financial Results

Lipocine reported a net loss of $13.0 million, or ($0.50) per diluted share, for the year ended December 31, 2019, compared with a net loss of $11.7 million, or ($0.55) per diluted share, for the year ended December 31, 2018.

Research and development expenses were $7.5 million for the year ended December 31, 2019, compared with $6.5 million for the year ended December 31, 2018. The increase in research and development expenses during the year ended December 31, 2019 was primarily due to increases in contract research organization and outside consulting and manufacturing costs for LPCN 1144 and an increase in costs for TLANDO XR (LPCN 1111), offset by a decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study and the filing of the NDA in the first half of 2019, a decrease in contract manufacturing costs for LPCN 1107 and a decrease in personnel expense.

General and administrative expenses were $5.6 million for the year ended December 31, 2019, compared with $5.3 million for the year ended December 31, 2018. The increase in general and administrative expenses was primarily due to increases in legal and corporate insurance costs offset by a decrease in personnel costs.

As of December 31, 2019, the Company had $14.1 million of unrestricted cash, cash equivalents and marketable investment securities compared to $15.3 million at December 31, 2018. Additionally, as of December 31, 2019 and December 31, 2018 the Company had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the SVB Loan and Security Agreement until TLANDO is approved by the FDA. In February 2020, the Company raised an additional $6.0 million in gross proceeds from a registered direct offering of common stock and warrants.