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LIPOCINE ANNOUNCES FINANCIAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2020

On March 11, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the fourth quarter and year ended December 31, 2020, and provided a corporate update (Press release, Lipocine, MAR 11, 2021, View Source [SID1234576480]).

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"Lipocine had a number of important accomplishments in 2020, most notably the U.S. Food and Drug Administration ("FDA") decision to grant tentative approval to TLANDO, the Company’s oral testosterone product for testosterone replacement therapy ("TRT") in adult males with hypogonadism. We are committed to taking action to receiving final approval to permit the launch of the product," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "We also made excellent progress advancing LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH"). We were pleased with the top-line results from our Phase 2 LiFT clinical study, announced in January 2021, which showed that treatment with LPCN 1144 resulted in significant liver fat reduction and improvement of key liver injury markers. The trial is on-going and we expect 36-week biopsy data in July/August 2021."

Fourth Quarter and Recent Corporate Highlights

Granted tentative approval by the FDA for TLANDO, Lipocine’s oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone
Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects
Both LPCN 1144 treatment arms met the primary endpoint, change in hepatic fat fraction via magnetic resonance imaging proton density fat fraction ("MRI-PDFF"), with statistical significance
Statistically significant reduction in markers of liver injury were observed for LPCN 1144 compared to placebo
36-week biopsy data from the LiFT study are expected in July/August 2021
Began enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144 (no placebo arm)
The extension will allow the collection of additional data on LPCN 1144 for up to a total of 72 weeks of therapy
Raised gross proceeds in January 2021 of approximately $28.7 million in a public offering of approximately 16,428,571 million shares of common stock
Year Ended December 31, 2020 Financial Results
Lipocine reported a net loss of $21.0 million, or ($0.38) per diluted share, for the year ended December 31, 2020, compared with a net loss of $13.0 million, or ($0.50) per diluted share, for the year ended December 31, 2019.

Research and development expenses were $9.7 million for the year ended December 31, 2020, compared with $7.5 million for the year ended December 31, 2019. The increase in research and development expenses compared with the prior year was primarily due increases in contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study, an increase in commercial manufacturing costs related to TLANDO, an increase in personnel expense, as well as a net increase in other R&D programs and expenses. Additionally, other costs related to TLANDO had a net decrease which was the result of a decrease in contract research organization expenses, offset by increases in other TLANDO expenses.

General and administrative expenses were $8.2 million for the year ended December 31, 2020, compared with $5.6 million for the year ended December 31, 2019. The increase in general and administrative expenses compared with the prior year was primarily due to an increase in legal costs, an increase in personnel costs, and an increase in other general and administrative expenses. These were offset by a decrease in administrative travel expenses and marketing expense.

As of December 31, 2020, Lipocine had $19.7 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million as of December 31, 2019. Additionally, as of December 31, 2020 and December 31, 2019 Lipocine had $5.0 million of restricted cash, which was required to be maintained as cash collateral under the Silicon Valley Bank ("SVB") Loan and Security Agreement until TLANDO is approved by the FDA. However, on February 16, 2021, Lipocine and SVB amended the Loan and Security Agreement to, among other things, remove the cash collateral requirement.

Subsequent to the end of the year, in January 2021, Lipocine raised gross proceeds of approximately $28.7 million in a public offering before deducting underwriting discounts and commissions and other offering expenses payable by Lipocine.

Lisa Anson discusses life science funding and investment with Pharmaphorum (Podcast)

On March 11, 2021 Redx Pharma reported a secured £3.9 million in funding from investors, including Alderley Park Ventures and BioCity (Press release, Redx Pharma, MAR 11, 2021, View Source [SID1234576479]). The funding marked a major milestone for KScan, its next-generation biomarker and molecular diagnostics platform for treating cancer patients and other conditions.

Redx Pharma’s Lisa Anson talked about the company’s multi-million global licensing deal with pharma giant AstraZeneca, which will further develop and commercialise its treatment for sufferers of fibrotic diseases, and its other recent fundraising milestones.

The episode also heard Dr Kath Mackay discuss Alderley Park’s business support programme the Alderley Park Accelerator, which mentors companies through the investment process, and showcase why creating connections is so important.

Alderley Park, a development by Bruntwood SciTech, is the UK’s largest single-site life science campus and offers bioscience facilities for R&D-focussed life science companies at every stage of their lifecycle, from start-up to global corporate.

Episode two of its podcast looked at why university connections are vital for a life science and tech cluster like Alderley Park and how the campus works to inspire the next generation of scientists.

Meanwhile, the first episode focused on the challenges of rapidly building capacity for thousands of COVID tests at the Alderley Park Lighthouse Lab.

Selecta Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2020 Financial Results

On March 11, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported recent business highlights and financial results for the fourth quarter and year ended December 31, 2020 (Press release, Selecta Biosciences, MAR 11, 2021, View Source [SID1234576478]).

"This is a very exciting time in Selecta’s history, having made significant progress across all aspects of the company," said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. "In 2020, we significantly de-risked the company through a strategic partnership with Sobi for SEL-212, under which we commenced the Phase 3 DISSOLVE program in the third quarter of 2020. We rapidly advanced our pipeline, having recently dosed our first subject with ImmTOR in combination with an AAV capsid, which builds on compelling non-human primate data announced earlier this year."

"We are very pleased by the continued progress of our gene therapy program. In collaboration with AskBio, our lead program in methylmalonic acidemia, is on track to enter the clinic in the second quarter of this year and we expect initial data by the end of the year. A key objective of 2021 will be to generate human data in our gene therapy programs and to continue to build our extensive pipeline in gene therapies, enzyme therapies—with an expected IND filing by the end of the year in IgA nephropathy—and autoimmune diseases, as we work to deliver on our mission to leverage our pioneering ImmTOR platform to improve the lives of patients and their families," Dr. Brunn added.

Recent Business Highlights and Anticipated Milestones

Enzyme Therapies:

SEL-212 for chronic refractory gout: The Phase 3 DISSOLVE clinical program for SEL-212 for the treatment of chronic refractory gout, which was licensed to Sobi, is progressing as planned with topline data expected in the second half of 2022.
The Phase 3 clinical program consists of two double blind, placebo-controlled trials of SEL-212 (DISSOLVE I and DISSOLVE II) (NCT04513366 and NCT04596540, respectively). Both studies have a 6-month primary endpoint of serum uric acid (SUA) < 6 mg/dL at month 6, and DISSOLVE I has a 6-month safety extension.
IgA nephropathy: Selecta’s second indication is IgA nephropathy, a kidney disease that occurs when immune complexes of an antibody called immunoglobulin A1 (IgA1) accumulates in the kidneys. Leveraging the learnings from SEL-212, Selecta will be researching a novel therapeutic approach by combining ImmTOR with an enzyme, IgA1 protease, which has been shown in animal studies to debulk the IgA1 immune complexes in the kidney, the root cause of IgA nephropathy. Selecta expects to file an Investigational New Drug, or IND, application, for this program by the end of 2021.
Gene Therapies:

MMA-101 for methylmalonic acidemia (MMA): Selecta’s lead gene therapy product candidate, MMA-101 combined with ImmTOR for the treatment of MMA, is expected to enter the clinic in the second quarter of 2021 with preliminary data expected by year-end. The MMA-101 program is being conducted in collaboration with AskBio.
Selecta and AskBio received Orphan Designation for MMA-101 from the U.S. Food and Drug Administration (FDA) in November 2020. MMA-101 previously received Rare Pediatric Disease Designation from the FDA in October 2020.
First-in-human trial of SEL-399: In collaboration with AskBio, Selecta recently initiated the first-in-human dose-escalation trial of SEL-399, an adeno-associated viral serotype 8 (AAV8) empty vector capsid (EMC-101) containing no DNA combined with ImmTOR. The trial aims to determine the optimal dose of ImmTOR to mitigate the formation of antibodies to AAV8 capsids used in gene therapies. Selecta and AskBio expect to report initial data in the fourth quarter of 2021.
The dose-escalation trial of SEL-399 is designed to evaluate the safety and preliminary efficacy of ImmTOR in combination with an AAV capsid. Preliminary efficacy will be measured by assessing levels of AAV8-specific neutralizing antibodies.
SEL-313 for ornithine transcarbamylase deficiency (OTC deficiency): Selecta’s proprietary gene therapy product candidate, SEL-313, is being developed to treat OTC deficiency, a rare genetic disorder that causes ammonia to accumulate in the blood due to mutations in the OTC gene, which is critical for proper function of the urea cycle. SEL-313 is currently in preclinical development and is expected to enter the clinic in 2022. A Pediatric Investigation Plan (PIP) for SEL-313 was submitted to the European Medicines Agency (EMA) pediatric committee in February 2021.
Non-human primate data of ImmTOR in gene therapy: Selecta’s gene therapy programs build on extensive preclinical data that have demonstrated the potential benefits of the ImmTOR platform in AAV gene therapy. Selecta observed that co-administration of AAV vector and ImmTOR in non-human primates (NHP) enabled higher and more durable transgene expression as well as robust inhibition of anti-AAV8 immunoglobulin G (IgG) and neutralizing antibodies.
Restoring Self-Tolerance in Autoimmune Diseases:

Selecta continues IND-enabling work on an ImmTOR-based approach to treating primary biliary cholangitis (PBC), a chronic, progressive liver disorder that leads to inflammation, damage and scarring of the small bile ducts. PBC has a well-defined target antigen, significant unmet medical need, and is well suited to the application of our ImmTOR immune tolerance platform. Selecta expects to file an IND in PBC in 2022.
Fourth Quarter and Full Year 2020 Financial Results:

Cash Position: Selecta had $140.1 million in cash, cash equivalents, and restricted cash as of December 31, 2020, which compares to cash, cash equivalents, and restricted cash of $147.6 million as of September 30, 2020. Selecta believes its available cash, cash equivalents, and restricted cash will be sufficient to meet its operating requirements into the second quarter of 2023.

Revenue: Revenue recognition for the fourth quarter and fiscal year 2020 was $12.0 million and $16.6 million, respectively, which compares with $6.7 million and $6.7 million for the same periods in 2019.

Revenue was primarily driven by the license agreement with Sobi resulting from the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program.

Research and Development Expenses: Research and development expenses for the fourth quarter and fiscal year 2020 were $15.1 million and $54.5 million, respectively, which compares with $15.2 million and $42.7 million for the same periods in 2019.

During the quarter ended December 31, 2020, there was a reduction in expenses for the SEL-212 clinical programs due to the timing of the initiation of the Phase 3 DISSOLVE clinical program compared to the Phase 2 COMPARE program in the prior period. This reduction was offset by increases in expenses incurred under the AskBio Collaboration combined with internal research and development to support our clinical programs. The annual increase reflects the initiation of the Phase 3 DISSOLVE clinical program. These costs are subject to the cost reimbursement arrangement under the license agreement with Sobi.

General and Administrative Expenses: General and administrative expenses for the fourth quarter and fiscal year 2020 were $4.8 million and $18.9 million, respectively, which compares with $4.1 million and $16.4 million for the same period in 2019. The quarterly and annual increase in expense was the result of increased patent and professional fees and facility and office expenses offset by a decrease in travel expense.

Net Loss: For the fourth quarter and fiscal year 2020, Selecta reported a net loss of $15.4 million, or $0.14 per share and $68.9 million, or $0.68 per share, respectively, compared to a net loss of $14.9 million, or $0.28 per share and $55.4 million, or $1.22 per share, for the same periods in 2019.

Conference Call and Webcast Reminder:
Selecta management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company’s fourth quarter 2020 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10147796. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

Vaccinex to Present at the Oppenheimer 31st Annual Healthcare Conference

On March 11, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that Dr. Maurice Zauderer, chief executive officer, will deliver a company presentation at the Oppenheimer 31st Annual Healthcare Conference, which is being held March 16-18, 2021 (Press release, Vaccinex, MAR 11, 2021, View Source [SID1234576477]).

Presentation details:
Date: Tuesday, March 16
Time: 2:30-3:00pm ET

A live webcast of the presentation is available at the following link during and following the conference: View Source;page=vcnx&url=View Source

Aldeyra Therapeutics Reports Full-Year 2020 Financial Results and Recent Business Highlights

On March 11, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, reported business highlights and financial results for the year ended December 31, 2020 (Press release, Aldeyra Therapeutics, MAR 11, 2021, View Source [SID1234576476]).

"During the past year, we have worked diligently to advance our lead investigational compound reproxalap into pivotal Phase 3 clinical trials in dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Based on clinical results to date, we believe reproxalap has the potential to be first-line therapy for the treatment of dry eye disease and an important alternative to corticosteroids for the treatment of allergic conjunctivitis. We look forward to the potential to further validate the opportunities for reproxalap with the results of the TRANQUILITY, TRANQUILITY-2, and INVIGORATE trials, as we begin 2021 in a strong financial position, with liquidity expected to fund our current clinical development plans and operations through 2023."

Recent Highlights and Program Updates

Phase 3 INVIGORATE Allergic Conjunctivitis Trial Enrollment Completed: Aldeyra has completed patient enrollment of its randomized, double-masked, crossover design, vehicle-controlled, allergen chamber Phase 3 INVIGORATE Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis. The primary efficacy endpoint is patient-reported ocular itching score assessed on a 9-point scale. Investigator-assessed ocular redness is a key secondary endpoint. Top-line results are expected in the first half of 2021.
Phase 3 TRANQUILITY Dry Eye Disease Trial Design Finalized: In February 2021, Aldeyra announced the finalization of the design of the multi-center, randomized, double-masked, parallel-group, vehicle-controlled Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Approximately 150 dry eye disease patients are expected to be enrolled per arm. The primary endpoint is ocular redness over 90 minutes in a dry eye chamber. Tear RASP levels, Schirmer’s Test, and dry eye disease symptoms will be secondary endpoints. The protocol will utilize the two-day dosing paradigm, dry eye challenge design, and enrollment criteria of the run-in cohort. Results from the run-in cohort, announced in January 2021, demonstrated statistically significant improvement of reproxalap over vehicle in eye dryness score and other dry eye disease symptoms after a single day of dosing, and, during exposure to a dry eye chamber, statistically significant improvement of reproxalap over vehicle in eye dryness symptom score, ocular discomfort score, and ocular redness. TRANQUILITY and the confirmatory Phase 3 TRANQUILITY-2 Trial are on schedule to initiate enrollment in the first half of 2021. Top-line results from both trials are expected in the second half of 2021.
Phase 2 Clinical Testing of Novel Orally Administered RASP Inhibitor ADX-629 Initiated: In the fourth quarter of 2020, Aldeyra announced the initiation of Phase 2 proof-of-concept clinical trials of ADX-629, a first-in-class orally administered RASP inhibitor for the treatment of psoriasis, atopic asthma, and COVID-19. The trials are part of a systematic strategy to assess the activity of ADX-629 across different types of systemic inflammatory disease. Top-line results from the trials are expected by the end of 2021.
Enrollment of Phase 3 GUARD Proliferative Vitreoretinopathy Trial of ADX-2191 Continues: Completion of enrollment is expected in 2021 for Part 1 of the Phase 3 GUARD Trial of ADX-2191 (0.8% methotrexate intravitreal injection) for the prevention of proliferative vitreoretinopathy, a rare but serious sight-threatening retinal disease with no approved treatment.
Public Offering Completed: Aldeyra announced the closing of an underwritten public offering of 7,868,421 shares of its common stock at a price of $9.50 per share, including 1,026,315 additional shares of common stock sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. The underwritten offering generated gross proceeds of $74.7 million and net proceeds of $70.0 million after deducting underwriting discounts, commissions, and offering expenses.
Full-Year 2020 Financial Summary

Cash and cash equivalents as of December 31, 2020 were $77.9 million. Based on its current operating plan and including the net proceeds from the underwritten public offering completed in January 2021, Aldeyra believes that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through the end of 2023, including the completion of the Phase 3 TRANQUILITY and TRANQUILITY-2 trials in dry eye disease; the completion of the Phase 3 INVIGORATE trial in allergic conjunctivitis; the Phase 2 clinical trials of ADX-629 in psoriasis, atopic asthma, and COVID-19; and the completion of Part 1 of the adaptive Phase 3 GUARD clinical trial in proliferative vitreoretinopathy.

The net loss for full-year 2020 was $37.6 million, or $1.11 per share, compared with a net loss of $60.8 million, or $2.24 per share, for full-year 2019.

Research and Development (R&D) expenses were $24.7 million for full-year 2020 compared with $44.4 million for full-year 2019. The decrease of $19.7 million in R&D expenses primarily reflected a reduction in clinical research and development expenditures, partially offset by an increase in non-cash compensation costs related to a portion of a contingent acquisition milestone.

Acquired in-process research and development expenses were $1.8 million for full-year 2020 compared with $6.6 million for full-year 2019. The $4.8 million decrease is related to lower in-process research and development expenses associated with the 2019 acquisition of Helio Vision.

General and administrative (G&A) expenses were $10.0 million for full-year 2020 compared with $12.2 million for full-year 2019. The decrease of $2.2 million in G&A expenses primarily reflected lower personnel costs, legal costs, public company costs related to continuing compliance with the Sarbanes Oxley Act of 2002, and miscellaneous administrative costs.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its full-year 2020 financial results. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6253616. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

A live webcast of the conference call will also be available on the Investor Relations page of the company’s website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.