On May 6, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported financial results for the first quarter of 2021 (Press release, Agenus, MAY 6, 2021, View Source [SID1234579398]).

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"We have delivered on multiple key initiatives since our last update and expect to achieve additional impactful milestones during the remainder of the second quarter and the rest of 2021," said Garo Armen, PhD, Chief Executive Officer of Agenus. "Among important developments are the continuing clinical responses we are seeing with AGEN1181. We intend to advance AGEN1181 in combination with balstilimab in cancers for which current immunotherapies have shown no activity given AGEN1181’s positive clinical responses in these tumors. Treating these cancers successfully will be of substantial value to patients while potentially representing large commercial opportunities for Agenus."

Balstilimab (anti-PD-1): BLA submitted to U.S. FDA for recurrent/metastatic cervical cancer

A Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for the accelerated approval of balstilimab for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The submission was based on an update to data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 and published in an Oncogene editorial. This updated dataset includes maturation of late patient responses, with the overall data showing response rates of 20% in PD-L1 positive tumors, 15% in all tumors (PD-L1 positive and negative), and a median duration of response of 15.4 months.

Data demonstrating that balstilimab is a potentially differentiated anti-PD-1 antibody will be presented at the 2021 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4 – 8, 2021.

Discussions with the FDA regarding accelerated BLA filing for balstilimab plus zalifrelimab are ongoing; additional guidance and updated response rate data will be provided upon the FDA acceptance of the balstilimab monotherapy BLA.
AGEN1181 (anti-CTLA-4): Data demonstrate continued strong activity, including in tumors unresponsive to immunotherapy, as presented at AACR (Free AACR Whitepaper) 2021

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, a new partial response with AGEN1181 monotherapy was reported in the first and only melanoma patient treated to date, as well as a new conversion to complete response with AGEN1181 plus balstilimab in an ovarian cancer patient.

Continued clinical activity in patients with biomarkers which indicate a poor prognosis with approved immunotherapies, including patients with microsatellite stable (MSS) tumors and melanoma, endometrial, and ovarian cancer with the low-affinity FcyRIIIA allele. No immune-mediated hypophysitis, pneumonitis, or hepatitis were reported.

As of AACR (Free AACR Whitepaper) 2021, a total of seven confirmed objective responses were achieved in a Phase 1/2 trial of AGEN1181 in solid tumors out of 52 evaluable patients: 2 confirmed responses among 21 treated with monotherapy, and 5 confirmed responses among 31 treated with AGEN1181 in combination with balstilimab.

Phase 2 trial in colorectal cancer was initiated; registrational trials are targeted to commence in 2021 with a focus on indications enabling a rapid path to BLA submission. Further data updates expected later this year.
AGEN1777 (anti-TIGIT bispecific): Phase 1 anticipated 2021

IND submission is planned for the current quarter.

Phase 1 study is expected to commence in the third quarter.
Intelligent cell platform: Phase 1 study ongoing with iNKT cell therapy in patients with cancer and ARDS secondary to COVID-19

Phase 1 trial in hematologic cancers was initiated; expansion into solid tumors is expected this year.

Preliminary Phase 1 data for acute respiratory distress syndrome (ARDS) secondary to COVID-19 suggest iNKTs (invariant natural killer T cells) can be dosed without adverse events attributable to the therapy and may demonstrate early signals of activity. Dose escalation is expected to be completed this year with data readouts to be presented at upcoming conferences.
Additional programs and initiatives continue to advance

A data update on a Phase 1 trial of AGEN2373 (a CD137 agonist antibody) will be presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.

Agenus entered into a clinical collaboration with Nelum Pharmaceuticals for zalifrelimab in combination with NLM-001, Nelum’s small molecule hedgehog inhibitor, and chemotherapy for first-line advanced pancreatic cancer.
First Quarter Financial Results

We ended our first quarter 2021 with a cash balance of $119 million as compared to $100 million at December 31, 2020.

Cash used in operations for the three months ended March 31, 2021 was $43 million compared to $35 million for the quarter ended March 31, 2020. Net loss for the quarter ended March 31, 2021 was $54 million or $0.27 per share which includes non-cash expenses of $12 million compared to a net loss for the same period in 2020 of $45 million, or $0.31 per share which includes non-cash expenses of $3 million.

We recognized revenue of $12 million and $15 million for the quarters ended March 31, 2021 and 2020, respectively, which includes revenue related to non-cash royalties earned and revenue recognized under our collaboration agreements.

On May 6, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Lipocine, MAY 6, 2021, View Source [SID1234579415]).

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First Quarter Recent Corporate Highlights

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
36-week biopsy data from the LiFT study are expected in August 2021
Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144
Announced the publication of results supporting the therapeutic potential of LPCN 1144 in the treatment of non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis
The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation
Continued to evaluate commercial options for TLANDO, our oral testosterone product for testosterone replacement therapy ("TRT") in adult males with hypogonadism
Posters featuring clinical data on TLANDO were presented at the ENDO 2021 Conference
Raised gross proceeds of approximately $28.7 million in a public offering of approximately 16.4 million shares of common stock
First Quarter Ended March 31, 2021 Financial Results
Lipocine reported a net loss of $3.4million, or ($0.04) per diluted share, for the first quarter ended March 31, 2021, compared with a net loss of $5.8 million, or ($0.14) per diluted share, for the first quarter ended March 31, 2020.

Research and development expenses were $1.6 million for the first quarter ended March 31, 2021, compared with $2.5 million for the first quarter ended March 31, 2020. The decrease in research and development expenses during the three months ended March 31, 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects and a decrease in raw material costs of TLANDO XR offset by increases in personnel expense and other R&D expenses.

General and administrative expenses were $1.5 million for the first quarter ended March 31, 2021, compared with $2.1 million for the first quarter ended March 31, 2020. The decrease in general and administrative expenses during the three months ended March 31, 2021 was primarily due to a decrease in legal costs due to less activity in 2021 as compared to 2020 in the following activities: lawsuit filed against Clarus Therapeutics Inc. for patent infringement in April 2019 and the on-going class action lawsuit defense. Additionally, personnel costs decreased in 2021. These decreases were offset by an increase in corporate insurance expenses.

As of March 31, 2021, the Company had $50.0 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

On May 6, 2021 Galapagos NV (Euronext & NASDAQ: GLPG) reported its unaudited Q1 results and operational highlights, which are further detailed in the Q1 2021 report available on the Galapagos website, www.glpg.com (Press release, Galapagos, MAY 6, 2021, View Source [SID1234579437]).

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"These last months, we completed a review of our portfolio and development plans with the goal to select a more risk-balanced pipeline. We decided to retain our focus on novel targets to address unmet medical needs in inflammation, fibrosis, and kidney diseases. We also remain fully committed to the launch of Jyseleca in Europe. Moving forward with confidence, we decided to:

Refocus our clinical pipeline by critically examining its risk profile and breadth;
Cut significant cost in the organization to support this re-sized pipeline development;
Task our business development team to identify and execute on a transformative opportunity.
We believe that our strong cash position, expert teams, and solid scientific foundation position us well for future growth," said Onno van de Stolpe, CEO of Galapagos.

Refocused pipeline
In the revision exercise, Galapagos set goals to focus and adjust the overall risk profile of its clinical pipeline. Consequently, we prioritized those assets with what we believe have enhanced chances of clinical success in our core therapeutic areas. As such, we announce:

We are testing our lead Toledo program ‘3970, a SIK2/3 inhibitor, in five Proof of Concept studies in different indications, and pending the outcome of the studies, we plan to roll out our further development plans in the second half of the year;
We selected an additional molecule from our Toledo program, SIK2/3 inhibitor ‘4876, as a candidate to accelerate from preclinical phase into clinical development;
We aim to progress our TYK2 inhibitor ‘3667 into Phase 2b;
We selected chitinase inhibitor ’4617 to progress to Phase 2 in IPF and decided to stop development of our other IPF molecule ’1205;
We stopped further work on ‘4059 for metabolic disease, given that this is not a core therapeutic area;
We discontinued our early research efforts in metabolic diseases and osteoarthritis; and
We challenged and fine-tuned our stage-gating process to advance compounds.

Commercial progress

We remain well on track in launching filgotinib in Europe. In the first quarter, we successfully completed the transitions of commercial and medical teams from Gilead in Germany, the UK, Spain, and Italy. We believe everything is in place to complete the final transitions from Gilead to us by year-end. Q1 also saw progress on access and reimbursement for filgotinib in rheumatoid arthritis (RA). Gilead submitted the new drug application in Japan for the treatment of ulcerative colitis (UC). We are encouraged by the primary endpoint outcome with the MANTA/RAy semen parameter studies as we await the Committee for Medicinal Products for Human Use (CHMP) opinion in UC.

Bart Filius, President and COO, added, "In line with our review, we decided to discontinue or cancel certain studies and consequently identified opportunities to reduce operational costs, for a total potential savings of €150M on a full-year basis. Roughly half of these savings will be realized in 2021, resulting in a 2021 cash burni guidance of between €580 million and €620 million. We are working towards a right-sized, refocused version of Galapagos, setting us on a path towards success with our first commercial product, new R&D opportunities, substantial clinical news flow, and a lengthened cash runway for validation of our early pipeline assets."

(*) The 2020 comparatives have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020.

Details of the financial results
Due to the sale of our fee-for-service business (Fidelta) to Selvita on 4 January 2021 for a total consideration of €37.1 million (including customary adjustments for net cash and working capital), the results of Fidelta are presented as "Net profit from discontinued operations" in our consolidated income statements for the three months ended 31 March 2021 and 31 March 2020.

Revenues and other income from continuing operations
Our revenues and other income from continuing operations for the first three months of 2021 increased to €124.2 million compared to €103.6 million in the first three months of 2020. Our revenues from the Gilead collaboration in the first three months of 2021 (€113.7 million) related to (i) the exclusive access to our drug discovery platform (€57.8 million), (ii) the filgotinib revenue recognition (€55.3 million) and (iii) royalties (€0.7 million).

Our deferred income balance on 31 March 2021 includes €1.9 billion allocated to our drug discovery platform that is recognized linearly over 10 years, and €0.8 billion allocated for the filgotinib development (including considerations for the previous and the renegotiated collaboration combined) that is recognized over time until the end of the development period.

Results from continuing operations
We realized a net loss from continuing operations of €12.8 million for the first three months of 2021, compared to a net loss of €52.3 million for the first three months of 2020.

We reported an operating loss amounting to €50.8 million for the first three months of 2021, compared to an operating loss of €46.2 million for the same period last year.

Our R&D expenditure in the first three months of 2021 amounted to €130.0 million, compared to €115.5 million for the first three months of 2020. This increase was due to an increase in subcontracting costs primarily related to our filgotinib program, our Toledo program and other clinical programs, compensated by a decrease for ziritaxestat, the OA program with GLPG1972 and the program in atopic dermatitis (AtD) with MOR106. Furthermore, the increase in personnel costs is explained by a planned headcount increase following the growth in our activities, and increased cost of the subscription right plans. This factor, and the increased cost of the commercial launch of filgotinib in Europe, contributed to the increase in our S&M and G&A expenses, which were respectively €14.6 million and €30.4 million in the first three months of 2021, compared to respectively €9.8 million and €24.5 million in the first three months of 2020.

We reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €2.0 million, mainly due to the decreased implied volatility of the Galapagos share price and its evolution between 31 December 2020 and 31 March 2021.

Net other financial income in the first three months of 2021 amounted to €36.2 million, compared to net other financial income of €14.8 million for the first three months of 2020, which was primarily attributable to €45.5 million of currency exchange gain on our cash and cash equivalents and current financial investments in U.S. dollars, and to €6.5 million of negative changes in (fair) value of current financial investments and financial assets.

Results from discontinued operations
The net profit from discontinued operations for the three months ended 31March 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for €22.2 million.

Group net results
We reported a group net profit for the first three months of 2021 of €9.4 million, compared to a group net loss of €50.6 million for the first three months of 2020.

Cash position
Current financial investments and cash and cash equivalents totaled €5,114.7 million on 31 March 2021, as compared to €5,169.3 million on 31 December 2020.

Total net decrease in cash and cash equivalents and current financial investments amounted to €54.6 million during the first three months of 2021, compared to a net decrease of €58.4 million during the first three months of 2020. This net decrease was composed of (i) €127.7 million of operational cash burn, (ii) offset by €2.3 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first three months of 2021, (iii) €3.6 million negative changes in (fair) value of current financial investments and €45.7 million of mainly positive exchange rate differences, (iv) €28.7 million cash in from disposal of subsidiaries, net of cash disposed.

Finally, our balance sheet on 31 March 2021 held a receivable from the French government (Crédit d’Impôt Rechercheiv) and a receivable from the Belgian Government for R&D incentives, for a total of both receivables of €142.3 million.

Outlook 2021
We anticipate several regulatory announcements on filgotinib as well as progress in our differentiated pipeline of novel target-based candidates.

We expect reimbursement decisions in most key European markets for filgotinib in RA this year, as we complete the transition to a full European commercial operation by year end. We anticipate a CHMP opinion and a European Commission decision for filgotinib in UC. We expect that our collaboration partner Gilead will complete recruitment for the global DIVERSITY Phase 3 trial in Crohn’s disease this year.

Within our broader inflammation portfolio, we expect to report topline results from several trials this year, including a Phase 1b trial with TYK2 inhibitor ‘3667 in psoriasis, and three Proof of Concept studies with lead Toledo candidate SIK2/3 inhibitor ‘3970 in psoriasis, UC, and RA.

Within our fibrosis portfolio, we expect to progress early clinical compounds with novel mechanisms of action, with the aim to develop novel treatments to help patients suffering from this debilitating condition.

Following the review of our plans for 2021, we give guidance for full year 2021 operational cash burn of €580 to €620 million.

First quarter report 2021

Galapagos’ financial report for the first three months ended 31 March 2021, including details of the unaudited consolidated results, is accessible via www.glpg.com/financial-reports.

Results of annual ordinary shareholders’ meeting

On 28 April 2021, Galapagos held its annual ordinary shareholders’ meeting. All agenda items were approved, including the re-appointments of Ms. Katrine Bosley and Dr. Raj Parekh as members of the supervisory board, and approval of the remuneration report. All documents relating to the shareholders’ meeting are posted on our website at View Source

Conference call and webcast presentation

Galapagos will conduct a conference call open to the public tomorrow, 07 May 2021, at 14:00 CET / 8 AM ET, which will also be webcasted. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:

A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

On May 6, 2021 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its first quarter 2021 results (Press release, Targovax, MAY 6, 2021, View Source [SID1234579261]).

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An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 CET today (details below).

FIRST QUARTER HIGHLIGHTS
REASEARCH & DEVELOPMENT
Reported continued survival benefit in Targovax’s ONCOS-102 trial in mesothelioma at the 21-month follow-up
Median Overall Survival (mOS) has still not been met for randomized first-line patients receiving ONCOS-102 plus chemotherapy
mOS will be at least 20.5 months for randomized first-line patients receiving ONCOS-102 plus chemotherapy, compared to mOS of 13.5 months in the chemotherapy-only control group
Received Fast-Track designation from the US FDA for ONCOS-102 in malignant pleural mesothelioma. This opens the potential for expedited development path and review
Entered a research collaboration with Papyrus Therapeutics to develop novel ONCOS viruses with receptor tyrosine kinase (RTK) inhibitor functionality
CORPORATE
Announced Dr Sonia Quaratino as a new member of the Board of Directors
Obtained US Patent for ONCOS-102 in combination with checkpoint inhibitors
Maintained TG + chemo patent as granted after opposition in European Patent Office
FINANCIALS

The interim financial information has not been subject to audit

Øystein Soug, CEO commented: "Targovax is at the beginning of a new and exciting development phase. Based on impressive ONCOS-102 clinical data, our main priority going forward is to start a next trial in PD1 refractory melanoma. At the same time, it is also important that we do it right and discuss our strategy with the FDA, since the aim of this trial is to support an accelerated approval. Moreover, based on the strength and breadth of the clinical and immune data, we believe our technology warrants a broader application. Hence, we envision several expansion possibilities beyond melanoma in other indications, with other novel combinations, and for our next generation pipeline products."

Presentation
We invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On May 6, 2021 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the first quarter 2021 (Press release, Acorda Therapeutics, MAY 6, 2021, View Source [SID1234579333]).

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"We were pleased to see the increase in INBRIJA net sales in the first quarter of 2021 over the same quarter of 2020. In addition, our organic growth, measured by the increase in dispensed cartons, was 25% compared to the first quarter of 2020 and also an acceleration versus last quarter. This is an encouraging sign that we may be starting to see the impact of a receding pandemic on our business," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We continue to see renewed interest in ex-US commercial partnerships for INBRIJA, owing to the reduced cost of goods that resulted from the sale of our manufacturing operations to Catalent earlier this year, as well as clarity from the GBA in Germany indicating that an early benefit assessment would not be required. We are in active discussions with several parties for commercialization both in Europe and around the world."

"We were also pleased to see stable year-over-year quarterly sales for AMPYRA for the first time since it went generic in September 2018 and believe this is due to the strategies we have executed to maintain the brand. The strength of the AMPYRA brand is an important contributor to Acorda’s financial stability and to our goal of becoming cash-flow neutral by the end of 2022," Cohen continued. "We also plan to address our $69 million convertible debt payment that is coming due in June of 2021."

First Quarter 2021 Financial Results

For the quarter ended March 31, 2021, the Company reported INBRIJA net revenue of $5 million, compared to $4.4 million for the same quarter in 2020.

For the quarter ended March 31, 2021, the Company reported AMPYRA net revenue of $20.3 million compared to $20.1 million for the same quarter in 2020. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended March 31, 2021 were $4.7 million, including $0.2 million of share-based compensation compared to $7.7 million, including $0.4 million of share-based compensation for the same quarter in 2020.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2021 were $34.0 million, including $0.5 million of share-based compensation compared to $41.1 million, including $1.5 million of share-based compensation for the same quarter in 2020.

Change in fair value of derivative liability for the quarter ended March 31, 2021 was $0.2 million compared to $(26.5) million for the same quarter in 2020.

Benefit from income taxes for the quarter ended March 31, 2021 was $3.2 million compared to a benefit from income taxes of $7.0 million for the same quarter in 2020.

The Company reported a GAAP net loss of $33.5 million for the quarter ended March 31, 2021, or $3.53 per diluted share. GAAP net loss in the same quarter of 2020 was $6.5 million, or $0.81 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2021 was $23.3 million, or $2.46 per diluted share. Non-GAAP net loss in the same quarter of 2020 was $24.4 million, or $3.06 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, asset impairment charges, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2021, the Company had cash, cash equivalents, short-term investments, and restricted cash of $148.4 million, compared to $102.9 million at year end 2020. Restricted cash includes $31.1 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the 2024 convertible senior secured notes. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.

Financial Guidance

For the full-year 2021, Acorda continues to expect AMPYRA net revenue to be $75 – $85 million, and operating expenses to be $130 – $140 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Webcast and Conference Call

The Company will host a conference call and webcast in conjunction with its first quarter 2021 update and financial results today at 4:30 p.m. EDT.

To participate in the Webcast/Conference Call, please note there is a new pre-registration process.

To register for the Webcast, use the link below:
View Source

To register for the Conference Call, use the link below:
View Source

**When registering please type your phone number with no special characters**

Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. EDT on May 6, 2021 until 11:59 p.m. EDT on June 3, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 2996776. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.