On May 12, 2020 BioXcel Therapeutics, Inc. ("BTI" or "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, reported its quarterly results for the first quarter ended March 31, 2020 and provided an update on key strategic and operational initiatives (Press release, BioXcel Therapeutics, MAY 12, 2020, View Source [SID1234557588]).

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"BioXcel continued to advance on its key milestones for 2020," stated Vimal Mehta, Chief Executive Officer of BTAI. "Beginning with our neuroscience program, we have made significant progress advancing BXCL501, as evidenced by our three ongoing clinical trials, SERENITY I & II and TRANQUILITY, and our Phase 1b/2 RELEASE trial initiating shortly. In parallel, we are investigating biomarkers associated with agitation in hopes of expanding the potential market for BXCL501 to additional indications. These significant achievements showcase the versatility of this candidate and we believe provides the foundation for creating a highly valuable neuroscience franchise. In addition, we have made great strides with our immuno-oncology program, identifying the recommended dose of BXCL701 when used in combination with KEYTRUDA for our Phase 2 efficacy trial for treatment emergent Neuroendocrine Prostate Cancer. We believe this candidate has the potential to provide a treatment for this advanced prostate cancer that currently does not have an effective standard of care."

Dr. Mehta added, "In light of the COVID-19 pandemic, we are continuously monitoring the safety of our team, as well as its potential impact on our clinical and corporate plans. To date, we have not experienced any significant delays with our ongoing clinical trials and have developed a risk mitigation strategy to manage business operations."

First Quarter 2020 and Recent Highlights

BXCL501-Neuroscience Program

BXCL501 is an investigational sublingual thin film of dexmedetomidine, a selective alpha-2A adrenergic receptor agonist, designed for the treatment of acute agitation. The Company believes BXCL501 may directly target a causal agitation mechanism.

·The SERENITY program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder, is ongoing, with more than one-third of the patients enrolled and treated as of March 19, 2020. Enrollment is progressing as planned, and the Company is on track to report topline data from both Phase 3 trials in mid-2020.
In January 2020, the first patient was enrolled in the TRANQUILITY study, a Phase 1b/2 trial of BXCL501 for the acute treatment of agitation associated with geriatric dementia. BTI is currently assessing safety and tolerability data in order to choose the next tested dose, and the Company expects to report topline results in mid-2020.

·Our Investigational New Drug application for the treatment of opioid withdrawal symptoms, a fourth indication for BXCL501, received clearance from the U.S. Food and Drug Administration in February 2020. The Company is planning to initiate the Phase 1b/2 RELEASE trial for the treatment of opioid withdrawal symptoms shortly.
·In February 2020, researchers at Yale University initiated a Phase 2 study designed to measure biomarkers associated with agitation in patients with schizophrenia and their response to treatment with BXCL501.
·The Company is currently completing the clinical planning stage for its fifth indication, agitation associated with hyperactive delirium, and is preparing to initiate a Phase 1b/2 trial of BXCL501 in the second half of 2020.

BXCL701-Immuno-Oncology Program

BXCL701 is an orally-delivered small molecule, innate immunity activator designed to inhibit dipeptidyl peptidase (DPP) 8/9 and block immune evasion by targeting Fibroblast Activation Protein (FAP). It has shown single agent activity in melanoma and safety has been evaluated in more than 700 healthy subjects and cancer patients.

·After completing the Phase 1b safety lead-in, the Company has initiated the Phase 2 portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab (KEYTRUDA) for treatment emergent Neuroendocrine Prostate Cancer (tNEPC). 0.3 mg of BXCL701 twice daily (BID) was found to be the recommended dose when used in combination with KEYTRUDA and this dose regime will be used for the efficacy assessment of the clinical program. The Company expects to report initial data from this trial in the fourth quarter of 2020.
·The open label Phase 2 basket trial evaluating the combination of BXCL701 and KEYTRUDA in patients with advanced solid cancers has been initiated. This study, which is being conducted at the MD Anderson Cancer Center, is following the dosing schedule used in the Phase 1b/2 study for tNEPC.
·The BXCL701 phase of the triple combination study of BXCL701, bempegaldesleukin (NKTR-214, Nektar Therapeutics, Inc.) and BAVENCIO (avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in pancreatic cancer is expected to begin following Nektar and Pfizer’s Phase 1b safety trial of a double combination of bempegaldesleukin and avelumab and the outcome of that trial.

Strengthened Balance Sheet

·In February 2020, the Company raised net proceeds of approximately $60 million in connection with its common stock offering. BTI believes that proceeds from this offering, together with current reserves, provide cash runway to fund key clinical, regulatory and operational milestones into 2021.

COVID-19

During the first quarter of 2020, the Company took steps in line with guidance from the U.S. Centers for Disease Control and Prevention (CDC) and the State of Connecticut to protect the health and safety of its employees and the community. In particular, the Company implemented a work-from-home policy for all employees and has restricted on-site activities to certain chemical, manufacturing and control ("CMC") and clinical trial activities. To date, the Company has not experienced any significant delays to its ongoing or planned clinical trials; however, this could rapidly change.

First Quarter 2020 Financial Results

BTI reported a net loss of $14.9 million for the first quarter of 2020, compared to a net loss of $7.2 million for the same period in 2019. The first quarter 2020 results include approximately $0.8 million in non-cash stock-based compensation.

Research and development expenses were $12.4 million for the first quarter of 2020, as compared to $5.7 million for the same period in 2019. The increase was primarily due to an increase in clinical trial expenses, salaries, bonus and related costs, professional research and project-related costs and chemical, manufacturing and controls costs related to our BXCL501 and BXCL701 product candidates.

General and administrative expenses were $2.6 million for the first quarter of 2020, as compared to $1.7 million for the same period in 2019. The increase was primarily due to professional fees for additional legal and patent services.

Total operating expenses for the first quarter of 2020 were approximately $15.0 million, as compared to total operating expenses of approximately $7.4 million for the same period in 2019.

As of March 31, 2020, cash and cash equivalents totaled approximately $80.1 million.

Conference Call:

BTI will host a conference call and webcast today at 8:30 a.m. ET. To access the call, please dial 877-407-2985 (domestic) and 201-378-4915 (international). A live webcast of the call will be available on the Investors sections of the BTI website at www.bioxceltherapeutics.com. The replay will be available through May 26, 2020.

On May 12, 2020 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that advances from its "off-the-shelf" or allogeneic platform at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual meeting which kicked off in virtual format today (Press release, Adaptimmune, MAY 12, 2020, View Source [SID1234557587]).

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Data from a poster summarized recent advances in Adaptimmune’s allogeneic platform demonstrating the production of engineered T-cells, differentiated from human induced pluripotent stem cells (hiPSC) (iT cells). The poster was presented by Garth Hamilton, PhD, a Principal Scientist at Adaptimmune, and Joanna Brewer, PhD, Adaptimmune’s SVP Allogeneic Research. There is a video webcast of this presentation available on the Adaptimmune website: https://bit.ly/2L6jtx5.

"We have clearly demonstrated that we can make T-cells from stem cells. These cells express our engineered SPEAR TCR targeting MAGE-A4 and can kill tumor cells in vitro as effectively as control cells," said Jo Brewer, Adaptimmune’s SVP of Allogeneic Research. "We have also reached a milestone in editing our engineered TCRs into the hiPSC genome to enable successful differentiation. This is one critical element as we plan to build large banks of pluripotent cells for our proprietary differentiation process, to generate functional T-cells expressing our engineered receptors. These are great advances as we prepare for clinical use."

Summary

·Poster Title: Driving ADP-A2M4 SPEAR Expression from an Endogenous Hematopoietic Lineage Promotor for "Off-the-Shelf" T-Cell Therapy for MAGE-A4+ Solid Tumors
·Edited hiPSCs (iT-cells) expressing the ADP-A2M4 TCR can kill cancer targets in vitro
·Data suggests that, like autologous SPEAR T-cells currently in clinical trials, ADP-A2M4 iT-cells have potential to be an efficacious cell therapy
·Ability to promote T-cell receptor expression in iT-cells via genetic knock-in at a defined locus offers an opportunity to produce multiple clonal iPSC banks encoding specific SPEAR TCRs against a range of tumor antigens

On May 12, 2020 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported results for its third quarter ended March 31, 2020 (Press release, Palatin Technologies, MAY 12, 2020, View Source [SID1234557585]).

Third Quarter Fiscal Year 2020 Financial Highlights

●Net loss of $(5.4) million, compared to $(5.7) million for the comparable quarter of 2019;
●Operating expenses of $5.7 million, compared to $5.8 million for the comparable quarter of 2019;
●Other income was $331,007, compared to $35,648 for the comparable quarter of 2019; and
●As of March 31, 2020, the Company had $88.9 million in cash and cash equivalents, compared to $91.5 million as of December 31, 2019, and no debt.

Recent Business Highlights and Updates

●Implemented multiple measures in response to the COVID-19 pandemic to safeguard the health and well-being of employees, their families, business partners and healthcare providers, while continuing to advance the Company’s programs;
●A Phase 2 clinical study with PL9643 for dry eye disease started in January 2020. Data readout is targeted for the fourth quarter of calendar year 2020;
●A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is delayed due to the pandemic and is now targeted to start in the first half of calendar year 2021; and
●AMAG has stated that they anticipate finalizing the divestiture of Vyleesi within the next several months.

"The entire Palatin team thanks healthcare workers across the nation for their selfless efforts in the treatment and care of COVID-19 patients, and I would also like to thank all of our employees for their dedication and commitment to ensure the advancement of our development programs and clinical trial patient support," said Carl Spana Ph.D., President and CEO of Palatin. "Although Palatin has experienced limited adverse impact on operations from the pandemic, we are cognizant there may be further disruptions to business activity based on a resurgence of the virus and have taken steps to be as prepared as possible for this potential outcome."

Dr. Spana further commented, "We continue to review AMAG’s process related to the divestiture of Vyleesi and their obligations under our license agreement and are prepared to take appropriate steps to protect our rights and Vyleesi’s significant value."

Programs Overview

Anti-Inflammatory / Autoimmune Programs

A Phase 2 clinical study with PL9643 for dry eye disease started in January 2020, and active patients continue treatment and monthly clinic visits. Enrollment of additional cohorts has been delayed, but we anticipate restarting enrollment in June 2020. Data readout is targeted for the fourth quarter of calendar year 2020.

A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is now targeted to start in the first half of calendar year 2021, with data readout in the first half of calendar year 2022.

The Company continues its assessment and development work related to the treatment of patients with diabetic retinopathy, with an IND targeted for mid-calendar year 2021.

The Company currently anticipates filing an IND and commencing clinical trials with PL8177 for non-infectious uveitis, for which FDA granted orphan drug designation, in the second half of calendar year 2021.

Hypoactive Sexual Desire Disorder ("HSDD") / Vyleesi (bremelanotide injection)

Due to the early commercial stage of Vyleesi and the sales and marketing strategy of our North American licensee AMAG Pharmaceuticals, Inc., including no charge for the first Vyleesi prescription, AMAG has not generated positive net sales through March 31, 2020. This has resulted in no royalties to Palatin during this period.

Vyleesi is the first as-needed treatment approved for premenopausal women with acquired, generalized HSDD. AMAG launched Vyleesi nationally in September 2019 through select specialty pharmacies with its established women’s health sales force.

In January 2020 AMAG announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America. In May 2020 AMAG stated that it is in negotiations regarding the divestiture of Vyleesi and will provide an update within the next few months.

Palatin continues to closely monitor AMAG’s process related to the divestiture of Vyleesi and AMAG’s obligations under the Vyleesi license agreement. Though sales of Vyleesi have been adversely affected by the COVID-19 pandemic, the Company believes that AMAG’s divestiture process has also adversely impacted Vyleesi sales. Palatin is prepared to take appropriate steps to protect its rights as the Vyleesi licensor and the significant value of the Vyleesi program.

Palatin continues discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during the second half of calendar year 2020 and calendar year 2021.

Natriuretic Peptide Receptor ("NPR") System Program

PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. The study is now anticipated to start patient enrollment in the second half of calendar year 2020.

Genetic Obesity Program

Palatin’s melanocortin receptor 4 (MC4r) peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designations, potential development, and licensing.

Third Quarter Fiscal Year 2020 Financial Results

Revenue

For the quarters ended March 31, 2020 and 2019, there were no revenues recorded.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2020 were $5.7 million compared to $5.8 million for the comparable quarter of 2019. The decrease in operating expenses was mainly due to the overall reduction in research and development expenses offset by an increase in general and administrative expenses.

Other Income/Expense, net

Total other income, net, was $331,007 for the quarter ended March 31, 2020, compared to total other income, net, of $35,648 for the quarter ended March 31, 2019. The difference is related primarily to the increase in investment income.

Net Loss

Palatin reported a net loss of $(5.4) million, or $(0.02) per basic and diluted share, for the quarter ended March 31, 2020, compared to a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the same period in 2019.

The difference in financial results between the three months ended March 31, 2020 and 2019 was mainly attributable to the increase in other income, net.

Cash Position

Palatin’s cash and cash equivalents were $88.9 million as of March 31, 2020, compared to $91.5 million at December 31, 2019, and cash, cash equivalents and accounts receivable of $103.8 million at June 30, 2019.

Management believes that existing capital resources will be adequate to fund the Company’s planned operations through at least March 31, 2022.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on May 12, 2020 at 11:00 a.m. Eastern Time to discuss the results of operations for the quarter ended March 31, 2020 in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-204-4368 (US/Canada) or 1-323-994-2082 (international), conference ID 8845359. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 8845359. The webcast and telephone replay will be available through May 19, 2020.

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On May 12, 2020 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported additional data from multiple oral and poster presentations during the ongoing 23rd American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting as well as its first quarter 2020 financial results (Press release, Beam Therapeutics, MAY 12, 2020, View Source [SID1234557584]).

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"The start to 2020 has been one of focused execution across our business and continued advancement of our proprietary base editing platform and portfolio, even with the uncertainty around the COVID-19 pandemic," said John Evans, chief executive officer of Beam. "We are pleased to have a strong showing during ASGCT (Free ASGCT Whitepaper), in which we are presenting our first in vivo proof of concept for base editing in alpha-1 antitrypsin deficiency as well as two potentially best-in-class approaches for base editing in sickle cell disease, including the direct correction of the HbS point mutation. These data are a testament to the compelling therapeutic potential of base editors and, coupled with our financial strength following our initial public offering, position us to continue our comprehensive investment to develop base editors as a new class of precision genetic medicines for patients."

Updated Data Presented at ASGCT (Free ASGCT Whitepaper)

Alpha-1 Antitrypsin Deficiency Program Demonstrates Proof-of-Concept in a Mouse Model: Beam reported additional data from its direct editing program for Alpha-1 in a poster at ASGCT (Free ASGCT Whitepaper) titled "Use of Adenine Base Editors to Precisely Correct the Disease-Causing PiZ Mutation in Alpha-1 Antitrypsin Deficiency." Updated data demonstrate that using Beam’s adenine base editors (ABEs) to directly correct the PiZ mutation resulted in an average of 16.9% correction of beneficial alleles at seven days and 28.8% at three months. This significant increase over the period suggests that corrected hepatocytes may have a proliferative advantage relative to uncorrected cells. In addition, treated mice demonstrate decreased alpha-1 antitrypsin (A1AT) globule burden within the liver and a durable increase in serum A1AT, roughly 4.9-fold higher than in controls, was observed at three months. These data support the potential for base editing to treat both the lung and liver manifestations of Alpha-1.

HbG-Makassar Program Demonstrates Significant In Vitro Direct Editing for Sickle Cell Disease: Beam reported additional data from its direct correction program for sickle cell disease in a poster titled "A Novel Base Editing Approach to Directly Edit the Causative Mutation in Sickle Cell Disease." Updated data show conversion of the causative HbS point mutation to HbG-Makassar, a naturally-occurring human variant that does not cause hemoglobin to polymerize or red cells to sickle, at levels greater than 80%. A simultaneous reduction of HbS globin to less than 20% of control levels was observed in edited in vitro-differentiated erythroid cells from a homozygous sickle cell disease patient. In addition, more than 70% of erythroid colonies derived from edited patient cells showed biallelic editing, with 20% monoallelic and 2% unedited. Further, when in vitro-differentiated erythroid cells were subjected to hypoxia, a very significant reduction in sickling was observed. These data demonstrate therapeutic levels of correction and support advancement of this program to potentially address the underlying genetic cause of sickle cell disease.

HPFH Program Demonstrates Therapeutically Relevant Increase in Gamma Globin Protein: Beam will present findings from its HPFH program in an oral presentation titled, "Base Editing of Gamma Globin Gene Promoters Generates Durable Expression of Fetal Hemoglobin for the Treatment of Sickle Cell Disease." Beam’s HPFH program aims to recreate naturally-occurring single base changes in the gamma globin gene promoters (HBG1 and HBG2) that disrupt repressor binding and lead to increased expression of gamma globin, which is half of the fetal hemoglobin (HbF) tetramer. Beam observed more than 90% editing and a more than 65% increase in gamma globin levels compared to less than 1.5% in unedited cells in mice at 16 weeks post-transplant. Beam was able to replicate these findings with a second donor at 18 weeks post-transplant. In addition, the data showed successful editing of CD34+ cells from a homozygous sickle patient, demonstrating greater than 60% increase in gamma globin levels with a concomitant decrease to less than 40% in sickle beta globin levels in vitro. The data demonstrate that ex vivo delivery of ABEs achieved precise editing, resulting in long-term engraftment and therapeutically relevant increases in target gene expression.

Business Continuity Plans

Beam continues to execute its business objectives for 2020, while closely monitoring the impact of the evolving COVID-19 pandemic. The company continues to operate under a remote model while advancing critical research and development activities to support an initial wave of Investigational New Drug (IND) applications beginning in 2021.

First Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $253.4 million as of March 31, 2020, which includes $188.3 million in net proceeds from the company’s initial public offering completed in February 2020.

Research & Development (R&D) Expenses: R&D expenses were $21.5 million for the quarter ended March 31, 2020, compared to $9.2 million for the quarter ended March 31,

2019. This increase was primarily due to the growth in the number of research and development employees and their related activities, as well as the expense allocated to R&D related to Beam’s leased facilities.

General &Administrative (G&A) Expenses: G&A expenses were $6.8 million for the quarter ended March 31, 2020, compared to $3.9 million for the quarter ended March 31, 2019. This increase was primarily a result of increased personnel related costs due to an increase in general and administrative employees and other administrative expenses.

Net Loss: Net loss attributable to common stockholders was $31.7 million, or $1.03 per share, for the quarter ended March 31, 2020, compared to $16.6 million for the quarter ended March 31, 2019.

On May 12, 2020 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer reported first quarter financial results for the period ended March 31, 2020 (Press release, SpringWorks Therapeutics, MAY 12, 2020, View Source [SID1234557583]).

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"We are pleased with our execution in the first quarter of 2020, which included building upon our existing intellectual property portfolio by extending the patent protection for our lead product candidate, nirogacestat, to 2039, while continuing to advance our diversified pipeline of targeted oncology programs," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our focus for the remainder of the year continues to be on enrolling patients in our ongoing clinical trials, advancing nirogacestat as a cornerstone of BCMA combination therapy for patients with multiple myeloma, and further expanding our portfolio through additional business development activities."

Recent Business Highlights

In March 2020, the United States Patent and Trademark Office issued a new composition of matter patent that covers the polymorphic form of nirogacestat that is currently in clinical development. This patent expires in 2039.

In March 2020, MapKure LLC, a clinical-stage company that is jointly owned by SpringWorks and BeiGene, Ltd., announced that the first patient was dosed in Australia in a Phase 1 clinical trial of BGB-3245, a selective RAF dimer inhibitor. This ongoing Phase 1 trial is enrolling adult patients with biomarker-defined advanced or refractory solid tumors that may benefit from BGB-3245 treatment. The companies also announced that the U.S. Food and Drug Administration has allowed the Investigational New Drug application submitted for BGB-3245 to proceed, which will enable this study to expand to U.S. sites as well.

In January 2020, SpringWorks entered into a clinical collaboration agreement with Allogene Therapeutics to evaluate nirogacestat in combination with ALLO-715, an investigational anti-B-cell maturation antigen (BCMA) allogeneic CAR T cell therapy, in patients with relapsed or refractory multiple myeloma. A Phase 1 study is expected to commence in the second half of 2020.

COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and the company is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2020 and refer to the Forward-Looking Statements section in this press release.

First Quarter 2020 Financial Results

 Research and Development (R&D) Expenses: R&D expenses were

$9.7 million for the first quarter, compared to $8.4 million for the comparable period of 2019. The increases in R&D expenses were primarily attributable to growth in employee costs, including non-cash share-based compensation associated with increases in the number of R&D personnel.

 General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the first quarter, compared to $3.3 million for the comparable period of 2019. The increases in G&A expenses were primarily attributable to growth in employee costs, including non-cash share-based compensation associated with increases in the number of G&A personnel, and increases in consulting and professional services related to the expansion of our business activities.

 Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $15.3 million, or a loss of $0.37 per share, for the first quarter of 2020. This compares to net loss of $11.4 million, or a loss of $5.41 per share, for the comparable period of 2019.

Cash Position: Cash and cash equivalents were $311.1 million as of March 31, 2020.