On November 12, 2020 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, reported its financial results for the third quarter and nine months ended September 30, 2020, and provided a corporate update (Press release, Revolution Medicines, NOV 12, 2020, View Source [SID1234570777]).

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"Revolution Medicines is a leader in developing innovative medicines and treatment strategies on behalf of patients with RAS-addicted tumors. We are advancing a growing portfolio consisting of both direct RAS(ON) Inhibitors and RAS Companion Inhibitors designed to enable combination approaches, including RMC-4630 targeting SHP2, RMC-5552 targeting mTORC1, and inhibitors of SOS1," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

"In our RAS Companion Inhibitor portfolio, we continue to make important strides with RMC-4630, our clinical stage inhibitor of SHP2. We selected the recommended Phase 2 dose and schedule (RP2DS) for both our monotherapy trial (RMC-4630-01) and the RMC-4630/cobimetinib (Cotellic) combination arm of the RMC-4630-02 clinical trial, and each trial will further evaluate the appropriate RP2DS in expansion cohorts of molecularly selected patients. As anticipated, we recently dosed a first patient in a new combination study of RMC-4630 with the third-generation EGFR inhibitor, osimertinib (Tagrisso). We also entered into a new clinical collaboration with AstraZeneca to study RMC-4630 in combination with an emerging asset targeting KRASG12C from AstraZeneca’s portfolio.

"In addition, we accelerated growth of our RAS(ON) Inhibitor platform, which has produced a collection of potent, cell-active inhibitors of diverse oncogenic RAS variants responsible for the vast majority of RAS-addicted cancers. Previously, we demonstrated significant anti-tumor effects of a representative potent and oral inhibitor of KRASG12C(ON). During the third quarter we confirmed the broad scope of our platform by demonstrating that representative KRASG12D(ON) inhibitors likewise induced tumor regressions in a preclinical model of human pancreatic cancer harboring the oncogenic KRASG12D mutation. We have advanced our KRASG12C/NRASG12C(ON), KRASG12D(ON), KRASG13C(ON) and KRASG12V(ON) inhibitor programs into lead optimization."

R&D Highlights

RAS Companion Inhibitors

Determined Recommended Phase 2 Dose and Schedule (RP2DS) for single agent RMC-4630 – Completed dose escalation and selected 200 mg administered on a Day 1/Day 2 (D1D2) weekly schedule as the RP2DS. The company plans to evaluate single agent RMC-4630 at the RP2DS in an expansion cohort of patients with gynecologic tumors harboring NF1LOF mutations, in addition to a small safety/tolerability cohort representing a broader set of histotypes and RAS pathway genotypes.

Determined RP2DS for RMC-4630 in Combination with the MEK Inhibitor, Cobimetinib – Completed dose escalation and selected RMC-4630 140 mg and cobimetinib 40 mg administered on a Day 1/Day 2 (D1D2) weekly schedule as the RP2DS. The company plans to further evaluate this combination at the RP2DS in expansion cohorts of patients with colorectal cancer harboring KRASG12V or KRASG12D mutations and others drawing from a broader set of histotypes and RAS pathway genotypes.

Interim Data Presented at ENA 2020 from Phase 1b/2 Clinical Trial Combining RMC-4630 with Cobimetinib – Interim data reported by investigators support a dual intermittent dosing strategy for RMC-4630 and cobimetinib that appears tolerable and exceeds target plasma exposures for each drug based on preclinical models of RAS pathway-driven cancers that project potential clinical activity. Investigators also reported preliminary evidence of anti-tumor activity in patients with colorectal cancer driven by KRAS mutations.

RMC-4630 Multi-Cohort Phase 1/2 Clinical Program Expanding as Potential Backbone for Combination Therapies –

Dosing and enrollment continue in the Amgen-sponsored Phase 1 study of RMC-4630 in combination with Amgen’s KRASG12C(OFF) inhibitor, AMG 510, or sotorasib
Dosing and enrollment continue in the Sanofi-sponsored Phase 1 study of RMC-4630 in combination with the PD-1 inhibitor, pembrozilumab (Keytruda)
Initiated a study evaluating RMC-4630 in combination with the EGFR inhibitor, osimertinib (Tagrisso)
Entered into a new clinical collaboration agreement with AstraZeneca to study RMC-4630 in combination with an emerging asset targeting KRASG12C from AstraZeneca’s portfolio
Clinical Results Support Dual Mechanisms of Anti-Tumor Activity by RMC-4630: Tumor Cell-Intrinsic and Stimulation of Immune Response – Data reported by the company from its ongoing RMC-4630-01 trial provide clinical evidence that SHP2 inhibition may act by stimulating arms of the immune system as a second anti-tumor mechanism in addition to its tumor cell-intrinsic benefits. These observations provide further rationale for the ongoing clinical combination study with RMC-4630 and pembrozilumab by Sanofi, the company’s SHP2 collaboration partner.
RAS(ON) Inhibitors

First-In-Class RAS(ON) Inhibitor Platform – The company’s proprietary tri-complex technology platform enables a highly differentiated approach to inhibiting RAS(ON) with potential biologic advantages. Revolution Medicines is developing a portfolio of compounds that it believes are the first and only RAS(ON) inhibitors to use this mechanism of action. The company has produced potent, cell-active RAS(ON) Inhibitors for variants driving the vast majority of RAS-addicted cancers.

Inhibitors for Five RAS(ON) Variants in Lead Optimization – KRASG12C/NRASG12C(ON), KRASG12D(ON), KRASG13C(ON), and KRASG12V(ON) inhibitors are in lead optimization, which include and expands on the company’s initial four priority RAS(ON) targets. The company remains on track to nominate a first development candidate from this platform by the end of 2020.

Preclinical Tumor Regressions Induced by First-in-Class KRASG12D(ON) Inhibitors – Data presented by the company at the RAS Targeted Drug Development conference demonstrated that the company’s first-in-class KRASG12D(ON) inhibitors induced significant decreases in tumor volume in a xenograft model of human pancreatic cancer driven by a KRASG12D mutation. The KRASG12D genotype is of particularly high clinical interest as there are currently no approved targeted therapies for the treatment of cancers driven by this mutation, which is found in approximately 35% of pancreatic cancers and 15% of colorectal cancers in the U.S.
Corporate Highlights

Completed Follow-On Financing – The company completed a follow-on equity public offering in July 2020. The upsized financing raised gross proceeds of $179.4 million before deducting underwriting discounts, commissions and other offering expenses payable by Revolution Medicines, further strengthening its balance sheet to support multiple clinical milestones and extend the company’s runway.
Upcoming Corporate Milestones

RAS(ON) Inhibitors

Nominate first development candidate (Q4 2020)
Nominate second development candidate (1H 2021)
RAS Companion Inhibitors

SHP2 (RMC-4630)
Report monotherapy dose escalation safety data set (1H 2021)
Provide preliminary activity data for combination with cobimetinib (2H 2021)
Provide initial tolerability and PK data for combination with osimertinib (2H 2021)
mTORC1/4EBP1 (RMC-5552)
Advance to IND-ready status (Q4 2020)
Begin treating patients with monotherapy (1H 2021)
Third Quarter 2020 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $466.1 million as of September 30, 2020, compared to $122.8 million as of December 31, 2019. The increase was primarily due to proceeds from the company’s initial public offering in February 2020 and follow-on equity public offering in July 2020.

Revenue: Total revenue, consisting of revenue from the company’s collaboration agreement with Sanofi, was $12.7 million for the quarter ended September 30, 2020, compared to $12.5 million for the quarter ended September 30, 2019.

R&D Expenses: Research and development expenses were $34.9 million for the quarter ended September 30, 2020, compared to $23.0 million for the quarter ended September 30, 2019. This increase was primarily due to an increase in research expenses associated with the company’s pre-clinical research portfolio, and an increase in personnel-related expenses related to additional headcount.

G&A Expenses: General and administrative expenses were $5.3 million for the quarter ended September 30, 2020, compared to $3.1 million for the quarter ended September 30, 2019. This increase was primarily due to an increase in expenses associated with operating as a public company.

Net Loss: Net loss was $27.2 million for the quarter ended September 30, 2020, compared to net loss of $12.8 million for the quarter ended September 30, 2019.

On November 12, 2020 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the third quarter ended September 30, 2020 (Press release, Schrodinger, NOV 12, 2020, View Source [SID1234570776]).

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"We are executing on our strategic plan across every area of our business," said Schrödinger CEO Ramy Farid, Ph.D. "We’re excited about the strong growth we’ve seen in our software business and the rapid progress of our internal and collaborative programs to discover and develop therapeutics."

Third Quarter Financial Results

Revenue was $25.8 million for the third quarter of 2020, an increase of 29% compared to the third quarter of 2019.

Software revenue was $22.9 million for the third quarter of 2020, an increase of 42% over the third quarter in 2019. Drug discovery revenue was $2.9 million for the third quarter of 2020, a decline of 24% versus the third quarter of 2019.

Gross profit reached $15.3 million in the third quarter of 2020, an increase of 43% over the third quarter in 2019. Software gross margin was 81% in the third quarter, unchanged versus the third quarter of 2019.

Operating expenses for the third quarter of 2020 were $30.7 million, an increase of 40% over the third quarter of 2019.

Other income, which includes gains on equity investments and changes in fair value of such investments, was $18.7 million in the third quarter of 2020 versus a loss of $0.9 million in the third quarter of 2019. Other income for the third quarter of 2020 included an $18.0 million non-cash gain from our equity in Relay Therapeutics which completed its IPO in July 2020.

Net income, after adjusting for non-controlling interests, was $3.9 million for the third quarter of 2020, compared to a net loss of $11.5 million in the third quarter of 2019.

Schrödinger ended the third quarter of 2020 with cash, cash equivalents, restricted cash and marketable securities of $599.5 million, an increase of $315.0 million from the end of the second quarter of 2020, primarily as a result of net proceeds of $325.6 million from the equity financing in the third quarter.

"In the third quarter, we continued the excellent momentum across our business established in the first half of 2020," said Schrödinger CFO Joel Lebowitz. "With our strong balance sheet and growing revenue, we believe we are well-positioned to continue to invest in R&D and execute on all elements of our strategy."

Third Quarter Business Update

Driving growth in our Software business

42% revenue growth in the third quarter of 2020, driven by growth in both Life Sciences and Materials Science revenue
Increased Financial resources

Raised $325.6 million of net proceeds from an equity follow-on offering
Ending cash, cash equivalents, restricted cash and marketable securities for the third quarter were $599.5 million
Advancing internal discovery programs and pipeline progress

Expect to initiate IND enabling studies in 2021 on most advanced internal programs
Presenting data on our MALT 1 inhibitor program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition; progressing research in single agent and combination studies targeting B-cell lymphomas
Advancing the underlying science of our platform and methods

Several scientific publications describing and validating our differentiated computational platform
Improved methods for accurately modeling the relative binding free energies of metalloenzyme inhibitors
Improved approaches to optimize binding selectivity
Validation and extension of our technologies to more comprehensively support macrocycle design and optimization
"We are very pleased with the significant progress we have made this year on our software business, our drug discovery collaborations and our internal pipeline," said Dr. Farid. "Our ongoing commitment to advance the science underlying our industry-leading physics-based computational platform to achieve new breakthroughs will drive our continued success."

Business Impact of COVID-19 Pandemic

While we did not see material impacts to our business from the COVID-19 pandemic during the first nine months of 2020, we have identified certain market risks that, if they materialize, could affect the growth of our software business and the timing of our drug discovery revenues for at least the remainder of 2020. Some of our software customers may experience increasing budgetary pressures, which may cause them to delay or reduce purchases. In addition, our sales force has limited in-person interactions, and their ability to attend industry conferences and events that promote and expand knowledge of our company and platform has been hampered. Relative to our drug discovery programs, certain programs, particularly ones that are in clinical studies or preparing to enter clinical studies, could be delayed which could result in delays in achieving milestones and related revenue. While there remains uncertainty about the extent of the effect of the COVID-19 pandemic, we do not envision a long-term impact from the COVID-19 pandemic on our ability to execute on our long-term strategy.

Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its third quarter financial results on Thursday, November 12, 2020 at 8:30 AM Eastern Time. The conference call can be accessed live over the phone by dialing (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and refer to conference ID 8486343. The webcast can be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website following the event.

On November 12, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported its financial results for the third quarter ended September 30, 2020 and provides a corporate update.

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"The third quarter saw continued advancement and validation of our clinical development programs, with a focus on our oncology pipeline of replicating arenavirus-based therapeutic candidates," commented Joern Aldag, Chief Executive Officer of HOOKIPA. "We continue to gain momentum as we expanded our ongoing Phase 1/2 HPV trial to explore HB-202/HB-201 as an alternating vector therapy with the first patient dosed with HB-202. We are also pleased that preclinical immunogenicity data from HB-201, our lead oncology candidate, was recognized in OncoImmunology, further demonstrating the potential of our arenavirus-based therapies to combat cancer. Additionally, I am proud that Professor Jean-Charles Soria, a globally recognized scientist and oncologist, who is General Director of Gustave Roussy, the leading European Cancer Center, joined our Board of Directors. His expertise will enhance our efforts as we seek to advance new, much needed cancer therapies."

R&D Pipeline Update and Clinical Progress

HB-101, lead product candidate in infectious diseases
HOOKIPA’s prophylactic Cytomegalovirus (CMV) vaccine candidate, HB‑101, is in a randomized, double‑blinded Phase 2 clinical trial in patients awaiting kidney transplantation who are at risk for CMV-associated complications post-transplant. In June 2020, HOOKIPA announced positive Phase 2 interim data on the trial’s primary endpoints: safety, and B cell and T cell immunogenicity. The interim data demonstrated that HB‑101 was well tolerated, with a lower rate of adverse events in patients with end-stage kidney disease than in the Phase 1 healthy volunteer trial. Patients who received the sponsor recommended three doses of HB‑101 showed comparable immunogenicity levels to those measured in the Phase 1 healthy volunteer trial. HOOKIPA continues to accrue patients and plans to report preliminary efficacy and updated safety and immunogenicity data by the end of 2020.

HB-201 and HB-202, lead programs in immuno-oncology treating Human Papillomavirus-positive cancers
HOOKIPA’s lead oncology product candidates, HB‑201 and HB‑202, are in development for the treatment of Human Papillomavirus 16‑positive (HPV16+) cancers. In December 2019, HOOKIPA initiated the Phase 1/2 clinical trial with endpoints of safety, immunogenicity and efficacy. The open label, dose escalating Phase 1/2 clinical trial in HPV16+ cancers is currently evaluating HB-201 alone and subsequently in combination with an approved checkpoint inhibitor. Accrual of patients for the first and the second dose levels at a three-week dosing frequency has been completed without safety concerns. Additional dose schedules and levels are being investigated to identify the recommended Phase 2 dose. HOOKIPA expects to report preliminary safety and efficacy data in late 2020 or early 2021.

A peer reviewed article in OncoImmunology issued in September 2020 recognized that HB-201 preclinical results demonstrated high immunogenicity. The paper verified that systemically administered HB-201 leads to dose-dependent induction of a robust, systemic cytotoxic T cell response directed against HPV16 proteins, tumor infiltration of HPV16 specific cytotoxic T cells, as well as significantly delayed tumor growth or complete tumor clearance accompanied with prolonged survival.

In October 2020, HOOKIPA announced the dosing of the first patient with HB-202. HB-202 is part of a sequential alternating vector regimen of HB-202/HB-201 for the treatment of HPV16+ cancers in the ongoing HB-201 Phase 1/2 trial. In pre-clinical studies, alternating administration of HB-202 and HB-201 resulted in a ten-fold increase in immune response and better disease control than either compound alone. The Company expects to provide interim safety, dose escalation, and efficacy data on the HB-202/HB-201 arm of the ongoing Phase 1/2 study in mid-2021.

Strategic Collaborations

Gilead Sciences Collaboration for HIV and HBV Therapeutic Vaccines
Since the start of the collaboration in 2018, HOOKIPA has received $21.0 million in upfront and milestone payments from Gilead for the delivery of research vectors and for advancing the programs towards clinical trials, including a milestone payment of $4.0 million, which the Company received in early 2020. Based on preclinical data generated to date, Gilead committed to advancing the HBV and HIV vectors toward development. To enable the development activities and expanded research programs, Gilead agreed to reserve manufacturing capacity and increase reimbursement planned for the Company’s expanded resources allocated to the Gilead collaboration.

Others
In October 2020, Professor Jean-Charles Soria, M.D., Ph.D., was appointed to HOOKIPA’s Board of Directors. Jean-Charles Soria is Professor of Medicine and Medical Oncology at the University of Paris-Saclay and currently serves as General Director of the Gustave Roussy Cancer Center, one of the world’s leading cancer research institutes.

COVID-19
HOOKIPA continues to monitor the COVID-19 pandemic closely and adapt to COVID-19 measures and recommendations issued by the U.S. and Austrian governments. For disclosures of risks and uncertainties resulting from the COVID-19 disease outbreak, including the impact on the enrollment of patients and timing of clinical results, see HOOKIPA’s quarterly reports on Form 10-Q for the quarters ended June 30, 2020 and September 30, 2020.

Third Quarter 2020 Financial Results

Cash Position:

HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2020 was $82.3 million compared to $113.6 million as of December 31, 2019. The decrease was primarily attributable to cash used in operating activities.

Revenue was $4.0 million for the three months ended September 30, 2020 compared to $2.0 million for the three months ended September 30, 2019. The increase was primarily due to higher cost reimbursements received under the collaboration agreement with Gilead following the expansion of the collaboration in the first half of 2020 and the partial recognition of a milestone payment we received from Gilead in February 2020.

Research and Development Expenses:
HOOKIPA’s research and development expenses were $16.0 million for the three months ended September 30, 2020 compared to $11.0 million for the three months ended September 30, 2019. The primary drivers of the increase compared to 2019 were an increase in clinical trial expenses of $2.7 million and an increase in internal research and development expenses of $2.3 million.

General and Administrative Expenses:

General and administrative expenses amounted to $4.4 million for the three months ended September 30, 2020 compared to $4.6 million for the three months ended September 30, 2019. The decrease was primarily due to a decrease in personnel-related expenses of $0.1 million, a decrease in professional and consulting fees of $0.5 million, partially offset by an increase of other general and administrative expenses of $0.4 million.

Net Loss:

HOOKIPA’s net loss was $13.6 million for the three months ended September 30, 2020 compared to a net loss of $11.4 million for the three months ended September 30, 2019.

On November 12, 2020 BioXcel Therapeutics, Inc. ("BTI" or the "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 third quarter ended September 30, 2020 and provided an update on key strategic and operational initiatives (Press release, BioXcel Therapeutics, NOV 12, 2020, View Source [SID1234570774]).

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"Building on the successful data readout from the Phase 3 SERENITY trials earlier this year, we have continued to make substantial progress with BXCL501’s development as a treatment for agitation across neuropsychiatric conditions," stated Vimal Mehta, Chief Executive Officer of BTI. "Recently, we completed our pre-NDA meeting with the FDA and have initiated rolling submission of the NDA. This is a key milestone for our neuroscience franchise, laying a strong foundation for multiple follow-on indications and a catalyst for the ongoing build of our commercial infrastructure. While the TRANQUILITY and RELEASE trials advance, we are preparing to initiate a Phase 2 trial for agitation associated with delirium. Together, we believe that these trials, along with our strong cash position, will help to support our long-term strategy of establishing BXCL501 as an innovative treatment for agitation regardless of the patient’s underlying diagnosis."

Dr. Mehta continued, "We are also making excellent strides advancing our immuno-oncology program, with two combination therapy trials progressing well. Earlier this week, we presented encouraging preliminary efficacy and safety data at SITC (Free SITC Whitepaper) from both the Phase 1b/2 trial of BXCL701 and KEYTRUDA for the treatment of advanced prostate cancer and the MD Anderson-led Phase 2 basket trial in advanced solid tumors. Across both trials, we have already seen promising signals of activity in numerous difficult-to-treat tumors."

Third Quarter 2020 and Recent Highlights

BXCL501-Neuroscience Program

BXCL501 is an investigational, proprietary, orally dissolving, sublingual thin film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, designed for the treatment of agitation and opioid withdrawal symptoms. The Company believes BXCL501 may directly target a causal agitation mechanism.

Following the recently announced positive topline results from the Phase 3 SERENITY trials, last month, BTI completed a successful pre-NDA meeting with the FDA for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders. The FDA agreed to a rolling review of the NDA and BTI has already submitted part of the application to the FDA, with plans to submit the complete application in the first quarter of 2021.
The Company initiated the third dose cohort (90 mcg) in the TRANQUILITY study, a Phase 1b/2 trial of BXCL501 for the acute treatment of agitation associated with dementia. Based on the findings, the Company expects to report topline results in the fourth quarter of 2020, or, if needed, proceed to an additional dose cohort.
The RELEASE study, a Phase 1b/2 trial of BXCL501 for the treatment of opioid withdrawal symptoms, is ongoing, with enrollment of the dose cohorts progressing well. The Company expects to report topline results from the study in the first quarter of 2021.
In October, BTI received FDA clearance of its Investigational New Drug ("IND") application for BXCL501 for the treatment of hospitalized patients with agitation associated with delirium, including COVID-19 patients. The Company plans to initiate a Phase 2 trial within the next several months.
BTI recently analyzed topline data from a cross-over study in healthy volunteers comparing the bioavailability of BXCL501 administered sublingually with the film placed drug-side down under the tongue, compared to the film placed drug-side up under the tongue, and administered buccally (between the lower lip and the gum). It was determined that all three administrations of BXCL501 are bioequivalent and were rapidly absorbed into the systemic circulation. Also, drinking water starting at 15 minutes following sublingual administration did not have any affect on bioavailability.
The Company was issued U.S. patent No. 10,792,24 on October 6, 2020, which covers film formulations containing Dex and methods of treating agitation using such film formulations. The patent is expected to extend intellectual property ("IP") protection until 2039.
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.

The Phase 2 portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab (KEYTRUDA) for treatment emergent Neuroendocrine Prostate Cancer ("tNEPC") and castrate-resistant prostate cancer ("CRPC") is advancing. Data from the 1b portion of this trial was presented recently at SITC (Free SITC Whitepaper), with an additional efficacy update planned.
The MD Anderson-led Phase 2 open label basket trial evaluating the combination of BXCL701 and KEYTRUDA in patients with advanced solid tumors is progressing well, and has already moved to the stage-2 efficacy phase. Preliminary efficacy data on 14 patients (5 patients in the checkpoint naïve cohort and 9 patients in the checkpoint pretreated cohort) was presented earlier this week at SITC (Free SITC Whitepaper).
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 second line pancreatic cancer was planned to initiate following Nektar and Pfizer’s Phase 1B dose-escalation trial of bempegaldesleukin and avelumab, which was delayed. All parties have agreed to discontinue activities on the triple combination study and instead reallocate resources to other studies and development programs. The parties terminated their clinical trial collaboration agreement, effective November 10, 2020.
Corporate Highlight

In July 2020, the Company raised net proceeds of approximately $187 million in connection with its common stock offering. BTI believes that the proceeds from this offering, together with current reserves, provide the cash runway to fund key clinical, regulatory, operational, and commercial activities well into 2022.
Third Quarter 2020 Financial Results

BTI reported a net loss of $24.8 million for the third quarter of 2020 compared to a net loss of $9.0 million for the same period in 2019. The third quarter 2020 results include approximately $5.3 million in non-cash stock-based compensation compared to $0.8 million for the same period in 2019.

Research and development expenses were $16.3 million for the third quarter of 2020, compared to $7.1 million for the same period in 2019. The increase was primarily attributable to increased clinical trial costs and professional research related to the acceleration of the Company’s research and development activities, primarily related to its SERENITY I and II clinical trials as well increased costs associated with its TRANQUILITY and RELEASE clinical trials for BXCL501. These amounts were partially offset by reduced costs related to the BXCL701 pancreatic cancer trial.

Personnel costs also increased, primarily related to the growth of BTI’s clinical team as the Company continues to expand its clinical programs, and in preparation of the potential commercial launch of BXCL501 in the U.S. Non-cash stock-based compensation also increased as result of the additional personnel combined with increased grant date fair values arising from higher market prices of the Company’s common stock.

General and administrative expenses were $8.5 million for the third quarter of 2020, compared to $2.0 million for the same period in 2019. The increase was primarily due to increased non-cash stock-based compensation and personnel costs related to the growth of BTI’s operations combined with increased grant date fair values arising from higher market prices of the Company’s common stock. Professional fees also increased which is primarily attributable to increased corporate legal and investor relations fees combined with increased insurance premiums.

Total operating expenses for the third quarter of 2020 were approximately $24.8 million, compared to total operating expenses of approximately $9.1 million for the same period in 2019.

As of September 30, 2020, cash and cash equivalents totaled approximately $233.4 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 at least November 26, 2020.

On November 12, 2020 Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, reported financial results for the three and nine months ended September 30, 2020 and provided a corporate update (Press release, Applied Therapeutics, NOV 12, 2020, View Source [SID1234570770]).

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"With our commercial launch of Twirla expected by the end of the year, we remain on track to deliver on our plan. The final validation of our commercial manufacturing process continues to progress as all three of our batches are expected to be released for commercial use in December 2020. By taking steps to build out an experienced sales force, secure major wholesaler agreements and increase market access for Twirla, we believe we are well-prepared to hit the ground running. Having our first FDA-approved product nearing launch marks an exciting time for Agile and we look forward to bringing to the market another choice for women to help fulfill their contraceptive needs," said Al Altomari, Chairman and Chief Executive Officer of Agile.

Third Quarter 2020 and Other Recent Corporate Developments:

Twirla Commercialization Update

The Company intends to begin shipping product to wholesalers by year-end 2020.

Agile remains on track to finalize the validation of its commercial manufacturing process of Twirla.
• All three validation batches are expected to be released for commercial use in December 2020.

The Company continued to build its distribution network by entering into an agreement with a third major U.S. wholesaler.

The Company continues to build awareness among prescribers and health care providers to gain market access for Twirla.
• Product sampling expected to begin at launch.

Through Syneos Selling Solutions, the Company’s contract sales force partner, Agile completed the hiring of an initial sales team of 73 persons.
• The sales force initiated discussions with healthcare providers after it was fully deployed in mid-October.
Strengthened Executive Leadership Team

In August 2020, the Company appointed Paul Korner, MD, MBA, as Chief Medical Officer. Dr. Korner is a board-certified obstetrician and gynecologist with more than 20 years of pharmaceutical and biotech industry experience, including significant experience within women’s healthcare.
Launched I’m So Done – A National Unbranded Campaign

In September 2020, the Company launched I’m So Done, an education and empowerment platform that encourages women to think about their current contraceptive method and decision-making journey.
Financial Guidance

The Company narrowed its operating expense guidance for the full year 2020 to be in the range of $52 million to $54 million, with general and administrative expenses accounting for approximately 70% of the spending as it builds out its commercial infrastructure. The Company’s operating expenses guidance includes $2.7 million to $3 million of non-cash stock compensation expense. The Company expects its gross revenue in the fourth quarter of 2020, reflecting expectations of initial stocking of Twirla by wholesalers, to be approximately $1 million.

Based on the Company’s current business plan and pending launch of Twirla, the Company believes that its cash, cash equivalents and marketable securities as of September 30, 2020 will be sufficient to meet its projected operating requirements through the end of 2021. If the COVID-19 pandemic or other factors impact the Company’s current business plans or its ability to generate revenue from the launch of Twirla, the Company believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations.
Third Quarter Financial Results

Cash, cash equivalents and marketable securities: As of September 30, 2020, Agile had $71.9 million of cash, cash equivalents and marketable securities compared to $34.5 million of cash and cash equivalents as of December 31, 2019.

Research and development (R&D) expenses: R&D expenses were $3.7 million for the quarter ended September 30, 2020, compared to $2.4 million for the comparable period in 2019. The increase in R&D expenses was primarily due to costs to conduct validation work for commercial manufacturing of Twirla by Corium, the Company’s contract manufacturer.

General and administrative (G&A) expenses: G&A expenses were $11.0 million for the quarter ended September 30, 2020, compared to $2.1 million for the comparable period in 2019. The increase in G&A expenses was primarily due to higher costs associated with the Company’s pre-commercialization activities for Twirla, such as brand building, advocacy, market research and consulting. The increase in G&A expenses was also attributable to activities related to building out the commercial organization and included higher salaries and higher professional fees related to recruiting fees and consultants, and an increase in stock compensation expense.

Net loss: Net loss was $15.5 million, or $0.18 per share, for the quarter ended September 30, 2020, compared to a net loss of $4.4 million, or $0.08 per share, for the comparable period in 2019.

Shares Outstanding: As of September 30, 2020, Agile had 87,434,604 shares of common stock outstanding.
Conference Call and Webcast
Agile Therapeutics will host a conference call and webcast to discuss financial results for the third quarter ended September 30, 2020 today at 4:30pm ET. Investors interested in listening to the conference call may do so by dialing (877) 407-2991 for domestic callers or (201) 389-0925 for international callers. A live webcast will be available in the Events and Presentations section of the Investor Relations page at View Source, or by clicking here.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events and Presentations section of the Company’s website.

About Twirla
Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated for use as a method of contraception by women of reproductive potential with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate to prevent pregnancy. Healthcare providers (HCPs) are encouraged to consider Twirla’s reduced efficacy in women with a BMI ≥ 25 to <30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch.