On November 4, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the third quarter ended September 30, 2021 and recent company developments, along with a business outlook for the remainder of 2021 (Press release, TG Therapeutics, NOV 4, 2021, View Source [SID1234594458]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "The third quarter of 2021 was an exciting time for us, as we achieved another major milestone by submitting a Biologics License Application (BLA) with the U.S. FDA for ublituximab to treat patients with relapsing forms of multiple sclerosis (RMS). With an estimated 1 million Americans currently living with multiple sclerosis, we believe if approved, ublituximab will provide an attractive new treatment option for patients battling RMS, which is the most common disease course."

Mr. Weiss continued, "For the remainder of 2021 and into 2022, we look forward to continuing to execute on the UKONIQ launch in patients with relapsed or refractory marginal zone and follicular lymphoma, and also continuing to prepare for the potential launches of ublituximab in combination with UKONIQ or U2 in CLL and ublituximab in RMS."

2021 Highlights & Recent Developments

Ublituximab in Multiple Sclerosis

Submitted a Biologics License Application (BLA) to the U.S. FDA for ublituximab to treat patients with relapsing forms of multiple sclerosis (RMS).
Presented positive results, including new analyses, from the ULTIMATE I and II Phase 3 trials at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). As previously reported, both trials met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period compared to teriflunomide in patients with RMS. Additional secondary, tertiary and post-hoc sensitivity analyses were also presented, including T1 and T2 lesions, no evidence of disease activity (NEDA), brain volume and multiple sclerosis functional composite (MSFC) score.
Ublituximab plus UKONIQ (U2) in Chronic Lymphocytic Leukemia

Received FDA acceptance of a BLA for ublituximab and a supplemental New Drug Application (sNDA) for UKONIQ, both submissions requesting approval of U2 as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These applications were based on results from the UNITY-CLL Phase 3 trial, which included both treatment-naïve and relapsed or refractory (R/R) CLL patients. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022 for both applications.
Completed enrollment in the Phase 2 portion of the ULTRA-V trial and launched the Phase 3 portion of the ULTRA-V trial, a randomized trial evaluating the triple combination of U2 plus venetoclax in patients with treatment-naïve and R/R CLL.
Presented updated results from the Phase 1 trials of U2 plus venetoclax evaluating patients with R/R CLL at the 2021 International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
UKONIQ (umbralisib) in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma

Launched UKONIQ in the U.S. for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
Generated $4.3M in total net UKONIQ revenue from launch through the end of Q3 2021, approximately seven months.
Achieved broad U.S. payor coverage for more than 95% of Medicare and commercial lives and inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for MZL and FL.
Published results from an integrated safety analysis of UKONIQ in Blood Advances.
TG-1701 in B-cell Malignancies

Presented updated data from TG-1701, our bruton tyrosine kinase (BTK) inhibitor, as a monotherapy and in combination with U2 in patients with B-cell malignancies at the 2021 iwCLL meeting.
Remaining Key Objectives for 2021 and Early 2022

Continue the commercialization of UKONIQ in R/R MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 in CLL and ublituximab in RMS.
Seek to obtain U.S. FDA approval of U2 in CLL and SLL by the PDUFA goal date of March 25, 2022.
Continue to enroll patients into the newly launched ULTRA-V Phase 3 trial evaluating the triple combination of U2 plus venetoclax.
Continue to advance our early pipeline candidates including TG-1501 (cosibelimab) our PDL1 inhibitor, TG-1701 our BTK inhibitor and TG-1801 our CD47/CD19 bispecific antibody.
Financial Results for the Three and Nine Months Ended September 30, 2021

Product Revenue, net: Product revenue, net was approximately $2.0 million and $4.3 million for the three and nine months ended September 30, 2021. Net product revenues represent U.S. sales from our sole commercial product, UKONIQ, which received accelerated approval from the FDA on February 5, 2021.

R&D Expenses: Total research and development (R&D) expense was $52.0 million and $159.9 million for the three and nine months ended September 30, 2021, compared to $50.5 million and $122.9 million for the three and nine months ended September 30, 2020. The increase was due primarily to costs associated with the submission of our BLA for ublituximab in RMS, manufacturing costs, as well as an increase in non-cash compensation R&D expense during the nine months ended September 30, 2021 over the comparable period in 2020.

SG&A Expenses: Total selling, general and administrative (SG&A) expense was $34.9 million and $95.7 million for the three and nine months ended September 30, 2021, and $35.3 million and $64.0 million for the three and nine months ended September 30, 2020. The increase during the nine months ended September 30, 2021 was due to selling, general and administrative costs associated with execution of the launch of UKONIQ and planning for the potential launches of U2 in CLL and ublituximab in RMS. We expect our selling, general and administrative expenses to increase for the remainder of 2021 as we continue to prepare for those potential 2022 launches.

Net Loss: Net loss was $85.6 million and $254.8 million for the three and nine months ended September 30, 2021, compared to $87.2 million and $191.2 million for the three and nine months ended September 30, 2020. Excluding non-cash compensation, the net loss for the three and nine months ended September 30, 2021 was approximately $71.6 million and $207.8 million, compared to a net loss of $58.8 million and $144.4 million for the three and nine months ended September 30, 2020.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $381.4 million as of September 30, 2021, which the Company believes will be sufficient to fund the Company’s planned operations into 2023.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, November 4, 2021, at 8:30 AM ET, to discuss the Company’s third quarter ended September 30, 2021 financial results and provide a business outlook for the remainder of 2021.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

On November 4, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Jounce Therapeutics, NOV 4, 2021, View Source [SID1234594457]).

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"Jounce has had another very productive quarter as we have made significant progress across all areas of the company and continue to build momentum as we head into the new year. We were pleased to report that we are now actively recruiting patients in the monotherapy and combination therapy expansion portion of the INNATE study, testing JTX-8064 +/- pimivalimab, our own PD-1 inhibitor, in 8 distinct cohorts across 7 tumor types. We also continue to advance patient enrollment in our randomized SELECT study which employs our stringent patient selection strategy and have continued our commitment to build our discovery pipeline," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We believe our focus on translational science, biomarker approaches, and targeting new immune mechanisms leads us closer to bringing the right immunotherapies to the right patients."

Pipeline Update:

JTX-8064 (LILRB2 / ILT4)

Completed monotherapy and combination therapy dose escalation 3 week safety review of INNATE: Jounce has completed the monotherapy and pimivalimab (PD-1 Inhibitor) combination therapy dose escalation 3 week safety review of the Phase 1 trial of JTX-8064, and a preliminary recommended phase 2 dose (RP2D) of 700 mg has been established. To date, JTX-8064 has been well tolerated with no dose limiting toxicities.

Enrollment initiated in tumor-specific monotherapy and pimivalimab combination expansion cohorts of INNATE: Jounce previously announced the initiation of patient enrollment in INNATE tumor-specific expansion cohorts for both JTX-8064 monotherapy and combination therapy of JTX-8064 with pimivalimab in August and October, respectively. The expansion cohorts will study JTX-8064 in three subsets of patients in order to identify the most rapid development paths for JTX-8064 alone or in combination with PD-1 inhibitors:

Patients who have progressed on PD-1 inhibitors and are now PD-1 inhibitor resistant,
PD-1 inhibitor naïve patients with tumors that do not typically respond to PD-1 inhibitors, and
PD-1 inhibitor naïve patients with tumors for which PD-1 inhibitors are approved, but there is still room for improvement.

Vopratelimab (ICOS) and Pimivalimab (PD-1)

Continued enrollment in Phase 2 SELECT trial of vopratelimab: Enrollment continues in SELECT, a randomized Phase 2 trial to evaluate vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients. The SELECT trial also aims to provide additional important single agent data for pimivalimab in a new biomarker selection paradigm. Jounce is on track to report data from the SELECT trial in 2022.

Gilead Sciences begins Phase 1 clinical trial of GS-1811 (formerly JTX-1811)

The clinical study of GS-1811 (formerly JTX-1811) was initiated by Gilead Sciences. GS-1811, which Jounce discovered and progressed through to IND, is out licensed to Gilead and is the fourth internally developed candidate to enter the clinic.

Corporate Update:

Jigar Raythatha Appointed to the Board of Directors

On September 15th, 2021, Jounce announced the appointment of former chief executive officer of Constellation Pharmaceuticals and former Jounce chief business officer, Jigar Raythatha, to its board of directors.

Third Quarter 2021 Financial Results:

Cash position: As of September 30, 2021, cash, cash equivalents and investments were $249.0 million, compared to $213.2 million as of December 31, 2020. The increase was primarily due to receipt of $90.9 million in net proceeds from the follow-on public offering and sales under Jounce’s at-the-market ("ATM") offering program completed first quarter of 2021 and receipt of a $25.0 million milestone from Gilead in the third quarter of 2021, offset by operating expenses incurred.

License and collaboration revenue: No license or collaboration revenue was recognized in the third quarter of 2021 or 2020.

Research and development expenses: Research and development expenses were $23.3 million for the third quarter of 2021, compared to $18.0 million for the same period in 2020. The increase in research and development expenses was primarily due to increased clinical and regulatory costs for INNATE and SELECT, increased manufacturing activities performed for Jounce’s development programs and payroll and stock-based compensation expense.

General and administrative expenses: General and administrative expenses were $6.9 million for the third quarter of 2021, compared to $7.1 million for the same period in 2020. The decrease in general and administrative expenses was primarily a result of decreased professional fees offset by increases in other administrative costs.

Net loss: Net loss was $30.1 million for the third quarter of 2021, resulting in basic and diluted net loss per share of $0.59. Net loss was $24.9 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.73. The increase in net loss is attributable to increased operating expenses, the decrease in the net loss per share is attributable to increased number of shares outstanding as compared to the same period in 2020.

Financial Guidance:

Based on its current operating and development plans, Jounce is narrowing its financial guidance on gross cash burn on operating expenses and capital expenditures for the full year 2021 to $100.0 million to $110.0 million. Jounce expects to end fiscal year 2021 with approximately $220.0 million in cash, cash equivalents and investments.

Given the strength of its balance sheet, Jounce continues to expect its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the third quarter of 2023.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6873343. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

About JTX-8064

JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is the first tumor-associated macrophage candidate developed from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and the 2019 and 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meetings support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial named INNATE (NCT04669899) of JTX-8064 as a monotherapy and in combination with Jounce’s internal anti-PD-1 inhibitor, pimivalimab (formerly JTX-4014) is currently enrolling patients with advanced solid tumors into tumor-specific expansion cohorts.

About Pimivalimab

Pimivalimab (formerly JTX-4014) is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Pimivalimab demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, pimivalimab was shown to have an acceptable safety profile. Pimivalimab is currently being assessed in the INNATE Phase 1 trial (NCT04669899) in combination with JTX-8064, a LILRB2 (ILT4) inhibitor. Pimivalimab is also being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with vopratelimab, a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors.

About Vopratelimab

Vopratelimab is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab is currently being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with Jounce’s internal investigational PD-1 inhibitor, pimivalimab (formerly JTX-4014), compared to pimivalimab alone. The SELECT trial is currently enrolling approximately 75 immunotherapy naïve NSCLC patients who have been pre-selected with the TISvopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor. SELECT is powered to demonstrate the statistical superiority of the combination of vopratelimab plus pimivalimab compared to pimivalimab.

On November 4, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the third quarter ended September 30, 2021 (Press release, Athenex, NOV 4, 2021, View Source [SID1234594456]).

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"Following our recent Type A meeting with U.S. FDA to discuss our New Drug Application for oral paclitaxel and encequidar (Oral Paclitaxel) in metastatic breast cancer, we determined that deploying our resources towards other ongoing clinical programs of Oral Paclitaxel and our cell therapy programs would be a better way to maximize value for all of our shareholders and stakeholders," said Johnson Lau, Chief Executive Officer of Athenex. "Our management team is focused on advancing the clinical pipeline where we believe Athenex has a strong competitive advantage, as well as exploring various other approaches for our assets that will unlock shareholder value. We are particularly pleased with the continued positive momentum and increasing visibility of our cell therapy programs."

Third Quarter 2021 and Recent Business Highlights

Clinical Programs

Orascovery

Held a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Oral Paclitaxel in metastatic breast cancer.
Presented positive interim data from a Phase 1 trial evaluating Oral Paclitaxel in combination with pembrolizumab in patients with advanced solid malignancies at ESMO (Free ESMO Whitepaper) 2021.
Received confirmation from the Innovative Licensing and Access Pathway (ILAP) in the UK that encequidar in combination with oral anticancer medicines has been awarded the innovative medicine designation, the Innovation Passport. ILAP was set up by the UK Medicines & Healthcare products Regulatory Agency (MHRA) and other UK government agencies to efficiently accelerate the time to market and facilitating patient access to innovative medicines.
Cell Therapy

Interim data from the ongoing Phase 1 ANCHOR trial evaluating KUR-502 in patients with CD19-positive relapsed or refractory lymphoma and leukemia have been accepted for poster presentation at the 2021 ASH (Free ASH Whitepaper) Annual Meeting.
The U.S. Patent and Trademark Office allowed patent claims around the NKT cellular immunotherapy platform developed by Athenex and the Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children’s Hospital and Houston Methodist Hospital.
Opened enrollment in Phase 1 trial to evaluate TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 solid tumors).
Commercial Update

Klisyri (tirbanibulin)

Athenex’s partner, Almirall (Almirall, S.A., BME: ALM), launched Klisyri (tirbanibulin) in Germany and the UK. Klisyri received approval by the European Commission and the UK MHRA in July and August of 2021, respectively, for the topical treatment of actinic keratosis (AK) of the face and scalp in adults.
Specialty Pharmaceutical Business

Athenex Pharmaceutical Division (APD) currently markets a total of 33 products with 64 SKUs.
Athenex Pharma Solutions (APS) currently markets 5 products with 16 SKUs.
Corporate

Dr. Michael Smolinski promoted to Chief Scientific Officer. Dr. Smolinski has been with Athenex for 13 years and previously served as Vice President of Preclinical Operations.
Key Anticipated Milestones

ANCHOR Phase 1 poster presentation at 2021 ASH (Free ASH Whitepaper) in December
Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022
Almirall to continue phased roll-out of Klisyri in other European countries in 2022
Third Quarter 2021 Financial Highlights

Revenues from product sales increased to $27.0 million for the three months ended September 30, 2021, from $24.8 million for the three months ended September 30, 2020, an increase of $2.2 million or 9%. This increase was primarily attributable to an increase in 503B product sales of $2.1 million as the result of the increase in demand for certain drugs used to treat patients hospitalized with COVID-19. API product sales and contract manufacturing sales each experienced an increase of $0.4 million. These increases were offset by a decrease in APD product sales of $0.7 million, resulting primarily from a significant prior year increase in demand for COVID-19 related drugs and for FDA shortage products during 2020, including some significant non-recurring orders.

License fees and other revenue decreased by $5.4 million, for the three months ended September 30, 2021. This decrease was primarily due to the recognition of $5.1 million in license and royalty revenue from Almirall for the launch of Klisyri in Europe in September 2021, while we recognized $10.4 million in license revenue during the three months ended September 30, 2020, pursuant to license agreements with Xiangxue and PharmaEssentia.

Cost of sales for the three months ended September 30, 2021 totaled $25.6 million, an increase of $1.1 million, or 5%, as compared to $24.5 million for the three months ended September 30, 2020. The increase was primarily due to an increase of $2.9 million in cost of 503B product sales as production levels increased. Cost of APD product sales increased by $0.9 million, while the cost of API product sales decreased by $0.1 million. Additionally, cost of sales related to royalties for license income decreased by $2.5 million due to the royalty payment that incurred in 2020 on the license revenue from Xiangxue.

R&D expenses for the three months ended September 30, 2021 totaled $17.7 million, a decrease of $0.7 million, or 4%, as compared to $18.4 million for the three months ended September 30, 2020. This was primarily due to a decrease in costs of clinical operations of $2.4 million after the completion of the Phase 3 studies for tirbanibulin ointment and Oral Paclitaxel, a decrease in Oral Paclitaxel product development and medical affairs costs of $1.8 million incurred in connection with the potential product launch, a decrease in costs of preclinical operations of $1.0 million, and a decrease in R&D related compensation expenses of $0.4 million. The decrease in these R&D expenses was partially offset by a $2.6 million increase in cell therapy development costs, a $2.0 million increase in drug licensing costs related to licenses for specialty drug products, and a $0.3 million increase in costs of other product development.

SG&A expenses for the three months ended September 30, 2021 totaled $22.8 million, an increase of $0.6 million, or 3%, as compared to $22.2 million for the three months ended September 30, 2020. This was primarily due to a $3.2 million increase from the change in fair value of contingent consideration, a $2.1 million increase in operating costs including insurance and IT costs and professional fees, a $1.9 million increase in compensation related costs, and a $1.1 million increase in site preparation costs related to the manufacturing facility in Dunkirk. The increase was partially offset by a $7.7 million decrease in costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and slowed upon receipt of the Complete Response Letter in February 2021.

Interest expense totaled $5.1 million and $3.6 million for the three months ended September 30, 2021 and 2020, respectively. Interest expense in the current period was incurred from the Senior Credit Agreement with Oaktree, while interest expense in the prior period was primarily incurred from debt under a former credit agreement with Perceptive Advisors LLC and its affiliates.

Income tax expense for the three months ended September 30, 2021 amounted to $0.3 million, compared to income tax expense of $1.1 million for the same period in 2020. The income tax expense in the prior year was primarily attributable to foreign income tax withholdings on our revenue earned under our out-license arrangements.

Net loss attributable to Athenex for the third quarter was $36.1 million or 33 cents per diluted share, as compared to a net loss of $36.8 million or 44 cents per diluted share, for the same period in 2020.

For further details on the Company’s financial results, including the results for the nine months ended September 30, 2021, refer to the Form 10Q filed with the SEC.

Financial Guidance

In terms of product sales guidance, the Company is limiting financial guidance to the existing Athenex product portfolio only. In 2020, the Company recorded a significant amount of revenues from international customers as a result of the global pandemic. However, it does not see these revenues as recurring in nature. In the first nine months of 2021, the Company experienced significant COVID-related challenges in our Indian supply chain and to a lesser extent China, which slowed down APD product sales during the period. As a result, the Company now expects its full year product sales in 2021, excluding any royalties from Klisyri, to decline by 6% to 12% year-over-year compared with 2020 levels.

Cash Conservation Update

As of September 30, 2021, the company had cash and cash equivalents of $73.6 million, restricted cash of $16.5 million, and short-term investments of $14.9 million, for a total of $105.0 million. Given the earlier uncertainty stemming from the CRL for Oral Paclitaxel in metastatic breast cancer, the Company has already identified and adopted certain cash conservation measures. The Company is seeking additional cash conservation and funding opportunities to further extend the cash runway.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Thursday, November 4, 2021, at 10:00 am Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

On November 4, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it has entered into an agreement with BVF Partners L.P. (BVF) and RA Capital Management (RA) to raise gross proceeds of $65 million (Press release, Concert Pharmaceuticals, NOV 4, 2021, View Source [SID1234594455]). In addition, Concert will have the potential to receive an additional $103 million upon the full exercise of warrants being issued in connection with the agreement. Closing of the financing is expected on or about November 5, 2021. With the $65 million raised in this financing, Concert now expects to be able to fund its operations into the fourth quarter of 2022. If the warrants being issued in connection with this financing are fully exercised, Concert expects to be funded beyond the anticipated submission of its New Drug Application for CTP-543, which is expected in early 2023.

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The financing consists of the sale of common and preferred stock, warrants and a portion of Concert’s right to receive potential future AVP-786 royalties under an existing licensing agreement with Avanir Pharmaceuticals, Inc. (Avanir).

As part of the financing, BVF and RA will receive an aggregate of 16,250,000 common stock equivalents, warrants to purchase up to 8,125,000 common stock equivalents at an exercise price of $5.34 per share and warrants to purchase up to 8,125,000 common stock equivalents at an exercise price of $7.35 per share. The common stock equivalents will be issued as either shares of common stock or convertible preferred stock.1

Previously, Concert granted Avanir, a subsidiary of Otsuka America, Inc., worldwide rights to develop and commercialize AVP-786 for the treatment of neurologic and psychiatric disorders in exchange for potential future milestones and royalties. Pursuant to this financing, BVF and RA will also receive a portion of potential future AVP-786 royalties currently payable to Concert by Avanir. AVP-786 is currently being evaluated in a number of clinical trials, including Phase 3 trials for the treatment of agitation in patients with dementia of the Alzheimer’s type. Upon the closing of the financing, BVF and RA will collectively own 35% of such royalties, with the percentage increasing incrementally up to 50% if all of the warrants issued in connection with the financing are exercised by the holders.

The securities described above are being offered by Concert pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (SEC), which the SEC declared effective on November 16, 2020. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On November 4, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported it will host a live webcast presentation highlighting the clinical data being presented at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) on Friday, November 12, 2021 at 8:00 a.m. ET (Press release, Shattuck Labs, NOV 4, 2021, https://ir.shattucklabs.com/news-releases/news-release-details/shattuck-labs-host-conference-call-and-webcast-highlighting-data [SID1234594454]).

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The event will be led by Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck, and will include presentations by Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck and Andrew Neill, M.B.A., Chief Financial Officer of Shattuck. During the event, the company will highlight dose-escalation data for SL-172154 (SIRPα-Fc-CD40L), its lead bi-functional fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor, in platinum-resistant ovarian cancer patients, and dose-escalation data for SL-279252 (PD1-Fc-OX40L), which is designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor, in patients with advanced solid tumors or lymphoma. Members of Shattuck leadership will be available to answer questions at the end of the event.

The live call may be accessed by dialing (833) 614-1555 (domestic) or (516) 575-8754 (international) and entering the conference code: 4068596. The live and archived webcast will be available on the Events & Presentations section of the Company’s website. A replay of the webcast will be archived for up to 90 days following the presentation date.