On November 9, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the third quarter ended September 30, 2021 (Press release, Veracyte, NOV 9, 2021, View Source [SID1234594902]).

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"We are pleased with our third quarter performance as we experienced strong year-over-year revenue growth despite the headwind of the COVID-19 Delta variant," said Marc Stapley, Veracyte’s chief executive officer. "With the completion of our acquisition of HalioDx, the launch of our novel noninvasive Percepta Nasal Swab test for early lung cancer risk assessment and of our Decipher Bladder test to help guide bladder cancer treatment decisions, the pieces are coming together to transform our company into a global cancer diagnostics leader."

Third Quarter 2021 Financial Results

For the third quarter of 2021, as compared with the third quarter of 2020:

Total Revenue was $60.4 million, an increase of 94%, including $4.7 million of HalioDx revenue;
Gross Margin was 64%, a decrease of 300 basis points including the impact of HalioDx and the associated purchase accounting; Gross Margin equaled 68%, an increase of 100 basis points, before the impact of HalioDx;
Operating Expenses, Excluding Cost of Revenue, were $55.4 million, an increase of 123%, including $7.5 million of HalioDx expenses and $5.8 million in acquisition-related expenses;
Net Loss was $14.1 million, an increase of 243%, including $5.8 million of acquisition-related expenses and $6.3 million of HalioDx net loss;
Basic and Diluted Net Loss Per Common Share was $0.20, an increase of 150%;
Net Cash Used in Operating Activities was $1.4 million including $3.9 million of acquisition-related expenses; and
Cash and Cash Equivalents were $164.0 million at September 30, 2021.
For the nine months ended September 30, 2021, compared to the prior year:

Total Revenue was $152.2 million, an increase of 83%, including $4.7 million of HalioDx revenue;
Gross Margin was 66%, an increase of 200 basis points including the impact of HalioDx and the associated purchase accounting; Gross Margin equaled 68%, an increase of 400 basis points, before the impact of HalioDx;
Operating Expenses, Excluding Cost of Revenue, were $170.2 million, an increase of 113%, including $7.5 million of HalioDx expenses and $45.3 million of acquisition-related expenses;
Net Loss was $65.0 million, an increase of 142%, including $45.3 million of acquisition-related expenses and $6.3 million of HalioDx net loss;
Basic and Diluted Net Loss Per Common Share was $0.97, an increase of 87%, including $0.68 per share attributable to acquisition-related expenses recorded in general and administrative expenses; and
Net Cash Used in Operating Activities was $40.1 million, including $43.4 million of acquisition-related expenses.
Third Quarter 2021 and Recent Business Highlights

Commercial Growth:

Grew volume to 20,972 tests, including a small contribution from the Immunoscore Colon Cancer test, an increase of 79% compared to the same period in 2020.
Gained a new Blues coverage policy for Decipher Prostate, making the test a covered benefit for the plan’s 5 million members and bringing the total number of covered lives to over 150 million. Also secured contracts for the test with a large Blues plan and national government payer.
Evidence Development and Guideline Inclusion:

Six abstracts demonstrating the performance and utility of our genomic pulmonology and urology tests were presented at the 2021 American College of Chest Physicians (CHEST) and American Society for Radiation Oncology (ASTRO) annual meetings, respectively.
New long-term clinical utility data for the Afirma Genomic Sequencing Classifier were published in the Journal of the Endocrine Society and showed that the test helped reduce unnecessary surgeries in patients with indeterminate thyroid nodule cytology.
Data published in the Journal of Urology demonstrated that the Decipher Bladder genomic test accurately identifies bladder tumors that are most likely to respond to chemotherapy prior to radical cystectomy.
New NCCN Clinical Practice Guidelines for Oncology were published and include specific treatment recommendations for men with prostate cancer uniquely based on their Decipher Prostate RP genomic classifier score.
New Pan-Asian adapted ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines recommended the Immunoscore Colon Cancer test to refine the prognosis of stage 2 and stage 3 colon cancer patients in conjunction with traditional assessment.
Pipeline Advancement:

Began offering the Percepta Nasal Swab test to a limited number of sites as part of a clinical utility study to build the clinical evidence needed to support reimbursement.
Commenced the commercial launch of the Decipher Bladder test following Medicare coverage.
HalioDx Acquisition:

Completed the acquisition of HalioDx for $321 million on August 2, 2021, bringing to Veracyte IVD manufacturing and development capabilities, deep scientific expertise in immuno-oncology and the Immunoscore Colon Cancer test.
2021 Financial Outlook

Veracyte is updating its 2021 annual total revenue guidance to $210 million to $218 million, from the previous guidance range of $200 million to $208 million, with HalioDx expecting to contribute approximately $10 million. This range represents 79% to 86% total revenue growth for fiscal 2021 compared to fiscal 2020.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

On November 9, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported it is advancing HB-201 to Phase 2, to be evaluated in combination with pembrolizumab as 1st- or 2nd-line treatment for Human Papillomavirus Positive 16 (HPV16+) squamous cell head and neck cancers (HNSCC) (Press release, Hookipa Biotech, NOV 9, 2021, View Source [SID1234594901]). Interim Phase 1 data in heavily pre-treated patients continue to show HB-200 monotherapy (both HB-201 alone and HB-202/HB-201) is highly effective at expanding T cells, has a favorable tolerability profile and promising, early anti-tumor activity. As of November 1, 2021, among 28 patients dosed intravenously, HB-200 resulted in a 75 percent disease control rate and shrinkage of target lesions in 53 percent of patients. In these patients, HOOKIPA has observed three partial responses (including one confirmed and one unconfirmed in an ongoing patient) and one ongoing patient with a near partial response (29 percent tumor shrinkage). Based on the strength of the HB-200 data, HOOKIPA has prioritized its oncology portfolio and plans further development of its infectious disease programs to be done in partnership with other companies. HOOKIPA will host an investor conference call to review the data at 4:30 p.m. ET.

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"We are incredibly excited about our Phase 1 HB-200 data, especially the demonstrated tumor-specific T cell responses and tumor shrinkage in heavily pre-treated HNSCC patients, which we believe are highly differentiated from other active immunization technologies," said Joern Aldag, Chief Executive Officer at HOOKIPA. "Based on these data, we’re excited to advance our promising HB-200 program into Phase 2, initially with the HB-201 and pembrolizumab combination for head and neck cancer patients, while accelerating the development of our earlier stage immuno-oncology candidates HB-300 and HB-700 in prostate and KRAS-mutated cancers, respectively, and focusing our efforts on exploring the potential of our novel arenaviral technology to address unmet needs in cancer."

HB-200 data update
Interim data from the ongoing Phase 1 dose escalation study (NCT04180215) show that
HB-200 (either as HB-201 or as alternating two-vector HB-202/HB-201) rapidly induces high levels of tumor-specific CD8+ T cells considered to be predictive of response, with a favorable tolerability profile and promising, early anti-tumor activity in heavily pre-treated HPV16+ HNSCC cancer patients.

As of the November 1, 2021 data cut-off, 62 patients (representing 24 new patients since the data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June 2021) with advanced HPV16+ tumors were enrolled and received HB-200 therapy. Forty patients with HNSCC tumors were treated intravenously every three weeks, including 20 patients who received single vector HB-201 and 20 patients who received alternating two-vector HB-202/HB-201. The other 22 patients had either other HPV16+ tumor types (not HNSCC) and/or received different HB-200 regimens. Participants received a median of three prior therapies (ranging from zero to 11), and 87 percent had previously received a checkpoint inhibitor regimen. The following safety and interim efficacy data reflect the November 1 cut-off date.

Safety results
HB-200 continued to demonstrate a favorable tolerability profile in heavily pre-treated patients with HPV16+ cancers, highlighting its potential in possible combination with checkpoint inhibitors and other agents. Treatment-related adverse events were reported in 66 percent of 62 evaluable patients, with only 8 percent experiencing treatment-related adverse events rated grade 3 or higher.

Interim efficacy results
HB-200 demonstrated promising, early anti-tumor activity in the 28 evaluable patients with advanced HNSCC. Specifically:

HB-201 showed a 71 percent disease control rate (10/14 evaluable patients, including one confirmed partial response and one unconfirmed partial response, previously reported in December 2020);
Alternating two-vector HB-202/HB-201 demonstrated a 79 percent disease control rate (11/14 evaluable patients, including one ongoing unconfirmed partial response and one ongoing near partial response with 29 percent tumor shrinkage); and,
HB-200 showed tumor shrinkage in 53 percent of patients (15/28 evaluable patients) and an ongoing median progression-free survival (mPFS) of 3.45 months.
These results compare favorably to the standard of care treatments nivolumab and pembrolizumab used in a 2nd plus-line setting in PD1-inhibitor naïve HNSCC patients. Based on peer-reviewed published data, nivolumab showed a mPFS of 2 months1 whereas pembrolizumab had disease control rates of 35 percent overall and 40 percent in the HPV+ subset in the 2nd plus-line setting.2

T cell data
Interim data continued to show that HB-200 rapidly induces high levels of activated, tumor-specific CD8+ T cells. As of the September 1, 2021 data cut-off, 20 patients were evaluable, including 10 patients who received HB-201 and 10 who received alternating two-vector HB-202/HB-201. The analysis showed:

More than 90 percent of patients showed an increase in tumor-specific CD8+ T cells within 2 weeks of initial HB-200 dose (either HB-201 or HB-202/HB-201),
More than 50 percent of patients had tumor-specific CD8+ T cell levels that exceeded the single-digit percentage threshold of the circulating T cell pool, which is generally considered a strong indicator of response; and,
50 percent of patients with paired biopsies (3/6 patients) showed elevated tumor infiltrating lymphocytes ("TILs"), or an increase in CD8+ T cells in their tumors.
Based on a review of published literature, we believe that no other active immunization approach has demonstrated these types of results, which highlight the magnitude of tumor-specific CD8+ T cells induced by HB-200 therapy as well as the potential for HOOKIPA’s versatile arenaviral platform to enhance anti-tumor activity across tumor killing mechanisms.

"While these T cell data are preliminary, it’s clear that HB-200 induces a rapid and robust vaccine-specific T cell response at magnitudes that we as a field have theorized would result in efficacy, if such levels were ever achieved," said Dmitriy Zamarin, MD, PhD, Translational Research Director in Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center (MSK) and co-investigator in this study. "Hookipa’s arenavirus vectors are, for the first time, generating these levels and, with that, we are seeing monotherapy efficacy in patients with advanced heavily-pretreated cancers."

Oncology pipeline expansion
There is considerable unmet need in head and neck cancers, and the HB-200 program represents broad potential for additive benefits in combination with current standard of care and novel agents to improve anti-tumor immune response in these patients. HOOKIPA has initiated the Phase 2 expansion portion of its ongoing HB-200 study to evaluate HB-201 in combination with pembrolizumab in 1st- and 2nd-line HNSCC patients.

The company also plans to initiate a separate, randomized Phase 2 study of HB-200 in combination with pembrolizumab as part of its clinical collaboration with Merck & Co., Inc., Kenilworth, NJ, USA.

Based on the positive HB-200 data to-date, HOOKIPA is focusing future research and development in oncology, advancing efforts in head and neck cancer with HB-200 and prostate cancers with HB-300, as well as expanding its pipeline to include HB-700, a new program targeting KRAS-mutated colorectal, pancreatic and lung cancers.

Infectious disease portfolio update
Updated interim data from the ongoing Phase 2 clinical trial (NCT03629080) of HB-101, a prophylactic Cytomegalovirus (CMV) vaccine candidate, show strong immunogenicity and reduced incidence of CMV viremia in people who received three doses of HB-101, consistent with results previously reported in November 2020. Compared to placebo, participants vaccinated with three HB-101 doses prior to kidney transplant had:

Strong immunogenicity with 86 percent seroconversion and 100 percent CD8+ T cell responses;
a 41 percent reduction in CMV viremia (presence of CMV DNA in the blood);
a 41 percent reduction in the use of antiviral therapy; and,
No change in CMV disease.
While there were two cases of CMV disease reported in the placebo group in November 2020, these cases have since been re-classified as not CMV disease.

Safety and tolerability were evaluated in 80 participants who were enrolled in the trial by the cut-off date of July 30, 2021. HB-101 was generally well tolerated with 21 percent of HB-101 recipients experiencing side effects related to vaccine administration. A total of five cases of human leukocyte antigen (HLA)-sensitization have been reported, four characterized as serious adverse events.

Enrollment closed in June 2021 with 80 patients enrolled, and participants will continue to be monitored for the 12-month observation period following kidney transplantation. Final results are anticipated in 2023. With no approved CMV vaccine, there remains considerable unmet need for people with solid organ transplants. HOOKIPA will explore partnership opportunities for further development of HB-101 in order to focus on advancing its promising oncology portfolio.

HOOKIPA is progressing its research collaboration with Gilead to develop a potential functional cure for Hepatitis B virus (HBV). The HBV program successfully passed Gilead’s Request for Development milestone, and Gilead plans to progress the program into IND-enabling stage in 2022 to support IND filing for the arenavirus vector combination. For the HIV program, after HOOKIPA successfully completed all pre-clinical research obligations in accordance with the mutual Collaboration Agreement, Gilead informed HOOKIPA of their intention not to move forward with this program according to current terms. HOOKIPA is in ongoing discussions with Gilead regarding a revised Collaboration Agreement.

Investor call
HOOKIPA will host an investor conference call to review the data at 4:30 p.m. ET.

A live webcast of the call can be accessed on HOOKIPA’s website at View Source An archived webcast will be available for 30 days on the Events webpage.

About HB-202/HB-201
HB-201 and HB-202 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (Lymphocytic Choriomeningitis Virus for HB-201 and Pichinde Virus for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone. HB-201 is being tested clinically as a single vector therapy and also in an alternating vector combination with HB-202.

About the HB-200 trial (NCT04180215)
This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ head and neck cancers who progressed on standard of care, including check point inhibitors. The trial is evaluating HB-201 as a monotherapy, as an alternating 2-vector therapy with HB-202, and in combination with a PD-1 inhibitor. The primary endpoint of Phase 1 is a recommended Phase 2 dose. Secondary endpoints include safety and tolerability, as well as preliminary efficacy defined by RECIST 1.1. The study also includes exploratory objectives on immunogenicity and pharmacodynamic biomarkers.

On November 9, 2021 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the third quarter ended September 30, 2021 (Press release, NanoString Technologies, NOV 9, 2021, View Source [SID1234594900]).

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Third Quarter Financial Highlights

Product and service revenue of $36.9 million, 23% year-over-year growth
Instrument revenue of $14.5 million, 13% year-over-year growth. Instrument revenue includes:
$8.5 million of GeoMx Digital Spatial Profiler (DSP) instrument revenue, 14% year-over-year growth
$6.0 million of nCounter Analysis System instrument revenue, 11% year-over-year growth
Consumables revenue of $18.0 million, 32% year-over-year growth. Consumables revenue includes:
$4.5 million GeoMx DSP consumables revenue, 224% year-over-year growth
$13.5 million of nCounter consumables revenue, 10% year-over-year growth
Service revenue of $4.4 million, 24% year-over-year growth
Cash, cash equivalents and short-term investments of $369.9 million at September 30, 2021
"NanoString’s Spatial Biology franchise is having a banner year, as we continue to build on our leadership position in this dynamic market and pursue our mission to map the universe of biology. Our GeoMx DSP instrument orders grew approximately 40%, as our Whole Transcriptome Assays using next generation sequencing readout appealed to customers across both discovery and translational research. We’ve highlighted the power of our new CosMx Spatial Molecular Imager with a newly-released dataset and manuscript that demonstrate in situ imaging of lung cancer samples using both the largest number of RNA targets and currently the only workflow compatible with formalin-fixed paraffin-embedded (FFPE) tissue samples," said Brad Gray, President & CEO of NanoString. "Meanwhile, our nCounter franchise posted strong instrument placements, while consumables revenue continued to be impacted by residual effects of the pandemic."

GeoMx DSP

GeoMx Installed Base: Grew installed base to approximately 225 GeoMx DSP Systems at September 30, 2021, as compared to approximately 100 at September 30, 2020
Spatial Organ Atlas: In October 2021, released an annotated reference dataset of whole transcriptomes from six organs spatially resolved using GeoMx DSP, providing a publicly-accessible database for understanding organ structure and function
GeoMx Publications: Increased cumulative peer-reviewed publications to approximately 70 as of September 30, 2021, with approximately 10 new publications during the quarter
CosMx Spatial Molecular Imager (SMI)

Branding: Introduced the ‘CosMx’ branding for our SMI platform. Together, CosMx SMI and GeoMx DSP represent a compelling portfolio of technologies that span the continuum of applications in spatial biology
First Public Dataset: Released the first high resolution dataset generated using CosMx SMI, including RNA expression from almost 1,000 genes mapped at single cell and subcellular resolution within eight FFPE non-small lung cancer specimens
Technology Publication: Published a manuscript in the online journal BioRxiv describing the CosMx SMI technology, performance specifications and applications of the platform
nCounter

nCounter Installed Base: Grew installed base to approximately 1,030 nCounter Analysis Systems at September 30, 2021, as compared to approximately 915 systems at September 30, 2020
nCounter Antibody Drug Conjugates (ADC) Development Panel Launch: In October 2021, launched the nCounter ADC Development Panel, a specialized gene expression tool that is designed to provide molecular insights into important biological questions and challenges of oncology therapies
nCounter Publications: Surpassed 4,900 cumulative peer-reviewed publications utilizing nCounter technology at September 30, 2021
2021 Outlook

The company updated its revenue outlook for 2021, with results expected as follows:

GeoMx DSP revenue of approximately $49 to $50 million, as compared to previous guidance of $48 to $50 million, driven by instrument orders trending to the top end of the company’s 40% to 50% expected annual growth range
nCounter revenue, inclusive of all service revenue, of $91 to $94 million, as compared to previous guidance of $95 to $97 million, due to reduced consumables utilization caused by the residual effect of the pandemic
Total product and service revenue of $140 to $144 million, as compared to previous guidance of $143 to $147 million
The company reiterated its full-year outlook on gross margin, operating expenses and adjusted EBITDA.

Third Quarter Financial Results

We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the notes and table at the end of this press release.

Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at www.nanostring.com, supplemental financial data that includes our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the third quarter and the nine months ended September 30, 2021 and for each quarter of and the full year of 2020.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent, including dial-in details and unique conference call codes for entry. Registration is open throughout the call, but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning November 9, 2021 at 7:30pm ET through midnight ET on November 16, 2021. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 2826727. The webcast will also be available on our website for one year following the completion of the call.

On November 9, 2021 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the quarter ended September 30, 2021 (Press release, Janux Therapeutics, NOV 9, 2021, View Source [SID1234594899]).

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"In the third quarter, we continued to utilize our novel TRACTr and TRACIr platforms to advance our pipeline of next generation immunotherapies. We remain on-track to execute key milestones, including two IND submissions next year for our PSMA-TRACTr and EGFR-TRACTr candidates," said David Campbell, Ph.D., President and CEO of Janux. "Further, we welcomed Dr. Ron Barrett and Alana McNulty to Janux’s Board of Directors. These two key leadership additions bring important expertise to the company as we work to advance our programs towards the clinic."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

TRACTr product candidates advancing as planned. Janux’s lead TRACTr programs of next-generation T cell engagers remain on-track.

In the first half of 2022, Janux expects to submit an Investigational New Drug (IND) application for its PSMA-TRACTr candidate, targeting prostate-specific membrane antigen (PSMA).
In the second half of 2022, Janux expects to submit an IND application for its EGFR-TRACTr candidate, targeting epidermal growth factor receptor (EGFR).
In 2023, Janux expects to submit an IND application for its TROP2-TRACTr, targeting trophoblast cell surface antigen 2 (TROP2).
On track for selection of TRACIr development candidate in 2022 as planned. Janux is applying its TRACIr technology to develop a costimulatory bispecific product candidate against programmed death-ligand 1 (PD-L1) and Cluster of Differentiation 28 (CD28) to further enhance the anti-tumor activity of T cells. This will be Janux’s first program derived from its TRACIr platform.
Strengthened Board of Directors with appointment of Ron Barrett, Ph.D., and Alana McNulty. Dr. Barrett is a scientist entrepreneur with more than 30 years of experience in the biopharmaceutical industry as a co-founder and leader of biopharmaceutical companies and has been responsible for advancing research that led to FDA approval of three drugs. Ms. McNulty has more than 30 years of experience in finance and business development for private and publicly traded biopharmaceutical companies, playing a key role over her career in a breadth of strategic transactions.
THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS:

Cash and cash equivalents and short-term investments: As of September 30, 2021, Janux reported cash and cash equivalents and short-term investments of $387.5 million, compared to $7.8 million at December 31, 2020.
Research and development expenses: Research and development expenses for the quarter ended September 30, 2021 were $8.4 million, compared to $0.8 million for the comparable period in 2020. The increase in research and development expenses in 2021 was primarily attributable to the development of Janux’s platform technologies and programs. Janux also incurred additional personnel-related expenses, including stock-based compensation, as operations grew in support of program advances.
General and administrative expenses: General and administrative expenses for the quarter ended September 30, 2021 were $3.6 million, compared to $0.4 million for the same period in 2020. The increase in general and administrative expenses was primarily attributable to an increase in personnel-related expenses, including stock-based compensation, due to increased headcount in 2021. The increase in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses, as Janux now operates as a public company.
Net loss: For the quarter ended September 30, 2021, Janux reported a net loss of $10.8 million, compared to a net loss of $1.3 million for the comparable period in 2020.

On November 9, 2021 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the third quarter 2021 and changes to its leadership team (Press release, Acorda Therapeutics, NOV 9, 2021, View Source [SID1234594898]).

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"Acorda made significant progress this quarter. We saw a 34% increase in INBRIJA net sales over the same quarter in 2020, despite the continuing impact of the pandemic on our business. Today we announced an agreement with Esteve to commercialize Inbrija in Germany, the largest pharmaceutical market in Europe and fourth largest in the world. Esteve expects to launch INBRIJA there in mid-2022," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We have also added two seasoned executives to Acorda’s leadership team. Mike Gesser is a highly experienced CFO who will enhance our efforts to maintain fiscal discipline and increase the efficiency of our organization. Neil Belloff has a long track record of success as a General Counsel for biotech companies and at the Securities and Exchange Commission. We thank Dr. Blank for his years of service to Acorda; under his leadership, Acorda secured marketing authorizations for INBRIJA from both the FDA and the European Medicines Agency. We are pleased that Dr. Blank will continue to provide the benefit of his expertise to Acorda as a consultant."

"We are making excellent progress on our top corporate priorities: accelerating Inbrija’s sales trajectory, maintaining our Ampyra brand in the face of generic competition, commercializing Inbrija outside the US, which provides a significant additional revenue stream to Acorda, and aligning our operating expenses to our revenue. Our goal is to be cash flow positive on a run rate basis by the end of 2022."

Third Quarter 2021 Financial Results

For the quarter ended September 30, 2021, the Company reported INBRIJA net revenue of $7.8 million, compared to $5.8 million for the same quarter in 2020.

For the quarter ended September 30, 2021, the Company reported AMPYRA net revenue of $20.0 million compared to $27.3 million for the same quarter in 2020. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended September 30, 2021 were $1.9 million, including $0.2 million of share-based compensation compared to $5.7 million, including $0.6 million of share-based compensation for the same quarter in 2020.

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2021 were $29.6 million, including $0.6 million of share-based compensation, compared to $39.9 million, including $1.8 million of share-based compensation for the same quarter in 2020.

Change in fair value of derivative liability for the quarter ended September 30, 2021 was $(0.3) million compared to $(4.9) million for the same quarter in 2020.

Benefit from income taxes for the quarter ended September 30, 2021 was $3.1 million compared to a provision for income taxes of $1.5 million for the same quarter in 2020.

The Company reported a GAAP net loss of $27.1 million for the quarter ended September 30, 2021, or $2.43 per diluted share. GAAP net income in the same quarter of 2020 was $7.3 million, or $0.32 per diluted share.

Non-GAAP net loss for the quarter ended September 30, 2021 was $15.9 million, or $1.43 per diluted share. Non-GAAP net loss in the same quarter of 2020 was $10.9 million, or $1.36 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At September 30, 2021, the Company had cash, cash equivalents, and restricted cash of $62 million, compared to $103 million at year end 2020. Restricted cash includes $25 million in escrow related to the 6% semi-annual interest portion of the 2024 convertible senior secured notes, which is payable in cash or stock. If the Company elects to pay interest due in stock, a corresponding amount of restricted cash will be released from escrow.

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

INBRIJA Ex-US

Acorda announced that it has entered into distribution and supply agreements with Esteve Pharmaceuticals GmbH for the commercialization of INBRJIA in Germany. Acorda will receive a €5 million upfront signing fee, and will receive additional sales-based milestones. Acorda will also receive a significant double-digit percent of the selling price of INBRIJA in Germany in exchange for supply of the product. Esteve expects to launch INBRIJA in Germany in mid-2022.

Leadership Team

Michael Gesser has joined Acorda as Chief Financial Officer (CFO). Mr. Gesser was most recently the CFO of Tergus Pharma and has also held CFO positions at BioMedomics, Inc., HAP Innovations, LLC, Suntech Medical, Inc., and Osmotica Pharmaceutical Corp. Previous to those roles, he held several senior-level financial positions at Allergan Pharmaceuticals. Mr. Gesser received his M.B.A. from the Belk School of Business at the University of North Carolina at Charlotte and his B.S. in Finance at the Cameron School of Business at the University of North Carolina at Wilmington.

Neil Belloff has joined the Company as General Counsel. Mr. Belloff has over 30 years of business and legal experience and was formerly the Chief Operating Officer, General Counsel and Corporate Secretary of Eloxx Pharmaceuticals and held senior level positions at Celgene Corporation, Deutsche Telekom, AG, and the United States Securities and Exchange Commission. Mr. Belloff received his J.D. from the University of Bridgeport School of Law, M.A. from New York University, his B.A. from Queens College of the City University of New York, and completed post-graduate studies in the LL.M Program in Securities Regulation at Georgetown University Law Center. Andrew Mayer will remain Deputy General Counsel and Corporate Secretary.

Burkhard Blank, M.D., the Company’s Chief Medical Officer, will leave his position at the end of this year. He is expected to serve as a consultant to Acorda following his departure.

Mr. Gesser and Mr. Belloff were each granted options to purchase 85,000 shares of Acorda’s common stock (for an aggregate of 170,000 shares). In accordance with Nasdaq Listing Rule 5635(c)(4), these stock options were granted to Mr. Gesser and Mr. Belloff under the company’s 2016 Inducement Plan as a material inducement to their accepting employment with the company as Chief Financial Officer and General Counsel, respectively.

The stock options have an exercise price of $3.74 per share, equal to the closing price of the company’s common stock on the grant date of November 8, 2021, which is the date Mr. Gesser and Mr. Belloff commenced employment. The stock options will vest over four years, with 25% vesting on the one-year anniversary of the commencement of employment, and the remaining 75% vesting on a quarterly basis over the remaining three years thereafter, subject to continuing employment. The stock options have a 10-year term and are subject to the terms and conditions of the 2016 Inducement Plan.

Webcast

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

To participate in the Webcast, please use the following pre-registration link:

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

A replay of the audio portion will be available from 7:30 p.m. ET on November 9, 2021 until 11:59 p.m. ET on December 9, 2021. To access the replay, please dial (866) 813 9403 (domestic) or +44 204 525 0658 (international); access code 602929. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.