On October 28, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported an update on the ongoing development of its product candidates, eftilagimod alpha ("efti") and IMP761 for the quarter ended 30 September 2021 (Press release, Immutep, OCT 28, 2021, View Source [SID1234592105]).

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Efti Development Program for Cancer

AIPAC – Phase IIb clinical trial – ongoing
Immutep will report final Overall Survival (OS) data from its Phase IIb AIPAC clinical trial evaluating efti in metastatic breast cancer as a late breaker poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2021 taking place in the US and virtually from 10-14 November.

Immutep previously reported initial OS data from approximately 60% of events in December 2020 at the San Antonio Breast Cancer Symposium. The study reported a promising and improving trend in OS in the total population with a median survival benefit of +2.7 months from efti plus chemotherapy, compared to chemotherapy plus placebo. In addition, a statistically significant OS benefit was observed in the efti group in key pre-defined patient groups, including patients under 65 years of age and those with low starting monocyte count.

AIPAC-003 – Phase III – new
Immutep is continuing the preparation and planning steps for its Phase III clinical trial evaluating efti in patients with metastatic breast cancer.

TACTI-003 – Phase IIb clinical trial – new
In July 2021, Immutep completed all the necessary competent authority steps with the US Food and Drug Administration (FDA) and has received institutional review board approval to commence its Phase IIb TACTI-003 trial in the US. Recruitment has also opened in the Ukraine and more sites and countries will be added in the coming months. This follows the receipt of Fast Track designation in 1st line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) from the US FDA in April 2021.

In addition, Immutep will be presenting the trial design for TACTI-003 via a poster at the SITC (Free SITC Whitepaper) 2021 conference in November.

TACTI-002 (also designated KEYNOTE-PN798) – Phase II clinical trial – ongoing
In September 2021, Immutep enrolled the last patient into Stage 2 of Part B of the Phase II TACTI-002 study, completing recruitment of 2nd line PD-1/PD-L1 refractory non-small cell lung cancer (NSCLC) patients into the trial. Recruitment is continuing for the additional 74 1st line NSCLC patients for the expansion of Part A, with 70 patients already enrolled. Recruitment for the expansion of Part A of the study continues to be ahead of the expected recruitment rate.

Immutep reported favourable interim Overall Response Rates (ORR) together with encouraging duration and depth of response in 1st line NSCLC (Part A) and 2nd line HNSCC (Part C) at ASCO (Free ASCO Whitepaper) in June 2021. The Company will report data from Part C of TACTI-002 at the SITC (Free SITC Whitepaper) 2021 conference in November. Additional data from this study trial are planned to be reported in the first half of calendar year 2022.

INSIGHT
INSIGHT is an investigator-initiated Phase I trial at the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) investigating different combination treatments with efti and a different route of administration for efti. INSIGHT consists of 5 different arms from stratums A to E.

INSIGHT-003 – triple combination
In August 2021, the first patient was enrolled and safely dosed in INSIGHT-003, also referred to as stratum C of INSIGHT. Patient recruitment is ongoing with 4 out of a total of 20 patients with various solid tumours now participating in the trial. First interim results are expected to be reported in 2022.

INSIGHT-004 – combination with avelumab
Results from INSIGHT-004 were presented at the ESMO (Free ESMO Whitepaper) Congress 2021 held 16-21 September. The results are in line with the previous poster presentation at ASCO (Free ASCO Whitepaper) 2021.

INSIGHT-005 – combination with bintrafusp alpha
INSIGHT-005, known as stratum E of INSIGHT, will involve 12 patients with solid tumours and will evaluate efti in combination with bintrafusp alfa. It will be conducted under Immutep’s collaboration agreement with Merck KGaA, Darmstadt, Germany.

Separately to Immutep’s ongoing collaboration agreement with Merck KGaA, Merck KGaA and GlaxoSmithKline announced a mutual decision to terminate their agreement to co-develop bintrafusp alfa. Accordingly, Immutep and Merck KGaA are working closely to determine the next steps for the INSIGHT-005 study.

EAT COVID – Phase II clinical trial – ongoing
The investigator-initiated EAT COVID study is continuing at the University Hospital Pilsen in the Czech Republic. Patient recruitment into the trial by the hospital has been slower than anticipated due to a significant decline in the number of infections and improving vaccination rates in the Czech Republic. The Company will provide an update on the trial in due course.

IMP761 Development Program for Autoimmune Disease

During the quarter, Immutep continued GMP manufacturing preparations for IMP761 and is planning for toxicology studies and other pre-clinical evaluations of this promising candidate.

Partnerships

EOC Pharma
Immutep’s Chinese partner for efti, EOC Pharma, announced it plans to expand its clinical trial pipeline for efti (designated EOC202 in China) in China. EOC is preparing to initiate a clinical study of efti in combination with an anti-PD-1 therapy in the first half of calendar year 2022. This new trial builds on EOC’s previously announced Phase II trial evaluating efti in combination with chemotherapy in metastatic breast cancer patients.

Novartis
Immutep’s partner, Novartis presented two posters at the ESMO (Free ESMO Whitepaper) Congress 2021. One poster included data from its PLATForM Phase II study of novel spartalizumab combinations in melanoma, concluding patients with LAG-3+ melanoma may be more likely to respond to spartalizumab + ieramilimab (LAG525) treatment.

Novartis also presented data from its Phase II, open-label, 3-arm study, in patients with advanced triple-negative breast cancer regardless of PD-L1 status progressing after adjuvant or one prior line of systemic therapy for metastatic disease, but who had not received an immune checkpoint inhibitor. Patients were randomised 1:1:1 to LAG525 + spartalizumab, LAG525 + spartalizumab + carboplatin, or LAG525 + carboplatin. As no arms of the study met the proof of preliminary efficacy criteria, no further investigation is planned for this study.

LAG525 is a humanised anti-LAG-3 antibody derived from Immutep’s IMP701 antibody, which is out-licensed to Novartis.

Intellectual Property

Immutep was granted three new patents relating to the protection of LAG525 (IMP701), which is fully out-licensed to Novartis, by the Chinese Patent Office, the Indian Patent Office and the Malaysian patent office during the quarter. The patents are co-owned by Novartis AG and Immutep SAS and follow the grant of the corresponding Australian, United States, European, and Japanese patents announced in 2018 through 2020.

Financial Summary – Q1 FY221

Cash receipts from customers for the quarter was $56k, compared to $10k in Q4 of FY21 (i.e. the quarter ended 30 June 2021).

The net cash used in G&A activities in the quarter was $1.01 million compared to $409k in Q4 FY21. The increase compared with last quarter is mainly due to capital raising related costs that were expensed in July 2021. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $135k in payment of Non-Executive Director’s fees and Executive Director’s salary.

The net cash used in Research and Development activities in the quarter was $6.83 million, compared to $5.45 million in Q4 FY21. The significant increase is mainly due to increased clinical trial and manufacturing activities. Total net cash outflows used in operating activities in the quarter was $5.37 million. In comparison, total net cash outflows from operating activities in Q4 FY21 was $5.71 million.

Immutep received a €2,126,617 (~$3.42 million) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR) during the quarter in respect of expenditure incurred during calendar year 2020 on eligible R&D activities conducted in the European Union.

As part of the Company’s two-tranche financing announced in June 2021, shareholders approved the second tranche of an institutional placement of shares at the Company’s Extraordinary General Meeting in July 2021. The second tranche of the institutional placement raised $46.3 million. In total, Immutep raised $60 million via the institutional placement, which was supported by multiple institutional investors in Australia and offshore.

A further $7.2 million was raised from a Share Purchase Plan (SPP) completed in July 2021, which enabled existing eligible shareholders to participate in the financing on the same terms as the institutional placement. Due to strong demand from eligible shareholders, the amount raised exceeded the targeted amount sought to be raised ($5 million) under the SPP.

The Company’s cash and cash equivalent balance as at 30 September 2021 was $106.39 million compared to a balance of $60.59 million as at 30 June 2021. The enhanced cash balance puts the company in a strong financial position with an estimated cash reach of December 2023.

A copy of the Appendix 4C – Quarterly Cash Flow Report for the quarter is attached.

On October 28, 2021 ImmunoPrecise Antibodies (IPA) reported that it will attend the Festival of Biologics held at the Congress Centre, Basel November 9-11th (Press release, ImmunoPrecise Antibodies, OCT 28, 2021, View Source [SID1234592104]). The Festival of Biologics is a combination of four conferences: the European Antibody Congress, the World Immunotherapy Congress, the World Biosimilar Congress, and the Clinical Trials World Congress. IPA will be exhibiting at booth 13 as well as presenting on successful rabbit mAb CDR-grafting during Poster Session 1 at the European Antibody Congress.

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On October 28, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that the company will host a conference call and live webcast on Wednesday, November 3, 2021 at 4:15 p.m. ET to report third quarter 2021 financial results and discuss recent business highlights (Press release, Heron Therapeutics, OCT 28, 2021, View Source [SID1234592103]).

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The conference call can be accessed by dialing 877-311-5906 for domestic callers and 281-241-6150 for international callers. Please provide the operator with the passcode 7242566 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

On October 28, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the third quarter 2021 (Press release, Gilead Sciences, OCT 28, 2021, View Source [SID1234592102]).

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"This was a very strong third quarter with continued positive momentum for both our commercial performance and our pipeline progress," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Veklury is making a significant impact as the COVID-19 pandemic continues to evolve. The dynamics of the HIV treatment market further improved and this contributed to record Biktarvy revenue. In oncology, our marketed portfolio continues to expand with four new country approvals for Trodelvy for metastatic triple-negative breast cancer, the approval of Tecartus in relapsed or refractory acute lymphoblastic leukemia and two new trial starts for magrolimab in solid tumors."

Third Quarter 2021 Financial Results

Total third quarter 2021 revenue of $7.4 billion increased 13% compared to the same period in 2020, due to increased demand for Veklury (remdesivir 100 mg for injection).
Diluted Earnings Per Share ("EPS") increased to $2.05 for the third quarter 2021 compared to $0.29 for the same period in 2020. The increase was primarily driven by lower acquired in-process research and development ("IPR&D") expenses, higher net sales and lower unrealized losses from our equity securities.
Non-GAAP diluted EPS increased 26% to $2.65 for the third quarter 2021 compared to $2.11 for the same period in 2020, primarily due to higher operating income, partially offset by lower interest income.
As of September 30, 2021, Gilead had $6.8 billion of cash, cash equivalents and marketable debt securities compared to $7.9 billion as of December 31, 2020.
During the third quarter 2021, Gilead generated $3.3 billion in operating cash flow.
During the third quarter 2021, Gilead made $2.5 billion in debt repayments, paid cash dividends of $900 million and utilized $145 million to repurchase common stock.
Product Sales Performance

Total third quarter 2021 product sales increased 13% to $7.4 billion compared to the same period in 2020. Total product sales excluding Veklury decreased 3% to $5.4 billion for the third quarter 2021 compared to the same period in 2020, primarily reflecting the expected loss of exclusivity of Truvada(emtricitabine ("FTC") 200 mg/tenofovir disoproxil fumarate 300 mg ("TDF")) and Atripla(efavirenz 600 mg/FTC 200 mg/TDF 300mg) in the United States, partially offset by continued increased demand for Biktarvy(bictegravir 50 mg/FTC 200 mg/tenofovir alafenamide 25 mg ("TAF")) and Trodelvy (sacituzumab govitecan-hziy).

HIV product sales decreased 8% to $4.2 billion for the third quarter 2021 compared to the same period in 2020, reflecting, as expected, the loss of exclusivity of Truvada and Atripla in the United States, as well as lower channel inventory as compared to the same period in 2020, primarily driven by pandemic-related stocking in the prior year, partially offset by higher Biktarvy demand and improved trends in the treatment market.

Biktarvy sales increased 20% year-over-year in the third quarter 2021, reflecting higher treatment demand and net price.
Descovy (FTC 200 mg/TAF 25 mg) sales decreased 15% year-over-year in the third quarter 2021, primarily driven by lower net price.
Truvada and Atripla sales decreased 87% and 76% year-over-year, respectively, in the third quarter 2021, as expected, due to the loss of exclusivity in the United States in late 2020.
Hepatitis C virus ("HCV") product sales decreased 8% to $429 million for the third quarter 2021 compared to the same period in 2020, primarily driven by a favorable settlement in the same period 2020 that did not repeat, fewer patient starts outside the United States, and timing of Department of Corrections purchases on a relative basis.

Hepatitis B virus ("HBV") and hepatitis delta virus ("HDV") product sales increased 17% to $247 million for the third quarter 2021 compared to the same period in 2020. Vemlidy (TAF 25 mg) sales increased 18% in the third quarter 2021 compared to the same period in 2020, driven primarily by uptake in geographies outside the United States. Hepcludex (bulevirtide) contributed $12 million in the third quarter 2021 as launch activities continued across Europe.

Cell Therapy product sales increased 51% to $222 million for the third quarter 2021 compared to the same period in 2020.

Yescarta(axicabtagene ciloleucel) sales increased to $175 million in the third quarter 2021, driven by continued demand in relapsed or refractory large B-cell lymphoma ("LBCL") and strong uptake in relapsed or refractory indolent follicular lymphoma in the United States and Europe.
Tecartus(brexucabtagene autoleucel) sales were $47 million for the third quarter 2021, driven by increased adoption in mantle cell lymphoma in the United States and Europe.
Trodelvy sales for the third quarter 2021 were $101 million, reflecting increased use for the second-line treatment of metastatic triple-negative breast cancer ("TNBC") and metastatic urothelial cancer in the United States.

Veklury sales were $1.9 billionfor the third quarter 2021. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations.

Third Quarter 2021 Product Gross Margin, Operating Expenses and Tax

Product gross margin was 83.4% for the third quarter 2021 compared to 82.4% in the same period in 2020, driven by the reversal of a previously recorded $175 million litigation reserve following a favorable court decision, as well as lower royalty expense and change in product mix, partially offset by higher amortization of intangibles acquired from Immunomedics, Inc. and MYR GmbH ("MYR"). Non-GAAP product gross margin was 90.0% for the third quarter 2021 compared to 86.5% in the same period in 2020, driven by the reversal of the aforementioned previously recorded litigation reserve following a favorable court decision, as well as lower royalty expense and change in product mix.
Research and Development ("R&D") expenses and non-GAAP R&D expenses for the third quarter 2021 were $1.1 billion compared to $1.2 billion in the same period in 2020. Lower R&D expenses reflect completion or wind-down of remdesivir and inflammation related clinical programs, partially offset by increases in Trodelvy and magrolimab clinical activities.
Selling, General and Administrative ("SG&A") expenses and non-GAAP SG&A expenses for the third quarter 2021 were $1.2 billion compared to $1.1 billion in the same period in 2020. The increase in SG&A expenses was driven by increased promotional and marketing activities across all geographies, primarily for Trodelvy.
The GAAP effective tax rate ("ETR") and non-GAAP ETR for the third quarter 2021 were 24.8% and 18.9%, respectively, compared to 57.2 % and 18.4%, respectively, for the same period in 2020.
Key Updates Since Our Last Quarterly Release

Viral Diseases

Presented positive results at the IDWeek conference from the Phase 3 double-blind, placebo-controlled trial (PINETREE) of Veklury administered intravenously in non-hospitalized COVID-19 patients at high risk for disease progression. Results demonstrated statistically significant reduction in risk for COVID-19 related hospitalization with Veklury compared with placebo.
Received Priority Review designations from FDA for the lenacapavir New Drug Applications ("NDAs") for the treatment of HIV-1 infection in heavily treatment-experienced patients with multidrug resistance in combination with other antiretroviral agents. The NDAs have been granted a Prescription Drug User Fee Act action date of February 28, 2022.
Announced that the Marketing Authorization Application ("MAA") for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, was fully validated by European Medicines Agency ("EMA"). The proposed indication is for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.
Announced the initiation of the Phase 2 study evaluating an oral weekly combination of lenacapavir and islatravir in people who are living with HIV who are virologically suppressed on an antiretroviral therapy.
Began enrollment into the Phase 3 PURPOSE 1 trial in cisgender girls and young women, the second Phase 3 study of lenacapavir for HIV pre-exposure prophylaxis. The first Phase 3 study (PURPOSE 2) was initiated in July and is enrolling cisgender men, transgender men and women, and gender non-binary individuals who have sex with men.
Received FDA approval for the supplemental NDA of a new low-dose tablet form of Biktarvy (bictegravir 30mg/FTC 120mg/TAF 15mg), expanding the indication to include younger children weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. Biktarvy (bictegravir 50mg/FTC 200mg/TAF 25mg) is approved for appropriate pediatric patients weighing at least 25 kg.
Oncology

Announced the inclusion of Trodelvy into the National Comprehensive Cancer Network Guidelines for Breast Cancer as a preferred regimen for the treatment of adult patients with metastatic TNBC who received at least two prior therapies, with at least one for metastatic disease.
Received a positive opinion from the Committee for Medicinal Products for Human Use of the EMA for Trodelvy for the treatment of adults with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease. The final European Commission decision is anticipated later in 2021.
Received approval from Health Canada for Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior therapies, at least one of them for metastatic disease. Canada represents the fifth approval for Trodelvy in metastatic TNBC under the Project Orbis Initiative, following approvals in Australia, Great Britain, Switzerland, and the United States.
Presented sub-analyses data from the Phase 3 ASCENT study evaluating Trodelvy in patients with relapsed or refractory metastatic TNBC at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting. Results showed significant and clinically-meaningful improvements in health-related quality of life, and, in patients whose initial diagnosis was not TNBC but changed to triple-negative, Trodelvy demonstrated similar positive outcomes to the overall metastatic TNBC population.
Announced the submission of a supplemental Biologics License Application to FDA for Yescarta to expand its current indication to include the treatment of adults with relapsed or refractory LBCL in the second-line setting.
Received FDA approval for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Announced a collaboration and license agreement with Appia Bio, Inc. to research and develop hematopoietic stem cells-derived cell therapies directed toward hematological malignancies.
Corporate

Announced that the company’s Board of Directors has declared a quarterly dividend of $0.71 per share of common stock for the fourth quarter of 2021. The dividend is payable on December 30, 2021, to stockholders of record at the close of business on December 15, 2021. Future dividends will be subject to Board approval.
Announced donation of 100,000 vials of Veklury to Indonesia and 3,000 vials to Armenia to help patients hospitalized with COVID-19.
Guidance and Outlook

Gilead has updated its full-year guidance, and now expects:

Total product sales between $26.0 billion and $26.3 billion, compared to $24.4 billion and $25.0 billion previously, reflecting year-to-date results and our updated expectations for the fourth quarter 2021.
Total product sales, excluding Veklury, of approximately $21.5 billion, compared to $21.7 billion and $21.9 billion previously, primarily reflecting the longer than expected pandemic impact on our business.
Total Veklury sales between $4.5 billion and $4.8 billion, compared to $2.7 billion and $3.1 billion previously, primarily reflecting the surge in COVID-19 hospitalizations in the third quarter 2021, and our expectations for a significant step-down in hospitalization rates in the fourth quarter 2021.
GAAP earnings per share between $5.50 and $5.70, compared to $4.70 and $5.05 previously.
Non-GAAP earnings per share between $7.90 and $8.10, compared to $6.90 and $7.25 previously.
A reconciliation between GAAP and non-GAAP financial information for the 2021 guidance is provided in the accompanying tables. Also see the Forward-Looking Statements described below. The financial guidance is subject to a number of risks and uncertainties, including uncertainty around the duration and magnitude of the COVID-19 pandemic. While the pandemic can be expected to continue to impact Gilead’s business and broader market dynamics, the rate and degree of these impacts as well as the corresponding recovery from the pandemic may vary across Gilead’s business.

Non-GAAP Financial Information

The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges, acquired IPR&D expenses, and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. Acquired IPR&D expenses reflect IPR&D impairments as well as the initial costs of externally developed IPR&D projects, acquired directly in a transaction other than a business combination, that do not have an alternative future use, including upfront and other payments related to various collaborations and the initial costs of rights to IPR&D projects. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation.Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables.

Conference Call

At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.

On October 28, 2021 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the third quarter ended September 30, 2021 (Press release, Genocea Biosciences, OCT 28, 2021, View Source [SID1234592101]).

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"We continue to make significant progress. Most notably, we are very excited about our TiTAN clinical trial for GEN-011, our neoantigen-targeted peripheral T cell therapy (NPT) candidate, from which we expect to have initial data from a small subset of patients in the first quarter or early in the second quarter next year," said Chip Clark, Genocea’s President and Chief Executive Officer. "We are also pleased that our SITC (Free SITC Whitepaper) presentations will continue to showcase the neoantigen selection capabilities of our ATLAS platform, through differentiated long-term immunogenicity and clinical response data for GEN-009, our neoantigen-targeted vaccine candidate, and through its potential application to novel autoimmune disease treatments."

Operational updates

Strengthened Board of Directors

Jennifer Herron was appointed to the Company’s Board of Directors, effective September 8, 2021. Ms. Herron is currently Senior Vice President and Chief Commercial Officer at ADC Therapeutics SA ("ADCT"), leading global commercialization strategy and execution including the launch of ADCT’s first commercial product. She is a seasoned biopharmaceutical leader with extensive oncology experience.
Upcoming presentations
Festival of Biologics November 9-11, 2021 Event Details

Keynote panel discussion: What does the future of Immunotherapy hold for Oncology and Infectious Diseases
Date/Time: Tuesday, November 9, 2021 at 10:00 a.m. C.E.T.
Presentation: Unleashing the TiTANs: the GEN-011 neoantigen-targeted peripheral T cell therapy for solid tumors
Date/Time: Tuesday, November 9, 2021 at 4:50 p.m. C.E.T.
Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting November 10-14, 2021 Event Details

Poster Presentation #475: GEN-011-101 (the TiTAN-1 trial): Phase 1 study to evaluate the safety, proliferation and persistence of GEN-011, an autologous neoantigen-targeted peripheral T cell therapy in solid tumors
Poster Presentation #485: Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors
Poster Presentation #521: GEN-009, a personalized neoantigen vaccine candidate, elicits diverse and durable immune responses associated with clinical efficacy outcomes
Poster Presentation #753: InhibigenTM administration promotes aberrant T cell responses in cancer but may be beneficial for amelioration of autoimmune disease
Poster Presentation #248: Empiric profiling of peripheral T cell recall responses to tumor mutanomes versus in silico predictions in NSCLC patients undergoing pembrolizumab treatment ± chemotherapy
Date/Time: ePosters will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform on Friday, November 12, 2021 at 7:00 a.m. E.T.
Cellular Immunotherapies for Solid Tumors Summit November 16-18, 2021 Event Details

Presentation: GEN-011 PLANET Process: A Robust and Rapidly Scalable Manufacturing Process to Generate Neoantigen-targeted Peripheral T cells (NPTs)
Date/Time: Wednesday, November 17, 2021 at 4:30 pm E.T.
World Vaccine & Immunotherapy Congress November 30-December 2, 2021 Event Details

Panel discussion: Are neoantigens living up to their initial promise? What questions remain unanswered?
Date/Time: Wednesday, December 1, 2021 at 11:40 a.m. P.T.
Financial updates

Third quarter 2021 financial results

Cash position: As of September 30, 2021, cash and cash equivalents were $48.9 million compared to $79.8 million as of December 31, 2020.

Net loss: Net loss was $3.6 million or $0.05 diluted net loss per share for the quarter ended September 30, 2021, compared to $4.6 million or $0.26 per share for the same period in 2020. Net loss was $19.9 million or $0.54 diluted net loss per share for the nine months ended September 30, 2021, compared to $28.7 million or $1.01 per share for the same period in 2020.

Research and Development ("R&D") expenses: R&D expenses were $9.5 million for the quarter ended September 30, 2021, compared to $7.5 million for the same period in 2020. R&D expenses were $28.7 million for the nine months ended September 30, 2021, compared to $26.1 million for the same period in 2020.

The increase in R&D expenses for both periods is mainly due to growth in our internal research and manufacturing teams and GEN-011 manufacturing and clinical costs.
General and Administrative ("G&A") expenses: G&A expenses were $3.9 million for the quarter ended September 30, 2021, compared to $3.6 million for the same period in 2020. G&A expenses were $11.6 million for the nine months ended September 30, 2021, compared to $10.5 million for the same period in 2020.

The increase in G&A expenses for both periods is mainly due to growth in our internal G&A team, partially offset by decreased facility costs.
Other income: Other income was $8.1 million for the quarter ended September 30, 2021, compared to $6.2 million for the same period in 2020. Other income was $18.8 million for the nine months ended September 30, 2021, compared to $6.5 million for the same period in 2020.
The increase in other income for both periods is mainly due to the non-cash impact of the fair-value adjustment for the 33.6 million liability-classified warrants issued in connection with the Company’s July 2020 private placement (the "2020 Warrants"). During the quarter ended September 30, 2021, the 2020 Warrants were remeasured to their fair value of $36.0 million and subsequently reclassified to equity.

Guidance

Genocea’s operating plan extends its cash runway into the third quarter of 2022.
Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 8729366. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.