On November 2, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported that Enrique Conterno, Chief Executive Officer, will participate in a fireside chat at the following healthcare conferences (Press release, FibroGen, NOV 2, 2021, View Source [SID1234594126]):

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Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16 at 4:40 PM EST.
12th Annual Jefferies London Healthcare Conference on Thursday, November 18 at 3:00 AM EST.
An audio webcast will be available on the "Events & Presentations" section of the FibroGen Investor webpage at www.fibrogen.com. A replay will be available for approximately 30 days.

On November 2, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the third quarter of 2021 ended September 30, 2021 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, NOV 2, 2021, View Source [SID1234594125]).

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"I am pleased to report that AstraZeneca has completed dosing in part 1a of the phase 2a study of PRS-060/AZD1402. We look forward to announcing the completion of the safety review by AstraZeneca before initiating the second part of that study and presenting topline data informing our co-development opt-in decision next year. Also within our respiratory franchise, we are progressing PRS-220 toward the clinic next year, and we recently presented preclinical data for that program, reinforcing our enthusiasm about it. Additionally, we have made important strides in getting the next phase of clinical trials for our immuno-oncology programs cinrebafusp alfa and PRS-344 activated, and we are excited to see those trials progress," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "We have a solid balance sheet of over $125 million as we continue to advance a diverse and rich pipeline of fully proprietary and co-developed assets into and through the clinic this year and anticipate several key inflection points in 2022."

PRS-060/AZD1402 and AstraZeneca Collaboration: Dosing has been completed in part 1a (safety) of the global phase 2a study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Data unblinding and review will now follow, the outcome of which the Company will publicly disclose, gating progression to the second part of the study, where efficacy will be assessed in moderate, uncontrolled asthmatics. Pieris and AstraZeneca expect to announce topline data from the entire phase 2a study next year.Upon completion of the study, which is being sponsored and funded by AstraZeneca, Pieris will have the options to co-develop and, separately, co-commercialize PRS-060/AZD1402 in the United States. Pieris and AstraZeneca continue to advance each of the four programs in the collaboration beyond PRS-060/AZD1402.
Cinrebafusp Alfa (PRS-343): Pieris plans to dose the first patient in a two-arm phase 2 study for cinrebafusp alfa, a 4-1BB/HER2 bispecific for the treatment of HER2-expressing solid tumors, in gastric cancer this quarter and reconfirms its plan to report initial data from the arm evaluating cinrebafusp alfa in combination with tucatinib in HER2-low gastric cancer next year. The Company has decided to focus enrollment on second line patients and now expects to report data from the arm evaluating cinrebafusp alfa in combination with ramucirumab and paclitaxel in HER2-high gastric cancer in 2023.
PRS-344/S095012 and Servier Collaboration: Regulatory approval for the phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 bispecific, has been granted by multiple countries. Pieris holds exclusive commercialization rights for PRS-344/S095012 in the United States and will receive royalties on ex-U.S. sales for this program, should it receive regulatory approval. Additionally, Servier is continuing development of PRS-352, an undisclosed Anticalin-based bispecific beyond 4-1BB.
PRS-220: Pieris presented initial preclinical data for PRS-220, a proprietary inhaled Anticalin protein targeting connective tissue growth factor (CTGF) for the treatment of idiopathic pulmonary fibrosis (IPF), at the European Respiratory Society International Congress 2021 (ERS) demonstrating a more potent and durable target engagement profile compared to a clinical-stage, systemically delivered anti-CTGF antibody benchmark. Additionally, the targeting of CTGF locally in the lung showed increased attenuation of fibrotic lung remodeling in vivo compared to the systemically delivered antibody. This outcome correlates with superior lung tissue exposure of PRS-220 compared to that of the systemically administered antibody in head-to-head studies, where intratracheally administered PRS-220 efficiently penetrates the fibrotic, interstitial lung tissue of mice. Clinical development for the program in IPF and post-COVID pulmonary fibrosis, as supported by a grant from the Bavarian government, is expected to begin next year.
Seagen Collaboration: Pieris has initiated the second program within the bispecific immuno-oncology collaboration with Seagen, a program that includes a co-promotion option for Pieris in the United States. Additionally, Seagen is continuing development of the first program, an undisclosed Anticalin-based bispecific.
Genentech Collaboration: Pieris and Genentech initiated joint discovery activities for the two committed programs, one in respiratory and one in ophthalmology, as part of their research collaboration and license agreement to discover, develop, and commercialize locally delivered therapies that leverage Pieris’ proprietary Anticalin technology.
Executive Leadership: Pieris announced the promotion of Thomas Bures to Senior Vice President and Chief Financial Officer. Mr. Bures oversees all financial matters at the company, including treasury, tax, financial planning, procurement and investor relations. Pieris additionally announced the promotion of Ahmed Mousa to Senior Vice President and Chief Business Officer. In his new role, Mr. Mousa heads business development and portfolio strategy, in addition to serving as General Counsel and Boston site head.
First Quarter Financial Update:

Cash Position – Cash and cash equivalents totaled $125.1 million for the quarter ended September 30, 2021, compared to a cash and cash equivalents balance of $70.4 million for the year ended December 31, 2020. The increase since December 2020 is due to cash received from new and existing collaboration agreements, including milestone achievements and use of the Company’s ATM program. This increase was partially offset by cash used to fund operations for the first nine months of 2021. The September 30th cash position does not include the impact of the Bavarian government grant, as those proceeds will be reimbursed for qualifying program costs incurred over the PRS-220 development period. In the third quarter ended September 30, 2021, the Company raised more than $23 million in cash through the use of the ATM program.

R&D Expense – R&D expenses were $18.9 million for the quarter ended September 30, 2021, compared to $11.8 million for the quarter ended September 30, 2020. The increase reflects higher spending on preclinical and manufacturing activities for PRS-220, an increase in manufacturing costs across multiple immuno-oncology programs, higher clinical costs on cinrebafusp alfa and higher employee related costs. These increases were partially offset by lower manufacturing costs on PRS-060, which are fully reimbursable.

G&A Expense – G&A expenses were $4.1 million for the quarter ended September 30, 2021, compared to $4.1 million for the quarter ended September 30, 2020. There were no significant changes in categories of spending as G&A departments continue to efficiently leverage spending to support the Company’s overall needs.

Other Income – For the quarter ended September 30, 2021, $1.8 million of other income was recorded for PRS-220 program costs that qualified for reimbursement under the Bavarian grant that was announced in June 2021.

Net Loss – Net loss was $16.5 million or $(0.24) per share for the quarter ended September 30, 2021, compared to a net loss of $14.3 million or $(0.26) per share for the quarter ended September 30, 2020.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Tuesday, November 2, 2021, to discuss finance results for the third quarter of 2021 and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

On November 2, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $456.4 million for the third quarter ended September 30, 2021, compared to $408.4 million for the same period of 2020 (Press release, Exact Sciences, NOV 2, 2021, View Source [SID1234594124]).

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"Exact Sciences is entering an exciting period for its pipeline, generating evidence to support innovative tests that will help defeat cancer through earlier detection," said Kevin Conroy, chairman and CEO. "Our powerful commercial engine will help us achieve our mission by getting more people tested with Cologuard, Oncotype DX, and our future tests."

Third quarter 2021 financial results

For the three-month period ended September 30, 2021, as compared to the same period of 2020 (where applicable):

Total revenue was $456.4 million, an increase of 12 percent
Screening revenue was $280.4 million, an increase of 31 percent
Precision Oncology revenue was $145.4 million, an increase of 59 percent
COVID-19 testing revenue was $30.6 million, a decrease of 70 percent
Gross margin including amortization of acquired intangible assets was 70%, and non-GAAP gross margin excluding amortization of acquired intangible assets was 75%
Intangible asset impairment of $20.2 million was related to a supply agreement asset recorded as part of the combination with Genomic Health
Net loss was $166.9 million, or $0.97 per share, compared to a net loss of $202.5 million, or $1.35 per share
EBITDA was $(119.9) million, and adjusted EBITDA was $(16.3) million
Cash, cash equivalents, and marketable securities were $1.22 billion at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products and laboratory service revenue from Ashion.

2021 outlook

The company anticipates revenue of $1,722-$1,737 million during 2021, including Screening revenue of $1,050-$1,055 million, Precision Oncology revenue of $547-$552 million, and COVID-19 testing revenue of $125-$130 million.
Updated revenue guidance has been narrowed toward the high end of our previously expected range of $1,705-$1,745 million, which included Screening revenue of $1,100-$1,125 million, Precision Oncology revenue of $530-$540 million, and COVID-19 testing revenue of $75-$80 million.
Screening revenue expectations are lower due to the rapid rise in Delta variant cases starting in late July, causing in-person sales calls to significantly decrease in August and September.
Non-GAAP disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

Third quarter conference call & webcast
Company management will host a conference call and webcast on Tuesday, November 2, 2021, at 5 p.m. ET to discuss third quarter 2021 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-952-1519 and international callers should dial +1-236-714-2125. The access code for both domestic and international callers is 2782364.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 2782364. The webcast, conference call and replay are open to all interested parties.

About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated. The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit www.cologuardtest.com.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With more than 1 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On November 2, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company") reported its third quarter 2021 financial results and provided a corporate update on eganelisib, its potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic (Press release, Infinity Pharmaceuticals, NOV 2, 2021, View Source [SID1234594123]).

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"Infinity had a very successful 3rd quarter reaching major clinical milestones with eganelisib and welcoming two outstanding R&D executives to our management team," said Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals. "In particular, data presented in July from MARIO-3 and MARIO-275 show that eganelisib, with its unique role in reprogramming macrophages, increases the effectiveness of current checkpoint inhibitors and improves patient outcomes across multiple indications and treatment settings. These data show that eganelisib has the potential to drive the next generation of cancer immuno-therapy."

"The data on prolonged progression-free survival in metastatic triple negative breast cancer, increased overall survival in metastatic urothelial cancer, and translational evidence of modulation of the tumor microenvironment highlight the broad potential of eganelisib to improve immune checkpoint inhibitor-based treatments for patients regardless of PD-L1 status. This is particularly meaningful for PD-L1 negative 1L mTNBC patients for whom no checkpoint inhibitors have been approved and for PD-L1 negative mUC patients for whom checkpoint inhibitors are less effective," said Dr. Robert Ilaria, Chief Medical Officer, Infinity Pharmaceuticals. "We look forward to presenting a TNBC update at SABCS in December for which we are especially interested in seeing if the encouraging PFS data presented this summer is maintained in the maturing data set and to providing an update on eganelisib in UC in our January 5th guidance for 2022."

Recent Updates:

MARIO-3: Updated data was presented from 43 patients (43 patients evaluable for safety and 38 patients evaluable for efficacy) were presented on July 27, 2021, from the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination with Tecentriq (atezolizumab) and Abraxane (nab-paclitaxel) in unresectable locally advanced or metastatic triple negative breast cancer (TNBC). Updated safety and efficacy data will be presented at the San Antonio Breast Cancer Symposium (SABCS) Annual Meeting, December 7-10, 2021.

Encouraging efficacy data presented on July 27, 2021, suggest the addition of eganelisib to Tecentriq and Abraxane has the potential to extend progression-free survival regardless of PD-L1 status.
86.8% (33/38) of evaluable patients demonstrated tumor reduction, with the majority of patients still on treatment.
The addition of eganelisib appears to extend progression-free survival (PFS) in both PD-L1(+) and PD-L1(-) patients relative to the Tecentriq and Abraxane combination from the benchmark IMpassion130 study.
In PD-L1(-) patients, median PFS was 7.3 months (3.5, NA) in MARIO-3, compared to median PFS of 5.6 months for Tecentriq and Abraxane in IMpassion130. There are currently no approved checkpoint inhibitor regimens, including the combination of Tecentriq and Abraxane, for PD-L1 (-) 1L mTNBC patients.
In PD-L1(+) patients, median PFS was 11.2 months (5.3, 11.2) in MARIO-3 compared to 7.5 months for Tecentriq and Abraxane in IMpassion130. The Tecentriq and Abraxane combination is approved in PD-L1(+) 1L mTNBC patients in over 70 countries.
Overall safety in MARIO-3 was consistent with the safety profile of eganelisib and the published safety profile of the marketed products Tecentriq and Abraxane, and no new safety signals were observed. The most common ≥GR3 treatment-related adverse events (AEs) were hepatic AEs (18%); neutropenia AEs (16%); skin AEs (12%); fatigue (6%); peripheral sensory neuropathy (6%); and diarrhea (6%).
MARIO-275: Updated data on 49 patients were presented on July 27, 2021, from the Company’s randomized, placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with Opdivo (nivolumab) in platinum-refractory, I/O naïve patients with locally advanced or metastatic urothelial cancer (UC).

Median overall survival (mOS) in the intent to treat population was 15.4 months (6.2, NE) on the eganelisib plus Opdivo arm compared to 7.9 months (2.3, NE) on the Opdivo control arm (hazard ratio of 0.62 (0.28, 1.36)), reflecting a 38% lower probability of death.
Median overall survival was equally strong in PD-L1(-) patients with a hazard ratio of 0.60 (0.21, 1.71), reflecting a 40% lower probability of death.
The most common ≥Grade 3 treatment-related adverse events (AEs) were, across all doses, all causality, anemia (12.1%), and hepatic AEs including hepatotoxicity (15.2%), increased ALT (12.1%) and increased AST (12.1%) with no Hy’s Law. No Grade 5 hepatic AEs were reported.
Corporate:

Appointed Stéphane Peluso, Ph.D., as Chief Scientific Officer, joining Infinity from Ipsen.
Appointed Robert Ilaria, Jr., M.D. as Chief Medical Officer, joining Infinity from Bristol Myers Squibb/Celgene.
Appointed Brian Schwartz, M.D., to Board of Directors, transitioning from consulting Chief Physician to the Board.
Third Quarter 2021 Financial Results:

At September 30, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $90.1 million, compared to $97.3 million at June 30, 2021.
Research and development expense for the third quarter of 2021 was $7.1 million, compared to $6.1 million in the same period in 2020. The increase is primarily related to an increase in compensation related expenses and clinical development expenses to support continued development of eganelisib.
General and administrative expense was $3.8 million for the third quarter of 2021, compared to $2.9 million for the same period in 2020. The increase in G&A expense is primarily due to an increase in consulting expenses, professional services and stock compensation.
Net loss for the third quarter of 2021 was $10.7 million, or a basic and diluted loss per common share of $0.12, compared to a net loss of $9.5 million, or a basic and diluted loss per common share of $0.16 in the same period in 2020.
Financial Outlook: Infinity’s 2021 financial guidance remains as follows:

Net Loss: Infinity expects net loss for 2021 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2021 with a year-end-cash, cash equivalents and available for sale securities balance ranging from $70 million to $80 million. Infinity’s financial guidance does not include additional funding or business development activities.
Conference Call Information

Infinity will host a conference call today, November 2, 2021, at 4:30 PM ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 2938945. An archived version of the webcast will be available on Infinity’s website for 30 days.

On November 2, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that the Company’s third quarter 2021 financial results will be released on Tuesday, November 9, 2021 (Press release, Calithera Biosciences, NOV 2, 2021, View Source [SID1234594122]). Company management will host a conference call on Tuesday, November 9, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 3797324. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.