On November 3, 2021 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported financial results for the quarter ended September 30, 2021 and highlighted recent corporate progress (Press release, Tyra Biosciences, NOV 3, 2021, View Source [SID1234594230]).

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"2021 has been transformational for TYRA. We’re pleased to have made meaningful progress across our business with important advancements in our programs, people and financial strategy," said Todd Harris, CEO of TYRA. "With the capital raised in our IPO from top tier institutional investors, key additions to our leadership and board and the growth of our pipeline, TYRA is well-positioned to execute on our strategy of delivering next-generation therapies to patients with acquired tumor resistance."

Third Quarter 2021 and Recent Corporate Highlights

Completed $198.7 Million Upsized Initial Public Offering. In September 2021, TYRA sold 12,420,000 shares of common stock in its initial public offering, which included the exercise in full by the underwriters of their option to purchase 1,620,000 additional shares of common stock, at a public offering price of $16.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by TYRA, were $198.7 million.

Appointed Rehan Verjee to Board of Directors. Rehan Verjee, former President of EMD Serono and Global Head of the Innovative Medicine Franchises for Merck KGaA, was appointed to TYRA’s Board of Directors.

Strengthened Leadership. TYRA made key senior appointments including Esther van den Boom as Chief Financial Officer, John Healy as General Counsel, and Allison Kemner as Vice President, Clinical Sciences and Operations.

Nominated 2nd Product Candidate for Clinical Development, TYRA-200 (FGFR2 Inhibitor). In October 2021, TYRA nominated its product candidate, TYRA-200, for clinical development to treat patients with tumors due to activating mutations and gene alterations in FGFR2. Similar to therapies designed for the treatment of FGFR3-driven cancers, resistance to both approved and investigational FGFR inhibitors has been shown to arise due to well-characterized mutations in FGFR2. TYRA has designed TYRA-200 to be active against multiple acquired resistant mutations that arise during treatment with other FGFR inhibitors, which remains a high unmet medical need, particularly in intrahepatic cholangiocarcinoma. TYRA anticipates filing an Investigational New Drug application (IND) for TYRA-200 with the U.S. Food and Drug Administration in the second half of 2022.
Third Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents were $312.8 million as of September 30, 2021, as compared to $15.2 million as of December 31, 2020. TYRA expects its current cash and cash equivalents balance to fund operations through at least 2024.

R&D Expenses: R&D expenses were $5.5 million for the quarter ended September 30, 2021, compared to $1.9 million for the quarter ended September 30, 2020. The increase was primarily driven by expenses incurred in connection with the advancement of TYRA-300 and other development programs as well as increased personnel costs to support increased development activities and the growth of TYRA’s pipeline.

General and Administrative (G&A) Expenses: G&A expenses were $1.2 million for the quarter ended September 30, 2021, compared to $0.5 million for the quarter ended September 30, 2020. The increase was primarily driven by increased personnel costs and professional services including accounting, legal and consulting fees.

Net Loss: For the quarter ended September 30, 2021, TYRA reported a net loss of $6.6 million, or $(0.72) per basic and diluted share, compared to a net loss of $2.3 million, or $(1.47) per basic and diluted share, for the quarter ended September 30, 2020.
About TYRA’s SNÅP Platform

TYRA has developed a proprietary, in-house discovery platform named SNÅP that enables TYRA scientists to see the real-world interaction between drug and target in rapid, sequential, structural SNÅPshots. Through the rapid generation of these precise molecular SNÅPshots, TYRA is able to continually gain deeper insights into the structure of inhibitor binding sites and how commonly occurring genetic alterations lead to acquired drug resistance to existing therapies. Leveraging these insights, TYRA aims to predict the genetic alterations most likely to cause resistance to specific existing therapies and develop compound candidates with innovative structures that are designed to inhibit the target while avoiding those mutations.

On November 3, 2021 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended September 30, 2021 (Press release, Adaptive Biotechnologies, NOV 3, 2021, View Source [SID1234594229]).

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"We are pleased to deliver another quarter of strong growth with continued momentum across research, diagnostic and drug discovery," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Achievements during the quarter mark important advancements in the evolution of our immune medicine platform as a clinical product development engine."

Recent Highlights

Revenue of $39.5 million for the third quarter 2021, representing a 50% increase from the third quarter 2020
clonoSEQ clinical sequencing volume in the third quarter 2021 grew 47% versus prior year and 8% over the second quarter of 2021
Launched an enhanced version of the clonoSEQ Assay for CLL patients, which provides IGHV mutation status in the same test where we measure the trackable MRD sequence
Received positive Tech Assessment from MolDX for coverage of T-Detect COVID in certain cases including immunocompromised patients
Increased interest by research collaborators and vaccine manufacturers to use immunoSEQ T-MAP COVID to assess whether T cells may provide a correlate of protection
Vaccibody initiated its phase 1/2 study to address emerging SARS-CoV-2 variants of concern and use as a potential universal booster with their two candidates, one of which includes T cell-based components identified by Adaptive Biotechnologies’ immune medicine platform
Third Quarter 2021 Financial Results

Revenue was $39.5 million for the quarter ended September 30, 2021, representing a 50% increase from the third quarter in the prior year. Sequencing revenue was $22.1 million for the quarter, representing a 96% increase from the third quarter in the prior year. Development revenue was $17.4 million for the quarter, representing a 16% increase from the third quarter in the prior year.

Operating expenses were $95.8 million for the third quarter of 2021, compared to $63.3 million in the third quarter of the prior year, representing an increase of 51%.

Net loss was $56.0 million for the third quarter of 2021, compared to $36.7 million for the same period in 2020.

Adjusted EBITDA (non-GAAP) was a loss of $41.1 million for the third quarter of 2021, compared to a loss of $28.4 million for the third quarter of the prior year.

Cash, cash equivalents and marketable securities was $632.4 million as of September 30, 2021.

2021 Financial Guidance

Adaptive Biotechnologies reiterates full year 2021 revenue to be in the range of $148 million to $155 million, representing 54% growth at the mid-point of the range over full year 2020 revenue.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its third quarter 2021 financial results after market close on Wednesday, November 3, 2021 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On November 3, 2021 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported that financial results for the third quarter ending September 30, 2021 and provided an update on clinical programs (Press release, NewLink Genetics, NOV 3, 2021, View Source [SID1234594228]).

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"During our third quarter we continued to advance our LUM-201 program for the treatment of pediatric growth hormone deficiency (PGHD), with the opening of a number of new OraGrowtH210 Trial sites," said Rick Hawkins, Chairman and CEO of Lumos Pharma. "The screening and enrollment for both our OraGrowtH210 and OraGrowtH212 Trials are progressing well. We continue to expect the primary outcome data readout for our OraGrowtH210 trial in the second half of 2023. Beyond PGHD, we believe LUM-201 represents a pipeline-in-a-product and are encouraged by discussions with KOLs regarding the potential to expand our LUM-201 platform into other indications currently treated by injectable growth hormone."

Clinical Update:

OraGrowtH210 Trial of LUM-201 in PGHD

Enrollment in the Phase 2 OraGrowtH210 Trial of LUM-201 in PGHD continues, with the majority of the approximately 50 planned sites activated and open for enrollment. OraGrowtH210 is a global clinical trial and is evaluating orally administered LUM-201 in approximately 80 patients diagnosed with PGHD. The objective of the trial is to identify the optimal dose of LUM-201 based on annualized height velocity to be used in a Phase 3 registration trial and to prospectively confirm the preliminary validation of our Predictive Enrichment Marker (PEM) strategy. The Company continues to anticipate six-month data read-out for the OraGrowtH210 Trial in the second half of 2023, with additional 12-month data to be collected.

OraGrowtH212 Trial of LUM-201 in PGHD Initiated Q2 2021

The OraGrowtH212 Trial was initiated in June and is also continuing to enroll patients. OraGrowtH212 is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of LUM-201 in up to 24 PGHD patients at two dose levels, 1.6 and 3.2 mg/kg/day. Given the open-label design of this trial, the Company has the ability to perform an interim analysis at its discretion. The objective of OraGrowtH212 is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone unique to LUM-201 and its potential for this mechanism of action to contribute to efficacy in PGHD. The primary endpoint is six months of PK/PD and height velocity data, with additional 12-month data to be captured.

LUM-201 Life-Cycle Management

Injectable recombinant human growth hormone (rhGH) and derivative products are currently approved for multiple indications, including PGHD. LUM-201, through its unique mechanism of promoting increased secretion of endogenous GH, may have the potential to be efficacious in many of these indications. Lumos Pharma is in advanced discussions with key opinion leaders and our Clinical and Scientific Advisory Board to expand our LUM-201 pipeline. The Company is actively reviewing the pathway for LUM-201 in other indications including Turner Syndrome, Prader-Willi Syndrome, Idiopathic Short Stature (ISS), and Children Born Small for Gestational Age (SGA).

Financial Results for the Quarter Ended September 30, 2021

Cash Position – Lumos Pharma ended the third quarter on September 30, 2021, with cash and cash equivalents totaling $100.7 million compared to $98.7 million on December 31, 2020. Cash on hand as of the end of Q3 2021 is expected to support operations through the primary outcome data readout from OraGrowtH210 and OraGrowtH212 Trials.
R&D Expenses – Research and development expenses were $4.1 million, an increase of $2.0 million for the three months ended September 30, 2021 compared to the same period in 2020, primarily due to increases of $1.8 million in clinical trial and contract manufacturing expenses, $0.4 million in personnel-related expenses and $0.1 million in stock compensation expenses, offset by a decrease of $0.3 million in supplies and other expenses.
G&A Expenses – General and administrative expenses were $3.4 million, a decrease of $1.8 million for the three months ended September 30, 2021, as compared to the same period in 2020, primarily due to decreases of $1.3 million in personnel-related expenses, $0.3 million in legal, consulting and other expenses and $0.2 million in operating expenses for insurance, rent, supplies, and depreciation.
Net Loss – The net loss for the third quarter ended September 30, 2021 was $7.5 million compared to net income of $1.8 million for the same period in 2020.
Lumos Pharma ended Q3 2021 with 8,357,391 shares outstanding.
Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical programs. There will also be a question-and-answer session following management’s prepared remarks.

Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at View Source in the "Investors & Media" section under "Events and Presentations" or through this link: View Source To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 2891824. The replay will be available for two weeks from the date of the call.

On November 3, 2021 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") reported its financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Protagonist, NOV 3, 2021, View Source [SID1234594227]).

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"We are excited to share the substantial progress made thus far in all of our clinical programs, highlighted by the presentation of proof-of-concept data on rusfertide in hereditary hemochromatosis at the upcoming AASLD meeting, and the new rusfertide data in polycythemia vera, which will be presented by the year’s end," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer. "We were very pleased that the FDA reached a swift resolution regarding the clinical hold placed on rusfertide, and we are in the process of resuming all rusfertide clinical studies. Additionally, we are highly encouraged with the rate of enrollment in the Phase 2 study of our oral alpha-4-beta-7 integrin antagonist PN-943, for ulcerative colitis, an indication with a large patient population and unmet treatment need. We maintain our guidance of a data readout in Q2 2022, and in anticipation of this, we are excited that Dr. Scott Plevy has joined our team as Executive Vice President and Therapeutic Head, Gastroenterology. As a renowned gastroenterologist, Dr. Plevy will oversee the clinical development of PN-943 and other future programs focused on gastrointestinal diseases. Finally, our oral IL-23 receptor antagonist program, in partnership with Janssen, continues to make demonstrated progress, with PN-235 now advancing into a Phase 2 study in psoriasis in early 2022."

Third Quarter 2021 Recent Developments and Upcoming Milestones

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

On October 11, 2021, Protagonist announced that the U.S. Food and Drug Administration (FDA) removed the full clinical hold on rusfertide’s clinical studies after the Company provided the FDA with all requested information, including the individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, conducted a comprehensive review of the most recent safety database, and added new safety and stopping rules in the study protocols. This was in response to the Company receiving a communication from the FDA that Protagonist’s clinical studies for rusfertide had been placed on clinical hold on September 17, 2021. Protagonist has been working closely with study investigators and clinical trial sites to resume enrollment and dosing of patients in ongoing clinical trials with rusfertide.
An abstract highlighting new, preliminary data from a Phase 2 proof-of-concept study in hereditary hemochromatosis (HH) has been selected for oral presentation by Dr. Kris Kowdley, from the Liver Institute Northwest in Seattle. These data will be presented on November 13, 2021 at The Liver Meeting 2021, hosted by the American Association for the Study of Liver Diseases (AASLD).
The Company intends to report updated data from the Phase 2 study of rusfertide in polycythemia vera (PV) by the end of 2021.
The Company is on track to initiate the Phase 3 study of rusfertide in PV in Q1 2022.
The Company resolved its collaboration agreement dispute with Zealand Pharma, reducing future development and sales milestone payments and royalties owed to Zealand for rusfertide under the companies’ 2012 collaboration agreement. Under the new terms of the agreement, future development and sales milestone payments (other than $2.5 million in near-term milestones) and royalties for rusfertide have been reduced by 50 percent. Milestones and royalty payments will be due for sales and milestones achieved by either Protagonist or any future rusfertide licensee or partner. Protagonist will also make a $1.5 million payment to Zealand in August 2022.
PN-943: Oral, gut-restricted, alpha-4-Beta-7 Integrin Antagonist for Ulcerative Colitis

We are continuing to see steady progress in the enrollment and execution of the Phase 2 IDEAL study of PN-943 in ulcerative colitis. This study includes a 12-week induction period and a 40-week open label extension. Topline data from the 12-week induction period is expected in the second quarter of 2022.
Scott Plevy, M.D., renowned expert in translational and clinical research in gastroenterology and immunology, was appointed Executive Vice President and Therapeutic Head, Gastroenterology, and he will oversee clinical operations and development of Protagonist’s ongoing and future programs in gastrointestinal diseases, including PN-943.
Oral IL-23 Receptor Antagonists (collaboration between Janssen Biotech, Inc. and Protagonist)

Following a pre-specified interim analysis criteria, a portfolio decision was made to stop further development of the first-generation IL-23 receptor antagonist (IL-23R) candidate PTG-200 (JNJ-67864238), in favor of continued development of the two second generation candidates PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186) with superior product profiles. In particular:
The Phase 1 study of PN-235 is completed, and a Phase 2 study in psoriasis is anticipated to initiate in early 2022.
The Phase 1 study with PN-232 is under progress with study completion expected by mid-2022.
Additional development in IBD is expected to initiate in 2022.
Protagonist will earn a $25 million milestone in connection with the initiation of the first Phase 2 study of a second-generation candidate, and a $10 million milestone in connection with the initiation of the second Phase 2 study of a second-generation candidate. Protagonist remains eligible for up to approximately $900 million in development-related milestone payments, in addition to the $87.5M in milestones already earned.
Protagonist received a $7.5 million milestone payment from Janssen, triggered by the completion of the clinical data collection Phase 1 activities for PN-235 (JNJ-2113).
Third Quarter 2021 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2021, were $352.5 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through 2024.
License and Collaboration Revenue: License and collaboration revenues were $10.3 million and $18.7 million for the three and nine months ended September 30, 2021, respectively, as compared to $13.1 million and $23.0 million reported for the same periods of 2020. The Company recognized $8.0 million as a cumulative catch-up amount during the three months ended September 30, 2021, following the amendment of its collaboration agreement for the development of IL-23 receptor antagonist assets with Janssen Biotech. This cumulative catch-up was primarily the result of an acceleration of our cumulative performance completed under our obligation, following the amendment to the collaboration which reduced the remaining services the Company is responsible to conduct. We are nearing completion of our remaining services to be provided to Janssen under the collaboration, in particular, both the ongoing Phase 1 trials in PN-235 and PN-232, are expected to be complete in the fourth quarter of 2021 and second quarter 2022, respectively. Revenue for the prior year’s third quarter of 2020 also included an estimate update for services completed versus remaining services to be performed under the Janssen collaboration agreement which accelerated revenue recognition.
Research and Development ("R&D") Expenses: R&D expenses for the three and nine months ended September 30, 2021, were $37.0 million and $87.6 million, respectively, as compared to $16.0 million and $55.0 million, respectively, for the same periods of 2020. The increases were primarily due to additional costs associated to advancing our clinical trials with our pipeline assets rusfertide and PN-943, as well as our second-generation IL-23 receptor antagonist assets under the Janssen collaboration (PN-235 and PN-232). The increases also relate to higher research spending and employee related costs, including stock-based compensation expenses following recent hiring in support of our advancing research and development programs. Following the amendment to the Zealand collaboration agreement we also recorded $4.0 million in the quarter ended September 30, 2021 in R&D expense related to these collaboration payments.
General and Administrative ("G&A") Expenses: G&A expenses for the three and nine months ended September 30, 2021, were $7.3 million and $19.9 million, respectively, as compared to $4.9 million and $13.6 million for the same periods of 2020. The increases were primarily related to professional fees, insurance costs and employee compensation related expenses, including stock-based compensation expenses, supporting the growth in our operations.
Stock Based Compensation ("SBC") Expenses: SBC expenses for the three and nine months ended September 30, 2021, were $4.8 million and $11.4 million, respectively, as compared to $1.8 million and $5.9 million, respectively, for the same periods of 2020. SBC increases included in R&D and G&A expenses are primarily attributable to the addition of new employees and related stock grants in support of the Company’s continued growth coupled with the increase in the Company’s stock price at grant date which is used in the SBC expense calculation.
Net Loss: The third quarter 2021 net loss was $33.8 million, or a net loss of $0.70 per share, and the nine months ended September 30, 2021, net loss was $88.6 million, or a net loss of $1.94 per share, compared to the third quarter of 2020 net loss of $7.8 million, or a net loss of $0.21 per share, and the nine months ended September 30, 2020, net loss of $47.3 million, or a net loss of $1.45 per share.

On November 3, 2021 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that results for the third quarter and first nine months of 2021 (Press release, Qiagen, NOV 3, 2021, View Source [SID1234594226]).

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In Q3 2021, net sales rose 11% (+10% at constant exchange rates, CER) to $535 million, which was well above the outlook for CER sales to be at the same level as in the year-ago period. Key drivers were a 48% CER gain in sales of the QuantiFERON-TB test to $79 million over Q3 2020 and solid growth in DNA sample technologies products. Also supporting the performance was a stronger-than-expected demand for COVID-19 testing solutions. Diluted earnings per share (EPS) were $0.57 in Q3 2021, up from $0.07 per share in the same period of 2020. Adjusted diluted EPS was $0.58 ($0.58 CER), which was above the outlook for $0.52-0.53 CER and unchanged from Q3 2020.

"QIAGEN’s results for the third quarter of 2021 confirm that our business continues to build strong momentum, especially our non-COVID product groups that delivered 17% CER growth," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "We are on track to reach our 2021 sales targets for our five pillars of growth while crossing a significant milestone of more than $2 billion in net sales. Our performance during 2021 has underscored the relevancy of QIAGEN in the molecular research and testing market, while we stand ready to address the volatile trends in COVID-19 testing."

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "We have upgraded our full-year outlook for 2021 to reflect the stronger-than-expected results in the third quarter of 2021. Using the boost from the COVID-19 pandemic demand, as well as the momentum in our non-COVID product groups, we are making significant progress on initiatives to support the business expansion in the coming years thanks to our record operating cash flow combined with a commitment to disciplined capital allocation. This has given us the flexibility to make investments to further accelerate our five pillars of growth while increasing returns to shareholders, such as through the recently completed $100 million share repurchase program."

Please find the full press release incl. tables here

Investor presentation and conference call

A conference call is planned for Thursday, November 4, 2021, at 14:30 Central European Time (CET) / 9:30 Eastern Daylight Time (EDT). A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a replay will also be made available after the event. A presentation is available at View Source as of Thursday, November 4, 2021, at 12:30 Central European Time (CET) / 7:30 Eastern Daylight Time (EDT).