On November 3, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported its third quarter 2022 financial results for the period ended September 30, 2022 (Press release, Merrimack, NOV 3, 2022, View Source [SID1234622982]).

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"During the third quarter we continued to see the benefits of reduced operating expenses," said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We will continue to monitor developments in Ipsen’s Onivyde (irinotecan liposomal injection) program and Elevation’s seribantumab program."

Third Quarter 2022 Financial Results

Merrimack reported a net loss of $442 thousand for the third quarter ended September 30, 2022, or $0.03 per basic and diluted share on a fully diluted basis, compared to a net loss of $525 thousand, or $0.04 per basic and diluted share on a fully diluted basis, for the same period in 2021.

General and administrative expenses for the third quarter ended September 30, 2022, were $504 thousand, compared to $619 thousand for the same period in 2021.

As of September 30, 2022, Merrimack had cash and cash equivalents of $13.1 million, compared to $14.6 million as of September 30, 2021.

As of September 30, 2022, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On August 3, 2022, Ipsen announced results from its Phase III RESILIENT trial evaluating Onivyde in second-line monotherapy for small cell lung cancer. The announcement indicated that "the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency." Ipsen indicated in its update that it will analyze the data further before making decisions about next steps.

– On October 27, 2022, Ipsen provided a public update on its sales performance for the first 3 quarters of 2022 and indicated that top line data from its continuing Phase 3 study of ONIVYDE in first line pancreatic ductal adenocarcinoma were anticipated to be available during the second half of 2022.

Elevation Oncology

– On November 3, 2022 Elevation provided their third quarter investor update and indicated that top line data from its phase 2 CRESTONE Study evaluating the HER3 monoclonal antibody seribantumab in patients with tumors harboring NRG1 fusions are expected in 2024.

On November 3, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the third quarter ended September 30, 2022 and provided business highlights (Press release, Akebia, NOV 3, 2022, View Source [SID1234622981]).

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"Our team continues to execute a strategy aligned with our three strategic pillars, drive Auryxia revenue while managing costs, support the regulatory processes for vadadustat globally, and thoughtfully invest in our pipeline," said John P. Butler, Chief Executive Officer of Akebia. "Our team is leading the regulatory review of vadadustat in Europe and select ACCESS markets. Between those review processes and the submission of a request for formal dispute resolution with the FDA regarding the Complete Response Letter for vadadustat in the U.S., we anticipate the fourth quarter could bring some clarity and a timeframe for our ability to potentially obtain approval for vadadustat in various markets."

In October 2022, Akebia submitted a Formal Dispute Resolution Request (FDRR) with the U.S. Food & Drug Administration (FDA) regarding the Complete Response Letter (CRL) received in March 2022 for vadadustat, which was under review as a treatment for anemia due to chronic kidney disease (CKD). The FDRR focuses on the favorable balance of the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis in light of safety concerns expressed by the FDA in the CRL related to the rate of adjudicated thromboembolic events driven by vascular access thrombosis for vadadustat compared to the active comparator and the risk of drug-induced liver injury. Based on the typical FDRR process, Akebia expects to receive a response to its submission by the end of 2022.

"We act in the interest of patients impacted by kidney disease and believe in the favorable balance of the benefits and risks of vadadustat as a treatment for anemia due to chronic kidney disease," said John P. Butler, Chief Executive Officer of Akebia. "To that end, we are continuing to pursue a path that could potentially lead to an approval of vadadustat for dialysis dependent patients in the U.S."

The company had additional important business updates since the beginning of the third quarter of 2022:

Akebia assumed responsibility from Otsuka Pharmaceuticals Co. Ltd. (Otsuka) for the marketing authorization application (MAA) for vadadustat that Otsuka submitted to the European Medicines Agency (EMA). Based on the current review timeline, Akebia expects a decision on the MAA from EMA in the first quarter of 2023.
Akebia continued to strengthen its balance sheet position by retiring $33 million of its $100 million debt facility with Pharmakon, inclusive of the first quarterly principal repayment.
In August 2022, Akebia released initial findings from an investigator-sponsored clinical study with the University of Texas Health Sciences Center, Houston (UTHealth) evaluating vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS). Akebia has since further collaborated with UTHealth to begin outlining potential next steps associated with an ARDS development program.
"Managing operating expenses is critical as we look for opportunities to add value to the company," said David A. Spellman, Chief Financial Officer of Akebia. "By focusing on operating expenses and winding down certain projects, we’re pleased to report a reduction in spend quarter over quarter in 2022. Auryxia net product revenue increased in the third quarter of 2022 from the third quarter of 2021. There was a slight decline from the second quarter of 2022 partially due to the drawdown of inventory at certain customers during the third quarter of 2022. In addition, since the start of COVID, the phosphate binder market has contracted 15%. While the phosphate binder market has continued to decline, the work we’ve done to increase net price per pill puts us in a position to affirm our 2022 net product revenue guidance for Auryxia of $170 – $175 million."

Financial Results

Revenues: Total revenue was $49.0 million in the third quarter of 2022 compared to $48.8 million for the third quarter of 2021.
Net product revenue was $42.2 million in the third quarter of 2022 compared to $36.8 million in the third quarter of 2021, a 14.9% increase; and compared with $43.7 million in the second quarter of 2022, a 3.3% decrease. The increase compared to the third quarter of 2021 is primarily due to pricing and improved payer mix. The decrease compared to the second quarter of 2022 was due to a reduction in inventory drawdowns of Auryxia by certain customers.
License, collaboration and other revenue was $6.7 million in the third quarter of 2022 compared to $12.0 million in the third quarter of 2021. The decrease was primarily related to a reduction in revenue from the termination of the U.S. and international collaboration agreements between Akebia and Otsuka in the second quarter of 2022.
COGS: Cost of goods sold was $37.9 million in the third quarter of 2022 compared to $15.9 million in the third quarter of 2021. The increase compared to the prior year period was primarily due to a $13.2 million non-cash charge related to an increase in the liability for excess purchase commitments during the third quarter of 2022 and a $6.0 million non-cash benefit related to a decrease in the liability for excess purchase commitments in the third quarter of 2021 which did not reoccur.
R&D Expenses: Research and development expenses were $27.4 million in the third quarter of 2022 compared to $40.5 million in the third quarter of 2021. The decrease compared to the prior year period was primarily due to decreased headcount related costs due to the previously announced reduction in force and decreased clinical trial costs.
SG&A Expenses: Selling, general and administrative expenses were $30.9 million in the third quarter of 2022 compared to $46.4 million in the third quarter of 2021. The decrease compared to the prior year period was primarily due to decreased headcount related costs as a result of the reduction in force, lower one-time legal costs, and lower marketing expenses.
Net Loss: Net loss was $51.9 million in the third quarter of 2022 compared to $59.5 million in the third quarter of 2021.
Cash Position: Cash and cash equivalents as of September 30, 2022 were $144.8 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months. Akebia’s operating plan includes assumptions pertaining to cost avoidance measures and the reduction of overhead costs resulting from the planned amendment of contractual arrangements with certain supply partners, and the reduction of operating expenses. The outcome of these assumptions, such as the potential amendment of contractual arrangements with certain supply partners, are outside of Akebia’s control. In addition, future decisions by the FDA or other regulatory agencies related to the potential regulatory approval of vadadustat or our ability to generate additional value from vadadustat through partnerships or other transactions may potentially further extend our cash runway, but such future decisions or transactions are not contemplated in our operating plan.
Conference Call

Akebia will host a conference call on November 3 at 4:30 p.m. ET to discuss its financial results and recent company highlights. Access to the call will be provided via a new process. To access the call, please register by clicking on this Registration Link, and then you will be provided with dial in details. To avoid delays, we encourage dialing into the conference call fifteen minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the Investors section of Akebia’s website at: View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

On November 3, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported financial results for the third quarter and first nine months of 2022 and provided a business update (Press release, Prothena, NOV 3, 2022, View Source [SID1234622980]).

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"Significant scientific and clinical progress has reinforced our understanding of the biology of Alzheimer’s disease and the impact that lowering amyloid plaque has on slowing cognitive and functional decline of people suffering from this devastating condition. This further strengthens our belief that PRX012, our next-generation subcutaneous anti-Aβ antibody, with a best-in-class profile, is positioned to lead a paradigm shift in the treatment of Alzheimer’s disease. Additionally, we look forward to presenting data on the observed survival benefit of birtamimab from the Phase 3 VITAL study in patients with Mayo Stage IV AL amyloidosis during an oral presentation at ASH (Free ASH Whitepaper) next month," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "With our deep portfolio of investigational therapies and a strong cash position, Prothena remains well positioned to address the urgent needs of patients affected by neurodegenerative and rare peripheral amyloid diseases."

Third Quarter and Recent Business Highlights and Upcoming Milestones

Neurodegenerative Diseases Portfolio

Alzheimer’s Disease (AD)

PRX012, a potential best-in-class, next-generation subcutaneous treatment for AD, is an investigational monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency

•Phase 1 multiple ascending dose (MAD) study initiation expected by year-end 2022
•Topline data from Phase 1 study expected in 2023

PRX005, a potential best-in-class treatment for AD, is an investigational antibody that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic

encephalopathy (CTE), and other tauopathies. PRX005 is part of the global neuroscience research and development collaboration with Bristol Myers Squibb

•Topline data from Phase 1 study expected by year-end 2022

PRX123, a potential first-in-class dual Aβ/tau vaccine treatment and prevention therapy for AD, is a dual-target vaccine targeting key epitopes within the Aβ and tau proteins to promote amyloid clearance and blockade of pathogenic tau

•IND filing expected in 2023

Parkinson’s Disease (PD)

Prasinezumab, a potential first-in-class treatment for PD, is a humanized monoclonal antibody designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche

•Phase 2b PADOVA study in patients with early PD is being conducted by Roche (NCT04777331); topline data expected in 2024

Rare Peripheral Amyloid Diseases Portfolio

AL Amyloidosis

Birtamimab, a potential best-in-class amyloid depleter treatment for AL amyloidosis, is an investigational humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure

•Poster presented at the XVIII International Symposium on Amyloidosis (ISA) on September 5, 2022 titled: Birtamimab in Patients with Mayo Stage IV AL Amyloidosis: Rationale for Confirmatory AFFIRM-AL Phase 3 Study
•Abstract selected for oral presentation on Monday December 12, 2022, at 11:15 AM ET at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition titled: Survival Benefit of Birtamimab in Mayo Stage IV AL Amyloidosis in the Phase 3 VITAL Study Consistent After Adjustment for Baseline Variables
•Confirmatory Phase 3 AFFIRM-AL topline data expected in 2024

ATTR Amyloidosis

NNC6019 (previously PRX004), a potential first-in-class treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the transthyretin (TTR) protein, that is being developed by Novo Nordisk for the treatment of ATTR cardiomyopathy

•Phase 2 trial of NNC6019 in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk (NCT05442047)

Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

•Jefferies 2022 London Healthcare Conference on Wednesday, November 16, 2022, a fireside chat will be held at 12:00 PM ET
•Jefferies 5th Annual Denver Biopharma Summit on Wednesday, December 14, 2022, 1×1 investor meetings will be held

Third Quarter and First Nine Months of 2022 Financial Results
For the third quarter and first nine months of 2022, Prothena reported a net loss of $45.8 million and $123.3 million, respectively, as compared to a net income of $109.2 million and $100.2 million for the third quarter and first nine months of 2021, respectively. Net loss per share for the third quarter of 2022 and first nine months of 2022 was $0.97, and $2.63, respectively, as compared to net income per share on a diluted basis of $2.13 and $2.12 for the third quarter and first nine months of 2021, respectively.
Prothena reported total revenue of $1.5 million and $4.0 million for the third quarter and first nine months of 2022, respectively, primarily from collaboration revenue from BMS. As compared to total revenue of $139.2 million and $199.4 million for the third quarter and first nine months of 2021, respectively. Revenue for the third quarter of 2021 included collaboration revenue of $78.5 million from BMS for the option exercise and US license for PRX005 and $60.7 million from the sale of the clinical stage antibody NNC6019 (formerly PRX004) program and related rights to the Company’s ATTR amyloidosis business and pipeline to Novo Nordisk. In addition to third quarter 2021 revenue, the first nine months of 2021 revenue included collaboration revenue of $60 million in clinical milestone payment from Roche for dosing of first patient in the global Phase 2b PADOVA study for prasinezumab and license revenue from Roche.
Research and development (R&D) expenses totaled $39.9 million and $98.7 million for the third quarter and first nine months of 2022, respectively, as compared to $18.0 million and $60.2 million for the third quarter and first nine months of 2021, respectively. The increase in R&D expense for the third quarter and first nine months of 2022 compared to the same periods in the prior year was primarily due to higher manufacturing costs primarily related to the birtamimab, PRX012, PRX019, PRX123 and PRX005 programs, higher personnel related expenses, higher clinical trial expenses primarily related to the PRX012 and birtamimab programs, higher other R&D expense and higher consulting expenses. For the nine months ended September 30, 2022, the higher costs were offset in part by lower collaboration expenses related to the prasinezumab program with Roche as a result of the cost share opt-out exercised in May 2021 and lower manufacturing expenses related to the NNC6019 (formerly PRX004) program. R&D expenses included non-cash share-based compensation expense of $4.2 million and $11.3 million for the third quarter and first nine months of 2022, respectively, as compared to $2.5 million and $6.6 million for the third quarter and first nine months of 2021, respectively.
General and administrative (G&A) expenses totaled $12.0 million and $36.8 million for the third quarter and first nine months of 2022, respectively, as compared to $12.0 million and $34.1 million for the third quarter and first nine months of 2021, respectively. The increase in G&A expenses for the third quarter and first nine months of 2022 compared to the same periods in the prior year was primarily related to higher personnel related expenses. offset in part by lower legal expenses. G&A expenses included non-cash share-based compensation expense of $3.8 million and $12.6 million for the third quarter and first nine months of 2022, respectively, as compared to $3.6 million and $11.1 million for the third quarter and first nine months of 2021, respectively.
Total non-cash share-based compensation expense was $8.0 million and $23.9 million for the third quarter and first nine months of 2022, respectively, as compared to $6.1 million and $17.8 million for the third quarter and first nine months of 2021, respectively.

As of September 30, 2022, Prothena had $497.0 million in cash, cash equivalents and restricted cash, and no debt.
As of October 26, 2022, Prothena had approximately 48.4 million ordinary shares outstanding.

2022 Financial Guidance

The Company is updating its projected full year 2022 net cash burn from operating and investing activities, and expects it to be $108 to $120 million (versus prior guidance of $120 to $132 million) which includes an expected $40 million clinical milestone payment from Novo Nordisk, and expects to end the year with approximately $522 million in cash, cash equivalents, and restricted cash (midpoint) (versus prior guidance of $454 million) which is primarily driven by operating and financing activities. The updated estimated full year 2022 net cash burn from operating and investing activities is primarily driven by an updated estimated net loss of $121 to $137 million (versus prior guidance of $154 to $170 million), which includes an estimated $31 million of non-cash share-based compensation expense.

On November 3, 2022 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the third quarter ended September 30, 2022 (Press release, Nektar Therapeutics, NOV 3, 2022, View Source [SID1234622979]).

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Cash and investments in marketable securities on September 30, 2022, were approximately $546.4 million as compared to $628.2 million at the end of the second quarter of 2022. Our cash and marketable securities are expected to support our strategic development activities and operations through the middle of 2025.

"In the third quarter, we made progress advancing our biologics pipeline in oncology and immunology," said Howard W. Robin, President and CEO of Nektar. "With our partner, Eli Lilly, we presented positive proof-of-concept data for NKTR-358 in atopic dermatitis which demonstrate the potential for this first-in-class Treg stimulator to emerge as a differentiated therapy for patients with serious inflammatory conditions. In the first half of 2023, we expect Lilly to report topline data from the Phase 2 study of NKTR-358 in lupus as well as initiate a Phase 2 study in atopic dermatitis."

"In addition, we are also advancing NKTR-255 in large B-cell lymphoma, with plans to launch a comparative study in combination with approved autologous CD19 CAR-T therapies," continued Robin. "NKTR-255 targets the IL-15 pathway and we have conducted and published extensive preclinical studies showing that IL-15 can potentiate these approved cell therapies by expanding and extending the persistence of CAR-T cells. Finally, we are planning presentations at both SITC (Free SITC Whitepaper) and ASH (Free ASH Whitepaper) for both our preclinical and clinical programs that will showcase the strength of our science and lay the foundation for continued pipeline progress."

Summary of Financial Results

Revenue, which primarily includes non-cash royalty revenue, in the third quarter of 2022 was $23.6 million as compared to $24.9 million in the third quarter of 2021. Revenue for the first nine months of 2022 was $70.0 million as compared to $76.9 million in the first nine months of 2021. Revenue was lower compared to 2021 as a result of a decrease in non-cash royalty revenue.

Total operating costs and expenses in the third quarter of 2022 were $77.9 million as compared to $138.5 million in the third quarter of 2021. Total operating costs and expenses in the first nine months of 2022 were $393.7 million as compared to $410.1 million in the first nine months of 2021. Operating costs and expenses for the first nine months of 2022 include $124.3 million in restructuring, impairment and other costs of terminated program.

R&D expense in the third quarter of 2022 was $33.6 million as compared to $103.7 million for the third quarter of 2021. For the first nine months of 2022, R&D expense was $183.6 million as compared to $300.7 million in the first nine months of 2021. R&D expense decreased for both the third quarter and the first nine months of 2022 primarily due to the wind down of the bempegaldesleukin program.

G&A expense was $22.5 million in the third quarter of 2022 and $29.5 million in the third quarter of 2021. For the first nine months of 2022, G&A expense was $70.4 million as compared to $90.7 million in the first nine months of 2021. G&A expense decreased for both the third quarter and the first nine months of 2022 primarily due to the wind down of the bempegaldesleukin program.

Restructuring, impairment and other costs of terminated program was $16.8 million in the third quarter of 2022 and $124.3 million in the first nine months of 2022. The year-to-date amount includes $58.5 million in non-cash lease and equipment impairment charges, $29.8 million in employee severance expense and $28.9 million for clinical trial and related employee compensation costs for the wind down of the bempegaldesleukin program, as well as $7.1 million in other restructuring costs.

Net loss for the third quarter of 2022 was $59.0 million or $0.31 basic and diluted loss per share as compared to a net loss of $129.7 million or $0.70 basic and diluted loss per share in the third quarter of 2021. Net loss in the first nine months of 2022 was $308.5 million or $1.65 basic and diluted loss per share as compared to a net loss of $378.2 million or $2.07 basic and diluted loss per share in the first nine months of 2021.

Third Quarter 2022 and Recent Business Highlights:

In September 2022, Nektar presented data from two Phase 1b proof-of-concept studies of rezpegaldesleukin in patients with atopic dermatitis (AD) and plaque psoriasis at the 2022 European Academy of Dermatology and Venereology (EADV) Congress. Data from both studies showed rezpegaldesleukin’s ability to stimulate Tregs to target an immune system imbalance resulting in an improvement of disease activity in patients. Particularly in AD patients, dose-dependent improvements in key efficacy measures including EASI and vIGA-AD scores were observed for an additional 36 weeks following the 12-week treatment period.
In August 2022, Nektar announced the publication of preclinical data for NKTR-255 in Blood Advances, the open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The data highlighted the effects of NKTR-255 on natural killer cell function and proliferation in multiple myeloma (MM), supporting the clinical development of NKTR-255 and further evaluation of the novel immunotherapeutic approach in MM, alone or in combination with monoclonal antibodies or potentially with other immunomodulatory drugs.
Nektar also announced upcoming presentations at the following scientific congresses:

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting
November 8-12, 2022 (In person and virtual)

Poster presentation: "NKTR-288, a polymer-conjugated interferon gamma mutein for the treatment of solid tumors", Hamel, D., et al.
Poster presentation (Trials in Progress): "JAVELIN Bladder Medley: a phase 2 trial of avelumab in combination with other antitumor drugs as first-line maintenance therapy for advanced urothelial carcinoma", Hoffman-Censits, J., et al. (collaborator presentation with Merck KGaA)
2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting
December 10-13, 2022 (In person and virtual)

Poster presentation: "Safety, Tolerability, PK/PD and Preliminary Efficacy of NKTR-255, a Novel IL-15 Receptor Agonist, in Patients with Relapsed/Refractory Hematologic Malignancies", Patel K., et al.
Poster presentation (Trials in Progress): "A Phase 2/3, Randomized, Double Blind, Placebo-Controlled, Multicenter Study of NKTR-255 Vs Placebo Following CD-19 Directed CAR-T Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma", Perales M., et al.
Conference Call to Discuss Third Quarter 2022 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, November 3, 2022.

This press release and a live audio-only webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through December 3, 2022.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in this press release, or explained on the conference call, related information will be made available on the Investors section of the Nektar website as soon as practical after the conclusion of the conference call.

On November 3, 2022 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, 2022 and highlighted recent corporate progress (Press release, Tyra Biosciences, NOV 3, 2022, View Source [SID1234622978]).

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"We are proud of the steady advancement of our next-generation precision oncology pipeline designed to address the limitations of current and emerging product candidates, as highlighted by data presentations at ESMO (Free ESMO Whitepaper) and the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, which demonstrated the potency and selectivity of our lead FGFR programs, TYRA-300 and TYRA-200," said Todd Harris, CEO of TYRA. "Our team remains focused on enrolling and executing on our first clinical trial for TYRA-300, SURF301, submitting an IND for TYRA-200, and advancing our discovery pipeline of additional programs designed to overcome tumor resistance and improve outcomes for patients with cancer."

Recent Corporate Highlights

On November 2, 2022, TYRA announced that its Chief Financial Officer, Esther van den Boom, will be stepping down to transition into an advisory role at the end of 2022. Alan Fuhrman has been appointed as Chief Financial Officer effective January 1, 2023.

TYRA-300

As previously disclosed, in July 2022, the U.S. Food and Drug Administration (FDA) cleared TYRA to proceed with its Phase 1/2 SURF301 clinical study of TYRA-300, an FGFR3-selective inhibitor, in patients with metastatic urothelial carcinoma of the bladder and urinary tract. SURF301 is a two-part study designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300.
In September 2022, TYRA presented preclinical results that it believes showcase the enhanced anti-tumor activity and selectivity of TYRA-300 as compared to other agents in the class in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022.
TYRA-200

In October 2022, TYRA presented preclinical results of TYRA-200, an FGFR1/2/3 inhibitor, with potency against FGFR2 fusions, molecular brake mutations and gatekeeper resistance at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium 2022. TYRA remains on track to submit an IND with the FDA for TYRA-200 by year-end 2022.
SNÅP Platform and Pipeline

During the third quarter, TYRA continued to progress its proprietary in-house discovery platform, SNÅP, and its pipeline of programs targeting achondroplasia and other FGFR3-related skeletal dysplasias, FGFR4-driven cancers, and RET (REarranged during Transfection kinase) driven cancers.
Third Quarter 2022 Financial Results

Third quarter 2022 net loss was $12.5 million compared to $6.6 million for the same period in 2021.
Third quarter 2022 research and development expenses were $10.9 million compared to $5.5 million for the same period in 2021.
Third quarter 2022 general and administrative expenses were $2.7 million compared to $1.2 million for the same period in 2021.
As of September 30, 2022, TYRA had cash and cash equivalents of $263.2 million.