On November 2, 2023 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Protagonist, NOV 2, 2023, View Source [SID1234636785]).

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"In the third quarter of 2023, Protagonist continued to make rapid progress with its key programs," said Dinesh V. Patel, Ph.D., the Company’s President and CEO. "Positive Phase 2b data from the FRONTIER 1 study with JNJ-2113, established it as a first- and only-in-class oral IL-23 receptor antagonist peptide and triggered the decision to progress into several advanced studies for broad clinical development. In October 2023, Janssen initiated two Phase 3 psoriasis studies, and a Phase 2b ulcerative colitis study, and plans to undertake additional Phase 3 psoriasis studies in the first quarter of next year. The extraordinary pace of progress in multiple indications reflects strong confidence in JNJ-2113’s potential to have a meaningful impact on these and other diseases mediated by the IL-23 pathway."

Dr. Patel continued: "We are equally excited about the potential of rusfertide, currently in the Phase 3 VERIFY study, to transform the treatment paradigm for polycythemia vera. We are very pleased with the continuing level of enthusiasm among PV-treating physicians and patients participating in the ongoing Phase 3 VERIFY study and look forward to sharing our latest findings in Polycythemia Vera and from our ongoing studies through five oral and poster presentations at the upcoming ASH (Free ASH Whitepaper)2023 Annual Meeting."

1 Based on $322.7 million in cash, cash equivalents and marketable securities as of September 30, 2023 and including expected $60.0 million in JNJ-2113 milestones.

Q3 and Recent Corporate Highlights

· Positive Phase 2b FRONTIER 1 topline results were presented at the World Congress of Dermatology in Singapore in July 2023. All primary and secondary efficacy endpoints were achieved in the study, which evaluated five different dosing regimens of JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis. JNJ-2113 is a novel oral IL-23R antagonist peptide which binds with high affinity to the IL-23 receptor.
· Following positive data from the FRONTIER 1 study, advanced clinical studies in multiple indications were announced and recently initiated:

§ ICONIC-LEAD is a randomized controlled Phase 3 trial to evaluate the safety and efficacy of JNJ-2113 compared with placebo in participants with moderate-to-severe plaque psoriasis, with PASI-90 and IGA score of 0 or 1 as co-primary endpoints.
§ ICONIC-TOTAL is a randomized controlled Phase 3 trial to evaluate the efficacy and safety of JNJ-2113 compared with placebo for the treatment of plaque psoriasis in participants with at least moderate severity affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet) with overall IGA score of 0 or 1 as the primary end point.
§ ANTHEM-UC is a Phase 2b randomized control trial to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in patients with moderately to severely active ulcerative colitis.

· Dosing of the third patient in the ICONIC-LEAD Phase 3 trial in late October 2023 earned Protagonist a $50 million milestone from Janssen Biotech, Inc. under the terms of the licensing and collaboration agreement between both companies.
· Five abstracts related to rusfertide, an investigational hepcidin mimetic, were accepted for oral or poster presentation at ASH (Free ASH Whitepaper)2023, as follows:

Oral presentations

§ Title: Real-World Analysis of Thromboembolic Event Rates in Patients in the United States with Polycythemia Vera. Presenting author: Andrew T. Kuykendall, MD (Moffitt Cancer Center, Tampa, FL).
§ Title: Durability of Hematocrit Control in Polycythemia Vera with the First-in-Class Hepcidin Mimetic Rusfertide: Two-Year Follow up Results from the Revive Study. Presenting author: Ellen K. Ritchie, MD (Weill Cornell Medical College New York Presbyterian, NY).

Poster presentations

§ Title: Iron Restricted Erythropoiesis Under Hepcidin Mimetic Treatment (PN23114) Improved Disease Parameters in a Mouse Model for Sickle Cell Disease. Presenting author: Roopa Taranath, PhD (Protagonist Therapeutics, Inc., Newark, CA).
§ Title: Rusfertide Improves Markers of Iron Deficiency in Patients with Polycythemia Vera. Presenting author: Yelena Ginzburg, MD (Mount Sinai, New York, NY).
§ Title: Prevalence of Second Cancers in Patients with Polycythemia Vera (PV): A Retrospective Analysis of US Real-World Claims Data. Presenting author: Naveen Pemmaraju, MD (MD Anderson Cancer Center, Houston, TX).

At the 5th International Congress on Myeloproliferative Neoplasms, held November 2-3, 2023, Dr. Naveen Pemmaraju presented a poster titled, "Summary of Malignancies Observed Across 5 Open Label Clinical Trials of the Hepcidin Mimetic Rusfertide." The poster can be found on the Protagonist corporate website at View Source

Third Quarter 2023 Financial Results

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2023, were $322.7 million.

· License and Collaboration Revenue: License and collaboration revenue was zero for the three and nine months ended September 30, 2023, as we completed our performance obligation associated with the Janssen License and Collaboration Agreement as of June 30, 2022. License and collaboration revenue for the three and nine months ended September 30, 2022, was zero and $26.6 million, respectively. The nine months ended September 30, 2022, included a one-time $25.0 million milestone earned by the Company following the dosing of the third patient in the Janssen Phase 2b FRONTIER 1 clinical trial of JNJ-2113.

· Research and Development ("R&D") Expenses: R&D expenses were $30.7 million and $91.3 million for the three and nine months ended September 30, 2023, respectively, as compared to $25.4 million and $96.3 million for the same periods in 2022. The increase in R&D expenses from the prior year quarter was primarily due to an increase in rusfertide expenses related to the Phase 3 VERIFY clinical trial, partially offset by a decrease in PN-943 expenses. The decrease in R&D expenses from the prior year was primarily due to decreases in PN-943 expenses and costs related to preclinical and discovery research, partially offset by an increase in rusfertide expenses.

· General and Administrative ("G&A") Expenses: G&A expenses were $7.7 million and $25.4 million for the three and nine months ended September 30, 2023, respectively, as compared to $6.9 million and $25.1 million for the same periods in 2022. The increase in G&A expenses from the prior year quarter was primarily due to increases in payroll, stock-based compensation, and general expenses.

· Net Loss: Net loss was $34.1 million, or $0.58 per share, for the three months ended September 30, 2023, as compared to a net loss of $31.2 million, or $0.64 per share, for the three months ended September 30, 2022. Net loss was $106.3 million, or $1.91 per share, for the nine months ended September 30, 2023, as compared to a net loss of $93.2 million, or $1.90 per share, for the nine months ended September 30, 2022.

On November 2, 2023 Prokarium, a biopharmaceutical company at the forefront of applying synthetic biology to create novel cancer treatments, reported that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for their immunotherapy ZH9 (Press release, Prokarium, NOV 2, 2023, View Source [SID1234636784]). The approval enables initiation of the clinical development program for ZH9 in the U.S., focusing on patients with non-muscle invasive bladder cancer.

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"The FDA’s approval of our IND application is an important milestone and a clear recognition of the preclinical data already generated for ZH9," stated Prokarium’s CEO, Kristen Albright, PharmD. "Importantly, it also validates the innovative design of the PARADIGM-1 study, paving the way for collaboration with top-tier research centers in the U.S."

"Urologists are excited to see the emergence of new therapies in clinical development for bladder cancer patients," stated Sam S. Chang, MD, Chief Surgical Officer at the Vanderbilt Ingram Cancer Center. "The urgent and continuous need to prevent bladder cancer recurrence, especially given the ongoing shortage of BCG, the standard treatment option for high-risk patients, makes the development of innovative alternatives a matter of importance."

In a strategic move, Prokarium strengthens their leadership team with the appointment of Dara Henry, PhD, as Chief Operating Officer. Dara brings over two decades of experience in biotech and large pharma. His recent role as an entrepreneur-in-residence at Evotec, and prior senior positions in operations and business development at Achilles Therapeutics and GlaxoSmithKline, demonstrate his commitment to advancing biopharmaceutical innovation.

"Prokarium is uniquely positioned in the biotech landscape with a compelling lead program targeting an underserved population of bladder cancer patients," stated Henry, "and beyond the immediate value of this program, Prokarium’s Living Cures platform has the potential to be a game-changer in the field of immunotherapy, enabling a new generation of highly innovative, off-the-shelf programmable therapeutics."

"I’m excited to welcome Dara to our team during this transformative phase, as Prokarium enters clinical development, solidifying our status as a leader in synthetic biology and immuno-oncology," said Albright.

On November 2, 2023 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the third quarter of 2023 (Press release, Pacira Pharmaceuticals, NOV 2, 2023, View Source;991.htm [SID1234636783]).

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Third Quarter 2023 Financial Highlights

•Total revenues of $163.9 million
•Net product sales of $128.7 million for EXPAREL, $28.8 million for ZILRETTA, and $5.3 million for iovera°
•Net income of $10.9 million, or $0.23 per share (basic and diluted)
•Adjusted EBITDA of $52.9 million

See "Non-GAAP Financial Information" below.

"Pacira continues to operate from a position of financial strength with substantial revenues, improving gross margins, and ongoing operating discipline, which have resulted in significantly positive adjusted EBITDA of $53 million for the third quarter," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Our strong and durable cash flows, fueled by EXPAREL exclusivity through 2041, leave us well positioned to self-fund our growth and deliver multiple value-creating milestones in the coming year including the anticipated launch of EXPAREL in two key lower extremity nerve blocks. Looking ahead, we will continue to actively manage operating expenses while deploying capital in a manner we believe will maximize shareholder return and unlock the significant untapped potential within our best-in-class opioid-sparing commercial portfolio."
Recent Business Highlights
•Four New Independent Directors Appointed to Board of Directors. In October 2023, the company announced the appointments of Marcelo Bigal, MD, PhD, Abraham Ceesay, Michael Yang, and Alethia Young, to its Board of Directors. Each of the new directors adds diversity of experience and background to the Pacira board of directors, while also enhancing racial and gender diversity. Pacira now has 12 experienced directors, all with relevant industry experience.
•New Initiatives Supporting the American Society of Anesthesiologists to Advance Education and Enhance Patient Care. In October 2023, the American Society of Anesthesiologists (ASA) and Pacira announced a new grant from Pacira to the ASA Charitable Foundation to advance the medical specialty of anesthesiology and pain medicine, facilitate best-in-class clinician education and improve patient care. The company has also joined ASA’s Industry Supporter Program to support the Society’s more than 56,000 physician anesthesiologist members to improve patient care and reduce reliance on opioids for the treatment of postsurgical or chronic pain.
•Leadership Succession Plan. In September 2023, the company announced that David Stack will retire from his role as chairman and chief executive officer. To ensure a seamless transition, Mr. Stack has committed to continuing in his current role until a replacement is appointed by the Board of Directors after which Mr. Stack will continue with the company in a consulting role through August 2025.

Third Quarter 2023 Financial Results

•Total revenues were $163.9 million in the third quarter of 2023, versus $167.5 million reported for the third quarter of 2022.
•EXPAREL net product sales were $128.7 million in the third quarter of 2023, versus $132.6 million reported for the third quarter of 2022. Third quarter average daily volume growth of 5 percent was offset by a lower net selling price primarily due to the implementation of 340B Drug Pricing in October 2022 and other contracted relationships. There were 62 selling days in the third quarter of 2023 and 64 selling days in the third quarter of 2022.
•ZILRETTA net product sales were $28.8 million in the third quarter of 2023, versus $26.5 million reported for the third quarter of 2022.
•Third quarter 2023 iovera° net product sales were $5.3 million, versus $4.5 million reported for the third quarter of 2022.
•Sales of bupivacaine liposome injectable suspension to third-party licensees were $0.9 million in the third quarter of 2023, versus $3.0 million reported for the third quarter of 2022.
•Total operating expenses were $146.2 million in both the third quarter of 2023 and 2022.
•Research and development (R&D) expenses were $20.8 million in the third quarter of 2023, compared to $19.4 million in the third quarter of 2022. R&D expenses included $9.4 million and $7.2 million of product development and manufacturing capacity expansion costs in the third quarters of 2023 and 2022, respectively.
•Selling, general and administrative (SG&A) expenses were $67.9 million in the third quarter of 2023, compared to $61.3 million in the third quarter of 2022.
•GAAP net income was $10.9 million, or $0.23 per share (basic and diluted) in the third quarter of 2023, compared to a net loss of $0.7 million, or $(0.02) per share (basic and diluted) in the third quarter of 2022.

•Non-GAAP net income was $36.6 million, or $0.79 per share (basic) and $0.72 per share (diluted) in the third quarter of 2023, compared to $29.9 million, or $0.65 per share (basic) and $0.59 per share (diluted), in the third quarter of 2022.
•Adjusted EBITDA was $52.9 million in the third quarter of 2023, compared to $55.2 million in the third quarter of 2022.
•Pacira ended the third quarter of 2023 with cash, cash equivalents and available-for-sale investments ("cash") of $235.2 million. Cash provided by operations was $44.4 million in the third quarter of 2023, compared to $42.7 million in the third quarter of 2022.
•Pacira had 46.4 million basic and 52.1 million diluted weighted average shares of common stock outstanding in the third quarter of 2023.
See "Non-GAAP Financial Information" below.
Financial Guidance
While the company remains confident in the business and its long-term growth outlook, today it is revising its full-year EXPAREL guidance to reflect an updated view of the remainder of the year. Pacira now expects full-year EXPAREL net product sales of $535 million to $540 million versus the company’s previously guided range of $550 million to $560 million.
Pacira is reiterating the following full-year financial guidance:
•ZILRETTA net product sales of $110 million to $115 million;
•iovera° net product sales of $17 million to $20 million;
•Non-GAAP gross margin of 73% to 74%;
•Non-GAAP R&D expense of $70 million to $80 million;
•Non-GAAP SG&A expense of $220 million to $230 million; and
•Stock-based compensation of $46 million to $49 million.
See "Non-GAAP Financial Information" below.

Today’s Conference Call and Webcast Reminder
The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, November 2, 2023, at 8:30 a.m. ET. For listeners who wish to participate in the question-and-answer session via telephone, please pre-register at investor.pacira.com/upcoming-events. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

On November 2, 2023 Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, reported that new data will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 9-12 in San Diego, CA (Press release, Orca Bio, NOV 2, 2023, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-positive-clinical-data-on-its-novel-high-precision-cell-therapies-at-the-65th-american-society-of-hematology-annual-meeting [SID1234636782]). Specifically, an oral presentation will highlight the outcomes of myeloablative Orca-T, Orca Bio’s lead investigational high-precision cell therapy, in patients over the age of 55. A second oral presentation will share updated results in an expanded group of patients with haploidentical donors treated with Orca Bio’s second investigational high-precision cell therapy, Orca-Q.

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Orca Bio will also present two posters highlighting the results of patients with high-risk myelodysplastic syndrome who were treated with Orca-T, and the outcomes of patients treated with Orca-T who received reduced intensity conditioning.

The ASH (Free ASH Whitepaper) abstracts are now available at www.hematology.org. Details of the Orca Bio presentations follow:

Oral Session: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Optimizing Conditioning Regimens for Lymphoid Malignancies and Fanconi Anemia

Title: Optimizing Outcomes with Myeloablative Conditioning in Older Patients: Efficacy and Safety of Precision Engineered Orca-T in Patients > 55 Years Old with Hematologic Malignancies

Abstract Number: 230

Date and Time: Saturday, December 9, 2023 at 2:15 PM PT

Location: Marriott Marquis, Marriott Grand Ballroom 5-6

Oral Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas

Title: Safety and Efficacy of Orca-Q with Haploidentical Donors for the Treatment of Advanced Hematologic Malignancies Without the Use of Post-Transplant Cyclophosphamide

Abstract Number: 773

Date and Time: Monday, December 11, 2023 at 11:30 AM PT

Location: San Diego Convention Center, Room 6CF

Poster Session: 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies

Title: High Disease-Free Survival in Patients with High-Risk MDS Treated with Orca-T

Abstract Number: 2230

Date and Time: Saturday, December 9, 2023 at 5:30 PM PT

Location: San Diego Convention Center, Halls G-H

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution

Title: Phase 1 Trial Results for Patients with Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT with Orca-T Donor Cell Therapy Product and Single Agent Tacrolimus

Abstract Number: 3560

Date and Time: Sunday, December 10, 2023 at 6:00 PM PT

Location: San Diego Convention Center, Halls G-H

About Orca-T
Orca-T is an investigational high-precision allogeneic cell therapy for the treatment of multiple hematological malignancies. Orca-T includes infusions containing regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial at leading transplant centers across the U.S. and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

About Orca-Q
Orca-Q is an investigational high-precision allogeneic cell therapy designed to treat hematological malignancies in patients with haploidentical donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform. Orca-Q has the potential to improve patient outcomes and reduce the risks of toxicities without the use of post-transplant cyclophosphamide (PTCy) in patients unable to identify a full human leukocyte antigen (HLA) match.

On November 2, 2023 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a clinical-stage biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended September 30, 2023 and provided business highlights (Press release, NGM Biopharmaceuticals, NOV 2, 2023, View Source [SID1234636781]).

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"In the third quarter, we continued to advance our efforts to develop novel medicines for cancer and other grievous diseases. This includes steady progress across our clinical-stage solid tumor oncology portfolio," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "We also announced that comprehensive data from our completed Phase 2b 48-week ALPINE 4 trial of aldafermin in compensated cirrhosis, or F4, patients due to NASH was selected for an oral plenary presentation at the upcoming AASLD The Liver Meeting in November. We are pleased that the ALPINE 4 trial achieved its primary endpoint with positive, statistically significant results across multiple measures, demonstrating clinical impact in this very advanced, difficult-to-treat patient population. This is an important milestone as we seek to partner aldafermin for continued, late-stage development."

Key Third Quarter and Recent Highlights

Solid Tumor Oncology

•In the Phase 1/2 trial evaluating NGM707, an ILT2/ILT4 antagonist antibody product candidate, as a monotherapy and in combination with KEYTRUDA (pembrolizumab) for the treatment of patients with advanced or metastatic solid tumors, completed enrollment in the Phase 1, Part 1a (monotherapy dose escalation) cohort. Enrollment in the Phase 1, Part 1b (combination dose escalation with pembrolizumab) cohort is ongoing.
•In the Phase 1/1b trial evaluating NGM438, a LAIR1 antagonist antibody product candidate, as a monotherapy and in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors, completed enrollment in the Phase 1, Part 1a (monotherapy dose escalation) cohort and the Phase 1, Part 1b (combination dose escalation with pembrolizumab) cohort is nearing completion of enrollment. NGM438, alone and in combination with pembrolizumab, has been well-tolerated and there have been no dose limiting toxicities to date.
•In the Phase 1/1b trial evaluating NGM831, an ILT3 antagonist antibody product candidate, as a monotherapy and in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors, completed enrollment in both a Phase 1, Part 1a and a Phase 1, Part 1b cohort. NGM831, alone and in combination with pembrolizumab, has been well-tolerated and there have been no dose limiting toxicities to date.

Aldafermin

•Upcoming oral plenary presentation of data from Phase 2b ALPINE 4 trial of aldafermin in compensated cirrhosis (F4) due to NASH to be presented at AASLD The Liver Meeting taking place November 10–14, 2023, in Boston, MA.
Corporate
•Jean-Frédéric Viret, Ph.D., has been appointed as Chief Financial Officer (CFO) effective November 3, 2023. Dr. Viret brings a wealth of experience to this role, having previously served for seven years (2014–2021) as CFO of Coherus BioSciences, Inc., a commercial-stage, publicly traded, biopharmaceutical company focused on the research, development and commercialization of biosimilars and biologics to treat cancer, and more recently as CFO of Shasqi, Inc. and Blade Therapeutics, Inc., two privately held biotechnology companies focused on oncology and fibrotic disease, respectively. Earlier in his career, Dr. Viret was CFO at diaDexus, Inc., XDx, Inc. (now CareDx, Inc.) and Anesiva, Inc. and worked in a variety of finance roles at Tularik Inc. and PricewaterhouseCoopers LLP (now PwC).
Third Quarter 2023 Financial Results
•NGM Bio reported a net loss of $28.8 million for the quarter ended September 30, 2023, compared to a net loss of $47.3 million for the same period in 2022.
•Related party revenue from our collaboration with Merck Sharp & Dohme LLC, or Merck, was $0.6 million for the quarter ended September 30, 2023, compared to $7.9 million for the same period in 2022. Our related party revenue from Merck will continue to decrease in 2023 and we expect minimal funding from Merck from October 1, 2023 through March 31, 2024.
•Research and development expenses were $22.9 million for the quarter ended September 30, 2023, compared to $46.1 million for the same period in 2022.
•General and administrative expenses were $8.7 million for the quarter ended September 30, 2023, compared to $10.1 million for the same period in 2022.
•Cash, cash equivalents and short-term marketable securities were $166.0 million as of September 30, 2023, compared to $271.5 million as of December 31, 2022. NGM Bio expects its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into mid-2025. NGM Bio has based this estimate on plans and assumptions that may prove to be insufficient or inaccurate (for example, with respect to anticipated costs, timing or success of certain activities), and NGM Bio could utilize its available financial resources sooner than it currently expects.