Terns Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Updates

On March 27, 2023 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity today reported financial results for the fourth quarter and full year ended December 31, 2022 and corporate updates (Press release, Terns Pharmaceuticals, MAR 27, 2023, View Source [SID1234629390]).

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"As announced in our release earlier this month, 2023 promises to be another transformative year for Terns as we make meaningful strides to advance our pipeline of medicines to address serious unmet needs. In addition to data from our Phase 2a DUET trial in NASH, expected in the third quarter of 2023, we also anticipate key clinical readouts in 2024 from our clinical trials in chronic myeloid leukemia and obesity. We are fortunate to have a strong balance sheet to support development activities and the growth of our company into 2026," said Mark Vignola, chief financial officer of Terns.

"We look forward to having Emil join us as chief medical officer of Terns oncology, as his deep relationships and clinical development experience in hematologic and solid malignancies will be vital as we advance TERN-701 for CML and expand our oncology development team," said Sen Sundaram, chief executive officer at Terns. "Jay brings over a decade of experience across finance and biotech industries, and we are excited to have him lead our strategic business development efforts across both metabolic disease and oncology. Together, these new appointments further strengthen our senior leadership team, and we are well positioned to advance our pipeline towards three significant readouts in the next 18 months or so."

Key Leadership Appointments

Emil Kuriakose, MD will join Terns in May 2023 as chief medical officer of Terns oncology, bringing over a decade of clinical development expertise including early through late-stage development in several oncology indications. Prior to Terns, Dr. Kuriakose served as chief medical officer at Calithera Biosciences overseeing clinical development strategy and execution

Jason Lettiere joined Terns in November 2022 as vice president of business development, bringing more than 13 years of experience in the finance and biotechnology industries

Fourth Quarter and Full Year Financial Results

Cash Position: As of December 31, 2022, cash, cash equivalents and marketable securities were $283.1 million as compared with $166.0 million as of December 31, 2021. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.

Research and Development (R&D) Expenses: R&D expenses were $10.7 million and $39.6 million for the quarter and year ended December 31, 2022, respectively, as compared with $9.5 million and $31.3 million for the quarter and year ended December 31, 2021, respectively.

General and Administrative (G&A) Expenses: G&A expenses were $6.2 million and $22.4 million for the quarter and year ended December 31, 2022, respectively, as compared with $5.4 million and $19.5 million for the quarter and year ended December 31, 2021, respectively.

Net Loss: Net loss was $15.8 million and $60.3 million for the quarter and year ended December 31, 2022, respectively, as compared with $14.2 million and $50.2 million for the quarter and year ended December 31, 2021, respectively.

Common Stock and Pre-Funded Warrants: As of December 31, 2022, there were 53.7 million shares of common stock and 14.6 million pre-funded warrants issued and outstanding.

ReCode Therapeutics to Present at Guggenheim Healthcare Talks: Genomic Medicines and Rare Disease Days

On March 27, 2023 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that David Lockhart, Ph.D., President and Chief Scientific Officer of ReCode Therapeutics, will participate in a fireside chat at 9:35 a.m. ET on Monday, April 3, 2023 at the virtual Guggenheim Healthcare Talks: Genomic Medicines and Rare Disease Days (Press release, ReCode Therapeutics, MAR 27, 2023, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-present-at-guggenheim-healthcare-talks-genomic-medicines-and-rare-disease-days [SID1234629389]).

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Precision BioSciences to Participate in Upcoming Guggenheim Healthcare Talks Conference

On March 27, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that the Company will participate in the Guggenheim Healthcare Talks – Genomic Medicines and Rare Disease Days taking place April 3-4, 2023 (Press release, Precision Biosciences, MAR 27, 2023, View Source [SID1234629388]).

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Details for the company presentation are as follows:
Date: Monday, April 3, 2023
Time: 3:20 PM ET
Location: Lotte New York Palace Hotel

The presentation will be available via a recorded webcast accessible on Precision’s website in the Investors section under Events & Presentations: View Source An archived replay will be available for approximately 30 days following the event.

Oncternal Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)

On March 27, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the approval of an inducement award to one new employee, Erik S. Nelson, who joined Oncternal as Head of IT (Press release, Oncternal Therapeutics, MAR 27, 2023, View Source [SID1234629387]).

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The award will be made on April 3, 2023 under Oncternal’s 2021 Employment Inducement Incentive Award Plan, which provides for the granting of equity awards to new employees of Oncternal as an inducement to join the Company. The award will consist of an option to purchase 64,900 shares of Oncternal common stock. The option will have a 10-year term and an exercise price equal to the closing price of Oncternal’s common stock on the date of grant. The option will vest over a four-year period, with 25% of the shares subject to the option vesting on the first anniversary of the employee’s start date, and the rest vesting in equal monthly installments over three years thereafter. The award was approved by Oncternal’s compensation committee, comprised entirely of independent directors, as required by Nasdaq Rule 5635(c)(4), and will be granted as an inducement material to the employee entering into employment with Oncternal in accordance with Nasdaq Rule 5635(c)(4).

Monopar Announces Result of Interim Analysis of Phase 2b/3 VOICE Trial Evaluating Validive for Severe Oral Mucositis

On March 27, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported completion of a pre-specified interim analysis for its Validive Phase 2b/3 VOICE trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) (Press release, Monopar Therapeutics, MAR 27, 2023, View Source [SID1234629386]). This is an indication for which there is currently no FDA-approved preventative or treatment.

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The interim analysis included the first approximately 50% of the total planned patients to be enrolled. It was conducted by an independent Data Safety Monitoring Board (DSMB), which informed the Company that the trial did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo. The DSMB also reported that there were no safety concerns attributed to Validive. Based on not meeting the pre-specified efficacy threshold, Monopar announced today that it will be discontinuing the study along with the active development of Validive.

"We are very grateful to the patients and investigators who participated in the VOICE trial. The Phase 2b/3 VOICE trial was intended to further evaluate a novel treatment for SOM following the promising signals observed in a prior randomized, double-blinded Phase 2 study with OPC patients. While we are disappointed with the outcome of this study, we are now focused on re-deploying the financial and human resources previously dedicated to Validive in order to advance our Phase 1b camsirubicin clinical trial and our MNPR-101 radiopharmaceutical program partnered with NorthStar Medical Radioisotopes," said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

Monopar also noted today that it has sufficient funds to support its currently planned activities further beyond the first quarter of 2024.