On March 29, 2022 Lyell Immunopharma, Inc., (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported fourth quarter and full year 2021 financial results and provided business highlights (Press release, Lyell Immunopharma, MAR 29, 2022, View Source [SID1234611113]).

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"With the recent FDA clearance of two INDs that incorporate our novel genetic and epigenetic reprogramming technologies, we are now a clinical stage-company advancing a pipeline of novel cell therapies for patients with solid tumors," said Liz Homans, CEO of Lyell Immunopharma. "During the past year, we’ve further strengthened our team with key executive and Board appointments and have grown the organization to focus on executing as a fully integrated clinical stage company. The coming year will be an exciting one for us as we initiate multiple clinical trials across our product pipeline. We are eager to clinically assess the impact of our innovative technologies designed to enable reprogrammed T cells to outlast and eradicate solid tumors in patients."

"We are embarking on what I believe to be among the most informative clinical trials in the field of oncology this year, as they will specifically evaluate the questions of exhaustion and durable stemness as key barriers to successful cell therapies for solid tumor cancers," stated Rick Klausner, MD, Chair of Lyell’s Board of Directors.

Full Year 2021, Recent Highlights, and Upcoming Milestones

LYL797, a chimeric antigen receptor (CAR) T-cell therapy targeting ROR1+ solid tumors that incorporates Gen-R and Epi-R reprogramming technologies

Announced FDA clearance of the IND for LYL797, a CAR T-cell therapy for patients with solid tumors expressing receptor tyrosine kinase-like orphan receptor 1 (ROR1).
The two Lyell technologies incorporated are designed to address major barriers to successful Adoptive Cell Therapy (ACT): Gen-R, a genetic reprogramming technology that endows T cells with the ability to resist exhaustion, and Epi-R, an epigenetic reprogramming technology that creates populations of T cells with the properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist and self-renew, as well as generate differentiated effector cell progenies to provide durable anti-tumor functionality.
Initiated screening for the Phase 1 open label dose escalation and expansion trial with relapsed/refractory triple-negative breast cancer or non-small cell lung cancer who have failed at least two lines of therapy, initial data expected in 2023.
LYL132, a TCR therapy targeting NY-ESO-1 solid tumors that incorporates Epi-R, being developed in collaboration with GSK for solid tumors

Announced FDA clearance of the IND for LYL132, a T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1).
LYL132 incorporates Epi-R and is under investigation as a potential next-generation enhancement to letetresgene autoleucel (lete-cel), a GSK TCR therapy targeting NY-ESO-1 currently in pivotal clinical development.
LYL845, a TIL therapy designed to target multiple solid tumor indications that incorporates Epi-R

On track to submit an IND in the second half of 2022 for LYL845, a tumor infiltrating lymphocyte (TIL) therapy.
Initially targeting melanoma, with plans to expand into other solid tumor indications, potentially including non‑small cell lung cancer (NSCLC), colon, head and neck, cervical, breast and pancreatic.
LYL331, a TCR therapy targeting NY-ESO-1 solid tumors that incorporates Gen-R, being developed in collaboration with GSK for solid tumors

GSK has communicated to Lyell that due to updated manufacturing timing, the IND for LYL331 is likely to be submitted in late 2022 / early 2023.
LYL331 is a TCR therapy for patients with solid tumors expressing NY-ESO-1.
LYL331 incorporates Gen-R and, along with LYL132, is under investigation as a potential next-generation enhancement to lete-cel.
Corporate and Operational

Lyell had the following corporate and operational highlights during 2021:

Announced cGMP qualification of LyFE, Lyell’s manufacturing facility designed to produce cell products at scale for upcoming clinical trials across its CAR, TIL and TCR products.
Completed an initial public offering with net proceeds of $391.8 million from the sale of 25 million shares of common stock.
Expanded executive management team with appointments of scientific and business leaders: Gary Lee, PhD appointed as Chief Scientific Officer and Charlie Newton appointed as Chief Financial Officer.
Expanded Board of Directors with appointments of industry and medical leaders: Otis Brawley, M.D., Elizabeth Nabel, M.D. and Lynn Seely, M.D.
Fourth Quarter and Full 2021 Financial Results

GAAP and Non-GAAP Operating Results

Lyell reported a net loss of $83.7 million and $250.2 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $38.9 million and $204.5 million for the same periods in 2020. Non-GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and non-cash impairment adjustment of other investments, was $41.7 million and $147.9 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $24.3 million and $165.9 million for the same periods in 2020.
Research and development (R&D) expenses were $19.3 million and $138.7 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $35.1 million and $182.2 million for the same periods in 2020. The quarterly decrease in R&D expense on a GAAP basis was primarily due to a decrease in success payment expense, which offset an increase in personnel and infrastructure costs to support the expansion of our R&D and manufacturing capabilities. The annual decrease in R&D expense on a GAAP basis was primarily due to a decrease in collaboration and business development activity. Non-GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, for the fourth quarter and year ended December 31, 2021 were $32.2 million and $119.7 million, respectively, compared to $27.6 million and $161.9 million for the same periods in 2020.
General and administrative (G&A) expenses were $31.9 million and $89.1 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $14.9 million and $46.9 million for the same periods in 2020. The increase in G&A expense on a GAAP basis was primarily due to an increase in personnel-related expenses, including stock-based compensation expense. Non-GAAP G&A expenses, which exclude non-cash stock-based compensation, for the fourth quarter and year ended December 31, 2021 were $13.4 million and $42.2 million, respectively, compared to $7.8 million and $28.6 million for the same periods in 2020.
Total other (loss) income, net was $(36.2) million and $(35.4) million for the fourth quarter and year ended December 31, 2021, respectively, compared to $0.7 million and $7.5 million for the same periods in 2020. The decrease in total other (loss) income, net was due primarily to the full impairment of our investment in PACT Pharma, Inc. Series C-1 convertible preferred stock valued at $36.4 million for the year ended December 31, 2021.
A discussion of these non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of December 31, 2021 were $898.3 million, compared to $692.6 million as of December 31, 2020, an increase of $205.7 million that supports the advancing of our multi-modality cell therapy pipeline. Lyell successfully completed its initial public offering in June 2021 with net proceeds of $391.8 million. Based on the current operating plan, Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2025.

On March 29, 2022 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the appointment of Gary Romano, M.D., Ph.D., as Chief Medical Officer (Press release, Alector, MAR 29, 2022, View Source [SID1234611112]). In this role, Dr. Romano will lead the company’s global clinical development strategy, including oversight of the clinical development, clinical operations, biometrics and digital science, and medical affairs functions. Dr. Romano will report to Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development of Alector. Dr. Romano’s appointment is effective May 23, 2022.

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"We are delighted to welcome Gary to our executive leadership team," said Dr. Kenkare-Mitra. "He is a board-certified neurologist, neurodegeneration expert, and recognized clinical leader in the industry with a demonstrated track record in progressing the development of therapeutics for multiple neuroscience indications. Gary’s extensive research and medical experience coupled with his doctorate degree in Neuroscience will further enable our vision of seamless integration of our drug discovery, translational and clinical development areas. I believe Gary’s clinical vision and leadership will prove to be invaluable as we continue to advance our rich clinical pipeline toward late-stage studies and bring novel drug candidates into the clinic."

Alector is deeply grateful to Sam Jackson, M.D., M.B.A., Senior Vice President, Clinical Sciences, who served as interim CMO since September 7, 2021. Sam is pursuing a new opportunity outside of Alector though he will continue to consult with Alector. Dr. Kenkare-Mitra added, "Sam has been an important contributor and leader at Alector, playing an instrumental role in the development of AL001, the expansion of our clinical development function, and the advancement of our robust pipeline. We thank Sam for his impactful contributions to Alector and wish him well in his future endeavors."

"Alector’s deep scientific expertise in microglial biology and ongoing rigorous clinical interrogation of compelling genetically-validated neuro-immune targets for neurodegenerative diseases are trailblazing a novel and promising approach to treatment that provides new hope for those with diseases such as frontotemporal dementia, Alzheimer’s disease, ALS and Parkinson’s disease," said Dr. Romano. "My passion is to make a meaningful impact in the lives of patients and families suffering from neurodegenerative diseases through the development of transformative treatments. Joining Alector is a natural next step for me, and I look forward to working with the team to develop effective therapies that preserve brain health."

Dr. Romano joins Alector with more than 25 years of experience in neurodegenerative disease, including 18 years in industry roles at Merck, the Janssen Pharmaceutical Companies of Johnson & Johnson, and Passage Bio. Dr. Romano served as the Chief Medical Officer of Passage Bio until May 2021, where he was responsible for the clinical development of gene therapies targeting rare monogenic central nervous system disorders and achieved Investigational New Drug and Clinical Trial Application clearances for three gene therapies. Prior to Passage Bio, Dr. Romano oversaw clinical development of the neurodegenerative disease portfolio for more than five years at Janssen as the Deputy Leader, Neurodegenerative Disease Area and Head of Development, Neurodegenerative Disease. He previously held other leadership positions at Janssen, including Head of Neuroscience Biomarkers and Head of Early Clinical Development. Earlier in his career, Dr. Romano served as the Alzheimer’s Disease Therapeutic Area Group Co-Leader and Leader, Neuroscience Experimental Medicine at Merck.

Dr. Romano earned a B.S. in Biology from Trinity College, a Ph.D. in Molecular Neurobiology from Rockefeller University, and an M.D. from The Johns Hopkins University School of Medicine. He completed his medical internship, neurology residency and neuromuscular fellowship at the University of Pennsylvania. He has served on the executive committee of the Innovative Medicines Initiative – European Prevention of Alzheimer’s Disease, and as the industry co-chair of the Critical Path Institute Coalition Against Alzheimer’s Disease. Dr. Romano currently serves on the board of directors of the ALS Hope Foundation and is an adjunct member of the neurology department at the Lewis Katz School of Medicine at Temple University.

On March 29, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported its full year 2021 financial results and provided corporate highlights (Press release, Infinity Pharmaceuticals, MAR 29, 2022, View Source [SID1234611111]).

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"Based on the strength and breadth of eganelisib’s activity across mTNBC and mUC as well as ovarian cancer, SCCHN, and melanoma, we raised $92 million in early 2021 to advance eganelisib to its first registration-enabling study by the end of this year. We have prioritized front-line TNBC based on prolonged progression-free survival in both PD-L1(+) and PD-L1(-) patients relative to the IMPassion130 reference benchmark. In addition, encouraging overall survival data from a randomized, controlled study in patients with second line urothelial cancer provides another attractive future registrational path. Importantly, in both TNBC and UC, supporting translational data show on-mechanism modulation of the tumor microenvironment to reduce immune suppression," said Adelene Perkins, Chief Executive Officer and Chair of Infinity.

Ms. Perkins continued, "With the additions of Dr. Robert Ilaria as our CMO and Dr. Stéphane Peluso as our CSO, in 2022 we are leveraging our data and financial resources to initiate MARIO-4, a randomized, double-blind Phase 3 study of eganelisib in a triplet combination regimen in front-line mTNBC. In parallel, we plan to initiate MARIO-P, our platform study to evaluate eganelisib in additional combinations and indications where eganelisib may increase the effectiveness of available therapies. As we prepare for the initiation of our first eganelisib registration study, we are very pleased to have Sujay Kango rejoining Infinity. He previously served as our executive vice president and chief commercial officer and now will be providing commercial insights as a member of our board of directors."

Key 2021 Updates:

MARIO-3: Updated data from the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination with Tecentriq (atezolizumab) and Abraxane (nab-paclitaxel) in unresectable locally advanced mTNBC was presented at SABCS in December 2021. This included 50 patients enrolled and evaluable for safety and 44 evaluable for efficacy as of the October 2, 2021 data cutoff date, with a median duration of follow-up of 9.9 months.

Tumor reduction:
Of evaluable patients, tumor reduction was observed in 92.8% patients with PD-L1 (+) tumors and 85.2% patients with PD-L1 (-) tumors.
Progression free survival (PFS):
In patients with PD-L1(+) tumors, median PFS in MARIO-3 was 11.0 months, a 47% improvement in mPFS compared to the 7.5 months reported for atezolizumab and nab-paclitaxel in IMpassion130.
In patients with PD-L1(-) tumors, median PFS in MARIO-3 was 7.3 months, a 30% improvement compared to the 5.6 months reported for atezolizumab and nab-paclitaxel in IMpassion130.
Safety:
MARIO-3 safety profile was consistent with expectations for the three component drugs and did not show any new safety signals compared to the IMpassion130 benchmark trial.
MARIO-275: Updated data from the Company’s randomized, placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with Opdivo (nivolumab) in platinum-refractory, I/O naïve patients with locally advanced or metastatic urothelial cancer (UC) were presented at ASCO (Free ASCO Whitepaper) GU in February 2021 with OS data in July 2021 and January 2022.

Median overall survival (mOS) in the PD-L1(-) population (30 patients) was 15.4 months (4.7, NE) on the eganelisib plus nivolumab combination arm and 7.9 months (1.9, NE) on the control arm of nivolumab alone, with a hazard ratio of 0.60 (0.21, 1.71), reflecting a 40% lower probability of death on the combination arm, which was subsequently updated in January 2022 to a hazard ratio of 0.58, reflecting a 42% lower probability of death on the combination arm.
At the one-year landmark, 59% of patients in the ITT population receiving the eganelisib plus nivolumab combination remained alive, compared to 32% in the nivolumab control arm.
2021-2022 Corporate Updates:

Appointed Stéphane Peluso, Ph.D., as Chief Scientific Officer, joining Infinity from Ipsen.
Appointed Robert Ilaria, Jr., M.D. as Chief Medical Officer, joining Infinity from Bristol Myers Squibb.
Appointed Brian Schwartz, M.D., to Board of Directors, transitioning from consulting Chief Physician to the Board.
Appointed Mr. Sujay Kango to Board of Directors effective March 30, 2022. Mr. Kango is an experienced executive with more than 25 years of experience in the pharmaceutical and biotechnology industries. He has been instrumental in successfully transforming earlier stage organizations to later-stage development and commercial global biotech companies. He joined Acceleron Pharma in 2018, where he most recently served as the executive vice president and chief commercial officer. Under his leadership the team launched luspatercept, led multiple rare disease franchises, and established N.America and international presence for Acceleron. He played a key leadership role in Acceleron’s $11.5B acquisition by Merck in the second half of 2021. Mr. Kango has additionally led multiple global product launches across several therapeutic areas including oncology-hematology, rare diseases, immunology, and virology. Previously Mr. Kango was vice president of global commercial development for oncology at AbbVie and the co-chair of the oncology therapy area committee, prior to which he served as the executive vice president and chief commercial officer at Infinity Pharmaceuticals. Mr. Kango also served as vice president, global marketing, and sales operations at Onyx Pharmaceuticals, an Amgen subsidiary. Prior to Onyx, he held several leadership positions including vice president hepatitis franchise and integrated oncology business unit at Merck & Co., global commercial leader-Procrit/Eprex at Ortho-Biotech, and various sales and marketing positions at Schering-Plough. Mr. Kango also serves as a director of MEI Pharma. Mr. Kango earned a B.S. in Microbiology and an M.B.A. from McNeese State University.
Anticipated 2022 Milestones:

Initiate MARIO-4, a front-line metastatic TNBC randomized, double-blind, pivotal trial by year-end 2022
Infinity will finalize the MARIO-4 trial design following its meeting with global regulatory authorities
Progression free survival and overall survival as key endpoints
PD-L1 negative patients: eganelisib will be evaluated in combination with chemotherapy and a checkpoint inhibitor (the eganelisib triplet regimen) vs chemotherapy
PD-L1 positive patients: the eganelisib triplet regimen will be evaluated vs chemotherapy and a checkpoint inhibitor
Initiate MARIO-P, a study to evaluate the clinical benefit of eganelisib in combination regimens in additional solid tumor indications, on a rolling basis in 3Q 2022
Additional Eganelisib Clinical and Translational Data Releases in 2H 2022:

MARIO-3 study update in metastatic TNBC patients
MARIO-275 study update in urothelial cancer patients
MARIO-3 study in renal cell carcinoma patients
Investigator-sponsored study in head and neck squamous cell carcinoma patients sponsored by Dr. Ezra Cohen
Full Year 2021 Financial Results:

At December 31, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $80.7 million, compared to $34.1 million at December 31, 2020.
Research and development expense for 2021 was $31.6 million, compared to $26.8 million in 2020. The increase is primarily related to an increase in clinical development expenses, an increase in compensation expense due primarily to new hires during the year, and an increase in consulting expense to support continued development of eganelisib.
General and administrative expense was $14.2 million for 2021, compared to $12.4 million for 2020. The increase in G&A expense is primarily due to an increase in stock compensation, professional services, and consulting expense.
Net loss for 2021 was $45.3 million, or a basic and diluted loss per common share of $0.53, compared to a net loss of $40.5 million, or a basic and diluted loss per common share of $0.68 in 2020.
Financial Outlook: Infinity’s 2022 financial guidance remains as follows:

Net Loss: Infinity expects net loss for 2022 to range from $45 million to $55 million.
Cash and Investments: Infinity expects to end 2022 with a year-end cash, cash equivalents and available for sale securities balance ranging from $25 million to $35 million. Infinity expects to have cash for at least 12 months from the filing of its annual report on Form 10-K. Infinity’s financial guidance does not include additional funding or business development activities.
Conference Call Information

Infinity will host a conference call today, March 29, 2022, at 4:30 PM EDT to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 7567637. An archived version of the webcast will be available on Infinity’s website for 30 days.

On March 29, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that it intends to offer and sell shares of its common stock, or for certain investors that so choose, in lieu of shares of its common stock, pre-funded warrants to purchase shares of its common stock, together with accompanying warrants to purchase shares of its common stock in an underwritten public offering (Press release, Geron, MAR 29, 2022, View Source [SID1234611110]). All of the securities in the proposed offering are to be sold by Geron. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Stifel and Baird are acting as joint book-running managers for the proposed offering. Needham & Company is acting as lead manager for the proposed offering.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock, pre-funded warrants and accompanying warrants described above was previously filed with the Securities and Exchange Commission (SEC) and subsequently declared effective by the SEC. A preliminary prospectus supplement relating to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to the proposed offering may also be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected] or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Avenue, Milwaukee, Wisconsin 53202, by telephone at 800-792-2473 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 29, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the year ended December 31, 2021 and provided a corporate update (Press release, Tempest Therapeutics, MAR 29, 2022, View Source [SID1234611109]).

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"We are excited by the numerous achievements the Tempest team made in 2021, including emerging as a public company from a competitive merger process and establishing the collaboration with Roche that moved TPST-1120 into a first-line global, randomized HCC study," said Stephen R. Brady, chief executive officer of Tempest. "This and the broader progress made in the pipeline positions Tempest for a potentially transformative 2022. Our first clinical data presentation planned for ASCO (Free ASCO Whitepaper) in June is the first in a series of planned data releases over the course of the next 12-18 months, including initial ORR data from both our ongoing randomized TPST-1120 study with our partner Roche and the first monotherapy and combination therapy data from TPST-1495, our dual EP2/EP4 antagonist. We are excited about this ongoing positive evolution of Tempest, and we will continue to work to develop what we believe to be is a robust and diversified pipeline of novel cancer programs with the potential to treat a wide range of patients."

1 If approved by the FDA

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) completed Phase 1 monotherapy arm and nearing completion of the anti-PD-1 checkpoint inhibitor, nivolumab, combination dose escalation arms, and selected recommended Phase 2 dose ("RP2D"); and (ii) continued enrollment in first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating monotherapy dose and schedule optimization towards establishing an RP2D; and (ii) commenced enrollment of a study evaluating combination dose and schedule optimization study with the anti-PD-1 checkpoint inhibitor, pembrolizumab.
SITC Presentation: at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, presented new preclinical efficacy data demonstrating that dual inhibition pf the EP2 and EP4 receptors with TPST-1495 is an optimal approach for targeting the prostaglandin pathway in cancer.
Expansion of Patent Portfolio: the U.S. Patent and Trademark Office issued patents covering composition of matter for our therapeutic product candidate TPST-1495.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): (i) if accepted to present, presentation of Phase 1 monotherapy and combination data at ASCO (Free ASCO Whitepaper) 2022; and (ii) reporting of objective response data from the first 40 HCC patients in the first-line randomized study expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; and (ii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): (i) presentation of the first data demonstrating therapeutic benefit in tumor-bearing mice treated with systemically-administered proprietary targeted molecules at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting; and (ii) planned selection of development candidate in the second half of 2022.
Financial Results

Year End 2021

Tempest ended the year 2021 with $51.8 million in cash and cash equivalents, compared to $18.8 million at December 31, 2020. The increase was primarily due to the merger and concurrent PIPE financing, which closed in June 2021.
Net cash used in operations for the year ended December 31, 2021 was $26.0 million.
Net loss and net loss per share for the year ended December 31, 2021 were $28.3 million and $7.47, respectively, compared to $19.2 million and $41.03, respectively, for the same period in 2020.
Research and development expenses for the year ended December 31, 2021 were $17.2 million compared to $14.4 million for the same period in 2020. The $2.8 million increase was primarily attributable to expanded research and development efforts and increased fees for consulting services and compensation expenses.
For the year ended December 31, 2021, general and administrative expenses were $9.8 million compared to $4.9 million for the same period in 2020. The increase of $4.9 million was primarily due to increased fees for audit and tax services and compensation expenses.
Based on current cash position and operating plan, Tempest expects to have sufficient resources to fund operations into the second half of 2023.