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.

On March 29, 2022 Alphamab Oncology (stock code: 9966.HK) reported financial results for the full year ended December 31, 2021 and highlighted recent progress and upcoming milestones (Press release, Alphamab, MAR 29, 2022, View Source [SID1234611143]).

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Highlights

First product launch: In November 2021, KN035 (Envafolimab) has received marketing authorization from the Chinese National Medical Products Administration (NMPA), becoming the world’s first and currently only subcutaneously injected PD-L1 antibody approved for marketing.
First year of commercialization: We recorded total revenue of RMB146.0 million yuan for the year ended December 31, 2021, of which RMB11.62 million yuan of revenue from the shipment of Envafolimab, RMB134 million yuan of revenue from KN026.
Rapid advancement of pivotal clinical trials: Several pivotal clinical studies of KN046 are ongoing, including squamous non-small cell lung cancer, PD-(L)1 refractory NSCLC, pancreatic cancer, thymic carcinoma, etc. BLA is expected to be submitted in 2022.
Exploring cornerstone therapies in the post-PD-(L)1 era: 10 clinical data of KN046 presented, continuing to explore major indications, PD-(L)1 refractory and PD-(L)1 inadequate response tumors; KN046 in combination with KN026 is expected to offer a chemotherapy-free solution.
Build a core commercialization team: In 2021, the company established a core commercialization team to accelerate the commercialization of KN046 and subsequent blockbuster products.
Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, "2021 is the first year of the company’s commercialization. Envafolimab is the first domestic PD-L1 antibody approved for marketing in China and the world’s only subcutaneously administered PD-L1 antibody. KN046 has demonstrated excellent efficacy and potential for benefit in treating PD-(L)1 refractory and PD-(L)1 inadequate response tumors, etc. The BLA of KN046 insquamous NSCLC will be submitted soon. The pivotal phase III trials of KN046 in pancreatic cancer and PD-(L)1 refractory NSCLC have been initiated. A pivotal clinical trial of KN026, an anti-HER2 bispecific antibody, combined with chemotherapy as second-line treatment for gastric cancer has been initiated, and trials in the 1st-line and perioperative setting are under way. Data from the phase II study of KN026 combined with KN046 pave the way for further exploring chemotherapy-free regimens for HER2-positive solid tumors.

In 2021, the company has also made significant progress in our innovative R&D platform and product pipeline. We expect the innovative mechanism and preclinical efficacy of KN052 and JSKN-003 to be validated in clinical studies in 2022. Unmet medical needs, differentiation and global edge are the principles we have always adhered to.

The MRCT pivotal trial of KN046 in thymic carcinoma demonstrated our ability and confidence to develop innovative drugs to meet global health needs. Through cooperation with Pfizer, CSPC and other partners, we hope to accelerate the research and development of our candidates, and to benefit oncology patients worldwide as soon as possible.

Through the launch of Envafolimab, the company’s GMP has been fully validated. We will further expand our production capacity, improve our system, and expand our commercialization capability to lay a solid foundation for the launch of KN046 and subsequent new drugs. With 2021 already behind, we look forward a more exciting and rewarding 2022. Alphamab Oncology will stick to its vision and mission and develop steadily. We are working for more effective cancer medicines and will generate great returns for our long term shareholders.

BUSINESS HIGHLIGHTS

Since April 20, 2021, being the latest practicable date of the Company’s 2020 annual report, we have been making significant progress with respect to our product pipeline and business operations.

Product Pipeline

Our highly differentiated in-house pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Our differentiated tumor product pipeline includes one approved for marketing by the NMPA, three in late clinical stage, and two that have received IND approval or ready for IND submission.

KN046

KN046 has completed phase I clinical trials in Australia and has simultaneously been under a phase II clinical trial in the U.S. Currently, four pivotal clinical trials of KN046 in China have been launched, including two pivotal clinical trials in NSCLC, one pivotal phase III clinical trial in PDAC and one pivotal trial in thymic carcinoma. There are approximately 20 clinical trials around the world covering more than 10 types of tumors including NSCLC, triple-negative breast cancer, ESCC and thymic carcinoma. The results of these clinical trials have demonstrated a preliminary profile of good safety and promising efficacy of KN046.

Events during the Reporting Period

In April 2021, we entered into a clinical trial collaboration and supply agreement with Pfizer Inc. to evaluate the efficacy and safety of KN046 in combination with Inlyta (axitinib), for the first-line treatment of NSCLC.
We achieved positive results of KN046 with respect to its preliminary efficacy and safety in combination with nab-paclitaxel and gemcitabine as first-line treatment for unresectable locally advanced or metastatic PDAC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We achieved promising preliminary results in a phase II, open-label and multi-center study of KN046 in combination with chemotherapy in patients with advanced NSCLC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We made progress in obtaining the efficacy and safety results of KN046 plus paclitaxel/ cisplatin as first-line treatment for unresectable locally advanced, recurrent or metastatic ESCC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We made progress in obtaining the preliminary efficacy and safety results of a prospective phase II trial of KN046 in combination with Lenvatinib in the first-line treatment for advanced unresectable or metastatic HCC. Such research progress was presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
We obtained research results of a phase II, open-label and multi-center clinical trial of KN046 in combination with platinum doublet chemotherapy as first-line treatment for advanced NSCLC harboring resistant oncogenic driver alterations. Such research results were presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
In September 2021, we received an IND approval for KN046 from the NMPA for initiating a multi-center, open-label and randomized-controlled phase II/ III pivotal clinical study (ENREACH-LUNG-02/KN046-302) to evaluate the efficacy, safety and tolerability of KN046 combined with Lenvatinib versus Docetaxel in disease progression of patients with advanced NSCLC who have accepted PD-(L)1 treatment.
We achieved significant efficacy and safety results of KN046 in combination with nab-paclitaxel/gemcitabine in the first-line treatment of locally advanced unresectable or metastatic PDAC. Such results were presented at the 2021 CSCO Annual Meeting.
In September 2021, the Company entered into a partnership agreement with Hangzhou Raygene Pharmaceutical Co., Ltd. to jointly develop the combination therapy of KN046 and RG001, a proprietary anti-tumor small molecule drug, for the posterior line treatment for advanced HCC and liver metastasis colorectal cancer.
In October 2021, a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial of KN046 to evaluate the efficacy and safety of KN046 in combination with the platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous NSCLC, completed the enrollment of 482 patients.
In October 2021, the first patient was successfully dosed in a multi-center, open-label and randomized-controlled phase II/III pivotal clinical trial of KN046 in Mainland China, which aims to evaluate the efficacy, safety and tolerability of KN046 combined with Lenvatinib versus Docetaxel in disease progression of patients with advanced NSCLC who have accepted anti-PD-(L)1 treatment.
In November 2021, the first patient was successfully dosed in a clinical trial of KN046 in combination with ALK-1 (activin receptor-like kinase-1) antibody developed by Kintor Pharmaceutical Limited, for the treatment of advanced or refractory solid tumors.
In November 2021, the Company entered into a collaboration agreement with Guangzhou MaxiNovel Pharmaceuticals Co., Ltd., for joint clinical cooperation of MAX-40279, a multi-target tyrosine kinase inhibitor independently developed by MaxiNovel, in combination with KN046 for the treatment of gastric cancer and other indications as agreed by both parties.
In November 2021, the Company received an IND approval for KN046 from the NMPA for initiating a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial to evaluate the efficacy and safety of KN046 in combination with nab-paclitaxel/ gemcitabine in the treatment of locally advanced unresectable or metastatic PDAC without systemic treatment.
In December 2021, the first patient was successfully dosed in the U.S. in an open-label and multi-center phase II pivotal clinical trial of KN046 to evaluate efficacy, safety and tolerability of KN046 in subjects with advanced thymic carcinoma.
Events after the Reporting Period and expected milestones for 2022

In February 2022, the first patient was successfully dosed in a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial of KN046 to evaluate the efficacy and safety of KN046 in combination with nab-paclitaxel/gemcitabine versus placebo in combination with nab-paclitaxel/gemcitabine, in the treatment of locally advanced unresectable or metastatic PDAC without systemic treatment.
In February 2022, the Company received an IND approval from the NMPA for initiating a phase II clinical trial to evaluate the efficacy, safety, tolerability of KN046 in combination with Inlyta (axitinib) in the treatment of advanced NSCLC.
In February 2022, the Company received an IND approval from the NMPA for initiating a phase I/II clinical trial of KN046 in combination with MAX-40279, for the treatment of advanced or metastatic solid tumors.
KN046+chemo,1L sq-NSCLC: Complete the interim analysis and arrange for the BLA application as planned by mid-2022.
KN046+chemo,1L pancreatic cancer: Enroll in the majority of subjects for Phase III clinical trials.
KN046+Lenvatinib,1L HCC: Plan to start pivotal trial in 2022H2.
KN026

Events during the Reporting Period

We made advancement in evaluating the preliminary efficacy of KN026 for the treatment of HER2 expression in patients with advanced GC or GEJ. Such results were presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
In August 2021, the first patient was successfully dosed in a phase II clinical trial of KN026 for the neoadjuvant treatment of HER2 positive early or locally breast cancer.
In August 2021, the Company received a notice of approval from the NMPA for the supplementary application for a pharmaceutical change of KN026 for clinical use, which allows KN026 liquid formulation to be used in clinical research. This is the first HER2 bispecific antibody in liquid formulation approved for conducting clinical research in China.
In August 2021, Jiangsu Alphamab Biopharmaceuticals Co., Ltd., the principal operating subsidiary wholly owned by the Company, entered into a licensing agreement with Shanhai JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited ("CSPC"), to develop and commercialize KN026 for the treatment of breast cancer and GC in Mainland China.
We made advancement in evaluating the preliminary efficacy and safety results of KN026 in combination with KN046 in patients with HER2-positive GI tumors. Such results were presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
We made progress in obtaining the preliminary safety and efficacy results of a phase II clinical trial of KN026 in combination with KN046 in patients with metastatic HER2-positive breast cancer. Such research progress was presented at the SABCS 2021.
We made progress in a phase I clinical trial of KN026 for the treatment of patients with HER2-positive metastatic breast cancer. Such research progress was presented at the SABCS 2021.
Events after the Reporting Period and expected milestones for 2022

In January 2022, the Company received an IND approval from the NMPA for initiating a randomized and multi-center phase II/III clinical trial of KN026 to evaluate the efficacy and safety of KN026 combined with chemotherapy in patients with HER2-positive GC (including GEJ) who have failed first-line treatment.
In January 2022, the phase II clinical trial of KN026 combined with KN046 in the treatment of HER2-positive solid tumors, successfully completed patient enrollment. The interim analysis is expected to be conducted in the second quarter of 2022.
In February 2022, data from a phase I clinical study of the KN026 for the treatment of HER2-positive metastatic breast cancer were published in Clinical Cancer Research, a journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
In March 2022, the preliminary results of phase II clinical trial of KN026 in combination with KN046 for the treatment of locally advanced unresectable or metastatic HER2-positive solid cancer were accepted for e-poster presentation at the 2022 AACR (Free AACR Whitepaper) annual meeting.
KN046+KN026, Chemo-free, HER2+1L GC: Start the pivotal trial in 2022Q2.
KN035 (Envafolimab)

Events during the Reporting Period

In June 2021, the study design of the ENVASARC pivotal trial conducted in the U.S. for KN035 was presented by TRACON in a poster session at the 2021 ASCO (Free ASCO Whitepaper) annual meeting.
In June 2021, the U.S. FDA has granted orphan drug designation (ODD) to KN035 for the treatment of patients with soft tissue sarcoma. This is the second ODD for KN035 after the first ODD in advanced biliary track cancer and the fourth ODD that we obtained from the FDA.
In September 2021, we obtained an IND approval from the NMPA for KN035 in combination of Lenvatinib for the treatment of patients who have failed or are intolerant of platinum containing chemotherapy and are not suitable for radical treatment with locally advanced metastatic or recurrent non-microsatellite instability-high phenotype/non-DNA deficient mismatch repair endometrial cancer.
In November 2021, we obtained formal conditional approval from the NMPA for marketing KN035 (Envafolimab). The approval is for the treatment of MSI-H or dMMR advanced solid tumors.
In December 2021, the Company, 3D Medicines and Simcere, jointly announced that the first batch of prescriptions for KN035 (Envafolimab), the world’s first subcutaneously injected PD-L1 antibody, has been implemented across China.
KN019

The phase II clinical trial of KN019 for the treatment of rheumatoid arthritis completed the patient enrollment. The final analysis of clinical results is expected to be completed in the first half of 2022.
In 2021, we initiated a clinical study on the bioavailability of KN019 in the switch from intravenous infusion to subcutaneous administration.
KN052

In February 2022, the Company received an IND approval for KN052 from the NMPA for initiating a phase Ia/Ib clinical trial to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics, and antineoplastic activity of KN052 in the treatment of advanced solid tumors.
JSKN-003

The Company completed the efficacy validation and process development for JSKN-003 in June 2021 and targets to submit IND application in the second quarter of 2022.
Manufacturing Facilities

The facility of Jiangsu Alphamab is designed to house over 40,000L production capacity in total. We obtained a drug production license for the phase I-(1) of our new manufacturing facilities from Jiangsu Drug Administration, on July 6, 2020. Phase I-(2), including product workshop, pilot plant and R&D center, is under construction and expected to be put into operation in the first half of 2022; Phase I-(3) of our new manufacturing facilities has started construction.

Other Highlights

In May 2021, Jiangsu Alphamab entered into a collaboration agreement with Suzhou Alphamab Co., Ltd. for two technology development projects, namely, JSKN003 and the preparation process development project for mGalt1, a key material of conjugation process, and KN062 COVID-19 neutralizing bispecific antibody development project.
In December 2021, the Company was listed as one of the 2021 Top 100 Chinese Pharmaceutical Innovative Enterprise. The Company has been acknowledged as such for the third consecutive year.
In January 2022, the Company was awarded "The Most Valuable Pharmaceutical and Medical Company" award at the Sixth Golden Hong Kong Stocks Awards ceremony.
Financial Summary

For the year ended December 31, 2021，we recorded total revenue of RMB146.0 million. The Group mainly generates revenue from (i) sales of pharmaceutical product; (ii) royalty income; (iii) license fee income; and (iv) goods or consumables for R&D projects.
For the year ended December 31, 2021, the Group’s other income decreased by RMB64.1 million to RMB47.0 million, as compared to RMB111.1 million for the year ended December 31, 2020.
For the year ended December 31, 2021, our R&D expenses increased by RMB150.2 million to RMB481.4 million, compared to RMB331.2 million for the year ended December 31, 2020, primarily due to (i) the increase in the number of ongoing clinical trials; (ii) the expansion of the scale of our clinical studies; (iii) the advancement of clinical trials of our drug candidates; and (iv) the increase in staff cost due to the increase in our R&D staff.

On March 29, 2022 SYNSIGHT, a biotech company specialized in RNA-targeting small molecules drugs, reported a $1.5 million fundraising (Press release, SYNSIGHT, MAR 29, 2022, View Source [SID1234644755]). The financing was led by an international investor.

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SYNSIGHT is pleased to announce today a $1.5 million fundraising This financial opportunity was realized with a Chinese investor who well recognized SYNSIGHT’s potential, which is completed by financial help from Region Ile-de-France and BPIfrance.

This fundraising will allow SYNSIGHT to accelerate its growth and development. The company will continue to refine its innovative platform and expand the drug discovery platform potentials. Thus, SYNSIGHT’s advantage in RNA targeting will be even enhanced.

The fundraising will also advance the SYNSIGHT pipelines and expand its portfolio. Noted that the SYNSIGHT pipelines are innovative targets which could only be treated by SYNSIGHT’s indoor innovative platform mentioned above, these targets (neurogenerative, oncology and infectious diseases related) were considered to be undruggable since the lack of breakthrough RNA target platform.

The fundraising will allow SYNSIGHT to expand its team and welcome new experts: senior project manager, AI research scientist, senior cell biologist and High-Content Screening engineer.

On March 29, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that new data were published in the peer-reviewed journal, Diagnostics (Basel), in an article titled, "Analytic and Clinical Validation of a Pan-Cancer NGS Liquid Biopsy Test for the Detection of Copy Number Amplifications, Fusions and Exon Skipping Variants (Press release, Biodesix, MAR 29, 2022, View Source [SID1234611085])." This peer-reviewed publication further validates the GeneStrat NGS test and the use of multiple classes of tumor markers in circulating free nucleic acid analysis as a surrogate for tumor tissue biopsies. [i]

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"These data extend on Biodesix’ testing of plasma for somatic nucleotide variants and indels in circulating nucleic acids by detecting amplifications, fusions and exon skipping. We can broadly assay for the major variant classes which includes actionable mutations in support of comprehensive molecular testing in lung cancer," said Gary Pestano, Ph.D., Chief Development Officer, Biodesix.

Additionally, Biodesix will present data associated with the GeneStrat ddPCR and NGS blood tests in a poster presentation focused on reporting validation studies of key actionable mutations in NSCLC entitled: Analytic and clinical validation of a new pan-cancer NGS liquid biopsy test for the detection of copy number variations, fusions/exon skipping, somatic variants and indels (Abstract number 5323), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 8-13, 2022. The full abstract can be found on the official AACR (Free AACR Whitepaper) website here. Poster presentations will be viewable after April 8th, 2022.

The company believes that the coupling of highly sensitive, rapid stand-alone droplet digital PCR (ddPCR) and the NGS techniques offers more comprehensive blood-based testing support for patients with non-small cell lung cancer (NSCLC) and provides clinically relevant information both before and after targeted treatment of patients with cancer.

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.