On March 29, 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported its financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, CohBar, MAR 29, 2022, View Source [SID1234611114]).

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"2021 was a year of significant growth for CohBar, highlighted by positive topline data from our first human study and the demonstration of clinical proof-of-concept for our platform, the nomination of our second clinical candidate, and the addition of high-quality talent to our leadership and Board," stated Dr. Joseph Sarret, Chief Executive Officer. "As we begin 2022, we are well-positioned to advance our mission and execute on our goals. Today, we announced that we have aligned our resources to focus on three main areas – the development of our IPF program, CB5138-3, the discovery of additional novel peptide families through our novel Mito+ platform, and securing a partner for further development of CB4211. I’m optimistic about this focused strategy and excited for what our team can achieve in 2022 and beyond."

Recent Corporate Updates

●Focused Pipeline to Advance Key Programs: CohBar has aligned its resources to focus on three main areas: (1) the development of its novel peptide analog, CB5138-3, for the treatment of idiopathic pulmonary fibrosis (IPF). In addition to the ongoing IND-enabling studies, the company is focused on optimizing drug delivery to increase the likelihood of success in the clinic for this hard-to-treat patient population. The IND for this program is now expected to be submitted in the second half of 2023; (2) the discovery and development of additional novel peptide families using the company’s novel Mito+ platform; and (3) the pursuit of a partnership for further development of CB4211.

●Appointed Nick Vlahakis, MBBS, as Acting Chief Medical Officer: Today, CohBar announced the appointment of Nick Vlahakis, MBBS, as acting Chief Medical Officer. Dr. Vlahakis is an experienced pulmonary and critical care clinician with clinical development expertise encompassing both early and late stage trials across a wide range of therapeutic areas, including IPF. Before joining CohBar, he was VP and Head of Clinical Development at Global Blood Therapeutics Inc. (GBT) where he advanced voxelotor (Oxbryta) to approval in sickle cell disease. Prior to GBT, he served as the VP and Head of the Respiratory Disease Area at Unity Biotechnology, developing clinical strategy for pre-clinical assets across a broad range of respiratory diseases. Dr. Vlahakis began his industry career at Genentech, serving as clinical lead for products in early and late clinical development. Prior to Genentech, Dr. Vlahakis was on faculty at Mayo Clinic and had an NIH-funded lab studying the biology of fibrosis, acute lung injury and angiogenesis. Dr. Vlahakis received his MBBS medical degree at the University of Adelaide in Australia and completed his Internal Medicine residency and Pulmonary Fellowship at Mayo Clinic. He is also a published scientist with more than 60 peer-reviewed articles.

Fourth Quarter 2021 Highlights

●Announced Changes to its Board of Directors and R&D Leadership. In December 2021, the company announced that its founders Drs. Nir Barzilai, Pinchas Cohen, and John Amatruda transitioned from the Board of Directors to a reconstituted Scientific Advisory Board. In addition, Ken Cundy, Ph.D., resigned as Chief Scientific Officer, effective March 31, 2022, and the company appointed Kent Grindstaff, Ph.D. as Senior Vice President of Research, effective January 4, 2022.

●Completed Equity Financing: In November 2021, the company completed an underwritten public offering of common stock and warrants, with aggregate gross proceeds of approximately $15 million. The company intends to use the proceeds from this offering to fund research and development and other general corporate purposes.

●Presented Late-Breaking Poster on CB4211 at The Liver Meeting 2021: In November 2021, the company presented data from its Phase 1a/1b clinical study of CB4211 during The American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting 2021).

Fourth Quarter 2021 Financial Highlights

●Cash and Investments: The company had cash and investments of $26.2 million as of December 31, 2021, compared to $21.0 million as of December 31, 2020. The cash burn for the quarter ended December 31, 2021 was approximately $3.0 million.

●R&D Expenses: Research and development expenses were $0.8 million for the three months ended December 31, 2021, compared to $2.7 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower clinical trial and preclinical costs due to the timing of those costs.

●G&A Expenses: General and administrative expenses were $2.0 million for the three months ended December 31, 2021, compared to $1.7 million in the prior year quarter. The increase in general and administrative expenses was primarily due to higher stock-based compensation costs.

●Net Loss: For the three months ended December 31, 2021, net loss, which included $0.6 million of non-cash expenses, was $2.8 million, or $0.04 per basic and diluted share. For the three months ended December 31, 2020, net loss, which included $0.6 million of non-cash expenses, was $4.7 million, or $0.08 per basic and diluted share.

Fourth Quarter and Full-Year 2021 Investor Call:

Webcast

-A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.

For individuals participating in the Investor Call or webcast, please call or login to the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available. beginning at 8:00 p.m. Eastern Time on March 29, 2022, through 11:59 p.m. Eastern Time on April 19, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13726040. The audio recording will also be available at www.cohbar.com during the same period.

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.