It’s Illogical To Think That Johnson & Johnson Has Dropped Geron

Vector Graphics by <a target="_blank" href="https://www.vecteezy.com">www.vecteezy.com</a>

Background Story

Imetelstat, a first-in-class telomerase inhibitor and Geron’s sole product candidate, is currently in phase 2 (IMbark) and phase 2/3 (IMerge) clinical trials. Ever since Geron and JNJ announced a joint collaboration agreement in November 2014 to develop and commercialize Imetelstat, investors have been waiting with crossed fingers for the outcomes of the clinical trials. A JNJ decision to continue with the collaboration agreement would trigger either a $65 million or $135 million milestone payment to Geron depending on whether or not Geron decides to opt-in to the sales and marketing of Imetelstat.

(Mis)Analyzing Data from JNJ Slides

A recent article that was published on Seeking Alpha selectively picked instances of Imetelstat being excluded in various JNJ slides and presentations to use as proof that JNJ would drop their partnership with Geron. Let’s do an apples-to-apples comparison of some JNJ slides to see what the truth is. For example, let’s examine an excerpt from JNJ’s Full-Year 2016 earnings slides to see if we can figure out where Imetelstat is headed (pages 24-25, the page numbers can be seen in the lower right hand corner). As you can see, Imetelstat is mentioned in the “Pharmaceutical Pipeline – Key Events in 2017” slide.

12

庐, in Crohns disease s such 庐s anti-coagulants, , and STELARA 庐 Drive continued growth while deliveringf high psoriasis,and Sirukumabing anti-psychotics Ph Iadrmstry-LeeadtcnaPlipeline & Commercial Excellencery approval for Guselkumab
 LTVTHErpronenta茂oHIratsTtaitaCcnrLnv/s-1lrlkuse/efrscrySmoldering Multiple Myeloma (SMM) 庐 庐 庐 庐 庐 庐 PoPtehielCsilkcaaLata Presentations Psoriasissre2r etelat J-1N7J58L28DkR)*fLeEnXza RSV  PsA *Ba*s*tanasaisionwsi20d1e6termined by enrollment rates, driven by RSV seasonality  RelaHI() defaHctrylipstAlef(LSomiU(())s)oisH(IU()()/UG) VHDHroapone-/e茂rectota(tSt)ic PC (EU) 庐 庐 庐 庐 庐/ 庐 庐 Pharmaceutical Pipeline  Key Events in 2017SIMPONI ARIA Arthritis (US/ EU))l/eIFrSTIIAPAre-metastatic PC (US) Click to enlarge

Notes:

Full-Year 2016

Now let’s look at the same 2 page excerpt from the full-year 2017 slides (pages 27-28, the page numbers can be seen in the lower right hand corner). As you can see Imetelstat, is not mentioned in this excerpt simply because the “Pharmaceutical Pipeline – Key Events” slide has been removed from the presentation altogether! Please go to the full slides for 2016 and 2017 to see for yourself. It is simply disingenuous to suggest that Imetelstat was removed from a particular slide in the Full-Year 2017 presentation when the truth is that the entire slide was omitted from the presentation.

12

Industry-Leading Pipeline & Commercial Excellence Priority: Drive continued growth while delivering on our near-term pipeline Strategy: Focus on six therapeutic areas of high unmet medical need, robust innovation and commercial capabilities Plans for Growth:  Expand profile on key lifesaving and life changing products, such as DARZALEX , IMBRUVICA , and STELARA 庐  Enable best in class uptake of TREMFYA 庐  Secure regulatory approvals for apalutamide  Submit NMEs and line extensions 27
Comprehensive Portfolio & Accelerated Growth Strategy Priority: Accelerate growth through innovation, partnerships, portfolio management, and new business models Strategy: Strengthen foundation and simplify operations, reshape our business and portfolio in anticipation of and in response to major changes in the industry Plans for Growth:  Build world-class commercial capabilities across the portfolio  Execute robotics and digital surgery solutions  Deliver forward-looking innovative pipeline  Integrate holistic, insights-driven capabilities to help health systems navigate value-based care 28 Click to enlarge

Notes:

Full-Year 2017

Furthermore, let’s look at the contents of the “Pharmaceutical” slide from both years presentations to understand that these slides cannot be used as a crystal ball to figure out what JNJ is thinking or planning. In the 2016 slides, we see that JNJ lists Sirukumab for anticipated regulatory approval. As I pointed out in a previous article, we know that Sirukumab was dropped by JNJ in October 2017. In addition, JNJ issued a continuation decision for Talacotuzumab in March 2017. As you can plainly see, Talacotuzumab is not listed anywhere in the entire presentations for the full-year 2016 and 2017 slides. My point is that JNJ issued a continuation decision for a drug that was not mentioned anywhere in these slides, so basically the mention of a drug’s name in these slides is not a good litmus test for what JNJ has planned.

There is a single page “Pharmaceutical Pipeline Key Events in 2018” slide that is available on the JNJ website. For completeness, let’s take a look at what it says and see how it differs from the Key Events in 2017 slide from the Full-Year 2016 slides. In the Key Events 2017 slide, it is clear that Imetelstat is listed under “Phase 2.” However, in the Key Events 2018 slide, there is no longer a “Phase 2” section. Instead it has been replaced by a “Phase 2, Potential Clinical Data Presentations” section where Imetelstat does not appear. Reading this literally, I would take this to mean JNJ has no plans to present clinical data from Imetelstat trials in 2018 at any medical conference and not to mean that JNJ has dropped development of Imetelstat!

Furthermore, the slide itself has an asterisk in the title. When you refer to what the asterisk means the slide says “This information is accurate as of April 17, 2018 to the best of the Company’s knowledge. Johnson & Johnson assumes no obligation to update this information.” In other words, use the info in this slide at your own risk, and even so the data might not be current.

11

TM ERLEADA (apalutamide)  Non-metastatic prostate cancer (US)  VTE prevention medically ill pts (MARINER) XARELTO庐  Congestive heart failure (COMMANDER) JULUCA (Rilpivirine+ dolutegravir FDC ViiV)  HIV (EU) STELARA 庐  Ulcerative Colitis TM SYMTUZA  HIV (US) Potential Esketamine  Treatment-resistant depression Approvals DARZALEX 庐  Frontline multiple myeloma non-transplant (US/EU) ERLEADA TM US/EU 庐 Potential  Non-metastatic prostate cancer (SPARTAN) XARELTO  CAD/PAD (US) Clinical Data (apalutamide) 庐 INVOKANA  CANVAS/CANVAS-RCV outcome (US/EU) Presentations Apalutamide + 庐  Chemo-na茂ve prostate cancer (ACIS) ZYTIGA  Hormone-na茂ve metastatic prostate cancer (US) arbiraterone acetate Phase 3 IMBRUVICA 庐  Treatment-naive WM combo w/rituximab (US^^ DARZALEX 庐  Frontline multiple myeloma non-transplant (MAIA)^ SYMTUZA TM  HIV Esketamine  Treatment-resistant depression (US/EU) Erdafitinib  Solid tumors (US/ EU) Frontline CLL combo w/obinutuzumab (PCYC1130) 庐  DLBCL frontline (PHOENIX) XARELTO 庐  Congestive heart failure (US) IMBRUVICA  Treatment-naive WM combo w/rituximab (iNOVATE) Planned TM ERLEADA (apalutamide)  Non-metastatic prostate cancer (EU) Submissions US/EU Apalutamide +  Chemo-naive prostate cancer (US) abiraterone acetate HIV Vaccine  HIV (TRAVERSE)  DLBCL frontline (US/EU) Potential IMBRUVICA 庐  Frontline CLL combo w/obinutuzumab (US/EU) Clinical Data IMBRUVICA 庐  DLBCL relapsed (PCYC1123)  Treatment-naive WM combo w/rituximab (US /EU) Presentations  Frontline CLL (IV fixed duration) (PCYC1142) OPSUMIT 庐  Chronic thromboembolic PH (US/EU) 庐  Frontline multiple myeloma transplant (GRIFFIN) DARZALEX MRD and safety 庐 Phase 2 TREMFYA  Psoriasis Patient-Controlled Injector (/ EU) Erdafitinib  Metastatic urothelial cancer (BLC2001) *This information is accurate as of April 17, 2018 to the best of the Company's knowledge.Johnson & Johnson assume. no obligation to update this information = Achieved ^ Depending on the event rate ^^ Assuming priority review 1 Click to enlarge

Notes:

Pharmaceutical Pipeline Key Events in 2018*

Let’s move on to examining the NME planned filing slides that JNJ releases quarterly. In an attempt to not pick and choose which slides to show, I will present the last 4 quarterly pipeline updates.

11

RSV elderly Esketamine RSV infection Influenza A BacteriJNJ-4178 (3DAA) Seltorexant (JNJ-7922) Lumicitabine (JNJNJ-1860 (ExPEC vaccine)ir (JNJ-3872 ) Relapsing multiple sclerosis Treatment resistant depressionfectious Diseases & VacVAC18193 (RSV vaccine) Adjunctive treatment for major depressive disorder rostate p NME PLANNED FILINGS 2017-2021* (ARN-509) Imetelstat Nirapirib Myelofibrosis Urothelial cancer cancer (mCRPC) Apalutamide harma Mar S.A.; Seltorexant (Orexin -2) antagonist codeveloped with Minerva Neurosciences; Imetelstat licensed from Talacotuzumab (CSL362) Pre-metastatic prostate cancer AML frontline not fit for chemo the best of the Companys knowledge. Johnson & Johnson assumes no obligation to update this information. Sirukumabed by Actelion, Erdafitinib (FGFRI kinase inhibitor) Ponesimod Metastatic castration-resistant Selective Highlights as of July 18, 2017 Sirukumab Janssen Pharmaceutical Companies of Johnson & Johnson Selected NMEPharmaceutical Pipeline - Recent Approvals/Potential Filings* Psoriasis OncDARZALEX庐 Immuno(guselkumab) Immunology Oncology Neuroscience (daratumumab) NMEs APPROVED 2016/2017 NMEs IN REGISTRATION Double Refractory multiple myeloma *FdevGeeloaropiavhaNtaiJolclaopdnifytrhtenPhAEhaXncsleiocuGieranpmaaribbAloLISTedseavroe;loTpaeladciontucozullambaobralitcioennsweitdh P Click to enlarge

Notes:

Selective Highlights as of July 18, 2017

11

Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* Selective Highlights as of October 17, 2017 NMEs APPROVED 2016/2017 NMEs IN REGISTRATION NME PLANNED FILINGS 2017-2021* Oncology Oncology Oncology Neuroscience DARZALEX庐 Apalutamide (ARN-509) Imetelstat Esketamine (daratumumab) Pre-metastatic prostate cancer Myelofibrosis Treatment resistant depression Double Refractory multiple myeloma Immunology TREMFYA庐 Erdafitinib (FGFRI kinase inhibitor) Seltorexant (JNJ-7922) (guselkumab) Urothelial cancer Adjunctive treatment for major depressive disorder Psoriasis Niraparib Ponesimod Metastatic castration-resistant prostate Relapsing multiple sclerosis cancer (mCRPC) Infectious Diseases & Vaccines Lumicitabine (JNJ-1575) RSV infection VAC18193 (RSV vaccine) RSV elderly JNJ-1860 (ExPEC vaccine) Bacterial infection Pimodivir (JNJ-3872 ) Influenza A *Filings/approvals assumed to be in the US and EU unless otherwise noted. This information is accurate asof the date hereof to the best of the Companys knowledge. Johnson & Johnson assumes no obligation to update this information. DARZALEX licensed from Genmab A/S; Seltorexant (Orexin -2) antagonist codeveloped with Minerva Neurosciences; Imetelstat licensed from Geron; Pimodivir (JNJ-3872) licensed from Vertex Pharmaceuticals, Inc.; Niraparib licensed from Tesaro; Talacotuzumab licensed from CSL Limited; Erdafitinib discovered in collaboration iwth Astex Pharmaceuticals, Inc.; Ponesimod developed by Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson Click to enlarge

Notes:

Selective Highlights as of Oct. 17, 2017

11

Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* Selective Highlights as of January 23, 2018 NMEs APPROVED 2017/2018 NMEs IN REGISTRATION NME PLANNED FILINGS 2018-2021* Immunology Oncology Oncology Neuroscience TREMFYA庐 (guselkumab) Apalutamide (ARN-509) (US) Imetelstat Esketamine Psoriasis Pre-metastatic prostate cancer Myelofibrosis Treatment resistant depression Erdafitinib (FGFRI kinase inhibitor) Seltorexant (JNJ-7922) Urothelial cancer Adjunctive treatment for major depressive disorder Niraparib Ponesimod Metastatic castration-resistant prostate Relapsing multiple sclerosis cancer (mCRPC) Infectious Diseases & Vaccines Apalutamide (ARN-509) (EU) Lumicitabine (JNJ-1575) Pre-metastatic prostate cancer RSV infection Pimodivir (JNJ-3872 ) Influenza A JNJ-1860 (ExPEC vaccine) Bacterial infection *Filings/approvals assumed to be in the US and EU unless otherwise noted. This information is accurate as of the date hereof to the best of theCompanys knowledge. Johnson & Johnson assumes no obligation to update this information. Seltorexant (Orexin - 2) antagonist codeveloped with Minerva Neurosciences; Imetelstat licensed from Geron; Pimodivir (JNJ-3872) licensed from Vertex Pharmaceuticals, Inc.; Niraparib licensed from Tesaro; Erdafitinib discovered in collaboration iwth Astex Pharmaceuticals, Inc.; Ponesimod developed by Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson Click to enlarge

Notes:

Selective Highlights as of Jan. 23, 2018

11

Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* Selective Highlights as of April 17, 2018 NMEs APPROVED 2017/2018 NMEs IN REGISTRATION NME PLANNED FILINGS 2018-2021* Immunology Oncology Oncology Neuroscience TREMFYA庐 (guselkumab) ERLEADA (apalutamide) (EU) Imetelstat Esketamine Psoriasis Non-metastatic prostate cancer Myelofibrosis Treatment resistant depression Erdafitinib (FGFRI kinase inhibitor) Urothelial cancer Ponesimod Oncology Relapsing multiple sclerosis Niraparib Metastatic castration-resistant prostate ERLEADA (apalutamide) (US) cancer (mCRPC) Non-metastatic prostate cancer CAR-T (JNJ-4528) Infectious Diseases & Vaccines Multiple Myeloma Lumicitabine (JNJ-1575) RSV infection Pimodivir (JNJ-3872 ) Influenza A *Filings/approvals assumed to be in the US and EU unless otherwise noted. This information is accurate as of the date hereof to the best of the Companys knowledge. Johnson & Johnson assumes no obligation to updatethis information. Imetelstat licensed from Geron; Pimodivir (JNJ-3872) licensed from Vertex Pharmaceuticals, Inc.; Niraparib licensed from Tesaro; Erdafitinib discovered in collaboration with Astex Pharmaceuticals, Inc.; Ponesimod developed by Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson. CAR-T licensed from Legend Biotech. Click to enlarge

Notes:

Selective Highlights as of April 17, 2018

As can plainly be seen, Imetelstat shows up in either the 1st or 2nd position from the top in the “NME Planned Filings, Oncology” section in every pipeline update. It is clear that other drugs are added and removed in the different slides as they progress through the various stages of development, so these slides are indeed actively maintained by JNJ. The fact that Imetelstat is always on them can only be taken as a good sign.

In addition, let’s take a look at one difference between the full-year slides for 2016 and 2017. The 2017 slides has an added bullet point of “Submit NMEs and line extensions” that does not appear in the 2016 slides. This fact along with the fact that Imetelstat is always listed in the “NME Planned Filing, Oncology” (while other drugs are added and removed) seems to go hand in hand with the JNJ “plans for growth” bullet item from the 2017 slides. I think this goes to show that Imetelstat is still actively and currently a part of JNJ’s game plan (submitting NMEs for growth).

Let’s take a look at another slide that is being used as evidence Imetelstat has been dropped by JNJ. Here are the last 4 quarterly updates for “Selected Pharmaceuticals In Late Stage U.S. and E.U. Development or Registration.”

11

collaboration with GlaxoSmithKline; PharmaMar S.A.; Talacotuzumab licensed from CSL Limited as of 07/18/17 U.S. Development Stage E.U. Development Stage PhasePIhIIaPsheaIIsIePIIhIaPsheaIIIIh4a/eaIseaIIsIe III/IVveFle1Pdas6ilIdIFI i9le/P1III1a2s/e1PhasPeha1IIIse III/IV/16aIsIIeFiledA9p/pP1rh6oavseedI6II/15edh5a/1ePIIhIase IIIsheasIIeIhIaIIse IIIerov4sda7IIledIhPIIsa7hsIIehPshIIIsIaIIIsIshIaIeaPIIhhaIaIIsseePIIhIIIIIhaPsheasIeIhIaIIPsIIeIIsIheasIIeI PIIh ) ( 2 ) ) (MY3003 (MY3004 ill pts (2) loped in collaboration with ViiV Healthcare; YONDELIS developed in collaboration with lished, or risk for, cardiovascular disease. (CANVAS Indication Sought elomealoinacoinmcboinmabtiioioitnhwleitndroezidoem/dixaexaemtheasoanene gation to update this information.NT STR deve y y ensed from Genmab A/S; IMBRUVICA developed in collaboration with Pharmacyclics, LLC, an AbbVie company; Sirukumab developed in multm ipuleple m y y ReCduocernhvreeitsiorktDSaioerstev(2ar)tsiarEdiaancdveTnEt-srlatAdEd)eianthpaintiehnigtsh-wriisthk,Clyeart Failure and significantdeslFaorpuceineefra0uc0ltt6)RyeelalseaTtreararnpadttrnei茂ietuantiMotDLb-th(ai)o2at2lei)thCbeollpihbo,thaaliinomidbeinaantdiodnewxiethnadsaneustine and Rituximabizhn(ePsCoYfC SELECTED PHARMACEUTICALS IN LATE STAGE U.S. AND E.U. DEVELOPMENT OR REGISTRATION PREZISTA STR and EDURANT STR (R/F/TAF) developed in collaborat XARELTO庐 (rivaroxaban) INVOKANA庐 (canagliflozin)庐elkusiruRkSumEaLbA(gRomu(umsatebk)inumab)eitieaLzonlgiilpcivginneaannodsudsopluetnesgiroanvifro)r IMBRUVICA庐 (ibrutinib) apalutamidaepa (ZAuRttG-idoO)azZumaT-bI9n)庐(rLaac3bbe6iret2aac)ttteeer)doinne) acetate) Therapeutic Area Product Name Cardiovascular and Immunology InfeVcatciocuisiseases and Neuroscience Oncology * Th(2isXARELTO co-developed with Bayer HealthCare; INVEGA SUSTENNA includes technology licensed from Alkermes, Inc.; DARZALEX lic Johnson assumes no obli Click to enlarge

Notes:

July 18, 2017

12

Therapeutic Area Product Name Indication Sought U.S. Development Stage E.U. Development Stage XARELTO庐 (rivaroxaban) Reduce the risk of major adverse cardiac events (MACE) in patients with Chronic Heart Failure and significant Phase III Cardiovascular and Coronary Artery Disease (2) Prevention of Symptomatic VTE and VTE-related death in high-risk, medically ill pts (2) Phase III Metabolism Secondary prevention of stroke in patients who have experienced Embolic Stroke of undetermined source Discontinued (ESUS) (2) Reduce the risk of MACE in patients with coronary or Peripheral Artery Disease (2) Phase III VTE prophylaxis in ambulatory cancer patients receiving chemo at high-risk for VTE (2) Phase III Long-term Prevention of Recurrent Symptomatic VTE (2) Filed 4/17 Infrainguinal revascular (2) Phase III INVOKANA庐 (canagliflozin) Diabetic Nephropathy (2) Phase III Phase III Reduce the risk of death in type 2 diabetes with established, or risk for, cardiovascular disease.(CANVAS Filed 9/17 Filed 10/17 /CANVAS-R ) (2) Immunology TREMFYA庐 (guselkumab) Moderate to Severe Plaque Psoriasis Approved 7/17 Positive CHMP Opinion 9/17 Psoriatic arthritis Phase III Phase III SIMPONI ARIA庐 (golimumab) Ankylosing spondylitis Filed 12/16 Psoriatic arthritis Filed 12/16 Juvenile Idiopathic Arthritis (JIA) Phase III sirukumab Rheumatoid Arthritis Withdrawn 10/17 Withdrawn 10/17 STELARA庐 (ustekinumab) Adolescents Psoriasis Approved 10/17 Approved 6/15 Pediatric Psoriasis Phase III Phase III Ulcerative Colitis Phase III Phase III Infectious Diseases SYMTUZA Single tablet regimen for HIV in treatment na茂ve patients and treatment experienced patients (2) Filed 9/17 Approved 9/17 and Vaccines (darunavir/cobicistat/emtricitabine/ tenofovir alafenamide) EDURANT庐 STR (rilpivirine and Single tablet regimen for HIV in treatment experienced patients (2) Filed 6/17 Filed 5/17 dolutegravir) Rilpivirine Long Acting HIV Infection Phase III Phase III nanosuspension forinjection cadazolid Clostridium difficile-associated diarrhea (2) Phase III Phase III Neuroscience esketamine Treatment-resistant depression Phase III Phase III Major depressive disorder with imminent risk for suicide Phase III Phase III ponesimod Relapsing multiple sclerosis (2) Phase III Phase III Oncology DARZALEX庐 Frontline multiple myeloma transplant eligible in combination with bortezimib, thalidomide and dexamethasone Phase III Phase III (MMY 3006) (2) Frontline multiple myeloma transplant ineligible patients in combination with bortezomib, melphalan, and Phase III Phase III prednisone (MMY 3007) (2) Frontline multiple myeloma transplant ineligible patients in combination with lenalidomide and low dose Phase III Phase III dexamethasone (MMY 3008) (2) Relapsed Refractory MM 1+ prior lines w/PomDex (2) Phase III Phase III IMBRUVICA庐 (ibrutinib) Treatment na茂ve patients with Mantle Cell Lymphoma in combination with Bendamustine and Rituximab Phase III Phase III (randomizedstudy MCL-3002) (2) Relapsed/refractory patients with Indolant Non-Hodgkins Lymphoma in combination with Bendamustine and Phase III Phase III Rituximab or R-CHOP; (randomized study FLR-3001) (2) Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma in combination with Phase III Phase III R-CHOP (randomized study DBL3001) (2) Previously Treated Adults with Waldenstrom's Macroglobulinemia with Rituximab (PCYC-1127) (2) Phase III Phase III Frontline Chronic Lymphocytic Leukemia (Young and Fit) (in combination with Rituximab) (ECOG 1912) (2) Phase III Phase III Chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy (2) Approved 8/17 Frontline Chronic Lymphocitic Leukemia in combination with obinutuzumab (PCYC-1130) (2) Phase III Phase III Frontline Chronic graft-versus-host-disease (cGVHD) (2) Phase III Phase III apalutamide (ARN-509) Prostate cancer pre-metastatic castration-resistant Filed 10/17 Phase IIIMetastatic hormone sensitive prostate cancer Phase III Phase III Localized prostate cancer Phase III Phase III apalutamide (ARN-509)/ Prostate Cancer metastatic castration resistant chemotherapy na茂ve Phase III Phase III ZYTIGA庐 (abiraterone acetate) talacotuzumab (CSL362) AML frontline not fit for chemo (2) Discontinued Discontinued YONDELIS庐 (trabectedin) Relapsed Ovarian Cancer (2) Phase III ZYTIGA庐 (abiraterone acetate) Prostate Cancer Newly Diagnosed Hormone Na茂ve Metastatic Filed 9/17 Positive CHMP Opinion 10/17 * This information is accurate as of the date hereof to the best of the Company's knowledge. Johnson & Johnson assumes no obligation to update this information. (2) INVOKANA licensed from Mitsubishi Tanabe Pharma Corporation; SYMTUZA developed in collaboration with Gilead Sciences; EDURANT STR developed in collaboration with ViiV Healthcare; YONDELIS developed in collaboration with PharmaMar S.A.; XARELTO co-developed with Bayer HealthCare; INVEGA SUSTENNAincludes technology licensed from Alkermes, Inc.; DARZALEX licensed from Genmab A/S; IMBRUVICA developed in collaboration with Pharmacyclics, LLC, an AbbVie company; Talacotuzumab licensed from CSL Limited Ponesimod and Cadazolid developed by Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson
Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* Selective Highlights as of October 17, 2017 NMEs APPROVED 2016/2017 NMEs IN REGISTRATION NME PLANNED FILINGS 2017-2021* Oncology Oncology Oncology Neuroscience DARZALEX庐 Apalutamide (ARN-509) Imetelstat Esketamine (daratumumab) Pre-metastatic prostate cancer Myelofibrosis Treatment resistant depression Double Refractory multiple myeloma Immunology TREMFYA庐 Erdafitinib (FGFRI kinase inhibitor) Seltorexant (JNJ-7922) (guselkumab) Urothelial cancer Adjunctive treatment for major depressive disorder Psoriasis Niraparib Ponesimod Metastatic castration-resistant prostate Relapsing multiple sclerosis cancer (mCRPC) Infectious Diseases & Vaccines Lumicitabine (JNJ-1575) RSV infection VAC18193 (RSV vaccine) RSV elderly JNJ-1860 (ExPEC vaccine) Bacterial infection Pimodivir (JNJ-3872 ) Influenza A *Filings/approvals assumed to be in the US and EU unless otherwise noted. This information is accurate asof the date hereof to the best of the Companys knowledge. Johnson & Johnson assumes no obligation to update this information. DARZALEX licensed from Genmab A/S; Seltorexant (Orexin -2) antagonist codeveloped with Minerva Neurosciences; Imetelstat licensed from Geron; Pimodivir (JNJ-3872) licensed from Vertex Pharmaceuticals, Inc.; Niraparib licensed from Tesaro; Talacotuzumab licensed from CSL Limited; Erdafitinib discovered in collaboration iwth Astex Pharmaceuticals, Inc.; Ponesimod developed by Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson Click to enlarge

Notes:

Oct. 17, 2017

11

Therapeutic Area Product Name Indication Sought U.S. Development Stage E.U. Development Stage Cardiovascular and XARELTO庐 (rivaroxaban) Reduce the risk of major adverse cardiac events (MACE) in patients with Chronic Heart Failure and significant Phase III Coronary Artery Disease (2) Prevention of Symptomatic VTE and VTE-related death in high-risk, medically ill pts (2) Phase III Metabolism Reduce the risk of MACE in patients with coronary or Peripheral Artery Disease (2) Filed 12/17 VTE prophylaxis in ambulatory cancer patients receiving chemo at high-risk for VTE (2) Phase III Long-term Prevention of Recurrent Symptomatic VTE (2) Approved 10/17 Infrainguinal revascular (2) Phase III Pediatric VTE (2) Phase III INVOKANA庐 (canagliflozin) Diabetic Nephropathy (2) Phase III Phase III Reduce the risk of death in type 2 diabetes with established, or risk for, cardiovascular disease. (CANVAS /CANVAS- Filed 9/17 Filed 10/17 R ) (2) Immunology TREMFYA庐 (guselkumab) Moderate toSevere Plaque Psoriasis Approved 7/17 Approved 11/17 Psoriatic arthritis Phase III Phase III SIMPONI ARIA庐 (golimumab) Ankylosing spondylitis Approved 10/17 Psoriatic arthritis Approved 10/17 Juvenile Idiopathic Arthritis (JIA) Phase III STELARA庐 (ustekinumab) Adolescents Psoriasis Approved 10/17 Approved 6/15 Pediatric Psoriasis Phase III Phase III Ulcerative Colitis Phase III Phase III Infectious Diseases and SYMTUZA Single tablet regimen for HIV in treatment na茂ve patients and treatment experienced patients (2) Filed 9/17 Approved 9/17 Vaccines (darunavir/cobicistat/emtricitabine/ tenofovir alafenamide) JULUCA庐 (rilpivirine and Single tablet regimen for HIV in treatment experienced patients (2) Approved 11/17 Filed 5/17 dolutegravir) Rilpivirine Long Acting HIV Infection Phase III Phase III nanosuspension for injection cadazolid Clostridium difficile-associated diarrhea (2) Phase III Phase III Neuroscience esketamine Treatment-resistant depression Phase III Phase III Majordepressive disorder with imminent risk for suicide Phase III Phase III ponesimod Relapsing multiple sclerosis (2) Phase III Phase III paliperidone palmitate 6 month long- Maintenance treatment of schizophrenia Phase III Phase III acting injectable Oncology DARZALEX庐 Frontline multiple myeloma transplant eligible in combination with bortezimib, thalidomide and dexamethasone Phase III Phase III (MMY 3006) (2) Frontline multiple myeloma transplant ineligible patients in combination with bortezomib, melphalan, and prednisone Filed 11/17 Filed 11/17 (MMY 3007) (2) Frontline multiple myeloma transplant ineligible patients in combination with lenalidomide and low dose Phase III Phase III dexamethasone (MMY 3008) (2) Relapsed Refractory MM 1+ prior lines w/PomDex (2) Phase III Phase III Amyloidosis (AMY 3001) (2) Phase III Phase III Subcutaneous (SC) formulation (MMY3012) (2) Phase III Phase III Smoldering multiple myeloma (SMM3001) (2) Phase III Phase III IMBRUVICA庐 (ibrutinib) Treatmentna茂ve patients with Mantle Cell Lymphoma in combination with Bendamustine and Rituximab Phase III Phase III (randomized study MCL-3002) (2) Relapsed/refractory patients with Indolant Non-Hodgkins Lymphoma in combination with Bendamustine and Phase III Phase III Rituximab or R-CHOP; (randomized study FLR-3001) (2) Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma in combination with R- Phase III Phase III CHOP (randomized study DBL3001) (2) Previously Treated Adults with Waldenstrom's Macroglobulinemia with Rituximab (PCYC-1127) (2) Phase III Phase III Frontline Chronic Lymphocytic Leukemia (Young and Fit) (in combination with Rituximab) (ECOG 1912) (2) Phase III Phase III Frontline Chronic Lymphocitic Leukemia in combination with obinutuzumab (PCYC-1130) (2) Phase III Phase III Frontline Chronic graft-versus-host-disease (cGVHD) (2) Phase III Phase III apalutamide (ARN-509) Prostate cancer pre-metastatic castration-resistant Filed 10/17 Phase IIIMetastatic hormone sensitive prostate cancer Phase III Phase III Localized prostate cancer Phase III Phase III apalutamide (ARN-509)/ Prostate Cancer metastatic castration resistant chemotherapy na茂ve Phase III Phase III ZYTIGA庐 (abiraterone acetate) YONDELIS庐 (trabectedin) Relapsed Ovarian Cancer (2) Phase III ZYTIGA庐 (abiraterone acetate) Prostate Cancer Newly Diagnosed Hormone Na茂ve Metastatic Filed 9/17 Approved 11/17 Pulmonary OPSUMIT庐 Fontan-palliated in adolescent (>12 years old) and Phase III Phase III Hypertension Pediatric pulmonary arterial hypertension Phase III Phase III UPTRAVI庐 IV Pulmonary arterial hypertension Phase III Phase III * This information is accurate as of the date hereof to the best of the Company's knowledge. Johnson & Johnson assumes no obligation to update this information. (2) INVOKANA licensed from Mitsubishi Tanabe Pharma Corporation; SYMTUZA developed in collaboration with Gilead Sciences; EDURANT STR developed in collaboration withViiV Healthcare; YONDELIS developed in collaboration with PharmaMar S.A.; XARELTO co-developed with Bayer HealthCare; paliperidone palmitate includes technology licensed from Alkermes, Inc.; DARZALEX licensed from Genmab A/S; IMBRUVICA developed in collaboration with Pharmacyclics, LLC, an AbbVie company Ponesimod and Cadazolid developed by Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson Click to enlarge

Notes:

Jan. 23, 2018

11

Therapeutic Area Product Name Indication Sought U.S. Development Stage E.U. Development Stage XARELTO庐 (rivaroxaban) Reduce the risk of major adverse cardiac events (MACE) in patients with Chronic Heart Failure and Phase III Cardiovascular and significant Coronary Artery Disease (2) Prevention of Symptomatic VTE and VTE-related death in high-risk, medically ill pts (2) Phase III Metabolism Reduce the risk of MACE in patients with coronary or Peripheral Artery Disease (2) Filed 12/17 VTE prophylaxis in ambulatory cancer patients receiving chemo at high-risk for VTE (2) Phase III Infrainguinal revascular (2) Phase III Pediatric VTE (2) Phase III INVOKANA庐 (canagliflozin) Diabetic Nephropathy (2) Phase III Phase III Reduce the risk of death in type 2 diabetes with established, or risk for, cardiovascular disease. (CANVAS Filed 9/17 Filed 10/17 /CANVAS-R ) (2) TREMFYA庐 (guselkumab) Psoriatic arthritis Phase III Phase III Immunology Psoriasis Patient-Controlled InjectorFiled 3/18 Phase III SIMPONI ARIA庐 (golimumab) Juvenile Idiopathic Arthritis (JIA) Phase III STELARA庐 (ustekinumab) Pediatric Psoriasis Phase III Phase III Ulcerative Colitis Phase III Phase III Infectious Diseases SYMTUZA Single tablet regimen for HIV in treatment na茂ve patients and treatment experienced patients (2) Filed 9/17 Approved 9/17 and Vaccines (darunavir/cobicistat/emtricitabine/ tenofovir alafenamide) JULUCA庐 (rilpivirine and Single tablet regimen for HIV in treatment experienced patients (2) Approved 11/17 Positive CHMP Opinion 3/18 dolutegravir) Rilpivirine Long Acting HIV Infection Phase III Phase III nanosuspension for injection pimodivir (JNJ-3872) Influenza A Phase III Phase III cadazolid Clostridium difficile-associated diarrhea (2) Discontinued Discontinued Neuroscience esketamine Treatment-resistant depression Phase III Phase III Major depressive disorder with imminent risk for suicide Phase III Phase III ponesimod Relapsing multiple sclerosis (2) PhaseIII Phase III paliperidone palmitate 6 month Maintenance treatment of schizophrenia Phase III Phase III long-acting injectable Oncology DARZALEX庐 Frontline multiple myeloma transplant eligible in combination with bortezimib, thalidomide and Phase III Phase III dexamethasone (MMY 3006) (2) Frontline multiple myeloma transplant ineligible patients in combination with bortezomib, melphalan, and Filed 11/17 Filed 11/17 prednisone (MMY 3007) (2) Frontline multiple myeloma transplant ineligible patients in combination with lenalidomide and low dose Phase III Phase III dexamethasone (MMY 3008) (2) Relapsed Refractory MM 1+ prior lines w/PomDex (2) Phase III Phase III Relapsed Refractory multiple myeloma w/carfilzomib/dex (Amgen sponsored) (2) Phase III Phase III Amyloidosis (AMY 3001) (2) Phase III Phase III Subcutaneous (SC) formulation (MMY3012) (2) Phase III Phase III Smoldering multiple myeloma (SMM3001) (2) Phase III Phase III IMBRUVICA庐 (ibrutinib) Treatment na茂ve patients withMantle Cell Lymphoma in combination with Bendamustine and Rituximab Phase III Phase III (randomized study MCL-3002) (2) Relapsed/refractory patients with Indolant Non-Hodgkins Lymphoma in combination with Bendamustine and Phase III Phase III Rituximab or R-CHOP; (randomized study FLR-3001) (2) Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma in combination Phase III Phase III with R-CHOP (randomized study DBL3001) (2) Previously Treated Adults with Waldenstrom's Macroglobulinemia with Rituximab (PCYC-1127) (2) Filed 04/18 Phase III Frontline Chronic Lymphocytic Leukemia (Young and Fit) (in combination with Rituximab) (ECOG 1912) (2) Phase III Phase III Frontline Chronic Lymphocitic Leukemia in combination with obinutuzumab (PCYC-1130) (2) Phase III Phase III Frontline Chronic graft-versus-host-disease (cGVHD) (2) Phase III Phase III ERLEADA (apalutamide) Prostate cancer non-metastatic castration-resistant Approved 02/18 Filed 02/18 Metastatichormone sensitive prostate cancer Phase III Phase III Localized prostate cancer Phase III Phase III apalutamide/ Prostate Cancer metastatic castration resistant chemotherapy na茂ve Phase III Phase III abiraterone acetate YONDELIS庐 (trabectedin) Relapsed Ovarian Cancer (2) Discontinued ZYTIGA庐 (abiraterone acetate) Prostate Cancer Newly Diagnosed Hormone Na茂ve Metastatic Approved 02/18 Approved 11/17 Pulmonary OPSUMIT庐 Fontan-palliated in adolescent (>12 years old) and adult patients Phase III Phase III Hypertension Pediatric pulmonary arterial hypertension Phase III Phase III UPTRAVI庐 IV Pulmonary arterial hypertension Phase III Phase III * This information is accurate as of the date hereof to the best of the Company's knowledge. Johnson & Johnson assumes no obligation to update this information. (2) INVOKANA licensed from Mitsubishi Tanabe Pharma Corporation; SYMTUZA developed in collaboration with Gilead Sciences; EDURANT STR developed in collaboration with ViiVHealthcare; YONDELIS developed in collaboration with PharmaMar S.A.; XARELTO co-developed with Bayer HealthCare; paliperidone palmitate includes technology licensed from Alkermes, Inc.; DARZALEX licensed from Genmab A/S; IMBRUVICA developed in collaboration with Pharmacyclics, LLC, an AbbVie company Ponesimod and Cadazolid developed by Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson Click to enlarge

Notes:

April 17, 2018

If you look at these slides you’ll see that JNJ’s drugs in development basically fall into these categories: currently in phase 3, filed for approval, discontinued, or approved. Since Imetelstat is currently in phase 2 (IMbark) and phase 2/3 (IMerge) clinical trials, there should be no reasonable expectation that it would show up on these slides. We should not see it on this slide until one of three things happen: It moves into a phase 3 clinical trial, filing for approval occurs, or JNJ discontinues development of it. The fact that it is currently not on these slides should not be taken as a bad sign, in fact since Imetelstat does not show up as discontinued on the 4/17/18 update should indicate that Imetelstat is still proceeding with phase 2 trials in both IMerge and IMbark.

Clinical Trials Update

In an effort to avoid confirmation bias and rely too much on a single source of information (slides from JNJ), let’s take a look at a recent update to the IMbark clinical trial that happened just last week (April 24). Before the most recent update, the detailed description section of the clinical trial stated that:

This is a randomized (study medication assigned to participants by chance), multicenter (more than one hospital, medical school team or medical clinic work on a medical research study) study of 2 dosing regimens (treatment arms) of single-agent Imetelstat in participants with intermediate-2 or high risk myelofibrosis (MF) whose disease is relapsed after or refractory to Janus Kinase (JAK) inhibitor treatment. Enrollment in the study may be approximately 160 participants if enrollment in Arm 1 is resumed after the second interim review. The study consists of 3 parts: Screening Phase (21 days before randomization); single-blind Treatment Phase (from randomization until study drug discontinuation); and Follow up Phase (until death, lost to follow-up, withdrawal of consent or study end, whichever occurs first). Participants in Arm 1 will receive Imetelstat 9.4 milligram (mg)/kilogram (kg) intravenously (IV) for every 3 weeks until disease progression, unacceptable toxicity, or study end and Arm 2 will receive Imetelstat 4.7 mg/kg IV for every 3 weeks until disease progression, unacceptable toxicity, or study end. Participants in Arm 2 may continue with their current Imetelstat dose or have it increased to 9.4 mg/kg at the investigator’s discretion. Percentage of spleen response and symptom response will be evaluated primarily. Participants’ safety will be monitored throughout the study.

The new update is the same except it has an addition to the end of the description. The detailed description now ends with:

The study is closed to further participant enrollment. Participants benefiting from study treatment will continue to receive Imetelstat in Extension Phase for approximately 1 year or until loss of benefit or unacceptable toxicity. Participants entering to Extension phase from Follow up Phase will continue follow up for safety via serious adverse event collection and for survival status. The Extension Phase will end approximately 1 year after the clinical cutoff for the final analysis of the main study, or when the sponsor terminates the study, whichever occurs first.

JNJ is now planning to extend the trial for 1 year for participants who are “benefiting from study treatment.” If Imetelstat is being dropped by JNJ, how does it make sense that that are also concurrently planning to extend IMbark for another year? Wouldn’t it already be medically unethical to allow patients to continue with a treatment that JNJ knew to be ineffective, let alone to extend an ineffective treatment for an additional year?

Also let’s not lose sight of the fact that JNJ also extended the time frame for the secondary outcome measures of overall survival and adverse events. With the 1 year trial extension, the time frame for secondary outcome measures of overall survival and adverse events has been extended from 3 years to 4 years. I guess it is obvious if the trial is been extended from 3 to 4 years, it means that overall survival will be to to 4 years for patients participating in the extension. I think it is reasonable to believe that this extension was indeed implemented to allow patients in the trial to continue receiving treatment and benefiting from Imetelstat. The fact that overall survival will now be in excess of 3 years for patients participating in the extension should be pretty exciting for people who are keeping tracking of the overall survival statistics.

The fact that this update to the clinical trial happened should not come as a surprise. In Geron’s March 2018 update they announced that:

Janssen completed a third internal data review of IMbark in March 2018, based on a January 2018 data cut, to enable a protocol amendment to allow the long-term treatment and follow up of patients, including for survival, and the Collaborations Joint Steering Committee (JSC) made the following observations and implemented the following actions:

The safety profile was consistent with prior clinical trials of Imetelstat in hematologic malignancies, and no new safety signals were identified. Outcome measures for efficacy, including spleen volume responses and reductions in Total Symptom Score remain consistent with the prior data reviews. With a median follow up of approximately 19 months, the median overall survival has not been reached in either dosing arm. The trial is officially being closed to new patient enrollment. More than 100 patients have been enrolled in IMbark to date, which is expected to be adequate to assess overall survival. Patients who remain in the treatment phase may continue to receive Imetelstat, and until the primary analysis, all safety and efficacy assessments are being conducted as planned in the protocol, including following patients, to the extent possible, until death to enable an assessment of overall survival. Based on the rate of deaths occurring in the trial, the protocol-specified primary analysis, which includes an assessment of overall survival, will begin by the end of the second quarter of 2018. Upon the protocol-specified primary analysis, the main trial will be completed. The IMbark protocol is being amended to establish an extension phase of the trial to enable patients remaining in the treatment phase to continue to receive Imetelstat treatment per investigator discretion. During the extension phase, standard data collection will primarily consist of safety information.

Geron states here that in March 2018 the Joint Steering Committee (a committee made up of both Geron and JNJ people) came to many conclusions. Namely, the safety profile was consistent with prior clinical trials of Imetelstat, no new safety signals were identified, and that the IMbark protocol is being amended to establish an extension phase of the trial to enable patients remaining in the treatment phase to continue to receive Imetelstat treatment per investigator discretion. So the fact that the clinical trial has now been updated shows that JNJ is following through with what Geron announced in March 2018. This shows that both JNJ and Geron are on the same page in terms of the development of Imetelstat, and also that things are proceeding as planned as far as Geron has announced.

Another important update in the clinical trial was that the estimated primary completion date was changed to April 26, 2018. The previous date was May 4, 2018. Taking this at face value and the fact that April 26th has now passed, it seems reasonable to conclude that the protocol-specified primary analysis is now in progress.

The Risk

Investing in Geron is not risk-free. If JNJ were to not move forward with developing Imetelstat or the FDA were to halt the ongoing Imetelstat trials, then the price of GERN would likely drop precipitously as it did in March 2014. When that happened the price of GERN cratered to below $2, and I believe the price would drop well below $2 if that were to happen again. However, with the price currently at $3.72, and the fact that the price of GERN skyrocketed to $6.68 by March 19 following positive information from Geron’s March 16, 2018 press release, I believe that the price could triple following a continuation decision by JNJ and head north of $10. This is where the price was headed, before the share price of GERN was continually eroded by a stream of negative articles and law firm investigations. JNJ is due to issue a continuation decision by Q3 2018, so we should see this event happening in about 5 months.

The Conclusion

There is a ton of information out there regarding JNJ, Geron, and Imetelstat. It is relatively easy to cherry pick bits of information to use as evidence to back any particular viewpoint. However, I believe it is a mistake to believe viewpoints that do not use data in a consistent manner and purposely exclude certain key pieces of information. I have tried to deliver an argument that shows Geron is in good standing with JNJ by analyzing a historical progression of slides and clinical trial updates. I used an apples-to-apples comparison of slides and data whenever possible. This analysis leads me to believe that JNJ and Geron are in good standing with each other. I was not able to identify any true inconsistency in data, slides, or statements; in fact it is the opposite that is true, JNJ has consistently shown Imetelstat in their “Pharmaceutical Pipeline” updates. In addition, the progress of Imetelstat’s development seems to be proceeding according to Geron’s March 2018 statement (which relies on decisions by the Joint Steering Committee). This is a pretty good sign that things are indeed proceeding as planned.

Disclosure: I am/we are long GERN.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.