EFTA00810552.pdf

EFTA00810552  Forward looking statements veru INICOMMoNC063ACOMOnSkeeeed-1501Ing Skilanenlswankt the MeONN2 Of the Prty0105,3~10(4 U110060nRelOrM ACIOl 1995. 11.93 SIONMUMIS Ore Subjekt 10 bidral on unknown aks. uncortalmes and assumptin adb:ny such risks or uncerlonles malorkiao or i any of the assurnplions prove incorrocl. os aclual ros" coud delar molbed Man Mose aquessed ar ~ed by sua staemeres. factors bal may causa aclud results to older material:y korn Mose contemreated by such lonvad bobrq s101eMennnekt». bul ote n3Y briter:110: raf reelked SO tre Cltrekenu3n101Verv MC. % (Me - COrrgeny,OrOrirel pollab. bidvang ~0116M. reoul0ary OpprOwlIS end Kne and cosi to ang to merket potentat deby. M tne ~cote, Iming cd and raud; from locol onn end sbxlos end n Ire %ting of bly wbrrysson to the rogulalory aumonlet: Mellit in °Maning are regi-foton oppmed ond tro produch bong commercicey soccesske rista reeatrq to Me °bitt od Ide Corrpcny lo °elan suffleer* Monene On OCOM)10ble terms ...hen n.)~0 ro lund deveropmenl ond Comp0ny OCKYOlier6.PrvduCt elemonClorKlenOrtelOCCesalonCe. COmpemon in Me COnp0nys maten and Me rist ol news Sting ~petiten~ arealer rosources and capablees and reve company* procbc1rntroduchons: the ilsk In sale: bong oflocted by ropulakey dembpments. Inaludng a readuncatnn od Me producle price erosen. bom hom ~pang procbch and inaecced government 'anane prosauros: mcnufaclurhg Ond Crspedly CORNY prOblenrs: COMplonce ond regylolay ~len hauding COM ond dele»MIJIM2 frem tie exremke gOverrenenSOIMENIotert Ond etled, d nretlen0ere Murane* Ond roguSatbn. includng reductbnsInreabursemenl and coverago: same ol Me Compansli producrscre ler dauda:ment and tre Campere,' malt fal to successkOr cornmeroalm sud, products: mk. rokeed lo inlelleclual propan,. nolocIng mo uncortarty od aceanng pasanis. the e/kalvenes% of the patent% or *Mor hlelectuOla0PertyrX0Yechons ond obit710 enlorte Iren, 000Yrt I1V0 ~EM. Me unCedeinly regeretg 001ent coyeroges. the POSSbilly Ol htMoho 011V0 Ø'S polens ordne' Inteheclual properly %MK. and Icensng råske government car...can° ras. ncludng ble operaen: bm process and /undng ~lot pasened beseaucrac ddays awardng contrach. procest ~dolkesOr olier am -res, and ble risk Mal adyornmore torden ard contracts mor/ bo subjecitocanmetahndeloy.reseucluMg wbsionlied mo*, pournents, goyernmenta masa asoid. incbdhp Car0Ony's rapen. Saum Aldcø •anole cOnClan lenda ~ard. hocola, OCCepionce of Me tidderi øke raner mon on ada a ananes of Me arena.« Orry nifaner rer "aber 01enis. ti d 0,0~ aramwheni Meti6e$010111« OVIMCSOCIOF Gutane', MP/ Ø ti d over= (mva unn Man Ire hil ~moro sender crnounl:ponclties anda cktarmone lor lak« to sann tander °svarets: Mo lang ol orden undermo Canpora's recent Soalh Al6co fane» condom lenda ~ad b .ncen0h. ond OM deby M elde° unO9F the Onad cald minen h Iowa 'mynte bits OrdiebOled in Me °aller pen 01 the liree-rea parod cated by Me timda: Ire COnrpaly5tecMl South ~co lande conck)m lenda Ow0r0 could be %Moe. Inme lokke kmeonocalion la polentalkcal manufactumg relattves. whchcouldrectce mo sto od ble emmi lo Ile [brobry: te Company% ~ce onlIs internalkeed partners and onMe lovd ol lOendngtn Country gMISMMIMII. ClOb0100n3rs onda'« pek ne0eh ofoonizolions in the Øb0l podia secea:fislmeloied 10 otnamlicfon 01<taum.,ecaeoble 'Mb ow kipena/ganen ond the coh9clion of Mose eoehaSes: n,9 SCOnank Ond bukrenn artsramen Ond Me impoci Ol gtmentneal pOWAfres: Mk% incONed M deing buineis en animanaknoilevet includng amency ras.rea.eatay reguremenls. pakketniks, export reshictora oller trade brak sno Company% prodlcInncapaosy, eticency Ond Suy)plyCOMM:inn Ond inlentplfars. inClutIng due 10 leter ~MI Or at« Mk, ~sed so tre coM ond aner &fea.01Ploorron. Mcludinp prOduCI lobihy «ans: Ond OlheirdskS Cle102M1b 11. Company. press 'Sose.. 'borehode, oommankolions and %arne% Ond ExChOrX* Canni1U0n dings. inCluong Compony's ^mua Repal On Fan' 1041a the yap. ondod September 30. 2017. Mil cbcument is avolatlo on Me SEC Ringe sectonol oswebule al owy, vaken-r.7'^ .-nri "y. M IC/WiTd4COICha siolemenh ore boed On irdormoron~oble bus sd The dele hes0l. ond Comooly Gass not mane onyoblpalion ond domna blend auodale (my lomad-lockinp ,leiemens. ~Opi Os rettvist" by ire Carpony nos lied 0 Moillr011On slden,enlar barn 5.3 fnelvtling 0 prOSpeChys) with tre %CLAES% Ond entreroe Commis~ ("SEC" mal wes deCkretlelfeClive on November 14. 2017. Bekre yOu hvest h me «ekg k> ym'chMb communicoeonre.ales. ytt, utdun Æsa. Me aopedtsh m0t regitiOrkn slOkeMent. Ire aelm'rcry reospecias sua:lemen. robled lo the &føring Odenayalabbl and Me od, docuwenls the Company has Mod andedl Ile sNIM Me SEC lor more correlolo nlormallay obol tere COMPOrry«Kl Me OMAN. YOu encri del tffle OOeunenhfa NIS by vatn° EDGAR On the SEC unlibfte Ot unnu.SeC.Cten. AllftM011uely. me Genpony. Ony ondenaer aly 40041dOrliCtrelktg n the offerM0 wi ononde to send yOu the prOsteClus Ond Me pngmhoty prospeclo...hen OvOl0ae, by <eting Conbafilipsord d Co_ Alet Capllal Malers, 459 tak Avenue. da Hoa. Ho* York, NY 101122, by telephone al 2124129.7122. EFTA00810553 Pipeline of proprietary product candidates and specialty pharmaceuticals vent PRODUCT INDICATION TARGET PREcuNICAE PHASE, PHASE 2 PHASE 3 PHASE.. PROSTATE CANCER NOVEL MEDICINES Zuclomiphene Hot flashes caused Nonsteroidal Capsules by prostate cancer estrogen agonist hormone treatment VERU• I 1 (13 nclole) Metastatic prostate Oral, targeted Capsules cancer a • $ htbulin inhibitor UROLOGY SPECIALTY PHARMACEUTICALS Tomsulosin DRS BPH (no food effect) Super selective a- granules 8 XR capsules receptor blacker (tamsulosin HCI) with no food effect EI:112== Todolafli-finasteride IIPH a erectile PDS • combo tablets (5mg So reductose todalafli /5mg dysfunction inhibitors CS2=322aa linasteilde) Soldenacln DRG Overactive Selective M3 (solltenacln granules bladder muscarinic oral suspension) antagonist 3 EFTA00810554  Experienced in clinical practice, drug development and commercialization vett Mitchell Steiner, MD Michele Greco, CPA Gary Barnette, PhD Harry Fisch, MD CHAIRMAN, PRESIDENT & CHIEF FINANCIAL & CHIEF SCIENTIFIC OFFICER CHIEF CORPORATE OFFICER CEO ADMINISTRATIVE OFFICER Sr. VP Scientific and Reg Affairs Chairman Aspen Park CFO/EVP the Female Health Camorgo Phcrm. Services. VP Pharmaceuticals and Millennium CEO & President Aspen Pork Company. 28 years with Frost & Cfnical & Reg and Founder GTx, Sciences. Inc.: urologist Pharmaceuticals. President of Urology at OPKO Health. Inc.: Young, 15 yeas as an Audit Inc., Director Reg Affairs Solvay CEO & Founder Cir. Inc.: Partner Phormo. Clinical Pharmacology! Biopharmoceutics Reviewer FDA. urologist PhD Basic Pharmaceutical Sciences west Virgin° University Kevin Gilbert, JD, CPA Philip Greenberg, JD Phil Kuhn, MBA EVP CORPORATE EVP LEGAL EVP STRATEGY AND DEVELOPMENT COMMERCIALIZATION General Counsel Latin Arnenca Corporate Development & Legal Teva Pharmaceuticals with prior Global Strategy and Commercial Third Stream Bioscience. Attorney senior legal positions in expertise in medical devces. at McDermott. Will & Emery, international and North America aognostics. and biologics: Motorola. dosed more that 100 divisions; Deputy General leadership roles at ISTO Biologics, transactions in 25 countries Counsel for VAX Corporation Orthofix, Smith & Nephew, Boston Scientific, Johnson & Johnson. and Abbott UPDATED EFTA00810555 u 1 Prostate Cancer - Novel Medicines EFTA00810556 Zuclomiphene: potential to be the first FDA approved drug for hot flashes caused by prostate cancer hormone therapy veru Hot flashes are one of the most Zuclomiphene (aka cis-clomiphene) common and debilitating side effect is an oral estrogenic agent" of androgen deprivation therapy • Isolated cis-clomiphene from CLOMID (ADT) for advanced prostate cancerl•2 (30% cis- and 70% trans-clomiphene; • Occurs in up to 80% of men treated approved in 1967 for female infertility( with ADT (leuprolide or degarelix) with • Efficacy established for estrogens: off- 30-40% having moderate to severe hot label steroidal estrogens are effective flashes'-3 but have safety concerns" • Symptoms do not subside over time • FDA database and scientific literature • 44% of men of S yews and 40% of men of 8 show cis-clomiphene component of yeas slit suffer from hot floshes2 CLOMID is well tolerated with over • Concern over hot flashes make 88,000 men/years using CLOMID off patients less likely to begin ADT and label for infertility or hypogonadism can lead to early discontinuation2A Gomelb LG el al EUU intsi:25.292037likarinp P el all UV 15211701173 199A %•Gavale2 BDatoll Urol 194690495 20151, 03101SerallSuppore Dace. 43,5 320 2004 I guano' It1el cd Endocnnolow 1397771220 Fontenot GC el dim ht I I 7N4,50. 20161..fones lm tt cl Auon JAr4obae 14:192.19720, 21' Spell AC el of 1Supped OrCei 426.3.2732C431., COmeree Plume Clekof Report 3/ 17 axl FDA SdeiroDoCurnenl BRUDAC AcNiscee rneerg 17/16 EFTA00810557  a Zuclomiphene clinical development plan: Phase 2 trial design veru IND accepted 7/18 Phase 2 placebo controlled dose finding study First subject expected in 9/18 & final data expected 1H 2019 0 mg Plan to enroll 120 men who have moderate & severe hot flashes on ADT in 10 US clinical sites • Primary efficacy endpoint- mean change in frequency of moderate 8, severe hot flashes from baseline to week 4 and maintained until week 12 • Power 8O%; 40% improvement compared to placebo • Placebo effect from literature is 22%' Primary endpoint Primary endpoint • Secondary endpoints- bone turnover markers 4 weeks 12 weeks Lopinzi el o12009. Annals of Oncology p1.8 ICOLI0.I093/annenc/mcfn644 :Table 21 7 EFTA00810558  Zuclomiphene: greater than $600 million/year expected market veru Market potential • Indication: treatment of castration-induced hot flashes in men with advanced prostate cancer on ADT • Estimated 600,000 men on hormonal therapies (androgen deprivation therapy as well as novel androgen blocking agents) in the U.S.' • Over a $600 million/year expected market? Intellectual property • Patent (U.S. No. 9.913.815) issued March 2018, expiry 2035- method of use • Polymorph identified- composition of matter patents filed Scher et cr. PtoS ONE 2015 101-12 (DOI:10.1371(rotmeloone013Pee0IrRd to:oleo ocoinike boon on XX of 400000 men io US on AD1have moderole to more ivt norhesilthe once was Sa3C0 hoot of freemen! 8 EFTA00810559 VERU-111 may address key limitations of current prostate cancer treatments The only effective agents against advanced and metastatic prostate cancer are hormonal and antitubulin cytotoxic drugs Androgen blocking agents ZYTIGA (abiraterone) and XIANG' (enzolutomide) have significant cross resistance Men who progress on these agents are being healed with antilubulin chemotherapies Current antitubulins have challenges' • Only evadable as intravenous administration • Drug resistance is common- multidrug resistance proteins. tubulin mutations and overexpression • Safety concerns- hypersensitivity reactions, neutropenia, and neufoloxicily (peripheral neuropathy & muscle weakness) 'Domoid t ar olart Treat Opica:Oncci 16:9 2015 9 EFTA00810560 VERU-111: novel, oral, next generation, tubulin inhibitor targeting a and p subunits of microtubuies veru Precllnical Product profilel-3 • low nanomolar inhibition of tubulin polymerization MICROTUBULE • High oral bioovailability • High brain penetration • Not a substrate for MDRs MRPs. and BCRP) • Not a substrate for CYP3A4 • Efficacy against prostate and other cancers in vitro and in vivo • Demonstrated activity against taxane. vinca alkaloid, doxorubicin, enzalutarnide, and abiraterone resistant cancers • Favorable safety profile (less neurotoxicity than docetaxel and unlike taxanes and vinca alkaloids -no neutropenia or myelosuppression)4 Chen J el al. J Med Chem 55:7285-7289 2012 I1Li CM el CI. MOM, Res 29:3053-3043 2012 I Le Y el all Abed Chem 57:73553364 2014 I'28 day ral and dog lox ily :ladies an file al veta. hC. EFTA00810561  VERU-111 builds on a proven mechanism - inhibiting microtubule assembly yew Microtubule assembly Microtubules (red) disrupted from spindle to globular shape control VERU-111 VERU-111 "spindle shape" "globular shape" (Crossilnks a and (1 subunits Triple negative human breast cancer xenograft and Inhibits polymerization) (MDA-M8-231)i ',unmet, ASCO abstrach 2018 ct profile 11 EFTA00810562 VERU-111 inhibits growth of taxane-resistant prostate cancer' veru • PC-3 and taxane-resistant PC-3 (PC- PC -3 PC-3/TxR 3/TxR) human prostate cancer 2503 xenografts were grown in mice 'coo • . Wittes • .,e 20:0 600 cee...rcaroma • Figure a- demonstrates that PC-3 E e a.. € 1503 calk ore inhibited by a 'axone E 600 • Idocetaxel) °. • Z 100 • : TKO • Figure b- indicates PC-3/NR are 2P O - e - -1 4/., f indeed resistant too taxone 100 i 2 303 Idocetaxel) o. .. 0 • 2 4 • • II 12 14 IS 16 16 0 . . . .•• 12 14 16 IS 20 • VERU-111 inhibited growth of taxane resistant human prostate cancer xenografts (3.3.6.7 mg/kg) I = VERU-I 11: PO- oral dosing: intravenous dosing: mpk- mg per kg Treatment flitiated when tumors reached 150-300 mms ' U Caa et d. otxnnR0689.70534363 2012 12 EFTA00810563 VERU-111 inhibits prostate cancer tumors resistant to novel androgen blocking (AB) agents with no effect on body weight (surrogate for toxicity) veru 22Rv1- human prostate cancer model' • Contains androgen receptor • Resistant to novel AB agents: variants including AR-V7 enzalutamide and obiroterone Efficacy (median tumor volume) Safety (% starting body weight rats) •••••••••••••• WM.MA Receb) 12226 12211 VERµ111 Say)* 12753 1251$ 00370 to P0) VERIA11120100 PO) 12412 124.33 02031 Dxsisca1 lOnvoltg II106 moo 0/133 011 DOIMAI teleateMUM ••••••••0010!OW ID ',WOW tell1011101•••••11P4.0415) . P'1101 SPNcelo0 ...WO .II )0•41141001 .Y•••0111111.I MAW* SOKKOt110•04*I PASCO obf000IS 2018 13 EFTA00810564  VERU-111 clinical development plan: Target castration and novel androgen blocking agent resistant metastatic prostate cancer veru First in class, next generation, novel oral agent that targets a and 13 subunits of tubulin nor. antiogon 604641.11441 ADT rt S ADT • novel A8 agent: enzatutornde or abiraterone 71:re VERU•111 reap/ ispptht aear000n bMWq OWN. ere0/04Ticin 0440144040.614 4pOlularlikle nog '401 P IF 4 Hormone sensitive Castration resistant Castration and novel androgen metastatic prostate metastatic prostate blocking agent resistant cancer cancer metastatic prostate cancer 14 EFTA00810565 VERU-111 clinical development: we expect open label clinical data Q1 2019 veru Successful pre-IND meeting with FDA 9/18 IND and Phase 1/2 expected calendar Q4 2018- Johns Hopkins Cancer Center (lead center) Men with metastatic castration resistant prostate cancer who have progressed on novel androaen blocking agent (either enzalutamide or abiraterone) and ± 1 taxane r‘ Phase 1 Phase 2 open label study 3+3 design Primary endpoint- PSA reduction N=15 N=26 castration and novel androgen blocking agent resistant metastatic prostate cancer Fix superscript. EFTA00810566  VERU-111 has potential to treat multiple indications in prostate cancer veru Indication 2- novel AS agent and taxane chemotherapy resistant mCRPC antioarnarerbedah reeler t ni t AD1 • neme MI 59~ t• enzalutarrkle or obioierone ataCeteeel cabcartwel VERU• Ill enZaklarrele CO ralenCee. Ondageteleeide --.—± t CO:nutan ten:tent rennet AD agent DOCetaXel (lanCetel latale rentlent trek.. ute ettneate ractent metcaolic tenGlant rneneelata mole:tale latettatn con[...• pratale Cancer POState <0.100‹ COPSE, Indication 3- Is fine mCRPC resistant to novel Al agents Indication 4- I* line hormone sensitive metastatic prostate cancer ee, MelplOsiS PM/ AD? • cpaeMridea ALIT plus 0~1 syvhol win IV Sniaulan'ide vERU-I I I VERU-I It ciccelaxel pus A011:24 IN 9 t a ADI dens, tionmelOstate costa:Mon Hanle,. %MOW* eneta•aliC enCRPC fe./%1Off IO pasta* cancer Mealtime (MO) with Noll RSA 00,9! AS 00enh ckobang time on ADI Seeenei NUM 2015 (0C1 10 10050*.loolS0)747) 16 EFTA00810567 VERU-111 has applications in multiple areas of oncology; strong IP veru 4 abstracts at ASCO 2018 Over 29 peer-reviewed publications VERU-I II HAD EFFICACY AGAINST THE FOLLOWING HUMAN CANCER XENOGRAFT MODELS • 22Rv1- human metastatic prostate cancer line resistant to enzalutamide and abiraterone 7 issued composition of matter patents • Triple negative breast cancer Including U.S. 9029408, EU 2959900 and • Ovarian cancer Japan 5507552 • Pancreatic cancer • U.S. potent expiry 2029 with possible extension to 2034 and 63 foreign granted or pending patents • Polymorphs identified to extend time for composition of matter coverage EFTA00810568 VERU-111 market opportunity veru VERU-111, like current antitubulins, Current market for advanced may have efficacy against broad prostate cancer drugs cancer types • $5 billion market for secondary novel androgen • VINCA ALKALOIDS: VELBAN (VINBLASTINE): blocking agents for prostate cancer' ONCOVIN (VINCRIST1NE): NAVELBINE (VINORELBINE) Prirricrily used in combination • $4.8 billion market for anlitubulins such as vino chemotherapy (ABVD. Stonford-V, CHOP. MOPP) For alkaloids & taxans Idocetaxel $1 baron ond hematologic malignancies (leukemia. tympharna, caborilaxel $500 ~on in prostate cancer) and myeloma). and neuroblastoma. thyroid cancer, sarcoma ond non smal cell lung cancer • VERU-I I I potential global market greater than $5 billion for prostate and other cancer types • TAXANES: TAXOL (PACLITAXEL); TAXOTERE (DOCETAXEL): JEVTANA (CABA/ITAXEL): ABRAXANE (PROTEIN BOUND PACLITAXEL) ~only used for said tumors such as breast, ovarian. endometriol. cervical. lung. head and neck, esophageal. bladder. gastric. and prostate ~me krellgen:e I nips 'Haw the rAo:toTecercer matte:vet cner.ae over nod decode' ar Kevn Gregon EFTA00810569  19 EFTA00810570 Urology specialty pharmaceuticals: NDAs for 3 drug products to be submitted 2019 veru Product Indication Formulation and Market Status advantages Tamsulosin XR BPH 0.4 mg Stow release 2017 US market- Final bioequivolence capsules and granules with no food 28,341A04 scripts study will be granules Branded- Flomax effect completed 2018 Long term core- Sprinkles for dysphagia 3.126.003 scripts NDA 2019 Compliance & safely Tadalafil-finasteride BPH- enlarged Combination tablet Bioequivolence combination tablet prostate containing 5 mg tadolafil study will be Erectile and 5 mg finasteede Estimated US $150 completed 2018 dysfunction Convenience and NDA 2019 Brand- Compliance Cioks/Proscar Solifenacin DRG Overactive Sprinkles for dysphagia Long term core Bic-equivalence granules bladder study 2018/2019 Estimated US $150 Brand- Vesicore NDA 2019/2020 EFTA00810571 Commercial Product 21 EFTA00810572  FC2 Female Condoms business profitable from FY 2006- 2017' veru FC2 Female Condom only FDA approved female use product that protects against pregnancy & STDs • Sold in U.S. and 149 countries ) and • Manufacturing plant with 100 noon units annual capacity nd • Public sector represents approx. 90% of revenue (customers include UNFPA, USAID. Brazil, and South Africa( • FC2 business profitable from FY 2006-FY 2017' Global public sector revenues Building US prescription business for high margin revenue • Base revenue $14 million in FY 2017 • Working with Cardinal Distribution. Amerisource Bergen, McKesson. • Awarded South African tender and Anda to support broad FC2 8/18 - should add $10.4 miEion in pharmacy avaiability revenue/year for approx. $31 million over 3 yeas • Prescription business is growing 'Forli:colvCa12wolnougt,lmcci yea 7316. prolloOlty is =eel on Vents rot income ottne,itoble to common Ilocknotder. Foe It col yaw 2017.11101n' rscol wof .11Chintle0e$ me l'nonCol, 09" Of Aspen Nut PhoirroCeol;Oci,. peonl0taily 6 boyecj on opero+ro inccrne 'tom ON COmmerC101 Wren!. 22 EFTA00810573  10 Financial highlights (in millions) Capitalization approximately 54.7 million' common shares outstanding as of June 30, 2018 Balance sheet as of June 30, 2018 • Cosh and receivables $9.2 • UK NOL carryforward $62.2 • US NOL carryforwarcl $10.5 $10 million received In March 2018 under SWK Holdings synthetic royalty financing on FC2 Female Condom" product sales Results of operations for the nine months ended June 30. 2018 • Net revenues $10.7 • Gross ptotil $ 5.6 • Operating loss $17.1 Results of operations for the year ended September 30, 2017 • Net revenues $13.7 • Gross atoll, $7.0 • Operating loss $8.5 Adittos.4 440onts reelscOef elett4 setts estl Wren,. awe outtesArtt are are, or wail rct +'airy be seedwclly ensue et 'Inn 54 test Pen oyerron oNa.o. aSoto I Soo 'ettet Ito, SEC clocuteos14 S:e acIatcPal rtcrrnati:n 23 EFTA00810574 Veru projected development milestones veru PRODUCT INDICATION 2018 2019 2020 PROSTATE CANCER NOVEL MEDICINES Hot flashes caused by ND Zuclomlphene P2 1 prostate cancer IND P. capsules hormone therapy VERU-111 (bisindole) Metastatic prostate P3 PlID/P2 capsules cancer UROLOGY SPECIALTY PHARMACEUTICALS Tamsulosin XR NDA.. PoR approval 'clef), Rudy BPH without food granules 8. capsules effect US launch Tadalafil-lina steride BPH and erectile NDA US launch combo tablets dysfunction Solifenacin DRG Overactive bladder in US launch granules patients with dysphagia 24 EFTA00810575