EFTA00810552

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 s101eMenn nekt». bul ote n3Y briter:110: raf reelked SO tre Cltrekenu3n101 Verv 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* procbc1 rntroduchons: the ilsk In sale: bong oflocted by ropulakey dembpments. 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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 an imanaknoi levet 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. 01 Ploorron. Mcludinp prOduCI lobihy «ans: Ond OlheirdskS Cle102M1 b 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 dom na 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'ch Mb 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 Capsules VERU• I 1 (13 nclole) Capsules Hot flashes caused by prostate cancer hormone treatment Metastatic prostate cancer Non steroidal estrogen agonist Oral, targeted a • $ htbulin inhibitor EI:112== UROLOGY SPECIALTY PHARMACEUTICALS Tomsulosin DRS granules 8 XR capsules (tamsulosin HCI) Todolafli-finasteride combo tablets (5mg todalafli /5mg linasteilde) Soldenacln DRG (solltenacln granules oral suspension) BPH (no food effect) IIPH a erectile dysfunction Overactive bladder Super selective a- receptor blacker with no food effect PDS • So reductose inhibitors Selective M3 muscarinic antagonist CS2=322aa 3 EFTA00810554 Experienced in clinical practice, drug development and commercialization vett Mitchell Steiner, MD CHAIRMAN, PRESIDENT & CEO CEO & President Aspen Pork Pharmaceuticals. President of Urology at OPKO Health. Inc.: CEO & Founder Cir. Inc.: urologist Michele Greco, CPA CHIEF FINANCIAL & ADMINISTRATIVE OFFICER CFO/EVP the Female Health Company. 28 years with Frost & Young, 15 yeas as an Audit Partner Kevin Gilbert, JD, CPA EVP CORPORATE DEVELOPMENT Corporate Development & Legal Third Stream Bioscience. Attorney at McDermott. Will & Emery, Motorola. dosed more that 100 transactions in 25 countries Gary Barnette, PhD CHIEF SCIENTIFIC OFFICER Sr. VP Scientific and Reg Affairs Camorgo Phcrm. Services. VP Cfnical & Reg and Founder GTx, Inc., Director Reg Affairs Solvay Phormo. Clinical Pharmacology! Biopharmoceutics Reviewer FDA. PhD Basic Pharmaceutical Sciences west Virgin° University Philip Greenberg, JD EVP LEGAL General Counsel Latin Arnenca Teva Pharmaceuticals with prior senior legal positions in international and North America divisions; Deputy General Counsel for VAX Corporation Harry Fisch, MD CHIEF CORPORATE OFFICER Chairman Aspen Park Pharmaceuticals and Millennium Sciences. Inc.: urologist Phil Kuhn, MBA EVP STRATEGY AND COMMERCIALIZATION Global Strategy and Commercial expertise in medical devces. aognostics. and biologics: leadership roles at ISTO Biologics, 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 Hot flashes are one of the most common and debilitating side effect of androgen deprivation therapy (ADT) for advanced prostate cancerl•2 • Occurs in up to 80% of men treated with ADT (leuprolide or degarelix) with 30-40% having moderate to severe hot flashes'-3 • Symptoms do not subside over time • 44% of men of S yews and 40% of men of 8 yeas slit suffer from hot floshes2 • Concern over hot flashes make patients less likely to begin ADT and can lead to early discontinuation2A veru Zuclomiphene (aka cis-clomiphene) is an oral estrogenic agent" • Isolated cis-clomiphene from CLOMID (30% cis- and 70% trans-clomiphene; approved in 1967 for female infertility( • Efficacy established for estrogens: off- label steroidal estrogens are effective but have safety concerns" • FDA database and scientific literature show cis-clomiphene component of CLOMID is well tolerated with over 88,000 men/years using CLOMID off label for infertility or hypogonadism 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' It1 el 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 1 Supped OrCei 426.3.2732C431.,COmeree Plume Clekof Report 3/ 17 axl FDA SdeiroDoCurnenl BRUDAC AcNiscee rneerg 17/16 EFTA00810557 Zuclomiphene clinical development plan: Phase 2 trial design IND accepted 7/18 Phase 2 placebo controlled dose finding study First subject expected in 9/18 & final data expected 1H 2019 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%' • Secondary endpoints- bone turnover markers a veru Lopinzi el o12009. Annals of Oncology p1 .8 ICOLI0.I093/annenc/mcfn644 :Table 21 0 mg Primary endpoint Primary endpoint 4 weeks 12 weeks 7 EFTA00810558 Zuclomiphene: greater than $600 million/year expected market 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 veru Scher et cr. PtoS ONE 2015 101-12 (DOI:10.1371(rotmeloone013Pee0 I r Rd to:oleo ocoinike boon on XX of 400000 men io US on AD1 have 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 ol art Treat Opica:Oncci 16:9 2015 9 EFTA00810560 VERU-111: novel, oral, next generation, tubulin inhibitor targeting a and p subunits of microtubuies Precllnical Product profilel-3 • low nanomolar inhibition of tubulin polymerization • 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 MICROTUBULE veru Chen J el al. J Med Chem 55:7285-7289 2012 I1 Li 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 VERU-111 (Crossilnks a and (1 subunits and Inhibits polymerization) control "spindle shape" Microtubules (red) disrupted from spindle to globular shape VERU-111 "globular shape" Triple negative human breast cancer xenograft (MDA-M8-231)i ',unmet, ASCO abstrach 2018 ct profile 11 EFTA00810562 VERU-111 inhibits growth of taxane-resistant prostate cancer' PC-3 2503 'coo • • .,e 20:0 600 E e E 600 • € 1503 °. • • Z : TKO 2P 100 i O - e - -1/4., f 2 303 100 o. .. 0 • 2 4 • • II 12 14 IS 16 16 PC-3/TxR . Wittes cee...rcaroma a.. 0 . . . .•• 12 14 16 IS 20 I = VERU-I 11: PO- oral dosing: intravenous dosing: mpk- mg per kg Treatment flitiated when tumors reached 150-300 mms veru • PC-3 and taxane-resistant PC-3 (PC- 3/TxR) human prostate cancer xenografts were grown in mice • Figure a- demonstrates that PC-3 calk ore inhibited by a 'axone Idocetaxel) • Figure b- indicates PC-3/NR are indeed resistant too taxone Idocetaxel) • VERU-111 inhibited growth of taxane resistant human prostate cancer xenografts (3.3.6.7 mg/kg) ' U Caa et d. otxnn R0689.70534363 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) •••••••••••••• WM. MA to .P'1101 PASCO obf000IS 2018 SPNcelo0 ...WO .II )0•41141001 .Y•••0111111. I MAW* SOKKOt110•04*I Safety (% starting body weight rats) Receb) 12226 12211 VERµ111 Say)* 12753 1251$ 00370 P0) VERIA11120100 12412 124.33 02031 PO) Dxsisca1 lOnvoltg II106 moo 0/133 011 DOIMAI teleate MUM ••••••••0010! OW ID ',WOW tell1011101•••••11P4.0415) 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 nog ADT P Hormone sensitive metastatic prostate cancer S rt '401 ADT • novel A8 agent: enzatutornde or abiraterone re71: VERU•111 IF 4 Castration resistant Castration and novel androgen metastatic prostate blocking agent resistant cancer metastatic prostate cancer nor. antiogon 604641.11441 reap/ ispptht aear000n bMWq OWN. ere0/04Ticin 0440144040.614 4 pOlularlikle 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 3+3 design Phase 2 open label study 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 t • Indication 2- novel AS agent and taxane chemotherapy resistant mCRPC AD1 • enzalutarrkle or obioierone t t ataCeteeel ni t cabcartwel VERU• Ill --.—± veru antioarnarerbedah reeler neme MI 59~ enZaklarrele CO ralenCee. Ondageteleeide 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 AD? • cpaeMridea Sniaulan'ide tionmelOstate costa:Mon Mealtime (MO) with Noll RSA ckobang time on ADI ee, MelplOsiS PM/ vERU-I I I enCRPC fe./%1Off IO 00,9! AS 00enh ALIT plus VERU-I It 0~1 syvhol win IV ciccelaxel pus A011:24 IN 9 t a ADI dens, Hanle,. %MOW* eneta•aliC pasta* cancer Seeenei NUM 2015 (0C1 10 10050*.loolS0)747) 16 EFTA00810567 VERU-111 has applications in multiple areas of oncology; strong IP 4 abstracts at ASCO 2018 VERU-I II HAD EFFICACY AGAINST THE FOLLOWING HUMAN CANCER XENOGRAFT MODELS • 22Rv1- human metastatic prostate cancer line resistant to enzalutamide and abiraterone • Triple negative breast cancer • Ovarian cancer • Pancreatic cancer veru Over 29 peer-reviewed publications 7 issued composition of matter patents Including U.S. 9029408, EU 2959900 and Japan 5507552 • 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 Current market for advanced prostate cancer drugs • $5 billion market for secondary novel androgen blocking agents for prostate cancer' • $4.8 billion market for anlitubulins such as vino alkaloids & taxans Idocetaxel $1 baron ond caborilaxel $500 ~on in prostate cancer) • VERU-I I I potential global market greater than $5 billion for prostate and other cancer types veru VERU-111, like current antitubulins, may have efficacy against broad cancer types • VINCA ALKALOIDS: VELBAN (VINBLASTINE): ONCOVIN (VINCRIST1NE): NAVELBINE (VINORELBINE) Prirricrily used in combination chemotherapy (ABVD. Stonford-V, CHOP. MOPP) For hematologic malignancies (leukemia. tympharna, and myeloma). and neuroblastoma. thyroid cancer, sarcoma ond non smal cell lung cancer • 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 Product veru Indication Formulation and advantages Market Status 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 ) and nd FC2 Female Condoms business profitable from FY 2006- 2017' FC2 Female Condom only FDA approved female use product that protects against pregnancy & STDs • Sold in U.S. and 149 countries • Manufacturing plant with 100 noon units annual capacity • 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 • Base revenue $14 million in FY 2017 • Awarded South African tender 8/18 - should add $10.4 miEion in revenue/year for approx. $31 million over 3 yeas veru Building US prescription business for high margin revenue • Working with Cardinal Distribution. Amerisource Bergen, McKesson. and Anda to support broad FC2 pharmacy avaiability • Prescription business is growing 'Forli:colvCa12wolnougt,lmcci yea 7316. prolloOlty is =eel on Vents rot income ottne,itoble to common Ilocknotder. Foe It col yaw 2017.11101n' rscol wof .11Chintle0e$ me l'nonCol,09" Of Aspen Nut PhoirroCeol;Oci,. peonl0taily 6 boyecj on opero+ro inccrne 'tom ON COmmerC101 Wren!. 22 EFTA00810573 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 10 23 EFTA00810574 Veru projected development milestones veru PRODUCT INDICATION 2018 2019 2020 PROSTATE CANCER NOVEL MEDICINES Zuclomlphene capsules VERU-111 (bisindole) capsules UROLOGY SPECIALTY Tamsulosin XR granules 8. capsules Tadalafil-lina steride combo tablets Solifenacin DRG granules Hot flashes caused by prostate cancer hormone therapy Metastatic prostate cancer PHARMACEUTICALS BPH without food effect BPH and erectile dysfunction Overactive bladder in patients with dysphagia IND P2 1 P. PlID/P2 NDA.. ND P3 PoR approval 'clef), Rudy US launch NDA US launch US launch 24 EFTA00810575